Sinéad Murphy

On 6th November, Dublin launched its Autism Friendly City plan in a bid to become the world’s most autism friendly capital city.

‘It’s a really exciting day,’ Dublin’s Lord Mayor said. ‘I do hope where Dublin leads, the rest of the country can follow also because it’s so, so important that we are inclusive and, at the moment, we still have a long way to go.’

Sixteen years ago, the French collective The Invisible Committee predicted that imperial expansion in the twenty-first century would rely on bringing into the fold those previously on the edges of Western societies: women, children and minorities.

‘Consumer society,’ they wrote, ‘now seeks out its best supporters from among the marginalized elements of traditional society.’

The Invisible Committee summarized this latest phase of empire as ‘YoungGirl-ism’ – the strategic championing of young people, of women and of those disadvantaged by disability, illness, or ethnicity.

Though the aim of YoungGirl-ism is to bring the general population under a new kind of control, societies’ focus on cherishing previously marginal cohorts has the look of emancipation and progress. For this reason, The Invisible Committee explained, women, children and minorities ‘find themselves raised to the rank of ideal regulators of the integration of the Imperial citizenry.’

If the theory of the YoungGirl was unsettling at the time of its publication, its prescience is now borne out, as versions of the mechanism it describes dominate the societal breakdown that is the objective of government policies worldwide.

YoungGirl-ism has too many aspects to summarize here. Let it suffice to suggest the following:

• That the drive to nurture our children continues to license a level of surveillance of people and censorship of the materials to which they have access that ought to be anathema in any society purporting to be free, and that the messaging of the general population by government, corporations and legacy media has become so simplistic as to constitute a widespread infantilization.
• That the rage to acknowledge and be sensitive to women’s experiences supports the ongoing emotionalizing of work and of public debate and increases institutional control over human reproduction.
• That centralised solicitousness for those characterised as ‘vulnerable’ has excused a degree of micro-management of our lives hitherto unimaginable and is the ongoing rationale for biochemical interference with the healthy population including children and the unborn.
• And that the promotion of all forms of sexual expression and identification has robbed us of our most fundamental designators, making us a stranger in our mother tongue which regularly denounces us as bigots.

The Invisible Committee proposed their theory of the YoungGirl as what they called ‘a vision machine.’ There is no doubt that familiarity with its structure sheds much light on what might otherwise pass as disparate and well-meaning social and political enterprises.

Not least of these enterprises is Dublin’s new initiative to become the world’s most autism friendly capital city. Its programme of ‘inclusivity’ is YoungGirl-ism by another term, rolled out by a provincial official with neither the will nor the wit to understand the havoc he wreaks, his head turned by a cheaply bought appearance of virtue.

More than this, the growing concern to be inclusive of those with autism may be YoungGirl-ism in its most intense form, the condition of autism being peculiarly fitted to the dismantling of existing ways of life and submission to newly-invented social strategies that form the basis of the expansion of a new world order.

*

My son is autistic. My remarks here are made in the context of personal experience of autism and sympathy with those whose lives have been changed by the condition.

Firstly, let it be said that autism is a misfortune, not the less so for its often unfolding gradually in a young child, its profound diminution of life’s hopes and joys manifesting over time as an irresistible fate, slowly but surely eroding the energy and engagement of those who live with it.

This requires to be said because there is a vague consensus abroad that autism is not a misfortune – that it is just a different way of seeing things and doing things, even a better and truer way.

The language of ‘neurodiversity’ is partly responsible for this misapprehension, feeding the sentiment that it is only a matter of being more open to autism, of re-educating ourselves and reorganising our society.

But the misapprehension is also bolstered by the widespread and increasing institutional practice of giving a diagnosis of Autism Spectrum Disorder to those whose connection with autism is tangential, consisting in being a little inattentive, or somewhat solitary, or otherwise troubled in some way.

We are presented with celebrities who have received a retrospective diagnosis of autism, and we conclude that it is possible in a properly inclusive milieux to live a normal life, even an abnormally successful life, with the condition.

This conclusion is pernicious for all of those who suffer from what we are reduced to describing as ‘profound autism,’ ‘severe autism,’ even ‘real autism,’ whose alarming increase ironically is hidden by the ease with which the label is wielded among the general population.

A 2019 study at the University of Montreal, which reviewed a series of meta-analyses of patterns of diagnosis of autism, concluded that in less than ten years it will be statistically impossible to identify those in the population who merit the diagnosis of autism and those who do not.

As the descriptive force of ‘autism’ is eroded and the fiction put abroad that our main task is only to be inclusive of the condition, what is more and more concealed is the outrage of the rising prevalence of real autism among our children, the steady growth in the numbers of children whose life prospects are blighted by the condition, children who have little to no hope of being ‘included’ and whose being made the excuse for strategies of ‘inclusion’ is a travesty, children like my son who will never find gainful employment, never live independently, most likely never make a friend.

Autism is not a difference. Autism is a disability. It describes – and ought to be reserved to describe – a lack of capacity for meaningful experience of the world and those in it, condemning its sufferers to a life more or less bereft of significance and sympathy.

Autism may come with corners of aptitude, which we may like to call brilliance. But the reality is that these instances of aptitude are mostly remarkable because they occur in the context of blanket inaptitude, and at any rate that we no longer live in a society in which such uneven excellence is valued or can find an outlet.

My son can quickly add together any two of the same numbers, even very large ones, though he cannot do simple addition. The talent is mysterious and striking, but it occurs in the context of a general lack of ability at maths and, even if developed, would have no use in a world where computer calculation is ubiquitous and where a base level of skills is required to access any form of employment.

And yet the myth is perpetuated, that autism is a problem primarily because we are not inclusive of it.

In March 2022, The Irish Times published an article citing a report produced by Ireland’s national autism charity AsIAm, chiding its readers because 6 in 10 Irish people were found to ‘associate autism with negative characteristics.’

Rather than take this reasonable majority of the populace seriously, the article proceeded to support the view that Ireland requires enhanced policies and programmes to educate the general population that autism is in fact something between a talent and a blessing and to increase access of those with autism to all of life’s opportunities.

The negative characteristics that 6 in 10 Irish people associated with autism included ‘difficulty making friends,’ ‘not making eye contact,’ and ‘no to little verbal communication.’ This was reported in The Irish Times article as regrettable prejudice against those with autism, even though these characteristics are classic symptoms of autism and often the reason that autistic children are given the diagnosis. The Irish Times may as well have blamed the still-thinking Irish public for associating autism with autism.

The article went on to observe that the AsIAm report found that ‘people were less likely to know about the positive characteristics of autism, such as honesty, logical thinking and detail oriented [sic]’.

To describe these characteristics of autism as positive is to actively efface the reality of autism as a disability, obscuring the profound inability to attend to and understand context that is the condition of autistics’ honesty, logical thinking and attention to detail.

My son reminds me to serve him his morning tonic if I forget to do it, though he hates to drink it. This is surely endearing, but it stems from a total inability to identify his own interests, to act in accordance with them or to be strategic in any way. What we call honesty is admirable because it occurs in the context of possible dishonesty. My son is not capable of dishonesty or honesty.

Similarly, if autistic people are logical, it is likely because they have little or no understanding of context or nuance; without the ability to interpret or exercise judgement, everything is reduced to a matter of simple deduction or induction. And if autistic people are detail oriented, it is probably because they are unable to grasp any big picture; they are attuned to minutiae because they cannot be enchanted by the world.

Living with autism has its joys; the human spirit ekes energy and interest from all kinds of calamity and takes its pleasures even if sadly. But make no mistake: autism is a blight; the rise of autism, a tragedy.

*

In March 2020, NHS GPs in Somerset, Brighton and South Wales placed blanket Do Not Resuscitate orders on several support settings for those with intellectual disabilities, including one for autistic adults of working age.

Despite acknowledged objections at the time, during the second UK shutdown similar DNR orders were placed on similar settings.
For anyone who cares for a child with autism and who faces the unhappy prospect of her child being consigned to the state once she herself is infirm or deceased, little more requires to be said about the commitment to real inclusion of those state institutions that like to bandy the term.

Meanwhile, the frenzy of so-called ‘inclusion’ continues apace, and with an entirely other rationale than that of promoting health and happiness.

Quite the opposite. So-called ‘inclusion’ of those with autism is aimed at the breakdown of what remains of our shared world all the better to reconstruct it in accordance with the pursuit of hyper-control.

Children with autism are not worlded – above all else, that is what defines their situation. For whatever reason, the world – our world – does not speak to them. They are not carried along by the projects around them; they are not captivated by the scenes before them; they are slow even to discern the outline of another living being, often colliding with people and hardly ever hearing what they say.

Autistic children do not share our world. It is not only that they do not understand it – they appear not even to notice it.

So, what happens to a city when it commits to the inclusion of those whose situation is defined by exclusion? Anyone who spends their life in efforts at such inclusion knows very well what happens.

Because our world is not salient to young people with autism, the task for those who care for them is somehow to make our world salient, so that every event is not a shock, every arrival not a setback, every departure not a reversal, every meeting not an assault.

The task is a heavy one, requiring that you ceaselessly intercede between the world and your child so as to bring the world’s most vital aspects into a stark enough relief to break through autistic indifference.

On the one hand, you are a drill sergeant, reordering the world so that some of its patterns are made stable, relentlessly establishing and maintaining routines whose finest detail cannot be allowed to alter without meltdown. A door left ajar, a word carelessly spoken, a glove dropped, a Lego brick lost: grinding trivia are assiduously marshalled under threat of the kind of prolonged and impenetrable distress as will break your heart and theirs.

On the other hand – curious combination – you are a children’s TV presenter, advertising the highly-regulated scenes and scenarios produced by the drill sergeant with the most exaggerated facial expressions, the most simple and carefully articulated phrases, with pictures and signs, with the primary-coloured repetitiveness that is your only hope of selling the hyperbolic version of the world you have constructed.

Certainly, there is some success to be had through these means, though it is slow and halting. Also certainly, the need for such unrelenting efforts would be greatly relieved if our world were a more compatible one.

Children with autism – all children, no doubt – would be infinitely better off if they were surrounded by a stable cohort of familiar people; if the projects that supported them were grass roots; if their food came from the soil and their learning from routine; and if the rise and fall of season and festival were the rhythm by which they lived. Nothing would mitigate the effects of autism better than a fulsome way of life.

As it is, our world is almost the opposite of a way of life: precariousness carries the day, virtuality abounds, the human touch is reduced and anonymous, and what we eat and learn, highly processed and abstract.

Because of this, your efforts to get the attention of your child with autism cannot be suspended for a moment without threat of regression and despair, as you strive to bring our flattened-out, screened-off world up close enough and personal enough for the dawning of significance and sympathy.

And one thing is sure: only you can do it. You, who live by your child daily, who walk beside him with an arm ready to steer, who know just the hold to use to prevent destruction while allowing a modicum of self-determination, who wait just the right amount of time to let a thought reveal itself but not so long that it is lost in the mire. You, who rub along together with your child. You, who know him by heart.

Schools cannot do it, though they spend enough time describing it and documenting it and continue to relinquish their role of teaching children to read and write in their enthusiasm for recording the inventiveness of their inclusion strategies.

And – needless to say – cities cannot do it.

What, then, of the Autism Friendly City? What can it do, if it cannot include those with autism?

If we allow our energies and understanding to be directed at finding solutions to the apparently failing strategies of our Autism Friendly City, what we will miss is how successful its strategies really are – not at including those with autism, of course, which is an impossible task for our cities, but at controlling the rest of the population.

Something that is rarely mentioned and never broadcast is that the effect of your efforts at including your child with autism is that you yourself become excluded. As you translate the most important worldly possibilities into contrived routines with accompanying signals and slogans, the hold upon you of those possibilities is loosened. All that ought to be organic is programmed; all that should be spontaneous is controlled; all that is background recedes or is brought into too-brilliant relief; nothing is taken for granted; nothing relied upon as given.

As you strain to make the world of interest to your child, the world loses its interest for you. You become, well, like someone with autism.

Relationship breakdown is rife where there is a child with autism; some studies estimate that it runs at about 80 percent. No surprise, as shared experience is eroded by the requirement to reorder the world, to stay on message, and to start from zero a thousand times a day. Autism-for-two is no kind of companionship.

But what of autism-for-all, which is the inevitable effect of the Autism Friendly City? How might that play out, and what would its uses be in bringing the population under control?

Luckily in this regard, we have living proof of what the Autism Friendly City would look like. During Covid, quite startling strategies were implemented to seize the routines of human life, to regulate them artificially and promote them with simplistic messaging.

The Covid queue is an easy example, as an implicit human arrangement was taken hold of, made painfully explicit, administered beyond endurance and promoted as for nursery children. Large, coloured dots were stuck two metres apart to pavements outside of supermarkets, sometimes with cartoon feet depicted on them. Signs were posted showing two stick-men with an arrow between them and 2M printed on top.

Gone was the human queue, the rules for its formation embedded in a shared world, relying upon and testimony to the civilized self-regulation of a reasonable people, modified in ad hoc ways by everyone who joins it to give priority to those who cannot stand easily or who appear hurried, the occasion for chat on common subjects and assistance of those with a heavy load, shuffling along effortlessly in accordance with the knowledge inscribed in our bodies’ latent awareness of the proximity of those around.

Gone was one small performance of a shared world. In its place: a hyper-regulated routine, monitored by trumped-up officials, with no requirement for the exercise of judgement and every best impulse remade as a threat to order.

The Autism Friendly City would be the Covid queue writ large – seizing upon our human rituals, dismantling their organic reciprocity, undoing their taken-for-granted equilibrium, and remaking them without the human element in primary coloured inertia and infantile slogans. The mutual experience of formation in and by a shared world, rendered null and void by an artificially constructed submission to hyperbolic routines and their garish promotion.

It is true that children with autism are not easily attuned to the human queue, lacking receptiveness to the implicit judgements that order it, being largely unaware of the presence of other people before them or behind them, and, most of all, not being prone to waiting. You must keep a firm hold of them for many years before they get a feel for the human queue. But it is good formation for them, a chance to be in sync with those about them, to share in a worldly routine, and to realise – oh so slowly – that they must stand and wait and move and wait in concert with others around.

But children with autism have no chance at all of joining the autism-friendly queue, which lacks the physical scaffolding of nearby bodies and the purposeful hum of voices. They will not appeal to the coloured dots on the pavement with their abstract depictions of feet because they will not be looking for guidance on queue formation. They will not consult the signs with the stick men because they will not be seeking assistance with queue formation.

The autism-friendly queue only works for those who already wish to form a queue – who are already part of the world but suddenly unsure about the rules that apply there. For those who are not already part of the world, nothing could be less effective than the autism-friendly queue. Nothing could be less inclusive.

The Autism Friendly City would mean little to those with autism. It would mean control to everyone else. For, the Autism Friendly City is blatant YoungGirl-ism, cynically championing the disadvantaged in order to replace the humanness of our shared world a with top-down deadness overlain with primary colours and Tannoy infantilism.

Let us not forget the dystopia of the Covid queue. The hush where there had been hum. The inert progress, nervous and accusatory.

Let us not forget that as we inched forwards like automata, self-conscious and humiliated, we gradually ceased to make eye contact with our fellows, engaged in little to no verbal interaction and found it increasingly difficult to make a friend – those very characteristics that 6 in 10 Irish people associate with autism.

Beware the Autism Friendly City, which delivers autism for all.

Sinéad Murphy is author of Effective History (2010), The Art Kettle (2012), and Zombie University (2017), and co-editor of Pandemic Response and the Cost of Lockdowns (2022).

This is a third talk in a series that began with Relationship Based Medicine , continued with Beware of Doctors Bearing Gifts and concludes with this talk, which could called History of a Medical Psychosis, Medical Neoliberalism, Evident versus Evidence Based Medicine, A Lutheran Moment, or Does Objectivity Come from using Chance to Control Bias or Bias to Control Chance?

It is the most important talk I have ever given.

The first lecture was delivered to clinicians in New York with a Q and A afterwards.

The second was delivered to the public in Lethbridge Alberta, thanks to Jennifer Williams and Dan Johnson but owing to tech difficulties at the venue (See In Memory of Dexter Johnson), it was difficult to record the Q and A with the public. Suffice to say though between the technical difficuties, the lecture and the Q and A, we were all there for the better part of 3 hours and the discussion was great.

This third lecture was delivered to Aaron Kesselheim’s PORTAL group – Program on Regulation, Therapeutics and Law. There are two versions. The History of a Medical Psychosis was recorded by Bill James the day before in case of glitches – same day as Putin and Biden gave speeches. The second was recorded by Aaron – Faulty Evidence and Moral Hazard.

There are slight differences between them. The text and slides below add some detail to both talks but the tone of voice and gestures in the talks likely convey things not in the text.

Slide 1: Faulty Evidence and Moral Hazard

Welcome to a very conservative talk – based on a belief in the medical model and in evaluating the drugs we use thoroughly.

Slide 2: These quotes are a precis of key points in the deposition of Ian Hudson, Chief Safety Officer of GlaxoSmithKline (GSK) in 2000 in the Tobin v SmithKline trial.

Forty-Eight hours after starting Paxil Don Schell shot his wife, daughter and granddaughter and then himself. Hudson is being asked – Can SSRIs cause Suicide?

The jury dismissed Hudson’s Evidence Based Medicine view in favor of Evident Based Medicine and in this Civil trial found GSK guilty of negligence that resulted in the death of this family.

Hudson’s view, however, remains ensconced at the top of Britain’s drugs regulator, of which he was later the CEO – as well as FDA, EMA, TGA, Health Canada, WHO, and Boston institutions like Harvard, MRCT, and Vivli. Joe Biden and the Pope’s advisers will also endorse and tell their bosses to say – Yes RCTs are the Way the Truth and the Light.

Slide 3: Hudson’s views originate 70 years earlier in the work of a strange man – Ronnie Fisher.

Here you see Fisher smoking a pipe. He dismissed the later link between smoking and lung cancer, saying personality types predisposed to both cancer and smoking. Evidence was not Fisher’s strong point.

He had nothing to do with medicine and never ran an RCT. Controlled trials and randomization were there before Fisher and were no big deal but for no clear reason his book the Design of Experiments transformed what came next.

Fisher ran a thought experiment to characterize expert knowledge. He mentioned randomization as a means to control for any trivial unknown unknowns. Randomization later became semi-mystical.

Fisher’s expert knew parachutes worked so if we set up two groups, one with parachutes and the other not, we might randomize in case there was someone with webbed feet who might behave differently when falling. Otherwise, we would expect those wearing parachutes to live and those not to die – unless a chance strong wind lands a person in snow covered trees.

If randomization eliminated webbing as a factor, the only thing that could get in the way of an expert being right was chance and this could be assigned a statistically significant value. If 1 in 20 of those without parachutes lived we wouldn’t say the expert didn’t know what he was talking about. Fisher was characterizing expertise rather than characterizing an exploration of the unknown.

Randomization can’t control for ignorance.

Slide 4: Fisher’s expert is a Robin Hood who 19 times out of 20 can split a prior arrow lodged in the Bull.

Slide 5: But the trials done to license drugs especially antidepressants look more like this. A mismatch on this scale indicates medical RCTs are nothing like what Fisher had in mind.

Slide 6: The first RCT in medicine was a trial of streptomycin for tuberculosis. Tony Hill used randomization as a method of fair allocation – he was not managing mystical confounders. Hill helped put the effects of smoking on the map. He had no time for Fisher. He also knew doctors were not experts. His trial was not a demonstration of expertise.

Hill’s RCT found out less about streptomycin than a prior non-randomized trial in the Mayo Clinic, which showed it can cause deafness and tolerance develops rapidly.

Slide 7: Twenty years later, here is Tony Hill taking stock of controlled trials. In this 1965 lecture, he mentions that it is interesting that the people who are most heavily now promoting controlled trials are pharmaceutical companies.

Hill didn’t think trials had to be randomized. He thought double-blinds could get in the way of doctors evaluating a drug. He was a believer in Evident Based rather than Evidence Based Medicine.

Hill said we needed RCTs around 1950 to work out if anything worked. By 1960 he figured we had lots of things that worked – none of which had been brought on the market through an RCT – and he thought the need was to find out which drug worked best. This is not something RCTs can do – there is no such thing as a best drug. RCTs have instead become a way for companies to get weaker drugs on the market.

He said that RCTs produce average effects which are not much good in telling a doctor what to do for the patient in front of them.

All drugs do 3000 + things – one of which might be useful for treatment purposes. In focusing on one element, by default, Hill is saying RCTs are not a good way to evaluate a drug. All RCTs generate ignorance. But we can bring good out of this harm if we remain on top of what we are doing. Hill never saw RCTs replacing clinical judgement.

Slide 8: This 1960 RCT run by Louis Lasagna makes Hill’s point well. Thalidomide has therapeutic efficacy as a sleeping pill but the trial missed the SSRI-like sexual dysfunction, suicidality, agitation, nausea and peripheral neuropathy it causes.

Two years later, Lasagna was responsible for incorporating RCTs in the 1962 Food and Drugs Act Amendments – in order to minimise the chance of another thalidomide. By doing this, more than anyone else, Lasagna was the man who got us using RCTs

This trial would have licensed thalidomide today. The 1938 Act had no requirement for RCTs.

Slide 9: Many claim RCTs demonstrate cause and effect in a way no other study design can.

The 1950s was a golden age of new drugs that gave us the best antihypertensives, hypoglycemics, antibiotics and psychotropic drugs we have ever had without RCT input into any discoveries.

Imipramine was the first antidepressant. It and other antidepressants beat SSRIs in later RCTs. It can treat melancholia – SSRIs can’t. Melancholia comes with a high risk of suicide.

Imipramine was launched in 1958. At a meeting in 1959, European experts made clear that while it was a wonderful treatment imipramine made some people suicidal. Stop the drug and it clears. Re-introduce and it comes back. This was Evident Based Medicine showing this drug can cause suicide.

Like Fisher, let’s do a thought RCT of imipramine versus placebo in melancholia. The red dots here are suicides or suicide attempts.

Even though it can cause suicide, we would expect it to reduce the number of suicides because it treats this high risk condition. If you didn’t know better, this RCT would look like evidence antidepressants do not cause suicide.

Slide 10: Here is the data on the trials in mild depression that brought the SSRIs to market – mild depression because SSRIs are no use in melancholia. You see an increase of suicidal events compared to placebo in people at little or no risk of suicide.

Slide 11: This is what the data for imipramine look like in the same mild depressions. This is not a thought experiment – it was used as a comparator in SSRI trials. Now it too causes suicides.

RCTs can give us diametrically opposite answers. This is because these are not Drug Trials. They are Treatment Trials and if the condition and treatment produce superficially similar effects, randomized trials cause confounding rather than solve it. This is true for most medical conditions and their treatments.

People evaluating drugs in traditional clinical trials, before RCTs, knew this. When a patient becomes suicidal in a trial you have to use your judgement to work out what is happening but in RCTs clinicians are not supposed to use their judgment. RCTs are more objective than our judgments – supposedly.

Slide 12: Here is what a Drug Trial looks like. In healthy volunteer studies in the 1980s, companies found SSRIs cause volunteers to become suicidal, dependent and sexually dysfunctional. We heard nothing about these problems when the drugs launched in part because Drug Trials enabled companies to engineer Treatment Trials to hide these problems.

Slide 13: If you break a limb and get recruited to an RCT randomly applying casts to one limb – not necessarily the broken one – the trial will show random application beats placebo. Practicing Evidence Based Medicine rather than Evident based Medicine here would clearly be crazy.

Slide 14: Here is a James Webb telescope image. James Webb is marvellously bringing out the infinite individuality of stars.

In addition to randomization, Fisher put a premium on Statistical Significance. By 1980 every leading medical statistician was saying we need to get rid of statistical significance in favor of Confidence Intervals.

Confidence Intervals had been introduced by Gauss around 1810. Because of measurement error, the telescopes in use often failed to establish whether there was one or two stars in a location. Measurement errors should distribute nornally and so constructing confidence intervals could help us distinguish individual stars.

We have moved a long way forward in this respect with the James Webb telescope you see here.

Slide 15: Confidence intervals rushed into medicine in the mid-1980s. All the authorities on the right – many linked to Boston – argued they were much more appropriate than significance testing. They are appropriate for measurement error but are they any more a cure for ignorance than statistical significance?

Slide 16: Confidence intervals we are told allow us to estimate the size of an effect and the precision with which it is known. We have much more precise details on the likelihood of the Red Drug here killing you than we have for the Yellow Drug. The best estimate of the lethal effect for the Yellow Drug however is greater. The standard view is that if we increase the size of the Yellow Drug Trial we will have greater precision and know better what the risks are. As we shall see, this is wrong.

As things stand, if you are asked to take one of these drugs, should you be guided by precision or effect size? Ian Hudson, FDA and WHO say the only dangerous drug here is the Red One. This is because more than 95% of the data, more than 19 out of 20 lie to the right of the line through 1.0 – confidence intervals have defaulted into statistical significance.

I would take the Red rather than the Yellow one. This is not measurement error and we don’t know what confidence intervals represent when they are not representing measurement error.

Slide 17: Faced with claims Prozac causes suicide, Lilly analysed their clinical trials and claimed there is no evidence their drug causes suicide. Confidence Intervals are being spun here as indicating we don’t know Prozac causes suicide as nothing is statistical significant. This is Ian Hudson thinking – at odds with all statistical expertise. It’s wrong. The consistency across young and old, depression and eating disorders strongly suggests in real life there is an excess of suicidal events.

Slide 18: There is an intriguing mystery behind these figures. Here you see a representation of suicidal events that happened in the trials that brought Prozac, Paxil and Zoloft to market around 1990. You’ll note there are events under the word screening here. There is a 2 week washout period before a trial starts where people are whipped off their prior drugs before being put on the new treatment or placebo. This is a highly dangerous phase where people are in withdrawal and very likely to go on to a suicide attempt.

Slide 19: And here you see the moves companies made to avoid having a confidence interval excess of suicidal events on treatment. Companies only moved the events – not the people.

These moves were justified on the basis that people in the run in phase were not on active treatment – which is equivalent to being on placebo – but they often were withdrawing from active treatment which is highly dangerous. Some who stopped treatment at the end of the active phase of the trial committed suicide and were designated placebo too. Some on placebo, put on active treatment in the follow up period, committed suicide and were designated as placebo suicides on an intention to treat basis.

There are two articles from 2006 that bring out this point Did Regulators Fail and The Antidepressant Tale: Figures Signifying Nothing. The Antidepressant Tale gives other examples of confidence interval abuse.

After all these maneuvers, there was still an excess of suicidal events on these SSRIs but the confidence interval was no longer entirely to the right of 1.0. Confidence intervals have degenerated into statistical significance tests because regulators need a Stop-Go mechanism and statistical significance provides this. But doctors don’t need an external Stop-Go mechanism to replace their clinical judgement, so why do they go along with this?

Slide 20: Nobody noticed these maneuvers around 1990, but fourteen years in a crisis about children becoming suicidal on antidepressants, questions began to be asked. GSK and Pfizer responded:.

‘GSK did not intentionally submit any erroneous or misleading information to FDA. The suicide data submitted to FDA explicitly identified when events occurred during the placebo run-in period. FDA had all this information right from the beginning.’

“Pfizer’s 1990 report to FDA plainly shows … that 3 placebo attempts as having occurred during single blind placebo phases… FDA has neither criticized these data or the report as inappropriate, nor required additional analyses”.

These maneuvers breach FDA regulations and FDA staff noted this in memo’s at the time. But not only did FDA ignore these breaches of regulations senior figures, like Tom Laughren, put their name to articles that embraced these breaches of regulation – in one case in the cause of showing it was not unethical to have placebo controls in RCTs, as those on placebo were not at any greater risk than those on treatment.

There was much back and forth between FDA and companies in 1990. Was it criminal? Perhaps. I prefer the idea of strategic ignorance.

What I think we are seeing are events circling around a major crisis in knowledge production. This is not something you can expect FDA to take a lead on – they are not political actors, they are bureaucrats. Companies create knowledge or were creating the appearances of knowledge at this point, but doctors are surely primarily responsible for the creation of medical knowledge and doctors were missing in action around 1991– other than as spokespeople for companies.

Slide 21: The Sacred Mantra is that randomization controls for all possible confounders in all possible universes. The reality is randomization introduces confounders into clinical trials.

The images for the next 3 slides come from a GSK paper prepared in 2006 for submission to FDA. The small print is hard to read – the bold at the bottom gives you the key details.

The data for suicidal events on Paxil in Major Depressive Disorder trials in this first slide show it causes suicidal events. Even Ian Hudson would have to agree and these data were available at the time of the Tobin trials. But randomization is about to come to GSK’s rescue.

Slide 22: Faced with a problem like this, had GSK consulted me I’d have said do a trial in Intermittent Brief Depressive Disorders (IBDD). They might have said but there are trials of SSRIs in IBDD and they don’t work. I’d have said do one. They did and it had to be terminated early, Paxil did so poorly. I’d have said do another. Why – the figures for Paxil still look bad in this group?

Slide 23: But when you add the IBDD data to the MDD data, all of a sudden the figures say Paxil protects against suicidal events.

This scenario can happen every time a condition we are treating is heterogenous – that is dementia, diabetes, parkinson’s disease, breast cancer, back pain, hypertension – pretty well everything in medicine. In these cases randomization will act to hide effects good and bad and leave us able to use a problem a drug causes to hide a problem a drug causes.

Slide 24: Graphically this is what it looks like. The Red Drug here is the MDD curve alone – more than 95% of the data are to the right of the 1.0 line. The traditional wisdom is that adding some more events to the Red Drug above should give us a more precise version of the same estimate

In fact when you add a few more people, about 3%, we have shifted the curve to the opposite side of the 1.0 line. Its far a more precise confidence interval but this is a precision that speaks to our ignorance rather than to better knowledge. No medical statistics book ever hints at this possibility.

We could add 40 suicidal events to the paroxetine IBDD arm before Ian Hudson would have to admit paroxetine causes a problem – on the basis that the results are now statistically significant.

IBDD patients could be admitted to MDD trials – we have no way to distinguish them. Some patients become IBDD by virtue of a poor response to an SSRI.

Randomization in heterogenous conditions will hide effects drugs cause. It allows us to use an adverse effect a drug causes to hide the same adverse effect that drug causes. Confidence intervals do not help us work out what is going on in these cases.

Nor do they help in heterogenous drug responses. Lets take 20 Aarons who are all sedated by a Red Drug and 20 Davids all stimulated by it. The best estimate in the confidence interval in this case will lie on the 1.0 line, showing the drug has no effect. A method to distinguish between one and two stars should not produce an answer that there are no stars here. Algorithmic judgements cannot substitute for a human judgement.

Slide 25: Here is another problem with Confidence Intervals. Young men take Finasteride to restore a thick head of hair. We could count hairs and build confidence intervals around before and after hair follicle numbers.

Finasteride also causes suicide and permanent sexual dysfunction and like most drugs has 3,500 other effects. Confidence intervals for hair numbers before and after is one thing, but applying them to suicidality or sexual function, which were not measured in the trial, and for Merck to then claim on this basis that the science does not support a link between finasteride and suicide on the basis that not all the data lie to the right of the 1.0 line isn’t managing measurement error. It’s a confidence trick – that happens all the time.

Slide 26: There are more dead bodies on antidepressants in trials than on placebo, yet the RCTs as Ian Hudson told you show the drugs work. This is because most RCTs have a surrogate outcome. For antidepressants its the Hamilton Rating Scale for Depression.

Fifteen years after its creation, Max Hamilton commented on his scale:

It may be that we are witnessing a change as revolutionary as was the introduction of standardization and mass production in manufacture. Both have their positive and negative sides

Hamilton saw this scale as a checklist of things to ask about in an interview – a mixed blessing.

Slide 27: Checklists are now viewed as more scientific than David Healy in a clinic asking you about your family. They will produce standardized but possibly disastrous interviews.

For instance, on this scale, there is a suicide item. Suicidality can stem from the illness or the drug. This needs a judgement call. If caused by the drug you should rate a Zero. If caused by the illness you might rate 3 or 4. If you just check yes for suicidality, the default is to the illness. Ditto for sex, and for sleep.

In the case of sleep, the illness can produce too much sleep or not enough sleep and each of the medicines can inhibit sleep or heavily sedate. There are 3 sleep questions. A scientific interview has a multitude of options requiring judgement calls.

In the 1980s, we brought problems to doctors needing help to get on with the lives we wanted to live. Since then, for drug companies, rating scales, sometimes left in the waiting room, ensure you do an interview that produces figures for which a company drug might seem an answer. Your interview will help you to help your patient to live the life Pfizer want him to live. Do that and you are no longer practicing medicine.

Slide 28: Many think RCTs are fine if only they were done by angels.

Study 329 was conducted in the very best university centres in North America. It has an authorship line to die for, starting with Marty Keller and including a Canadian Liberal Party Senator – Stan Kutcher. It was published in the Journal with the highest impact factor in child psychiatry. The article claims Paxil works wonderfully well and is safe for depressed teens.

What I am about to tell you applies to all industry trials across medicine.

Slide 29: Three years earlier, in 1998, GSK concluded Paxil didn’t work in Study 329 and was not safe. That could not be published so they were going to pick out the good bits of the data and publish them. The good bits formed the Keller et al 2001 paper.

This 1998 internal SKB document led New York’s Attorney General to file a fraud action against GSK. As part of the resolution of this, GSK agreed to make their Paxil trial data public. A decade later, GSK resolved a Dept of Justice action, which also involved Study 329, for $3 Billion dollars.

Slide 30: These actions gave a team of us an incentive to Restore Study 329 and we now had more raw data from this study than FDA or other regulators had seen for this or any company study.

Slide 31: In contrast to Keller, we found the 8-week acute phase showed no difference between Paxil or placebo. We found the same for the never published 6 month continuation phase – never published till we published it 18 years after the trial ended.

Slide 32: Keller noted 6 emotionally labile events in the trial, some of which might have been suicidality, 4 on paroxetine. But in our hands a fifth of the children on Paxil had a behavioral event mostly suicidality – 18 out of 93 children.

Suicide is not what I want to focus on. It’s the ability of company studies to hide adverse events. Our paper lists 10 ways to hide things. Coding – as in calling suicidality emotional lability, is top of this list – this is the first act of authorship but no reviewer or journal pays any heed to it.

Slide 33: In a Pfizer trial, at the same time, a man on active drug got agitated, poured gasoline/petrol on himself and set fire to it intending to kill himself but he only died from his burns 5 days later. Pfizer coded him as death by burns. Once the coding is done, the paper is all but written.

There is some chance FDA found out about this man because if you have to go to hospital or you die companies had to file a report outlining what happened and did so for this man.

Slide 34: But in Study 329, FDA know nothing about a 15 year old boy, 2 weeks after being put on Paxil, who was out on the street waving a gun, threatening to kill people. He was brought to hospital by the police. There was no report to tell FDA what happened. Thirty years ago companies found a way to legally avoid filing these reports. Companies are still using this trick in trials published this year in all major journals and regulators either don’t spot or are not bothered to close a very obvious loophole. In Study 329, 4 children vanished through this loophole.

Slide 35: The sentences on the right are the 3 sentences with which this article ends – the message is companies have created an impression that RCT articles are like tablets of stone brought down from the mountain top, commanding doctors to prescribe and us to take. But when we have access to RCT data, this raises questions – as science should – rather than issues commands.

In addition to Coding, Grouping is also an act of authorship. If you have 500 events in 93 children on Paxil, rather than list them all, cardiac events are usually grouped in a Cardiac group etc. Behavioral events are usually grouped in a Psychiatric group. GSK grouped all behavioral events under Neurological. This groups emotional lability with headaches and dizziness, which are very common. Grouped this way the behavior problems disappear. Grouped as Psychiatric, the problem is immediately clear.

The Restoring Study 329 article took over a year to get it published. What was fascinating was the BMJ did not contest the data but they were very exercised by the act of interpretation. They appeared to assume that the data had spoken and GSK faithfully transmitted what they had heard. They found it heard to grasp that GSK used a coding dictionary that even FDA had never heard of.

Any scientific analysis inevitably involves an act of authorship or interpretation. But BMJ found it hard to let us author the behavioral events out of the neurological group into a Psychiatry group. There is no such thing as data without an interpretation. Ideally the interpretation should command consensus but for BMJ this appeared to mean that we should adopt what GSK had done without question.

Slide 36: Everyone knows Prozac was approved for children who are depressed but not that Paxil was too. A year after the Keller paper came out, this is part of an FDA approvable letter for Paxil.

It says GSK have told FDA Study 329 is negative. FDA agree its negative – in fact all 3 trials are negative – but FDA will still approve Paxil for kids. FDA also agree with GSK’s suggestion not to mention the negative trials in the label of the drug. Why would FDA agree to this?

Before answering that, let me note FDA also viewed the Prozac trials in teens as negative.

Slide 37: This slide from Erick Turner’s 2008 article shows published adult ‘trials’ on various antidepressants, almost all indicating the drugs work well and are safe. Look at the sertraline column – 3 from the right. It shows two studies – the minimum needed for approval.

Slide 38: Another slide shows the trials as FDA viewed them. 46% of these trials are negative. Many published as positive were negative to add to the unpublished negative trials. Look at the sertraline column – only one positive study.

Why do FDA say nothing about this? Well if FDA said trials are negative – the companies might get sued for fraud or fined – as happened for Study 329.

Slide 39: Here you see the PTSD page of a 30 page document listing Zoloft articles in progress. These papers aim at capturing markets not at informing us on how to use Zoloft safely.

Pfizer did 4 Zoloft PTSD trials. All negative. FDA approved it on the basis of 2 trials with a minimal benefit for women. These good bits plucked out are what’s being published. You see under Status on the right two articles are complete and will be sent to the very best journals. On the left you see TBD – to be determined – when Pfizer decide which names would sell most Zoloft.

You saw a 24 person authorship line for Study 329 but the real author is not there. Across medicine studies of on-patent drugs are ghostwritten.

In the case of children’s antidepressant trials the entire literature was written by ghosts and there is a complete mismatch between the published claims and the data – the greatest mismatch in all of science. On the basis of published claims the use of these drugs is escalating rapidly in teenagers with predictably bad results.

Slide 40: Fifty years ago, Britain joined the EU and ran into trouble. Cadbury’s chocolate, their favorite chocolate, they were told, could not be called chocolate. It didn’t have the right quota of cocoa solids. British consternation over chocolate led to Brexit some decades later.

What FDA do is in their name – they regulate Food and Drugs. Faced with butter or chocolate or drugs, companies must meet an assay standard – so much cocoa solids, animal fats, or so many points on a Depression rating scale in 2 trials. Meet that and FDA let you use the words chocolate, butter, or antidepressant. It’s not FDA’s job to decide if this is good butter, or if chocolate is good for you, or to police the medical literature.

Sllide 41: Since 1990, however, regulators increasingly say they approve drugs on the back of a supposed positive Benefit-Risk ratio. This is Ian Hudson thinking. If there are no proven adverse effects and just a benefit then of course there is a positive Benefit-Risk ratio.

The medical act of bringing good out of the use of a poison is incompatible with all this.

We would all agree there is a positive benefit-risk ratio for parachute approval in terms of lives saved versus lives lost – even though some men might have difficulties making love in the weeks afterwards, owing to harness effects. If things aren’t clear enough for us all to endorse, regulators are de facto getting us to live the lives companies want us to live when they make Benefit-Risk claims.

Unlike parachutes, SSRI RCTs have more dead bodies on SSRIs than placebo. In addition. the commonest effect of an SSRI is to cause genital numbness in close to everyone who takes one within 30 minutes of a first tablet. Almost everyone will have the way they make love changed while on an SSRI and they may later find themselves unable to make love ever again, either because they can’t stop or because the drugs can wipe out sexual function for ever. This may be far more important to a person than any mood benefit.

But the focus on the mood effect, means the sexual effect was missed entirely in the trials regulators scrutinized both because that’s how trials work but also with a little extra gaming from companies.

Some years ago treating a man with OCD, I tried an SSRI – the first line treatment and then more heavy duty drugs when the SSRI didn’t work. All made him worse. One day he came in much better – he had stopped all his drugs but he was cured by going back smoking. He had also googled nicotine and OCD and found studies showing nicotine and related drugs can help OCD.

When I say the Art of Medicine lies in Bringing Good out of the Use of a Poison, people hiss at me but everyone would likely agree this man was bringing good out of the use of a poison. SSRIs however are prescription-only because we expect them to be more dangerous than over the counter alcohol and nicotine.

The important thing is that this man (perhaps with input from me) is the only person in a position to make a meaningful Benefit Risk call. I can’t see what role FDA could have in this. Benefit-Risk calls are an individual matter. Making the claims FDA now make puts them in a role of getting people to live the life Pfizer want them to live.

Am I making all claims on the basis of Citizen Research more than Expert input? No – among the articles this man found about nicotine and OCD was one whose significance passed him by. One of the authors was Arvid Carlsson, who created SSRIs and won a Nobel Prize for Medicine.

But when you have Skin in the Game, Motivation can be worth just as much as Expertise.

Slide 42: As a result of Ian Hudson’s views, as I wrote 25 years ago, everyone who participates in a company trial today puts all the rest of us in a state of Legal Jeopardy. We should boycott trials, until this changes. See Clinical Trials and Legal Jeopardy.

Slide 43: That article was 25 years ago, this is 25 days ago and argues everyone entering a trial now are deceived by consent forms that promise coverage for injuries, unaware that there are no injuries on modern treatment, or no injuries that can be admitted. See The Coverage of Medical Injuries in Compary Trial Informed Consent Forms.

Slide 44: However, since 2010, the US Supreme Court in the Matrixx case made it clear that Ian Hudson’s views do not apply to investors wanting to make up their mind about the Benefits and Risks of investing. We who are investing our lives in these treatments still do not have such rights.

Slide 45: The beating Tell Tale Heart of this talk came with the publication of this article 33 years ago this month, in which 3 Boston clinicians claimed fluoxetine caused 6 people to become suicidal. Analyzing the cases closely and following traditional clinical approaches for determining causality, this article nailed beyond doubt that fluoxetine could cause some people to become suicidal.

Lots of other groups reported similar findings. I published 2 cases of men, who were challenged, dechallenged and rechallenged with an SSRI. There was no other way to explain what happened them except that fluoxetine had caused it. This was Evident Based Medicine .

Slide 46: Almost the same week as my article came out, BMJ published an article in which Lilly claimed an analysis of their clinical trials showed no evidence fluoxetine made people suicidal. The cases being reported, therefore, were sad but anecdotal – and the plural of anecdote is not data. Depression was the problem not fluoxetine. Clinical trials are the science of cause and effect. Doctors, the public, media, and politicians were being asked – are you going to believe the science or the anecdotes?

This was a knowledge creation moment that likely had input from all companies and perhaps FDA. This article created Evidence Based Medicine and just as with RCTs 30 years earlier, the people most commonly exhorting doctors to practice EBM today are Pharma companies.

In fact, the original phrase is the plural of anecdotes is data – otherwise Google wouldn’t work.

The idea the disease is responsible for suicide attempts and suicides in healthy volunteers is hard to believe but companies can wheel out experts to say just that.

My key point is that the Teicher paper is the science – the Lilly data is an artefact. My challenge to you is which are you going to believe the Science or the Artefact?

The Science of Medicine lies in making hard judgement calls. The made by algorithm approach, combined with inappropriate statistics, creates artefacts not science.

You’ve seen earlier how Lilly cooked the books. When you get the trial data, the Evident Based Medicine and Evidence Based Medicine approaches here can be reconciled – as you might expect with real science.

But even there was an incompatability there isn’t a problem. Resolving discrepancies is how we do science.

This points to a deep problems with Lilly’s argument. They are not in the business of being scientific – resolving discrepant observations. Lilly’s argument is a religious one – a dogmatic one – they forbid us to believe the evidence of our own senses.

This is papal infallibility riding again.

Peter Drucker, the doyen of marketing gave us a secular update – the goal of marketing is not to increase the sales of Prozac, its to own the market. This was the moment Pharma took ownership of the market.

This ownership allows companies to dictate what the risks, the benefits and the trade-offs of drugs are. Allows them to force us to live the lives they want us to live rather than engage with the risky and unprofitable business of producing products that will help us to live the lives we want to live. Following this Artefact is profoundly alienating.

Slide 47: This faces us with a what is science question? The usual histories start with the foundation of The Royal Society in 1660, which established the ground rules for Science. Science would deal with matters that could be Settled by Data. Participants could be Xtian, Hindu, Jew, Muslim, or Atheist, but participants were called on to leave these badges at the door and make a consensus based judgement call about the best way to explain the experimental outcome in front of them.

The histories of science emphasize the word Data. Settled is the more important word. Statistics played no part in this science. The experiments were events and didn’t need the descriptions statistics can provide. Science was emphatically not about replacing judgment calls with a statistical artefact. It only became so 33 years ago.

Slide 48: This account of our history overlooks an earlier event. In 1618, Walter Raleigh was executed – for being too close to those pesky Europeans. Raleigh was convicted on the basis of things said about him by people who did not come into court to be cross-examined.

Legal systems worldwide recognized the injustice of this and introduced Rules of Evidence. Hearsay could not be used as evidence. Jurors – a group of 12 people, Xtians, Hindus, Muslims, Atheists and Jews, can only base a verdict on material put in front of them that can be examined and cross-examined. The process of forcing 12 people with very different biases to come to a Verdict about what is in front of them is the essence of science.

Verdicts and diagnoses are provisional – the view that best fits the current facts. This might appear to contrast with the objectivity of science, but scientific views are similarly provisional. Scientists attempt to overturn verdicts with new data.

Let’s say I gave Aaron fluoxetine 33 years ago and he became suicidal. I could examine and cross-examine him, run labs and scans, raise the dose, stop the drug, add an antidote, check with colleagues has anyone else seen anything like this or can they explain it in any other way. Aaron is the data – all of the data. He is the apparatus in which the experiment is taking place.

If Aaron and I conclude fluoxetine made him suicidal and report this to FDA, the first thing FDA does is to remove his name. No-one can now examine or cross-examine him and come to a scientific view about whether there is a link or not. His injury has been made Hearsay – indeed misinformation.

If you are later injured in the same way and see tens of thousands of reports of suicidality on SSRIs on FDA’s adverse event reporting system, you cannot bring this into court because no-one can be brought into court. It’s Hearsay not Evidence.

Company RCTs are equally hearsay and should not be let into Court as evidence. Accessing the data in this case means accessing people – like Aaron or me – and we cannot do that with the people in company trials, who often don’t exist. Except rarely, the authors on the articles have seen none of these people and cannot speak to what happened either.

In contrast, if Aaron and I report his case in he New England Journal or the American Journal of Psychiatry as a Case Report, with our names on it, we can both be brought into Court.

Slide 49: By 1983 the view was emerging that RCTs offered the scientific and sophisticated way to establish if a drug had adverse effects as this quote by Rossi et al indicates:

Spontaneous reporting is “the least sophisticated and scientifically rigorous . . . method of detecting new adverse drug reactions.

A mid-career Lasagna, the man who more than anyone introduced RCTs, responded:

This may be true in the dictionary sense of sophisticated meaning ‘adulterated’ . . . but I submit spontaneous reporting is more ‘worldly-wise, knowing, subtle and intellectually appealing’ than grandiose, expensive RCTs.

Slide 50: Here you have an older Louis Lasagna saying:

In contrast to my role in the 1950s which was trying to convince people to do controlled trials, now I find myself telling people that it’s not the only way to truth.

Evidence Based Medicine has become synonymous with RCTs even though such trials invariably fail to tell the physician what he or she wants to know which is, which drug is best for Mr Jones or Ms Smith – not what happens to a non-existent average person.

Slide 51: Here is James Webb again to remind you that confidence intervals were a step on the way to revealing the individuality of stars. In medicine, statistical approaches operate against individuality.

Using Chance to control Bias does not foster clinical science, especially when we allow a mindless algorithm to replace clinical judgement. Clinical medicine, like law, and the first 300 years of science uses Bias to Control Chance and both medicine and law need to assert the validity of this approach.

Slide 52: Using Bias to control Chance rather than some algorithmic method of controlling Chance is critical when numbers enter the frame. This is our only defense against medical neo-liberalism.

Around 1980 Pharma began treating healthy people. They discovered that numbers for our peak flow rates, bone densities, blood pressure, lipids, or sugar provided opportunities to sell drugs. Up to 1980, we brought our problems to healthcare – seeking help to live the lives we wanted to live. After that health services began to give us problems and the amount of medicines consumed rose dramatically. We began treating numbers rather than people.

Remaining on top of data like this is difficult. Just after weighing scales for people were introduced in the 1860s, we got the first descriptions of anorexia nervosa. In the 1920s, weighing scales in drug stores came with norms for our ideal weight given our height and sex and eating disorders mushroomed. When scales migrated into our homes in the 1960s eating disorders became epidemic – in the countries that had weighing scales. Measurements can make both us and our doctors neurotic.

Slide 53: There is an extra element to the equation. The service industries emerged in the 1950s. Through to 1980, no-one viewed health as a service industry – doctors were professionals who exercised judgement the way a Judge might. But service industries have managers and health got managers. With this the exercise of clinical discretion, the jewel in the crown of Health Care became a problem for those who manage services.

The idea of bringing good out of the use of a poison does not compute for managers, insurers, politicians or increasingly the public.

Before 1980, clinicians mobilized the resources of the organization they worked to handle the risks your condition posed to you. Now instead you can palpably feel the clinicians you meet are managing the risks you pose to the organization we work for.

Slide 54: Managers manage what they can measure. For them figures have a sheen of scientific gold. We are re-running the King Midas story – this gold coating is incompatible with Human Care and Life.

This governance by numbers is the essence of the neoliberalism that began in Chile and Britain – treat the money supply numbers or inflation numbers regardless of what is happening a country. Medicine is the best place to see this and its deleterious effects in action – aggravated by the fact that bowing down before a golden algorithmic idol inhibits anyone from leading us out of this desert in which we now wander.

Slide 55: When the pilot here reports problems, safety systems pay heed because they know she won’t fly if they don’t because of the consequences for her.

Jane Frazer is the CEO of Citibank. Since the financial crisis, bankers have an Early Warning System. Who knows if it helps? The financial crisis was linked to a moral hazard. Bankers were outsourcing risk, knowing that if things crashed you and I would suffer but they would continue to collect their bonuses. This made it hard for them to do the right or brave thing.

If the doctor on the left reports a problem, no-one pays any heed. She too outsources risk putting pills that like mortgages look too good to be true in our mouths. This is morally hazardous. Like a mortgage, if a drug looks too good to be true it probably is. If we blow up, she continues to be well paid. There is no incentive for her to do the right thing.

Slide 56: This moral hazard is leading to a pharmaceutical crisis that maps onto the financial crisis of 15 years ago. Here is a recent New York Times image of Life Expectancy in the US. You’ll see it began dropping in 1980, when we began treating numbers rather than people and converted health into a service industry. This Fall cannot be attribued to COVID. My view is that it is most likely linked to polypharmacy. The UK has similar falling Life Expectancy data – again pre-COVID.

Slide 57: Drugs like guns are techniques – amoral. The morality of their use lies in us. If we stop thinking about what we are doing when we use them, we are highly likely to be diminished.

Like Guns, Drugs create an arms race. The country with the best Medical Techniques and Guns wins wars and both armament and medical developments have been driven forward by military needs – to keep men able to fight in the case of drugs.

There is difference between Guns and Drugs. The chemicals in drugs are always risky. The information that transforms those chemicals into medicines has become increasingly dangerous. At the moment, the Drugs Race is not a better Chemical Race – it’s about creating more effective propaganda. The best propaganda is invisible – in this case it masquerades as science. The greatest concentration of fake literature on earth now centers on the reports of RCTs on the Drugs our doctors give us.

With both Guns and Drugs there is a limit to effectiveness. In the case of the Atom Bomb it is so effective that it cannot be used. It is the same with Drugs, if you are on more than 3, the effectiveness of each falls off as you add more meds into the mix.

To get the most effectiveness you need to be on 3 or less. As of 2016, over 40% of over 45s in the United States were on 3 or more drugs every day of the year – this figure includes the people who never come to see doctors. Over 40% of over 65s are on 5 or more drugs every day of the week. Knowing what is happening teenagers, this can only increase.

We know that reducing medication burdens can increase life expectancy, reduce hospitalizations, and improve quality of life.

Slide 58: Reducing a medication burden is not easy – as this image from the movie The Hurt Locker illustrates. Many of these drugs explode on attempting to withdraw them. This is the primary medical task of our age and there will never be any RCTs to help us out. The best evidence will likely lie in clinical experience of tackling similar situations. Great if I have a walkie-talkie to clinical colleagues but my key partner in this is you – you bring cues from missing doses of some of these drugs, and your sense of what they are doing that I can only access through you. And of course you ultimately dictate which risks we take.

In the 1940s and 1950s, RCTs had a role when we didn’t know if things worked. From the 1960s we had so many good drugs that worked – brought on the market without an RCT in sight – a new role beckoned for RCTs – to work out what worked best. RCTs cannot do this and besides it did not suit company interests. Companies instead created Randomized Controlled Assays which among other things allow weaker and weaker drugs on the market.

The pressing medical need now is to get people off the meds they are on and RCTs and what is called EBM have little or no role to play in helping us with this.

Slide 59: If a doctor tries to modestly reduce medication burdens or recognize that in some cases a treatment might have become a problem, current public health systems will not accommodate her. In the US, it is current culture that will mobilize against this. The doctor will be told this would be a good private practice offer that people can choose, but the public health system expectation is that people want and should get more diagnoses and drugs.

This is because getting treatment to save our lives was once a privilege and wealth and public health systems want everyone to be able to access treatment. They cannot now see that these good intentions are killing people. Now we have to be wealthy to get off medicines to save our lives.

Canada now leads the world in MAiD – Medical Assistance in Dying. In places like Belgium and Holland young women are getting MAiD because they have drug induced treatment resistant depression. While there must be concerns when young women in their 20s get MAID for treatment resistant depression – an antidepressant induced illness – I’m not quibbling about the morality of MAiD – any good doctor will almost certainly have cases where MAiD is the caring thing to do.

What I am quibbling about is the morality of a system that encourages us to have any service we want, including MAiD, but denies us the option of having less services. Denies us a Greener, more sustainable HealthCare. At the moment, not even Green parties have got a handle on this.

Slide 60: This lady comes from an Arthurian Legend. Arthur has been out-fought by a Black Knight who spares his life if he can answer a riddle – What do Women Most Desire. He has a year to find the answer. He and his court hunt desperately for it. The day he is due to die, Arthur and his troop meet this woman who tells him that she has the answer to the riddle but one of his knights must become her husband. Gawain jumps down and offers himself up. Arthur answers the riddle, and a furious Black Knight lets him go.

Slide 61: Gawain gets married. Everyone at the Court is unhappy for him.

Slide 62: In the bedchamber Gawain can’t bear to look at her. She takes control and asks him – do you want me to look like this by night with you and the way I was by day in court or like this by day in court. He has no idea and says – whatever you want. This is the right answer.

The answer to both riddles is she, like us, wants to control her own life. There may be a disease that needs treating – but she doesn’t want us to tell her how to live life, or want her negative emotions eliminated with a pill. She may be doing better at living life than you or I.

The evidence based medicine we now practice creates a False We – a non-existent average person – a fairy tale.

Rather than paying heed to the non-existent average person who comes out of clinical trials, when we relearn that we can learn much more from the person right in front of us, she and others who come to see us will seem more interesting and as they sense that we will be more attractive to them – easier to work with.

A relationship based medicine is the only validly scientific form of clinical practice. If you can’t build up a relationship with people because you and they see a different doctor every time, a relationship in which you are looking closely at and listening attentively to them – perhaps even detecting if there is a change in their smell, you are not doing science. The person in front of you is the apparatus in which the experiment is taking place. The computer screen is not.

Both science and morality depend on collaboration. Collaboration creates a virtuous circle – an Us – that leaves us all better placed to live the life we want to live. It creates Social Capital.

Redesignate Company Trials as Assays

Government of the People by the People has been replaced by governance.
If it is not to perish entirely from the earth…
We need to do…

Footnotes

This may be the most important lecture I have ever given – it’s the longest at least. It has been heavily shaped by Dee Mangin, Peter and Julie Wood and everyone linked to RxISK – Bill James, Johanna Ryan, Peter Selley, Sarah Tilley, Mary Hennessey, Annemarie Kelly and many others who have worked behind the scenes but don’t want to be named and others whose comments on posts are often more illuminating than the posts themselves.

It has been shaped over a 25 year period by Andy Vickery, Cindy Hall, Skip Murgatroyd and Michael Baum who in the legal cases they involved me in brought me face to face with the many issues covered here.

It has been shaped by Jon Jureidini, Melissa Raven, Joanna Le Noury, and Elia Abi-Jaoude, who along with Mickey Nardo and Catalin Tufanaru, both now dead, were the team behind the Restoration of Study 329 – see the final article at Restoring Study 329.

It would not be possible to leave Peter Goetzsche out of the frame and an intense struggle to restore the Prozac trials in adolescents – along with the bravery of Ralph Edwards in publishing this paper. See Flat as Kansas.

Finally to complete a set of Peters, Peter Doshi has been one of the most remarkable people working on all these issues extraordinarily effectively.

There have been any number of fabulous media people like Shelley Jofre and Andy Bell who brought key issues to light, along with Ariane Denoyel and others who have grappled with the issues outlined here.

More recently, Dan Johnson, along with Yoko Motohama and Vincent Schmitt who have lost teenage sons to the drugs mentioned here, triggered the series of lectures noted above of which this is the third in the series. Jon Thompson and his colleagues in the math department in the University of New Brunswick, along with Peter Selley and colleagues in the Devon and Exeter Medical Society allowed me to dress rehearse and improve the talk.

I have stolen ideas from lots of people such as Steve Lanes – too many to acknowledge. As Steve’s example shows, some of the best help has come from people working in industry.

The Q and A after this talk in Boston reveals a tendency we all have to say things would be fine if industry just weren’t involved in trials. This is not my view. Industry don’t help but they are primarily exploiting medical failures to get to grips with the faultlines in RCTs – and a medical willingness to accept a simplistic solution to the problem of objectivity rather than engage with others in establishing what is objective or at least the best provisional version of objectivity.

The Covid-skeptic world has been claiming the World Health Organization (WHO) plans to become some sort of global autocratic government, removing national sovereignty and replacing it with a totalitarian health state. The near-complete absence of interest by mainstream media would suggest, to the rational observer, that this is yet another ‘conspiracy theory’ from a disaffected fringe. 

The imposition of authoritarian rules on a global scale would normally attract attention. The WHO is fairly transparent in its machinations. It should therefore be straightforward to determine whether this is all misplaced hysteria, or an attempt to implement an existential change in sovereign rights and international relations. We would just need to read the document. Firstly, it is useful to put the amendments in context.

The changing role of WHO

Who’s WHO?

The WHO was set up after the Second World War as the health arm of the United Nations, to support efforts to improve population health globally. Based on the concept that health went beyond the physical (encompassing “physical, mental and social well-being”), its constitution was premised on the concept that all people were equal and born with basic inviolable rights. The world in 1946 was emerging from the brutality of colonialism and international fascism; the results of overly centralized authority and of regarding people to be fundamentally unequal. The WHO constitution was intended to put populations in charge of health.

In recent decades the WHO has evolved as its support base of core funding allocated by countries, based on GDP, evolved to a model where most funding is directed to specified uses, and much is provided by private and corporate interests. The priorities of the WHO have evolved accordingly, moving away from community-centered care to a more vertical, commodity-based approach. This inevitably follows the interests and self-interests of these funders. More detail can be found on this evolution elsewhere; these changes are important to putting the proposed IHR amendments in context.

Of equal importance, the WHO is not alone in the international health sphere. While certain organizations such as UNICEF (originally intended to prioritize child health and welfare), private foundations and non-government organizations have long partnered with the WHO, the past two decades have seen a burgeoning of the global health industry, with multiple organizations, particularly ‘public-private partnerships’ (PPPs) growing in influence; in some respects rivals and in some respects partners of the WHO.

Notable among PPPs are the Gavi – the Vaccine Alliance (focused specifically on vaccines) and CEPI, an organization set up at the World Economic Forum meeting in 2017 specifically to manage pandemics, by the Bill & Melinda Gates Foundation, Wellcome Trust and the Norwegian Government. Gavi and CEPI, along with others such as Unitaid and the Global Fund, include corporate and private interests directly on their boards. The World Bank and G20 have also increased involvement in global health, and especially pandemic preparedness. The WHO has stated that pandemics occurred just once per generation over the past century and killed a fraction of those who died from endemic infectious diseases, but they nonetheless attract much of this corporate and financial interest. 

The WHO is primarily a bureaucracy, not a body of experts. Recruitment is based on various factors, including technical competency but also country and other equity-related quotas. These quotas serve a purpose of reducing the power of specific countries to dominate the organization with their own staff, but in doing so require the recruitment of staff who may have far lower experience or expertise. Recruitment is also heavily influenced by internal WHO personnel, and the usual personal influences that come with working and needing favors within countries. 

Once recruited, the payment structure strongly favors those who stay for long periods, mitigating against rotation to new expertise as roles change. A WHO staffer must work 15 years to receive their full pension, with earlier resignation resulting in removal of all or part of the WHO’s contribution to their pension. Coupled with large rental subsidies, health insurance, generous education subsidies, cost-of-living adjustments and tax-free salaries, this creates a structure within which protecting the institution (and thus one’s benefits) can far outlive initial altruistic intent.

The DG and Regional Directors (RDs – of which there are six) are elected by member states in a process subject to heavy political and diplomatic maneuvering. The current DG is Tedros Adhanom Ghebreyesus, an Ethiopian politician with a checkered past during the Ethiopian civil war. The amendments proposed would allow Tedros to independently make all the decisions required within the IHR, consulting a committee at will but not bound by it. Indeed, he can do this now, having declared monkeypox a public health emergency of international concern (PHEIC) against his emergency committee’s advice, after just five deaths globally. 

Like many WHO employees, I personally witnessed, and am aware of, examples of seeming corruption within the organization, from Regional Director elections to building renovations and importation of goods. Such practices can occur within any large human organization that has lived a generation or two beyond its founding. This is, of course, why the principle of the separation of powers commonly exists in national governance; those making rules must answer to an independent judiciary according to a system of laws to which all are subject. As this cannot apply to UN agencies, they should automatically be excluded from direct rulemaking over populations. The WHO, like other UN bodies, is essentially a law unto itself.

WHO’s new pandemic preparedness and health emergency instruments. 

The WHO is currently working on two agreements that will expand its powers and role in declared health emergencies and pandemics. These also involve widening the definition of ‘health emergencies’ within which such powers may be used. The first agreement involves proposed amendments to the existing International Health Regulations (IHR), an instrument with force under international law that has been in existence in some form for decades, significantly amended in 2005 after the 2003 SARS outbreak.

The second is a new ‘treaty’ that has similar intent to the IHR amendments. Both are following a path through WHO committees, public hearings and revision meetings, to be put to the World Health Assembly (WHA – the annual meeting of all country members [‘States parties’] of the WHO), probably in 2023 and 2024 respectively.

The discussion here concentrates on the IHR amendments as they are the most advanced. Being amendments of an existing treaty mechanism, they only require approval of 50 percent of countries to come into force (subject to ratification processes specific to each member State). The new ‘treaty’ will require a two-thirds vote of the WHA to be accepted. The WHA’s one country – one vote system gives countries like Niue, with less than two thousand residents, equal voice to countries with hundreds of millions (e.g. India, China, the US), though diplomatic pressure tends to corral countries around their beneficiaries.

The IHR amendments process within the WHO is relatively transparent. There is no conspiracy to be seen. The amendments are ostensibly proposed by national bureaucracies, collated on the WHO website. The WHO has gone to unusual lengths to open hearings to public submissions. The intent of the IHR amendments to change the nature of the relationship between countries and the WHO (i.e. a supra-national body ostensibly controlled by them), and fundamentally change the relationship between people and central supranational authority – is open for all to see.

Major amendments proposed for the IHR

The amendments to the IHR are intended to fundamentally change the relationship between individuals, their country’s governments, and the WHO. They place the WHO as having rights overriding that of individuals, erasing the basic principles developed after World War Two regarding human rights and the sovereignty of States. In doing so, they signal a return to a colonialist and feudalist approach fundamentally different to that to which people in relatively democratic countries have become accustomed. The lack of major pushback by politicians and the lack of concern in the media and consequent ignorance of the general public is therefore both strange and alarming.

Aspects of the amendments involving the largest changes to the workings of society and international relations are discussed below. Following this are annotated extracts from the WHO document (REF). Provided on the WHO website, it is currently under a process of revision to address obvious grammatical errors and improve clarity.

Resetting international human rights to a former, authoritarian model

The Universal Declaration on Human Rights, agreed by the UN in the aftermath of World War Two and in the context of much of the world emerging from a colonialist yoke, is predicated on the concept that all humans are born with equal and inalienable rights, gained by the simple fact that they are born. In 1948 the Universal Declaration of Human Rights was intended to codify these, to prevent a return to inequality and totalitarian rule. The equality of all individuals is expressed in Article 7: 

“All are equal before the law and are entitled without any discrimination to equal protection of the law. All are entitled to equal protection against any discrimination in violation of this Declaration and against any incitement to such discrimination.” 

This understanding underpins the WHO constitution, and forms a basis for the modern international human rights movement and international human rights law.

The concept of States being representative of their people, and having sovereignty over territory and the laws by which their people were governed, was closely allied with this. As peoples emerged from colonialism, they would assert their authority as independent entities within boundaries that they would control. International agreements, including the existing IHR, reflected this. The WHO and other international agencies would play a supportive role and give advice, not instructions.

The proposed IHR amendments reverse these understandings. The WHO proposes that the term ‘with full respect for the dignity, human rights and fundamental freedoms of persons’ be deleted from the text, replacing them with ‘equity, coherence, inclusivity,’ vague terms the applications of which are then specifically differentiated in the text according to levels of social and economic development. The underlying equality of individuals is removed, and rights become subject to a status determined by others based on a set of criteria that they define. This entirely upends the prior understanding of the relationship of all individuals with authority, at least in non-totalitarian states.

It is a totalitarian approach to society, within which individuals may act only on the sufferance of others who wield power outside of legal sanction; specifically a feudal relationship, or one of monarch-subject without an intervening constitution. It is difficult to imagine a greater issue facing society, yet the media that is calling for reparations for past slavery is silent on a proposed international agreement consistent with its reimposition.

Giving WHO authority over member States.

This authority is seen as being above states (i.e. elected or other national governments), with the specific definition of ‘recommendations’ being changed from ‘non-binding’ (by deletion) to ‘binding’ by a specific statement that States will undertake to follow (rather than ‘consider’) recommendations of the WHO. States will accept the WHO as the ‘authority’ in international public health emergencies, elevating it above their own ministries of health. Much hinges on what a Health Emergency of International Concern (PHEIC) is, and who defines it. As explained below, these amendments will widen the PHEIC definition to include any health event that a particular individual in Geneva (the Director General of the WHO) personally deems to be of actual or potential concern.

Powers to be ceded by national governments to the DG include quite specific examples that may require changes within national legal systems. These include detention of individuals, restriction of travel, the forcing of health interventions (testing, inoculation) and requirement to undergo medical examinations.

Unsurprising to observers of the COVID-19 response, these proposed restrictions on individual rights under the DG’s discretion include freedom of speech. The WHO will have power to designate opinions or information as ‘mis-information or disinformation, and require country governments to intervene and stop such expression and dissemination. This will likely run up against some national constitutions (e.g. the US) but will be a boon to many dictators and one-party regimes. It is, of course, incompatible with the Universal Declaration of Human Rights, but these seem no longer to be guiding principles for the WHO.

After self-declaring an emergency, the DG will have power to instruct governments to provide WHO and other countries with resources – funds and commodities. This will include direct intervention in manufacturing, increasing production of certain commodities manufactured within their borders. 

Countries will cede power to the WHO over patent law and intellectual property (IP), including control of manufacturing know-how, of commodities deemed by the DG to be relevant to the potential or actual health problem that he /she has deemed of interest. This IP and manufacturing know-how may be then passed to commercial rivals at the DG’s discretion. These provisions seem to reflect a degree of stupidity, and unlike the basic removal of fundamental human rights, vested interests here may well insist on their removal from the IHR draft. Rights of people should of course be paramount, but with most media absent from the fray, it is difficult to see a level of advocacy being equal.

Providing the WHO DG with unfettered power, and ensuring it will be used.

The WHO has previously developed processes that ensure at least a semblance of consensus and an evidence-base in decision-making. Their process for developing guidelines requires, at least on paper, a range of expertise to be sought and documented, and a range of evidence weighed for reliability. The 2019 guidelines on management of pandemic influenza are an example, laying out recommendations for countries in the event of such a respiratory virus outbreak. Weighing this evidence resulted in the WHO strongly recommending against contact tracing, quarantine of healthy people and border closures, as the evidence had shown that these are expected to cause more overall harm to health in the long term than the benefit gained, if any, from slowing spread of a virus. These guidelines were ignored when an emergency was declared for COVID-19 and authority switched to an individual, the director general.

The IHR amendments further strengthen the ability of the DG to ignore any such evidence-based procedures. Working on several levels, they provide the DG, and those delegated by the DG, with exceptional and arbitrary power, and put in place measures that make the wielding of such power inevitable.

Firstly, the requirement for an actual health emergency, in which people are undergoing measurable harm or risk of harm, is removed. The wording of the amendments specifically removes the requirement of harm to trigger the DG assuming power over countries and people. The need for a demonstrable ‘public health risk’ is removed, and replaced with a ‘potential’ for public health risk.

Secondly, a surveillance mechanism set up in every country under these amendments, and discussed also in the pandemic preparedness documents of the G20 and World bank, will identify new variants of viruses which constantly arise in nature, all of which, in theory, could be presumed to pose a potential risk of outbreak until proven not to. The workforce running this surveillance network, which will be considerable and global, will have no reason for existence except to identify yet more viruses and variants. Much of their funding will originate from private and corporate interests that stand to gain financially from the vaccine-based responses they envision for infectious disease outbreaks.

Thirdly, the DG has sole authority to declare any event rated (or potentially related) to health an ‘emergency.’ (The six WHO Regional Directors (RDs) will also have this power at a Regional level). As seen with the monkeypox outbreak, the DG can already ignore the committee set up to advise on emergencies. The proposed amendments will remove the need for the DG to gain consent from the country in which a potential or perceived threat is identified. In a declared emergency, the DG can vary the FENSA rules on dealing with private (e.g. for-profit) entities, allowing him/her to share a State’s information not only with other States but with private companies.

The surveillance mechanisms being required of countries and expanded within the WHO will ensure that the DG and RDs will have a constant stream of potential public health risks crossing their desks. In each case, they will have power to declare such events a health emergency of international (or Regional) concern, issuing orders supposedly binding under international law to restrict movement, detain, inject on mass scales, yield intellectual property and know-how, and provide resources to the WHO and to other countries the DG deems to require them. Even a DG uninterested in wielding such power will face the reality that they put themselves at risk of being the one who did not ‘try to ‘stop’ the next pandemic, pressured by corporate interests with hundreds of billions of dollars at stake, and huge media sway. This is why sane societies never create such situations.

What happens next?

If these amendments are accepted, the people taking control over the lives of others will have no real legal oversight. They have diplomatic immunity (from all national jurisdictions). The salaries of many will be dependent on sponsorship from private individuals and corporations with direct financial interest in the decision they will make. These decisions by unaccountable committees will create mass markets for commodities or provide know-how to commercial rivals. The COVID-19 response illustrated the corporate profits that such decisions will enable. This is a situation obviously unacceptable in any democratic society. 

While the WHA has overall oversight on WHO policy with an executive board comprised of WHA members, these operate in an orchestrated way; many delegates having little depth in the proceedings whilst bureaucrats draft and negotiate. Countries not sharing the values enshrined in the constitutions of more democratic nations have equal vote on policy. Whilst it is right that sovereign States have equal rights, the human rights and freedom of one nation’s citizens cannot be ceded to the governments of others, nor to a non-State entity placing itself above them.

Many nations have developed checks and balances over centuries, based on an understanding of fundamental values, designed specifically to avoid the sort of situation we now see arising, where one group is law unto itself can arbitrarily remove and control the freedom of others. Free media developed as a further safeguard, based around principles of freedom of expression and an equal right to be heard. These values are necessary for democracy and equality to exist, just as it is necessary to remove them in order to introduce totalitarianism and a structure based on inequality. The proposed amendments to the IHR set out explicitly to do this.

The proposed new powers sought by the WHO, and the pandemic preparedness industry being built around it, are not hidden. The only subterfuge is the farcical approach of media and politicians in many nations who seem to pretend they are not proposed, or do not, if implemented, fundamentally change the nature of the relationship between people and centralized non-State powers. The people who will become subject to these powers, and the politicians who are on track to cede them, should start paying attention. We must all decide whether we wish to cede so easily what it has taken centuries to gain, to assuage the greed of others.

Annotated summary of significant clauses in the IHR amendments.

Notes. (Within qualities from the IHR draft, italics are added for emphasis here.

DG: Director General (Of the WHO) 
FENSA: (WHO) Framework for Engagement of Non-State Actors
IHR: International Health Regulations
PHEIC: Public Health Emergency of International Concern.
WHA: World Health Assembly
WHO: World Health Organization
“States Parties’ in UN parlance (i.e. self-governing countries) is simplified below to ‘State(s)’ or ‘country’.

See full document at the WHO IHR portal.

1. Setting the scene: Establishing WHO authority over individuals and national governments in health-related decision-making.

Article 1: Definitions

‘Health technologies and knowhow’;: Includes ‘other health technologies’, [any of these that solve a health problem and improve ‘quality of life’ and includes technologies and knowhow involved in the] ‘development and manufacturing process’, and their ‘application and usage’.

Note relevance to requirement for countries to give these up to other entities on WHO demand. This must be unacceptable to most existing legal systems and corporations.

“standing recommendation’ means non-binding advice issued by WHO

“temporary recommendation” means non-binding advice issued by WHO

‘standing recommendations’ and ‘temporary recommendations:’ The removal of the ‘non-binding’ is consistent with the requirement later for States to consider the ‘recommendations’ of the DG as obligatory.

Article 2: Scope and purpose (of the IHR)

_“The purpose and scope of these Regulations are to prevent, protect against_, prepare**, control and provide a public health response to the international spread of diseases including through health systems readiness and resilience in ways that are commensurate with and restricted to public health risk all risks with a potential to impact public health**, and which …”

Wording changed from “restricted to public health risk” to “restricted to all risks with a potential to impact public health.” Public health is an extremely broad term, and potential risks can be any virus, toxin, human behavioral change, article or other information source that could affect anything in this vast field. This is an open slather that would in operation provide the WHO with a jurisdiction over anything potentially vaguely pertaining to some change in health or well-being, as perceived by the DG or delegated staff. Such broad rights to interfere and take control would not normally be allowed to a government department. In this case, there is no direct oversight from a parliament representing people, and no specific legal jurisdiction to comply with. It allows the WHO director general to insert himself and give recommendations (no longer ‘non-binding’ to almost anything pertaining to societal life (health, in the WHO’s definition, is physical, mental and social well-being).

Article 3: Principles

“The implementation of these Regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons based on the principles of equity, inclusivity, coherence and in accordance with their common but differentiated responsibilities of the States Parties, taking into consideration their social and economic development”

This signals a fundamental change in the human rights approach of the UN, including the Universal Declaration on Human Rights (UDHR) that all UN countries have signed up to. The concept of broad, fundamental rights (equal in all) is removed, and replaced with vacuous wording ‘equity, inclusivity, coherence.’ Human rights (of the individual) are seen as based on economic and ‘social’ development. This implies that the wealthy and poor have different rights, and there is a hierarchy of ‘development’ that defines one’s rights. This is a return to a feudalist or colonialist view of human rights (in many respects the excuses used to justify slavery), that the post-War WHO and UDHR had sought to move away from.

“shall be guided by the goal of their universal application for the protection of all people of the world from the international spread of disease. When implementing these Regulations, Parties and WHO should exercise precaution, in particular when dealing with unknown pathogens.“

Again, addition of a clause that enables the WHO to override human rights previously stated, including for speculative (unknown) threats.

Article 4: Responsible authorities

Each country is required to appoint an ‘authorized responsible authority’ for WHO to liaise with. Seemingly innocuous, but reflects the mindset change in status within these regulations, with the WHO becoming a body requiring compliance, no longer ‘suggesting’ or ‘supporting.’

2. Establishing the international pandemic preparedness bureaucracy with WHO at the center

Article 5: Surveillance.

These amendments establish /expand a periodic review mechanism, similar to the UN human rights office. This seems in itself innocuous, but is a very large resource drain, especially for smaller countries, and requires (as in the human rights compliance case) a dedicated large international (WHO) bureaucracy and consultant base. WHO will require regular detailed reports, send assessors, and require changes. This raises questions both on (1) sovereignty in health and (2) rational and appropriate use of resources. WHO is not assessing the country’s health needs here, it is assessing one small aspect and dictating the resources spent on it, irrespective of other health burdens. This is a fundamentally poor and dangerous way to manage public health and means resources are unlikely to be spent for maximum benefit overall.

Article 6: Notification.

Countries (States Parties) to make information available to WHO at WHO request, and WHO can make this available to other parties (see later clauses) in a manner yet to be determined by the WHA. This may seem innocuous but in reality, removes State sovereignty over data (which had been significant prior to 2005 IHA amendments). It is unlikely that powerful States will comply, but smaller ones will be left with little choice (China has significantly inhibited information and will likely do so. It can be argued this is appropriate – such information can have significant economic and social implications).

Article 10: Verification

“If the State Party does not accept the offer of collaboration within 48 hours , WHO may shall , when justified by the magnitude of the public health risk, immediately share with other States Parties the information available to it, whilst encouraging the State Party to accept the offer of collaboration by WHO, _taking into account the views of the State Party concerned_.”

The WHO gains power to share information from a State or pertaining to a State with other States, without consent. This is remarkable: It is important to understand who the WHO is (essentially unaccountable beyond the WHA).

Article 11: Exchange of Information (Formerly provision of information by WHO). 

This article enables WHO to share information obtained as discussed above, to both UN and non-governmental bodies (allowed recipients changed from (formerly) relevant intergovernmental to (now) relevant international and regional organizations (i.e. now including organizations not related to national governments).

WHO can therefore share State information with ‘relevant international organizations’ – this presumably includes such as CEPI, Gavi, Unitaid – organizations that have private and corporate representation on their boards with direct financial conflicts of interest.

Further:

“Parties referred to in those provisions, shall not make this information generally available to other States Parties, until such time as when: (a) the event is determined to constitute a public health emergency of international concern, a public health emergency of regional concern, or warrants an intermediate public health alert, in accordance with Article 12; or …”

Widens the criteria determining when the WHO can disseminate information from sovereign States, from PHEIC to ‘health alert’ (which in practice the DG or subordinates could apply to almost anything). This could occur, as specified later in the Article, when WHO staff decide a sovereign State does not have ‘capacity’ to handle a problem, or when the WHO staff decide (with unspecified criteria) that it is necessary to share information with others to make ‘timely’ risk assessments. This allows unelected WHO staff, on salaries supported from external conflicted entities, to disseminate information from States directly relevant to those entities, based on their own assessment of risk and response, against undefined criteria.

3. Widening ‘public health emergency’ definition to include any health or pathogen-related event at DG’s discretion, and requiring States compliance.

Article 12: Determination of a public health emergency of international concern public health emergency of regional concern, or intermediate health alert

This Article both reduces the threshold for the DG to declare an emergency (it can just be a concern of a potential outbreak) and greatly increases the power of the WHO (removes requirement for State agreement) to then act.

“If the Director-General considers, based on an assessment under these Regulations, that a potential or actual public health emergency of international concern is occurring ….. determines that the event constitutes a public health emergency of international concern, and the State Party are in agreement regarding this determination, the Director-General shall notify all the States Parties, in accordance with the procedure set forth in Article 49, seek the views of the Committee established under Article 48 (but is not required to follow them)

Removes requirement for State to agree to release of information pertaining to that State. DG can declare a PHEIC against States wishes and instructions. The WHO becomes the dominant party, not the servant of the sovereign State.

Emergency committee review is optional for DG, who can act completely alone in determining PHEIC – a decision that can have vast health, social and economic implications and is allowed above to abrogate basic human rights norms.

_If, following the consultation in paragraph 2 above, the Director-General and the State Party in whose territory the event arises do not come to a consensus within 48 hours on whether the event constitutes a public health emergency of international concern, a determination shall be made in accordance with the procedure set forth in Article 49_.

Removes requirement of DG to seek agreement of State before acting. 

“Regional Director may determine that an event constitutes a public health emergency of regional concern and provide related guidance to States Parties in the region either before or after notification of an event that may constitute a public health emergency of international concern is made to the Director-General, who shall inform all States Parties”

Regional directors appear to be granted similar powers, though full implications are unclear.

“In case of any engagement with non-State actors in WHO’s public health response to PHEIC situation, WHO shall follow the provisions of Framework for Engagement of Non-State Actors (FENSA). Any departure from FENSA provisions shall be consistent with paragraph 73 of FENSA.”

The WHO Framework for Engagement of Non-State Actors (FENSA) allows the DG to “exercise flexibility in the application of the procedures of FENSA” in the case of a health emergency (which here in the IHR is widened, as above, to any concern the FG has of potential harm, irrespective of State agreement.

“Developed State Parties and WHO shall offer assistance to developing State Parties depending on the availability of finance, technology and know how…”.

A line fascinating mainly for its anachronistic (but telling) use of the colonialist-like terms developing and developed in this formerly egalitarian WHO context. 

“The State Party shall accept or reject such an offer of assistance within 48 hours and, in the case of rejection of such an offer, shall provide to WHO its rationale for the rejection, which WHO shall share with other States Parties. Regarding on-site assessments, in compliance with its national law, a State Party shall make reasonable efforts to facilitate short-term access to relevant sites; in the event of a denial, it shall provide its rationale for the denial of access”

WHO set as the dominant partner. The State must comply or provide excuses for not agreeing with WHO’s dictates.

“When requested by WHO, States Parties should shall provide, to the extent possible, support to WHO-coordinated response activities, including supply of health products and technologies, especially diagnostics and other devices, personal protective equipment, therapeutics, and vaccines, for effective response to PHEIC occurring in another State Party’s jurisdiction and/or territory, capacity building for the incident management systems as well as for rapid response teams”.

‘Should’ changed to ‘Shall,’ requiring States to provide resources at the WHO’s request for a PHEIC (e.g. monkeypox of an event the DG considers may pose a potential threat.) This begins a theme of the WHO acquiring the ability to order States to provide resources, and (later) know-how and intellectual property when ordered by the DG to do so.

NEW Article 13A WHO Led International Public Health Response

This new article explicitly lays out the new international public health order, with the WHO in charge at the center, rather than national sovereignty being paramount.

“States Parties recognize WHO as the guidance and coordinating authority of international public health response during public health Emergency of International Concern and undertake to follow WHO’s recommendations in their international public health response.”

This requires States to follow WHO recommendations in a PHEIC – declared by an individual (DG) whose position is determined by non-democratic states and who is open to wide influence by private and corporate money. The criteria for PHEIC are deliberately vague, and at the DG’s discretion. This is an amazing reversal of roles of the WHO versus States, and clearly abrogates sovereignty.

The wild failure of Covid response, and the WHO’s abrogation of its own guidelines, should give pause for thought here. The WHO could mandate abrogation of bodily autonomy on states regarding medication or vaccination, or testing.

“Upon request of WHO, States Parties with the production capacities shall undertake measures to scale up production of health products, including through diversification of production, technology transfer and capacity building especially in the developing countries.”

The WHO can require (tell) countries to scale-up production of certain products – to interfere with markets and commerce, at the WHO’s (DG’s) discretion.

NEW Article 13A WHO Led International Public Health Response

“**States Parties recognize WHO as the guidance and coordinating authority of international public health response during public health Emergency of International Concern and undertake to follow WHO’s recommendations in their international public health response**.”

This requires States to follow WHO recommendations in a PHEIC – declared by an individual (DG) whose position is determined by non-democratic states and who is open to wide influence by private and corporate money. The criteria for PHEIC are deliberately vague, and at the DG’s discretion. This is an amazing reversal of roles of WHO versus States, and clearly abrogates sovereignty. It is requiring sovereign states to submit themselves to an external authority, whenever that authority desires it (as the WHO DG can through previous amendments above, declare a PHEIC on the basis of just perceiving the potential form an infectious disease event).

The Covid response, including the WHO’s abrogation of its own guidelines and policies, should give pause for thought here. The WHO could mandate abrogation of bodily autonomy on states regarding medication or vaccination, or testing. 

“**Upon request of WHO, States Parties with the production capacities shall undertake measures to scale up production of health products, including through diversification of production, technology transfer and capacity building especially in the developing countries.**”

The WHO can require (tell) countries to scale-up production of certain products – to interfere with markets and commerce, at WHO’s (DG’s) discretion.

“ [WHO] shall collaborate with other international organizations, and other stakeholders consistent with the provisions of FENSA, for responding to public health emergency of international concern.**”**

This enables the WHO to collaborate with non-State actors (private individuals, Foundations, private corporations (Pharma, its sponsors etc.). FENSA, which restricts such contacts, can be varied by the DG in a ‘health emergency’ that the DG declares.

4. WHO requiring countries to provide resources, intellectual property and knowhow at WHO’s discretion.

New Article 13A: Access to Health Products, Technologies and Know-How for Public Health Response

“States Parties shall co-operate with each other and WHO to comply with such recommendations pursuant to paragraph 1 and shall take measures to ensure timely availability and affordability of required health products such as diagnostics, therapeutics, vaccines, and other medical devices required for the effective response to a public health emergency of international concern.”

The WHO determines response within States’ borders, and requires States to provide aid to other countries. At the WHO’s behest.

“**States Parties shall provide, in their intellectual property laws and related laws and regulations, exemptions and limitations to the exclusive rights of intellectual property holders to facilitate the manufacture, export and import of the required health products, including their materials and components**.”

States shall change their intellectual property (IP) laws, to allow sharing of IP on the DG’s determination of a PHEIC, at his/her discretion, to whom they determine. It is difficult to imagine a sane State would do this, but it is clearly required here.

“States Parties shall use or assign to potential manufacturers, especially from developing countries, on a non-exclusive basis, the rights over health product(s) or technology(ies)”

The WHO can require IP to be shared with other States (and thereby IP is passed to private corporations within those States.

“Upon request of a State Party, other States Parties or WHO shall rapidly cooperate and share relevant regulatory dossiers submitted by manufacturers concerning safety and efficacy, and manufacturing and quality control processes, within 30 days”

Requirement to release confidential regulatory dossiers to other States, including to WHO qualification programme, and to sovereign state regulatory agencies.

“[WHO shal]… establish a database of raw materials and their potential suppliers, e) establish a repository for cell-lines to accelerate the production and regulatory of similar biotherapeutics products and vaccines”,

WHO holding such materials is unprecedented. Under whose laws and regulatory requirements would this be done? Who is responsible for damage and harm?

“**States Parties shall take measures to ensure that the activities of non-state actors, especially the manufacturers and those claiming associated intellectual property rights, do not conflict with the right to the highest attainable standard of health and these Regulations and are in compliance with measures taken by the WHO and the States Parties under this provision, which includes:**

a) to comply with WHO recommended measures including allocation mechanism made pursuant to paragraph 1. 

b) to donate a certain percentage of their production at the request of WHO.

c) to publish the pricing policy transparently.

d) to share the technologies, know-how for the diversification of production.

e) to deposit cell-lines or share other details required by WHO repositories or database established pursuant to paragraph 5.

f) to submit regulatory dossiers concerning safety and efficacy, and manufacturing and quality

control processes, when called for by the States Parties or WHO.”

The ‘highest attainable standard of health is beyond what any State has now. This effectively means, as worded, that the WHO can require any state to release almost any confidential product and intellectual property on any product related to the health sector.

This is an amazing list. The DG (WHO) on their own criteria can declare an event, then require a State to contribute resources and give up sole rights to intellectual property of its citizens, and share information to allow others to manufacture their citizen’s products in direct competition. The WHO also requires States to donate products to the WHO /other States on DG’s demand.

To understand the scope of the intellectual property rights to be forfeited to the DG, the definitions (Article 1) describe them as:

“health technologies and know-how” includes organized set or combination of knowledge, skills, health products, procedures, databases and systems developed to solve a health problem and improve quality of life, including those relating to development or manufacture of health products or their combination, its application or usage …”.

5. WHO claiming control of individuals and their rights within States

Article 18 Recommendations with respect to persons, baggage, cargo, containers, conveyances, goods and postal parcels.

“Recommendations issued by WHO to States Parties with respect to persons may include the following advice:…..

–      review proof of medical examination and any laboratory analysis;

• require medical examinations;
• review proof of vaccination or other prophylaxis;
• require vaccination or other prophylaxis;
• place suspect persons under public health observation;
• implement quarantine or other health measures for suspect persons;
• implement isolation and treatment where necessary of affected persons;
• implement tracing of contacts of suspect or affected persons;
• refuse entry of suspect and affected persons;
• refuse entry of unaffected persons to affected areas; and
• implement exit screening and/or restrictions on persons from affected areas.”

This (article 18) was already in existence. New Article 13A, however, now requires States to follow WHO recommendations. The WHO will thus now be able to, based on the sole determination of an individual (DG) under influence of non-democratic states and private entities, order states to incarcerate their citizens, inject them, require identification of medical status, medically examine, isolate and restrict travel.

This is clearly insane.

“[Recommendations issued by WHO shall]…ensure mechanisms to develop and apply a traveller’s health declaration in international public health emergency of international concern (PHEIC) to provide better information about travel itinerary, possible symptoms that could be manifested or any prevention measures that have been complied with such as facilitation of contact tracing, if necessary.”

The WHO can require the availability of private travel (itinerary) information, and require the provision of medical travel documents. This is requiring the disclosure of private medical information to the WHO.

Article 23 Health measures on arrival and departure

“Documents containing information concerning traveller’s destination (hereinafter Passenger Locator Forms, PLFs) should preferably be produced in digital form, with paper form as a residual option. Such information should not duplicate the information the traveller already submitted in relation to the same journey, provided the competence authority can have access to it for the purpose of contact tracing.”

Text (which clearly needs further work) aimed at future requirements for vaccine passports for travel.

6. WHO setting the scene for digital health passports

Article 35 General rule

“**Digital health documents must incorporate means to verify their authenticity via retrieval from an official web site, such as a QR code.**”

Further presaging digital IDs containing health information, that must be available to enable travel (i.e. not at individual’s discretion).

Article 36 Certificates of vaccination or other prophylaxis

“Such proofs may include test certificates and recovery certificates. These certificates may be designed and approved by the Health Assembly according to the provisions set out for digital vaccination or prophylaxis certificates, and should be deemed as substitutes for, or be complementary to, the digital or paper certificates of vaccination or prophylaxis.”

As above. Setting up the WHO/WHA to set international travel requirements (the UDHR says there is a basic right to travel). While not new here, this is expanded by the expansion of PHEIC provisions, and focused more on the DG’s determination. It is moving from national sovereignty to a transnational travel control beyond national sovereignty – not directly answerable to populations, but heavily funded and influenced by private interests.

“Health measures taken pursuant to these Regulations, including the recommendations made under Article 15 and 16, shall be initiated and completed without delay by all State Parties”

Requirement for all countries to comply with these recommendations (they only take 50 percent of the WHA to implement).

“State Parties shall also take measures to ensure Non-State Actors operating in their respective territories comply with such measures**.”**

Also requires private entities and citizens within the state to comply (which likely requires changes of many national laws, and the relationship between government and people).

This requires a totalitarian approach from the State, subject to a totalitarian approach from a supra-state (but clearly not meritocratic) entity. Following these IHR revisions, the DG of WHO, at his discretion, has the capacity to order private entities and citizens in any country to comply with his/her directives.

7. WHO being empowered to order changes within States, including restrictions on freedom of speech.

Article 43 Additional health measures

“[Measures implemented by States shall not be more restrictive than.]… would achieve attain the appropriate highest achievable level of health protection.”

These changes are very significant. Appropriate’ meant taking into account the costs and balancing these against potential gains. It is a sensible approach that takes the whole of society and population needs into account (good public health).

‘highest achievable level of protection’ means elevating this problem (an infectious disease or potential disease) above all other health and human/societal concerns. This is stupid, and probably reflects lack of thought and poor understanding of public health.

“WHO may request that shall make recommendations to the State Party concerned reconsider to modify or rescind the application of the additional health measures …”

On removing health interventions, the WHO DG now can require such actions (States have agreed to ‘recommendations’ being binding above). As elsewhere, the WHO is not the instructing party, not the suggesting party. The WHO takes sovereignty over formerly State matters. The following paragraph requires a response in 2 weeks rather than formerly 3 months.

Article 44 Collaboration and assistance

“States Parties shall undertake to collaborate with and assist each other, in particular developing countries States Parties, upon request, _to the extent possible_, in:…”

Changes move the relationship from the WHO suggesting/requesting, to the WHO requiring.

“in countering the dissemination of false and unreliable information about public health events, preventive and anti-epidemic measures and activities in the media, social networks and other ways of disseminating such information.”

States undertake to work with the WHO to control information and limit free speech.

“the formulation of proposed laws and other legal and administrative provisions for the implementation of these Regulations.”

States agree to pass laws to implement restrictions on free speech and sharing of information.

“countering the dissemination of false and unreliable information about public health events, preventive and anti-epidemic measures and activities in the media, social networks and other ways of disseminating such information;…”

The WHO shall work with countries to control free speech and flow of information (based on their own criteria of what is right and wrong).

8. Nuts and Bolts of the verification bureaucracy to ensure countries follow WHO requirements.

NEW Chapter IV (Article 53 bis-quater): The Compliance Committee 

53 bis Terms of reference and composition

“The State Parties shall establish a Compliance Committee that shall be responsible for:

(a) Considering information submitted to it by WHO and States Parties relating to compliance with obligations under these Regulations;

(b) Monitoring, advising on, and/or facilitating assistance on matters relating to compliance with a view to assisting States Parties to comply with obligations under these Regulations;

(c) Promoting compliance by addressing concerns raised by States Parties regarding implementation of, and compliance with, obligations under these Regulations; and

(d) Submitting an annual report to each Health Assembly describing:

(i) The work of the Compliance Committee during the reporting period;

(ii) The concerns regarding non-compliance during the reporting period; and (iii) Any conclusions and recommendations of the Committee.

2. The Compliance Committee shall be authorized to:

(a) Request further information on matters under its consideration;

(b) Undertake, with the consent of any State Party concerned, information gathering in the territory of that State Party; (c) Consider any relevant information submitted to it; (d) Seek the services of experts and advisers, including representatives of NGOs or members of the public, as appropriate; and (e) Make recommendations to a State Party concerned and/or WHO regarding how the State Sarty may improve compliance and any recommended technical assistance and financial support.”

This sets up the permanent review mechanism to monitor the compliance of States with the WHO’s dictates on public health. This is a huge new bureaucracy, both centrally (WHO) and with a significant resource drain on each State. It reflects the review mechanism of the UN human rights office.

9. More on WHO requiring states to provide taxpayer money to WHO’s work, and restricting freedom of populations to question this work.

ANNEX 1 

A. CORE CAPACITY REQUIREMENTS FOR DISEASE DETECTION, SURVEILLANCE 

AND HEALTH EMERGENCY RESPONSE

“**Developed Countries States parties shall provide financial and technological assistance to the Developing Countries States Parties in order to ensure state-of-the-art facilities in developing countries States Parties, including through international financial mechanism…”**

States shall provide (i.e. divert from other priorities) aid funding to help other States develop capacity. This has a clear opportunity cost in other disease/societal programs where funding must accordingly be reduced. However, this will no longer be in the budgetary control of States, but required by an external entity (WHO).

“**At a global level, WHO shall… Counter misinformation and disinformation”.**

As above, the WHO takes the role of policing / countering free speech and exchange of information (funded by the taxes of those whose speech they are suppressing).

Useful links

The WHO documents regarding the IHR amendments
A summary of the amendments and their implications

WGIHR_Compilation-Annotated-1

Author

David Bell, Senior Scholar at Brownstone Institute, is a public health physician and biotech consultant in global health. He is a former medical officer and scientist at the World Health Organization (WHO), Programme Head for malaria and febrile diseases at the Foundation for Innovative New Diagnostics (FIND) in Geneva, Switzerland, and Director of Global Health Technologies at Intellectual Ventures Global Good Fund in Bellevue, WA, USA.

[](https://brownstone.org/author/david-bell/)

Multiple people have sent me the same story, on various blogs, in the last 48 hours. Just released medical studies show that mRNA COVID "vaccines" teach the human immune system to ignore and tolerate coronavirus-spike-protein, and also cancer-cells.

 We have multiple kinds of immunoglobulins ("antibodies") that we make to help us maintain health.

• IgM is the rapid-response immunoglobulin, like EMS.
• IgG comes in just before 2 weeks, and is the long-term learned antibody response. There are 4 kinds of IgG examined here, IgG1-4.
• IgG 1-3 antibodies bind to foreign proteins, like viral membranes, coat them, prevent them from working, and prepare them to be chewed-up by certain types of white blood cells. 
• IgG4 is different, a tolerance-antibody, which tags a thing in the body as "Don't-Destroy".

IgG4 responses are appropriate when the body is repeatedly exposed to non-harmful things like ragweed-pollen, which should not be ferociously attacked, because that causes more harm than ignoring them. When a person gets "Allergy Shots" of small amounts of what they are allergic to over a long time, and slowly increasing the amount, they are training this kind of immune response to ignore the allergen.

The Pfizer/Biontech mRNA product is what has been primarily tested, and it is assumed that the Moderna product, being so very similar, has the same effect of inducing IgG4 antibodies to the spike-protein of SARS-CoV2, as well as IgG3 antibodies, "blocking antibodies" early-on. The graphs show that after the first and second shot, the blocking antibodies increase and predominate, but as the months go by, following the second shot, the IgG3 blocking antibodies wane, and the IgG4 tolerance-antibodies increase. 

This is the same time frame that we have seen for the transition from "vaccines" inhibiting the coronavirus initially, but seeming to make infection with the coronavirus more-likely after 5-6 months. The world is now 3 years into this pandemic, and should be over it for the most part, but cases of infection are increasing across the world, notably in the more "vaccinated" countries and cities. The coronavirus levels in city sewage are the highest that they have ever been. in highly-"vaccinated" cities.

After a third "booster" injection of mRNA "vaccine", there is essentially no measurable IgG3, just high levels of IgG4. The immune system has been taught to ignore the SARS-CoV2 spike protein from January 2020. There is more to the virus than the 20% which is the spike-protein. People who caught COVID before getting mRNA "vaccine products" will still have their natural antibodies to the other 80% of the virus, but those who were mRNA "vaccinated" first, will probably have little to no antibodies other than those induced by the injection. Most of the human population has a gaping hole, the very same gaping hole in its immunologic defenses. 

Igor s Newsletter - Booster-Caused IgG4 Immune Tolerance Explains Excess Mortality and "Chronic Covid"

The world is therefore extremely susceptible to an infection which will breach that hole in the defenses of the "vaccinated". An engineered military coronavirus could be designed specifically to exploit that vulnerability, but coronaviruses will naturally mutate to whatever works, and exploit it without laboratory assistance. The current strains of coronavirus in circulation are very contagious, especially to the "vaccinated" and "boosted", but not often fatal, since they do not bind to ACE-2 receptors in the lungs and blood-vessels, as the pre-Omicron strains all did. The Omicron and later strains bind to the upper airways, like a "normal cold".

Arkmedic's blog - Two papers have appeared in quick succession that just need to be put together

Unacceptable Jessica - The immunological mechanism of action for lost immunity, a shift to tolerance and autoimmunity from the shots

Alex Berenson - Do Covid mRNA vaccines damage our ability to control the coronavirus after a booster shot?

The same NK-cells ("natural killer cells") that destroy viral-infected-human-cells also destroy mutated cells which become cancers if they multiply unchecked.

The suppression of this cancer-surveillance function leads to rapid growth of existing cancers. This is seen with people who have been undergoing treatment for cancer, and suddenly worsen after "vaccination" and "boosting". It would also allow new cancers to develop from mutated cells, which would take a little longer to notice, but would present as "suddenly developed cancer". This is happening, too. I recently posted this story below.

Academic Medical Oncologist Angus Dalgleish in the UK has been trying to get government agencies to evaluate the sudden rash of cancer recurrences, new diagnoses and deaths among the "vaccinated". Other cancer specialists agree with me about vaccine harm, but the authorities still won't listen

To summarize the timeline of adverse events we can say that some people get severe reactions like anaphylaxis and heart-inflammation quickly, which may kill them within hours to days. Other clotting disorders may kill them from bleeding, perhaps into their brains, within the first 2-4 weeks following the first or second injection. Production of large blood clots that block the lungs, major arteries, coronary arteries, or arteries feeding the brain, eyes or other vital organs may cause severe disability or death. Autoimmune disease, caused by similarities between parts of the spike protein, and normal proteins in the body, can cause chronic inflammation of organs like the liver and heart. Spike-protein in the bloodstream can cross into the brain, and cause it to be inflamed from autoimmune disease.

The function of the mRNA "vaccine products" is to get into human cells and induce them to produce and release January 2020 COVID spike-protein, which process continues for half a year, based upon spike-protein being found in the blood of "fully-vaccinated" 2-shot recipients at 6 months following the second injection. mRNA usually is degraded by enzymes in human cells after a few minutes, but the mRNA in these "vaccine products" has been modified so that it is not  ever broken down by those enzymes. 

What we see happening is analogous to the person getting "allergy shots" to become tolerant to pollen allergies. There is a long-term presence of January 2020 COVID spike-protein in the bodies of mRNA COVID "vaccine product" recipients. 

It stands to reason that this is what induces the IgG4 "tolerance antibody" response by the immune system. That has not yet been "proven", but it is a useful way to look at what has now been revealed, and it fits well with our understanding. It provides a working hypothesis, unless that hypothesis must later be revised for new information about the mechanisms of action of these experimental products in human immune systems.

Regrets:

Professor Shmuel Shapira, who headed the Israel Institute for Biological Research from 2013 to 2021, and led Israel's domestic coronavirus vaccine development program, has castigated the Health Ministry both over its push to impose lockdowns in 2020 and 2021, as well its support for the mass-vaccination campaign beginning in December 2020.

In a series of tweets, Professor Shapira criticized the Health Ministry for deeming Pfizer s mRNA vaccines safe and effective, and lamented having received three doses of the vaccine himself. "I am telling the unpleasant truth out the vaccine that is neither effective nor safe, " Shapira wrote. "I was wrong 3 times: In the first shot, in the second shot, and in the third shot."

Who said that those who are injected do not admit that they were wrong? People keep forgetting Israel was volunteered as the Lab of the World. There was hardly any data but very brief and minimal size clinical studies.

Global Disaster. Govt. Database Shows 10,000% Increase In Cancer Reports Due To Covid Vaccines. The damage caused by the coronavirus and the halting of studies in Israel (second place in the world) reveal a wave of problems in reading comprehension. So we will explain to you slowly and in easy Hebrew. _Hello First Grade: Those who are opponents and victims of injecting what is ineffective and unsafe are not opponents of vaccines, and certainly not vaccine deniers.

Jessica Rose Ph.D. has more on the cover-up of deaths and adverse events from COVID "vaccination". Information, already released, is "disappeared". Unacceptable Jessica - The lost myocarditis, death, neuropathy and pulmonary embolism safety signals as part of the free text purge from the VAERS Foreign data set

Questions about fertility issues, stillbirths, and neonatal deaths began to be raised last winter when Scotland experienced a month of higher infant mortality than at any time over the past three decades. Then in the spring of 2022, roughly nine months after most young adults were jabbed with the COVID shots, COVID data analysts began noticing unusual drops in birth rates. The hope was that these numbers were just short-term aberrations due to some unknown transient cause. But months later, the evidence is growing too strong to ignore, suggesting a much longer-term problem, which bizarrely has garnered little concern from policymakers, governments, the medical establishment, or the media. It ranks alongside died suddenly both in terms of its magnitude to humanity and the shocking degree of silence in response.

In fact, some media outlets were even celebrating the low birth rates without expressing any curiosity as to the sudden cause.

Sweden is a perfect country to study because it never locked down and should not have been affected socially by the lockdowns. Yet not only did the Swedes experience a sharp decline in births nine months after their vaccination program, the numbers are further deteriorating over time.

Furthermore, any hypothesis as to the cause of the plummeting birth rates would also have to logically account for the rise in neonatal deaths. For example, lockdowns would not explain why the babies being born are experiencing more health problems. The spike protein embedded in the babies blood, however, would.

Israeli researcher Josh Guetzkow obtained neonatal death data from Israeli health insurance fund Maccabi, which covers 25% of Israelis. He found a tripling of neonatal deaths in two of the quarters post-vaccination.

What if the  world is "sane" but the owners want to quietly kill half of us? In a sane world, the makers of these therapies would be behind bars, but instead they are getting a promotion to concoct even more products with this same dangerous technology.

Typically, failure of a corporate partner is an impetus for a government to break the partnership. In the case of vaccines, however, the more they fail, the more they are elevated, subsidized, and even mandated. Unless their definition of failure is the opposite of how humanity would define it.

Proceedings were paused at the public inquiry looking into the federal government's use of the Emergencies Act on Thursday afternoon after a medical incident.

A lawyer representing the Public Order Emergency Commission collapsed while he was questioning Ontario's deputy solicitor general, the second witness of the day.

One of the patterns you observe at every level in nature is that there are niches: Roles to play in an ecosystem that allow you to survive for an extended period of time. As you enter a niche and begin to dominate it, your environment will polish you like a raw gem, until eventually you perform your role in an optimal manner.

There’s this example, of Fortune 500 multinational corporations, which signal the pride flag in Western nations, but not in the Middle East or Africa. Institutions don’t really hold beliefs. Rather, they attempt to fit into their local niche through mutation. In the West that means the Catholic church for example will pretend to be OK with homosexuality. Corporations can go a step further, unbound by tradition they can proclaim they’re all in favor of all sorts of stuff.

Natural selection operates on institutions along with organisms. The Catholic church has survived for 2000 years, because it always sought to maintain appeal to wide sections of society. And so although it technically teaches you can go to hell for masturbation, it can simultaneously uphold an impression of having no real qualms with homosexuality anymore. The truth is that it will teach whatever its environment requires it to teach.

Religions are like viruses that infect the mind, they can be benign or virulent, depending on the environment they find themselves in. They also compete for hosts. Virulent versions like Salafism or Mormon fundamentalism can destroy lives, as patriarchs will end up marrying teenage girls and raping their own sons. These religions suffer from interference however. A more benign version like Hinduism, Buddhism, Evangelical Christianity or Catholicism will prevent such a highly virulent version from finding a host for itself.

As the population’s immune system develops, as people begin to recognize the damage caused to their society by virulent expressions of a religion, it becomes forced to evolve towards more benign forms, as its alternative is extinction through aggressive rejection. The Catholic church became more tolerant over time, as its alternative was to go extinct. Dutch priests who spend their days bemoaning unmarried couples living together, or homosexuality, or emphasizing other such doctrines tend to alienate what little flock they have left. Survival thus only happens insofar as the system purges more virulent variants of itself.

Once a religion becomes too benign however, once it ceases to control its followers lives, it risks moving towards extinction. If it’s benign enough to tolerate birth control, it becomes harder to produce new adherents. If it’s benign enough to cease warning people of hell, it’s benign enough for people to stop bothering with proselytizing. If a society’s immune system has grown sufficiently intolerant of the religion, it can drive it into extinction, but its myopic focus on its target can lead it to be blindsided by more virulent primitive versions that move into its host.

LGBTQI+ can be thought of as a competing religion that the immune system doesn’t recognize as a danger. It has its own theological doctrines reminiscent of neoplatonism, with people who have pre-existent “male” or “female” essences, that can be born into the “wrong body”, which can be solved through surgical and hormonal alterations to produce the “right body”, congruent with the pre-existing “gender identity”. It’s a religion shrouded in mystery that takes hold in societies that have eliminated competing religions.

Organisms tend to manipulate their environment to favor their own proliferation. If you have lactic acid bacteria and yeast in dough, they create the kind of PH and other environmental conditions that make it impossible for other organisms to conquer the bread. Similarly, religions try to create the kind of environment in which they can sustain themselves. For Catholicism this means abortion is eliminated, along with Internet porn. This then leads people to seek out sex with others, which leads to pregnancy, often unplanned, which then forces young people into the nuclear family framework that is compatible with Christian culture.

LGBTQI+ similarly creates an environment compatible with its own proliferation. You bombard social media with beautiful girls, so that the other girls start feeling insecure, they dissociate from their gender, feel unattractive to men and consider lesbianism or “non-binary” gender and associated solutions to their situation. Similarly, proliferation of Internet porn creates perverse sexual fetishes in men, which also helps proliferate the religion. Islam does similar things: By encouraging polygamy, the religion creates a deficit of women that men can have marital relations with. Those men are then encouraged to go out and conquer other communities.

This is basically the mob principle. You have different mobs to which you can pay protection money. The benign mob shatters your store’s window, the more virulent variants leave a horse’s head in your bed. If you pay the benign mob, it will help you avoid having to deal with the virulent mob, as they don’t wish to lose their milk cow.

But if you zoom in deep enough, at the level of self-replicating genetic material, you also encounter this principle. Before SARS-COV-2, there were four known corona viruses that regularly occupy our body. Those viruses are a product of natural selection. Their ancestors would have been relatively virulent, they would have injured or killed quite a few people they infected.

People who were infected with virulent variants of these viruses, would develop immunity that is relatively long-lasting and aggressive. People who were infected with more benign variants on the other hand, would develop less aggressive immunity. This would open them up to tolerance of the virus, or it would enable reinfection. Over time, the population would develop immunity against epitopes associated with virulence. And thus over time the four corona viruses known to infect our species became relatively benign, as is generally the case for all respiratory viruses capable of reinfection.

You don’t need the whole population to have immunity against every single epitope associated with virulence. In fact, a homogeneous immune response against anything is quite dangerous. Rather, you just need to make sure that every epitope associated with virulence, invokes a sufficiently aggressive immune response in a portion of the population, that more benign alternative varieties end up with a fitness advantage. When one in every ten shopkeepers shoots a mob guy who threatens him with a gun, variations of the mob that simply break your window will have a selective advantage.

The four known hCov viruses need to be thought of as benign domesticated versions of religion. You could think of a version of LGBTQIA+ that ceased believing in making fake penises out of forearm skin but now simply encourages girls to have boyish haircuts, or a version of Mormonism that ceased believing in polygamy. Through interference, these benign versions prohibit more virulent versions from spreading themselves. When you create a vacuum on the other hand, when you leave the niche unoccupied, it’s conquered by whatever shows up first, which tends to be something that aggressively replicated itself without consideration for its host.

The hCov viruses are capable of causing asymptomatic SARS-COV-2 infections, or preventing infection altogether. They are benign versions of the mob, that prevent SARS-COV-2 from spreading itself. Other viruses like rhinovirus also show such an effect. The social distancing experiment could be thought of as an attempt at State Atheism, that basically sought to ban all religions. Then once the experiment ended, Salafist extremism rapidly became the new form of Islam.

Rather than eliminating SARS-COV-2 through its social distancing experiments, Germany appears to have succeeded at almost eliminating the hCov viruses. The social distancing experiments would have caused a genetic bottleneck for these viruses. Whatever versions then survived were no match for the rapidly expanding genetic diversity and increasing ACE2 affinity of novel SARS-COV-2 variants. Just as the hCov’s interfere with SARS-COV-2, SARS-COV-2 interferes with its four cousins. And so the result could be a virological state shift: Just as a jellyfish dominated ocean creates the kind of conditions in which fish can’t replenish themselves, SARS-COV-2 can prevent the hCov’s from reestablishing themselves.

And so now you’re dealing with a situation where you chased the old mob out of town, only to be met with a new mob that is far more cruel. And when it comes to the process of viral domestication, people have been far too optimistic. You can go back a year and see how everyone hailed the arrival of Omicron as the end of the pandemic, yet today your excess mortality in the EU is higher than it was in 2021 and 2020 for the same period. The virus became less virulent but better capable of spreading itself. It is now readily returning to higher levels of virulence, as there is simply no proper discrimination against virulence-associated factors yet due to the mass vaccination program.

Medieval Europeans had wolf bounties, you could be paid for exterminating wolves, as they were recognized as dangerous animals that kill people and livestock. This is how wolves were exterminated in multiple countries. The same thing was done to bears, people received bounties for killing bears, which drove Norwegian bears into near extinction by the 1920’s. To such people, the idea that we would eventually regret extermination bears or wolves, that we would come to recognize them as vital elements of our ecosystem, would have been unthinkable.

In a similar manner, I’m quite convinced that as the global SARS-COV-2 experiment continues, along with the LGBTQI+ experiment, people will eventually start to look for ways to reign in the effect that these virulent viruses have on our population. There is a live vaccine against SARS-COV-2, that naturally spreads through populations. It’s called an hCov virus. How much genetic diversity of these viruses have we already lost? There may be rare variants out there, now lost to time, that would have infected people who were now infected with SARS-COV-2.

With every new virus that infects a population, it remains to be seen whether it is capable of losing its virulent characteristics. We’ve seen with Islam numerous times throughout history that virulent forms resurface. We’re biased by the anthropic principle: Viruses that don’t lose virulence would have wiped us out, so we wouldn’t be around to observe them today.

It could be that LGBTQI+ can’t lose its virulence, that installing fake penises on insecure teenage girls or making surgical wounds in porn-addicted nerds is a kind of fundamental pillar of this religion that no mutation can eliminate. LGBdroptheT was an attempt at producing a less virulent version of the religion, but it doesn’t get far.

Similarly, there’s no strict guarantee that SARS-COV-2 can lose its virulence. We fundamentally just don’t know. If virulence enables reinfection by killing or damaging T-cells, or if the virulence is tied to the furin cleavage site and losing that site creates a massive transmission disadvantage, then it’s possible to see a scenario in which this is just a permanent burden on our population that reduces life expectancy and accelerates the aging process for the rest of human history.

In that case, your best option may be something akin to rewilding of European nature. Rather than continuing the catastrophic social distancing experiments which attempt to artificially maintain a vacuum, you could become witness to intentional seeding of the hCov viruses. For those viruses to receive a helping hand in their natural role of functioning as a benign version of the mob against more cruel corona viruses that jump into our species from other animals could then enable them to move SARS-COV-2 towards extinction, aided by our own buildup of immunity against virulence associated epitopes over time.

Does this sound strange to you? Well then I would ask you: What do you think the polio virus vaccines are? They are an attempt to reduce the health impact of polio, by spreading more benign versions of the polio virus. Instead of 5000 cases of paralysis per million infections, these benign versions cause 3 cases per million. And similarly, the hCov’s are benign corona viruses that have withstood the test of time: We know they won’t spontaneously revert to some malignant form.

Attempts to eliminate the benign respiratory viruses need to be thought of as the insistence that the left has to kill off the vestiges of religion in the West. More virulent forms will just invade the niche: Salafism, LGBTQ, tradcats etc.

And just as the benign respiratory viruses train and strengthen the body so that it can deal with more malignant viruses, the benign religions train and strengthen the mind, so that it learns to be critical of authority. The absurdities and cruelties that happen within the religious system teaches you that all power has to be examined skeptically, even when it appeals to absolute unquestionable truths.

Without this kind of provoked immune response against authority, people stand no real chance when they are faced with a far more a malignant form, like a wealthy surgeon who proclaims in the name of “Science” that their LGBTQIA+ adhering daughter should have her breasts amputated.

And so perhaps we shouldn’t just be seeding the hCov’s. Perhaps we should start seeding the old religions again too.

Full paper - PDF 50 Pages Posted: 12 Sep 2022

• Kevin Bardosh
  University of Washington; University of Edinburgh - Edinburgh Medical School
• Allison Krug
  Artemis Biomedical Communications LLC
• Euzebiusz Jamrozik
  University of Oxford
• Trudo Lemmens
  University of Toronto - Faculty of Law
• Salmaan Keshavjee
  Harvard University - Harvard Medical School
• Vinay Prasad
  University of California, San Francisco (UCSF)
• Martin A. Makary
  Johns Hopkins University - Department of Surgery
• Stefan Baral
  John Hopkins University
• Tracy Beth Høeg
  Florida Department of Health; Sierra Nevada Memorial Hospital

Date Written: August 31, 2022

Abstract

Students at North American universities risk disenrollment due to third dose COVID-19 vaccine mandates. We present a risk-benefit assessment of boosters in this age group and provide five ethical arguments against mandates. We estimate that 22,000 - 30,000 previously uninfected adults aged 18-29 must be boosted with an mRNA vaccine to prevent one COVID-19 hospitalisation. Using CDC and sponsor-reported adverse event data, we find that booster mandates may cause a net expected harm: per COVID-19 hospitalisation prevented in previously uninfected young adults, we anticipate 18 to 98 serious adverse events, including 1.7 to 3.0 booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of grade ≥3 reactogenicity which interferes with daily activities. Given the high prevalence of post-infection immunity, this risk-benefit profile is even less favourable. University booster mandates are unethical because: 1) no formal risk-benefit assessment exists for this age group; 2) vaccine mandates may result in a net expected harm to individual young people; 3) mandates are not proportionate: expected harms are not outweighed by public health benefits given the modest and transient effectiveness of vaccines against transmission; 4) US mandates violate the reciprocity principle because rare serious vaccine-related harms will not be reliably compensated due to gaps in current vaccine injury schemes; and 5) mandates create wider social harms. We consider counter-arguments such as a desire for socialisation and safety and show that such arguments lack scientific and/or ethical support. Finally, we discuss the relevance of our analysis for current 2-dose CCOVIDovid-19 vaccine mandates in North America.

Note: Funding: This paper was partially supported by a Wellcome Trust Society and Ethics fellowship awarded to KB (10892/B/15/ZE) and Wellcome Trust grants to EJ (216355, 221719, 203132).
Competing Interest Statement: We do not have any competing interests to declare.

Keywords: COVID-19 vaccines, mandates, ethics, young adults, risk-benefit analysis

In the early-to-mid 1900s, the rates of stroke & heart attacks were on the rise.

Smoking was a known contributor to this phenomenon. It is a dense source of oxidative stress. When you take your first puff of cigarette smoke, it feels like your chest is on fire. In more ways than one, it is.

Oxidation reactions there needs fuel. So, if smoking is providing oxidative stress...then what is the fuel?

Unfortunately for us, there was a second culprit blamed for the rise of cardiovascular disease - saturated fats. That is the topic of this article.

Fire & Mitochondria

Before we continue with the danger to the circulatory system, we need to take a brief detour to discuss the relationship between fire and metabolism.

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Read the whole article

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The evidence is overwhelming (experimental and clinical) that oxidation of PUFAs play a role in every step of atherosclerosis, including fatty streak formation, atheromatous lesion, plaque instability and rupture. Instability & rupture causes strokes in the brain, heart attacks, and infarctions in every organ that has limited blood supply. The liver and skin are less impacted - they have a lot of redundant blood supply, and usually the other critical organs fail first (e.g brain, heart, kidneys).

The above diagrammed chain reaction is the reason why PUFAs are so dangerous.

Recall the description of combustion:

The combustion of fuel occurs in the absence of enzymes, and relies on a chain reaction to propagate itself until the fuel or oxygen has been consumed.

Lipid peroxidation chain reactions will continue until one radical encounters another radical, neutralizing one another.

Now, imagine that the cells which line your blood vessel (endothelium) have PUFAs in their membranes. The red blood cell membranes also have PUFAs. The balls of cholesterol floating in your blood stream have PUFAs. They are all waiting for an oxidation event.

Oxidation-reduction reactions are the norm throughout the body. But in the presence of PUFAs, this can lead to chain reactions that can propagate uncontrolled. Whether it's the inner wall of the blood vessel, or a ball of cholesterol rushing towards your brain.

The endothelium (blood vessel lining) is a very sensitive single-layer membrane that comes in direct contact with the contents of blood. Even a microsecond of a PUFA oxidation event can damage it, exposing the layers underneath. Once these layers are exposed, one of two things can happen which are potentially devastating:

1. Other reactive fatty acids (more PUFAs, for example) can bind to it. This results in fatty streak formation, and eventual atherosclerosis.
2. Platelets can start binding and aggregating to exposed basement membrane proteins. This can lead to clot formation ⇨ infarcts

This is why ulcerated atherosclerotic plaques are predictive of impending stroke, heart attack, or dissection. In my estimation, this mechanism also plays a role in aneurysm rupture.

Death by a Thousand Cuts

If the damage caused by these PUFAs was a brief episode, you probably wouldn't suffer long-term illness.

But, many people who consume PUFAs do so for years and decades, if not their whole life. You can hardly blame them - seed oils are in almost everything we consume. In fact, people who try to avoid seed oils often have a hard time both in restaurants and the grocery store. It is so widespread, it has likely contributed to the recent trend of extreme elimination diets.

These elimination diets have a point.

Lipid peroxidation and highly inflammatory states contribute to almost everything that's causing illness in the modern world:

• Cardiovascular disease (leading cause of death and disability)
• Cancer
• Dementia
• Kidney Failure
• Autoimmunity
• Even Osteoporosis ⇨ fractures, which is often categorized as traumatic

As a little experiment, go to a search engine and query:

"Lipid peroxidation" and "any chronic illness"

Every tissue needs blood perfusion. By slowly destroying the blood supply, you develop micro-infarcts that accumulate across time. And, by delivering highly reactive PUFAs to an organ, you are actively oxidizing it. It's lose-lose.

Brain MRI demonstrating grade of 'microvascular ischemia' - tiny infarcts that manifest as confluent loss of white matter across time

Connection to COVID

There are two connections to COVID, actually.

The first is reasonably well encapsulated in this tweet:

I believe the abnormally high rates of illness this past 2 years is due to:

1. Lockdowns/restrictions and the downstream health consequences
2. Inflation causing people to shift towards more affordable food (seed oil, cheap carbs)
3. Global-scale clinical trial

No one virus.

— Remnant | MD (@RemnantMd) April 17, 2022

When the lockdown and restrictions started to get really heavy-handed, reasonable people were concerned with the behavioral changes that would be harmful:

• More sedentary life
• Ordering food (for many reasons, including supporting local businesses)
• Increased alcohol and drug use

This is one connection to the "COVID era," and we are now seeing the consequences of these behaviors. I know some people want to blame the differences in rates of illness to the vaccines, but I think that is only one of three contributing factors.

Revisiting Oxidation

The second connection is directly related to oxidative stress.

Our lungs help bring oxygen into the bloodstream, so that it can be circulated to our organs. Oxygen is just one oxidant in the air. There's also ozone, amongst others. Our lungs are constantly exposed to oxidative stress - especially if you are a smoker.

You would think that our lungs have evolved mechanisms to resist oxidants - and they have! For example, surfactant (the fluid that keeps your lungs open) has a protein which binds to and neutralizes oxidants. But, even the lungs have their limit. At some point, they will give in. What happens when the lungs fail?

The lungs provide a boundary that allows your blood to engage with the air without letting free air into your blood stream, or fluid moving into your lungs. So when the lung fails...fluid tends to accumulate in the lungs.

Acute Respiratory Distress Syndrome

ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs - leading to fluid build-up.

Obesity is a risk factor for ARDS. It also happens to be a major risk factor for severe COVID-19. One mechanism accounting for this is that people who are obese tend to have a diet high in PUFAs. PUFAs stored in fat can be oxidized as part of a chain reaction, which will lead to a higher severity/amplitude of inflammation.

In the early days of COVID, people were admitted left and right with what looked like ARDS. Our central medical authorities decided this was 'severe COVID.'

But, if you take an unhealthy person, with an unhealthy diet...expose them to an infection...then refuse to treat them for 10 days...a large proportion of them will get ARDS. In this setting any infection is potentially fatal. If you are old, obese, or have high baseline oxidative stress...any infection can get real bad, real fast.

What is the Crime?

In the 1950s Ancel Keys was trying to make a name for himself. He saw an opportunity with heart disease. He had (stole) a hypothesis - and he ran with it.

But, how did he make it so far? Who were his benefactors? One group was Proctor & Gamble.

In the early 1900s, P&G were in the business of making wax and soap - from animal fat. At some point, animal fat got expensive. So, P&G collaborated with a German who had developed the process of hydrogenation. Here they saw an opportunity to mill cottonseed into oil, and hydrogenate it into something that was 'fatty.' This became a substitute for their wax & soap production, which allowed them to scale.

Eventually, electricity made candle-light obsolete. Which meant that P&G were stuck with a cheap way of making "oil," but no product to put it in. That is until unsaturated fatty acids were hailed (by Ancel et al) as a healthy alternative. P&G repurposed the cottonseed oil into Crisco vegetable oil - without telling people what was in it.

For some people in certain positions (e.g. P&G executives), the idea that their product might cause mass harm and suffering does not even cross their mind.

And, why should it?

The WHO & AHA have promoted PUFAs for decades, and to some extent still do.

This article is written for all readers, Year 9 students through elder adults. Methods and reasoning herein are pedestrian. Doctors and scientists may opt to skip to “BEGIN HERE TO VIEW DATA”. If you really want to cheat, skip to the bottom and look for yellow highlighted cells in spreadsheets. Understand what they represent. They represent significant, proven, excess death in the circulatory system matching what the pharmaceutical companies and governments call “rare”, another word seemingly redefined in 2021.

The official Massachusetts database of death certificates contains proof that C19 “vaccines” killed thousands of people in Massachusetts in 2021.

This article details a forensic journey in a one-of-a-kind, brute-force, pedestrian, forensic analysis of the official Massachusetts government data to discover what happened and is happening in a population of ~ 6.9 million people at the fore of C19 “science.” Massachusetts is a leading medical and pharmaceutical technology exporter to the world. Some leaders say it is a model for C19 response planning. The truth is that Massachusetts is a model for fraud on the people.

As demonstrated in particularity below, there was a short pandemic of respiratory deaths in 2020. Then, in the year of injections en masse, deaths switched to mainly circulatory system deaths. Something is attacking the circulatory systems of citizens of Massachusetts.

Three main events are initially depicted: a pandemic, an extremely attenuated second wave of disease no longer a pandemic, and a nearly steady-state excess death anomaly in the second half of 2021 (likely began around February 2021, but was obscured by lower than normal deaths of 85+yo’s due to culling from C19 in spring 2020).

Investigation of the anomaly indicates that excess deaths are circulatory system involved, also known and documented in the C19 vaccine trial data. Though myocarditis gets the most notoriety, the entire circulatory system is under attack.

Hereinafter, the C19 “vaccine” will be called “gene modification” because it is a more accurate descriptor of the biological injectable product. Industry and government chose “vaccine” because it is more psychologically acceptable to consumers. “Vaccine” has product-class recognition and reputation. Ergo, the definition of “vaccine” was changed in 2020 to accommodate the inclusion of C19 gene modification into this product-class. Lawsuits based on this issue of “definition” are pending.

EUA WARNING

It is an undeniable fact that the Emergency Use Authorization (EUA) for the C19 gene modification circumvented the normal course of years-long clinical trials that ensure safety and effectiveness of oral and injectable biological and pharmaceutical products.

Through the EUA, which granted immunity from tort to the manufacturers, the burden of precautions (clinical trials) was shifted from the least cost avoider (the manufacturer) to the most cost avoider (the consumer). Though the burden of precautions is pecuniary to the manufacturer, it entails loss of life to the consumer. Id est, pharmaceutical manufacturers avoid costs and increase profits, while consumers die or are maimed after assuming the burden of precautions as lab rats.

INTRODUCTION

Scientists disagree whether the C19 gene modification's spike protein or its lipid nanoparticle is the root cause of injury or death in a minority of people (a death lottery). Either or both theories are in harmony with this article’s conclusion.

To preemptively assuage decriers of “correlation does not equal causation,” this poignant allegory is offered. If five strong swimmers died in one month in a busy lake, would you: A) close the lake to swimmers pending results of investigation, or B) leave the lake open as a small percentage of swimmers continue to die during investigation? Regarding C19 gene modification, governments chose “B”.

While others start at the lowest level of abstraction (cellular & molecular) and then look upward to localized and systemic injuries in an effort to establish a causal chain, this article starts at the highest level of abstraction (all-cause deaths), then investigates downward into anomalies. 1) Is there an anomaly in all-cause deaths? If so, 2) Whom did the anomaly affect, and when? 3) How did the anomaly manifest in immediate and underlying causes? 4) Are the underlying causes traced to the C19 gene modification as a root cause?

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Read the whole article

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CONCLUSION

Three of the four questions posed have been answered:

1. There is an anomaly in all-cause deaths beyond the obvious 8 to 10-week spring 2020 pandemic. The anomaly lasted nearly all of 2021, but manifests visually only from July 2021 through the end of the year and continues into 2022. The first half of 2021, the anomaly was negated by the lack of 85+yo deaths evident by the vertical light blue stripe on the right of the 2021 heat map

2. The people affected in 2021 may be considered old, but they are younger on average than in the 2020 C19 pandemic as seen in the vertical pink alley in 2021 heat map.

3. In order to achieve an all-cause excess mortality of 10% to 20% during 2021, any single or few multiple cause increase would have to be higher in order to affect the all-cause full population denominator. Indeed circulatory system issues are much higher and account for many excess deaths in the order of thousands, but are likely masked by the numerous bleeds and deposits of clots yielding a smattering of different “I” and “D” and “R” codes.

4. No effort is made in this article to tie the C19 gene modification biological injectable product to a mechanism for the circulatory system deaths. Any doctor, scientist, or pedestrian reader can make that inference from the overwhelming correlative data herein. There are tens of thousands of life years lost in 2021 in excess of what was expected by any mathematical formula. These are not from C19. The math does not work out.

Again, the official Massachusetts database of death certificates contains proof that C19 gene modification biological injectable products killed thousands of people in Massachusetts in 2021.

Pandemics do not switch from respiratory to circulatory causes of death in one year. [add sarcasm now] Perhaps it can be done this way. Take the deadly part of the virus and change the mode of entry from aerosols entering lungs to direct injection into the blood stream [lottery win if it gets into a blood vessel].

NOTES

There is a table of eight (8) deaths mentioning “vaccin” or “immuniz” as string searches. Of the 8, only one has ICD-10 codes referring to the injection as a possible cause. The omission of ICD-10 codes is civilly negligent at the very least, and is likely a criminal act of intentional omission leading to fraud on a public record. This will be addressed in the next article. Massachusetts is rife with fraud throughout the entire medical establishment. They do not see it as fraud or as a crime. They see it as the normal course of business for the biggest industry in their little state of 6.9 million people. To those who are injecting children and pushing these death lottery shots, how can you get through another day knowing you were, are, or will be responsible for taking the lives of young children? Or leaving families without a mother or father?

Oh, let this article finally end. Please notice the two tables at the very end. Notice the change in average age by year for both “I” and “J” codes, but more importantly for all-cause total deaths each year in Massachusetts. The average age was lower in 2021 than any of the prior 6 years. That might be expected after a pandemic year that took the old people. However, the total deaths are 3,000 to 4,000 higher in 2021 than any other year except 2020. The average ages of those excess 3,000 to 4,000 who died in 2021 had to have been much younger to change the average as much as they did.

URGENT PLEA

There is not another dataset out there like that one that definitely proves prolonged excess death in causes specific to the circulatory system and in numbers in the thousands of lives and in younger people than expected. C19 was over in Massachusetts in June 2020. What has happened since then has been a hidden disaster of biological injectable product madness.
God bless you all and thank you for reading.

Everybody is vaccinated in Gibraltar; since October, increasingly large numbers of people are triple vaccinated there.

Here’s what their booster campaign looks like:

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As if on cue, infections in Gibraltar skyrocketed directly afterwards:

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This isn’t a seasonal or a regional effect. Neighbouring countries, where the booster campaign has yet to begin (Morocco) or kick into high gear (Portugal, Spain), see a slight upward, seasonal trend—nothing like the Gibraltar spike.

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When Israel rolled out boosters in August, they also saw spikes in infections and deaths. It is the same phenomenon we observed after dose 1. Only the second dose does not enhance infections, presumably because it is administered in the protective shadow of the first one. As with everything involving this virus and our vaccines, there are probably multiple causes at work here. For about ten days following vaccination, the vaccinated are more susceptible to infection, and a subset of them probably become minimally symptomatic super-spreaders.

Millions of people across Europe and North America will become eligible for Dose 3 at the very height of coronavirus season, in December and January. Uptake will be highest among medical professionals and nursing home personnel. There is the potential for real catastrophe here. While the vaccines don’t work as advertised, they are powerful pharmaceutical products and they have strange, unexpected effects — not only on the bodies of people who take them, but also on the dynamics of transmission and infection. Deranged medical bureaucrats, who refuse to abandon their dreams of controlling a highly contagious seasonal respiratory virus, have whole populations popping these things like aspirin. They could very well succeed in making Corona into the unprecedented public health disaster that the virus itself never quite was.

UPDATE: Always-sharp commenter someothercat points to this further proof: Infection peaks in Gibraltar are cascading from the oldest age groups to the youngest, following the order in which they were boosted.

[

Simon @stevin2021

@orwell2022 @MConceptions What are the chances that the dates of the day with highest daily cases for each boosted age group in Gibraltar follow a perfect chronological order? Those vaccinated first peaked first and so on. Isn't that proof that the booster are causing the current 🌊?

](https://twitter.com/stevin2021/status/1459987142231404552?s=20)[

November 14th 2021

11 Retweets18 Likes

](https://twitter.com/stevin2021/status/1459987142231404552?s=20)

Similarly close correlations plagued Dose 1. As @kingotnik discovered in May, infections in Germany were always around 2–7% of vaccine doses administered 17 days prior. The effect disappeared only with improving spring weather.

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Could the mystery be revealed here? Perhaps you may notice how this article artfully omits an obvious possibility.

TOKYO (AP) — Almost overnight, Japan has become a stunning, and somewhat mysterious, coronavirus success story.

Daily new COVID-19 cases have plummeted from a mid-August peak of nearly 6,000 in Tokyo, with caseloads in the densely populated capital now routinely below 100, an 11-month low.

The bars are packed, the trains are crowded, and the mood is celebratory, despite a general bafflement over what, exactly, is behind the sharp drop.

Japan, unlike other places in Europe and Asia, has never had anything close to a lockdown, just a series of relatively toothless states of emergency.

Some possible factors in Japan’s success include a belated but remarkably rapid vaccination campaign, an emptying out of many nightlife areas as fears spread during the recent surge in cases, a widespread practice, well before the pandemic, of wearing masks and bad weather in late August that kept people home.

But with vaccine efficacy gradually waning and winter approaching, experts worry that without knowing what exactly why cases have dropped so drastically, Japan could face another wave like this summer, when hospitals overflowed with serious cases and deaths soared — though the numbers were lower than pre-vaccination levels.

Many credit the vaccination campaign, especially among younger people, for bringing infections down. Nearly 70 percent of the population is fully vaccinated.

“Rapid and intensive vaccinations in Japan among those younger than 64 might have created a temporary condition similar to herd-immunity,” said Dr. Kazuhiro Tateda, a Toho University professor of virology.

Tateda noted that vaccination rates surged in July to September, just as the more infectious delta variant was spreading fast.

He cautioned, however, that breakthrough infections in the U.S., Britain and other places where inoculations began months earlier than in Japan show that vaccines alone are not perfect and efficacy gradually wears off.

Japan’s vaccinations started in mid-February, with health workers and the elderly first in line. Shortages of imported vaccines kept progress slow until late May, when the supply stabilized and daily inoculation targets were raised to above 1 million doses to maximize protection before the July 23-Aug. 8 Olympics.

The number of daily shots rose to about 1.5 million in July, pushing vaccination rates from 15% in early July to 65% by early October, exceeding the 57% of the United States.

Daily new cases surged just weeks ahead of the Olympics, forcing Japan to hold the Games with daily caseloads of more than 5,000 in Tokyo and around 20,000 nationwide in early August. Tokyo reported 40 cases Sunday, below 100 for the ninth straight day and lowest this year. Nationwide, Japan reported 429 cases Sunday for an accumulated total of about 1.71 million and 18,000 deaths since the pandemic began early last year.

So why the drop?

“It’s a tough question, and we have to consider the effect of the vaccinations progress, which is extremely big,” said Disease Control and Prevention Center Director Norio Ohmagari. “At the same time, people who gather in high-risk environments, such as crowded and less-ventilated places, may have been already infected and acquired natural immunity by now.”

Though some speculated that the drop in cases might be due to less testing, Tokyo metropolitan government data showed the positivity rate fell from 25% in late August to 1% in mid-October, while the number of tests fell by one-third. Masataka Inokuchi, the Tokyo Medical Association deputy chief, said falling positivity rates show infections have slowed.

Japan’s state of emergency measures were not lockdowns but requests that focused mainly on bars and eateries, which were asked to close early and not serve alcohol. Many people continued to commute on crowded trains, and attended sports and cultural events at stadiums with some social distancing controls.

The emergency requests have ended and the government is gradually expanding social and economic activity while allowing athletic events and package tours on a trial basis using vaccination certificates and increased testing.

To speed up inoculations, former Prime Minister Yoshihide Suga, who left office recently, expanded the number of health workers legally eligible to give shots, opened large-scale vaccination centers and promoted workplace vaccinations beginning in late June.

Kyoto University professor Hiroshi Nishiura told a recent government advisory board meeting that he estimates vaccinations helped some 650,000 people avoid infection and saved more than 7,200 lives between March and September.

Many experts initially blamed younger people, seen drinking on the streets and in parks when the bars were closed, for spreading the virus, but said data showed many in their 40s and 50s also frequented nightlife districts. Most serious cases and deaths were among unvaccinated people in their 50s or younger.

Takaji Wakita, director of the National Institute of Infectious Diseases, told reporters recently he is worried people have already resumed partying in nightlife districts, noting that the slowing of infections may have already hit bottom.

“Looking ahead, it is important to further push down the caseloads in case of a future resurgence of infections,” Wakita said Thursday.

On Friday, new Prime Minister Fumio Kishida said a preparedness plan to be compiled by early November would include tougher limits on activities and require hospitals to provide more beds and staff for COVID-19 treatment in case infections soar in a “worst-case scenario.”

He did not elaborate on details.

Many people are cautious about letting down their guard, regardless of the numbers.

Mask-wearing “has become so normal,” said university student Mizuki Kawano. “I’m still worried about the virus,” she said.

“I don’t want to get close to those who don’t wear masks,” said her friend, Alice Kawaguchi.

Public health experts want a comprehensive investigation into why infections have dropped off.

An analysis of GPS data showed that people’s movements in major downtown entertainment districts fell during the most recent, third state of emergency, which ended Sept. 30.

“I believe the decrease of people visiting entertainment districts, along with the vaccination progress, has contributed to the decline of infections,” said Atsushi Nishida, the director of the Research Center for Social Science & Medicine Sciences at the Tokyo Metropolitan Institute of Medical Science.

But people headed back to entertainment districts as soon as the recent emergency ended, he said, and that may “affect the infection situation in coming weeks.”

By MARI YAMAGUCHI October 18, 2021
AP journalist Chisato Tanaka contributed to this report.

Third part of a timeline of ivermectin-related events in theCOVID-19 pandemic

See Part 1 and Part 2

Mika Turkia M.Sc.
mika.turkia@alumni.helsinki.fi
September 30, 2021

Abstract

This review presents a third part extending two previous parts of a timeline describing ivermectin-related events in the COVID-19 pandemic, with this third part covering a period from July 2021 to September 2021.

Among the most notable developments during the period were allegations that a clinical trial about prophylaxis and late treatment of COVID-19 with ivermectin by Elgazzar et al. carried out in Egypt in mid-2020was fraudulent, with some of the introduction plagiarized and the patient data claimed to appear fabricated.

The government of Egypt initiated an investigation on the issue, the results of which were not available bythe end of the period.

Ivermectin skeptics noted that the retraction of the Elgazzar et al. trial, along with suspicions about failed randomization in another trial by Niaee et al., seemed to invalidate the various meta-analyses which had included these trials. Ivermectin proponents argued that the retraction did not affect the conclusions of their meta-analyses. Later, the validity of an Argentinian prophylaxis trial by Carvallo et al. was questioned; as an observational trial it had not been included in the meta-analyses.

Among new trial results were the results of ’Together’ trial led by a Canadian university but carried out in Brazil. The primary endpoint was extended emergency room observation or hospitalization, and the secondary endpoint was mortality. Fluvoxamine produced a statistically significant result for the first endpoint but not for the second. In 677 treated patients vs 678 controls ivermectin indicated some risk reduction but the differences were not statistically significant. One of the authors concluded that ivermectin had ’noeffect whatsoever’ on their endpoints. On the other hand, a intervention program in La Pampa province of Argentina with 3,269 treated and 18,149 untreated indicated mortality rates of 1.5% vs 2.1% (p=0.029),and in subjects over 40 years 2.7% vs 4.1% (p=0.005). A Cochrane meta-analysis concluded that all aspects regarding ivermectin’s efficacy for either treatment or prophylaxis were currently unknown.

After a 24-fold increase in ivermectin prescriptions from US pharmacies compared to the pre-pandemic baseline, US Food and Drug Administration (FDA), American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists campaigned against ivermectin, calling for‘an immediate end’ to prescribing, dispensing and using it. However, this campaigning also resulted in an increased public awareness of ivermectin.

A prominent social media figure with over ten million followers revealed that he had been prescribed ivermectin for COVID-19. The fact was subsequently propagated internationally by the news media which represented ivermectin as a dangerous ‘horse dewormer’. Several international news outlets published a false story about emergency rooms in Oklahoma being full of people having overdosed ivermectin, blocking out other patients including gunshot victims.

A Japanese doctor who had treated 500 patients with ivermectin reported having received death threats after telling about his methods on a television program. A group of British scientists which had published a meta-analysis about ivermectin reported having received death threats after questioning the efficacy of ivermectin. An ivermectin discussion forum was flooded with pornographic images and incoherent babbling.

A hospital was harassed for not administering ivermectin.

An Indian physician claimed that due to the World Health Organization’s opposition to ivermectin, India’s second wave had been countered by an almost nationwide covert use of early treatment protocols including ivermectin. Another physician reported that in one city in Amazonas, Brazil, a mass distribution of ivermectin had resulted in the city having no hospitalized COVID-19 patients during the surge of the gamma variant in the first half of 2021.

Frontline COVID-19 Critical Care Alliance (FLCCC) faced criticism for its ivermectin advocacy and communication style. With regard to treatment protocols, the addition of dual anti-androgen therapy to FLCCC’sMATH+ hospital treatment protocol was said to have restored the protocol’s efficacy against the delta variant in intensive care unit patients. FLCCC also published a scoping review of the pathophysiology ofCOVID-19, emphasizing the role of platelet activation with the release of serotonin and the activation and degranulation of mast cells contributing to the hyper-inflammatory state.

In an overview, the period from April 2020 to March 2021 could be characterized as a period of argumentation and attempted rationality, the period from April 2021 to June 2021 as a period of emotion and campaigning,and the period from July 2021 to September 2021 as a period of chaos.

Current best practices for meta-analyses were found to be unsound. A new approach based on individual patient data analysis was proposed.

Introduction

The period covering the first part of the timeline from April 2020 to March 2021 [1] could be characterized as a period of research, argumentation and rationality. During the period, smaller-scale research and experimentation of ivermectin for COVID-19 was pursued and eventually, alliances and groups of clinicians and researchers were formed to promote combination treatment protocols that included ivermectin. However, at the end of the period, first the European Medicine Agency (EMA) and second the World Health Organization(WHO) advised against the use of ivermectin except in clinical trials.

The second period from April 2021 to June 2021 [2] could be characterized as a period of emotion and campaigning. During the period, a failure of the approach based on argumentation led to a disillusionment of clinicians and researchers in favor of ivermectin treatments and stopped communication between the proponents and administrative agencies. Instead, ivermectin proponents turned directly to the public and the clinicians. The analysis related to the second part of the timeline focused on possible structural corruption and the role of the WHO.

The third period from July 2021 to September 2021 covered in this paper might best be characterized as a period of chaos, initiated by accusations of plagiarism and data fabrication in one of the early ivermectin trials [3]. As the trial was included in published meta-analyses of ivermectin’s efficacy [4,5,6], the allegations undermined the believability of these meta-analyses, although the authors of the meta-analyses at first stated that the exclusion did not essentially change the results of the analyses. Later, one of the groups diverged from this view.

The history, indications and safety of ivermectin have been described in the previous parts. Some events preceding July 2021 not included in the previous parts of the timeline have been included.

March 2020

On March 25, Waltner-Toews et al. wrote that COVID-19 requires a new approach to science [7]. They referred to ‘post-normal science’ (PNS) developed in the 1990s by Silvio Funtowicz and Jerome R. Ravetz which represented a novel approach for the use of science on issues where ‘facts are uncertain, values in dispute, stakes high and decisions urgent’ [8]. As an example, PNS recommended that models to predict and control the future should be replaced by models to map our ignorance about the future; it also stressed the importance of trust, participation and transparency, all of which had been lacking during the COVID-19pandemic. Waltner-Toews et al. wrote that ‘everywhere, we are seeing a total breakdown of the epistemic consensus required to make normal science “work”. This is happening not only in the fields you might expect– behavioral psychology, sociology, and ethics – but also in virology, genetics, and epidemiology. In other words, when “applied scientists” and “professional consultants” are no longer in their comfort zones but find themselves in a post-normal context, fitness for purpose changes meaning. And even in established fields, disagreements can’t be hidden (or consensus enforced) from broad audiences: are the present draconian measures justified or not? More data (even “reliable data”) and better predictive models cannot resolve the“distribution of sacrifice” which involves, among other things, the arbitration of dilemmas that appear at every scale. Hiding behind some general notion of science or the “lack of data” – as if data had the power to resolve these dilemmas – is feckless, feeble and confused’.

November 2020

On November 29, an article by Cherkes et al. in the clinical practice guidelines and recommendations section of an Ukrainian journal Proceedings of the Shevchenko Scientific Society – Medical Sciences gave a detailed description of FLCCC’s MATH+ hospital treatment protocol [9].

April 2021

On April 14, an article by Seet et al. described an open-label randomized trial (n=3,037) describing a 42-day prophylaxis regimen with four different medications, one of which was povidone iodine throat spray(n=735), compared to 500 mg per day of oral vitamin C (n=619), indicated 44.7% lower risk of severe disease (5.7% vs 10.3%, RR 0.55, p=0.05) and 31.1% lower risk of infection (46.0% vs 70.0%, RR 0.69,p=0.01) [10,11]. A single 12 mg dose of ivermectin (n=617) did not produce a statistically significant difference. Hydroxychloroquine produced a slightly smaller risk reduction than povidone iodine.

May 2021

On May 11, two Norwegian doctors presented data on ivermectin trials to the Norwegian government [12].

On May 26, an investigational monoclonal antibody for mild to moderate COVID-19, sotrovimab, was issued an emergency use authorization by the US Food and Drug Administration (FDA). Sotrovimab was to be administered as a single intravenous infusion of 500 mg over 30 minutes within 10 days of symptom onset [13].

The wholesale price of a single dose was USD 2,100 [14].

On May 28, Bloomberg Law discussed YouTube’s censorship practices [15]. YouTube chief executive officer Susan Wojcicki commented that ‘the complex nature of misinformation online presents a number of challenges for platforms such as YouTube and I welcome your suggestions as to what we can do better’.

June 2021

On June 1, a commentary by Chosidow et al. asked whether ivermectin would be a potential treatment forCOVID-19 [16].

On June 4, an article by Payne et al. about evidence-based approach to early outpatient treatment considered zinc gluconate, melatonin and vitamin D feasible options but repeated the usual objections to ivermectin[17].

On June 7, an article by Sajidah et al. discussed the host nuclear transport machinery in detail [18].

On June 10, Kumar et al. discussed the role of vitamins and minerals as immunity boosters in COVID-19, pointing out for example the protective roles of calcium, magnesium, copper, iodine, selenium, manganese,cobalt and sulfur, and the possibly harmful effect of iron [19].

On June 14, an article by Duru et al. described an in silico study suggesting that ivermectin bound well toSARS-CoV-2 spike glycoprotein [20].

On June 17, an article by Yanagida et al. concluded that ivermectin had low proarrhythmic risk [21].

On June 18, an article by Mart´ınez investigated the antioxidant properties of several pharmaceuticals, positing the idea that oxide reduction balance might help explain the toxicity or efficacy of these drugs, and noting that ivermectin and molnupiravir, two powerful COVID-19 drugs, were not good electron acceptors,and the fact that they were not as effective oxidants as other studied molecules might be an advantage [22].

On June 18, a commentary by Taibbi discussed politicization and censorship of ivermectin in the US [23,24].

On June 18, a Norwegian newspaper Aftenposten interviewed two Norwegian proponents of FLCCC protocols, one of whom was FLCCC founding member Eivind Hustad Vinjevoll [25] and the other Anders Bugge.

The Norwegian Medicines Agency remained unconvinced, stating that it was not their task to assess unapproved treatments: they only followed the recommendations of US National Institutes of Health and the World Health Organization.

On June 21, referring to lack of evidence and low quality of trials, eleven Norwegian senior physicians disagreed with Vinjevoll’s and Bugge’s views [26].

On June 22, Huang et al. summarized recent advances in the exploration of ivermectin’s anticancer properties [27].

On June 27, Salvador et al. published a protocol of a prospective observational study aiming to evaluate the effectiveness and safety of a single-dose ivermectin for treatment of uncomplicated strongyloidiasis in immunosuppressed patients [28].

On June 28, Bugge replied to the Norwegian senior physicians [29].

On June 28, an article by Roman et al. presented a meta-analysis of ten randomized controlled trials(RCTs) including 1,173 patients with mild or moderate disease [30]. The authors wrote that in comparison to standard of care or placebo, ivermectin did not reduce all-cause mortality, length of stay or viral clearance.

They concluded that ivermectin was not a viable option to treat COVID-19 patients. The article was based on a previous preprint [31,32]. The CovidAnalysis group noted that in addition to numerous uncorrected errors,the preprint and the PDF of the article stated that the authors had no conflicts of interest, yet Pasupuleti’saffiliation listed in the abstract on the journal’s website was a company delivering brand and portfolio commercial strategy for biotech and pharma, working with 24 of the top 25 pharmaceutical companies as well as hundreds of biotechs globally [33,34]. The company also stated that they were working withthe European Federation of Pharmaceutical Industries (EFPIA) to support their activities, and that the company’s regulatory consultancy practice in the US was preparing a number of emergency use authorizations to the FDA [35].

On June 28, an article by Patterson et al. presented a model for predicting COVID-19 severity and chronicity [36]. A score measuring severity of COVID-19 was defined as (IL-6 + sCD40L / 1000 + VEGF / 10 + 10 * IL-10) / (IL-2 + IL-8). A score measuring chronicity (long haul symptoms) was defined as (IFN-γ+ IL-2) / CCL4-MIP-1β. CCL4 (chemokine ligands 4), also called MIP-1β(macrophage inflammatory protein-1β),was related to the C-C chemokine receptor type 5 (CCR5) pathway. About VEGF, see also [37,38,39,40].

On June 30, Thailand’s FDA and Chiang Mai University’s faculty of pharmacy warned against using ivermectin for COVID-19 [41].

On June 30, an article by Nippes et al. reviewed research on the presence of chloroquine, hydroxychloroquine, azithromycin, ivermectin, dexamethasone, remdesivir, favipiravir and some HIV antivirals in the environment, and presented treatment technologies for each drug [42].

On June 30, Syed interviewed FLCCC’s Marik about treatments and the origin of SARS-CoV-2 [43].

July 2021

On July 1, HART group consisting of UK doctors compared adverse events reported to the WHO of ivermectin (20 deaths and 5,484 adverse events since 1992), remdesivir (534 deaths and 6,707 adverse events since 2020) and COVID-19 vaccines (6,667 deaths and 1,198,200 adverse events since 2020) [44]. They also suggested that some of the ongoing studies were designed to fail and actually aimed at stalling the adoption of ivermectin.

On July 1, Vice magazine wrote about ivermectin advocates, saying that ‘proponents of a dubious COVID19 cure have signaled they’re ready for a long fight against what they see as censorship in medicine and media’ [45].

On July 2, an article by Vallejos et al. described a low dose RCT with 501 relatively low-risk outpatients in Argentina which did not produce statistically significant results (NCT04529525) [46,47].

On July 2, an article by Adegboro et al. reviewed the antiviral effects of ivermectin [48].

On July 2, a Twitter post reported that a video featuring Nobel prize winner Satoshi ¯Omura discussing Japanese ivermectin emergency use authorization bill had been removed by YouTube for violating their terms of service [49].

On July 2, a blog post by Crawford investigated the details and the background of the meta-analysis by Roman et al., noting that the meta-analysis came at a politically contentious moment, the language and behavior appeared political, the work was error-laden, took research out of its true context, used numbers that didn’t seem to come from the actual studies, chose papers testing ivermectin under the least favorable circumstances, gave unexplained and inappropriate weights to the small amount of data that stood as outliers to the bigger picture, and extracted an unfavorable conclusion from a massive average mortality reduction that did not quite reach statistical significance while consistently complaining about the low quality of evidence represented by the studies [50]. Crawford asked whether these were ‘just mistakes’, adding that ‘a medical journal published all this – just in time to push back the Lawrie case. Think on all that for a moment’.

On July 3, an open letter signed by 43 researchers and clinicians requested retraction of the meta-analysis by Roman et al. [51,52].

On July 6, an article by Hill et al. (submitted on January 20) presented a meta-analysis including eleven RCTs of moderate/severe infection [5]. The analysis indicated 56% reduction in mortality (3% vs 9%, RR0.44, 95% CI 0.25-0.77, p=0.004), favorable clinical recovery and reduced hospitalization. In contrast to the preprint stating that ivermectin should be validated in larger studies before the results are sufficient for review by regulatory authorities [53], the published version said that a network of large clinical trials was in progress to validate the results seen to date.

On July 6, a TrialSite news report suggested that the WHO might have been attempting to limit the use of ivermectin to neglected tropical diseases only [54,55,56]. The report also discussed the apparent lack of objectivity of Wikipedia, noting that it had, among other omissions, mentioned the rejection of FLCCC’s review by Frontiers of Pharmacology but failed to mention that it had later been published in the American Journal of Therapeutics, failed to mention the meta-analysis by the BIRD group, and failed to mention USNIH’s transitioning to a neutral stance on ivermectin. The report asked why any positive aspects would be omitted unless there was an explicit goal to completely discredit this possible therapeutic option and researchers looking into the matter.

On July 6, Yahoo News UK published a news story featuring ivermectin in a positive light [57].

On July 6, WHO announced that it had updated its patient care guidelines to include interleukin-6 receptor blockers tocilizumab (by Roche) and sarilumab (by Regeneron Pharmaceuticals and Sanofi) [58]. The strong recommendation was based on findings from a prospective and a living network meta-analysis including data(also prepublication data) from over 10,000 patients enrolled in 27 clinical trials. The meta-analyses were said to show that in severely or critically ill patients these drugs reduced the odds of death by 13% and the odds of mechanical ventilation by 28% compared to standard of care, with high certainty of evidence [59]. WHO said tocilizumab and sarilumab were the first drugs found to be effective against COVID-19 since corticosteroids were recommended in September 2020 [58]. WHO director-general Tedros Adhanom Ghebreyesus said, however, that the drugs would remain inaccessible to most, and called on manufacturers to reduce prices and make supplies available to low-and middle-income countries. Ghebreyesus also encouraged companies to agree to transparent, non-exclusive voluntary licensing agreements using WHO’s Covid-19 Technology Access Pool (C-TAP) platform and the Medicines Patent Pool, or to waive exclusivity rights. Rochwerg et al. noted that compared with other treatments IL-6 receptor blockers were expensive but the the recommendation did not take account of cost effectiveness [59]. They also acknowledged that access to these drugs was challenging in many parts of the world and that the recommendation could exacerbate health inequity. However, the strong recommendation aimed at providing a stimulus to improve global access to these treatments.

On July 6, an article by WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) WorkingGroup presented a meta-analysis on the efficacy of tocilizumab and sarilumab [60]. Absolute mortality risk was 22% for IL-6 antagonists compared with an assumed mortality risk of 25% for standard of care or placebo, with especially sarilumab showing very low efficacy. Regarding conflicts of interests, one of the authors reported being involved with two patents owned by Genentech/Roche, one on treating COVID-19with an IL-6 antagonist, and another for tocilizumab and remdesivir combination therapy for COVID-19pneumonia. Two other authors reported being co-inventors of a filed patent covering the use of low-dose tocilizumab for treatment of viral infections. Nine other authors also reported associations with Roche.

Seven authors reported associations with Sanofi. Three reported being employees of and owning stock in Regeneron, and two reported other associations with it. Also associations with, for example, Merck Sharp and Dohme, Gilead Sciences, ViiV Healthcare, Janssen, Cilag, Thera technologies, Lilly, Biohope, Gebro, Bristo lMyers Squibb, Abbvie, Pfizer, Novartis, PharmaMar, GlaxoSmithKline, Boehringer Ingelheim, Celgene,Alexion, Inatherys, AB Science, Argenx, Oncoarendi, Biogen, Ose Pharmaceutical, Shionogi, Genetech, EliLilly, Swedish Orphan Biovitrum AB, Sanofi Genzyme, Aspen Pharmacare, Crist´alia and AM Pharma were reported.

On July 6, a press release by M´edecins Sans Fronti`eres (MSF) noted that the Swiss pharmaceutical company Roche continued to have de facto market exclusivity and tocilizumab was likely to remain unaffordable and inaccessible for most of the world [61]. MSF wrote that Roche had kept the price of tocilizumab very high in most countries (USD 410 in Australia, USD 646 in India and USD 3,625 in the US per dose of 600mg for COVID-19, while the manufacturing cost was estimated to be around USD 60).

On July 6, an article by Malin et al. presented a key summary of German national treatment guidance for COVID-19 inpatients [62]. The guideline recommended corticosteroids, prophylactic anti-coagulation, and optionally tocilizumab. Convalescent plasma, azithromycin, ivermectin and vitamin D3were recommended against. With regard to ivermectin, it was said that achievable tissue concentrations seemed to be far below the half maximal inhibitory concentration in vitro, that in February 2021 only one peer-reviewed RCT with 72 patients was available for consideration, and that the numerous preprints did not report clinically relevant endpoints or presented with significant methodological issues and a high risk of bias.

On July 6, a commentator asked why WHO targeted IL-6 instead of going upstream to block NF-kB [63] which in turn inhibits IL-6 (ivermectin is an NF-kB antagonist [64]) [65,66].

On July 6, the US president Biden proposed the creation of the Advanced Research Projects Agency for Health (ARPA-H), a new organization under the NIH, aimed at facilitating and accelerating more innovation and breakthroughs in fundamental biomedical and health research [67].

On July 6, an article by Margolin et al. described a small controlled trial (n=113) that suggested benefits from supplementation with zinc, zinc ionophores quina plant bark extract and quercetin, vitamins C, D3and E, and L-lysine [68].

On July 7, an article by Cadegiani et al. about an open-label observational prospective outpatient study indicated 98.0% lower risk of hospitalization (0% vs 19.7%, RR 0.02, p<0.001) and 94.2% lower risk of ventilation (0% vs 6.6%, RR 0.06, p=0.005) [69,70,71]. The authors said treatments showed overwhelming improvements; therefore, it had become ethically questionable to conduct further studies employing full placebo arms in early COVID-19.

On July 7, a preprint by Hazan et al. described a retrospective late treatment study with 24 outpatients and a synthetic control arm calculated from the US Centers for Disease Control and Prevention (CDC)database [72]. The study used a combination therapy protocol with ivermectin, doxycycline, zinc, vitaminD and vitamin C, resulting in 100% survival and cure in unselected ambulatory ‘moderate to severely’ illCOVID-19 outpatients, with some initially presenting with SpO2values as low as 73% and 77%. Despite a symptom to treatment delay of over nine days, mean SpO2values rose from 86.5 to 93.1 in the first 24 hours.

On July 8, an article by Muthusamy et al. described an in silico study identifying 32 anti-parasitic compounds effectively inhibiting the receptor binding domain of the SARS-CoV-2 spike protein [73]. The most effective compounds, in a descending order, were selamectin, ivermectin, artefenomel, moxidectin, posaconazole, imidocarb, piperaquine, cepharantine, betulinic acid and atovaquone.

On July 9, Cameron et al. proposed a two-axis model to describe variability in decision-making among critical care physicians [74]. The authors emphasized the necessity for a better understanding of the root causes of physician-attributable differences in patient management in order to foster a better collaborative and educational environment to help critical care systems adapt to emerging ideas. The first axis of the model measured interventionism (early, aggressive treatment) versus minimalism (’wait and see’) preferences. The second axis measured individualism versus collectivism.

On July 12, a preprint by Neil et al. described a Bayesian meta-analysis of ivermectin’s effectiveness in COVID-19 [75].

On July 13, a news report in the Atlantic by Mazer discussed FDA’s recent approval of Alzheimer’s disease medicine aducanumab [76]. It said aducanumab was approved despite scant evidence of benefit, and against the nearly unanimous advice of the agency’s expert advisers, with ten members against approval and one being uncertain [77]. Aducanumab was priced at USD 56,000 a patient per year. The estimated cost of treating all patients with it was larger than NASA’s yearly budget. The article said that ‘the actions of drug regulators, like those of industrial polluters, are often freighted with unacknowledged externalities .. . the FDA specifically does not really worry about those larger societal issues and doesn’t really worry about cost. . . instead, the agency is judged by how many drugs it can approve’.

On July 14, an opinion by Flam said that high hopes for ivermectin owe more to politics than to science[78].

On July 14, Mathachan et al. reviewed current uses of ivermectin in dermatology, tropical medicine andCOVID-19 [79].

On July 15, an article by Ravikirti et al. describing a clinical trial in India on patients with mild to moderate disease (n=112) using 12 mg of ivermectin on two consecutive days did not produce statistically significant results [80].

On July 15, referring to a 2020 preprint by Elgazzar et al. [3], a news article by Davey in the Guardian said that a huge study supporting ivermectin as COVID-19 treatment had been withdrawn over ethical concerns [81]. The article described ivermectin being promoted by right wing figures, then interviewed a person described as a medical student, Jack Lawrence, who had analyzed the preprint and the associated dataset for an assignment as a part of his master’s degree. He had found that the introduction section appeared plagiarized, raw data apparently contradicted the study protocol on several occasions, there were errors in data formatting, and the dataset didn’t match the numbers in the preprint. He also described that ivermectin hype was ‘dominated by a mix of right-wing figures, anti-vaxxers and outright conspiracists’.

A data analyst Nick Brown had helped Lawrence to analyze the data. He said that the main error was that at least 79 of the patient records were obvious clones of other records. An epidemiologist, Gideon Meyerowitz-Katz, commented that the data appeared totally faked, and since the study had been included in most meta-analyses, if removed, the conclusions of these meta-analyses would have their conclusions entirely reversed. Yet another researcher said the data appeared fabricated. Lawrence concluded that ‘something is clearly broken in a system that can allow a study as full of problems as the Elgazzar paper to run unchallenged for seven months . . . thousands of highly educated scientists, doctors, pharmacists, and at least four major medicines regulators missed a fraud so apparent that it might as well have come with a flashing neon sign’.

On July 15, a post by Lawrence on an online disinformation website discussed retraction of the preprint by Elgazzar et al. [82]. Jack Lawrence introduced himself on his blog as a journalist and a disinformation researcher [83].

On July 15, a blog post by Brown analyzed details of the study by Elgazzar et al [84].

On July 15, a blog post by Meyerowitz-Katz pictured ivermectin for COVID-19 research as ‘potentially the most consequential medical fraud ever committed’ [85].

On July 15, the Covid Analysis group removed Elgazzar et al. from their meta-analysis. Since the study was a preprint, the analysis of 37 peer-reviewed studies (n=11,352) in the July 15 version 99 of 60 studies [86] remained unchanged, indicating 88% efficacy in prophylaxis (95 % CI 70%-95%), 74% efficacy in early treatment (95% CI 58%-84%) and 42% efficacy in late treatment (95% CI 19%-58%). Since Elgazzar etal. only concerned prophylaxis and late treatment, also the early treatment results remained unchanged, indicating 64% reduction in mortality (95% CI 15%-85%). In comparison to the previous, July 9 version 98 of 62 studies [87] (Elgazzar study included prophylaxis (n=200) and late treatment (n=400) parts), the new version indicated the same or slightly improved prophylaxis efficacy but slightly widened confidence intervals, with all studies indicating 85% (95% CI 75%-91%) vs 85% (95% CI 75%-92%) efficacy, and RCTs indicating83% (95% CI 39%-95%) vs 84% (95% CI 25%-96%) efficacy. For late treatment, the new version indicated lower efficacy, with all studies indicating 46% (95% CI 30%-59%) vs 43% (95% CI 26%-56%) efficacy, and RCTs indicating 40% (95% CI 11%-60%) vs 29% (95% CI 3%-48%) efficacy.

On July 16, FLCCC and BIRD gave a joint statement saying that there was no scientific basis to state that the removal of one study from meta-analyses would ‘reverse results’, yet the Guardian article had reported it as a fact [88]. They also said that according to the most recent analyses by BIRD, excluding the Elgazzar data from the meta-analyses by Bryant and Hill did not change the conclusions of these reviews, with the findings still clearly favoring ivermectin for both prevention and treatment. They added that even the prestigious Institute Pasteur in France had confirmed that the evidence was sound [89].

On July 16, Hill tweeted that ‘after removal of Elgazzar trial from ivermectin meta-analysis, borderline significant effects still seen for hospitalization and survival, but small number of endpoints. More evidence still needed from large ongoing randomized trials – must be continued’ [90].

On July 16, a news article said that a study that had ‘lit up the right-wing sphere of COVID deniers had been retracted over questionable methods’, adding that it was ‘just totally faked’ [91].

On July 16, a South African news article reviewed the retraction [92]. It also featured video interviews of patients, doctors and officials which concentrated on the black market of ivermectin in South Africa and the possible dangers of counterfeit medications.

On July 16, an opinion by Razak, the rector of International Islamic University of Malaysia, aimed at ‘setting the pace for a more courageous narrative’ about ivermectin’s possibilities in COVID-19 [93].

On July 17, the United Arab Emirates announced the treatment results for intravenously administered monoclonal antibody sotrovimab, produced by GlaxoSmithKline, in treating mild to moderate COVID-19cases among high-risk outpatients [94]. 6,175 patients were administered sotrovimab in Abu Dhabi between30 June and 13 July. Within 14 days, 97 percent of recipients achieved full recovery. There were zero deaths. 1 percent were admitted to ICU.

On July 17, a news report by Weisser described that early in the pandemic in Indonesia, an enterprising philanthropist Haryoseno made ivermectin available to the masses for free or at low cost, which resulted in Indonesia having an extremely low COVID-19 mortality rate. On June 12, 2021, however, in line withthe WHO recommendation, the ministry of health decided to disallow ivermectin and threatened Haryoseno with a fine and a ten-year jail sentence. Subsequently, the supply of ivermectin dried up and mortality increased five-fold [95]. About Australia, the report noted that clinician Mark Hobart had been reported to the Australian Health Practitioner Regulation Agency (AHPRA) which had decided that there had been no infringement. Subsequently, federal health minister had written that off-label ivermectin prescribing was not regulated or controlled by the Therapeutic Goods Administration (TGA) but was at the discretion ofthe prescribing physician. The physicians had formed Covid Medical Network [96], the members of which predominantly followed a ‘triple-therapy protocol’ developed by Thomas Borody, consisting of ivermectin, zinc and doxycycline [97]. The report also said that although the research on ivermectin for COVID-19 had originated from Australia, the researchers had been starved of resources and the discovery ignored.

On July 20, BBC wrote about Indonesia, saying that local media reports had incorrectly stated that theIndonesian authorities had granted ivermectin emergency approval [98]. The reports had been based on a July 15 statement issued by the Food and Drugs Authority of Indonesia (BPOM) in which ivermectin had been listed together with other drugs, two of which had had emergency approval. Shortly afterwards the head of BPOM had told local media that no emergency approval had been given to ivermectin. It had been listed because it was undergoing clinical trials at eight hospitals, the results of which were not expected until October.

On July 20, Med Page Today wrote about retraction of the preprint by Elgazzar et al. [99].

On July 20, a Swedish medical newspaper published an opinion by three Swedish doctors suggesting that Sweden should follow the example of the Czech Republic, Slovakia and other countries which had adopted ivermectin [100].

On July 22, Los Angeles Times wrote that ‘ivermectin, another bogus treatment, becomes a darling ofconspiracy-mongers’ [101]. In addition to reviewing the main points behind the retraction of the Elgazzaret al. preprint the columnist delved into an analysis of ivermectin politics, saying it was rather different from hydroxychloroquine controversy, as ‘the political underpinning of the ivermectin craze involves a conspiracy-infused attack on the pharmaceutical and medical establishment. In this it resembles the antivaccine movement .. . like anti-vaxxers, ivermectin advocates claim that information about the drug is being “suppressed,” generally by agents of Big Pharma; the core idea is that because drug companies can’t make very much money out of a drug available in generic form, they prefer to foist vaccines, on which they canmake billions of dollars in profits, on the innocent public . . . let’s be clear: information about the drug isn’t being “suppressed” for political reasons. It’s being treated as what it is: dangerous misinformation’.

On July 23, an interview of science writer Matt Ridley in the Wall Street Journal said that science had lost the public’s trust and that the politicization of science had led to a loss of confidence in science as an institution, and whereas the distrust may have been justified it left a vacuum that was often filled by lessrigorous approaches to knowledge [102]. Ridley pointed to a distinction between ‘science as a philosophy’ and‘science as an institution’, with the former wanting to remain open-minded, and the latter wanting to present a unified and authoritative voice, fostering a naive belief in the supremacy of scientists in understanding the world, luring politicians to affiliate themselves with this alleged power. Regardless, scientists often deliberately published things that fit with their political prejudices, ignored things that didn’t, or presented models based on rather extreme assumptions. Pessimistic predictions often being more popular in the media introduced a bias. A third conceptualization of or a type of identification with the concept of science,‘science as a profession’, had become off-puttingly arrogant and political, permeated by motivated reasoning and confirmation bias, with increasing numbers of scientists falling prey to groupthink [103]. According to Ridley, the tendency of scientific establishment ‘to turn into a church, enforcing obedience to the latest dogma and expelling heretics and blasphemers’ had previously been kept in check by the fragmented natureof the scientific enterprise but social media was eliminating the space for heterodoxy, leaving those believingin science as a philosophy increasingly estranged from science as an institution.

On July 23, an article by Mansour et al. described a preclinical tolerance study on the safety of inhaled lyophilized ivermectin formulation indicating 127-fold increase in drug aqueous solubility but also safety issues [104].

On July 24, World Ivermectin Day was organized by the BIRD group, the FLCCC, TrialSite News and 15 other affiliates [105]. Panel discussions included Shabnam Palesa Mohamed in conversation with PinkyN.J. Ngcakani (South Africa) and Wahome Ngare (Kenya); Erin Stair in conversation with Hector Carvallo(Argentina), Lucy Kerr (Brazil) and Flavio Cadegiani (Brazil); Shabnam Palesa Mohamed in conversation with Pierre Kory (US), Ira Bernstein (Canada) and Sabine Hazan (United States); Vincent Rey Vicente(US) in conversation with Iggy Agbayani, Homer Lim and Allan Landrito (Philippines), and PriyamadhabaBahera, Binod Kumar Patro, Biswa Mohan Padhy and Rashmi Ranjan Mohanty (India); Daniel O’Connorin conversation with Juan Bertoglio (Chile) and Matjaˇz Zwitter (Slovenia); Daniel O’Connor in conversationwith Juan Chamie (US), Pierre Kory (US) and Nathi Mdladla (South Africa).

On July 25, a preprint by Ontai et al. described a nationwide implementation of multi-drug COVID-19inpatient and outpatient treatment protocol CATRACHO in Honduras since May 3, 2020 [106,107]. The inpatient protocol consisted of dexamethasone, colchicine, tocilizumab, ivermectin, zinc, azithromycin andheparin. There were two outpatient protocols, one consisting of mouthwash, azithromycin, ivermectin andzinc, and the other consisting of prednisone, colchicine and rivaroxaban. The results indicated a case fatalityrate (CFR) decrease from May 3,2020 baseline of 9.3% to 3.0%, or from June 10, 2020 baseline of 5.0% to3.0%. Mexico used as a control country failed to show a similar decline.

On July 27, upon receiving a Special Benevolence Award from Tan Sri Lee Kim Yew of Malaysia on World Ivermectin Day, Kory of the FLCCC gave a lecture outlining the history of ivermectin in COVID-19 [108,109].

He mentioned that the MATH+ protocol had been adopted as the standard protocol in Ukraine, and thatthe hospital mortality rate there was the lowest of the countries in the area.

On July 27, press releases by Cochrane Deutschland and the University of W¨urzburg stated that there was no evidence of ivermectin’s efficacy [110,111].

On July 27, the university hospital of St. Anny in Brno in the Czech Republic published a report about their ivermectin treatment, saying it had been well tolerated and likely had a positive effect on COVID19 [112]. Ivermectin had been available at hospitals and for outpatient treatment since late 2020. Head of internal cardioangiology clinic Michal Rezek described the results of their analysis of 150 patients with a mean age of 63 years (32-93 years, median 65 years) treated between December 2020 and January 2021 with two doses of 0.2 mg/kg of ivermectin. 117 patients had required oxygenation and corticosteroids, 42 had required high-flow oxygen, and 17 had received also remdesivir. 18 patients had needed mechanical ventilation, six of which had died. Hospital mortality had been 10%, with the average age of the deceased being 75 years. There had been no control group. The hospital intended to continue ivermectin treatment and was preparing a RCT in collaboration with Masaryk University and Czech Clinical Research InfrastructureNetwork (CZECRIN) [113]. Lack of COVID-19 patients was mentioned as a possible obstacle to the trial. Rezek said a combination antiviral therapy with ivermectin and remdesivir was likely more effective than single-agent therapies.

On July 28, a Cochrane review by Popp et al. concluded that its authors were uncertain about the efficacy and safety of ivermectin for treatment or prophylaxis of COVID-19 [114]. With regard to late treatment(inpatients), the authors were uncertain whether ivermectin compared to placebo or standard of care reduced or increased mortality (RR 0.60, 95% CI 0.14-2.51, 2 studies, n=185, very low certainty), mechanical ventilation (RR 0.55, 95% CI 0.11-2.59, 2 studies, 185 participants, very low certainty), need for supplemental oxygen (0 participants required supplemental oxygen, one study, 45 participants, very low certainty), adverse events within 28 days (RR 1.21, 95% CI 0.50-2.97, one study, 152 participants, very low certainty), or viral clearance at day seven (RR 1.82, 95% CI 0.51-6.48, 2 studies, 159 participants, very low certainty). With regard to outpatients, the authors were uncertain about mortality up to 28 days (RR 0.33, 95% CI 0.018.05, 2 studies, 422 participants, very low certainty), mechanical ventilation (RR 2.97, 95% CI 0.12-72.47,one study, 398 participants, very low certainty) and symptoms resolution up to 14 days (RR 1.04, 95% CI0.89-1.21, one study, 398 participants, low certainty). With regard to prophylaxis there was only one eligible study, with mortality up to 28 days being the only outcome eligible for primary analysis; the authors were uncertain whether ivermectin reduced or increased mortality compared to no treatment (zero participants died, one study, 304 participants, very low certainty). The Covid Analysis group criticized the meta-analysis for being ’a very biased meta analysis designed to exclude almost all studies’ [115].

On July 28, an opinion in the Wall Street Journal questioned FDA’s negative stance on ivermectin [116]. The next day the authors wrote that they had not been aware of the retraction of the Elgazzar et al. study, yet stated that ‘the broader point stands: there’s strong evidence of ivermectin’s efficacy in COVID-19’ [117].

On July 28, GlaxoSmithKline (GSK) and Vir Biotechnology announced a joint procurement agreement with European Commission to supply up to 220,000 doses of sotrovimab [118], a contract worth USD 462 million at the wholesale price of USD 2,100 per dose. The agreement enabled participating European Union member states to quickly purchase sotrovimab, following local emergency authorization or authorization at the EUlevel, to treat high-risk patients with COVID-19 who might benefit from early treatment with sotrovimab.

On July 29, an article in Times of India explained a much higher rate of infections in the state of Kerala bylower COVID-19 seropositivity [119].

On July 30, a Czech Republic newspaper published a timeline of ivermectin-related events in the CzechRepublic [120].

On July 30, an article by Rella et al. suggested that in the current conditions the vaccines-only pandemic response may create vaccine-resistant strains [121,122].

On July 31, Kiekens interviewed George Fareed about outpatient treatment protocols for newly infected andfor long haul COVID-19 syndrome (LHCS) patients, implemented jointly with Brian Tyson on thousands of patients in the US [123]. For neurological LHCS symptoms in some instances, Fareed suggested a two to three-day high-dose ivermectin treatment as suggested by Alessandro Santin [124].

August 2021

On August 2, a news article from Israel reported on a clinical trial by Biber et al. (NCT04429711) [125], saying that ivermectin could help reduce the length of infection for less than a USD 1 per day, and that only 13%of ivermectin-treated patients were infectious after six days, compared with 50% of patients in the placebo group [126]. Schwartz, the leader of the trial, said that three journals had rejected the paper: ‘No one even wanted to hear about it. You have to ask how come when the world is suffering’.

On August 2, an open letter by Covid Medical Network stressed the importance of early treatment and noted that the federal health minister had acknowledged and even encouraged off-label prescribing of some treatments including ivermectin [127].

On August 2, an article by Reardon in Nature said that shocking revelations of widespread flaws in the data of a preprint study by Elgazzar et al. dampened ivermectin’s promise and highlighted the challenges of investigating drug efficacy during a pandemic [128]. Gideon Meyerowitz-Katz, an Australian epidemiologist,said he had lost all faith in the results of ivermectin trials published to date.

On August 2, an article by Sengthong et al. said that repeated ivermectin treatment induced ivermectin resistance in Strongyloides ratti infected rats [129].

On August 3, an article by Santin et al. reviewed the current status of ivermectin research, mentioning that the indicated biological mechanism of ivermectin, competitive binding with SARS-CoV-2 spike protein, was ikely non-epitope specific, possibly yielding full efficacy against emerging viral mutant strains [130].

On August 3, BBC wrote about the mystery of rising infections in India’s Kerala [131]. The southern Indian state of Kerala, with barely 3% of India’s population, accounted for more than half of the country’s new COVID-19 infections. Kerala was testing more than double the people per million compared to the rest of the country. Antibody tests survey revealed that only 43% people above the age of six in Kerala had been exposed to the infection, compared to 68% nationwide. Kerala had fully vaccinated more than 20% of its eligible population and 52% had received a single jab (70% of people over 45 years) which was much higher than the national average. BBC wrote that the state appeared to be testing widely, reporting cases honestly and vaccinating quickly, ensuring that future waves of infection would be less severe. Yet Kerala was said to be at an early stage in runaway exponential growth of cases. More forceful enforcement of rolling lockdowns was suggested as a solution.

On August 3, George Fareed discussed early treatments on Fox News television [132].

On August 5, an article by Behera et al. described a prospective cohort study (n=3,532) in India, indicatingthat two doses of oral ivermectin (0.3 mg/kg/dose given 72 hours apart) as chemoprophylaxis among healthcare workers reduced the risk of COVID-19 infection by 83% in the following month (6% vs 15%, adjustedrelative risk 0.17; 95% CI, 0.12-0.23) [133].

On August 5, a preprint by Rana et al. described an in silico study showing strong binding affinity ofivermectin and doxycycline for SARS-CoV-2 main protease 3CLpro, and increased binding affinity for thecombination of both [134,135].

On August 5, a Finnish technology magazine wrote about ivermectin, saying that according to FLCCC,there was already an effective medication for COVID-19 but it was rarely used [136]. A head of unit at theFinnish Medicines Agency (FIMEA) commented that doctors were allowed to prescribe it off-label, providedthat the patient was informed about it not being officially approved for COVID-19. The official commentedthat ‘in an international comparison the Finnish medical community is quite conservative about adoptingnew treatments without a sufficiently strong evidence base’. Also, a process to officially adopt ivermectin forCOVID-19 could only be initiated by a producer of ivermectin or the European Medicine Agency (EMA).

On August 6, an article by Kow et al. reviewed sample size calculations in ivermectin trials, indicating thatexisting trials had been very underpowered [137].

On August 6, US National Institutes of Health (NIH) Collaboratory published a video interview of EdwardJ. Mills, the head researcher of Together adaptive platform trial [138]. Mills discussed interim results of their outpatient trial which included fluvoxamine and ivermectin (0.4 mg/kg for three days). For ivermectin,the risk reduction for extended emergency room observation or hospitalization was 9% (86/677 vs 95/678,RR 0.91, 95% CI 0.69-1.19) and for mortality 18% (RR 0.82, 95% CI 0.44-1.52); these were not statistically significant. Mills commented that ivermectin had had ’no effect whatsoever’ on their primary and secondary endpoints. For fluvoxamine, the risk reduction for extended emergency room observation or hospitalization was 31% (74/742 vs 107/738, RR 0.69, 95% CI 0.52-0.91) and for mortality 29% (17/742 vs 24/738, RR0.71, 95% CI 0.39-1.29); the first endpoint was statistically significant while the second was not. The trial was done at ten locations in Minas Gerais, Brazil. It was unclear whether over-the-counter ivermectin usehad been an exclusion criteria. At the time the gamma variant was prevalent and assumed to cause higher viral loads and a more severe disease than most other variants. The Covid Analysis group criticized various aspects of the trial [139].

On August 6, a report on SARS-CoV-2 variants by Public Health England indicated that concerning deathswithin 28 days of positive specimen date between February 1 and August 2 there had been 71 deaths in people under 50 years and 670 in people over 50 years [140]. In the first group, 18% had been vaccinatedtwice and 68% were unvaccinated. In the second group, 58% had been vaccinated twice and 31% were unvaccinated.

On August 6, a podcast by Nature discussed ivermectin [141].

On August 9, a commentary by US medical doctor using a pseudonym Justus R. Hope described a ‘blackouton any conversation about how ivermectin beat COVID-19 in India’ [142,143]. It claimed that the US newsmedia were trying to confuse the public with false information by saying the deaths in India were ten times greater than official reports. Using August 5 numbers as examples the author said that in ivermectin-using states of India such as Uttar Pradesh with a population 240 million of which 4.9% were fully vaccinated there were 26 daily cases and three deaths, in Delhi with a population of 31 million of which 15% were fully vaccinated there were 61 daily cases and two deaths, in Uttarakhand with a population of 11.4 million of which 15% were fully vaccinated there were 24 daily cases with zero deaths. In states not using ivermectin such as Tamil Nadu with a population of 78.8 million of which 6.9% were fully vaccinated there were 1,997daily cases with 33 deaths. In the US with a population of 331 million of which 50.5% were fully vaccinated there were 127,108 daily cases with 574 deaths. He compared FDA’s and WHO’s ban on ivermectin to Pope’sban on all books and letters that argued the Sun was the center of the universe instead of Earth, adding that the US government was ‘all-in with vaccines with the enthusiasm of a 17th century Catholic church’.

On August 10, a news story by Yahoo! Japan reported that a Japanese clinician Kazuhiro Nagao, appearingon the Fuji TV television program, had suggested that ivermectin should be distributed to all Japanese nationals in advance to be taken after COVID-19 infection, and that COVID-19 should be in the same administrative category as seasonal influenza in order to avoid delays and make early treatment possible [144].

On August 10, a news report from La Pampa province of Argentina described minister of health MarioRub´en Kohan releasing the latest results of the implementation of a monitored intervention program on the use of 0.6 mg/kg of ivermectin for five days in 3,269 treated patients versus 18,149 untreated patients[145,146]. The risk of death was 27.4% lower (RR 0.73) and the risk of death or ICU admission was 38.0%lower (RR 0.62). For people over 40 years of age the risk of death was 33.4% lower (RR 0.67). For people over 40 years of age and with comorbidities the risk of death was 44.0% lower (RR 0.56).

On August 11, Los Angeles Times wrote about ivermectin having ‘no effect whatsoever’ in the Togethertrial [147]. The head researcher Mills said that ‘in our specific trial we do not see the treatment benefit that a lot of the advocates believe should have been seen’. He complained that many researchers had faced unprecedented abuse from advocates of specific treatments.

On August 11, an article by Cobos-Campos et al. reviewed ivermectin for COVID-19 [148].

On August 12, vaccine expert Geert Vanden Bossche, who on May 24, 2021 had proposed mass chemoprophylaxis with ivermectin [149], demanded stopping of COVID-19 mass vaccination [150]. A rationale for the demand was the increased infectiousness of new variants already noted with respect to the alpha and delta variants, both more infective than the original variant, and the delta variant being significantly more infective than the alpha variant. Bossche expected this trajectory to continue, possibly resulting in an uncontrollable situation. In Bossche’s view, the increased infectivity had resulted from a natural selection of increasingly vaccine immunity escaping variants in the vaccinated part of the population. In other words, mass vacci11nation had created an evolutionary pressure for development of these variants which were then transferred to the non-vaccinated population. In addition, vaccine-induced antibodies possibly competed with natural antibody based, variant-nonspecific immunity, possibly rendering the population more vulnerable to some vaccine immunity escaping variants. The issue was also taken up by other researchers [151].

On August 12, a preprint by Elavarasi et al. described a retrospective study about hospitalized patients in India which did not show a statistically significant result [152].

On August 12, an article by Pedroso et al. described that self-prescribed use of early ivermectin treatment by 45 healthcare workers in Brazil was associated with a lower rate of seroconversion in a dose-dependentresponse [153].

On August 13, an article by Zhou et al. suggested that ivermectin might be a new potential anticancer drug therapy for human colorectal cancer and other cancers [154].

On August 13, on NIH Collaboratory, Smith discussed the history of proposed therapies for COVID-19 andthe adaptive platform trial ACTIV-2 [155].

On August 14, a Japanese clinician Kazuhiro Nagao wrote in a blog post that he had been harassed and had received death threats after appearing on TV and telling about treating 500 COVID-19 patients with ivermectin with no deaths [156,157].

On August 14, Kiekens interviewed an Italian physician Andrea Stramezzi about his early treatment protocol and his telehealth treatment method [158]. He was using hydroxychloroquine as a part of the outpatient protocol due to its easy availability. According to Stramezzi, it was useful in the first few days. Initially in the pandemic it had been provisionally recommended [159], then banned [160]. Stramezzi had initiated a legal proceeding about the ban, initially winning the case but subsequently losing an appeal. Regardless,the judge had decreed that physicians were free to prescribe medications off-label at their discretion. In addition, the protocol had included anti-inflammatories such as aspirin, and bromhexine. Also vitamins C and D were used, although Stramezzi did not consider high levels of vitamin D sufficient to prevent COVID19. Additionally, vitamin K was administered separately from vitamin D due to their antagonism. A later addition, ivermectin, useful also in later stages to reduce replication of the virus, needed to be imported from the neighboring countries. Stramezzi said that about 10% of Italians had a genetic vulnerability toSARS-CoV-2 induced hyperinflammation. For this group, prevention with corticosteroids and enoxaparin was necessary. He said that there were approximately 1,500 physicians in Italy working with the similar protocols, exchanging information with each other. The public’s awareness of early treatments in Italy was still low because health authorities did not recommend it or talk about it, instead just recommendingparacetamol and waiting for severe pneumonia to emerge before contacting healthcare facilities. Stramezzisaid they had met Sileri, a physician/researcher and deputy minister of health (M5s) [161,162], for an hour.

Sileri had said he was aware of the therapeutical options, had treated a hundred patients himself, and hadco-authored an article about the genetic defect [163]. Also, the parliament of Italy had voted in favor ofearly treatments [164]. Regardless, after several months nothing had happened with regard to adoption of these treatments. Stramezzi was developing a free mobile phone app for doctors who had too many patients or who were unsure of how to treat COVID-19: the app would give suggestions for a suitable treatment protocol.

On August 16, a letter to the editor by Chahla et al. in the American Journal of Therapeutics described a randomized controlled trial (n=234) in Argentina with ivermectin and iota-carrageenan as pre-exposureprophylaxis for health care workers (NCT04701710) [165,166,167]. The treated group (n=117) received 6mg ivermectin every seven days, and six nasal sprays of iota-carrageenan per day for 4 weeks. The risk ofCOVID-19 infection was 84.0% lower (3.4% vs 21.4%, RR 0.16, p=0.001), and the risk of moderate or severe disease was 95.2% lower (0.0% vs 8.5%, RR 0.05, p=0.002). The authors hypothesized that the combination treatment formed a double viral barrier: first, carrageenan behaved as a mucolytic agent in a barrier of sulfated polysaccharides with negative charge in the nasal cavity; second, ivermectin decreased viral load by systemic cellular action.

On August 16, an article by Winter examined the ongoing discussion about ivermectin [168].

On August 17, an article by Gonz´alez-Paz et al. described an in-silico elastic network model analysis of ivermectin components (avermectin-B1a and avermectin-B1b) providing a biophysical and computational perspective of proposed multi-target activity of ivermectin for COVID-19 [169,170].

On August 17, Associated Press reported that ’dozens of people in Oregon have contacted the state’s poisoncenter after self-medicating against COVID-19 with a drug used to treat parasites, with five becoming hospitalized and two of them winding up in intensive care units’ [171].

On August 18, Los Angeles Times wrote that fluvoxamine may actually work against COVID-19 [172].

On August 19, an article by Gonz´alez-Paz et al. described an in silico analysis of the components of ivermectin (avermectin-B1a and avermectin-B1b), suggesting different and complementary inhibitory activity of each component, with an affinity of avermectin-B1b for viral structures, and of avermectin-B1a for host structures [173,174].

On August 20, an article by Amaya-Aponte reviewed ivermectin in COVID-19 [175].

On August 20, the investigational monoclonal antibody sotrovimab was granted a provisional approval forthe treatment of COVID-19 in Australia [176].

On August 20, a letter by Popp et al. in the BMJ said that the different assessments between Popp et al’sCochrane meta-analysis and the one by Bryant et al. were partly due to baseline data of included studies:Bryant et al. pooled heterogeneous patient populations, interventions, comparators and outcomes whereasPopp et al. did not; thus, according to Popp et al., Bryant et al. compared apples and oranges, ‘serving a large bowl of a colorful fruit salad’ [177]. The authors accused Bryant et al. of ‘creating pseudotrustworthiness for substances that cannot be considered effective and safe treatment options nor game changers, at this stage’.

On August 21, an article by Karvanen et al. described a new algorithm for causal effect identification: do search based on do-calculus [178]. The algorithm might allow for improving clinical trial result analysis [179,180,181].

On August 21, due to overlap and confusion with the I-MATH+ prophylaxis and early outpatient treatment protocol, the FLCCC discontinued its I-MASS mass prophylaxis and home treatment protocol introduced a few months earlier [182].

On August 21, the US Food and Drug Administration (FDA) tweeted about ivermectin, stating that ‘You are not a horse. You are not a cow. Seriously, y’all. Stop it.’ [183]. The tweet linked to FDA’s March 2021advisory against ivermectin [184].

On August 21, a Slovenian newspaper reviewed ivermectin, mentioning two previous articles published in the same newspaper written by a Slovenian ivermectin proponent Matjaˇz Zwitter [185,186].

On August 21, a blog post by Meyerowitz-Katz discussed a study by Cadegiani et al. [69], claiming that thedata in a spreadsheet uploaded by the authors didn’t look real: ’data for this study may not be fake, but it is at least incredibly suspicious’ [187,188].

On August 21, a preprint by Izcovich et al. presented a systematic review about bias as a source of inconsistency in ivermectin trials [189]. Based on a review of 29 RCTs with 5,592 cases the authors concluded that previous reports about ivermectin’s benefits were based on potentially biased results, and further research was needed.

On August 22, an Indian geriatrician, preventive cardiologist and anti-aging specialist Lenny Da Costa described ivermectin use in India [190,191]. According to Costa, beginning from March 2020, India distributed an outpatient home treatment kit containing hydroxychloroquine, azithromycin, doxycycline, ivermectin and vitamin C. In March 2021, ignoring evidence from India, WHO stated that ivermectin should not be used.

The statement was given by an Indian epidemiologist, WHO chief scientist Soumya Swaminathan. A group of Indian physicians filed a legal case against her. To protect Swaminathan, Indian central government removedivermectin from official recommendations. However, state governments were responsible for guidelines for medical care in the states, not the central government; most states continued the use of ivermectin. Costasaid that no-one had stopped using ivermectin but they did not advertise the fact. According to Costa,during the deadly second wave in April-May 2021, India’s most populous state, Uttar Pradesh, reduced the number of daily cases from 60,000 to 15,000 in a month by distributing ivermectin for everyone for free. Clinicians did not wait for RT-PCR test results; instead, medication was started immediately on the presentation of symptoms. Prescriptions were given for free by telemedicine (WhatsApp). Ivermectin prevented people from infecting others, especially family members. Also, numerous physicians had been using ivermectin since March 2020 for prophylaxis, with none of them getting infected. On June 29, 2021, the government of Uttar Pradesh announced a home treatment kit for children, containing paracetamol, multivitamins and ivermectin. Costa claimed that India’s success in controlling the second wave was primarily due to an early administration of ivermectin, doxycycline, zinc and other medications used for early treatment.

On August 23, a medical doctor writing under a pseudonym Justus R. Hope continued on India’s ‘ivermectin blackout’ [192,193]. On August 15, Kerala, a state reportedly not using ivermectin, with a population of approximately 3% of India’s population, had accounted for 56% of India’s new cases and 25% of India’s new deaths. Delhi, a state with nearly the same population size as Kerala but using ivermectin, accounted for 0.2% of new cases and 0% of deaths. Uttar Pradesh, with a population almost eight times larger than

Kerala, accounted for 0.09% of new cases and 0.2% of deaths. Hope wrote that Kerala ranked in the top five most vaccinated of India’s 29 states, adding that Kerala’s failure in comparison to most other states of India could be explained by the facts that Kerala had not used ivermectin for early treatment whereas most other states had, and that ivermectin lowered the viral load and inhibited transmission whereas vaccination did not, giving a false sense of security. Those with prior infection, negative test result, or at least one vaccine dose (56% of adults) had been exempted from lockdown [194]. Hope called Kerala’s comparatively highvaccination rate its most problematic feature leading to rampant viral transmission. Kerala had adopted ivermectin in April but restricted its use to severe cases with additional risk factors. On August 5, Kerala had removed ivermectin from state guidelines completely. In contrast, Uttar Pradesh had been the first stateto introduce large-scale prophylactic and therapeutic use of ivermectin. The state had treated all contacts of an infected patient prophylactically with ivermectin. The lesson, Hope said, was that ivermectin could make up for the low use of vaccination but vaccination could not make up for the low use of ivermectin.

On August 23, ABC News report written by a medical toxicology fellow and an emergency medicine physician in New York stated that health officials had said that a potentially dangerous, unproven deworming drugs hould not be used to treat COVID-19 [195]. The report blamed social media for informing people about the medication ‘not authorized by independent regulators at the FDA’ (see e.g. [196]). Not a single trial to prove ivermectin’s usefulness existed and an interviewee advised that people ‘don’t have to go with something that doesn’t have a scientific basis’.

On August 23, CBS News reported that officials had warned against using anti-parasite drug for COVID19 [197].

On August 24, Mother Jones magazine interviewed Boulware, an ivermectin researcher, involved in a University of Minnesota trial (NCT04510194) [198,199]. Boulware had received hostile messages calling him ’are embodied Josef Mengele’ from people believing that ivermectin was a miracle cure and placebo-controlled trials were therefore unethical. Another researcher at Washington University in St. Louis commented on the polarization, saying that if she tweeted something about vaccines as positive, she was being attacked by people pro early treatment, and if she tweeted about potential treatments, she provoked the ire of vaccine advocates who ‘kind of seem to suppress any information about early treatment, maybe because they feel like it’s going to make people think they don’t need to be vaccinated’. The article also described Steve Kirsch’s frustration with the government’s unwillingness to recommend treatments on the basis of small trials with encouraging results. Researchers also worried that the recent reports of ivermectin self-dosing could scare people off of enrolling in any kind of treatment trials in the future.

On August 25, an article by Mohan et al. described a trial (RIVET-COV, n=157) investigating the effect of single-dose oral ivermectin (12 or 24 mg) in mild and moderate COVID-19 which indicated no statistically significant effects on viral load or RT-PCR negativity [200].

On August 25, on the social media platform Reddit, subreddit r/ivermectin which had been a public, uncensored discussion forum initiated a year before for discussions related to ivermectin research and treatments,was flooded with tens of horse-themed pornographic cartoon images, in reference to ivermectin as ‘horse paste’, as well as hundreds of sexual, offensive or irrelevant comments. The moderator said the attack had been coordinated by a group of moderators of other, large subreddits, yet refused to remove the irrelevant content, referring to his disbelief in censorship [201].

On August 25, in a FLCCC weekly update, endocrinologist and researcher Fl´avio Cadegiani described his experience in the state of Amazonas in Brazil during a gamma variant outbreak in 2021 (the gamma variantwas considered to cause a more severe disease than the delta variant) [202]. The research group had visitedvarious cities with hospitals overwhelmed with COVID-19 patients. However, in the city of Coari located afew hundred kilometers west from Manaus there had been no hospitalized COVID-19 patients at all. At first Cadegiani had been unable to get an explanation to the situation but later, in private, a health official had revealed that the city had been providing ivermectin for its whole population for two months already. As to the question why the explanation had not been given immediately the official replied that she had been afraid of being accused of giving unapproved treatments. Cadegiani said the experience had been shocking.

He added that secondary endpoints in single-agent trials were important indicators of possible efficacy as a component in a multi-agent treatment protocol.

On August 25, in the FLCCC weekly update, Kory and Marik discussed the addition of dual anti-androgentherapy (dutasteride 2 mg on day one followed by 1 mg daily for ten days [203], and spironolactone 100 mg twice daily for ten days [204]) to their delta variant early treatment protocol which at the time included twelve components [202]. They stated the addition provided ‘massive improvements’.

On August 26, Krolewiecki et al. published additional details about their trial on the antiviral effect of high-dose ivermectin in COVID-19 [205].

On August 26, Centers for Disease Control and Prevention (CDC) reported that ivermectin prescriptionsfrom US pharmacies had increased 24-fold from the pre-pandemic baseline [206]. Ivermectin-related calls to poison control centers had increased five-fold, respectively. The report gave two examples of adverse effects:one patient becoming disoriented after taking tablets of unknown strength (5 tablets per day for five days),and another patient presenting with confusion, drowsiness, visual hallucinations, tachypnea and tremors after drinking an injectable form of veterinary ivermectin.

On August 26, Newsweek interviewed Joe Varon of the FLCCC saying that since a year ago he had treated thousands of COVID-19 patients in the US with off-label ivermectin in combination with other pharmaceuticals in the FLCCC treatment protocols [207]. During the pandemic Varon had been widely featured in the US media but the reporters had chosen to not mention ivermectin.

On August 26, a news story in Vice magazine complained that Facebook did not properly censor ivermectin content and Facebook’s ivermectin groups were ‘unhinged and out of control’ [208,209].

On August 28, Newsweek reported about a far-right political commentator’s use of ivermectin for his COVID19 infection [210].

On August 28, Newsweek reported that a Republican representative from Texas had appeared to speak in support of unproven treatments for COVID-19, including ivermectin, a drug often used as a dewormer for cows and horses [211]. The representative was also said to have praised president Trump and have raised concerns about vaccines.

On August 29, Anthony Fauci warned against using ivermectin for COVID-19 [212].

On August 29, Cohen wrote in Forbes that ivermectin had become embedded in a ‘cultural war’, commenting that ‘of all drugs right-wingers would have gravitated to, ivermectin and hydroxychloroquine are most unusual candidates, in that they’re largely used in humans in developing nations for conditions rarely seen in the US’ [213]. Ivermectin for COVID-19 was pictured as unproven misinformation harming public health, and the politicization of the issue had been to the detriment of efforts to contain the pandemic, taking attention away from clinically confirmed instruments such as vaccines. The author worried that there were a surprising number of people in the medical profession who believed in ivermectin, such as the physician advisor to Florida’s governor. Cohen said that ‘these contrarians are not waiting for the completion of confirmatory studies to disseminate their advice to the gullible minions to take ivermectin off-label, even if doing so may endanger lives’.

On August 30, Newsweek reported that an US hospital had refused to administer FLCCC member FredWagshul’s prescription for a patient, after which a judge had ordered the hospital to administer it [214]. The next day, a regional US newspaper interviewed Wagshul who attributed the lack of adoption of ivermectinto ‘propaganda, money and big pharma’ [215].

On August 30, a report by German news agency said that ivermectin trials have been of a low quality and that Cochrane Deutschland and the University of W¨urzburg considered ivermectin inefficacious [216].

On August 30, a video interview of Fernando Valerio describes Honduras’ treatment protocols in detail [217].

On August 31, a preprint by Omrani et al. presented a systematic review and meta-analysis of effectiveness of ivermectin/doxycycline combination, concluding that based on low-quality evidence, the combination was accompanied with a shorter time of clinical recovery but did not significantly reduce all-cause mortality, viral clearance, and hospital stay [218].

On August 31, Pfeiffer described patients’ experiences in US hospitals [219].

On August 31, Kory of the FLCCC accused the US National Institutes of Health (NIH) of being the main agent in the ‘war against ivermectin’ due to not having given a recommendation for ivermectin [220]. Healso stated the FDA was only ‘running interference for [NIH] by telling jokes and lies’.

On August 31, a Swedish newspaper G¨oteborgs-Posten wrote about veterinary ivermectin use in the US [221].

On August 31, a preprint describing a randomized controlled trial of community-level surgical mask promotion in rural Bangladesh with 111,525 individuals in the intervention arm and 155,268 individuals in the control arm indicated 14% relative reduction in COVID-19-like symptoms, with absolute reductions of 7.5%vs 8.6%. Divided by age groups, differences were not statistically significant in people under 50. In people between 50-60 years there was a reduction of 23%, and in people over 60 a reduction of 35%, respectively.

The impact of the intervention faded after five months [222].

September 2021

On September 1, ABC News wrote that due to lack of evidence and increase in reports related to ivermectin toxicity, the American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists had called for an ‘immediate end’ to prescribing, dispensing or using the deworming drug ivermectin to treat or prevent COVID-19 [223].

On September 1, Washington Post wrote that people using ivermectin for prophylaxis had been shocked about having ended up being hospitalized for COVID-19 [224]. The story mentioned the rise in prescriptions and FDA’s tweet and warned about overdoses. Numerous interviewees advised against ivermectin, with the most critical comparing it to ‘snake oil’. Overall, a part of the population preferring ivermectin and vitamin cocktails over vaccines was seen to indicate ‘a broader problem: a public health crisis made worse by many people’s distrust of medical authorities while they rely on often faulty information from some ofthe country’s most influential people, which is amplified through social media’. Ivermectin was said to have gained particular traction in conservative circles. Wagshul of the FLCCC was quoted saying that ivermectin was more effective than vaccines against variants given waning immunity. A researcher working on an ongoingclinical trial on ivermectin in the US ([225,226]) commented that ‘there’s either people that believe it totally is a cure-all and works or that it is highly dangerous . . . and the reality is, neither extreme is true’.

On September 1, a letter by Keehner et al. in the New England Journal of Medicine reported about a dramatic decline in vaccine effectiveness from June to July in a highly vaccinated health system workforce in California, likely due to the emergence of the delta variant, waning of immunity over time, and the end of masking requirements in California [227].

On September 1, KFOR News published a news story in which a rural Oklahoma doctor, Jason McElyea,claimed that local emergency rooms were so backed up with patients having overdosed ivermectin that gunshot victims had hard time getting to the facilities [228]. In addition, ivermectin overdose patients were completely clogging ambulance services: McElyea was quoted saying that ‘all of their ambulances are stuck at the hospital waiting for a bed to open so they can take the patient in and they don’t have any, that’s it. . . if there’s no ambulance to take the call, there’s no ambulance to come to the call’.

On September 1, 2021 the subreddit r/ivermectin was ‘quarantined’ by the Reddit platform but that did notstop the flood of offensive posts. Alternative forums were created but they seemed to fail to capture largeaudiences (e.g. [229]). Another subreddit, r/IVMScience appeared to have stalled after August 23, 2021,with the moderator’s account deleted.

On September 1, podcaster Joe Rogan, with 11.1 million followers on YouTube, 13.2 million followers on Instagram and a USD 100 million contract to publish his podcast exclusively on Spotify, revealed on Instagram that he had got COVID-19 and had been treated with monoclonal antibodies, ivermectin, azithromycin, prednisone, nicotinamide adenine dinucleotide drip and a vitamin drip for three days in a row [230]. Rogan’s statement was widely taken up by news media [231,232,233]. On July 1, 2021, in the context of an unrelated controversy, a journalist at the New York Times had called Rogan ‘too big to cancel . . . one of the most consumed media products on the planet – with the power to shape tastes, politics, medical decisions’ [234].

On September 1, a letter to the editor by Bryant et al. commented on the recent report in the Guardian [81]discussing the effect of the removal of the Elgazzar et al. trial on the meta-analysis by Bryant at al. [4].

The authors stated that ‘while quantitative measures of effect do of course change on removal of any study,the overall findings of a significant mortality advantage in ivermectin treatment, and in prophylaxis, remain robust to removal of the disputed data. The claim that conclusions are “entirely reversed” cannot be sustained on the evidence’ [235].

On September 1, Due˜nas-Gonz´alez et al. discussed repurposing of ivermectin as a novel anticancer [236].

On September 2, Newsweek published a version of McElyea’s story, saying people taking the horse de-wormer medication were filling up the area’s emergency rooms [237]. The report mentioned FDA’s ‘stern warnings’against ivermectin, the unavailability of ambulances, and gunshot victims’ difficulties.

On September 2, Rolling Stone wrote about how Joe Rogan ‘became a cheerleader for ivermectin . . . no one has been more successful at promoting ivermectin than Rogan’ [238].

On September 2, a major Finnish newspaper Helsingin Sanomat republished a news article written by Finnish News Agency (STT) about an US podcast host Joe Rogan treating his COVID-19 infection with a ‘dewormer intended for horses’ warned against by ‘medical officials’ [239]. The article described that after his diagnosis Rogan begun taking ‘all kinds of potions’ including ivermectin, which, according to Washington Post and the Guardian, was used as a dewormer for horses. However, ‘some representatives of conservative media’had ‘advertised the controversial dewormer’. In addition to mentioning the negative stance of the European

Medicine Agency (EMA), the article also cited FDA’s tweet saying: ‘You are not a horse. You are not a cow.

Seriously, y’all. Stop it’. According to the article, calls about ivermectin exposure to poison control centers in the US jumped to five times over normal levels in July 2021. Rogan was also described having spread ‘lies’about COVID-19 and being against vaccines. The leading infectious diseases expert Anthony Fauci was said to have criticized Rogan’s earlier statements. Up to the 1990s, STT, founded in 1887, was often consideredt he ‘official’ national news source. Helsingin Sanomat, the most widely distributed newspaper in Finland,essentially holds a monopoly in the metropolitan area. The article was also republished by the most widely distributed yellow press media Ilta-Sanomat belonging to the same concern as Helsingin Sanomat [240]. In addition, the story was posted in some regional newspapers [241], essentially reaching the whole population of the country.

On September 2, a competing Finnish yellow press newspaper wrote about Rogan’s use of dewormer, saying that it had no proven efficacy and it could be dangerous, even deadly [242]. Rogan was said to regularly ‘flirt with misinformation’. The article also described FDA warnings and retraction of the Elgazzar et al. trial.

On September 2, citing insufficient evidence of efficacy, leading health experts in Sri Lanka urged people to stop using ivermectin for COVID-19; however, a local trial was ongoing [243].

On September 2, Marik and Kory published a reanalysis of the data of their earlier meta-analysis [6],saying that the summary point estimates were largely unaffected when the study by Elgazzar et al. was removed [244].

On September 2, a letter to the editor by Neil et al. said that their Bayesian analysis provided sufficientconfidence that ivermectin was an effective treatment for COVID-19, also after the exclusion of Elgazzar et al. study [245].

On September 2, a Cochrane review concluded that the authors were uncertain whether the investigational monoclonal antibody sotrovimab had an effect on mortality (RR 0.33, 95% CI 0.01-8.18) and invasive mechanical ventilation requirement or death (RR 0.14, 95% CI 0.01-2.76). Treatment with sotrovimab was said to possibly reduce the need for oxygenation (RR 0.11, 95 % CI 0.02-0.45), hospital admission or death by day 30 (RR 0.14, 95% CI 0.04-0.48) [246].

On September 2, an article by Alves et al. in the BMJ about poorly designed studies contributing to misinformation in Brazil said that ’much like a poorly written sequel to a blockbuster, the ivermectin narrative appears to be a subsidiary of the rationale that gave the world the HCQ pseudo-solution to COVID-19: cheap, readily available answer to the biggest sanitary crisis of our time’ [247]. The authors argued that public communication of science (i.e. news reporting) should be evidence based: any interaction between scientists and press should aim at summarizing and contextualizing the most important findings of an article for the general public, preserving context and limitations of the research, promoting transparency,integrity and scientific literacy. Also, research findings should be published without delay and include full datasets. Otherwise, the authors said, public communication may be only fueling polarization and an eventual implementation of harmful, inefficient or wasteful public health policies.

On September 2, an article by Chaudhry et al. presented a systematic review about the role of ivermectin in hospitalized patients [248].

On September 2, a report in BuzzFeed news questioned the validity of two prophylaxis trials by Carvallo etal. in Argentina [249]. The report claimed that the reported numbers, genders and ages of trial participants had slight inconsistencies. Carvallo was said to have declined to share the raw data even to his coauthors, the timeline and ethical approvals of the trials were unclear, as well as who had performed the statistical analyses.

It was also unclear which hospitals had been involved and in which ways. Carvallo denied accusations of fraud.

On September 3, an article by Okogbenin et al. described a retrospective study in Nigeria, with 300 patients treated with ivermectin, zinc, vitamin C and azithromycin, reporting zero mortality [250].

On September 3, a rapid response by Bryant et al. to Popp et al. [177] stated that their Bryant et al. metaanalysis was a non-commissioned research paper that strictly followed PRISMA systematic review guidelines,and that Popp et al. itself contained several misleading items, including using death instead of infection for the prophylaxis outcome, specifying outcome measures not found in the included trials but ignoring the outcome measures found in the trials, subsequently stating that they found ‘no data’ [251]. The authors concluded that in a pandemic context, the benefits of ivermectin almost certainly outweighed any risks.

On September 3, a blog post by Meyerowitz-Katz discussed the study by Carvallo et al. [252], pointing outissues that indicated possible fraud, yet noted that the study was not a randomized controlled trial and thus

not included in most meta-analyses or given the same credence, and it did not change recommendations forofficial medical organizations. However, Meyerowitz-Katz added, ’it perhaps had an even bigger impact onpeople actually taking ivermectin than previously fraudulent research. This paper showed a 100% benefit,it was enormously popular on social media, and it was given a huge amount of credence by promoters ofivermectin for nearly a year. It is not a stretch to say that this one study has perhaps caused hundreds ofthousands or even millions of people to take ivermectin as a prophylactic drug to prevent COVID-19’ [253].

On September 3, South African Health Products Regulatory Authority (SAHPRA) repeated its warnings against the use of ivermectin, saying its stance was aligned to that of US FDA [254].

On September 3, Yahoo News published a version of McElyea’s story, mentioning that he was an emergency room physician affiliated with multiple hospitals in Sallisaw, Oklahoma, and that the situation was so dire that even people with gunshot wounds have to wait their turn to get treatment [255]. McElyea added that people were suffering real ramifications from taking a dosage meant for a full-sized horse, including ‘scary’instances of vision loss, nausea, and vomiting.

On September 3, Rolling Stone magazine published a version of McElyea’s story [256].

On September 4, the Guardian published a version of McElyea’s story [257].

On September 4, BBC published a version of McElyea’s story [258].

On September 4, the administration of Northeastern Health Systems (NHS) Sequoyah posted a statement saying that although McElyea was not an employee of NHS Sequoyah, he was affiliated with a medical staffing group that provided coverage for the emergency room at Sallisaw but he had not worked there in over two months [259,260]. The administration clarified that NHS Sequoyah had not treated any patients due to complications related to taking ivermectin, including not treating any patients for ivermectin overdose. They added that all patients who had visited the emergency room had received medical attention as appropriate,and the hospital had not needed to turn away any patients seeking emergency care.

On September 4, KXMX interviewed a hospital administrator of NHS Sequoyah who stated that the hospital being overloaded by ivermectin patients was ‘simply not the case in Sallisaw .. . we have not seen or had anypatients in our ER or hospital with ivermectin overdose . . . we have not had any patients with complaints or issues related to ivermectin . . . we are not overrun with patients with ivermectin related issues’ [261].

The administrator added that McElyea had treated patients in the Sallisaw emergency room but not in the past several months, and added that she wanted the public to know that McElyea did not speak for NHSSequoyah.

On September 4, NPR wrote that poison control centers are fielding a surge of ivermectin overdose calls [262,263].

On September 4, Reuters published a fact-check article saying that ‘outrage has spread online that Afghan refugees entering the United States will receive the drug ivermectin although it does not have U.S. approval as a COVID-19 treatment. However, the posts miss the vital context that refugees are given ivermectin for infections unrelated to the novel coronavirus . . . ivermectin is administered as a presumptive treatment forintestinal parasite’ [264]. The ‘outrage’ was said to have been caused by ivermectin being administered to refugees but being largely unavailable for US citizens willing to use it for COVID-19.

On September 4, an article by Associated Press published in Indian Express said that efforts to stamp out use of parasite drug ivermectin for COVID-19 in US were growing [265]. It said that ivermectin was being‘promoted by Republican lawmakers, conservative talk show hosts and some doctors, amplified via social media to millions of Americans who remain resistant to getting vaccinated’, with the American Medical Association, two US pharmacist groups, FDA, CDC and WHO advising against it.

On September 5, the Guardian added an amendment to the end of their article, quoting parts of the statementby NHS Sequoyah, saying that the hospital had not treated any patients related to taking ivermectin,including overdose [266].

On September 5, a ‘fact check’ by Shore News Network called the McElyea story ‘completely false’, mentioning that the publishers had not issued retractions, saying that ‘the left continues to push a media narrativethat conservatives and Republicans are creating an ivermectin health crisis’ [267].

On September 6, a preprint by Buonfrate et al. described randomized controlled trial in Italy with results indicating statistically insignificant dose dependent viral load reduction (NCT04438850) [268]. The authors said that ivermectin remained safe with dosing regimes of 0.6 mg/kg and 1.2 mg/kg for five days. The study was terminated early due to lack of eligible patients.

On September 6, a blog post by an US doctor working on new models for mental health care called theMcElyea story ‘too good to check’, saying that ’the media has tried to spread the word that the scientific consensus [about ivermectin for COVID-19] remains skeptical. In the process, they may have gone a littleoverboard and portrayed it as the world’s deadliest toxin that will definitely kill you and it will all somehow be Donald Trump’s fault’ [269,270].

On September 6, a report by News On 6 said ‘a false report has Oklahoma trending nationally . . . the doctor at the center of the story told News 9 he was misquoted, and the story was wrong’. McElyea clarifiedthat ‘as the story ran, it sounded like all of Oklahoma hospitals were filled with people who have overdosed on ivermectin and that’s not the case, . . . the cases we are seeing, people who are overdosing on ivermectin,they are taking full strength cattle doses and coming in and that is something that could be avoided’.

The report mentioned another hospital in the area, Integris Grove, having stated that they had seen ‘a handful of ivermectin patients in their emergency rooms . . . while our hospitals are not filled with people who have taken ivermectin, such patients are adding to the congestion already caused by COVID-19 and other emergencies’. The report concluded with a mention that the Oklahoma Center for Poison and Drug Information had received 12 ivermectin-related calls last month [271].

On September 6, Soave analyzed the media reporting, saying that the media fell for a viral hoax about ivermectin overdoses straining rural hospitals [272]. He commented that McElyea clearly stated that ivermectin overdoses were a problem and claimed that some hospitals were dealing with strain in general but he neveractually connected these two issues. Instead, the KFOR’s journalist had added that framing; she had notresponded to a request for comment. If other media outlets had called the doctor or the hospitals they would have easily uncovered the error. Soave added that while the mainstream media had vigorously condemned COVID-19 misinformation in social media, readers could also encounter it in mainstream media such as Rolling Stone, New York Times or Associated Press (AP) which had recently reported that 70 percent of calls to Mississippi’s poison hotline were from people who had taken ivermectin while the actual figure was 2 percent [273] (AP was a member of the Trusted News Initiative (TNI) [274]).

On September 6, another judge reversed the earlier decision concerning administration of ivermectin prescribed by Wagshul to a patient in a US hospital, saying there ‘was no doubt that the medical and scientific communities do not support the use of ivermectin as a treatment for COVID-19’ [275]. The judge addedt hat ‘COVID-19 has ravaged the world. However, the rule of law must be followed once the court system is involved. The law in its purest form shall have neither hatred nor sympathy to anyone or anything. It shall stand unwavering in its truth, justice, and fairness to call’ [276]. A spokesperson for the hospital described the ruling as ‘positive in regards to the respect for science and the expertise of medical professionals’, adding that they implore the community ‘to do what we know works: wear a mask, become fully vaccinated and use social distancing whenever possible’. She added that the hospital appreciated scientific rigor and did not believe they should be ordered to administer medications ’against medical advice’.

On September 6, a German magazine for pharmacists reported about American Pharmacists Association’s recent demand to stop off-label ivermectin prescribing [277]. The article mentioned the ongoing PRINCIPLEtrial by University of Oxford.

On September 7, Fox News reported that McElyea was an employee of an agency that staffs emergencydepartments [278]. The report also mentioned that while NHS Sequoyah had stated they had not treatedany ivermectin patients, Integris Grove Hospital, had seen a handful’. Integris added that ‘there is a lotof media attention surrounding remarks reportedly made by Dr. McElyea. While we do not speak on hisbehalf, he has publicly said his comments were misconstrued and taken out of context’.

On September 7, a CNN reporter Daniel Dale tweeted about McElyea case, saying local media had misrepresented the interview of McElyea, national and international media had failed to do due diligence, and readers and critics had jumped to conclusions. He concluded that ‘lots of people involved here – certainly the local outlet/the big aggregating outlets/the prominent tweeters on the left, but also some critics on the right – could’ve done a better job pursuing facts/waiting for facts before coming to conclusions’ [279]. CNN published a ‘fact-check’ report with similar content [280].

On September 7, an Austrian newspaper wrote that the misconception that horse dewormer ivermectin wouldhelp against COVID-19 is widespread internationally and also in Austria [281]. The article mentioned thatno poisonings had been reported in Austria, and that Czech Republic had adopted ivermectin in hospitals.

A toxicologist commented that ivermectin was still dangerous and there was insufficient data on the safety of chronic consumption.

On September 7, the title of a January 2021 article in a German women’s magazine, originally asking whether ivermectin might be useful, was updated to ‘People are not horses’ [282].

On September 7, a Swedish newspaper Svenska Dagbladet wrote that instead of being vaccinated Americans are taking ivermectin as the latest alternative treatment for COVID-19, the only problem being that it was intended for treating parasites in horses and cows [283].

On September 7, Joe Rogan complained that CNN had reported that he had been taking ‘horse dewormer’;Rogan stated that ‘I literally got it from a doctor’ [284].

On September 7, wealthy Chinese exile Guo Wengui was said to be using his online misinformation network to promote the use of unproven treatments for COVID-19 [285].

On September 8, an article by Cruciani et al. presented a systematic review and meta-analysis of ivermectin for prophylaxis and treatment of COVID-19 [286]. Based on an analysis of eleven RCTs, the authors concluded that there was limited evidence for the benefit of ivermectin.

On September 8, a letter published in the Guardian by Hill, the main author of one of the meta-analyses about ivermectin [5], said that after his team had questioned the clinical benefits of ivermectin the team and his family had received daily death threats. As social media platforms had not reacted he had stopped using social media but abuse by email had continued. Hill described the situation as shocking, affecting many scientists, and said that scientists must be protected from anti-vaxxer abuse, possibly by police action [287].

On September 8, Wired magazine wrote about Together trial results, quoting the head researcher saying that ivermectin proponents had ignored their fluvoxamine findings, only being interested in ivermectin,‘feeling strongly’ about it but not about other possible options [288]. The article also mentioned US NIH’s ongoing ACTIV-6 ivermectin trial, into which people could sign up at home. A co-chair of the trial’s steering committee said that there was no data on ivermectin’s benefit but since people were using it, the point of their trial was to get a definitive answer.

On September 8, the Guardian worried about some Australian clinics’ off-label prescribing of ‘unapproved’ivermectin [289]. The president of the Royal Australian College of General Practitioners (RACGP) said that while RACGP did not consider its role to be looking over the shoulders of every GP, the advice from the health experts to not use ivermectin was ‘100% clear’. However, she added, ‘the status of other drugs, suchas sotrovimab, is very different. That is an example of a new drug for the treatment of Covid-19 that haspassed through the rigorous testing safety procedures of the Therapeutic Goods Administration’.

On September 9, Geert Vanden Bossche summarized the negative effects of mass vaccination as follows: itwill, first, eventually drive dominant propagation of super variants that are highly infectious and increasinglyresist vaccine-induced neutralizing antibodies; second, erode innate immune defense in the non-vaccinated(due to high infectious pressure exerted by enhanced circulation of more infectious variants); and third,erode naturally acquired immunity (due to increasing viral resistance to neutralizing spike protein specificantibodies). Of these, the second and third consequences together prevent herd immunity from being established.

Yet the solution, according to Bossche, would be induction of herd immunity by starting from scratch against the more infectious variants. This could be achieved by providing multidrug early treatment for the infected which would result in enhanced rates of recovery from disease and rise in the number of people who develop life-long protective immunity. Also, mass antiviral treatment with any drug that would effectively reduce viral infectious pressure would be required to prevent innate antibodies in previously asymptotically infected individuals from being suppressed by short-lived, spike protein specific antibodies and thus enable the healthy, unvaccinated part of the population to deal with all SARS-CoV-2 variants; these massantiviral campaigns might need to include pets and live-stock and be combined with lockdown rules foras long as titers of these short-lived antibodies were measurable (6-8 weeks).

Boscche said that a larger unvaccinated population would circulate also less infectious variants, attenuating circulation of more infectious variants. However, the above methods would still be unlikely to sufficiently reduce transmission among healthy individuals; therefore ultimately an immune intervention able to prevent infection in all susceptible age groups would be required, and as long as such an intervention, likely based on natural killer cell based vaccines, would not be available, repeated antiviral chemoprophylaxis might be necessary. However, as along term strategy the chemoprophylaxis would not be feasible, as overuse could promote viral resistance to the compound.

About his personal intentions Bossche wrote that ‘one can always do more, write morearticles, bring more scientific evidence to the table, do more interviews and podcasts, reply to more questionsand destroy more of the nonsense divulgated by scientifically incompetent experts or illiterate fact-checkers.

However, I’ve decided to not continue along this path as I knew from the very start that this big alliance of stakeholders would not listen and as the primary purpose of my endeavors has always been to share, as broadly as possible, my scientific insights on why this [mass vaccination] experiment is an incredible blunder, so that none the involved experts, key opinion leaders, public health authorities or peers from industry could ever pretend that this was unknown and simply unpredictable’ [290].

He said that he had a history of going against ‘groupthink’, for example speaking against the results of Gavi The Vaccine Alliance’s phase III Ebola vaccine trials conducted by the World Health Organization (WHO) and published in a peer-reviewed journal. Bossche said the results falsely concluded that the vaccine had 100% efficacy, whereas according to Bossche’s analysis ‘the truth looked extremely different’ [291]. He added that to him it seemed that ‘many of our experts and scientists, even including a substantial number of renowned professors, are so stuck within their small silos that they have simply lost touch with reality’.

On September 9, Hill responded to a tweet by the BIRD group which had said that according to Hill, the conclusions of the meta-analysis by Hill et al. remain clearly in favor of ivermectin even after exclusion ofElgazzar et al. trial [292,293]. Hill stated: ‘Misleading information from the BIRD group. In our analysis there is no significant survival benefit for ivermectin in randomized trials after exclusion of apparently fraudulent and biased studies’ [292]. Later on the same days he responded with ‘more misleading information from the BIRD group misquoting our research’ to another tweet by the BIRD group which had said that‘Hill’s work also shows that ivermectin not only reduces the risk of death, it clears the virus from the bloodstream faster than controls, thus ivermectin reduces the time that an infected person can transmit the virus’ [294].

On September 9, Joe Rogan discussed the ‘horse dewormer’ narrative, referring to regulatory capture in theUS [295].

On September 10, a news report in the BMJ discussed US court rulings and ivermectin prescriptions [296].

On September 10, the BIRD group announced that their meta-analysis by Bryant et al. [4] had reached a position in the top ten of 18.9 million articles tracked by Altmetric [297,298].

On September 10, Hill tweeted that the ‘survival benefit of ivermectin disappears when only trials at low risk of bias are analyzed. The reported survival effects are entirely driven by studies at high risk of bias or medical fraud’ [299]. An accompanying graph indicated slightly over 50% benefit (p=0.01) with Elgazzar et al. study included, slightly under 40% benefit (p=0.05) without it but including studies with a high risk for bias, and approximately 4% benefit (p=0.90) with only low risk studies included.

On September 10, a blog article discussing failed communication attempts between ivermectin skeptics and proponents commented that ‘what you are witnessing is just the most absurd example of a decades-long war on re-purposed (aka “non-profitable”) medicines’ [300,301,302].

On September 10, Hindustan Times wrote about a clinical trial (RIVET-COV) with 157 patients with mild to moderate disease carried out by All India Institute of Medical Sciences (AIIMS) which indicated that ivermectin did not reduce the viral load or duration of symptoms [303]. Mohan said that ‘all the ivermectin being prescribed or being taken by people left, right, and centre will definitely not show any effect’; therefore ivermectin should not be used outside clinical trials, although he added that their trial did not investigate possible effect on mortality.

On September 11, TrialSite News wrote about US NIH’s refusal to release information on who had been involved in its decision to recommend neither for nor against ivermectin [304]. However, US CDC had released the names of the members of the working group [305]. According to TrialSite News, three of the nine members, Adimora, Bedimo and Glidden, had disclosed a financial relationship with Merck & Co/MSD.

Another member, Naggie, had later received USD 155 million funding for US NIH’s ACTIV-6 trial which included ivermectin, fluvoxamine and fluticasone (NCT04885530) [306].

On September 11, TrialSite News wrote that Australia’s Therapeutic Good Administration (TGA) had formally placed a national prohibition on off-label prescribing of ivermectin to all general practitioners,citing interruption of vaccination as a factor in the decision [307].

On September 12, a three-day International Covid Summit started in Rome [308,309], with presentationsin the Roman Senate held also in Italian and Spanish and translated into sign language. Lecturers included Roberta Ferrero, Francesca Donato, Albert Bagnai, Luigi Icardi, Ivan Vilibor Sincic, Joseph Tritto, Robert Malone, Mauro Rango, Christof Plothe, David Anderson, Ira Bernstein, Fabio Burigana, Steven Hatfill,Roberto Accinelli, Tess Lawrie, Oswaldo Castaneda, Rosanna Chifari, Antonietta Gatti, Andrea Stramezzi, Peter Mccullough, George Fareed, Pierre Kory, Roberta Lacerda, Carlos Maggi, Bruce Patterson, DilipPawar, Victor Villa, Mattia Perroni and Francesco Matozza. In addition, the summit featured groups of researchers and clinicians from Italy, Croatia, Czech Republic, Poland, Romania, Bulgaria, Tanzania, South Africa, Nigeria, Mali, Spain, UK, France, Brazil, Bolivia, Argentina, Paraguay, Peru, Canada and US. Several treatment protocols including McCullough et al’s sequenced multidrug protocol [310] and FLCCC’s MATH+protocol were discussed.

On September 13, a Dominican Republic newspaper described details of an early 2020 ivermectin trial by Morgenstern et al. [311,312].

On September 13, a story in Rolling Stone ridiculed ‘anti-vaxxers’ for using povidone iodine mouthwash to prevent COVID-19 [313]. An interviewed gynecologist/obstetrician commented that ‘we use it before surgery to clean the vagina’ and that ‘it could result in iodine poisoning if taken orally’. Another physician who appeared unable to give statements without including profanities in his sentences commented that ‘drinking iodine’ had caused a patient a transient kidney failure and that povidone iodine definitely could not reducethe effects of COVID-19 or prevent its transmission. An ’Australian family physician’ stated that ‘there have been no human studies on the use of Betadine to treat COVID-19, just hypotheses and lab studies’.

On September 13, the Guardian wrote about ‘ivermectin frenzy’ being ‘a cottage industry of advocacy groups, anti-vaccine activists and telehealth companies’ despite stances of FDA, NIH and some US medical and pharmaceutical associations [314]. It noted that FLCCC had signed open letters in favor of ivermectin which had also been signed by ‘anti-vaxx’ organizations. Telehealth sites were said to have connections to a conservative doctor group America’s Frontline Doctors in favor of hydroxychloroquine treatments and whose opinions had been quoted by ‘Donald Trump, his son Donald Trump Jr and numerous QAnon conspiracists’.

On September 13, Mother Jones magazine wrote that people associated with Q-Anon had harassed a hospital where a Q-Anon member had been hospitalized with hundreds of calls and emails, in order to get ivermectin administered to her [315].

On September 14, in a Cochrane Collaboration author interview, Stephanie Weibel and Maria Popp described their ivermectin meta-analysis [316]. The authors said that because of a lack of good-quality evidence, it was unknown whether ivermectin reduces or increases mortality, caused adverse effects, improved or worsened patients’ condition, or increased or decreased viral load, led to more or fewer negative COVID-19 tests 7days after treatment. Likewise, they could not say whether ivermectin prevented COVID-19 infection or reduced the number of deaths after high-risk exposure to the SARS-CoV-2 virus.

On September 14, Menichella wrote about Peter McCullough’s influence in Italy and about a protocol developed in Italy by a group led by Giuseppe Remuzzi [317]. The Remuzzi protocol was mainly based on relatively selective COX-2 inhibitors [318]. In a retrospective observational matched-cohort study with 90outpatients and 90 controls with mild disease the proportions of patients who required hospitalization were2% vs 14% (p=0.01); cumulative days of hospitalization were 44 vs 481 days, and costs of hospitalization were EUR 28,000 vs EUR 296,000, respectively. Menichella wrote that the standard of care resulted in approximately 2% mortality; with a ’serious home treatment protocol’ mortality could be lowered to 0.05%.

On September 15, an article by Talwar et al. described a case of a successful management of ivermectinpoisoning [319]. A 6-year-old girl weighing 20.5 kg had accidentally consumed 600 mg of ivermectin (29.3mg/kg). Mechanical ventilation, ceftriaxone, clindamycin, intravenous midazolam, phenytoin and supportivemeasures were utilized. The girl was discharged after nine days of hospitalization.

On September 15, a news report in Willamette Week discussed US biologist Bret Weinstein’s role in the ivermectin controversy, including his influence on Joe Rogan [320].

On September 15, a letter to the editor by Boretti discussed quercetin, suggesting that quercetin might help to lower inflammation, as well as reduce the toxic effects of COVID-19 vaccines and the chances of being infected [321]. Quercetin had been included in the FLCCC protocols since early 2020.

On September 15, Fenton et al. discussed unreliability of current vaccine studies [322].

On September 16, Cheng et al. presented a meta-analysis about efficacy and safety of various medications for treating severe and non-severe COVID-19 patients [323].

On September 16, Malhotra discussed Indian Bar Association’s legal notice to WHO [324].

On September 16, an Australian medical newspaper wrote that a secretive organization called the COVID19 Antiviral Advisory Group had said it had been instructing 200 doctors to prescribe ivermectin and was planning on going public against TGA’s ivermectin ban [325].

On September 17, an article by Singh et al. suggested a positive correlation between European populations’zinc sufficiency status and COVID-19 mortality. The authors noted that the observed association was contrary to what would be expected if zinc sufficiency was protective in COVID-19, suggesting that controlled trials or retrospective analyses of the adverse event patients’ data should be undertaken to correctly guidethe practice of zinc supplementation in COVID-19 [326].

On September 17, an article by Gurung et al. described an in silico study which indicated that ivermectin demonstrated moderate binding to human serum albumin [327].

On September 17, a preprint by Karale et al. presented an updated systematic review and meta-analysis of mortality, need for ICU admission, use of mechanical ventilation, adverse effects and other clinical outcomes

[328]. 52 studies (n=17,561) were included in a qualitative analysis and 44 of those (n=14,019) were included in the meta-analysis. A mortality meta-analysis indicated lower odds of death (OR 0.54, 95% CI 0.34-0.86,p=0.009, 29 studies). As adjuvant therapy, the odds of viral clearance were higher (OR 3.52, 95%CI 1.816.86, p=0.0002, 22 studies), the duration to achieve viral clearance was shorter (p=0.02, 8 studies), andthe need for hospitalization was reduced (OR 0.34, p=0.008, 6 studies). The authors concluded that themortality benefit of ivermectin in COVID-19 is uncertain but as an adjuvant therapy ivermectin may improve viral clearance and reduce the need for hospitalization.

On September 17, a news report by Piper in Vox magazine questioned the validity of studies by Carvallo etal. [329,330], saying that experts on scientific fraud didn’t believe Carvallo conducted his study as described:the data appeared fabricated, key data was missing, study registration and published results didn’t match with each other, Carvallo could not explain these issues, and the hospital in which the study was said to have been conducted stated that it had not been conducted there, to which Carvallo replied that it had been but without the hospital administration knowing [331]. In another context, Lawrie of the BIRD group had been asked what evidence would persuade her that ivermectin didn’t work, to which she had replied thatthere could be nothing that would persuade her. Mills involved in the Together trial commented that themost culpable parties weren’t those who had believed in the apparently fraudulent studies but those whohad conducted, published, and boosted them.

On September 17, Business Insider wrote about FLCCC’s Kory and Marik, calling them ’fringe doctors whipping up false hope that could have deadly consequences’ [332]. According to Business Insider, Kory was’a once respected doctor whose hospital rejected his unsupported treatment ideas’ while Marik was ’a doctor who ostracized himself from mainstream medicine after his high-profile sepsis treatment was a dud’, adding that ’Marik’s failed sepsis protocol later became the backbone of the FLCCC’s first iterations of COVID-19treatment’ (the MATH+ inpatient protocol) [333]. Recently they had been ’sucked (willingly or not) into the embrace of the anti-vaccine far right .. . ivermectin is now a darling drug of QAnon’. A former FLCCCmember, Eric Osgood, had left the group in summer 2021. The editor in chief of Science Communication said that FLCCC’s communication style was objectionable but added that the existence of ’rogue opinions’was a necessary condition for scientific breakthroughs. However not everyone had the skills to assess claimsnor understood how science worked, which had led to ’a conflict between our commitment to freedom of speech and a clash with the nature of scientific truth and people’s right to say anything they want . . . the hype machine they’ve created is out of control’.

On September 17, Seheult on MedCram reviewed ivermectin, with comments from cell biologist Rhonda Patrick [334]. Seheult stressed the importance of taking all treatment options into account; Patrick said ivermectin had seemed to consistently reduce viral load but the hype around ivermectin was pushing researchers away from the subject.

On September 20, an Indian news agency reported that 31 of 75 districts of the state of Uttar Pradesh inIndia were COVID-19 free [335]. In total, the state reported 17 new cases in the last 24 hours out of 182,742samples tested.

On September 20, the Guardian worried about horses being deprived of a deworming agent [336].

On September 21, Brazil’s president Bolsonaro stated that Brazil had supported clinicians’ early treatment measures since the beginning of the pandemic, adding that he could not understand why some countries opposed early treatment measures [337].

On September 21, Ars Technica discussed the validity of Covid Analysis group’s ivmmeta.com meta-analysis[338].

On September 22, a letter to the editor by Lawrence et al. in Nature Medicine concluded that metaanalyses based on summary data alone were inherently unreliable [339]. The authors stated that most,if not all, of the flaws in recent ivermectin meta-analyses would have been immediately detected if metaanalyses were performed on an individual patient data (IPD) basis. They recommended that meta-analysts who study interventions for COVID-19 should request and personally review IPD in all cases, even if IPDsynthesis techniques were not used. They also recommended that all clinical trials published on COVID-19should immediately follow best-practice guidelines and upload anonymized IPD. They authors said that their proposal was a change to a nearly universally accepted practice over many decades and substantially more rigorous than current standards; regardless, the proposed change was imperative.

On September 22, in a FLCCC weekly update, Marik announced an upcoming publication of an article on the pathophysiology of COVID-19 [340].

On September 22, a video by John Campbell described the contents of ivermectin kits used in state of Goain India [341]. The kits in Goa contained pulse oximeter, a thermometer, paracetamol, vitamin C and D,multivitamin tablets containing zinc, ivermectin (10 x 12 mg), doxycycline (10 x 100 mg), and personal protective equipment. The cost of one kit was USD 2.65. The kits used in Uttar Pradesh contained ivermectin, doxycycline, vitamins B, C and D, zinc, paracetamol, thermometer and a pulse oximeter. Outpatients weremonitored by phone twice a day. Campbell said that the intervention had actually been organized under a WHO monitoring program. A WHO report described that since May 5, 2021, 141,610 government teams were moving across 97,941 villages in 75 districts over five days in Uttar Pradesh, a state with a population of 230 million [342]. WHO field officers monitored over 2,000 government teams and visited at least 10,000 households. WHO also said it was to support the Uttar Pradesh government on the compilation of the final reports; these reports had not yet been published.

On September 23, a preprint by Mayer et al. described an intervention program of high-dose ivermectin in COVID-19 carried out by the Ministry of Health of the Province of La Pampa, Argentina [343]. Within five days of symptoms onset, 0.6 mg/kg/day of ivermectin for five days was administered. Active pharmacosurveillance was performed for 21 days, with hepatic laboratory assessments performed in a subset of patients. From 21,232 subjects with COVID-19, 3,266 were offered and agreed to participate in the ivermectin program. 17,966 did not participate and were considered as controls. A total of 567 participantsreported 819 adverse events; 3.13% discontinued ivermectin due to adverse events. Mortality was lower in the ivermectin group in the full group analysis (1.5% vs 2.1%, OR 0.720, p=0.029), as well as in subjects over 40year-old (2.7% vs 4.1%, OR 0,655, p=0.005). ICU admission was significantly lower in the ivermectin groupcompared to controls among participants over 40 year-old (1.2% vs 2.0%, OR 0.608, p=0.024). According to Covid Analysis group [344], in a full group analysis the unadjusted risk of death was 27.6% lower (RR 0.72,p=0.03) and unadjusted risk of ICU admission was 26.0% lower (RR 0.74, p=0.13).

On September 23, several groups of clinicians in favor of early treatments announced a new organization,World Council for Health, an umbrella organization with over 45 affiliated organizations [345]. The council released a home treatment guide with a combination protocol consisting of vitamins C and D, zinc, quercetin, melatonin, ivermectin, mouthwash, ibuprofen, N-acetylcysteine, antihistamines, aspirin, and others [346].

The protocol was one of the first ones to tentatively include iodine (Lugol’s solution).

On September 23, the Indian Council of Medical Research (ICMR) dropped ivermectin and hydroxychloroquine from clinical guidelines for the management of adult COVID-19 patients [347,348,349,350].

On September 23, a fact-checking website discussed social media posts claiming that ’ivermectin apparently sterilizes the majority (85%) of men that take it’ and a news report claiming that ’ivermectin causes sterilization in 85 percent of men, study finds’ [351,352].

On September 24, the Guardian wrote about misinformation spreading globally [353].

On September 24, the Guardian wrote about fraudulent ivermectin studies [354].

On September 24, Mashable interviewed ex-FLCCC member Osgood who said that he had initially joined the FLCCC because they were ’forward thinking doctors who were able to get ahead of the profession’ on a few hospital treatments (e.g. the use of anticoagulants) but he had left the organization because of his view that FLCCC insisted on promoting ivermectin over vaccines [355]. He referred to povidone iodine prophylaxis of COVID-19 as misinformation.

On September 26, an article by Marik et al. presented a scoping review of the pathophysiology of COVID-19[356]. The article described severe COVID-19 as one of the most complex of medical conditions known to medical science, noting that an overarching and comprehensive understanding of its pathogenesis, a requirement for the formulation of effective prophylactic and treatment strategies, was still lacking. Threebasic pathologic processes were identified: a pulmonary macrophage activation syndrome with uncontrolled inflammation, a complement-mediated endothelialitis together with a procoagulant state with a thromboticmicroangiopathy, and platelet activation with the release of serotonin and the activation and degranulation of mast cells contributing to the hyper-inflammatory state (quercetin had been a part of FLCCC protocols sinceMarch 2020; in one study, it was found more effective than cromolyn in blocking mast cell cytokine release[357]). The article also mentioned the C-C chemokine receptor type 5 (CCR5) pathway which interacts with chemokine ligand 5 (CCL5 or RANTES).

On September 26, in a discussion with Robert Malone, Geert Vanden Bossche stated that the proper way would have been to vaccinate vulnerable groups only, and mentioned ivermectin chemoprophylaxis as a possible solution [358].

On September 26, the New York Times interviewed the acting head of the New Mexico (US) state health department who claimed that ivermectin ’had contributed to’ deaths of two hospitalized patients who had previously self-medicated with ivermectin ’instead of proven treatments like monoclonal antibodies’ [359].

On September 27, in a discussion with Anmol Ambani and Peter A. McCullough, Marik presented the contents of the new article in a video lecture [360].

On September 27, 5,200 doctors had signed a Global Covid Summit related ’Rome declaration’ [361].

On September 27, an article by Deng et al. presented a systematic review and meta-analysis about the efficacy and safety of ivermectin [362]. Based on an analysis of three observational studies and 14 RCTs representingvery low to moderate quality of evidence, the authors concluded that ivermectin was not efficacious atmanaging COVID-19.

On September 28, an article by Barkati et al. concluded that corticosteroid therapy was an important risk factor for Strongyloides hyperinfection but there were challenges associated with the performance, availability and quality of Strongyloides tests. The authors concluded that presumptive use of ivermectin was reasonablein selected situations [363].

On September 28, an article by Zhang et al. presented a Bayesian network meta-analysis of 222 randomized controlled trials with 102,950 patients, suggesting that imatinib, intravenous immunoglobulin andtocilizumab led to lower risk of death; baricitinib plus remdesivir, colchicine, dexamethasone, recombinanthuman granulocyte colony stimulating factor and tocilizumab indicated lower occurrence of mechanical ventilation; tofacitinib, sarilumab, remdesivir, tocilizumab and baricitinib plus remdesivir increased the hospital discharge rate; convalescent plasma, ivermectin, ivermectin plus doxycycline, hydroxychloroquine, nitazoxanide and proxalutamide resulted in better viral clearance [364]. On a treatment class level, the analysis found that the use of antineoplastic agents was associated with fewer mortality cases, immunostimulants could reduce the risk of mechanical ventilation and immunosuppressants led to higher discharge rates.

On September 28, the New York Times wrote that Facebooks groups promoting ivermectin continued to flourish [365].

On September 28, a rapid review by Cardwell et al. about pharmacological interventions to prevent COVID19 mentioned ivermectin prophylaxis trials [366].

On September 29, a preprint by Budhiraja et at. described secondary infections in hospitalized patients inNorth India, mentioning that 43.5% of the patients had been administered ivermectin [367].

On September 29, referring to FLCCC, BIRD and America’s Frontline Doctors (AFLDS), Scientific Americanwrote about fringe doctors’ groups promoting ivermectin for COVID despite a lack of evidence [368].

On September 29, Chemistry World wrote that ivermectin debacle had exposed flaws in meta-analysis methodology [369]. The report stated that ’the people who’ve done these meta-analyses haven’t stuffed up. . . they haven’t deviated from accepted standards or made big mistakes . . . instead, there is a fundamentalflaw in the approach’.

On September 29, the Hill, the largest independent political news site in the US, wrote that ivermectin disinformation had led to new kinds of chaos [370].

On September 30, a preprint by Schaffer et al. describing changes in dispensing of medicines proposed for re-purposing in the first year of the COVID-19 pandemic in Australia noted that there had a small but sustained increase in ivermectin dispensing between March 2020 and November 2020 [371].

On September 30, an introduction to Popp et al.’s Cochrane review by Jordan said that at this stage there were very few completed well conducted studies about either prevention or treatment but 31 trials were underway [372].

Discussion

On a closer look it appeared that the quality of some early ivermectin trials had been lower than assumed.

As individual patient data had not been generally available, most parties including various groups publishing meta-analyses had implicitly trusted the summary data and ignored slight inconsistencies. The current best practice guidelines did not require analysis of individual patient data. The proposal that meta-analyses should be performed on individual patient data appeared justified. An additional, likely necessary change to methodology would be adoption of the do-search method, assumedly the most general tool currently available for causal effect identification, and as such an improvement over Bayesian methods [179,373].

In 2014, Every-Palmer et al. noted that little ‘high quality’ (according to evidence-based medicine standards)empirical evidence existed that EBM should benefit the population, i.e. evidence about EBM’s superiority in improving patient outcomes [374]. In 2018, Anjum claimed that EBM relied on a flawed positivist methodology [375]. Recently, Martini claimed that the concept of evidence was insufficiently defined [376].

A fundamental error appeared to be the insistence on trialing single agents instead of combination protocols.

All of the currently utilized early treatment protocols were combination protocols and it was unlikely that the same results could have been obtained with a single agent. Thus, combination protocol trials would have been more likely to produce statistically significant effects. The insistence on large trials, instead of eliminating biases, possibly introduced them. For example, a lack of funding for repurposing may have introduced a severe funding-related bias.

It appeared that prolonged stress and continuing unpredictability of the situation had overwhelmed many,occasionally leading to actions whose consequences were perhaps badly thought out. The situation seemedto amplify preexisting tendencies and weaknesses within groups, leading to group-specific biases, formationof subcultures, or variants of ’groupthink’ [103]. Groups suspecting the pharmaceutical industry, authoritiesand ’the mainstream’ seemed to amplify these tendencies in-group, whereas groups suspecting anything’fringe’ but favoring mechanistic thinking and overreliance on specific methods or paradigms seemed toamplify these tendencies. Groups with a tendency to act out in panic or anger exhibited that behavior,while groups with a tendency to retreat into fearful inaction and silence did that. The central role of trustwas highlighted, yet trust seemed practically nonexistent.

Also strengths were exhibited, most prominently the capability of forming groups and alliances. However,these groups tended to become tribal in their nature, and the result resembled tribal warfare, a practice that the humanity should already have transcended. It seemed as if everyone was trying to take care of others in their own ways but these ways were incompatible with each other; someone once defined conflicts as ’failed attempts to love’.

It also seemed that journalists and the public had an idealized image of science and were trying to find solace in it as in a religion, with some scientists maybe trying to maintain these illusions. One commentator noted that ’society was not ready to watch science in real time’ [377]. Another added that ’science was not prepared to display itself to the public in real time’, while a third said that ’society was not ready to watch science in any other way either’.

In the news media, emotionally manipulative tactics seemed common. A prime example of arrogance and lack of due diligence was the case of Rolling Stone ridiculing povidone iodine use [313], claiming that there had been no human trials about it on COVID-19, despite the fact that there had been several, with promising results [10,378,379,380,381] (for observational studies, see e.g. [382,383]; for an updating list, see [384]).

Ways of reasoning appeared incompatible for example in the case of the Guardian’s critique of the BIRD group affiliating with organizations labeled as anti-vaccine for the purposes of promoting early treatment.

In the view of the BIRD group founder, vaccinations were unrelated to early treatments and, subsequently,the vaccination stances of the affiliates irrelevant. While technically correct, this view predictably appeared confusing.

In a similar manner it could be noted that, for example, the possible usefulness and validity of FLCCC’s protocols was unrelated to FLCCC members’ extra-medical opinions, and that ivermectin was only one component of the synergistic protocols consisting of more than ten components. Also, some news reports[332] severely misrepresented the sepsis protocol [333]. With regard to the social media communications of the FLCCC, it may have made a mistake in leaving these communications largely to a couple of ex-journalists whose communication style appeared unsuitable already in the first half of 2020.

With regard to conflicts of interest, the members of US National Institutes of Health’s (NIH) ivermectinworking group had disclosed several relationships to pharmaceutical companies working on COVID-19 treatments [385]. As mentioned, three of the nine members of the working group [305] had disclosed relationshipswith Merck & Co/MSD which, during the pandemic, had issued a statement against the use of ivermectinin COVID-19 [386], was working on a competing product molnupiravir [387,388,389], and had receivedsignificant US government funding for development of investigational pharmaceuticals for COVID-19 [390].

Adimora had received research support from Gilead Sciences and was a consultant and a member of an advisory board of Merck & Co/MSD; Bedimo was a member of advisory boards of Gilead Sciences, Merck &Co/MSD and ViiV Healthcare (a subsidiary of GlaxoSmithKline); Glidden was a consultant to Gilead Sciences and a member of an advisory board of Merck & Co/MSD [385]. A fourth member, Pavia, was a consultant to GlaxoSmithKline. A fifth member, Naggie, the head of US NIH’s ACTIV-6 trial (NCT04885530) [306]had received research support from AbbVie and Gilead Sciences, had a connection to Bristol Myers SquibbCompany, and was a stockholder and an advisory board member of Vir Biotechnology, the producer ofsotrovimab together with GlaxoSmithKline [391]. In summary, more than half of the members of the working group were associated with producers of molnupiravir, sotrovimab, remdesivir (Gilead Sciences),lopinavir/ritonavir (AbbVie), and investigational monoclonal antibodies (Bristol Myers Squibb Company).

However, NIH had specifically intended to involve the industry in its decision-making processes through the ACTIV public-private partnership [392]. Whereas this organizational structure likely appeared beneficialfrom the point of view of a swift development of investigational pharmaceuticals, with regard to repurposingit appeared to have included conflicts of interest by design.

For the pharmaceutical industry, incentives for unethical behavior may currently overpower those for ethical behavior. The current setting appeared designed for gambling [393], hardly the best method for optimizing public health, and it was difficult to see why societies considered it appropriate.

The event descriptions did not delve into details of the experiences of Honduras and the Dominican Republic; readers are encouraged to acquaintance themselves with the original sources [217,106,107,311,312].

These countries used relatively little clinical trial evidence to implement their protocols. Similarly, no RCT evidence on FLCCC protocols exists, yet they have been successfully used. These parties seemed to embrace uncertainty instead of requiring an unattainable level of certainty; high-income countries were probably less accustomed to radical uncertainty than developing countries.

Cameron described critical care archetypes on a two-axis model, with the first axis comparing interventionism(early, aggressive treatment) versus minimalism (’wait and see’) preferences, and the second axis measuring individualism versus collectivism [74]. In this model, the FLCCC appeared high on interventionism and individualism. The ’mainstream’, for example the World Health Organization and national authorities, appeared high on minimalism and collectivism.

During the whole pandemic (and before it), little to no attention was paid to the optimization of innate immunity. If the immune system is dysfunctional or in a suboptimal state, attempts at medicating symptoms including symptoms of SARS-CoV-2 infection are unlikely to be very effective, and the same likely applies to vaccines. While the role of zinc was acknowledged to some degree, the roles of, for example, copper, selenium and iodine were still mostly ignored. Conventionally, a long-term zinc supplementation without simultaneous copper supplementation is considered a risk for development of copper deficiency which would compromise immune function and host defence [394]; FLCCC recently lowered the dose of zinc supplementation. Astudy on European populations found a positive correlation between zinc sufficiency status and COVID-19mortality and incidence, contrary to what would be expected if zinc sufficiency was protective in COVID-19[326]; however, the result might also indicate lack of zinc ionophores.

Suggested solutions

In addition to the methodological issues there were other types of challenges to overcome. Considering that the nature of communication between parties involved in the ivermectin controversy was predominantly ofa rather violent nature, a method for improving communications would be needed. A suitable method forthe purpose may be the rather well known but rarely applied ’non-violent communication’ (NVC) method developed by Marshall Rosenberg [395,396]. The method presupposes a willingness to a certain degree ofvulnerability in order to express one’s real needs and feelings, and a willingness to actually listen to others without judging.

The method consists of two parts: expressing oneself, and empathically acknowledging others. NVC defines empathy as ’a process of connecting with another by guessing their feelings and needs’ [397]. Friesem describes the expressing part as a sequence of four steps: making observations (not evaluations) without blaming or criticizing, connecting feelings (bodily sensations instead of thoughts) to these observations, expressing the needs/values (not preferences) that caused the feelings, and making requests (concrete actions instead of vague wishes) without demanding [398]. The listening part consists of the same steps but the expressions use the pronoun ’you’ instead of ’I’. The four components are thus expressed as ’when I/you see/hear. . . ’(observation), ’I/you feel. . . ’ (feeling), ’. . . because I/you need/value. . . ’ (need), and ’would you be willing to/would you like. . . ’ (request).

The content must be as free from interpretations as possible, instead expressed in a neutral ’observation anguage’. Feelings, which are functions of the states of satisfaction of various needs, must be identified, named, connected with, and expressed without interpretation. Needs must be distinguished from strategies(strategies include objects and parameters while needs do not). Requests are aimed at assessing how likelyone is to get cooperation for particular strategies for meeting one’s needs; requests should be concrete and specific. Pandemic-specific examples are left as an exercise for the reader. With regard to therapeutics research, it might be worth a try to organize a conference whose participants would be required to find at least one detail they could agree on and then build on that foundation.

Considering that the communications at times appeared hopelessly dysfunctional, more potent methods are likely also needed. To a large extent, the damage associated with the pandemic was not caused by the virus itself but by a preexisting societal conditioning to fixed beliefs and subconscious biases which eventually led to disorganized and dissociative behavior. This ’inflexible disorganization’ subsequently created a massive amount of additional anxiety, burnout and depression.

Psychedelic therapy, currently maybe the second most trendy research subject after COVID-19 itself, wouldlend itself well for resolving these issues [399,400,401,402,403,404]. Psychedelics are likely the most effectivefacilitator of inspection of subconscious biases and fixed beliefs, and as such a valuable tool especially forscientists. Smaller doses may be preferable; this practice is called psycholytic therapy. It differs from the so-called ’microdosing’ in that doses are typically approximately a half or a third of a regular dose, and the effects of the substance are clearly perceived but different from those of high-dose psychedelic therapy.

Subconscious biases could be said to be a type of dissociative phenomena, in which a trigger related to a previous experience of overwhelming trauma triggers a slight dissociation, or a ’defence mechanism’. The mechanism of action of psychedelics in this case, in short, is to enable a person to relive the traumatic experience in order to neutralize the trigger. This must be done in an environment which provides thenecessary support so that the experience would not be experienced as overwhelming once again, as that would constitute a retraumatizing experience. Although various psychedelics produce slightly different effects, all of them would be useful for this kind of work. This includes also substances not always considered psychedelics,namely MDMA which is often called an ’empathogen’, and ketamine, often called a ’dissociative’.

Thus, an available pharmacological method would be off-label ketamine [405,406,407]. A trial by Federet al. compared treatment of post-traumatic stress disorder with either midazolam or ketamine (n=30)(NCT02397889) [408,409,410]. The mean score on the clinician-administered PTSD Scale for DSM-5(CAPS-5) was reduced from 40.1 to 33.2 in the midazolam group, and from 41.9 to 22.5 in the ketaminegroup. A similar reduction was observed for depressive symptoms.

A recent example of conflict resolution through altered states of consciousness, with promising results, was an attempt to alleviate the Israeli-Palestinian conflict by organizing ayahuasca group ceremonies [411].

The essence of psychedelic therapy, however, are not the molecules but the ’states of consciousness’, or states of mind, or emotional states, reached with the help of the molecules; change, progress or ’healing’ happens in or through these states. The same states may also be reached by other methods, although psychedelics provide a shortcut in situations in which there is a lack of time, skill or resources; the cost-effectiveness of psychedelic therapy is typically superior to other methods.

Non-pharmaceutical methods capable of inducing altered states include holotropic breathwork developed by Stanislav and Christina Grof [412]. Holotropic breathwork consists of continuous forceful circular breathing,combined with some bodywork and other techniques for guidance. The breathing technique leads to changes in oxygenation and typically to altered states of consciousness with the potential of resolving embodied traumatic experiences or opening new perspectives to overcome fixed beliefs. Grof developed the method as an alternative to LSD therapy sessions and has described the states and results as similar. A gentler approach from Buddhist traditions, also applicable to trauma therapy, is the Ch¨od method based on visualization[413,414].

The Wim Hof method is applicable for innate immune system enhancement [415]. In 2014, Kox et al.proved that sympathetic nervous system and immune system can be voluntarily influenced, and that itis possible to attenuate the innate immune response in humans [416,417]. Healthy volunteers practicing specific breathwork (hyperventilation), meditation and cold exposure techniques exhibited profound increases in the release of epinephrine, which in turn led to increased production of anti-inflammatory mediators and subsequent dampening of the proinflammatory cytokine response elicited by intravenous administration ofbacterial endotoxin. The Wim Hof method has numerous advantages: it is free, available to everyone,unlikely to produce adverse effects, and unconnected to health care systems and clinicians.

Conclusions

Similarly to SARS-CoV-2 virus emerging as a possibly inexhaustible source of ever more infectious variants,the issue of COVID-19 treatments emerged as a possibly inexhaustible source of increasingly complex epistemological challenges. Current best practices of clinical trial result meta-analysis were found to be unsound;methodological changes were proposed. More broadly, the whole approach based on sole reliance on single agent clinical trials that no-one really wanted to fund appeared fundamentally unsound. The pandemic also revealed various severe problems with mindsets and subconscious biases; methods to overcome these issues were also proposed. The impression of the ivermectin controversy as a whole was that what is ideally understood by science will remain out of reach if scientists are riddled with subconscious biases, methodologies are fundamentally unsound, commercial interests dominate, and the behavior more closely resembles tribal warfare than a silent meditation retreat.

Authors’ contributions

The author was responsible for all aspects of the manuscript.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Availability of data and materials

Not applicable.

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

The author declares that he has no competing interests.

Author details

Independent researcher, Helsinki, Finland. ORCID iD: 0000-0002-8575-9838

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Dr. Jessica Rose has a BSc in Applied Mathematics and completed her MSc in Immunology at Memorial University of Newfoundland in Canada. She completed her PhD in Computational Biology at Bar Ilan University and then did her first Post Doctorate at the Hebrew University of Jerusalem in Molecular Biology.

Estimating the number of COVID vaccine deaths in America

by Jessica Rose, Mathew Crawford

Abstract: Analysis of the Vaccine Adverse Event Reporting System (VAERS) database can be used to estimate the number of excess deaths caused by the COVID vaccines. A simple analysis shows that it is likely that over 150,000 Americans have been killed by the current COVID vaccines as of Aug 28, 2021.

The Vaccine Adverse Event Reporting System (VAERS) database is the only pharmacovigilance database used by FDA and CDC that is accessible to the public. It is the only database to which the public can voluntarily report injuries or deaths following vaccinations. Medical professionals and pharmaceutical manufacturers are mandated to report serious injuries or deaths to VAERS following vaccinations when they are made aware of them. It is a “passive” system with uncertain reporting rates. VAERS is called the “early warning system” because it is intended to reveal early signals of problems, which can then be evaluated carefully by using an “active” surveillance system.

The VAERS database can be used to estimate the number of deaths caused by the COVID vaccines using the following method:

1. Determine the significant adverse event under-reporting multiplier by using a known significant adverse event rate
2. Determine the number of US deaths reported into VAERS
3. Determine the propensity to report significant adverse events this year
4. Estimate the number of excess deaths using these numbers
5. Validate the result using independent methods

Determining the VAERS under-reporting multiplier

One method to discover the VAERS underreporting analysis can be done using a specific serious adverse event that should always be reported, data from the CDC, and a study published in JAMA. Anaphylaxis after COVID-19 vaccination is rare and occurs in approximately 2 to 5 people per million vaccinated in the United States based on events reported to VAERS according to the CDC report on Selected Adverse Events Reported after COVID-19 Vaccination. Anaphylaxis is a well known side effect and doctors are required to report it. It occurs right after the shot. You can’t miss it. It should always be reported.

A study at Mass General Brigham (MGM) that assessed anaphylaxis in a clinical setting after the administration of COVID-19 vaccines published in JAMA on March 8, 2021, found “severe reactions consistent with anaphylaxis occurred at a rate of 2.47 per 10,000” people fully
vaccinated. This rate is based on reactions occurring within 2 hours of vaccination, the mean time was 17 minutes after vaccination. This study used “active” surveillance and tried not to miss any cases.

When asked about this, both the CDC and FDA sidestepped answering the question. Here’s the proof at the CDC (see page 1 which incorporates the CDC response to the original letter on pages 2 and 3).

As noted in the letter, this implies that VAERS is underreporting anaphylaxis by 50X to 123X. The CDC chose not to respond to the letter.

Is the anaphylaxis under reporting rate a good proxy for reporting fatalities? Since anaphylaxis is such an obvious association, one could argue that the rate would be a lower bound. Others would argue that deaths are more important and would be more reported than anaphylaxis.

We don’t know, but it doesn’t matter because this is just an approximation to get to a ballpark figure. In general, most of us think It is therefore entirely reasonable to assert that deaths are reported even less frequently than anaphylaxis since deaths are not as proxmate to the injection event.

The MGH study used practically identical criteria as CDC used in its study to define a case of anaphylaxis. We ran the numbers ourselves and confirmed this.Therefore, a conservative estimate (giving the government the greatest benefit of the doubt) would use 50X as the underreporting rate.

However, after the MGH study was published, one doctor pointed out that doctors were more careful to avoid anaphylaxis; there was more careful screening of people likely to have anaphylaxis, and they were advised to see their allergist and take more precautions prior to
vaccination. This sort of thing would overstate the numbers above.

So we ran the numbers BEFORE the JAMA study appeared and got a more conservative estimate.

Here’s the data from Google (which uses World In Data):

We’ve vaccinated 97.5M people from the start thru March 2021 and there were 583 reports in VAERS who had an anaphylaxis reaction on their first dose. This suggests that the underreporting rate is 41X.

Other estimates such as How Underreported Are Post-Vaccination Serious Injuries and Deaths in VAERS? suggests a 30X factor based on VAERS.

However, this used a serious adverse event rate from the Pfizer Phase 3 study which we believe under-reported these events for three reasons:

1) the patients were much healthier than average with a 10X lower rate of cardiac arrest than the general public (for example),

2) it was hard to report adverse events if you were in the trial (the evidence of this was unfortunately deleted when Facebook removed the vaccine side effect groups), and

3) there was known malfeasance in the reporting of adverse events in the 12-15 year old trial where the paralysis of 12-year-old Maddie de Garay was never included in the trial results and the FDA and CDC refused to investigate and the mainstream media would not report on it.

The point of this paper is not to find the exact number of deaths, but merely to find the most credible estimate for deaths. We think that anaphylaxis is an excellent proxy for a serious adverse event that, like a death, should always be reported so we think 41X is the most accurate number.

Our hypothesis is that this number will be applicable to deaths as well. In order to confirm our hypothesis, we must derive the death count in different ways and see if we come up with the same answer.

When used for less serious events, such as a headache, it’s likely that 41X is going to be low since such events are less likely to be reported. So our hypothesis is that 41X is a safe, conservative factor useful for both serious and less serious adverse events.

Determining the number of US deaths

As of August 27th, 2021, a search of the VAERS database shows that there are 7,149 domestic deaths in the VAERS database (US/Territories/Unknown).

Estimate the propensity to report for 2021

Healthcare providers have been required by law to report serious adverse events in VAERS with passage of the National Childhood Vaccine Injury Act (NCVIA) in 1986.

Therefore, nothing has changed this year vs. previous years:
1. no new legal requirements,
2. no noticeable promotion or incentives to report into VAERS.

Even when there are strong promotions to report adverse events as there was with H1N1 in 2009 where there were serious campaigns to raise the visibility of reporting, this didn’t impact the background fatality event reporting: it didn’t go up at all in 2009 and 2010 as can be seen from the graph below.

In short, it is extremely difficult to materially change the propensity to report serious adverse events into the VAERS system; it is remarkably consistent from year to year. This makes sense: old habits die hard… behaviors are hard to change. And there was nothing “new” this year to incentivize a massive change in behavior.

Look at the weekly data below. The massive increase in reporting pretty much happened almost instantaneously as soon as the vaccines started rolling out. And it was proportional to the rollout. That is not how behavioral change works… behavioral change would happen very lowly over time; especially if you are trying to get doctors to change their long term behaviors. The reporting basically followed the rollout of the vaccine. Doctors were more likely to report to VAERS this year because there were simply more events to report. We have verified that by talking directly to the doctors as the reason they are reporting more for these vaccines.

To double check our hypothesis that the propensity to report is unchanged this year, we ran VAERS queries using symptoms unrelated to those impacted by the vaccines. We ruled out any known comorbidities like diabetes and obesity since these would likely be elevated since there are more adverse events.

We found that the reporting rates for these unrelated events (listed in the table below) are no different this year than in previous years and for some of these events, the reporting rate is dramatically lower. Note that the number in the 2015-2019 column is the total for the 5 years, not an average annual amount. The Rate Increase is an X factor (i.e., A/B*5)

A third way to see that 2021 isn’t simply over-reporting normal background adverse events is to look at the “adverse event (AE) footprint” of the vaccine. You do that by listing adverse events on the X-axis and AE counts on the Y-axis. If there is over-reporting this year, the overall outline of the boxes will be exactly the same as previous years, and they will just be higher due to the higher propensity to report the same types of events. As you can see, that is not the case here.

This vaccine is definitely causing a completely different “shape” of severe adverse events. Here we show 2018, 2019, 2020, and 2021.

For a more detailed set of vaccine fingerprints (COVID vs. other vaccines), see these charts from Jessica Rose.

A fourth way to confirm there wasn’t over-reporting is through informal physician surveys.

In our informal physician surveys we saw a bias to under-report serious adverse events in order to make the vaccines look as safe as possible to the American public since most physicians believe they are hurting society if they do anything to create vaccine hesitancy.

Secondly, we’d estimate that at least 95% of physicians have completely bought into the “safe and effective” narrative and thus any event that they observe they deem as simply anecdotal and don’t bother to report it since it couldn’t have been caused by such a safe vaccine that appeared to do so well in the Phase 3 trials.

Determining the number of excess deaths caused by the COVID vaccines

There are three ways to estimate the number of excess deaths caused by the vaccine. Using these three methods we can estimate the low and high likely bounds for the number of excess deaths caused by the vaccine:

1. Subtract the average number of background deaths in previous years
2. Use 86% based on the analysis in the Mclachlan study
3. Use 40% based on the estimate of Dr. Peter Schirmacher one of the world’s top pathologists

Here is the result we get from the three methods:

In the first method, we used 500 background deaths as normal for a year since the propensity to report is the same this year as in previous years as shown earlier. However, we should assume that the age cohort is older this year than previous years. For example, here are the vaccination rates shown in a CDC report for influenza:

So a conservative estimate is to take the <500 deaths per year and increase it by 50% to more than account for a shift to higher ages so subtract 750 background deaths.

In the second method, McLachlan examined 250 VAERS reports in detail and concluded that up to 86% of the deaths were consistent with the vaccine being causal for the death. We use the higher number, because using a lower number makes no sense since it leads to a background death rate that would be excessive compared to previous years (.14*7149 = 1,000 which is already higher than the 500/yr background death rate).

The third method uses estimates made by Dr. Peter Schirmacher, one of the world’s top pathologists, for the % of deaths examined by autopsy within 2 weeks of the vaccine that were clearly caused by the vaccine.

The range was from 30% to 40% and we used the high end of the range since we believed that in making a potentially career-ending revelation such as this that Dr. Schirmacher was being extremely conservative and only estimating what he was 100% certain of proving.

40% is likely very conservative since Norway was under no such reputational pressure and in the the first 13 bodies they assessed, 100% of the deaths were found to be caused by the vaccine (see Norwegian Medicines Agency links 13 deaths to vaccine side effects). Therefore using a 60% number seems relatively conservative (less than the 65% average of 30 and 100).

Therefore we have a range of death estimates from 148,000 to 216,000 deaths which averages to 182,000 deaths.

Validation using other methods

In order to validate that our estimates are reasonable (or simply that the evidence was more likely consistent with the hypothesis that the vaccine does more harm than good), we looked at four different quantitative methods from very small to very large and summarized their estimates in the table:

There are additional qualitative methods that show a large number of deaths. The point of these method is to show that the FDA assumption that “the vaccines are safe and all of the reports in VAERS are background events” is not even close to being true.

Example 5: The pericarditis data below shows that the number of events for these vaccines are anything but safe: they generate myocarditis/pericarditis at 860 times the rate of the typical flu vaccine in a year.

A friend of ours got pericarditis right after getting the influenza vaccine when she was 30 years old. It took her two years to recover. The heart muscle never really regenerates like other organs unfortunately.

Example 6: A total of 23 deaths have been reported in connection with the corona vaccination to the Norwegian Medicines Agency. Of those, 13 deaths were linked to the vaccine’s side effects. The other 10 haven’t been evaluated yet. Thus, 100% of the reported deaths have been deemed to be caused by the vaccine. If the vaccine is perfectly safe and has killed no one, then this is statistically impossible. Someone is lying. The fact that there are no autopsies being done in the US in public view suggests that it is more likely that the CDC is lying than the Norwegian Medicines Agency.

Example #7: An analysis of excess deaths in Israel, especially among young people, that was done by Dr. Steven Ohana, clearly shows a huge rise in excess deaths that have no explanation other than the rollout of a mass vaccination program.

Example #8: A published analysis of VAERS data by Dr. Jessica Rose and a more recent analysis of VAERS data done by Christine Cotton show massive numbers of cardiovascular and neurological adverse events occurring within temporal proximity to the injection date.

Example #9: Causality of these adverse events is confirmed using Dose 1 and Dose 2 studies done by Dr. Jessica Rose.

Example #10: If the vaccine is perfectly safe, the number of deaths would be equally likely after the first dose vs. the second dose since both are effectively “non-events.”

Because there are 15% fewer people who get the second dose than the first dose, we should expect the blue bars to be uniformly 15% lower than the red bars. This is not the case here. If the vaccine kills 50% of the 1% most vulnerable people each time it is administered, this can explain the dramatic drop off in events.

Another explanation is that the vulnerable population experienced severe adverse events following Dose 1 and thus chose not to get a second Dose despite the societal pressure (vaccine mandates, peer pressure, etc) to do so.

It is likely a combination of both effects. Here is an example of this from a comment posted to TrialSiteNews on A New Low For the FDA:

Whatever the cause, evidence to support the arisal and reporting of multiple severe adverse events that are dose-related is a very strong safety signal that requires investigation.

Example #11: The same commentary as before applies for cardiac arrest; a safe vaccine should have blue bars on average 15% below the red bars.

Example 12: Absolute numbers of VAERS reports plotted according to “time to death” is very revealing. We don’t know what the exact distribution of timing looks like because this was never measured. But we speculate that maximum accumulation of spike protein is achieved around 24 hours or so after injection and then it plateaus after that point as the mRNA disintegrates. Therefore, we would expect to see a death peak more than 24 hours after injection, i.e., on Day 1 and not on Day 0 This is exactly what happens in practice:

If these were simply random background deaths, we would expect to see a peak on the first day since that has the highest propensity to report, and it would drop from there; it would never peak on Day 1. In the graph above, we plot 8 months of the COVID19 vaccine reports compared to all death reports from all influenza vaccines for the past 10 years combined. So the blue line at 0 is 20 years of death reports, it is not an annual average. In short, the killing power of this vaccine is at least 200X greater than the influenza vaccine and probably a lot more than that since background deaths are included in both red and blue bars.

Furthermore, the shape of the two curves is completely different. The combined flu deaths are relatively flat with a slight rise in the first few days. The COVID vaccine generally kills people very quickly, and then gradually over time from there.

Example 13: A visual way to show that excess deaths are likely caused by the vaccine is to plot vaccinations and deaths on the same axis using data from the COVID-19 data explorer. For Israel we get this chart which shows a correlation between vaccine booster doses given
(cumulative booster doses per 100 people) and average daily deaths per million: they track almost in lock step.

This is hard to explain any other way.

In summary, the qualitative and quantitative confirmation techniques we used were all independent of each other and of our main method, yet all were consistent with the hypothesis that the vaccines cause large numbers of serious adverse events and excess deaths and are inconsistent with the null hypothesis that the vaccines have no effect on mortality and have a safety profile comparable to that of other vaccines.

We were not able to find a single piece of evidence that supported the FDA and CDC position that all the excess deaths were simply over-reporting of natural cause deaths.

Serious adverse events elevated by the COVID vaccines

We made a table comparing the rate of adverse events this year relative to the annual VAERS incidence rate reported for all vaccines over the period from 2015-2019 for ages 20 to 60.

We limited the age range to show that these events are affecting young people and not just the elderly. Also, the signal to noise ratio is much stronger in this younger age group since they are less likely to suffer “background” adverse events. A value of 473 means the rate reported in VAERS for the COVID19 vaccines in 2021 was 473 times higher than what is typical for all vaccines combined in the typical average year.

Nearly all serious adverse events we looked at were strongly elevated compared to the expected normal baseline event rate. This table is useful when assessing whether the vaccine may have been involved in causing death in cases.

The symptoms listed here are consistent with the presumed mechanism of action for how these vaccines kill people (producing spike protein throughout the body that cause inflammation, scarring, and blood clots).

Surprisingly, only a few of these symptoms appear in the labeling of the recently approved Pfizer vaccine. Thus, this table is important and timely.

Child deaths are consistent with symptoms elevated by the COVID vaccines

Perhaps most troubling of all is child deaths.

The CDC VAERS review of the 12-17 year old data released on July 30, 2021 showed there were 345 cases of myocarditis and 14 deaths. Unlike old people, kids don’t spontaneously die every day at anywhere near the same rate.

Using the table above and investigating each death, all of these deaths where there was sufficient detail in the death report showed that it involved one or more of the symptoms listed in the elevated adverse event table.

14*41 = 574 deaths

There are fewer total child deaths for 17 and under (which is a much wider age range than above) in the entire pandemic.

Therefore, the cost benefit case for children isn’t there.

Lack of a stopping condition

In 1976, they halted the H1N1 vaccine after 500 GBS cases and 32 people died.

However, there is no stopping mortality condition for these vaccines. We are likely at 150,000 deaths and counting and nobody in the mainstream medical establishment, mainstream media, or Congress is raising any concerns.

No member of the medical community is calling for any stopping condition nor autopsies. We find this troubling.

Negative efficacy

This paper shows that the vaccines we received may well shortly become completely useless to protect us and, to make matters worse, might enhance the ability of future variants to infect us due to vaccine enhanced infectivity/replication, rather than “classical” ADE.

In short, even if the vaccine were perfectly safe and killed no one, it’s rapidly becoming a net negative based on efficacy alone.

We are starting to see evidence of this today. UK data destroys entire premise for vaccine push. August 21. 2021. “Again, 402 deaths out of 47,008 cases or 0.855% CFR in fully vaccinated, and; 253 deaths out of 151,054 cases or 0.17% CFR in unvaccinated. If you get Covid having been fully vaccinated, according to this UK data, you are five (5) times more likely to die than if you were not vaccinated!”

All-cause mortality is the single most important thing to focus on and it’s not there

Today, most people focus on the relative risk reduction of the vaccines against infection, hospitalization death from COVID. They pay less attention to the absolute risk reduction from COVID. And they pay no attention at all to the absolute all-cause mortality benefit.

The funny thing is that we should be paying attention to these in the opposite order that we listed them.

All-cause mortality is key. If there is no improvement in all-cause mortality, nothing else matters.

In short, say our vaccine reduces the risk of dying from COVID by 2X. But it came at a cost, e.g., increasing your risk of dying from a heart attack by 4X. And let’s say both events are equally likely (which they aren’t). Then you’ve made a bad decision… you’re more likely to die if
you took the vaccine.

Here are the results from the Pfizer 6-month study:

Discussion of these results is quite a bit more complex than we have space to go into here, but these are the basic stats. For more information, see the 10-page discussion of the Pfizer 6 month trial at Why so many Americans are refusing to get vaccinated.

All the all cause mortality numbers are negative from the 6 month Pfizer study. This is not a surprise: it is caused by the high rates of adverse events we’ve already discussed.

There is no evidence of statistically significant mortality improvement.

If there was the CDC, FDA, and NIH would certainly let us know. But just the opposite happened: when the Pfizer 6 month study came out, the mainstream media and mainstream medical scientists were silent on the lack of all-cause mortality evidence. It didn’t even make it into the abstract. The fact that 4 times as many people were killed by cardiac arrest wasn’t even mentioned.

When you combine (1) the negative efficacy of the vaccine with (2) the negative all-cause mortality benefit, it’s impossible to justify vaccination. Either alone is sufficient to kill the benefit; both of them together makes things even more difficult for recommending vaccination.

The bottom line is clear: If you got the vaccine you were simply more likely to die. The younger you are, the greater the disparity.

Early treatment using repurposed drugs has always been the safer and easier way to treat COVID infections

Early treatment protocols such as those used by Fareed and Tyson have been shown to provide more than a 99% relative risk reduction, work for all variants, and the drugs don’t maim or harm the recipients. It is baffling that we are ignoring these treatments and waiting for more evidence when we have a vaccine which appears to kill more people than it saves, soon will be completely useless against future variants, and is likely going to make things worse for the recipient by enhancing replication and/or infectivity.

There are also a variety of prophylaxis techniques that are simple, safe, and highly effective including. The precautionary principle suggests that if there is evidence from a credible source of the benefits of these treatments (which there are), that doctors.

Because early treatments using repurposed drugs don’t create a measurable risk of death, the all-cause mortality for early treatments is always positive.

Many people assume that vaccination is the only path forward. It isn’t. Allowing people to be infected and develop recovered immunity leads to immunity which is broader against variants and lasts longer. See “Recovered immunity is broader and longer lasting” in this document.

It is instructive to compare Israel with India.

Israel is one of the most vaccinated countries on Earth with 80 percent of citizens above the age of 12 fully inoculated. As of Aug 24, 2021, Israel reported 9,831 new diagnosed cases on Tuesday, a hairbreadth away from the worst daily figure ever recorded in the country—10,000—at the peak of the third wave.

At the same time, India recorded 354 deaths in a day, Israel was reporting 26 deaths and record high cases. Here’s how they stack up:

Obviously, India has 11.6X lower deaths per capita than Israel.

The conclusion is clear, vaccination is not the only solution nor the best solution.

Summary

Using the VAERS database and independent rates of anaphylaxis events from a Mass General study, we computed a 41X under-reporting factor for serious adverse events in VAERS, leading to an estimate of over 150,000 excess deaths caused by the vaccine.

The estimates were validated multiple independent ways.

There is no evidence that these vaccines save more lives than they cost. Pfizer’s own study showed that adverse events consistent with the vaccine were greater than the lives saved by the vaccine to yield a net negative benefit. Without an overall statistically significant all-cause mortality benefit, and evidence of an optional medical intervention that has likely killed over 150,000 Americans so far, vaccination mandates are not justifiable and should be opposed by all members of the medical community.

Early treatments using a cocktail of repurposed drugs with proven safety profiles are a safer, more effective alternative which always improves all-cause mortality in the event of infection and there are also safe, simple, and effective protocols for prophylaxis.

An extension to a previous timeline covering April 2020–March 2021. The new timeline covers the period from April 2021 to June 2021.

Read the timeline by going to the source link.

The final discussion and conclusion is copied below.

Topics:

WHO's role and its funding, Gavi, COVAX, Trusted News Initiative, International Fact-Checking Network, the role of private philanthropy, Frontiers issue, comparison to the H1N1 pandemic, new treatment protocols, causal modeling.

Introduction

Ivermectin is a multifaceted medication invented in collaboration between Japanese professor emeritus Satoshi ¯ Omura from Kitasato University and US researcher William Campbell from Merck & Co/MSD between 1973 and 1979 [1];[2]. Each of them received one quarter of the 2015 Nobel Prize in physiology or medicine for their discoveries [3]. Ivermectin is best known as an antiparasitic agent, with approximately four billion doses having been administered since 1981, predominantly in Africa. Merck &Co/MSD’s patent expired in most countries in 1996, and ivermectin preparations are currently available internationally from many sources, with the production cost of a single dose estimated to be less than0.1 US dollars [4].

This article extends the timeline of ivermectin related-events described in a previous preprint available in two versions, March 30, 2021 and April 3, 2021 [5];[6]. The latter preprint covered the period from April 1, 2020 to March 31, 2021. This preprint extends the timeline to cover April–June 2021, as well as adding a few earlier events. Some caveats of the review are described in the previous preprint. Due to resource limitations, details of many developments are not covered in detail but only mentioned briefly,and omissions have been unavoidable. The focus of this review entails the social, organizational, financial and legal aspects of the situation with ivermectin, with less emphasis placed on presenting clinical trial results and biomedical research.Some of the main events in the previously covered period from April 2020 to March 2021 were an Australian in vitro study which initiated the interest in ivermectin [7]. This was followed by adoption of ivermectin in several South and Central American countries, the state of Uttar Pradesh in India, and Bangladesh in the second and third quarter of 2020. In late October 2020, the Front Line COVID-19Critical Care Alliance (FLCCC) published its ivermectin-based outpatient protocol called I-MASK+ [8];[9];[10].

A month later, another group called CovidAnalysis begun publishing a meta-analysis of ivermectin trials [11] and a list of ivermectin studies [12]. A main event in December 2020 was the US Senate hearing of Pierre Kory of the FLCCC [13]. The hearing raised interest of Lawrie et al. and Bryant et al. who produced additional meta-analyses [14];[15]. In conjunction, another group called British Ivermectin Recommendation Development (BIRD) was founded.

Another main event was the introduction of a preprint of a Unitaid/WHO-funded meta-analysis by Hillet al. [16]. Yet another notable event was the publication of an extensive review by a Japanese group including the discoverer of avermectins, the Nobel prize winner Satoshi ¯ Omura [2];[17].

In the first quarter of 2021, ivermectin had been adopted in several additional countries including Slovakia as the first European Union member country. However, in March 2021 both the European Medicine Agency (EMA) and the World Health Organization (WHO) advised against the use of ivermectin except in clinical trials, ignoring the various meta-analyses and the results of 26 existing randomized clinical trials, in addition to a similar amount of observational trials and other studies.

The majority of indications and the safety of ivermectin have been described in the previous preprint [6].In addition, in April 2021 ivermectin was found to effectively inhibit hepatitis E virus replication [18]. There is also a relatively large amount of research about the treatment of cancers with ivermectin [19][20][21][22][23][24][25], including breast cancer [26][27][28][29][30][31][32], ovarian cancer [33][34][35][36][37][38][39], cervical cancer [40], oesophageal squamous cell carcinoma [41], renal cancer [42], glioma [43][44][45], nasopharyngeal carcinoma [46], melanoma [47][48], gastric cancer [49][50], liver cancer [51] and leukemia [52][53] (list from [54]).

Recently, mass distribution of ivermectin has been studied for prophylaxis of malaria [55];[56];[57]. Ivermectin has also been found to promote wound healing partly through modulation of the inflammatory process and the levels of transforming growth factor beta 1 (TGF-β1) and vascular endothelial growth factor (VEGF) [58]. Ivermectin has also been proposed for the treatment of autoimmune disorders [59].

Omura has characterized ivermectin as “a panacea for resource-poor communities” [60]. Ivermectin has also been said to “continue to surprise and excite scientists, offering more and more promise to help improve global public health by treating a diverse range of diseases, with its unexpected potential as an antibacterial, antiviral and anti-cancer agent being particularly extraordinary” [61]. Possible issues include environmental toxicity [62];[63] and the emergence of ivermectin resistance [64].

April 2021...

Read the timeline by going to the source link. The final discussion and conclusion is copied below.

Discussion

In the United States and the European Union, most of the year 2020 appeared to have been characterized by an attempt to collect ivermectin-related data. The period from the beginning of November 2020 tothe end of March 2021 appeared to be characterized by disputes about interpretation of this data. The change of administration in the United States did not appear to significantly change its ivermectin-related health policy, likely to the disappointment of ivermectin proponents. Beginning from the March 30 guideline decision by the WHO against ivermectin, a period of a kind of trench warfare appeared to emerge. Ivermectin proponents, especially the FLCCC, announced they had resigned their attempts to influence the US National Institutes of Health, the Food and Drugs Agency, the European Medicines Agency and the World Health Organization. Similarly, the BIRD group turned directly to clinicians and the public. Changes to existing treatment protocols were mostly minor. Fluvoxamine emerged as an option and was added to many protocols including the FLCCC’s. The FLCCC introduced two new protocols: the I-MASS protocol for mass prophylaxis and the I-RECOVER for long haul COVID-19syndrome (LHCS). An interesting new development was the recognition of the role of mast cell activation and histamine release in LHCS [456].

The US NIH announced a new trial, ACTIV-6, for repurposed medicines, estimated to finish in March2023, almost two years in the future, rendering the trial practically irrelevant for the purposes of handling the pandemic. Simultaneously, pharmaceutical companies continued their attempts to finish their trials of new outpatient treatment pharmaceuticals as swiftly as possible, and new projects for the development of such treatments were initiated in the US and the UK.

A third concurrent process was the slower-than-expected progress of vaccination programs. A fourth concurrent process was the adoption of ivermectin in countries outside the US and EU. The countries who had adopted ivermectin previously, including Slovakia, implicitly disregarded the March 2021 guideline set by the WHO [171];[457]. India adopted ivermectin nationally after the announcement of the WHO guideline, then mostly dropped it, with the current situation being somewhat unclear. Legal action against the WHO was initiated in India. At the end of the period, Indonesia adopted ivermectin.With regard to researchers and clinicians, medical professionals whose practices appeared to be predominantly based on following existing regulations and protocols appeared to feel criticism against them unjustified and unfair. Similarly, medical professionals whose interest was in the further development of the protocols felt criticism against them unjustified and unfair. The first group may have perceived the latter group as deviants, whereas the latter group may have perceived the first group as anti-innovative.Presumably, both groups saw each others’ practices as somewhat unethical and antisocial. The difference was possibly due to different perspectives on collegiality and the perception of the role of patients. The first group appeared to put more weight on collegial cohesion and rule-adherence, with less weight put on individual patient outcomes, assumedly perceiving that patient outcomes were predominantly the product of the inflexible regulations which lay beyond their responsibility. The second group appeared to put less weight on collegial cohesion and regulations, placing more weight on individual patient outcomes, assumedly perceiving that patient outcomes superseded the rules and that validation of rules was the responsibility of individual clinicians.

With regard to COVID-19, knowledge about the mechanisms and treatments was somewhat scarce especially in the early phase of the pandemic. A recent study described that in such a situation, it would be adaptive to seek further information to resolve uncertainty and obtain a more accurate worldview but biases in such information-seeking behavior could contribute to the maintenance of inaccurate views [458].

The study indicated that more dogmatic individuals were less likely to seek out new information to refine an initial perceptual decision, leading to a reduction in overall belief accuracy despite similar initial decision performance. In addition, dogmatic participants placed less reliance on internal signals of uncertainty, rendering them less likely to seek additional information to update beliefs derived from weak or uncertain initial evidence. Dogmatism is often defined as a viewpoint or system of ideas based on insufficiently examined premises. Thus, differences in openness to research evidence may have been due to differences in personalities and habits which, in turn, may be seen as products of the life experiences(environments) of the individuals, including their medical education.

At times, the views appeared to differ up to a point in which the existence of a shared reality could be questioned, and the practice of presenting opposite conclusions on the same, existing data was in effect making further research irrelevant.

Validity of statistics-based research

In the context of clinical trials, the fundamental validity of the statistics-based research in general is rarely discussed. In 2011, Penston said that the extent and depth of the criticisms of statistics-based research usually comes as a surprise to investigators, doctors and other health care professionals who use the data from large-scale RCTs and epidemiological studies, as they rarely have the time, inclination and skill to read the related literature [459]. He questioned the large size of a study as a sign of strength,saying that as the number of patients recruited to a study increases, statistical significance may be achieved but causal inference is weakened, adding that the source of the problem was the belief that causal relationships of value can be derived from extremely heterogeneous samples. He also said that the methodology of statistics-based research cannot be tested independently of statistics; therefore it is unknown whether the causal inferences drawn from the data of large-scale RCTs and epidemiological studies are valid. According to him, lack of understanding of diseases and the properties of drugs, i.e.ignorance, were driving up the size of studies, and we had witnessed “an inexorable increase in the size of epidemiological studies and RCTs over the past 50 years without any concern for the consequences”.

Saint-Mont discussed the effect of randomization, detailing various false assumptions related to it, concluding that randomization does not lift experimental procedures in the medical and social sciences to the level of classical experiments in the natural sciences but may lull researchers into a false sense of security instead [460]. Both Saint-Mont and Penston stressed the importance of the existence of sound background theory as crucial for the success of science. Theory allows for stricter definitions of concepts and the identification of homogeneous reference classes that ensure regularity and, hence, reliable causal inference. In the context of COVID-19, the FLCCC appeared to present their conclusions more in the context of background theory (especially the MATH+ protocol [77]), while most others appeared to relymore on statistics.

An alternative or adjunct to RCTs to investigate could be causal modeling [461];[462];[463];[464]. According to Sgaier et al., causal modeling allows testing for causality in individuals and population groups faster and more efficiently, along with the ability to unravel the underlying complexity, and allows researchers and program designers to simulate an intervention and infer causality by relying on already available data [461]. Karvanen has provided examples of causal models for a case-control study,a nested case-control study, a clinical trial and a two-stage case-cohort study [463].

Journalistic ethics

With regard to journalistic ethics, the censorship discussion of April 11 appeared to indicate that journalistic principles that should have been self-evident no longer were, such as the responsibility of the media “to tell the truth” [165]. As described already for the period preceding April 2021, the financial press (e.g. the Wall Street Journal [163] and the Financial Express [171]) seemed to be more in favor of repurposed medicines, whereas the generalist press mostly continued to ignore or oppose them [217]. MacLeod has written about practices of the mass media in the United States, stating that corporate shareholders have no interest in the veracity of the news, only in short-term profits, and that reporting that challenges corporate profits is strongly discouraged [465]. A key factor shaping the content of the media is its reliance on advertising from large businesses for revenue. Advertisers wish to appeal to the groups and individuals with a greater spending power and to avoid controversial and critical content. Also, the collapse in advertising revenue in the traditional media has led to an increasing dependence on official sources, government and corporations which effectively subsidize the media by providing free content but expect something in return. In addition, in many cases, journalists are preselected based on their obedience to authority and their credulousness, and they increasingly come from the elite themselves [466]. The media houses also depend on social media for visibility which may be easily denied of them. Yet another factor are ideologies which in the United States were traditionally anti-communist but more recently anti-Trump and anti-Russian, for example. In the US media, ivermectin was often associated with hydroxychloroquine, and hydroxychloroquine with president Trump [467].

The dismissal of ivermectin in the press appeared to be related to the Trusted News Initiative (TNI) founded by Associated Press (AP), Agence France-Presse (AFP), British Broadcasting Corporation(BBC), Canadian Broadcasting Corporation (CBC), European Broadcast Union (EBU), Facebook, Financial Times, First Draft, Google, YouTube, The Hindu, Microsoft, Reuters, Twitter and Washington Post [321]. TNI appeared to function as some kind of peer-to-peer structured censorship mechanism.

Social media fact-checkers

In its COVID-19 medical misinformation policy, YouTube explicitly forbade treatment misinformation including “content that recommends use of ivermectin or hydroxychloroquine for the treatment of COVID-19” and “claims that ivermectin or hydroxychloroquine are effective treatments for COVID-19” [468]. The policy forbade also a large amount of peer-reviewed medical publications, in effect making YouTube an anti-science organization.

In a similar manner the policy forbade “prevention misinformation”, explicitly defined as “content that promotes prevention methods that contradict local health authorities or WHO”, specifically mentioning“content that recommends use of ivermectin or hydroxychloroquine for the prevention of COVID-19”. It also explicitly disallowed discussions of efficacy and possible adverse effects of vaccines which “contradict expert consensus from local health authorities or WHO”. Also diagnostic, transmission, social distancing and self-isolation information contradicting local health authorities or WHO were banned. The definitions of “expert” and “consensus” remained undefined, making the policy arbitrary, subsequently making YouTube an unpredictable promoter and enforcer of possibly arbitrary or authoritarian practices. In addition, technically, where local health authorities and WHO disagreed, application of the “or” operator banned content contradicting with either of them. Therefore in countries such as Slovakia and India,YouTube could not be used for content that recommended either for or against ivermectin for prophylaxis of COVID-19.

Clarke mentioned that YouTube and Facebook were relying on third party fact checkers funded partly by Charles Koch Institute [373];[374];[372]. Koch was listed as one of the 18 major funders of Poynter Institute, each with an undisclosed sum of at least USD 50,000, making it impossible to compare funders’ contributions [469];[470]. The International Fact-Checking Network (IFCN) is a unit of the Poynter Institute [471]. In May 2020, Facebook stated that all of its fact-checking partners were certified byIFCN [472]. IFCN stated it led an alliance of over 100 fact-checkers [473]. Poynter Institute described that the alliance was launched in January in response to “rampant misinformation globally” which the WHO classified as an “infodemic”, with the alliance “on the front lines in the fight against it”.

IFCN and the alliance also maintained a database of checked facts [474]. The database was updated daily, with members collaborating on the “massive crowdsourcing project” by using a shared spreadsheet and instant messaging apps. Poynter said the international collaboration had allowed the members to respond faster and reach larger audiences. All of the over 80 items found in the database with search term “ivermectin” dated between April 2020 and May 2021 were labeled either as no evidence, unproven, exaggerated, misleading, missing context, partly false, or false (the most common label), with two items labeled as explanatory [474]. Most of the items originated from South American partners such as Estadão Verifica in Brazil.

Some of the other major funders of Poynter included Facebook, Google News Initiative [475], Foundationto Promote Open Society (FPOS) of George Soros, a primarily US government funded agency National Endowment for Democracy (NED) [476], Democracy Fund created by eBay founder Pierre Omidyar, funding especially PolitiFact [477], and the Omidyar Network/Luminate also of Omidyar, Craig New-mark Foundation of Craigslist founder Craig Newmark, with at least USD 6 million donated to PoynterInstitute [478], and Rita Allen foundation involved in medical research, with its stated goal of “investing in transformative ideas in their earliest stages to promote breakthrough solutions to significant problems” [479].

It was of note that the major funders of Poynter included several individuals who were billionaires. Assumedly, they may have possessed influence over guidelines for what qualified as “facts”. While there was not enough information to ascertain whether the observed patterns of social media censorship were related to the values and previously observed practices of the any of the funders specifically, it was also not possible to rule out such influences.

An example may illustrate what kind of issues may arise from the use of donations as a tool for gaining political influence. With regard to funding by Koch, a report by Mayer in the New Yorker described the Koch brothers as “longtime libertarians who believe in drastically lower personal and corporate taxes,minimal social services for the needy, and much less oversight of industry .. . their combined fortune of thirty-five billion dollars is exceeded only by those of Bill Gates and Warren Buffett . . . many of the organizations funded by the Kochs employ specialists who write position papers that are subsequently quoted by politicians and pundits. David Koch has acknowledged that the family exerts tight ideological control. ‘If we’re going to give a lot of money, we’ll make darn sure they spend it in a way that goes along with our intent .. . and if they make a wrong turn and start doing things we don’t agree with, we withdraw funding’ ” [480];[481].

A republican political consultant commenting Kochs’ strategies for opposing climate change related oil industry reforms said that “the key .. . was to question the science – a public-relations strategy that the tobacco industry used effectively for years to forestall regulation”. As an example of health related interests, David Koch had served on the US National Cancer Advisory Board without disclosing his conflicts of interests as a major producer of formaldehyde, while simultaneously lobbying to prevent theUS Environmental Protection Agency (EPA) from classifying formaldehyde as a carcinogen, and funding members of Congress who had stymied the EPA, requiring it to defer new regulations until more studies would be completed.

Mayer’s article described Kochs’ operations as “covert”, referring to David Koch’s description of their businesses as “the largest company that you’ve never heard of”. According to Source Watch, in addition to denying climate change, other issues on the Kochs’ agenda included repealing health reform Obamacare), dismantling collective bargaining rights, fighting reductions in carbon emissions, keeping corporate money in elections and fighting internet neutrality [482];[483]. With regard to COVID-19, Koch Industries were producing test kit materials, sanitizers, alerting systems, healthcare IT systems related to COVID-19diagnostic testing, ventilators, and personal protective equipment [484].

Poynter’s largest custom training partners in 2019-2021 included Facebook, Huffington Post, Market-place, MRC Media, Middle East Broadcasting Networks, National Public Radio (NPR), Newsweek, New York Times, Southern Newspapers Publishers Association, Washington Post, TikTok, USA Today Network, Vice and Voice of America [469].

Academic journals

Regarding the academic journal publisher Frontiers Media SA’s, one of the members of its board of directors responsible for the financial and governance oversight of the company was Steve Koltes, founder and co-chairman of CVC Capital Partners Ltd [485]. In 2019, CVC Capital Partners, one of the world’s largest private equity and investment advisory firms, was said to have USD 75 billion of assets under management [486]. CVC announced that a group of its executives had helped fund University of Oxford’s vaccine research [487];[488]. CVC had also invested in System C, a company providing key software being used for planning and managing the UK’s COVID-19 vaccination programme [489]. The Times described CVC as “powerful, successful and extremely low profile” [490].

In 2015, Frontiers had removed 31 editors after the editors had complained that company staff were interfering with editorial decisions and violating core principles of medical publishing [491].

The WHO

During the period, an intensifying critique of the WHO emerged as a result of the March 2021 ivermectin guideline lacking transparency and breaking established practices of meta-analysis and research.Presenting criticism towards the feasibility of the vaccines-only approach and its possible relationship to financial interests of the pharmaceutical industry, or possible failures of entities such as WHO, FDA,NIH and EMA, has been difficult during the pandemic. Regardless, it is necessary to consider whether funding-related biases might exist with regard to the current practices of these agencies, especially the WHO.

First we may note that the main funders of the WHO for the 2018/2019 biennium were United States(USD 893 million), Bill and Melinda Gates Foundation (USD 531 million), United Kingdom (USD435 million), Gavi The Vaccine Alliance (USD 371 million), Germany (USD 292 million), Japan (USD214 million), UN Office for the Coordination of Humanitarian Affairs (UNOCHA) (USD 192 million),Rotary International (USD 143 million), World Bank (USD 133 million), European Commission (USD131 million), National Philanthropic Trust (USD 108 million), Canada (USD 101 million), China (USD86 million), Norway (USD 86 million), UN Central Emergency Response (USD 86 million), Sweden (USD77 million), France (USD 76 million), Kuwait (USD 70 million), Republic of Korea (USD 70 million) and Australia (USD 67 million) [492];[493];[494].

The Bill and Melinda Gates Foundation stated that its focus was on vaccine equity [307]. Also Gavi The Vaccine Alliance had been founded by the Bill and Melinda Gates Foundation in 1999, and the Gates foundation had invested a total of USD 4 billion in Gavi [495]. Gavi described the Gates foundation as“a key Gavi partner in vaccine market shaping”. The Gates Foundation also had long-term partnerships with Rotary International (polio vaccinations), National Philanthropic Trust, and the World Bank. Together, the USD 902 million contributions of the Gates Foundation and Gavi exceeded the United States contributions of USD 893 million, making the Gates-Gavi cluster the largest funder of the WHO in the2018/2019 biennium (in April 2020, president Trump announced that US halted funding to the WHO; the effects of this remained unclear [496];[497]). In addition, the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) contributed 33 million. Co-founded by the Bill and Melinda Gates Foundation in 2002, the foundation has contributed a total of USD 2.49 billion to GFATM [498]. Considering the recent USD 4 billion donation by the United States government to Gavi [89], one interpretation of the situation might be that the US outsourced a large part of its public health policy setting to Gavi and, subsequently, to Gates.

Yet another member of the Gates cluster was the Seattle-based PATH (Program for Appropriate Tech-nology in Health), one of the largest nonprofit organizations in global health [499]. In 2021, its website presented with a banner saying “600 million people are vaccinated. 7 billion haven’t had a shot. Help PATH today”. PATH’s CEO Nikolaj Gilbert, previously the global partnerships director for the United Nations Office for Project Services (UNOPS) and an employee of Novo Nordisk, described PATH’s priorities: “the partnership with the Bill and Melinda Gates Foundation and the U.S. government has shaped what this organization is all about today .. . so one of my key priorities will be to see: how can we sustain and grow those relationships that we have, how can we continue to be the preferred partner for those donors, and how can we also help them with their priorities?” [499].

A 2017 Politico article described Gates as “the world’s most powerful doctor”, saying his sway over the WHO spurred criticism about misplaced priorities and undue influence [500];[501]. The article quoted Gates’ critics saying that “Gates’ priorities have become the WHO’s . .. he is treated liked a head of state,not only at the WHO, but also at the G20”. Top WHO officials were said to have raised concerns that the foundation was distorting research priorities. Over three quarters of the WHO’s budget was coming from voluntary contributions which were usually earmarked for specific projects or diseases so that the WHO could not freely decide how to use them. The article stated that the Gates foundation’s focus on delivering vaccines and medicines, rather than on building resilient health systems, had drawn criticism.Changes had been made to the WHO’s budget approval process to in order to decrease the foundation’s influence. Yet a senior fellow for global health at the Council on Foreign Relations commented that “the foundation’s impact on the WHO is enormous . . . if they weren’t there, if they walked away with their money, the deleterious impact would be profound, and everyone is all too aware of that”.

Importantly, it should also be noted that the other top 20 funders predominantly represent high-income countries of the North America and Europe. None of the countries that had officially adopted ivermectin country-wide for COVID-19 up to April 2021 were represented [502]. Similarly, Coalition for Epidemic Preparedness Innovations (CEPI), an organization aiming to accelerate the development of vaccines against emerging infectious diseases and enable equitable access to these vaccines for people during outbreaks was founded by the governments of Norway and India, Bill and Melinda Gates Foundation, UK Wellcome Trust, and the World Economic Forum [503]. It had later secured financial support from Australia, Austria, Belgium, the Bill and Melinda Gates Foundation, Canada, Denmark, the European Commission, Ethiopia, Finland, Germany, Hungary, Iceland, Indonesia, Italy, Japan, Kuwait, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Romania, Saudi Arabia,Serbia, Singapore, Switzerland, The Republic of Korea, United Kingdom, USAID, and UK Wellcome Trust. Of these countries, as of June 2021, ivermectin had been officially adopted in Mexico, Panama and Indonesia, as well as mixed use or occasional off-label use in some other countries [502].

Additionally, CEPI had received support from undeclared private sector entities as well as public contributions through the UN Foundation COVID-19 Solidarity Response Fund [503]. Each investor was to get one representative to an Investors Council providing guidance and oversight of CEPI activities, with four members serving on the CEPI board. Another entity, a Joint Coordination Group, was intended to discuss how to best enhance CEPI’s efforts to deliver and deploy vaccines, and had a role in planning for rapid response to a priority pathogen or an unknown pathogen. The Joint Coordination Group included the WHO, Gavi, European Medicine Agency (EMA), United States Food and Drug Administration Agency (FDA), Médecins Sans Frontières (MSF), UNICEF, International Federation of Red Cross and Red Crescent Societies (IFRC), African Vaccine Regulatory Forum (AVAREF), UK National Institute for Biological Standards and Control (NIBSC) and UK Wellcome Trust.

The Wellcome trust had been previously found out to secretly invest in companies that contributed to the same problems the trust said it wanted to solve [504]. The trust’s known investments through offshore companies in the Cayman Islands amounted to USD 891 million in 2018.

In 2010, the Bill and Melinda Gates Foundation, Gavi, WHO, US NIH/NIAID, CDC, UNICEF, PAHO and several research organizations launched a Decade of Vaccines collaboration, initiated by the Gates Foundation [505]. The intention was to enable greater coordination across all stakeholder groups – national governments, multilateral organizations, civil society, the private sector and philanthropic organizations. The five-member leadership council included the director general of WHO, Anthony S. Fauci of the National Institute of Allergy and Infectious Diseases (NIAID), executive director of UNICEF, an representative of African Leaders Malaria Alliance, and the president of global health at the Bill and Melinda Gates Foundation. All the relevant organizations had thus intimately and for the long term participated in the vaccine-centric collaboration initiated by Gates.

According to a recent study, in 2020, governments had spent a total of EUR 93 billion on COVID-19 vaccine and therapeutics development projects, with 95% allocated to vaccines and 5% on therapeutics [506]. 32% of the funds came from the US, 24% from the EU, and 13% from Japan and SouthKorea (a total of 69%). Only 7% of funds were preferred loans or conventional grants. 93% were advance market commitments (AMCs), i.e. binding agreements to subsidize purchases of vaccine doses prior to availability. Interestingly, 71% of the vaccine funding was allocated to Small and Medium Enterprises(SMEs) and MidCaps, with only 18% allocated to large pharmaceutical manufacturers. The figures did not include private sector investments.

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership program initiated by the US National Institutes of Health aimed at developing a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines [228]. Its public partners included Biomedical Advanced Research and Development Authority (BARPA), Centers for Disease Control and Prevention (CDC), Department of Defense, Department of Veterans Affairs,European Medicines Agency (EMA), National Institutes of Health (NIH), The Operation (formerly known as Operation Warp Speed), and US Food and Drug Administration (FDA). Industry partners included AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Dewpoint Therapeutics, Eisai, Eli Lillyand Company, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck & Co/MSD, Moderna, Novartis,Novavax, Pfizer, Rhythm Therapeutics, Roche-Genentech, Sanofi, Takeda, and Vir Biotechnology. Nonprofit partners included Bill and Melinda Gates Foundation, Fred Hutchinson Cancer Research Center,Foundation for the National Institutes of Health, and RTI International.

According to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), as of February 2021, there were approximately 382 vaccine candidates in development, of which 24 in Phase I, 34 in Phase II and 23 in Phase III [507]. In addition to vaccines, there were over 1,000 clinical trials for therapeutics, of which 190 in Phase III. For example, Eli Lilly and Company and the Bill and Melinda Gates Foundation had entered into an agreement to facilitate access to future Lilly therapeutic antibodies under development, to benefit low- and middle-income countries.

Bill and Melinda Gates Foundation

According to Schwab, in five years up to 2020 the Gates Foundation had invested at least USD 250 million in companies that were currently working on COVID-19 vaccines, therapeutics, diagnostics or manufacturing [508];[509]. He also noted that Wellcome Trust had invested at least USD 1.25 billion to COVID-19 related industries [510]. Both funders were thus positioned to potentially gain from the pandemic financially. Wellcome’s director had a position on the Scientific Advisory Group for Emergencies advising the UK government on COVID-19, as well as a board seat on the Coalition for Epidemic Preparedness Innovations (CEPI). Earlier, the UK’s Scientific Advisory Group for Emergencies had failed to publicly disclose competing interests related to COVID-19. A Canadian professor emeritus of health policy and management commented that the funders were assumedly “acting the way they always have .. . looking after their own financial interests [and] pursuing their own privately developed objectives without being responsible to anybody but their own boards of directors”. Schwab said that despite the outsize role of the private charities in the pandemic response their financial interests had been little scrutinized, likely because foundations were not subject to the same oversight mechanisms as public institutions. A professor of sociology in the UK commented that the foundations were giving a false ideological impression that they are solving the problem even when they’re not.

The Gates foundation had also donated almost USD 2 billion to for-profit businesses, including USD 89 million to Novavax Inc., USD 65 million to GlaxoSmithKline Biologicals, USD 63 million to Evotec and Just Biotherapeutics, USD 61 million to Biologial E. Limited, USD 53 million to LG Chem Ltd., USD43 million to Dimagi Inc, USD 40 million to Inventprise, USD 38 million to Bharat Biotech International Ltd., USD 37 million to Janssen Vaccines and Prevention BV, and USD 35 million to AJ VaccinesAS [510]. Schwab claimed the foundation was subsidizing private companies’ research costs, opening up markets for their products, and bankrolling their bottom lines. He also claimed the foundation had funded groups pushing for industry-friendly government policies and regulation, including the Drug Information Association. He was also said to have funded nonprofit think tanks and advocacy groups that wanted to limit the role of government or direct its resources toward helping business interests. Schwab also noted that despite having given away USD 23.5 billion in the last five years up to 2020, Bill and Melinda Gates Foundation’s income from its investments had exceeded USD 28.5 billion in the same period [510].

Other commentators asked whether the Gates Foundation was addressing or reinforcing systemic problems raised by COVID-19, citing lack of transparency, dogmatic defence of intellectual property rights and monopolies, and intimate involvement with large pharmaceutical corporations as the main issues [511]. A 2016 report by Curtis gave details about Microsoft’s tax avoidance practices and its monopolistic nature, the foundation’s excessive global influence and support to various questionable practices including industrial agriculture with patented genetically modified seeds, Gates family’s “considerable personal access to senior levels of the WHO”, Gavi’s alleged overpaying for vaccines leading to excessive increases in vaccine prices, Gates’ dismissal of the issue, and the foundation’s agenda skewing health priorities and distorting health programmes [512]. Curtis wrote that one problem with the foundation’s heavy focus on developing new vaccines was that it detracted from other, more vital health priorities such as building resilient public health systems. As a rationale, Gates was said to have provided the following: “Vaccines are an extremely elegant technology. They are inexpensive, they are easy to deliver, and they are proven to protect children from disease. At Microsoft, we dreamed about technologies that were so powerful and yet so simple.. . all 193 member states, you must make vaccines a central focus of your health systems”. Curtis commented that Gates had “a fixation on vaccines”. He also claimed the foundation was stifling criticism through its media and NGO influence built on donations. An US professor of media, culture and communications was quoted saying the foundation “wielded enormous propaganda power”. A 2009 editorial in the Lancet, describing the foundation’s governance principle of being “driven by the interests and passions of the Gates family” as “whimsical”, proposed that the foundation should be more transparent and accountable and listen to opinions of external parties [513];[514].

In April 2020, the Bill and Melinda Gates Foundation awarded a five-year grant of USD 50 million to Unitaid to fight against HIV, tuberculosis and malaria, in addition to previous contributions of USD 100 million since 2006. Unitaid’s budget for the year 2021 was approximately USD 32 million [515]. In late 2020, Unitaid partially funded the ivermectin meta-analysis by Hill et al. published as a preprint [16].This meta-analysis was later ignored by the WHO in its March 2021 decision against the use of ivermectin except in clinical trials [6]. On April 22, the chief of Unitaid stressed the need to increase commercialresearch and development of new pharmaceuticals for the treatment of COVID-19 [242]. A core function of Unitaid is Medicines Patent Pool, a tool or practice to negotiate patents for low-income countries; this emphasis may have made unpatentable products seem foreign to the organization [516];[517]. Gates foundation was the chair of Unitaid’s Finance and accountability committee and a member of its policy and strategy committee [518].

Comparing the countries most heavily involved in the development and funding of vaccines to the countries with interest in ivermectin it can be noted that the two sets of countries have little overlap. Also, it can be noted that if influence is related to the amount of funding given, the first set of countries likely had more influence in the WHO in comparison to the rest of the countries.

The WHO, the philanthropic entity Bill and Melinda Gates Foundation, the public-private partnership Gavi, The Vaccine Alliance, and the philanthropic-commercial entity CEPI appeared to be strongly interconnected with each other and with high-income nation states. Major financial investments and commitments likely created propensities for various biases and a vulnerability to the sunk cost fallacy [519]. A haphazard or ideological commitment solely to vaccines (95% of government spending) may have overlooked considerations of cost-effectiveness and feasibility, such as vaccines likely being more expensive and more vulnerable to viral variants than repurposed medicines, their long-term safety being unclear, and vaccines likely requiring constant redevelopment and revaccinations, in addition to not being suitable for self-administration and requiring refrigerated delivery systems. With regard to the sunk cost fallacy, it would be more economical for the governments to reconsider the vaccine and investigative pharmaceuticals dominated pandemic policy and at least adjunct it with broad-spectrum repurposed medicines.

Comparisons to the H1N1 pandemic

After the H1N1 ‘swine flu’ pandemic of 2009-2010, the WHO was accused of malpractice when conflicts of interests of key WHO scientists led to unfeasible WHO recommendations which in turn led to billions of public money spent on inefficacious antivirals for H1N1 influenza [520];[521];[522];[523]. In her book, Abeysinghe has written about the role of the WHO [524]. A review by Andres summarizes keypoints, including the monopoly of the WHO to declare a pandemic [525]. In the case of H1N1, WHO was retrospectively criticized for unnecessarily declaring a pandemic, as for example the European Centre for Disease Control (ECDC) did not agree that the disease should be qualified as severe (measured by mortality), which at the time was considered a requirement for a pandemic but is no longer mentioned. At the time, an epidemiologist commented that the WHO, public health officials, virologists and pharmaceutical companies had “built this machine around the impending pandemic . . . there’s a lot of money involved, and influence, and careers, and entire institutions .. . all it took was one of these influenza viruses to mutate to start the machine grinding” [526].

WHO was later criticized by the Council of Europe for giving too much importance to vaccination and for not sufficiently emphasizing other measures such as the use of antivirals even though some arguments suggested that other measures, such as taking antivirals preventively, could be at least as efficacious as vaccines [525];[521];[522]. WHO emphasized mass vaccination as the most effective strategy against H1N1 [524]. According to Abeysinghe, this emphasis was a result of the path-dependent institutional reaction of the organization, where prior experience with infectious disease (including notable victories using mass vaccination strategies) resulted in the favoring of this reaction, whereas other potential actions were disregarded or underemphasized.

In June 2010, the rapporteur of Council of Europe Parliamentary Assembly described the acts of the WHO as foolish, saying “this is not going to go away” [524]. The rapporteur assumedly meant the criticism was not going to go away; yet it appears instead that the organizational patterns did not go away, leading the WHO and the national governments to repeat the same issues a decade later in theCOVID-19 pandemic.

Legal responsibility of public-private partnerships and the WHO

Clarke has noted that the regulation of global health has partially shifted from the hands of states and international organizations into the hands of public-private partnerships such as Gavi, The Vaccine Alliance and the Global Fund [527];[528]. These partnerships then become capable of also adversely impacting the rights of individuals, leading to concerns of responsibility under international law. However, the private entities in public-private partnerships typically fall outside the framework of responsibility under international law, and thus cannot be held responsible under it. In addition, in certain instances the partnerships have been granted immunity from the jurisdiction of domestic courts. This immunity applies to the staff, funds, properties and assets of these partnerships. The situation regarding Gavi andthe Global Fund appeared especially complicated and the legal details were therefore considered out of the scope of this review.

With regard to the WHO, Gostin has described WHO’s regulatory powers as extraordinary, noting that it may set regulations on a broad range of health topics including the safety, potency, and advertising of biologicals and pharmaceuticals, and a nomenclature for diseases, causes of death, and public health practices [529];[530]. These regulations, unlike most international law, are binding on member states unless they proactively “opt out”. In addition, also the WHO enjoys several privileges and legal immunities. Regardless of the original purpose of these privileges, the possibility of abuse of these privileges by the WHO also exists. Also here the details were considered out of the scope of this review.

Private philanthropy, society and science

In his recent book, Callahan discussed the role of private philanthropy, noting the rising influence and political significance of elite philanthropy, asking who is making choices over public life and who actually benefits from those choices [531]. Callahan described “today’s era of austerity” as a result of an orchestration of the upper class to reduce its taxes and the size of government, even so that in some US states, cuts to higher education specifically helped finance tax reductions for the wealthy and corporations. He noted that in a decade, Bill Gates and Warren Buffett, the main funders of the Bill and Melinda Gates Foundation, had added USD 25 billion and USD 80 billion, respectively, to their wealth, and that the Koch brothers had increased their wealth from USD 9 billion in 2005 to USD 85 billion in 2015.In a book review, Saunders-Hastings asked whether elite philanthropists are a counterweight to other, self-interested elites or to democracy itself, and noted that the distance between elite “charity” and elite political influence is small and shrinking, and that donors’ motivations matter less than the results of their actions [532].

Broad wrote that due to cuts to public funding and increase in private donations, “American science, long a source of national power and pride, is increasingly becoming a private enterprise” and quoted a policy analyst commenting that “the practice of science in the 21st century is becoming shaped less by national priorities or by peer-review groups and more by the particular preferences of individuals with huge amounts of money” [533].

Callahan proposed putting some curbs in place against the private philanthropy, yet noted that foundations and nonprofit trade groups are strongly against any new restrictions, partly due to their dependency on philanthropy. He noted that “rethinking philanthropic freedom is a Pandora’s box that almost nobody wants to open”, saying the current situation was a result of “yesterday’s mantras about philanthropic freedom and the dated regulation upholding it”.

Vaccines vs repurposed medicines

In Finland, a team led by two leading Finnish professors, Kari Alitalo and Seppo Ylä-Herttuala, had a patent and intellectual property free adenovirus-based nasal spray COVID-19 vaccine ready in May 2020. Despite taking approximately EUR 18 billion of public debt to mitigate damages caused by societal lockdowns and using hundreds of millions of Euros on diagnostic tests only, the Finnish government refused the approximately EUR 50 million needed to fund a phase III patient trial for the vaccine [534];[535].

The above case illustrates that the issue at hand is fundamentally not even about vaccines versus repurposed medicines or new pharmaceuticals versus repurposed medicines. Based on this data it is difficult to say whether it is about excessive adherence to inflexible regulations, subconscious biases present in corporate cultures and individuals, intellectual property enforcement, or intentional misleading for profit; likely, it is a mixture of all these factors. Personal biases, organizational cultures and commercial incentives of the vaccine cluster may have lead to attempts to build near-monopolies mass-producing proprietary but inferior products that outcompete more feasible alternatives. In Finland, significantly less interest has been present for any repurposed medicine than for the patent-free vaccine, with the sole exception of the company which developed the ivermectin-containing nasal spray not yet on the market [356].

More generally, the situation may partly be a result of the unprepared and rushed way in which the pandemic has been handled by the governments. Assumedly, from the perspective of governments with 95% of their funding committed to vaccines and international co-operation led by the WHO, paradigm change inducing innovations from outsiders may be perceived as unwanted disturbances. Considering these paradigms, the dismissal of ivermectin might be perceived as cultural discrimination, an instinctive reaction to avoid unfamiliar ideas. As a result of the chosen policy of vaccines and new pharmaceuticals only, in order to avoid losing the sunk costs and credibility, the interests of the governments and the pharmaceutical industry appeared to align with each other but likely not with the public health interest.

The concept of “regulatory capture” may be described as the agencies tasked with protecting the public interest coming to identify with the regulated industry and protecting its interests against those of the public, with the result of government failing to protect the public [536]. Whether rejection of ivermectin may be seen as an example of “regulatory capture” depends on how the vaccines-only policy was selected: primarily to align with the interests of the pharmaceutical industry, or because a better option could not be imagined. Curiously, options could be imagined early on in many low-income countries, but not in the high-income countries, possibly as a result of “technological capture”: when access to advanced technology exists, every problem looks like a problem to be solved with advanced technology, even though such solutions would be suboptimal due to being overly complex and unnecessarily expensive. For example, the idea of spending tens of billions of dollars per year for testing 20 percent of the global population every week assumedly for a single pathogen (SARS-CoV-2) appeared irrational at best [89]. Gates’s speeches repeated terms such as “war and “battle plan” [537]; these talks may easily be interpreted as priming fear in the public. Gates is also famous for regularly predicting the next pandemics [538].

Since the beginning of 2021 at the latest it should have been obvious that the continuing denial of early treatments could not be characterized either as accidental or as a rational choice with respect to public health interest. During the pandemic, a large part of the medical community seemed incapacitated like an old-fashioned military unit lacking leadership. The model based on the fear of losing medical license and an inflexible hierarchical chain of command appeared unsuitable for ensuring proper care of populations.While denial of treatments for certain illnesses such as drug addictions, post-traumatic stress disorder or “treatment-resistant” depression for years or decades for example by denying funding for the research of psychedelic therapies has become normalized, it was unexpected that in the case of COVID-19 this antisocial behavior on behalf of governments and the pharmaceutical industry would be extended to literally everyone in the world. In a comment suggesting adoption of ivermectin, a patent attorney and a former director of a pharmaceutical company referred to “potential civil/criminal liability for censorship, scientific misconduct for misrepresenting ivermectin and other generics” [387].

The exact causes of the situation remained unclear. Regardless, the consequences remain to be seenand felt. One way forward might entail the majority of governments halting their funding to the WHOin order to dissolve the whole organization which appeared beyond repair. Another necessary changemight be the eviction of the so-called philanthropic entities from healthcare contexts. In the long term,another beneficial action might be a worldwide conversion of the pharmaceutical industry into a nonprofit operation. Continuing on the current path may result in a further polarization or destabilization of societies.

Near-future objections to adoption of ivermectin will undoubtedly include the possible environmental impacts. In the mid-to-long term, due to the need to reduce water usage and enable better retention of nitrogen, phosphorus and ammonia [539], transition from water based sewer systems to toilet systems not using water and not requiring wastewater processing but utilizing for example composting and new kind of treatments to degrade pharmaceuticals will become inevitable in many areas in any case.

Conclusions

During this period, ivermectin was officially adopted in South Africa but not widely used, adopted but later dropped in most of India, and adopted in Indonesia. In the United States and the United Kingdom, projects with involvement of both the governments and commercial companies were announced for development of new pharmaceuticals for early outpatient treatment of COVID-19, indicating unclear boundaries between these entities. The dismissal of repurposed medicines including ivermectin continued in high-income countries due to very differing views on what constituted evidence of efficacy. The divide between ivermectin proponents and opposers remained mostly unchanged during the period, indicating a stagnated situation.

There was a noticeable centralization of power, with pandemic response and public discussions largely directed by a few organizations that were largely funded by a few billionaires which, in turn, were affectedby their own personal preferences and biases such as obsessive-compulsive attachment to testing and new technologies, primarily vaccines. Legal responsibilities of these organizations appeared, in the words of one researcher, “obscure”.

Commercial interests appeared to override public health interests during this period. As a result, several low-and-middle-income countries and regions either implicitly or explicitly disregarded the WHO guidance, accelerating an erosion of WHO’s credibility.

Introduction

This article aims at giving an overview of the ivermectin controversy, including current practices of research, publishing and governmental policy formation, by presenting a timeline of relevant events, compiled from peer-reviewed academic journals indexed in PubMed, preprint servers such as medRxiv, chemRxiv, SSRN, Research Square and ResearchGate, international clinical trials registers, international newspapers and medical news service providers as well as websites. As there have been a lot of sparsely documented events internationally, the search has not been systematic, the timeline is unavoidably incomplete, and there may naturally be some personal bias with regard to what has been selected. Also, the main focus of the article is on the last quarter of the 2020s and the first quarter of 2021. Despite these limitations the timeline may serve as a template for more detailed inquiries.

Due to the large number of studies and limited space, each study is mentioned only briefly, without a possibility to analyze methodologies or results in depth. Statistically significant endpoints are reported, with nonsignificant endpoints mostly left out. For consistency, results are in most cases formatted as they appear in a meta-analysis by the Covid Analysis research group, possibly reformulated in comparison to the original sources (e.g. odds ratios converted to relative risk or methodological errors corrected) [1];[2];[3].

Ivermectin was invented in Japan in 1975 by Kitasato University professor emeritus Satoshi ¯ Omura, for which he won the 2015 Nobel Prize in physiology or medicine [4]. The drug has proven effective in eradicating parasitic infections and it is therefore best known as an antiparasitic agent, with several billion doses having been administered since 1981. The patent for the product was owned by Merck & Co/MSD. In most countries the patent expired in 1996. Currently, ivermectin preparations are available internationally from many sources, with the production cost of a single dose estimated to be less than 0.1 US dollars [5].

For prophylaxis of onchocerciasis (river blindness) and strongyloidiasis ivermectin is administered as a single oral yearly dose of 0.15-0.20 mg/kg [6];[7]. For lymphatic filariasis, a once-yearly dose of 0.3-0.4 mg/kg or bi-yearly dose of 0.15–0.2 mg/kg is administered [6]. For classic scabies, two doses of 0.2 mg/kg approximately one week apart are recommended, and for crusted scabies three to seven doses of 0.2 mg/kg depending on the infection severity [8];[9]. With regard to malaria, repurposing ivermectin as a complement to current malaria vector control tools is currently being investigated, with a proposed dosing regime of 0.4 mg/kg repeated three times during the malaria season, and another proposed dosing regime of 0.3 mg/kg on three consecutive days in combination with two other pharmaceuticals also repeated three times during the season [10].

With regard to its in vitro antiviral action, ivermectin has shown robust antiviral action towards a range of RNA and DNA viruses, including HIV-1, dengue, Zika and West Nile Virus, Venezuelan equine encephalitis virus, Chikungunya, pseudorabies virus, adenovirus, and SARS-CoV-2 (COVID-19) [11]. For dengue virus, a combined phase II/III patient randomized controlled trial (RCT) has been completed[12].

Another recent line of research has been an investigation into ivermectin’s efficacy in cancer. A study found out that ivermectin at a very low dose drastically reversed the resistance of the tumor cells to the chemotherapeutic drugs both in vitro and in vivo [13]. Ivermectin could thus be used in combination with chemotherapeutic agents to treat drug-resistant cancers.

With regard to the mechanism of action of ivermectin as an antiparasitic medication, Chung et al. describe that ivermectin interacts with vertebrate and invertebrate γ-aminobutyric acid (GABA) receptor and invertebrate glutamate-gated chloride channels, increasing chloride ion influx with subsequent paralysis and death in the target organism [14]. Ivermectin is effective in killing nematodes and arthropods with a single dose of 0.1-0.3 mg/kg but has has a very wide margin of safety in mammals because in mammals GABA-mediated nerves occur only in the central nervous system and ivermectin does not readily cross the blood-brain barrier [14].

With regard to safety of overdosing, in chickens and most dogs subcutaneous doses of approximately 5 mg/kg have been shown to cause mild symptoms and doses of approximately 15 mg/kg severe symptoms up to coma and death. In two described cases on humans, a 16-month-old child ingesting 6.7 to 8.72 mg/kg ivermectin resulted in frequent vomiting, somnolence, mild tachycardia, and hypotension, and a 61-year old woman became comatose three hours after ingesting 15.4 mg/kg agricultural ivermectin, requiring supportive intensive care but was discharged uneventfully on day 9 [14].

A double-blind, placebo-controlled dose escalation study with 68 healthy volunteers found no indication of central nervous system or general toxicity, or a difference in adverse effects between ivermectin and placebo groups for doses up to 2 mg/kg (ten times the highest FDA-approved dose of 0.2 mg/kg), in either single doses of 90 mg (1.0-1.5 mg/kg) or 120 mg (1.4-2.0 mg/kg), or in a repeated dosing regime with 30 mg (0.35-0.54 mg/kg) or 60 mg (0.71-1.1 mg/kg) on days 1, 4 and 7 (a total of three doses) [15]. Mean plasma concentrations were 2.6 times higher when administered with food.

The FDA-approved dosing for treatment of parasitic diseases is 0.2 mg/kg. The doses used in COVID-19 related clinical trials described in this article varied between 0.2-0.6 mg/kg. With regard to safety of ivermectin in general, a current World Health Organization (WHO) document on the treatment of onchocerciasis states that “ivermectin is safe and can be used on a wide scale” [16]. With regard to safety for children, a recent systematic review and and an individual patient data meta-analysis of ivermectin use in children weighing less than 15 kg concluded that existing limited data between January 1980 and October 2019 suggest that oral ivermectin in children weighing less than 15 kilograms is safe [17]. Overall a total of 1.4% (15/1,088) of children experienced 18 adverse events all of which were mild and self-limiting. No serious adverse events were reported.

With regard to safety of ivermectin during pregnancy, a document from 2004 published by the WHO titled “Mass treatment with ivermectin: an underutilized public health strategy” describes safety during pregnancy, noting that “a number of follow-up studies have found that inadvertent filariasis mass campaign use of ivermectin during pregnancy has not been associated with adverse pregnancy outcomes or negative effects on pregnant women or their offspring”, referring to a study by Gyapong et al. who concluded “there is no evidence of a higher risk of congenital malformation or abortions in those who are inadvertently exposed” [18];[19].

April 2020

On April 3, a Monash University of Australia in vitro ivermectin study by Caly et al. reported that ivermectin is an inhibitor of SARS-CoV-2 virus in vitro, that a single treatment effected approximately 5000-fold reduction in virus at 48 h in cell culture, and that ivermectin is FDA-approved for parasitic infections and included on the WHO model list of essential medicines, thus being widely available [20];[21];[22];[23].

On April 6, a French biotechnology company MedinCell which had been studying ivermectin for malaria announced an initiative to develop an injectable form of ivermectin for prophylaxis of COVID-19 [24];[25];[26].

On April 10, mentioning increased interest in ivermectin after the Australian in vitro study, US FDA issued a warning against using veterinary ivermectin as treatment for COVID-19 in humans, citing safety concerns [27]. It noted additional testing is needed to determine whether ivermectin might be safe or effective in COVID-19 in humans.

On April 13, two Florida, US pulmonologists Rajter and Cepelowicz-Rajter were said to be pioneering early treatments with ivermectin, reporting a nearly 100% response rate with early administration, adding that they were initiating clinical studies [28].

On April 13, a preprint by Patel et al. described an observational registry-based study from 169 hospitals claiming that a single dose of 0.15 mg/kg of ivermectin produced a significant mortality reduction (7.7% vs. 18.6%) in 1,970 patients requiring mechanical ventilation [29];[30].

On April 14, two medical doctors, Gustavo Elera Arévalo and Fernando Polanco Hinostroza in La Merced (Chanchamayo) in Peru, begun treating a COVID-19 outbreak in a prison with ivermectin, later also treating the local police [31].

... and hundreds more events to April 3 2021. Go to the source to read the full chronology.

Discussion

A central question in the communications was whether more studies were needed. In October 2020, when the FLCCC Alliance recommendation on ivermectin was published, the decision to recommend it was assumedly largely based on the perceived consistent positivity of the effects: “seeing a ‘signal’ in the data”. This method could also be called reliance on “clinical experience” or even “intuition”. Comparing five Covid Analysis group’s meta-analyses from November 26 (n=21), December 29 (n=28),January 26 (n=35), February 27 (n=42), and March 31 (n=49) [438], calculated improvements in clinical indicators, with probabilities of an equal or greater percentage of positive results from an ineffective treatment, were as follows: improvements in prophylaxis (pre-exposure/post-exposure or total) we-re 98%/87% (p=0.063/0.25), 91%/90% (p=0.0078/0.25), 90% (p=0.00098), 89% (p=0.00049), and 89%(p=0.00024), respectively. In early treatment, the improvements were 91% (p=0.13), 87% (p=0.016), 84%(p=0.00098), 83% (p=0.00012), and 80% (p=0.0000076). In late treatment, the improvements were 60%(p=0.00024), 48% (p=0.00012), 39% (p=0.000031), 51% (p=0.0000038), and 50% (p=0.00000095). All together, the improvements were 75% (p=0.00000048), 78% (p=0.0000000037), 74% (p=0.000000000029),75% (p=0.00000000000023), and 72% (p=0.000000000000002). It appears that in 2021 the variation in estimated efficacy due to addition of more studies to the meta-analysis was too small to be clinically meaningful. Therefore, more studies provided little additional clinically relevant information, and the argument against the treatment was solely based on the assumed unreliability of all the existing data.The panel which prepared the WHO guideline of March 30, 2021 included in its meta-analysis only five studies that directly compared ivermectin with standard of care and reported mortality [428]. The result indicated 64% reduction in mortality (RR 0.36, 95% CI 0.17-0.75, no p value given, n=915,very low certainty evidence). The meta-analysis of six studies by Hill et al. indicated 75% reduction in mortality (RR 0.25, CI 0.12-0.52, p=0.0002, n=1,255) [275]. The March 31, 2021 meta-analysis of eight randomized controlled trials by the Covid Analysis group indicated 70% reduction in mortality (RR 0.31,95% CI 0.16-0.61, n=1,729, p<0.00032) [437]. The meta-analysis of thirteen trials by Bryant et al. devised using Cochrane standards indicated 68% reduction in mortality (RR 0.32, 95% CI 0.14-0.72, n=1,892,low to moderate-certainty evidence) [387]. The FLCCC group’s meta-analysis of four observational and six randomized controlled trials indicated an overall 69% reduction in mortality (RR 0.31, n=3,508,p<0.0001) [168];[214].

In addition to presenting the new meta-analysis, the guideline presented data from the WHO living guideline [439]. The living guideline analysis indicated 70 deaths per 1,000 patients (7%) for standard of care, and 14 (1.4%) for ivermectin, respectively, i.e. an absolute difference of 56 patients (5.6%) with a 95% confidence interval of 64 to 44 fewer deaths, and a relative mortality reduction of 80%. The odds ratio for mortality was 0.19 (OR 0.19, 95% CI 0.09-0.36) based on 1,419 patients in seven studies. The certainty of evidence was estimated to be very low due to serious risk of bias and very serious imprecision.

This imprecision was explained as follows: “for mortality there were only 31 deaths across all 915 patients randomised - an extremely small number of events on which to base conclusions” (referring to five studies instead of seven), suggesting unsuitability of the chosen methodology for evaluation of medicines that might significantly reduce mortality, as conclusions could then not be made.

As a reference for the above data the guideline cited Siemieniuk et al. [440] which did not contain theabove results but instead presented a third set of mortality results, indicating a mortality of 130 per1000 patients (13%) for stardard of care. For a combination of doxycycline and ivermectin, the estimated reduction in deaths was 130 (95% CI 130-123). For ivermectin alone, the reduction was 103 (95% CI117-78). For proxalutamide, the values were 130 (95% CI 130-118), for colchicine 78 (95% CI 110-9), and significantly less for other included options.

These two additional sets of results indicated larger reductions in mortality (approximately 80%) than the meta-analysis. With regard to the earlier meta-analysis by Hill et al. [275], Siemieniuk et al. stated that “several of these trials could not be included in the analysis . . . ten trials that reported no outcomesof interest”, citing the Hill et al. meta-analysis among the trials reporting no outcomes of interest. Thenew meta-analysis was presented in Rochwerg et al. [441]. This article mentioned neither the meta-analysis by Hill et al. nor the mortality results of Siemieniuk et al. Rochwerg et al. also noted that “we currently lack persuasive evidence of a mechanism of action for ivermectin in covid-19; any observed clinical benefit would be unexplained”, possibly suggesting that not even an effective intervention could be utilized unless the mechanism of action was “explainable”.

Based on their meta-analyses the other groups (FLCCC, CovidAnalysis, BIRD) recommended treatment, the WHO panel did not, referring to “the strong likelihood that chance may be playing a role in the observed findings” [441]. None of the authors of the WHO-funded meta-analysis by Hill et al. were included in the panel. The low cost and wide availability of ivermectin did not, in the panel’s view, mandate the use of a drug with uncertain benefits and possible harms. Resource considerations, accessibility,feasibility and impact on health equity “did not alter the recommendation”. The panel worried about drug shortages in helminth control and elimination programmes [441];[428]. The panel listed the risk of severe adverse events leading to drug discontinuation as a reason for non-adoption, apparently suggesting that a pharmaceutical should not be adopted at all if a small subset of patients might stop using it. For some reason the panel “inferred that almost all well-informed patients would want to receive ivermectin only in the context of a randomized trial, given that the evidence left a very high degree of uncertainty . . . the panel anticipated little variation in values and preferences between patients when it came to this intervention”, giving an impression of dictating patients’ preferences without asking them or giving them a choice.

The panel “raised concerns about diverting attention and resources away from care likely to provide a benefit such as corticosteroids in patients with severe COVID-19 and other supportive care interventions”. Considering that in the majority of countries, no prophylaxis or early treatment method was officiallyavailable, that corticosteroids were to be avoided in prophylaxis and early treatment, and that the useof corticosteroids in late treatment practically necessitated use of ivermectin to prevent strongyloidiasis-related hyperinflammation, this rationale appeared particularly illogical. The panel did note, however,that “ivermectin may still be considered in strongyloidiasis endemic areas, at the discretion of clinicians overseeing treatment, albeit not for treatment of COVID-19 itself”.

Considering the attitudes towards ivermectin in the industrialized countries in general, one of the main obstacles for reception of the idea of repurposed medicines may have been the Surgisphere scandal and the widespread controversy regarding hydroxychloroquine in early 2020, leading to a generalized distrust of research among the politicians, governmental administrative personnel and the public, especially in the more developed countries which appeared to put more importance on the research. This distrust, in turn, possibly opened new avenues for various kinds of societal manipulation.

The distrust appeared to have also lead to, for example, social media and video streaming platforms actively but inconsistently and indiscriminately censoring many subjects and groups, including ivermectin research groups and their results, regardless of their level of academic merit. These practices often appeared similar to censorship practices in authoritarian countries. Mainstream media appeared to maintain an inverted understanding on the process of science in which scientific knowledge was apparently assumed to flow down from the NIH and WHO to the researchers, not the other way around. Financial newspapers (Wall Street Journal, Financial Times) may have possessed a more realistic view on medical research and ivermectin than generalist press conventionally considered high quality (e.g. The New York Times, Associated Press, The Guardian), with some practically accusing researchers of not adhering to the guidelines given by the NIH, for example. The open encyclopedia Wikipedia took pains to only mention negative studies about ivermectin, listing it among the COVID-19 misinformation, even citing a commentator saying that “the narrative of ivermectin as a ‘miracle cure’ for COVID-19 is a ‘metastasized’ version of a similar conspiracy theory around the drug hydroxychloroquine, in which unspecified powers are thought to be suppressing news of the drug’s effectiveness for their own malign purposes” [442];[443];[444].

As noted by Wall Street Journal quite early on in the ivermectin saga, the majority of the medical establishment appeared to require almost absolute certainty, resulting in “too much caution killing patients”, both health-wise and financially [183]. This approach seemed to only take into account quite theoretical health risks, disregarding not only the very probable societal harms of not taking any action but also the possible health benefits of taking an action under uncertainty. Thus, the process appeared largely a failure of a relatively simple risk-benefit analysis.

The more medically oriented arguments against the adoption of ivermectin were usually based on the hypothesis that the required (as indicated by the Caly et al. in vitro study [22]) plasma and lung tissue concentrations for an antiviral effect would likely not be achievable. Another argument was based on the host-directedness and the assumed toxicity of larger doses.

An additional disagreement concerned the use of placebo in clinical trials. This disagreement may havebeen at least partly related to a long-standing divide of the research community into active-control and placebo orthodox proponents [445]. Vagueness of the Helsinki Declaration of 2013 may easily lead into opposite interpretations of what should be done [446]. For example, the sentence to allow the use of placebo “where no proven intervention exists” left open who should decide what is a “proven intervention”, easily leading to a circular reasoning according to which a proven intervention cannot exist without a placebo-controlled randomized trial, thus the use of placebo must be allowed to prove the efficacy of the intervention. Similar vagueness plagues the whole section about placebo controls. The parties involved in the ivermectin trial controversies appeared unable to find any common ground with regard to this issue.During the period there appeared to be somewhat scarce interest in treatments research, with the wealthy societies’ focus on vaccinations and lockdowns, despite vaccinations being largely unavailable and lockdowns harmful for the economy. These countries appeared to pursue expensive, narrow-spectrum vaccination and new pharmaceuticals based strategies, ignoring cheaper options, whereas developing countries put more emphasis on affordable, broad-spectrum antivirals. One factor may have been the developing nations’ clinicians’ familiarity with ivermectin and its easy availability, whereas it has been a rarely prescribed medicine in most industrialized countries. In addition, prejudices and a bias against ideas originating outside of familiar organizations or one’s own country may have played a part in the industrialized countries ignoring ivermectin research carried out in the developing countries [447]. Cost-effectiveness of government funding for development of new medications and vaccines is an important issue. The US government invested USD 356 million in 60,000-100,000 doses of MK-7110, indicating aunit price between USD 5,933.00 and USD 3,560.00, with the initial results of efficacy indicating the same or slightly smaller efficacy as that of ivermectin. A 2015 article about mass treatment of onchocerciasisin Africa stated that Merck & Co/MSD had offered ivermectin at USD 1.51 per treatment, indicating a2300 to 3900-fold difference between the prices of ivermectin and MK-7110 [448];[222]. In this example,allocation of US government funding appeared inefficient with respect to investment in an experimental product with the unit costs in thousands of dollars, versus the option to use an existing medication with similar efficacy proven at least on a similar level of evidence and the unit costs in single digits.

There was a widespread disagreement on the fundamentals: which methods were appropriate as a basis for decision making, what counted as evidence, and what was ethical. In a broader view, the appropriateness and usefulness of the evidence based medicine paradigm as it was understood and applied during the period appeared questionable. US and European governmental bodies appeared to reject or ignore most of the ivermectin-related data, referring to insufficient evidence. In the US, the paradigm appeared inconsistently applied; more specifically, not applied to US Food and Drug Administration Emergency Use Authorization of remdesivir, whereas strictly applied to other medications including ivermectin. In addition, a strict requirement to compare a significantly more effective treatment to placebo may be considered unethical with regard to high mortality of patients in control groups. These indicate a clear need for a new methodology better than the current understanding and application of evidence-based medicine.

With regard to conflicts of interest, the US Food and Drug Administration (FDA) issued an EmergencyUse Authorization (EUA) for the use of remdesivir in patients with severe disease on May 1, even before the initial results of an ongoing trial were published and despite remdesivir being an investigational drug not approved for any indication. The 1,063-patient randomized controlled trial of remdesivir publishedon May 22 only indicated that remdesivir shortened the time to recovery (11 days vs 15 days, p<0.001)[449]. There wasn’t an obvious difference in mortality rates (8% vs. 11.6%, p=0.059) and the endpoints were changed mid-study which was deemed a questionable practice [450]. The final results were published on October 8. On August 28 the EUA was extended to “no longer require a severe disease”.

The adoption of corticosteroids as a consequence of the WHO-initiated 2,000-patient RECOVERY trial results was relatively swift. Also the emergency use authorization of remdesivir in the US was swift,based on initial and conflicting evidence. Twenty randomized clinical trial results on ivermectin’s efficacy for COVID-19 were available in February 2021. These trials were predominantly carried out outside the US and the EU, and did not lead to emergency use authorizations in the US or the EU. US FDA document “Emergency Use Authorization of Medical Products and Related Authorities – Gui-dance for Industry and Other Stakeholders” section “1. Criteria for Issuance” subsection “d. No Alternatives” states that “For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative product may be considered ‘unavailable’ if there are insufficient supplies of the approved alternative to fully meet the emergency need. A potential alternative product may be considered ‘inadequate’ if, for example, there are contraindicating data for special circumstances or populations (e.g., children, immunocompromised individuals, or individuals with a drug allergy), if a dosage form of an approved product is inappropriate for use in a special population (e.g., a tablet for individuals who cannot swallow pills), or if the agent is or may be resistant to approved and available alternative products” [451].

It may thus be derived that licensing of repurposed medicines such as ivermectin for outpatient treatment and prophylaxis of COVID-19 would have prevented emergency use authorizations of new pharmaceuticals in development. In the case of prophylaxis, such licensing might even have affected vaccines. Thus,there appeared to exist substantial financial conflicts of interest against licensing of repurposed medicines.

Considering the total net utility of a society it is unlikely that unilateral support to only the investments of the pharmaceutical industry could ever offset the harms to other industries and the population. The society thus has a strong incentive to abolish the financial incentive structures of the pharmaceutical industry and the government that led to the current situation, in order to prevent a similar outcome in the future.

Considering the estimated efficacy of ivermectin around 90% in prophylaxis and the option of an early outpatient treatment with an estimated efficacy around 75%, an early introduction of ivermectin might have prevented a large part of COVID-19 infections post first wave in many European Union countries and in the United States.

Administrative issues, inconsistent requirements of evidence related to the evidence-based medicine paradigm, and possibly conflicts of interest with patentable, commercial products in development prevented introduction of early outpatient ivermectin treatments in the last quarter of 2020 and the first quarter of 2021. This lack of response is likely to have caused unnecessary deaths and difficult-to-repair financial and health consequences in the affected societies.

The culture of medical litigation prevalent in the United States may have created patterns of behavior that have also spread to countries with less actual litigation, yet leading to mental paradigms favoring extreme caution and non-action, in turn leading to stagnation. One of the features of a paradigm is an inability of the involved people to transcend it or even see that it is just one possible paradigm out of many options, some of which may be more optimal in a given situation.

Conclusion

The period appeared conflicted, with researchers, clinicians, governmental agencies and commercial entities holding deeply conflicting views on fundamental issues, including which methods were considered appropriate as a basis for decision making, what could be considered as sufficient evidence, and what was ethical. In a broader historical perspective, the timeline of events depicts rather dysfunctional societies unable to properly communicate and organize themselves, leading to misallocation of resources and decisions that may have conflicted with elementary ethical considerations, with this behavior rationalized by claiming adherence to mental paradigms that may have poorly matched the situation. In summary, the pandemic response especially in the United States and the European union appeared severely lacking.Further research on the details of these processes is warranted.

“I’m not going to arm wrestle with the administration about where to put you,” Dr. C., a highly skilled gastroenterologist, said gently to my friend who was in bed in a triage room in the ER. “We just want to get you into a bed so we can figure out what’s wrong and get you treated.”

We were at our small town’s hospital. No one was sure why, but my friend had not been able to keep anything more than a handful of raspberries down since a complicated surgery for a chronic health condition three weeks before. Dehydrated and unable to eat, my friend had been violently vomiting after taking just a sip of water or sucking on an ice chip, and had lost nearly twenty-five pounds.

I was by my husband’s side when he had a gallbladder attack so severe that it left his hands shaking. I’ve had three unmedicated childbirths and attended many more, both as a journalist and a patient advocate. Still, I’ve never seen a human in so much pain.

Diagnosed with a Pancreas Disorder, Admitted as a COVID Patient

After a battery of testing, my friend was diagnosed with pancreatitis. But it was easier for the hospital bureaucracy to register the admission as a COVID case.

Let me explain. This patient had none of the classic symptoms of COVID: No shortness of breath, no fever, no chills, no congestion, no loss of sense of smell or taste, no neurological issues. The only COVID symptoms my friend had were nausea and fatigue, which could also be explained by the surgery. However, nearly three weeks earlier, a COVID test had come back positive.

The mainstream media is reporting that severe COVID cases are mainly among unvaccinated people. An Associated Press headline from June 29 reads: “Nearly all COVID deaths in US are now among unvaccinated.” Another, from the same date: “Vast majority of ICU patients with COVID-19 are unvaccinated, ABC News survey finds.”

Is that what’s really going on? It’s certainly not the case in Israel, the first country to fully vaccinate a majority of its citizens against the virus. Now it has one of the highest daily infection rates and the majority of people catching the virus (77 percent to 83 percent, depending on age) are already vaccinated, according to data collected by the Israeli government.

After carefully reviewing the available data, including the safety and efficacy profiles of the mRNA vaccines, my friend had taken a cautious approach. Though a medical doctor who gives vaccines in the office every day, my friend opted to wait and see. According to WebMD, a “huge number” of frontline hospital workers have also chosen not to get the vaccine. Indeed, various news reports, from California to New York, confirm that up to 40 percent of health care workers have decided the risks of the vaccines do not outweigh the benefits.

After admission, I spoke to the nurse on the COVID ward. She was suited up in a plastic yellow disposable gown, teal gloves, and two masks underneath a recirculating personal respiratory system that buzzed so loudly she could barely hear. The nurse told me that she had gotten both vaccines but she was feeling worried: “Two thirds of my patients are fully vaccinated,” she said.

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](https://img.theepochtimes.com/assets/uploads/2021/08/01/Israel-confirmed-cases-table.jpg)

Data Limitations

How can there be such a disconnect between what the COVID ward nurse told me and the mainstream media reports? For one thing, it is very hard to get any kind of accuracy when it comes to actual numbers. In fact, the Centers for Disease Control and Prevention (CDC) have publicly acknowledged that they do not have accurate data.

As reported by the Associated Press, “The CDC itself has not estimated what percentage of hospitalizations and deaths are in fully vaccinated people, citing limitations in the data.”

At the same time, data collection is done on a state by state basis. In most states, a person is only considered fully vaccinated fourteen days after they have had the full series of the vaccine.

This means that anyone coming into an American hospital who has only had one dose, or who has had both vaccines but had the second one less than two weeks prior, will likely be counted as “unvaccinated.”

So when the South Carolina’s Department of Health and Environmental Control released a report about COVID severity on July 23, 2021, they reported higher morbidity and mortality rates in the “not fully vaccinated.” Are these people who have had one vaccine and gotten sick, two vaccines and gotten sick, or no vaccines at all? Without more details, it is impossible to know what is really going on.

“We don’t have accurate numbers,” insists Dr. James Neuenschwander, an expert on vaccine safety based in Ann Arbor, Michigan.

But what we do know, Neuenschwander says, is that the vaccines are not as effective as public health officials told us they would be. “This is a product that’s not doing what it’s supposed to do. It’s supposed to stop transmission of this virus and it’s not doing that.”

Overcounting COVID

Then there is the problem of attributing severe illness and deaths from other causes to COVID, like in my friend’s case. Health authorities around the world have been doing this since the beginning of the COVID crisis. For example, a young man in Orange County, Florida who died in a motorcycle crash last summer was originally considered a COVID death by state health officials (after Fox News investigation the classification was changed.) And a middle-aged construction worker fell off a ladder in Croatia and was also counted as a death from COVID (whether having COVID played a role in his death is still unclear.)

To muddy the waters further, even people who test negative for COVID are sometimes counted as COVID deaths.

Consider the case of 26-year-old Matthew Irvin, a father of three from Yamhill County, Oregon. As reported by KGW8 News, Irvin went to the ER with stomach pain, nausea, and diarrhea on July 5, 2020. But instead of admitting him to the hospital, the doctors sent him home.

Five days later, on July 10, 2020, Irvin died. Though his COVID test came back negative two days after his death and his family told reporters and public health officials that no one Irvin had been around had any COVID symptoms, the medical examiner allegedly told the family that an autopsy was not necessary, listing his death as a coronavirus case. It took the Oregon Health Authority two and a half months to correct the mistake.

In an even more striking example of overcounting COVID deaths, a nursing home in New Jersey that only has 90 beds was wrongly reported as having 753 deaths from COVID. According to a spokesman, they had fewer than twenty deaths. In other words, the number of deaths was over-reported by 3,700 percent.

Who’s Suffering from Severe COVID, Vaccinated or Unvaccinated?

In countries with the highest numbers of vaccinated individuals, we are also seeing high numbers of infections. Iceland has one of the most vaccinated populations in the world (over 82 percent) and is reporting that 77 percent of new COVID cases are in fully vaccinated Icelanders, according to Ásthildur Knútsdóttir, Director General of the Ministry of Health.

According to news reports, over 85 percent of the Israeli adult population has been vaccinated. But a July report from Israel’s Ministry of Health found that Pfizer’s vaccine is only 39 percent effective. Though Israeli health officials are telling the public that the cases are more mild in vaccinated individuals, this upsurge in COVID cases and deaths is leading Israel’s prime minister to issue new restrictions.

Dr. Peter McCullough, an academic internist and cardiologist in practice in Dallas, Texas, says that a large number of people in the hospitals right now have, indeed, been fully vaccinated. “Fully vaccinated people are being hospitalized, and … 19 percent of them have died,” McCullough says. “This is not a crisis of the unvaccinated. That’s just a talking point. The vaccinated are participating in this.”

Other physicians are seeing the same thing. “In my practice multiple patients who are fully vaccinated have been admitted to local hospitals,” says Dr. Jeffrey I. Barke, a board-certified primary care physician based in Newport Beach, California. Barke believes part of the problem is exaggeration of the efficacy: “If the vaccine works so well, why are we now pushing a booster?”

Jennifer Margulis

Jennifer Margulis, Ph.D., is an award-winning journalist and author of Your Baby, Your Way: Taking Charge of Your Pregnancy, Childbirth, and Parenting Decisions for a Happier, Healthier Family. A Fulbright awardee and mother of four, she has worked on a child survival campaign in West Africa, advocated for an end to child slavery in Pakistan on prime-time TV in France, and taught post-colonial literature to non-traditional students in inner-city Atlanta. Learn more about her at JenniferMargulis.net

Last week, the CDC announced a surprising finding: “Delta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people.” Public officials had known from the early days of vaccine development that vaccinated people could catch COVID-19, but the assumption had been made that they were not going to be spreaders of COVID-19.

It turns out that the delta variant is sufficiently different from the original Wuhan version of the virus that the vaccines work much less well. The CDC performed an analysis of COVID-19 cases arising from one public gathering in Massachusetts. They found that the gathering led to 469 COVID-19 delta cases among Massachusetts residents, with 74% of these cases in fully vaccinated attendees. Massachusetts is a highly vaccinated state, with approximately 64% of the population fully vaccinated.

There are other issues coming up as well. How long does the vaccine really last? Is the vaccine itself part of the reason that the virus is mutating as rapidly as it is? Are we making problems for ourselves by creating an army of people with very light cases of COVID-19 who can spread the virus to both the vaccinated and the unvaccinated without realizing that they have more than a cold? Aren’t we inadvertently killing off the least able of the virus mutations and allowing the most virulent to multiply?

My training is as an actuary, so I am familiar with modeling. I am also a “systems thinker.” I know that it is important to look at longer term impacts as well as short-term impacts. If a person works in the healthcare field, it is easy to consider only the obvious short-term benefits. It takes some analysis to figure out that today’s vaccines may lead to stronger variants (such as delta) and more overall spread of COVID-19.

In this post, I will explain some of the issues involved.

[1] Today’s vaccines provide only a fraction of the true level of protection required. Their actions are in many ways similar to applying weed killer at half the strength needed to kill the weeds or providing antibiotics at half the dose required to stop the spread of bacteria.

All of our lives, we have been told, “Be sure to complete the full course of the antibiotics. It is necessary to kill all of the bacteria. Otherwise, it will be easier for a few of the stronger bacteria not to be affected. If you stop too early, the bacteria that are least affected by the antibiotic will survive and reproduce, while the others will die. Stopping the drug too soon is a great way to achieve antibiotic resistance, quickly.”

Unfortunately, COVID-19 vaccine makers seem to have overlooked this issue. The respected BMJ published an editorial entitled, Will covid-19 vaccines save lives? Current trials aren’t designed to tell us. It makes the point:

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”

Yet the current phase III trials are not actually set up to prove either.

We were told that the new COVID-19 vaccines are “95% effective in preventing symptomatic disease,” but it turns out that this is far less adequate than what most people would assume. The vaccine is “leaky.” A big issue is that the virus mutates, and the vaccine works much less well against the mutations. The world can never reach herd immunity if immunized people keep catching new variants of COVID-19 and keep passing them on, as the evidence now suggests.

[2] In a way, getting sick from a virus is helpful. It tells us to stay at home, away from others. It is the fact that humans experience symptoms from viruses that tends to limit their spread.

If a virus has severe symptoms, those infected with the virus will not feel well enough to continue their usual activities. They will tend to stay at home.

If the symptoms are mild, as is the case with the common cold, people will likely go about their activities as usual. This is especially the case if people need to work to feed their families. Thus, viruses with mild symptoms often spread easily.

But, if citizens feel that they are protected by a vaccine, they will likely continue to go about their activities as usual. Most of them will not realize that they might be spreaders of delta, and perhaps other new COVID-19 variants. Symptoms are likely to be mild or non-existent.

[3] It is becoming clear that people immunized with today’s vaccines can both catch the delta variant and spread it to others.

As I mentioned above, the CDC concluded from looking at its analysis of 469 delta cases that the infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated individuals.

We have independent corroboration of the ability of vaccinated individuals to spread delta COVID-19 in a new analysis from Singapore. This article reports, “PCR cycle threshold (Ct) values were similar between both vaccinated and unvaccinated groups at diagnosis.” This is precisely the information that the CDC was relying on in Massachusetts when they reported that there were similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people. While this analysis has not yet been peer reviewed, it reaches precisely the same conclusion with respect to early viral load as the Massachusetts analysis.

The data from this same Singapore study indicates that there are about 3 times as many asymptomatic cases in the vaccinated (28.2%) as the unvaccinated (9.2%). The median number of symptoms reported by the vaccinated was 1, compared to 2 in the unvaccinated. Among the vaccinated, the most frequent symptoms were fever (40.9%), runny nose (38%) and cough (38%). One of these symptoms, especially if it occurred only briefly, could easily be overlooked as a sign of COVID-19.

[4] With nearly all of the current vaccines, the immune system is trained to look for the spike protein from the original Wuhan virus. This narrow focus makes it relatively easy for the virus to mutate in ways that outsmart the vaccine.

A “History of Vaccines” website indicates that there are several ways vaccines are being made, including weakened (“attenuated”) viruses, killed viruses, and segments of the pathogen. In the new COVID-19 vaccines, a particularly limited part of the virus is used, the spike protein. In fact, in the newer vaccines, only an mRNA code is injected, and the body is instructed to make the spike protein itself.

Using a very narrow target has made it easier for viruses to evade the effects of the vaccine. Delta is one variant of the original virus from Wuhan that is evading vaccines through its mutations. Another such variant is Lambda, which caused serious problems in Chile in the spring of 2021, despite vaccine usage as high as 60%. The virus underlying all of these variants is called SARS-CoV-2, reflecting the fact that this virus is closely related to the virus which caused the 2003 SARS epidemic.

Since vaccination began about December 15, 2020, we have so far encountered two variants that are poorly controlled by vaccines. This is not a promising sign for the long-term success of COVID-19 vaccines. As more time goes on, we can expect more such variants. These variants do not necessarily stay around for more than a few months, making it difficult to create and distribute new specially targeted vaccines.

[5] Given the likelihood of mutations away from the narrow target, it seems strange that the governments have set very high expectations for the new vaccines.

It seems to me that Pfizer and Moderna should have said, “We are producing new vaccines that will somewhat lessen symptoms. In a way, they will be like the annual influenza vaccines that various companies make each year. We will need to update the vaccines regularly, but we will likely miss. Hopefully, our guess regarding what will work will be ‘close enough,’ so the vaccine will provide some partial benefit for the upcoming variations.”

Such a statement would have provided a more realistic set of expectations, compared to what many people have been assuming. No one would expect that herd immunity would ever be reached. The vaccines would be perceived as fairly weak tools that need to be used alongside medications, if they are to be used at all.

[6] Leaky vaccines, if widely used, can encourage the virus to mutate toward more virulent (severe) forms. Ultimately, the problem becomes viruses that mutate to more virulent forms faster than the vaccine system can keep up.

If, as we are seeing today, vaccinated people can catch the variant and pass it on to both vaccinated and unvaccinated people, this extra boost can help the variant tremendously in its ability to spread. This extra boost is especially helpful for the variants that are very virulent, since in the normal situation, people who catch a virulent variant would recognize that they are sick and stay at home.

There would normally be a limit on how much the variant could spread based on its impact on the unvaccinated. This limit goes away if both the vaccinated and unvaccinated can catch and spread the illness. Without a vaccine, the variants might be either more or less virulent, with the more virulent tending to die out because the people who get them either die or stay at home because they are very ill. I would expect that this is the reason why quite a few viruses tend to become less severe (virulent) over time, when leaky vaccines are not available to artificially boost their virulence.

The article, Vaccines are Pushing Pathogens to Evolve, gives the example of how the vaccines for Marek’s disease in chickens have been failing, as the disease gradually evolves to become more virulent under pressure from the vaccines being used to keep this illness away. The first vaccine was introduced in 1970. A decade later, outbreaks of Marek’s disease began to be found in vaccinated flocks. A second vaccine was licensed in 1983, but it too began to fail. When the article was written in 2018 the industry was on its third vaccine, but it too was beginning to fail, as the disease became more deadly. But there was no new vaccine yet available.

A 2015 article in PLOS Biology is entitled, Imperfect Vaccination Can Enhance the Transmission of Highly Virulent Pathogens. A person would think everyone involved in vaccine technology would be very much aware of this issue.

The chase after new vaccines is precisely the problem we can expect to have with the vaccines for COVID-19. Only, our problem with the vaccine not really working correctly is coming after a few months, not 10 years. Trying to keep up with new vaccines for a virus that evolves away from us, this quickly, is likely to be an impossible task. It is not just the unvaccinated who have a problem; it is everyone, as the vaccines quickly lose their effectiveness.

[7] Another potential problem with COVID-19 vaccines is Antibody Dependent Enhancement (ADE). When this occurs, it worsens later infections by different variants.

ADE is a rather strange condition in which the antibodies against one variant gained from a first infection (or immunization) act to make some later infections by a different variant worse, rather than better. Dengue Fever is an example of an illness for which this is an issue.

Dr. Robert Malone thinks that ADE may be happening now for COVID-19. He sees the high virus levels in immunized individuals as evidence of possible ADE.

The large number of immunized patients in the hospital with COVID-19 in Israel (which has mostly delta cases) is also given as possible evidence:

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](https://i0.wp.com/ourfiniteworld.com/wp-content/uploads/2021/08/Israel-new-hospitalization-and-new-severe-patients-by-vaccination-status.png?ssl=1)

Figure 1. Image from Israel’s official COVID-19 website, showing new hospitalizations and new severe patients separately for fully vaccinated, partially vaccinated, and unvaccinated individuals.

The illness SARS is closely related to COVID-19. There is evidence that vaccinations against SARS tend to produce ADE. In fact, the National Institute of Health provided funding for a 2020 academic paper that reaches the following conclusion:

The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for trials and future patients after vaccine approval, in order to meet the medical ethics standards for informed consent.

[8] Another problem with the current vaccines against COVID-19 is that immunity may not last very long.

The virus that causes COVID-19 is a coronavirus. The common cold is another illness caused by a coronavirus. We know the immunity of the common cold doesn’t last very long, perhaps a year. While we don’t have long-term experience with COVID-19 vaccine immunity, we shouldn’t be surprised if its immunity begins to wane within a few months, or in a year or two.

Israel, after analyzing its recent COVID-19 experience (almost all with the Delta variant), is now offering anyone over 60 who was vaccinated more than 5 months ago a booster shot. Third doses are also being given to those with weakened immune systems.

It should be noted that if immunity doesn’t last very long, any strategy of “flattening the curve” by stretching out COVID-19 cases becomes counterproductive because it runs the risk of moving the timeframe of the next cycle beyond the time when natural (and vaccine-induced) immunity is still operative.

[9] The public has been led to believe that vaccines are the only solution to COVID-19 when, in fact, they are at best a very poor and temporary band-aid.

Vaccines are a tempting solution because the benefits have been oversold and no one has explained how poorly today’s leaky vaccines really work.

We are already past the period when these vaccines were well matched with the viruses they were aimed at. Now we are in a situation in which the viruses are constantly mutating, and the vaccines need to be updated. The catch is that the variants stick around for such a short time period that by the time the vaccine is updated, there is likely to be yet another new variant that the new vaccine does not really match up with well.

Requirements that employees be vaccinated against COVID-19 cannot be expected to provide much benefit to employers because workers will still be out sick with COVID-19. This happens because they are likely to catch a variant such as Delta, which does not line up with the original vaccine. Perhaps they will be out for a shorter period, and their hospital bills will be lower. These types of benefits are what people have expected of influenza vaccines. There is no reason for them to expect more of the new COVID-19 vaccines.

Even with 100% vaccination herd immunity can never be reached because the vaccine encourages the virus to mutate into more virulent forms. Each new variant stays around for only a few months, making it hard for vaccine makers to keep up with the changing nature of the problem. Vaccine makers can expect to face a constant battle in having to run to stay even. Someone will have to convince citizens that each new vaccine makes sense, even though injuries reported to the US Vaccine Adverse Event Reporting System seem to be much more frequent than those reported for vaccines for other diseases.

An erroneous, one-sided story is being told to the general public, in part because the pharmaceutical lobby is incredibly powerful. It has the support of influential people, such as Anthony Fauci and Bill Gates. The pharmaceutical industry can make billions of dollars in income from the sale of vaccines, with little in the way of sales expenses. The industry has managed to convince people that it is OK to sell these vaccines, even though injury rates are very high compared to those for vaccines in general.

Vaccines are being pushed in large part because the pharmaceutical industry needs a money maker. It also wants to be seen as having cutting-edge technology, so young people will be attracted to the field. It cannot admit to anyone that technologies from decades ago would perhaps work better to solve the COVID-19 problem.

[10] The pharmaceutical industry has been telling the world that inexpensive drugs can’t fix our problem. However, there are several low-cost drugs that appear helpful.

One drug that is being overlooked is ivermectin, which was discovered in the late 1970s. It was originally introduced as a veterinary drug to cure parasitic infections in animals. In the U. S., ivermectin has been used since 1987 for eliminating parasites such as ringworm in humans. Ivermectin seems to cure COVID-19 in humans, but it needs a higher dosage than has been previously approved. Also, it would not be a money maker for the pharmaceutical industry.

The possible use of ivermectin to cure COVID-19 seems to have been intentionally hidden. At approximately 32:45 in this linked video, Dr. David Martin explains how Moderna announced ivermectin’s utility in treating SARS (which is closely related to SARS-CoV-2) in its 2016-2018 patent modification related to the SARS virus. It sounds as though Moderna (and others) have participated both in developing harmful viruses and in developing vaccines to cure very closely related viruses. They then work to prevent the sale of cheap drugs that might reduce their sales of vaccines. This seems unconscionable.

Vitamin D, in high enough doses, taken well before exposure to the virus that causes COVID-19, seems to lead to reduced severity of the disease, and may eliminate some cases completely.

Various steroid drugs are often used in the later stages of COVID-19, when conditions warrant it. The medical community seems to have no difficulty with these.

Monoclonal antibodies are also used in the treatment of COVID-19, but they are much more expensive.

[11] Conclusion. Governments, businesses, and citizens need to understand that today’s vaccines are not really solutions to our COVID-19 problem. At the same time, they need better solutions.

Current vaccines have been badly oversold. They can be expected to make the mutation problem worse, and they don’t stop the spread of variants. Instead, we need to start quickly to make ivermectin and other inexpensive drugs available through healthcare systems. People do need some sort of solution to the problem of COVID-19 illnesses; it just turns out that the current vaccines work so poorly that they probably should not be part of the solution.

The whole idea of vaccine passports is absurd. Even with the vaccine, people will catch the new COVID-19 variants, and they will pass them on to others. Perhaps they may get lighter symptoms, so that they will be off work for a shorter length of time, but there still will be disruption. If those who catch COVID-19 can instead take ivermectin at a high enough dose at the first sign of illness, many (or most) of them can get well in a few days and avoid hospitalization completely. Other medications may be helpful as well.

I am skeptical that masks can do any good with the high level of transmission of Delta. But at least masks aren’t very harmful. We probably need to go along with what is requested by officials.

It is becoming clear that today’s pharmaceutical industry is far too powerful. Investigations need to be made into the large number of allegations against it and its leaders. Why did members of the pharmaceutical industry find it necessary to patent viruses, and then later sell vaccines for a virus closely related to the viruses it had patented?

In April and June of 2020 I wrote about something I referred to as LOKIN 20. In a series of articles I was among those in the so called “alternative media” who tried to highlight that lockdowns and other response measures, created by the Coronavirus Act, increased the risks to the most vulnerable.

This was entirely contrary to the rationale we were given for these new laws and subsequent policies. The response was promoted to the public as a “plan” to protect the most vulnerable. It was certainly a plan but increasing, rather than decreasing, the risks appears to have been the objective.

I reported the removal of the safeguards put in place following the Shipman Inquiry and Francis Report (Mid Staffs). I pointed to statistical evidence from the Office of National Statistics and the concerns raised, by people like Professor Carl Heneghan and David Spiegelhalter, that a dangerous withdrawal of healthcare was contributing toward unnecessary increased mortality among the most vulnerable.

I am not claiming any great insight or deductive powers. I was just one, among many others, in the inappropriately named alternative media who were reporting the obvious dangers inherent to government policy.

It is important to stress that the increased mortality risk from the policies, rather than COVID 19, was abundantly clear at the time. Many people tried to warn the public but they were widely dismissed and labelled as “COVID deniers.”

A year later a number of mainstream media (MSM) articles have emerged confirming, what appears to have been, a policy that would inevitably maximise the risks to the most vulnerable.

As usual, the possibility of deliberate policy intent is never broached in any of these MSM pieces. Their reports uncritically cite statements by politicians and consistently assume that these policies were mistakes and promote the notion that lessons need to be learned.

Speaking in June 2020 about the high risk discharge of 25,000 vulnerable patients into care setting, where they received neither medical care nor adequate social care, the former Health Secretary and chairman of the Health Select Committee, Jeremy Hunt, was unquestioningly reported as saying:

It seems extraordinary that no one appeared to consider the clinical risk to care homes despite widespread knowledge that the virus could be carried asymptomatically”

Leaving aside the clear scientific proof that there is no such thing as asymptomatic transmission of SARS-CoV-2, the evidence suggests that these were neither mistakes nor failures. Yet all we see from the mainstream media is a free pass for the politicians and a blanket refusal to ever question their deceitful statements.

We face a huge sociopolitical problem. Despite the mountain of historical and contemporaneous evidence that governments can and do intentionally harm us, it seems we are collectively incapable of grasping the reality of democide.

We wrongly assume that every policy is intentionally benign.

We must overcome this flawed and naive belief. Until we recognise that there are those within government, and its wider partnership networks, that wish us ill we will remain unable to address the threat they pose to all of us.

The Coronavirus Act

The UK government not only created the legislation to enable healthcare providers to increase the risks to the most vulnerable, they fully understood those risks. They had previously identified them in training exercises and had extensively modelled those risks.

Contrary to Hunt’s statement, there were many in the UK government who did “consider the clinical risk to care homes.” When the claimed pandemic arrived, rather than respond to limit and reduce the known dangers, the government, of which Hunt is a leading member, appeared to intentionally exacerbate them.

Section 14 of the Coronavirus Act removed the crucial NHS obligations under the NHS (standards) Framework. The NHS did not have to comply with clause 21(2)(a) and 21(12) of the 2012 Regulations.

The NHS no longer had a duty to assess a patient’s “eligibility for NHS Continuing Healthcare” before discharging them. In addition, no relevant body needed to have any “regard to the National Framework.” It is important to recognise what this meant within the context of a supposed global pandemic.

On 19th March 2020 the HCID group of Public Health England and the Advisory Committee on Dangerous Pathogens (ACDP) unanimously agreed to downgrade COVID 19, from a High Consequence Infectious Disease, due to low mortality.

The UK government issued instructions to the NHS that they must discharge as many patients as possible on the same day.

With no duty to assess a patient’s continuing healthcare needs, the government set very unsafe assessment criteria and compelled hospitals to discharge them. Unless they were in intensive care, receiving oxygen, on intravenous fluids or imminently close to death, the government decreed:

Every patient on every general ward should be reviewed on a twice-daily board round to determine the following. If the answer to each question is ‘no’, active consideration for discharge to a less acute setting must be made.”

This is worth reiterating. During an allegedly unprecedented health crisis the UK government removed the NHS duty to assess a patient’s health status (and conditions) before discharging them from hospital. They then issued instructions compelling the NHS to discharge as many patients as possible.

The government and the NHS accepted that this would mean discharging patients with an active COVID 19 infection into the community. COVID patients, and people with a range of potentially life-threatening conditions, were shipped into care settings where other vulnerable adults, who may not not have had any infection, were supposedly “shielding.”

There is no doubt that untested and COVID 19 positive patients entered the care system via this route. Both during the first and second “waves.” It is entirely reasonable to suspect that this policy, combined with others we are about to discuss, caused the said “waves.”

An August 2020 study by the Queen’s Nursing Institute found the following practices commonly operating in Care Homes during the spring 2020 outbreak. We should note the element of compulsion:

Having to accept patients from hospitals with unknown Covid-19 status, being told about plans not to resuscitate residents without consulting families, residents or care home staff…..21% of respondents said that their home accepted people discharged from hospital who had tested positive for Covid-19…..a substantial number found it difficult to access District Nursing and GP services….25% in total reporting it somewhat difficult or very difficult during March-May 2020.”

On January 11th 2021, during the alleged second wave, The Care Quality Commission stated:

These settings are admitting people who are discharged from hospital with a COVID-positive test who will be moving or going back into a care home setting.”

Even a few isolated voices in the mainstream media pointed out what they referred to as culpable neglect. Some of the UK’s leading charities for vulnerable people including the Alzheimer’s Society, Marie Curie, Age UK, Care England and Independent Age contributed toward an open letter to the UK government. Written on 14th April 2020 they highlighted a litany of policy “failures:”

Instead of being allowed hospital care, to see their loved ones and to have the reassurance that testing allows; and for the staff who care for them to have even the most basic of PPE, they are told they cannot go to hospital, routinely asked to sign Do Not Resuscitate orders.”

The policies operated both by the NHS and the care homes, as a consequence of Coronavirus Act’s “legislative easement,” did not protect the most vulnerable. Rather they maximised their clinical risk. Not just of COVID 19, but of every condition that rendered them vulnerable in the first place.

From the 17th March 2020 the NHS were discharging vulnerable patients into care homes without assessing their “eligibility for healthcare.” On 2nd April 2020 the NHS combined this with instructions that care home residents should not be conveyed to hospital. On the 6th April they issued guidance to GP’s which stated:

All patients should be triaged remotely.. Remote consultations should be used when possible. Consider the use of video consultations when appropriate.”

So-called “first wave” mortality peaked on the 11th of April and the UK government published its COVID 19 Action Plan on the 15th April. This seemingly insane policy agenda was deemed “necessary” by the UK state to create “capacity” in the NHS:

The UK Government with the NHS set out its plans on the 17th March 2020 to free up NHS capacity via rapid discharge into the community and reducing planned care…..We can now confirm we will move to institute a policy of testing all residents prior to admission to care homes.”

There was no commitment to improve the situation from the UK government, just a plan to move toward one. We know from the observations of the CQC that they continued these high risk policies during the subsequent virus “waves.” There is no evidence that any of these policies were designed to reduce the risks of the most vulnerable. They all, consistently tended to increase them.

It is not tenable for politicians to now claim that they didn’t know what was happening. They constructed and enabled all of the policies that made this dangerous negligence possible. Nor is it credible to simply blame the medical profession. The widespread use of Hospital Trust gagging orders (non disclosure agreements) was also in place.

Doctors who did speak out were disciplined or sacked. This was systemic policy initiative which physicians were expected to abide by.

Once the vulnerable were trapped in abandoned care homes, which were knowingly understaffed, the remaining, unprotected staff were then left to deal with both their own safety fears and the mounting mortality. The government decided this was an opportune moment to suspend all safety inspections in both hospital and care settings.

This was supposed to “limit infections,” although every other decision they made appeared to increase them. Yet again, ending inspections raised the mortality risk for the most vulnerable.

At the same time, Do Not Resuscitate (DNAR) notices were being attached to vulnerable people’s care plans, often without their consent or even their knowledge.

This coincided with a massive increase in orders for the potentially life-ending medication midazolam.

Midazolam

In March 2020 the NHS purchased the equivalent of two years worth of supply. French suppliers were then given regulatory approval by the MHRA to sell additional stock to the NHS. This was then distributed for out of hospital use in the community.

This benzodiazepine (midazolam) is a sedative/anaesthetic that suppresses respiration and the central nervous system (CNS). The British National Formula (BNF) recommends its use for sedation of anxious or agitated terminally ill patients using a mechanised syringe pump in doses of 30–200 micrograms/kg/hour. It is not recommended for conscious sedation in higher doses due to the following risks:

CNS (central nervous system) depression; compromised airway; severe respiratory depression.”

Therefore a frail, eight stone (50 kg) adult could receive an initial dose of up to 2.5mg followed by a total incremental dose of another 2.5mg over a 24hr period. The purpose of this would be to ease their anxiety and agitation if they were experiencing the frightening sensation of intense respiratory difficulty.

Midazolam becomes a conscious anaesthetic for use in intensive and palliative care when given in higher doses. The British Association for Palliative Medicine recommend:

Start with 2.5-5 milligrams – if necessary, increase progressively to 10 milligrams – maintain with 10-60 milligrams / 24h in a syringe pump”

Ten milligrams is twice the BNF recommended dose to ease anxiety (for an 8 stone vulnerable adult.) Therefore it is extremely concerning that NHS Clinical Guideline for Symptom Control for patients with COVID-19 recommended 10mg of Midazolam for patients with “distressing breathlessness at rest.” This risks a rapid deterioration of the symptoms causing them that distress.

Gosport Scandal

Police are still investigating an estimated 15,000 deaths that occurred at Gosport War Memorial Hospital between 1987 and 2001. An inquiry has already found that at least 456 people’s lives were “shortened” through the unwarranted use of unnecessary medication.

Many suspect that the true figure is in the thousands. The independent panel into the malpractice at Gosport War Memorial Hospital found:

There was a disregard for human life and a culture of shortening the lives of a large number of patients by prescribing and administering “dangerous doses” of a hazardous combination of medication not clinically indicated or justified…they were, in effect, put on a terminal care pathway…The risk of using them in combination has been consistently documented in the BNF. In particular, it has long been known that when given together, opioids and midazolam cause enhanced sedation, respiratory depression and lowered blood pressure.”

This report was published in September 2018. In 2020 the NHS treatment guidelines for COVID 19 patients, who were deemed to be “agitated,” was:

Start with Morphine 20mg and Midazolam 20mg”

This is precisely the mechanical syringe combination used at Gosport War Memorial to “shorten” thousands of peoples lives.

There are numerous reasons to suspect that the huge increase in midazolam ordered by the NHS, with the full knowledge of the government, was intended for this purpose.

In April 2020 the Health and Social Care Committee, chaired by Jeremy Hunt, heard submissions from medical professionals as they considered the government response to the global pandemic. In Q377 Dr Luke Evans (MP fror Hinckley and Bosworth) asked then Health Secretary about NHS provisions for “a good death.” This is medical shorthand for assisted dying or euthanasia. Dr Evans (MP) asked:

The syringe drivers are used to deliver medications such as midazolam and morphine. Do you have any precautions in place to ensure that we have enough of those medications?”

To which Matt Hancock replied:

Yes. We have a big project to make sure that the global supply chains for those sorts of medications [are] clear. In fact, those medicines are made in a relatively small number of factories around the world, so it is a delicate supply chain and we are in contact with the whole supply chain.”

Hancock was clearly referring to the huge midazolam order and MHRA approval of the French supply chain. The UK government had already passed the Coronavirus Act, removing the NHS Framework duties, and had ordered them to discharge patients en masse. The NHS had instructed care homes not to send sick patients to hospital and GP support from the care homes had effectively been withdrawn.

Jeremy Hunt was chairing this discussion. For him to claim two months later that no one had “appeared to consider the clinical risk to care homes” smacks of vile obfuscation. The best we can say about this statement is that he was wrong. We now have the documentation which shows that the clinical risk in care homes was very carefully considered and the withdrawal of care was planned.

Cygnus

In 2016 the UK government ran Exercise Cygnus. The training scenario was prepared by Professor Neil Ferguson and his team at Imperial College London (ICL). It simulated a flu outbreak and was a Command Post Exercise (CPX) designed to test the UK’s pandemic preparedness. Nearly a thousand key officials took part from central and local government departments, the NHS, public health bodies from across UK, as well as local emergency response planners.

Some of the Cygnus Report recommendations were implemented in response to COVID 19 and others not. For example, it recommended legislative easements.

The Coronavirus Act certainly eased the legislation surrounding the death registration process and the NHS duty of care. The legal requirements for inquests, post-mortems and cremations were also relaxed.

Exercise Cygnus also highlighted a number of deficiencies. It identified inadequate numbers of critical, general and acute care beds, which the government then proceeded to reduce further; it warned that whole sections of the NHS may have to be shut, which is exactly what the government did during the “pandemic;” it highlighted that the most vulnerable could be denied care, just as they were, and that the health service would have to be set on a war footing just to be able to cope.

These were warnings not policy suggestions. The UK government’s adoption of some of the Cygnus recommendations and determination not to address Gygnus alarms appears to have been their policy response to COVID 19.

COVID 19 healthcare strategies were seemingly set in 2016. The Cygnus scenario, modelled by Ferguson and ICL differed from their COVID 19 “models” only by virtue of being based upon influenza rather than a coronavirus.

Perhaps this explains why Exercise Cygnus was kept secret, reportedly for reasons of “national security.” When the report was released, after being exposed, it was heavily redacted and all the names of the senior officials involved were hidden.

The official explanation for this is that it was just too terrifying for the public to withstand. We might ask, terrifying for whom? Using the media to terrorise the public during the alleged pandemic was recommended by Spi-B (SAGE.)

It is reasonable to assume that many of those redacted names would have been people working for Ferguson’s ICL team and current members of SAGE. If so, this indicates that those involved in planning the response to COVID 19 not only understood what the risks were, they then provided the claimed “scientific” justification for policies which they knew would increase them.

One of the senior officials involved in Cygnus reportedly said:

These exercises are supposed to prepare government for something like this – but it appears they were aware of the problem but didn’t do much about it.”

Again, we see the assumption that everything must be explained away as error or unfortunate oversight. This stretches credibility beyond breaking point when we understand that Gygnus ultimately produced a plan to deny healthcare during a pandemic. This policy of increasing the risks of the most vulnerable was evidently operating during the first alleged pandemic wave. It also seems likely that it continued beyond that point.

Based upon the Cygnus conclusions, in September 2017, the NHS Surge and Triage briefing paper was made available to senior health and government officials. It discussed something called population triage:

The purpose of this paper is to provide an update to Chief Medical Officer (CMO) and the Chief Scientific Advisor (CSA) on continuing refinement of the knowledge and understanding behind the potential decision that may be required in a future extreme pandemic influenza scenario to move to a state of population triage across the country…”

Population triage means the potential denial of healthcare:

The majority of the detail in this paper will not be replicated in any publically available documentation…Difficult decisions will be needed about maintaining patient access to care…There is significant discussion in the paper about ceasing or changing care to patients in the HRG (Healthcare Resource Croups)…Patients would be assessed on probability of survival rather than clinical need and higher level services would no longer be provided…Total excess death rate would be in excess of 7,806 per week of the peak of the pandemic if all these services were stopped…So in the peak six weeks of a pandemic…46,836 excess deaths could be expected”

Between 7th March and 8th May 2020, there were 47,243 excess deaths in England and Wales. According to the Cygnus predictions, this was slightly higher than the numbers envisaged to result directly from the withdrawal of healthcare.

However, nearly all of these deaths were attributed to COVID 19. We should ask where, in the claimed COVID 19 mortality figures, the anticipated deaths from the denial of healthcare are.

In November 2017 a number of English stakeholders also met to discuss the a pandemic briefing paper for Adult Social and Community Care. This too was a product of Exercise Cygnus. Once again the intention was to keep the report secret.

The majority of the detail in this paper will not be replicated in any publically available documentation.. Whilst demand will increase, capacity, which is already under pressure because of recruitment challenges, will also reduce because of staff absences.. Adult social care will have an increased role in supporting rapid discharge from hospital. In a severe pandemic, only those services that are life-critical will be maintained.. More patients could be supported by a greater focus on telecare/tele-monitoring.”

It is known, from the reports of the CQC and national charities and other NHS documents cited in this article, that primary healthcare was withdrawn from care settings and the community. The staff shortages identified in 2016 became chronic and then severe during the pandemic. This was entirely predictable and was a known outcome of the track and trace and self-isolation polices of the UK government.

The briefing paper spoke about which services could be “reduced or deferred.” Crucially these included assessment of care needs, mobility support, personal care support, maintaining family connections and access to medical treatment.

During the “first wave” approximately 25,000 vulnerable people were discharged into care homes to face the extremely high risk environment created for them by the UK government. At the same time potentially life ending drugs were being liberally prescribed.

This was the COVID 19 policy response and we were told the intention was to “protect the most vulnerable”. All of it was predicted on the assumption that hospital were struggling to cope with the “surge” in COVID 19 patients. According to the UK government, patients needed to be discharged to free up capacity in the NHS.

At the height of the so called first wave, on the 13th of April 2020, the Health Service Journal reported that hospital bed occupancy was at a record low, with 4 times more beds available that usual for the time of year. There were 37,500 available beds.

The HSJ stated that the reason for this spare capacity was the discharge policy operated by NHS at the behest of the government. What they didn’t mention is that these figures show the high-risk discharge of the most vulnerable people in our society was entirely unnecessary.

You may not like it but is not “unthinkable” that this was deliberate, coordinated policy designed to increase the mortality statistics. Many have questioned the claimed severity of the alleged pandemic. If you wish to give the impression of a high mortality disease then you need the deaths to back up your claim.

It is feasible that all of these risk heightening factors happened to perfectly coalesce to increase mortality, but is it plausible? A refusal to contemplate the possibility of an intentional act does not rule it out. Only a thorough, truly independent investigation can.

Conclusion

While this system was in operation, the UK government encouraged widespread adoption of the Clap for Carers, often referred to as “clap for the NHS.” During lockdowns, as the whole nation was told to self isolate indoors and avoid all unnecessary congregation, between the 26th March and the 28th May, we were “allowed” to simultaneously congregate on the streets and show our appreciation by clapping, banging pots and pans and ringing bells.

Meanwhile vulnerable people were being discharged into unsafe care homes where access to medical care was withdrawn and essential social care removed.

Clapping for this was obscene.

The government clearly used this ploy both as a distraction and as propaganda. This does not suggest that doctors, nurses and carers do not deserve our support. Any medical professional or carer who blows the whistle is almost certainly making a career ending decision.

Given the evidence we have discussed, if we consider ourselves to be responsible citizens who live in a democracy, it is unconscionable for us to simply ignore what appears to have been a deliberate and illegal government policy of large scale euthanasia in the UK.

We must seek answers from policymakers and malfeasance in office must be prosecuted wherever it is identified.

You can read more of Iain’s work at his blog In This Together

Let's open this posting with a definition:

"Antibody-Dependent Enhancement or ADE occurs when the antibodies generated during an immune response recognize and bind to a pathogen, but they are unable to prevent infection. Instead, these antibodies act as a “Trojan horse,” allowing the pathogen to get into cells and exacerbate the immune response.

On a few occasions ADE has resulted from vaccination:

Respiratory syncytial virus (RSV) — RSV is a virus that commonly causes pneumonia in children. A vaccine was made by growing RSV, purifying it, and inactivating it with the chemical formaldehyde. In clinical trials, children who were given the vaccine were more likely to develop or die from pneumonia after infection with RSV. As a result of this finding, the vaccine trials stopped, and the vaccine was never submitted for approval or released to the public.

Measles — An early version of measles vaccine was made by inactivating measles virus using formaldehyde. Children who were vaccinated and later became infected with measles in the community developed high fevers, unusual rash, and an atypical form of pneumonia. Upon seeing these results, the vaccine was withdrawn from use, and those who received this version of the vaccine were recommended to be vaccinated again using the live, weakened measles vaccine, which does not cause ADE and is still in use today.

A more recent example of ADE following vaccination comes from dengue virus:

Dengue virus — In 2016, a dengue virus vaccine was designed to protect against all four serotypes of the virus. The hope was that by inducing immune responses to all four serotypes at once, the vaccine could circumvent the issues related to ADE following disease with dengue virus. The vaccine was given to 800,000 children in the Philippines. Fourteen vaccinated children died after encountering dengue virus in the community. It is hypothesized that the children developed antibody responses that were not capable of neutralizing the natural virus circulating in the community. As such, the vaccine was recommended only for children greater than 9 years of age who had already been exposed to the virus."

Here is another quote about ADE and SARS-CoV-2 vaccines from a paper entitled "Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies" by Wen She Lee et al as found in Nature Microbiology with my bolds throughout:

"Antibody-based drugs and vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are being expedited through preclinical and clinical development. Data from the study of SARS-CoV and other respiratory viruses suggest that anti-SARS-CoV-2 antibodies could exacerbate COVID-19 through antibody-dependent enhancement (ADE). Previous respiratory syncytial virus and dengue virus vaccine studies revealed human clinical safety risks related to ADE, resulting in failed vaccine trials."

Here is the conclusion from the paper:

"ADE has been observed in SARS, MERS and other human respiratory virus infections including RSV and measles, which suggests a real risk of ADE for SARS-CoV-2 vaccines and antibody-based interventions. However, clinical data has not yet fully established a role for ADE in human COVID-19 pathology. Steps to reduce the risks of ADE from immunotherapies include the induction or delivery of high doses of potent neutralizing antibodies, rather than lower concentrations of non-neutralizing antibodies that would be more likely to cause ADE.

Going forwards, it will be crucial to evaluate animal and clinical datasets for signs of ADE, and to balance ADE-related safety risks against intervention efficacy if clinical ADE is observed. Ongoing animal and human clinical studies will provide important insights into the mechanisms of ADE in COVID-19. Such evidence is sorely needed to ensure product safety in the large-scale medical interventions that are likely required to reduce the global burden of COVID-19."

To put it very simply, ADE can occur in vaccinated humans and animals when they are exposed to the wild virus (the challenge).

With that background, let's look at a very little-reported article that appeared on the National Institutes of Health National Liberary of Medicine website entitled "Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease" by Timothy Cardozo and Ronald Veazey as shown here:

The authors open by noting the following:

"Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus."

Here is another definition, also from the NIH website:

"Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention. Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to their body. Implicit in providing informed consent is an assessment of the patient's understanding, rendering an actual recommendation, and documentation of the process. The Joint Commission requires documentation of all the elements of informed consent "in a form, progress notes or elsewhere in the record." The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patient's understanding of elements 1 through 4.

It is the obligation of the provider to make it clear that the patient is participating in the decision-making process and avoid making the patient feel forced to agree to with the provider. The provider must make a recommendation and provide their reasoning for said recommendation."

In other words, medical practitioners have the legal and moral obligation to ensure that the people that they are treating understand the risks and benefits of the medical procedure (including vaccinations) and that they do not feel coerced into receiving the medical procedure.

Let's go back to the article by Cardozo and Veazey. The authors reviewed published literature and clinical trial protocols to identify evidence that COVID-19 vaccines could worse disease if the vaccine recipients are exposed to the wild virus. Here are the results of the study:

"COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials."

Since the technocracy has a way of making things disappear from the internet in this post-truth era, here is a screen capture of the entire article:

The authors concluded that the specific risk of ADE linked to the COVID-19 vaccines should have been prominently and independently disclosed to research subjects in trials and for future patients after the vaccines are approved for use. Given that the current crop of COVID-19 vaccines are not scheduled for completion for at least another year and that they are currently being used under an Emergency Use Authorization, one would think that providing informed consent to all vaccine recipients would be critical.

In closing, as one example, let's look at the COVID-19 vaccine consent form for the State of New York:

This is the only warning given to vaccine recipients about the nature of the COVID-19 vaccine that they are about to receive:

Here is Walgreen's Informed Consent document for COVID-19 and other vaccines:

I wonder how many recipients actually read all of the fine print which, as you will notice, says nothing about ADE? Note that recipients are stating that they were given the "chance to ask questions which were answered to my satisfaction" and that they "understand the benefits and risks of the vaccination as described". How many laypeople actually understand the risks and benefits of the mRNA vaccine technology let alone know what questions to ask? How many laypeople understand that the "jab" could well lead to a greater susceptibility to ADE, making future exposures to the new variants of the SARS-CoV-2 virus even riskier?

This study is the smoking gun in the COVID-19 narrative and is should be of particular interest to all of us given that it appears on the website of Anthony Fauci's employer. Recipients of COVID-19 vaccines are not properly being informed of the risks of antibody-dependent enhancement by governments, vaccine manufacturers, the mainstream media and public health officials. Most people have absolutely no concept of ADE and its potential impact on their future health and are being coerced into accepting an unproven vaccine with the promise of a return to societal normalcy by their governments (the carrot) and the threat of having their freedom restricted for the indefinite future (the stick), contradicting the very concept of informed consent.

Dr. Charles D. Hoffe, BSc, MB, BCh, LMCC
Lytton Medical Clinic
Lytton BC V0K 1Z0

5 April, 2021

OPEN LETTER

Dr. Bonnie Henry,
British Columbia Provincial Health Officer
Ministry of Health
1515 Blanchard Street
Victoria, BC, V8W 3C9

Dear Dr. Henry,

The first dose of the Moderna vaccine has now been administered to some of my patients in the community of Lytton, BC. This began with the First Nations members of our community in mid-January, 2021. 900 doses have now been administered.

I have been quite alarmed at the high rate of serious side-effects from this novel treatment.
From this relatively small number of people vaccinated so far, we have had:

1. Numerous allergic reactions, with two cases of anaphylaxis.
2. One (presumed) vaccine induced sudden death, (in a 72 year old patient with COPD. This patient complained of being more short of breath continually after receiving the vaccine, and died very suddenly and unexpectedly on day 24, after the vaccine. He had no history of cardiovascular disease).
3. Three people with ongoing and disabling neurological deficits, with associated chronic pain, persisting for more than 10 weeks after their first vaccine. These neurological deficits include: continual and disabling dizziness, generalised or localized neuromuscular weakness, with or without sensory loss. The chronic pain in these patients is either generalised or regional, with or without headaches.

So in short, in our small community of Lytton, BC, we have one person dead, and three people who look as though they will be permanently disabled, following their first dose of the Moderna vaccine. The age of those affected ranges from 38 to 82 years of age.

So I have a couple of questions and comments:

1. Are these considered normal and acceptable long term side-effects for gene modification therapy? Judging by medical reports from around the world, our Lytton experience is not unusual.
2. Do you have any idea what disease processes may have been initiated, to be producing these ongoing neurological symptoms?
3. Do you have any suggestions as to how I should treat the vaccine induced neurological weakness, the dizziness, the sensory loss, and the chronic pain syndromes in these people, or should they be all simply referred to a neurologist? I anticipate that many more will follow, as the vaccine is rolled out. This was only phase one, and the first dose.
4. In stark contrast to the deleterious effects of this vaccine in our community, we have not had to give any medical care what-so-ever, to anyone with Covid-19. So in our limited experience, this vaccine is quite clearly more dangerous than Covid-19.
5. I realize that every medical therapy has a risk-benefit ratio, and that serious disease calls for serious medicine. But we now know that the recovery rate of Covid-19, is similar to the seasonal flu, in every age category. Furthermore, it is well known that the side effects following a second shot, are significantly worse than the first. So the worst is still to come.
6. It must be emphasised, that these people were not sick people, being treated for some devastating disease. These were previously healthy people, who were offered an experimental therapy, with unknown long-term side-effects, to protect them against an illness that has the same mortality rate as the flu. Sadly, their lives have now been ruined.
7. It is normally considered a fundamental principal of medical ethics, to discontinue a clinical trial if significant harm is demonstrated from the treatment under investigation.
8. So my last question is this: Is it medically ethical to continue this vaccine rollout, in view of the severity of these life altering side-effects, after just the first shot? In Lytton, BC, we have an incidence of 1 in 225 of severe life altering side-effects, from this experimental gene modification therapy.

I have also noticed that these vaccine induced side effects are going almost entirely unreported, by those responsible for the vaccine rollout. I am aware that this is often a problem, with vaccines in general, and that delayed side-effects after vaccines, are sometimes labelled as being “coincidences”, as causality is often hard to prove. However, in view of the fact that this is an experimental treatment, with no long-term safety data, I think that perhaps this issue should be addressed too.

Furthermore I have noticed, that the provincial vaccine injury reporting form, which was clearly designed for conventional vaccines, does not even have any place to report vaccine injuries of the nature and severity that we are seeing from this new mRNA therapy.

It is now clearly apparent with medical evidence from around the world, that the side-effect profiles of the various gene modification therapies against Covid-19, have been vastly understated by their manufacturers, who were eager to prove their safety.

Thank you for attention to this critically urgent public health matter.

Yours sincerely,

Dr. Charles Hoffe

Printable PDF of Open Letter

Dr. Hoffee’s letter to his Congregation

April 2021

Dear brothers and sisters in Christ,

I greet you in the name of our Lord and Saviour Jesus Christ. For those of you who do not know me, I am a Christian family physician in Lytton, BC.

I have been rather concerned about the experimental Covid vaccines that are being rolled out at a rapid rate. The leader of the World Economic Forum, Claus Schwab, (author of the book, “ The Great Reset”), has declared that; “No one is safe, until everyone is vaccinated.” This intention has been echoed by many world leaders.

All previous coronavirus vaccine research following the SARS epidemic in 2002/3, in creating RNA or DNA vaccines against coronaviruses ended, because great harm was seen in the animal trials.

But with the appearance of COVID-19, the same technology was rapidly revamped, with different delivery systems. However this time, animal trials were not done, and the experiment was taken directly to the population at large, after limited short-term trials. The vaccines have been rolled out, with absolutely no long-term safety data. This is a global experiment, on the entire world’s population.

In my own medical practice, I now have 6 patients who are enduring long-term side-effects from these experimental therapies. They all indicate neurological damage, which is evolving. I suspect that it may be multiple sclerosis, or something along those lines. I have written to the Medical Health Officer, in charge of the vaccine rollout in the BC interior, to express my concerns and questions, with absolutely no response.

I therefore drafted an open letter to Dr Bonnie Henry, who is the Provincial Health Officer for British Columbia, to ask the same questions, and expressed the same concerns. I had been warned by my medical colleagues, not to expect a reply from her either. But to my complete astonishment, I received a prompt reply the next day inviting me to attend a virtual meeting, with a designated vaccine safety specialist. The meeting is scheduled for 4 pm (Pacific time) on Tuesday April 13, 2021.

Meanwhile I am sending urgent referrals, to a neurologist, to investigate my three most serious vaccine injured patients. My hope is that once we can identify what disease process has been initiated by this experimental gene therapy, we can raise public awareness more effectively.

So I have attached my open letter, to Dr Bonnie Henry, which documents my personal experience of the vaccine injuries in my own medical practice. Please feel free to share it with anyone who might feel tempted, to except this experimental vaccine, for a veneer of “safety”.

I invite you to join with me in prayer, in preparation for my meeting on Tuesday afternoon, that the Lord would guide my thoughts and words. I pray too, that the Lord would prepare the heart of the vaccine specialist that I will be speaking to, so that they take this matter very seriously. A global experiment on this scale, on uninformed participants who are driven by fear, is a crime against humanity.

All of the Covid vaccines are effectively genetic modification. They vary only in the mode of delivery. They all work, by introducing a gene to our bodies to manufacture an antibody against the Covid spike protein. The problem is, that there are 20 human tissue types that also have a spike protein. So there is a possibility that the Covid antibody may target one of our own human tissues too. In other words, that this new therapy will trigger an autoimmune reaction in some people.

There have been hundreds of reported miscarriages in pregnant women who have received the Covid vaccines. The placenta is one of the 20 tissue types that also has a spike protein. So it is most likely, that the cause of these miscarriages, is that these women, now have an antibody that targets placental tissue. They have effectively been vaccinated against any future pregnancy.

So if you know any woman of childbearing age, who is planning to receive a Covid vaccine, please warn her about this possibility, of permanent sterility, through recurrent miscarriage.

I request your prayers, and I very much hope that this information may be helpful to you and those dear to you. Please feel free to share it with anyone who might heed these warnings. I have attached my open letter to Dr Bonnie Henry. Please feel free to share it too.

May the Lord bless and keep you.

Dr Charles Hoffe

Printable PDF – Letter to Congregation