The uncritical, blind faith in vaccines is the preeminent sacred cow of modern medicine. (It happens to be its preeminent cash cow as well.) It is a quasi-religious, dogmatic article of conviction, rather than a sound scientific theory or an empirically-based clinical precept.

Vaccines have been controversial since their introduction centuries ago. Only in very recent history has there been a rigidly enforced orthodoxy of belief within the medical establishment that vaccines must be unanimously regarded as “safe and effective,” no questions asked.

Even more recent is the practice of smearing and labeling anyone questioning this doctrine as a heretic: an “anti-vaxxer.” In fact, according to the Merriam-Webster Dictionary, the earliest known use of that now-ubiquitous epithet was only in 2001. 

Religious faith has tremendous potential for good in society, but when it is misrepresented as science, its track record is miserable and deadly. “Safe and effective” is not scientific shorthand, or even an advertising slogan; it is a mantra. “Anti-vaxxer” is not a category of person, it is a charge of heresy. And just as vaccine critics are heretics, so the high priests of vaccines, the Faucis of the world, the people who in their own words “represent science,” are fanatics.

Does that really sound like science to you? Galileo, Semmelweis, and a few others might disagree.

Any honest person who lived through the COVID-19 era in the United States will acknowledge that the Department of Health and Human Services (HHS) with its lengthy “alphabet soup” of agencies (CDC, NIH (with its NIAID), FDA (with its CBER), etc., etc.), promoted and repeated the “safe and effective” mantra regarding the COVID-19 vaccines throughout an era of intense public fear. 

Any honest person will also acknowledge that the mainstream media avidly repeated and amplified the “safe and effective” mantra and stoked the fear, all while ruthlessly attacking anyone questioning that same dogma, labeling them “anti-vaxxers,” or sometimes even “murderers.”

Little to no mention was made – or allowed – of the gigantic financial incentives and other entanglements these powerful entities have with the vaccine manufacturers, nor the trillions of dollars involved. 

Religious dogmas, especially those relentlessly inculcated by powerful forces under extreme conditions, are hard to break free from.

To readers who may know people caught in the rigid, dogmatic belief in the infallibility of vaccines, I offer the following 10 sentences.

Share them with friends, family, and colleagues who cannot seem to reconsider vaccine dogma, especially those with an uncritical view of the current vaccine schedules. Ask them to carefully read each of the 10 sentences below, one at a time, and ask themselves: does this sentence seem true or false to me? If it seems false, on what basis do I think it is false? Then move on to the next one and do the same.

(Some of the sentences are complex, but I am confident an intelligent layperson can understand them all.)

When they are finished with all 10 sentences, encourage your friends to ask themselves: 

• Do they truly believe that every child in the United States should receive 20 or more different vaccines before age 18? 
• Should vaccines ever be mandated? 
• Shouldn’t we, as an educated, free society, systematically review the official vaccine recommendations, and, just as we would do with Grandma’s overflowing pill box, reduce them to the truly necessary minimum?
• Shouldn’t we reassert the autonomy of patients over their own bodies?

Here is the trouble with vaccines, in 10 sentences:

1. Like “antibiotics,” “vaccines” are a large and diverse class of medicines, and as with all large classes of medicines, different products in the class work by different mechanisms, some being quite effective while others are ineffective, some being reasonably safe for appropriate human use while others are fraught with side effects and toxicities, and therefore to assume that any large class of medicines – including vaccines – is categorically “safe and effective,” is naïve, illogical, false, and dangerous.

2. While the full extent of vaccine toxicity is undetermined, it is a historical fact that numerous vaccines have been proven to be highly toxic and even deadly to patients, via multiple pathophysiological mechanisms, including: a) direct contamination of the vaccine (e.g. the Cutter Incident), b) disease caused by unintended, pathological immune response to the vaccine (e.g. Guillain–Barré syndrome caused by the swine flu vaccine), c) unintended contraction and/or transmission of the disease the vaccine was designed to prevent, caused by the vaccine itself (e.g. the current oral polio vaccine), and d) vaccine toxicity of unknown or uncertain cause (e.g. intestinal intussusception with the rotavirus vaccine, and fatal blood clots with the Johnson & Johnson COVID-19 vaccine).

3. In fact, the known toxicity of vaccines is so well-established that a Federal law – the National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) was passed to specifically exempt vaccine manufacturers from product liability, based on the legal principle that vaccines are “unavoidably unsafe” products.

4. Since the 1986 NCVIA act protecting vaccine manufacturers from liability, there has been a dramatic increase in the number of vaccines on the market, as well as the number of vaccines added to the CDC vaccine schedules, with the number of vaccines on the CDC Child and Adolescent schedule rising from 7 in 1986 to 21 in 2023. 

5. Of the 21 vaccines on the 2023 CDC Child and Adolescent Immunization Schedule, only a small minority (e.g. measles, mumps, rubella, varicella, and HiB) are capable of providing genuine herd immunity, a fact that negates the common, population-based arguments for mandating the other vaccines, which comprise the sizable majority of the vaccines on the schedule.

6. The pharmaceutical industry has established an almost unimaginable degree of media control, institutional influence, and regulatory capture, via its funding of other entities, as it is a) the largest industry lobby in Washington, DC, b) the second largest industry in TV advertising, c) a major source of personal revenue for high-level HHS “alphabet soup” agency bureaucrats, many of whom hold patent and royalty rights on pharmaceutical products, d) a major funder of influential physician organizations (e.g. the American Academy of Pediatrics and prominent medical journals, and e) involved in payment-based incentivization of practicing physicians, who frequently receive monetary bonuses for high rates of vaccination in their patient panels.

7. The COVID-19 mRNA vaccines were developed and administered to the public a) much faster and with much less testing than any other vaccines on the market, b) under Emergency Use Authorization, c) utilizing a technological platform that had never seen commercial use before, and, despite generating reports of vaccine-related deaths and serious adverse events at much higher rates than traditional vaccines, and despite the fact that they have been removed from the pediatric market in multiple other developed countries, the COVID-19 mRNA vaccines have already been placed on the CDC Child and Adolescent Immunization Schedule, just a little over 2 years after their introduction to the public.

8. There has been no systematic public accounting by the CDC (or any of the HHS agencies) for the more than 35,000 reported COVID-19 vaccine-related deaths and more than 1,500,000 reported COVID-19 vaccine-related adverse events reported as of July 7, 2023, to the CDC’s own Vaccine Adverse Event Reporting System (VAERS), nor for the corresponding numbers of COVID vaccine-related deaths and adverse events reported to Eudravigilance (the European Union’s equivalent to VAERS), even as the CDC continues to strongly promote these vaccines for use, including placing them on the CDC Child and Adolescent Immunization Schedule.

9. By labeling the novel COVID mRNA products as “vaccines,” the definition of the term “vaccine” has become so broadened that essentially any medication that induces an immune response against a disease may now be dubbed a “vaccine,” thereby shielding pharmaceutical companies from liability under the National Childhood Vaccine Injury Act of 1986 to a previously unimagined extent.

10. Vaccine mandates thereby compel citizens to submit to medical treatments a) that are regarded under Federal law to be “unavoidably unsafe,” b) that because they are unavoidably unsafe, their manufacturers are protected by Federal law from liability for harm done to citizens, c) whose manufacturers and government agencies nevertheless promote publicly as “safe and effective,” in direct contradiction to their legal status as “unavoidably unsafe,” and d) that have increased tremendously in number in recent decades, and, with mRNA technology and a broadened definition of the term “vaccine,” stand to multiply at an even greater rate in the future.

I hope these 10 sentences will help the unconvinced to reconsider the central dogma surrounding vaccines. We, as a society, need to reject the article of faith that vaccines are fundamentally “safe and effective.” 

Vaccines, due to their unavoidably unsafe nature, should NEVER be mandated, and a thorough, product-by-product accounting of the individual vaccines needs to be done outside of government agencies.

How can we accomplish this?

Please forgive me if you thought I was done. I have 10 more sentences listing my proposed solutions to the trouble with vaccines. I ask you to trudge through these as well. Most of them are shorter than the first 10. Thank you.

A Proposed Solution to the Trouble with Vaccines in 10 (more) Sentences:

1. The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) should be repealed, returning vaccines to the same liability status as other drugs. 

2. Federal law should be passed prohibiting the mandating of any and all vaccines at all levels of government.

3. Federal law should be passed prohibiting all direct-to-consumer advertising of prescription drugs.

4. Federal law should be passed prohibiting all collaboration between the Department of Health and Human Services’ “alphabet soup” agencies (FDA, CDC, NIH, etc.) and either the Department of Defense (US Army, DARPA, etc.) or the Federal Intelligence Agencies (CIA, DHS, etc.) with regard to vaccine development or vaccine distribution to the public.

5. Federal law should be passed prohibiting all persons working within the HHS agencies from gaining any personal financial benefit from vaccines, including the gaining and holding of patents or royalties, and civil servants in those agencies should be required to take an oath of office not to profit off  of any products they approve, regulate, or about which they advise the public.

6. A thorough and public investigation, including criminal prosecutions where appropriate, should be made regarding the key players (both public and private) involved in the development, marketing, manufacture, sale, and administration of the COVID-19 mRNA vaccines, and following the investigation, there should be appropriate reform within the HHS agencies.

7. Detailed, independent, Cochrane-style reviews of every vaccine on the CDC vaccine schedules should be undertaken and made public, and no scientists with financial interests within the pharmaceutical industry should conduct these reviews.

8. Detailed, independent reviews of all reports from the Vaccine Adverse Event Reporting System (VAERS) related to the COVID-19 mRNA vaccines should be undertaken and made public, and appropriate reforms to VAERS should be made.

9. A detailed Congressional review of the money trails related to COVID-era programs, including Operation Warp Speed and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, should be conducted, focusing on fraud and abuse at all levels, including how private companies such as Pfizer and Moderna profited so enormously from taxpayer-funded initiatives.

10. A open, public discussion and debate should be undertaken on the appropriate role of vaccines in public health, including, among other issues, a) a critical review of the current medical dogma on vaccines, b) an accounting of the mistakes, abuses, and potential lessons of the COVID-19 era, and c) a thorough discussion of the undeniable conflicts between public health as it is now practiced and the fundamental civil rights of citizens.

The medical establishment’s current dogma on vaccines (“safe and effective,” no questions asked) and its corresponding catechism (the ever-expanding vaccine schedules) are in desperate need of reform. I submit that we begin with the above steps.

Reformers are not heretics, although they are commonly labeled as such by powerful persons resisting reform. I, for one, am not a heretic, nor am I an “anti-vaxxer.” I don’t want to throw the baby out with the bathwater. The problem is, when one looks closely at the vaccine schedules, there turns out to be a lot more bathwater and a lot less baby than advertised.

It is time for the profession of medicine, and society as a whole, to come out of the Dark Ages on this topic. It is time for an open, forthright reevaluation of vaccines and their role in public health.

Clayton J. Baker, MD

C.J. Baker, is an internal medicine physician with a quarter century in clinical practice. He has held numerous academic medical appointments, and his work has appeared in many journals, including the Journal of the American Medical Association and the New England Journal of Medicine. From 2012 to 2018 he was Clinical Associate Professor of Medical Humanities and Bioethics at the University of Rochester.

Most sane people believe that the burden of proving safety should lie on the party conducting a questionable action, rather than their victim. For example, if a criminal shot someone, the prosecution would not be required to prove that the victim’s sudden death after the gunshot wound was not just a spontaneous coincidence, a result of extreme stress from the situation, or due to a pre-existing medical condition.

Unfortunately, the pharmaceutical industry has been able to establish a special type of privilege within the legal system which has made it very difficult to demonstrate that vaccines (along with many other pharmaceuticals) can ever be at fault for anything. Because of this, we recently had a flood of experimental vaccines mandated upon the population, which were never tested for safety (despite many serious concerns with their design), whose (likely fraudulent) clinical trial data was never made accessible to the public.

We then had, as far as I know, the most aggressive propaganda campaign in history, and I watched the majority of my colleagues lose the ability to recognize any problems related to the vaccines. Instead, they developed an almost surreal religious devotion to the coming salvation of the vaccines becoming available.

Once the vaccines entered the market, a variety of red flags began going off indicating that these vaccines were killing people, and rather than address these concerns, the government—in concert with the media—chose to deny any of this was occurring. Instead they mandated the vaccines upon the entire population. I was understandably worried that the vaccines would cause problems and tried to do my part to head this off in 2020, but I did not expect anything on the scale of what we have encountered since then.

I personally became involved in all of this because soon after the vaccines entered the market, I began to have many friends and patients reach out to ask me if the vaccine could kill as someone they knew had had a tragic sudden death after vaccination. Once the magnitude of the problem dawned on me, I realized that even though my available options were limited, I could at least do my best to document each case sent my way so that someone would bear witness to what had happened. Otherwise, the dead had no voice. Beyond knowing I had a duty to compile this list however, I was not sure what to do with it. Later after someone kindly helped launch this Substack, I decided to post it, it ended up being seen by a lot of people…and that is how I ended up writing here.

Because of how long it took to verify each case, I realized that I had to end it a year in (at which point I knew of 45 individuals who had either critical or fatal injuries of a similar nature in close proximity to vaccination). Since that time, I still continue to hear reports I periodically document and discuss.

For example, a good friend is a nurse in a cardiac unit and has told me many of the patients she sees now with heart failure are much younger than they were a few years ago. I previously advised her against getting the vaccine due to her history of rheumatic fever (a condition where the immune system attacks and damages part of the heart). This was because I had noticed both COVID-19 and especially its vaccine seemed to cause inflammatory flares at previous sites of injuries or inflammation (Lyme is also known for doing this). The vaccine also has a remarkably high rate of exacerbating pre-existing autoimmune conditions—such as the 24.2% rate found in a recent Israeli survey which is comparable to what a few colleagues have observed, and I suspect exacerbation of preexisting inflammation within the circulatory system, like what this study of 566 patients found, is a key mechanism behind vaccine deaths.

A month ago, the nurse informed me that she had decided to vaccinate and had subsequently developed a heart condition. Additionally, she shared that the same had also happened to her mother following vaccination and that her sibling's partner is suffering longterm complication from a large stroke that immediately followed receiving a booster.

Looking back on it, the thing I found the most disappointing about my own documentation project was that once it went viral, it should have triggered the drug regulators evaluating the vaccines to take preventative action. Instead, due to the meticulously planned campaign of mass censorship that we all found ourselves in, more red flags than I can count were ignored by the “very rigorous” vaccination surveillance systems that were allegedly ensuring there were no safety issues with these vaccines.

Because of the immense power behind the medical-industrial complex, those debating this program have been stuck fighting an uphill battle. However, despite the immense degree of corruption, withholding of critical data, and censorship, these vaccines are dangerous enough that more and more evidence is nonetheless emerging of their danger, and the public is beginning to recognize it (e.g., consider how resistant the public has been to get COVID boosters). The previous article here discusses polling that shows this appears to be happening:

We Now Have A Clear Estimate Of The Rate Of Vaccine Injuries
Throughout my entire life, I’ve always found that trying to argue against Big Business is like fighting with one or both hands tied behind your back because large industries can always co-opt and buy out every authoritative source on the subject, and then censor any inconvenient facts that still persist. This is an immensely challenging situation.

Immediately after it was published, I was informed by a reader that possibly the most important dataset over the last two years was released today. For those interested, much of the context for today’s article can be found in the article above.

Thanks for reading The Forgotten Side of Medicine! Subscribe for free to receive new posts and support my work.

German Data

One of the depressing realizations one gains from studying the evidence-based literature is discovering how many issues exist within it and how difficult it is to know which data sources can be trusted. One of my favorite authors, Dr. Malcom Kendrick, devoted a book to addressing this subject and shared a pertinent anecdote for today’s events:

“In truth, the figures on vaccine damage are exceedingly difficult to analyse, because causality is very difficult to prove on a case by case basis. However, when it comes to negative findings I always like to go to Germany. It has been demonstrated many times that the Germans are the most likely to report negative findings accurately. Yes I know, terrible racial stereotyping, but a fact is a fact. What do the Germans have to say on the matter?

“Between 1978 and 1993 approx. 13,500 cases of undesired effects resulting from medications for vaccinations was reported to the Paul Ehrlich-Institute [PEI]…the majority was reported by the pharmaceutical industry. In 40% [5,400] of these cases the complications were severe, 10% [1,350] pertained to fatalities on account of effects.”

Additionally, as I learned from Kendrick, since early 2001, the federal infection protection law has mandated that specific severe vaccine injuries be immediately reported directly to the PEI (Germany’s equivalent of the FDA for vaccines and biologics). The German’s list of reportable injuries is much broader than what I have seen acknowledged by many other countries (e.g., those which are possible to receive compensation for within the United States) and includes the previously discussed complications of DPT along with many of the reactions typically associated with the COVID-19 vaccines. However, while that historical trend exists, Germany has not been one of the best countries for reporting COVID vaccine injuries (which I suspect is due to the political direction their government has moved in).

(The above graph illustrates why many of my German friends are not happy with their government)

Because of their tradition of reporting adverse reactions to vaccination, Germans (or at least some of them) have been more resistant to toeing the party line on concealing the dangers of the COVID-19 vaccines than citizens of many other countries (my friends there are enraged by the egregious concealment of critical safety data by the German government). In turn, some of the most critical vaccine data available comes from the German people as many of them have retained their intellectual integrity throughout the pandemic.

For instance, although autopsies should always be conducted on those who died suspiciously after vaccination, due to the global climate of intimidation against conducting any type of research that challenges the COVID vaccine program, it is rarely done. Instead, almost every autopsy has been performed by a few brave pathologists in Germany, and I have tried to detail the pathologist’s work throughout my postings (e.g., see here).

Some of the most important contributions of these autopsies include:

• Demonstrating that there is highly unusual tissue inflammation in those who died after vaccination. Pathologists had not observed this phenomena before the COVID-19 vaccines, and stated the inflammation they observed would likely be fatal.
• Demonstrating that the COVID spike protein could also be found in the tissues of those who died.
• Demonstrating that another key part of the SARS-CoV-2 virus was not present, meaning that the only possible source of the spike protein was the vaccine.

The most definitive study on this subject was recently completed. It examined 35 individuals who died within 20 days of vaccination, and after a lengthy examination excluded 10 who had a potential cause of death other than vaccination. Of the remaining 25, most had causes of death that frequently been linked to vaccination, and of those, 5 were found to have myocarditis potentially linked to the vaccine, and in 3 cases the vaccine was determined to be the definitive cause of their myocarditis and death. These results are very important for convicting the vaccines if it can also be proven that a large number of unexpected deaths are occurring following vaccination.

The Religion of Data

Every group needs to have some type of ideology to unite behind. Presently, one of the fixations within the Western world is on more and more data being the solution to everything. In turn, there are many concerns with this approach (e.g., it dehumanizes people, its “necessity” is used to justify violating citizen’s right to privacy while collecting it and it is being used to build an infrastructure that controls every aspect of our lives).

Although data is often claimed to be our salvation, and I will admit sometimes is quite helpful, in many other cases, it fails abysmally to address our problems. A major reason for this failure is that no one wants to critically analyze data this is gathered if that data suggests we should stop supporting an entrenched financial interest.

I am most aware of this in healthcare, as I know of numerous systems which were designed to analyze electronic medical records and either identify which pharmaceutical worked best for a condition, or if a pharmaceutical (or vaccine) was unsafe. Not surprisingly, all of these systems were never adopted, and the endless data we collect in healthcare (e.g., all the diagnostic coding data which medical insurance providers provide as a condition of reimbursement to healthcare providers) is rarely utilized to improve the public good. However, while prevailing biases frequently produces flawed analyses of data, data itself does not lie and has immense potential to expose dangerous health care practices if people are willing to look at it.

The largest insurance provider in Germany, BKK, provides coverage to approximately 10.9 million Germans. A board member, Andreas Schöfbeck, observed some very concerning signs in their data, and unlike everyone else, had the courage to disclose it in a letter to the German government (e.g. he addressed the PEI), after which, he was dismissed from his position. The BKK dataset (discussed by Jessica Rose) was the one which showed 2.05% of vaccine recipients subsequently sought medical care with a healthcare provider (others estimated it demonstrated 3.5% were struggling with persistent vaccine side effects).

This concerning safety signal prompted one German Political Party, the AFD (a controversial right wing party that has gained appeal through opposing the mandates) to file the German equivalent of FOIA for the rest of the insurance data (note: a few friends in Germany who are lifelong liberals joined AFD told me they believe “conservative” is a more appropriate label for AFD). Recently AFD obtained AOK Sachsen-Anhalt’s data, which once analyzed, demonstrated that many of the conditions we associate with COVID-19 injuries noticeably increased when the vaccination campaign initiated. According to this interview and Google translate, the conditions which rose five-fold or more were:

AFD’s FOIA Request

AFD also submitted a FOIA request to KBV, the association which represents all physicians who receive insurance in Germany and thus the largest insurance dataset available. The official response to their FOIA request reads as follows (this was my attempted translation):

”Dear Mr. Sichert,

With an e-mail dated October 27th, 2022 you have submitted an application to the KBV after the Freedom of Information Act (IFG) on access to data of the diagnostic codes by law health-insured patients.

You have asked for the following data packages to be sent by email:

Package 1: Filtering of all insured persons who will have an ICD coding in 2021 had vaccine side effects. You have applied for the codes T88.1, T88.0, U12.9 and Y59.9 apply.

Package 2: You request the transmission of a list of the frequency of all ICD codes of the insured persons from package 1 for the period 2016 to 2021, if proportionately available also for 2022, by quarter. The data query should after your request with V and G.

Package 3: You request the transmission of a listing of the frequency of all ICD codes of all insured persons - without the number of insured persons from package 1 - for the period from 2016 to 2021, if proportionately available also for 2022 quarters. The data query should be done with V and G.

The KBV corresponds to your application and includes a tabular overview as an attachment with the desired information about the frequency of at.

The abbreviations used in the table have the following meaning:

nw= number of patients with “vaccination side effects” (defined according to requested Filtering 1 in 2021)
onws= patient numbers "without vaccination side effects" (defined according to requested Filtering 2 in 2021)

Quarters of the reporting period are set as YYYYQ (e.g. 20214=Q4 2021).

The small font size in the printout is again unavoidable, since we want to make it easier to compare wanted to show all quarters of the two comparison groups on one sheet (the pdf document). However, like last time, it can be enlarged.

Today, the AFD hosted a press conference to unveil the data of those 72 million patients (the 90% of Germans with statutory health insurance) AFD had obtained from KBV. This data summarizes the number of times all ICD-10 (an international standard) diagnostic codes were used by German healthcare providers for these patients (outside of hospitals) from the first quarter of 2016 to the first quarter of 2022.

Tom Lausen is a data activist who had previously revealed the PEI and the RKI (the German equivalent of the CDC) were concealing concerning vaccine safety data and was allowed to analyze both BKK and AOK’s data. For this presentation, Lausen was able to provide a preliminary summary of the KBV data a few days after it was released:

A rough translation of this presentation can be found here (additionally YouTube now will translate the subtitles). If this video is deleted it can also be found here.

A few of the points emphasized in this presentation include:

• The [PEI](http://Paul Ehrlich Institute), the RKI and the German government have failed in their duty by federal law to evaluate COVID-19 vaccine injuries. Many of my friends and readers likewise believe they have done an atrocious job by attempting to conceal the vaccine injuries, and these agencies are frequently chastised by the German people for their conduct. Many of the arguments against the validity of this data must be viewed in the context of the fact it would be very easy to the government agencies to access and analyze this data, but despite many requests to over the last two years, they have all adamantly refused to, which is why AFD had to force them to act with its FOIA.
• It is estimated that 90% of the suspicious deaths that occur after vaccination are not reported to the PEI, and approximately 90% of those reported come from the patient themselves or their relative (which again demonstrates that German healthcare providers are failing in their duty to report vaccine injuries).
• The PEI has nonetheless received over 3,000 reports of suspicious deaths following vaccination, but has refused to perform any autopsies on those deaths. The excuse the PEI has used for their inaction is not having the explicit authority to order the autopsies (which is a spurious excuse). Fortunately as noted above, other groups without any official authority to order autopsies have nonetheless taken the initiative to perform them.

For this press conference, a presentation was put together detailing Lausen’s preliminary findings and the correspondences with the regulatory agencies, all of which can be found here. To the best of my ability, I translated and slightly modified the key portions of the presentation so that they could be accessible to English speakers, but I am certain more will be translated in the upcoming days.

The KBV Data

All of the KBV data can be reviewed with a simple search tool here, although it does not seem to work for certain ICD-10 codes. Due to the importance of this data, for data preservation purposes, I am also providing a copy of the raw data the AFD received:

Germany Total Icd 10 Code Submissions 2016 2022 1.87MB ∙ PDF File

This PDF file was supplied in a manner that makes the data quite difficult to analyze. Fortunately, one of my readers was able to move the above file into an easily sortable spreadsheet and thereby address some of the challenges with the PDF:

German Data Sortable Sheet 3.06MB ∙ XLSX File

Finally, the above sheet was sorted by that reader into a smart spreadsheet which allows you to easily observe which codes had the greatest increase in 2021-2022 (e.g. to sort them or create graphs). For those of you who are data inclined, you will likely want to create this sheet yourself, but for everyone else this is an excellent reference to start with). They were also able to use a script to put about one third of the names for the ICD-10 codes, but since there are fifteen thousand of them, it wasn’t practical for us to manually add in the rest and you will frequently need to directly look up the codes themselves (if a group wants to add the other codes in, I will be happy to repost that).

When Lausen presented the data, for each time period (e.g., 2016 quarter 1), he chose to add two different values together (code_20161 and nocode_20161). As best as I can tell from reviewing the FOIA request and the provided data, these categories represent those who also received a vaccine injury code and those who did not (as a result the majority of Germans belong to the “nocode” category).

I believe Lausen’s rationale for presenting the data in this manner was that a large number of vaccine injuries will go unreported and many vaccine injured patients are thus within the “nocode” category. Conversely, the total number of medical conditions observed in the country is not dependent upon accurate recognition of vaccine injuries.

Separating the patients by (the somewhat inaccurately classified) vaccine injury status is nonetheless a helpful means for evaluating vaccine injuries (I saw a variety of interesting trends in my preliminary examination). However, for the reasons outlined in this article, for the initial spreadsheet presented below, those result are combined.

Additionally, some of the extreme outliers exist because new ICD-10 codes are added each year and thus did not exist prior to 2021/2022. Finally, some of the codes you would expect to have large changes may not show in this dataset if they are codes typically used in a hospital setting as this dataset does not include hospital code submissions.

Kbv Data Sorted Into Accessible Excel Sheet - 9.46MB ∙ XLSX File

In the coming days, I know many will use this data to verify our work identifying which codes in 2021-2022 had the greatest increase (you can also do that piece by piece with the already available tool), and then cross reference those to the increases reported in VAERS or other datasets. There is an immense amount to be ascertained here, and I believe it represents the credible evidence we have been looking for since the start of the pandemic to have an objective metric for quantifying the impact of vaccine injury. However, it is also critical we determine which of the observed trends are not due to artifacts within the data.

Lausen’s Presentation of the KBV Data

This is probably the most important graph of Lausen’s presentation. We have all heard stories of individuals dying suddenly after vaccination (I’ve even read a report of an individual who appeared to be in good health making a thump in another room and being found dead shortly after by their spouse).

This issue was recently brought to the public’s attention with Died Suddenly, a documentary that effectively brought attention to this issue, but also had factual errors which were counterproductive for persuading the public that this issue is real. However, while some of the proof that Died Suddenly provided to assert the existence of the sudden death phenomenon could not stand up to outside scrutiny, the same cannot be said of the KBV data.

Additionally, one way that individuals have analyzed the unusual changes in health following the vaccination campaigns has been to assess how far they fall outside of the expected range of variation (this was also done for the final spreadsheet). I did a quick calculation for the above graph and found that 2021’s increase from 2016-2020 was 37.7σ, while 2022’s was 41.0σ. This is quite a big deal (the rarity of an event happening by chance increases exponentially as the σ increases). For context, a 7σ event has a 1/390,632,286,180 chance of spontaneously occurring (it is thought to occur once in a billion years), a 10σ event happens spontaneously once every 5.249e+020 years, and a 25σ event happens by chance every 1.309e+135 years (I was not able to find a reference on the probabilities for the even higher σ events observed here).

Given these numbers, it is very difficult to argue that these events were not caused by something. In this regard, we are also quite fortunate that while the vaccines were rushed to the market over a period of time far too short to establish safety, that process still took a year. Because of this lag, it is possible to refute the reflexively cited counterargument that these changes were due to COVID-19 or the lockdowns, as these only occurred in 2020 (the only possible exception I can think of is that Delta emerged near the end of 2020, but the spike started well before Delta became prevalent in Europe later in 2021).

This is a similar graph to the previous one, but include sudden cardiac death, which as many of you know also “unexpectedly” increased. Many authoritative sources have argued Lausen made a mistake to correlate vaccine injuries with the spike in sudden death because very few vaccines were given at the start of 2021 and thus if a correlation was there, it should have been not emerged until the second quarter.

For context, this was the rate of COVID vaccination in Germany:

As you can see, many vaccines were given in the first quarter of 2021.

COVID-19 is not the only vaccination regularly received. For example in Germany in 2019, it was estimated that 39% of those 65 and older received an influenza vaccination. However, unlike previous vaccines, the introduction of the COVID-19 vaccine caused far more people to require medical care for a vaccine side effect.

Given that Germany has a longstanding practice of evaluating vaccine injuries, this graph makes a very important point. An actual increase in vaccine injuries is occurring and it is not a result of a bias leading to over-reporting; it is a result of the vaccines being dangerous and patients needing medical care for the injuries.

Additionally, an outside team which looked at this data concluded approximately 5% of vaccine recipients subsequently required medical care, which is in line with the 7.7% discovered in V-Safe’s data and required a court order to be released as the CDC understandably did not wish to disclose this information. Note: I believe this discrepancy could be partially explained by the undercounting of vaccine codes highlighted in this article.

The general correlation between these two datasets is important. V-safe monitored 10 million vaccine recipients for a few specific things and was arguably the best surveillance system in place for tracking the side effects of these vaccines as it had a large but defined sample who were provided an easy way to report the chosen side effects. Since one of its key metrics matches the KBV data, this argues that at least some of the KBV data is valid.

Note: I am not sure if this specific dataset is referring to the total number of patients who sought care or the total number of times codes were submitted for vaccine injuries (which would mean a smaller number in total were injured).

Given that there are thousands of ICD codes that I could search the database for (many other increases, such as those of certain cancers, were highlighted in Lausen’s presentation), I had to put some thought into which of those many increases would be the best to show for this article (there were a lot of compelling candidates).

Previously, I proposed a model for the unusual fibrous clots observed in Died Suddenly that revolved around spike proteins causing protein misfolding. In support of this model, I highlighted an observed increase of an extremely rare protein misfolding disease which continues to be reported in VAERS.

Creutzfeldt-Jakob disease typically develop over years and occurs in approximately one in a million people annually, making its occurrence immediately after vaccination rare to the point that suggests causation (and as Jessica Rose noted, new reports are continuing to arrive in VAERS). The increase I proposed was a key point of contention for those who did not agree with my misfolded clot hypothesis, so I was eager to see if a current dataset could evaluate what was occurring.

This increase is also quite large, and for all practical purposes impossible to have occurred by chance (although I will mention the authors who published the original case series linking COVID vaccination to 26 cases of CJD also determined that Delta appeared to have an increased capacity to trigger protein misfolding but I do not believe that can explain the above trend).

Since this article was published, one reader has now attempted to present a longer analysis of this data which shows multiple interesting trends (e.g., many of the side effects commonly attributed to COVID vaccination appeared to have increased) along with raising additional questions about this data. It is my hope others will also do so!

Citizen’s Substack
Analysis of the recently published German insurance data
A dataset listing ICD-10 disease codes for all insurance claims filed by German doctors (outside of hospitals) for publicly insured Germans from 2016–1Q22 was recently published (more information). I’ll start with the obvious charts: chest pain, myocarditis and pericarditis increased by 17.8%, 48.5% and 25%, respectively, in 1Q22 compared to 1Q19…

Finally, the presentation on the KBV data proposes a fatality rate for the COVID vaccines. This chart was compiled by Lausen from the officially reported adverse events to the vaccines and likely are significantly undercounting the vaccine fatality rate.

Is This Data Valid?

Following the AFD’s press conference, the leading medical research institute in Germany, ZI, acted as a third party to present a rebuttal of how AFD interpreted KBV’s data. I did not agree with their argument (that there results were an artifact of AFD also requesting for everyone who specifically died in 2021), but did note that their response acknowledged the authenticity of this data.

The primary argument presented by ZI was that since the FOIA request selected for all patients who were vaccine injured in 2021-2022, the rise in deaths observed in 2021-2022 was simply due to the fact anyone who was vaccinated in 2021-2022 could not have died prior to 2021-2022 and thus the increase in deaths observed in 2021-2022 compared to what occurred prior to this time was due to the cohort effect.

On the surface this seems like a credible way to dismiss anyone who would make such an elementary mistake and believe in this data. However, the German authorities have a long track record of attempting to cover up evidence of COVID vaccine harm (in addition to the points discussed above, the German government has been perpetually delaying releasing the death statistics for 2021), so these arguments require a critical evaluation. In turn, there is a few major issue with it:

First, the “nocode” group should not suffer from the cohort effect and it was this group that comprised the majority of the increase in sudden deaths (review the wording of the FOIA request shown above). If the “code” group were to be removed (which potentially suffers from the cohort effect), an almost identical trend would still be present. Lausen presented his data by merging the code and nocode groups together which invalidated this counterargument, and I cannot see how a “cohort effect” is present in the combined data unless KBV failed to fulfill the FIOA in the manner that was requested (Lausen also subsequently provided an interview addressing the government criticisms of his analysis).

An outside analyst also looked at this data and demonstrated that other fatal conditions (which should be vulnerable to same the cohort effect ZI is asserting) did not have the same 2021 spike:

Second, the large σ found for many, (but by no means all) non-fatal conditions in the dataset indicates that something besides artifacts relating to time of death is causing the changes observed. I acknowledge that it is very possible some of the discrepancies present are due to not yet identified artifacts within the data, but at this point in time I have not been able to identify them. I believe that since KBV was focused on debunking the rise in sudden death codes, they did not focus on the rise in other codes for conditions associated with COVID vaccine injuries that were also observed. However, while this was not their focus, this point must nonetheless be considered since it does negate their counterargument.

Additionally, The death argument ZI made was also inconsistent with the death codes in question nonetheless being reported prior to 2021, which they attributed to “coding errors or unaddressed billing fraud.” To some extent this is hand-waving that many others have contested (and something any type of auditing algorithm should have caught years before), but I do not believe it is as important as the first two points.

Conversely, the strongest argument ZI put forward to establish that a cohort effect was occurring for the reported deaths was this spreadsheet. I have not yet been able to discern how the data in it was derived as it does not match the other things I looked at, so I cannot comment on if this is correct (an independent analyst arrived at the same conclusion I did). This spreadsheet is the one source of data that could refute AFD’s argument so I would greatly appreciate any additional thoughts on this one). However, I must also note that if this data is actually correct, it still does not negate the non-fatal complications of vaccination being observed.

A German rebuttal of ZI’s arguments was posted here. AFD also discussed the above rebuttal in a thread here stating:

"Hello all. The death-numbers that we have published are being hotly debated right now. Now the Central Institute for the KBV has joined in has said that the data we presented were quite easy to explain: 'The data is only for people who have accessed a medical service in 2021 and only such people had been billed and therefore would be in the data and everything in the years before are statistical runaways. There are also different causes of death that were significantly higher in the years before such as I46.9 (heart attack without successful reanimation). ' All together 104 000 people have been coded as deaths in the years 2016-2020 of whom the Central Institute of the KBV now says that they were billed medical services in 2021. Now we have a question: If this is really true, we demand an explanation from the Central Institute of the KBV how 104 000 persons that have died in the years 2016-2020 have been billed medical services in 2021.” [Translated courtesy of a reader]

The following was also written in the tweet: “Allegedly, the figures from the KBV are only for patients with health insurance, for whom services were billed in 2021. However, the causes of death were coded for 104,000 patients in previous years. Do we have a data scandal or a billing scandal?”

This table also refutes ZI’s argument that only those who were able to see a doctor and thus were alive in 2021 comprised the cohort of the insurance data.

Many of the German commentators I saw online were also skeptical of the official rebuttals to this data. I was recently sent a detailed summary of the events after the press conference which demonstrated that the rationale for debunking the data changed as time went forward. As best as I can tell, no clear reason was presented for why Lausen’s analysis was flawed given. Instead it was insinuated either that Lausen incorrectly filtered the data (my team and others however arrived at the same results Lausen did) or that there was a data transmission error from the KBV (which is possible but would have had to have been deliberate or inconceivable incompetence).

KBV also issued an astonishing statement refuting AFD’s presentation:

The KBV board clarifies: Based on the billing data transmitted by the KBV to the AfD or. ICD-10 codes cannot be used to establish causal relationships between COVID-19 vaccinations and deaths. From the KBV's point of view, the increase in deaths shown in quarters I-IV 2021 and quarter I 2022 is largely pandemic-related mortality. This once again illustrates the importance of COVID 19 vaccination as an effective measure to prevent serious forms of progress up to deaths. Without the vaccination, mortality would probably have been much higher.

This statement also cited the previously referenced ZI letter and another one which noted:

• The codes in this database do not include codes entered on death certificates and thus cannot be assigned as the cause of death [however all of these codes cannot be entered unless the patient died; also as the statement above shows KBV is admitting an increase in deaths did occur].

• The codes in this database cannot be correlated with vaccination status because many people received the COVID vaccines in settings that did not result in codes being submitted and coding for COVID vaccination has not yet been included in the dataset due to special regulations [I agree with this point, but it fails to refute this dataset since Lausen chose to combine the code and nocode groups; instead, it simply argues that vaccine injuries are underreported in this dataset].

• This database was not created for the purpose of conducting medical research and therefore no conclusion can be drawn from it [I don’t believe this is a valid argument; a lot can be inferred from it and it is the best available database we have, so until the government chooses to make a better database available, it is “the evidence.” Additionally, this is a very similar argument to what is said for VAERS, but unlike VAERS there is not an over or underreporting issue present with this dataset].

I do not believe any of the above points refute the sudden increases in submitted billing codes (hypothesized to correlate with vaccine injuries) that occurred a year after the pandemic started at the exact same time the vaccination campaign began. However, I also believe some type of not yet identified artifact could account for at least some of what was observed and I have spent the last week revising this article to account for the additional information I come across. If anyone can provider a stronger refutation of the data presented here (preferably, at the pinned comment), I would greatly appreciate it. We need to help each other stay honest and I will gladly retract this article if a critical mistake was made.

Note: An independent analyst who reviewed the entire dataset found that it showed many other signs of being plausible.

Conclusion

Given the extremely concerning implications of the German data, it is not surprising that governments around the world and healthcare systems or insurance providers have been reluctant to release their own data. It is my sincere hope that this release will open the flood gates to additional disclosures and I am in complete agreement with the conclusion of this presentation:

I wish we had an American political party stating the same. There are signs of hope however; today Ron DeSantis did something incredible and requested a grand jury against Pfizer and Moderna, an essential step a few leaders in our movement have been working to lay the groundwork for over the last two years. I am also hopeful that this grand jury will compel the state of Florida to release similar data that can be used to assess the safety of these vaccines.

I strongly encourage those of you who who are able to begin looking through the KBV dataset and identifying important trends that can be correlated to other observations we have made over the last two years. I believe there are many excellent articles that could be written on them. I sincerely thank all of you for your continued support!

My primary goal is to draw attention to this data so numerous independent parties can objectively analyze it and independently verify if the trends it shows correlate to “controversial” increases observed in other datasets like VAERS. This data is extremely important as it is the only access we have ever been given to observe the changes in illness that follow the COVID vaccination campaigns. I also suspect the most important use of this data **will be to establish causality for specific vaccine injuries.

**This matters because typically when someone suffers a pharmaceutical injury, it is not acknowledged by the the government and the courts because “there is no evidence the product is associated with that injury,” and as you might expect, the pharmaceutical industry work tirelessly to make sure the evidence that could implicate their product never emerges.

At this point I’ve lost track of how many sad instances I’ve seen where this happened to a medically injured patient (in some cases to the point the gaslighted victim gives up and ends their lives), so I greatly support having an independent means to assess causality for vaccine injuries. Those injured by the COVID-19 vaccines are profoundly suffering and they really need help (on the bright side however, recently Senator Johnson and shortly after Governor DeSantis gave a voice to these victims).

Postscript: It appears a similar rise in unexplained deaths is occurring in Canada.

In this article, I will discuss the observations of unethical and criminal activity that have been repeatedly made by whistleblowers in the pharmaceutical industry. The focus will be on insider disclosures of the toxic corporate culture at Pfizer and the company’s habitual tendency to conduct illegal activity in order to maximize pharmaceutical sales. In many cases, this misconduct has lead to disastrous consequences (e.g., for participants in its experimental trials or for the public at large their drugs were marketed to), and in each case, Pfizer has done everything it can to conceal its illegal activity.

In the first part of this series, I discussed the profound challenges a whistleblower faces when they break the code of silence held by the pharmaceutical industry. Nonetheless, a few people have been willing to make that sacrifice, and there is so much to learn from each of them. If you have not yet read it, I would highly recommend reading it first.

The Forgotten Side of Medicine -- What Can We Learn From the Pfizer Whistleblowers?

Because that code of silence has been in place for decades, the public is relatively unaware of what goes on within the industry. When insiders provide a window into that dark world, it is both shocking and difficult to believe. I had been working on this series for a while and felt that this was the time to release it because it helps create the context for both what Jordan Walker confided to Project Veritas about Pfizer and his surreal breakdown once he realized what he had done.

In this series, I chose to focus on Peter Rost, a pharmaceutical executive who, through a very odd set of circumstances, became a Pfizer Vice President (Pfizer typically never lets outsiders assume that role). Once appointed, he found himself in the very odd position of having to dig up as much dirt on Pfizer as possible to avoid getting fired. Rost witnessed the Pfizer company cruelly abusing his Pharmacia coworkers and to a lesser extent Pfizer’s own employees (detailed in part 1); therefore, he was not opposed to unearthing information that incriminated Pfizer. Best of all, because Rost had been stripped of his work responsibilities, he had plenty of time to investigate his employer.

Rost’s Vendetta

Rost’s talent was recognized by his sales-focused industry, and many of his superiors held him in high regard. Unfortunately for Pfizer, as detailed in part 1, Rost was not comfortable being complicit in criminal activity, so when he encountered it, he would choose to take action against it (thereby putting himself in conflict with the ethos of his industry).

In a previous job, Rost had reported Wyeth (another large pharmaceutical company) for tax evasion, and as fate would have it, that lawsuit became publicized shortly after Rost had managed to put himself in a position where Pfizer could not fire him. Nonetheless, Pfizer did all that they could against Rost, including providing much of the incriminating information they had collected on him to Wyeth.

Due to the previous lawsuit against Wyeth, Rost was able to obtain a copy of all documentation on him that Pfizer and Pharmacia had sent to his previous employer to Wyeth (which began occurring once they were made aware of his lawsuit against Wyeth). From these documents, Rost learned that Pfizer and Pharmacia had hired private investigators to dig up as much dirt as possible on him to prove that he was a security risk, and then they had forwarded these documents to Wyeth:

I had never seen anything like this before and I was truly shocked and appalled. I had gone from company high performer to security threat in a matter of days. This was something I couldn’t have imagined in my wildest dreams. Pharmacia was a company that I had trusted—the fact that I had found illegal marketing and sales methods in my department didn’t mean that I stopped trusting the entire corporation. But now, I felt as if I had been in a beautiful candlelit room, only to have a lightning flash suddenly reveal cracks, mold, and cob- webs. I just couldn't believe what I saw, and even worse, they had sent all this to Wyeth. All the loyalty I had felt to the company, all the respect I had had for executives in the organization vanished. And I was left with the ugly truth: I couldn’t trust anyone. To even try to talk to them and reason with them was futile.

But it got worse. As I flipped through the pages, I found more notes that Pharmacia’s lawyer had written after I had spoken with him. The most sensitive parts were blocked out by a fat black marker, but what remained was astonishing in itself. According to his conclusions, I had no choices; I was out of a job with no likelihood of employment in the industry; I had every incentive to fight Pfizer, and he also claimed that I already hated them. This was news to me: I hardly knew Pfizer, but I certainly was reevaluating what I thought of Pharmacia after reading this. Then came the whopper—the notes implied that I might put a gun to my head so my family could get my life insurance.

All of a sudden I realized what a mistake I had made, trying to get help from a Pharmacia lawyer. I recalled that during our conversation he had suggested for me to contact the Employee Assistance Program. Perhaps this attitude shouldn’t have been surprising; Pharmacia’s lawyer clearly thought that anyone who tried to resolve potential criminal acts within the company and keep his job was a mental case [_Rost also highlighted that a common tactic utilized by the Soviet Union against political dissidents was to diagnose them as being psychotic and then forcefully confine them to asylums_].

Fortunately, Pfizer failed to realize the mess they were in, because they had never dealt with someone who knew how to fight back:

In the next round of documents Pharmacia delivered to Wyeth a few weeks later, I saw Ronald’s reaction first-hand. His first mail to Pharmacia’s chief legal officer asked, “What the heck is this all about?”? Pharmacia responded that I seemed to believe that by not offering me a job, Pfizer was unlawfully retaliating against me. Then Pharmacia’s general counsel wrote, “I haven't done the research, but the theory seems dubious.”

This was very interesting. Pharmacia’s most senior legal officer admitted that he hadn't checked the legal implications of the actions they had taken against me. They clearly didn’t think I was al that important. While this is always a sobering realization, it also showed me how unprepared they were for dealing with an employee who actually knew some of his rights.

In short, a wonderful confluence of circumstances arose, which positioned Rost to do something no one else to my knowledge has ever done.

Digging for Dirt

Since he needed to ensure his job security, Rost decided that the best use of his time at work was to dig up as much dirt on Pfizer as possible:

I went on an info hunt, and it didn’t take long until I found my next surprise. Back in 2001, thirty Nigerian families had sued Pfizer in federal court, saying the company conducted an unethical clinical trial of an antibiotic [as the sole treatment for meningitis] on their children. The suit referred to a letter from the hospital saying the study had been approved by the ethics committee, and the suit claimed that Pfizer had backdated the letter.

Moreover, a Pfizer infectious disease specialist [discussed later in the article] had repeatedly told Pfizer management that the company was violating international law and medical ethics standards. He was subsequently dismissed and later settled with the company, according to other newspaper reports. Clearly, the fact that Pfizer was accused of backdating one letter and that I might have received another one was significant. And so was the fact that they had fired one alleged whistleblower already.

One of the many red flags raised here is Pfizer’s tendency to repeat the same criminal activity (Rost uncovered this series of events shortly after receiving a legal letter which he was almost certain was backdated).

Pfizer’s Employee Survey

Note: The quotations in this section and the next one comprise what is arguably the most important parts of the article.

Given that I didn’t have much to do anymore I had ample time to seek out Pfizer's weaknesses. As I searched the corporate intranet, I found exactly what I needed. Pfizer had done an exhaustive employee survey in 2001, and it was clear from the first page that CEO Hank McKinnell was proud about the fact that 88 percent of Pfizer’s employees had responded. There was lots of wonderful information about what Pfizer employees thought of the company; the highest ranked statement was, “I like working for Pfizer.” A whopping 89 percent of the employees agreed with this sentence.

The second most favorable result was generated by the statement, “I am proud to work for Pfizer,” a full 88 percent agreed with this. Only a contrarian might wonder why 12 percent weren't proud to work at Pfizer, or what those employees might have known about the company. At the time this survey was taken, 12 percent was equivalent to 6,000 employees.

But those weren't the numbers I was interested in. There was a different table in the survey that showed the lowest-ranked statements, and here things started to get interesting. The two most unfavorable ratings were given to the statements, “The right people get promoted,” and “People are promoted for the right reasons.” Only 36 percent and 42 percent agreed with these statements.

Soon I also discovered some data that didn’t rank at the bottom, but still was a major red flag to anyone that cares about corporate ethics. Some 30 percent of Pfizer’s employees, or about 15,000 persons at the time, didn’t agree with the statement, “Senior management demonstrates honest, ethical behavior.” And 34 percent didn’t agree with, “I have confidence and trust in senior management.” But the real surprise was that 49 percent didn’t agree with the statement, “Management is willing to give up short-term gain to do the right thing.” What was going on in Pfizer’s executive suite?

Note: Pfizer subsequently tried to bury these embarrassing results. The 2004 survey removed the embarrassing questions and the 2001 survey was wiped from the server after Rost discovered it. As this article will show, Pfizer has a tendency to make inconvenient documents disappear.

Unprofessional Boundaries

It wasn't hard to make the connection with the rumors I had heard before the acquisition. Pfizer had a stellar public reputation, but what Pharmacia employees had been told by their Pfizer counter- parts was something very different. This was a company managed by a group of people who had grown up together, partied together, and some of them had also allegedly spent time together between the sheets. What we heard was amazing—almost unbelievable.

I set out to find the truth. First I spoke to someone I knew well, an HR manager who had left Pfizer quite recently. He had spent many years working at Pfizer and believed the rumors were true—a group within Pfizer’s management had been in and out of bed with each other for a number of years. In one instance a senior person allegedly dated a direct report while he was married. Soon after, that direct report turned and dated a guy reporting to her. And then this guy dated several women in his department.

The problem with this alleged situation was that it could create tensions if someone thought someone else received a favorable treatment because of sexual favors. Real or imagined, this is a situation that can’t be tolerated by any management, since senior executives need to lead by example and can’t be effective if they aren't respected, which, clearly, certain Pfizer executives were not.

I actually knew someone who had worked with the woman in one of these alleged relationships. We met over lunch and I asked him to confirm if the stories were true. He claimed that not only were the stories true, he had personally observed the woman and her subordinate touch and make loving gestures. He also said that their behavior had been embarrassing to other people who were in the same room as these two.

He explained how they'd had to make special arrangements when the female executive was dating her boss, whenever his wife appeared at corporate functions.

I realized that if any of this were true, it could cause a public meltdown of Pfizer’s management team, much like the recent scandal at Boeing that had forced the CEO’s resignation. I also sensed that if Pfizer knew that I knew, they might just handle me more carefully.

After Rost alerted Pfizer to these issues, he succeeded in further raising their alarm, and their legal team immediately moved to investigate them. In the process, he learned even more about Pfizer’s leadership structure:

Before the meeting ended I repeatedly asked them to hire an independent law firm that could shield the identities of the people who had given me this information. In response, they made it clear that was not “how they operated.” They also discussed, and half laughed, about the impossibility of approaching the managers that were allegedly involved in these affairs. It was clear to me that they didn’t think they could confront members of senior management. I wondered if they would have been so cautious if this had been, for example, a district manager having an affair with a sales rep or someone else further down in the power structure.

More Fraud

In Rost’s continued quest to investigate wrongdoings, he found evidence that executives from Pharmacia’s Japan division had been cooking the books to inflate their sales numbers by reassigning sales from the next year to the previous one, in order to inflate their sales numbers to obtain a bonus. They also paid off wholesalers to go along with them. As he continued to look further into it, he also found evidence that this practice was also occurring in Pharmacia’s European markets.

This deceptive method is known as channel stuffing (“selling” more to the distribution channels than they can sell) and it inevitably unravels itself, since that increase keeps on needing to pull from more and more revenue in subsequent years to sustain itself.

Since channel stuffing constitutes investor fraud (as it provides incorrect data used to determine stock prices), the government will frequently prosecute it. Channel stuffing caused Enron’s downfall (the CEO was criminally sentenced but died shortly before his sentencing). In 2004, another pharmaceutical company, Bristol-Myers Squibb, was fined 150 million dollars for doing this. Similarly, another lawsuit involving channel stuffing eventually resulted in a 750 million dollar fine for ArthroCare, a surgical medical device manufacturer (along with prison sentences for its CEO and CFO).

I believe this prioritization of legal prosecution has developed because the wealthy write our laws, and the government is more incentivized to protect the interests of the rich (as opposed to those of the general public who are harmed by bad drugs). Similarly, my friends in the financial industry have seen that the most truthful information you can ever get from a pharmaceutical company is in its financial reports to investors.

Given the penalties for channel stuffing, this report also was of great concern to Pfizer, and gave Rost even more leverage over them. This was especially the case once Pfizer failed to appropriately address the issues, which in return gave Rost the grounds to open a U.S. Securities and Exchange Commission( SEC) investigation.

Pfizer’s Purgatory

Because Pfizer could not fire Rost, they tried to make things uncomfortable for him. He soon was reduced to having one employee (a secretary), isolated from everyone while at work, and left with nothing to do except show up at his office. They also repeatedly moved his office, until he pointed out that this constituted illegal harassment of a whistleblower. Since Rost was not allowed to do any work for Pfizer, he used that free time to research Pfizer’s internal workings, motivated also by their unconscionable abuse of their employees.

As Rost began bringing more improper and even illegal activity to Pfizer’s attention, he also noted this his emails would disappear, and incriminating documents he’d located would disappear. Eventually, Pfizer cut his access to his email without stating who had done it. Similarly, his communications (email and phone) were constantly monitored (despite this being against company policy), and Pfizer’s operators were instructed to prevent anyone from reaching him over the phone (although a sympathetic employee in the PR department sometimes would put them through).

To evaluate exactly how Pfizer was treating him behind his back, Rost would periodically utilize contacts in the industry to probe their behavior:

I spoke to the recruiter later in the day and I asked her where she had called and what the operator had said. The recruiter told me she had called Pfizer in New York, they had asked what her name was and the reason she wanted to talk to me, as well as some other questions.

“This happens al the time,” she said.

“Does this happen with al the pharmaceutical companies?” I asked.

“No, only with Pfizer. No one else does this.”

I asked her why she thought Pfizer did this, and she responded that based on the questions she had received she thought they recorded the information.

Rost Goes Public

The New England Journal of Medicine (NEJM) is considered to be one of the most prestigious medical journals in the world, and is also a frequent repository for fraudulent studies used to push some of the best selling pharmaceutical products onto the market (e.g., the human papillomavirus (HPV) vaccine or the COVID vaccine). In 2004, four years after her retirement (and a year into Rost’s purgatory), the chief editor of the NEJM, Marcia Angell M.D., published an excellent exposé of the issues within the drug industry, and the medical journals' complicity in this enterprise.

One of the quotes Dr. Angell is best known for is:

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine.”

_Note: More quotes from Dr. Angell can be found here._

On a whim, Rost decided to pen a review on Amazon, strongly endorsing Dr. Angell’s book, and within it openly declared that he was a Pfizer executive (it’s worth reading). This quickly got the attention of a journalist from USA Today who quoted Rost’s review in an article on the subject:

"It's really hard to find new drugs, and it's getting harder and harder," Rost, representing himself, not Pfizer, said in an interview. "There is a lot of low-hanging fruit out there that has been picked off. It is very, very difficult to really find a breakthrough." Instead, Rost says, drugmakers focus on tweaking existing drugs to make money, not to advance science.

_Note: As discussed in the previous article, in recent decades the inability to produce breakthrough drugs has been a major challenge for the industry (most of the new drugs are redundant unneeded “Me-too” drugs). I believe this dearth was a key motivation for why the mRNA technology was pushed through, as there is an almost limitless number of proprietary drugs that could be made with it._

Drug Reimportation

For decades, America has been known for having the worst ratio between healthcare expenditures and healthcare quality in the world (i.e., many places that spend far less than us have much better healthcare outcomes for their populace). Most tragically, this ratio only continues to worsen as we move forward in time (presently about 20% of all spending in the United States goes to healthcare).

Because there is so much money involved, I would argue that the systemic corruption within our healthcare system is almost inevitable. There is the tendency towards monopolization to protect its industry from competition In turn, the debacle we’ve witnessed throughout COVID-19 represented the inevitable progression of this industry’s greed.

It should, thus, come as no surprise that the drug industry charges as much for medications as it believes it can get away with. The cost of the same drugs varies widely from country to country, and as you might guess, the worst price-gouging occurs within the United States. Many people who struggle to afford their medications in the U.S. have noticed that these medications are much cheaper on the other side of the U.S. border (e.g., a Canadian pharmacy).

This observation has given rise to the practice of “drug reimportation” where drugs made in the United States that were exported for sale are bought in the international market and then imported back to the United States, and sold for a much lower price than they typically cost domestically. If you believe in capitalism and the free-market, drug reimportation should be allowed to correct market imbalances created by price gouging. However, if your business goal is to maintain a monopoly (and pay off the government to enforce it), drug reimportation is a huge problem, as it cuts into a lot of the profits made by ripping off the American public.

At this point, I have watched decades of failed attempts to reform the out-of-control costs in the healthcare system. In each case, because the legislators responsible for writing those laws (in one way or another) are bought out, no one was willing to tackle the real sources of price gouging in our healthcare marketplace, and each of those attempts failed. I would argue that this is why healthcare spending continues to rise in the United States.

As luck would have it for Rost, at the time he penned his review, the hot political issue was allowing drug reimportation (which the pharmaceutical was trying to torpedo by arguing that it somehow threatened consumer safety). Since Rost was a pharmaceutical executive willing to speak out against these practices (something virtually unheard of due to the consequences of doing so), and he knew a lot about the subject (e.g., Europe had had no issues with drug reimportation), he rapidly attracted the attention of the press and politicians who were trying to advance this issue.

I have to admit that my lawyer was not happy about al this. His job was to protect my legal case, which he told me was excellent. The fact that I was speaking up made me vulnerable and could have ruined the whole case. He was surely right that I took a big risk, but I felt that it was more important that I got the message out. And after a few months, Jon even said that I was doing a pretty good job. “Who knows,” he admitted. “You might actually achieve some change.”

Before long, Rost was called before congress to testify on the reimported drug issue. This was a nightmare for Pfizer (as their business depended upon inflated American drug prices), and in their panic, Pfizer managed to make things even worse for themselves through their crude attempts to discredit Rost and prevent him from communicating with the public. Before long, Rost’s message was heard throughout America.

But journalists and news anchors were still very surprised that I didn’t get fired [Rost could not publicly disclose his whistleblower status at the time]. It was as if everyone had forgotten that we live in a democracy with freedom of speech and other basic rights.

The biggest surprise, however, wasn't the flood of e-mails, or that many employees were upset about what I had said. The biggest surprise was that so many actually agreed with my comments. In fact, about 40 percent of the e-mails I received were supportive. I imagine it took a lot more guts to write a positive e-mail than to send a critical message and copy a superior. In truth, I wished my supporters hadn’t written, since I assumed that Pfizer was reading my e-mail.

Even a retiree wrote and agreed with me, “I applaud your efforts to encourage a more constructive approach to pharmaceutical importation. As a recent retiree from Pfizer, I am worried that by being short- sighted, Pfizer is doing something that is not its own best interest.”

_Note: Alex Berenson who wrote for the New York Times when Rost went public played a critical role in bringing Rost’s story to America. I suspect one of the reasons Berenson later became a critic of the COVID-19 response was because his career began in a bygone era when liberal journalists could still criticize the pharmaceutical industry and Bernson made a point to do just that during his time at the NYT._

Ultimately, Rost became too hot for anyone at Pfizer to handle, eventually leading to a situation where:

I never heard from either one of them [his assigned supervisors] again. To the best of my knowledge, I became the only Pfizer employee without a boss.

Pfizer nonetheless continued to harass Rost (e.g., they sent lawyers to monitor him at presentations he gave), while Rost continued to find creative ways to cause headaches for Pfizer (many are detailed within his book). One of the most impressive results he achieved was a group of doctors (unhappy with how Pfizer was treating Rost) independently deciding to ban Pfizer sales reps from their practices.

Pfizer is a very sales-oriented company and these events shook them up. Their worst nightmare would be a national boycott of their products.

What Happened with Drug Reimportation?

Although Rost was able to make the issue of drug reimportation a nationwide issue, it ultimately failed to be legalized because the “safety concerns could not be addressed.” While this result was expected, there were three interesting things I took away from all of it.

The first was how the issue was squashed (this should sound familiar to all of you):

By the end of December 2004, the Department of Health and Human Services came out with their report on drug importation. The report admitted that it would be possible to safely import drugs on a large scale, but claimed that establishing such a system wouldn't be cost effective.' The report also concluded that such a system would harm pharmaceutical companies’ research and development efforts.

The report was required by the new Medicare law, and had been developed by a thirteen-member panel led by U.S. Surgeon General Richard Carmona. Not surprisingly, the panel consisted of many rep- resentatives from several government agencies that oppose prescrip- tion drug reimportation.

They [and later Pfizer] used a study by the London School of Economics, which claimed that national health systems within the EU realized minimal savings from parallel- traded products. There was just one thing both the HHS report and the Pfizer letter forgot to mention. This “study” had been funded by the drug industry.

The second was the FDA’s promises to develop a “safe” way to import and reimport pharmaceuticals which two decades later still has not happened.

The final one was that some congressmen who had supported Rost at the time were still in the government twenty years later (e.g., Bernie Sanders), at which point, they chose to switch sides and stand behind Pfizer and their COVID-19 vaccine. Somewhat analogously, although many of my friends love Bernie Sanders, I have always been suspicious of him, because I know of cases where parents of vaccine-injured children tried to raise this issue with him and he shut them down instead of listening (Sanders has built a reputation as an advocate for disenfranchised groups that no one else will listen to).

Other Whistleblowers

John Virapen

The only other whistleblower I know of who was a pharmaceutical executive was John Virapen, so I will include him even though he was not involved with Pfizer. Virapen began life as a colonial subject of the British Empire (which translated to a childhood of abuse, discrimination, and poverty), in British Guyana, and eventually became a pharmaceutical sales rep. He excelled at what he was doing and eventually became an Eli Lilly executive in Sweden, who played the pivotal role in getting Prozac approved globally. Like Rost, he was backstabbed by the industry. Specifically, Eli Lilly fired Virapen after he won the approval, something he believed was due to Eli Lilly, like Pfizer being an old boys’ network that did not want an outsider of color like him in the management (Rost’s story likewise shows a similar old boys’ network existing at Pfizer).

Virapen experienced a great deal of guilt for what he was complicit in, and like Rost after he was fired, found himself in circumstances where he could speak out against the industry. In his memoir, he shared the routine criminal activity he engaged in (e.g., he had to make bribes to get Prozac approved in Sweden). He resorted to blackmail, such as photographing physicians with Eli-Lilly-provided prostitutes, to pressure them to conform to Eli Lilly’s sales requirements.

Note: a more detailed version of Virapen’s story can be found here. If Youtube pulls the above video, it can also be found here.

Dr. Juan Walterspiel

Although to my knowledge, no other executive has come forward, the pharmaceutical industry has many other whistleblowers including former Pfizer employees. For example, in the previously mentioned illegal Pfizer experiment in Nigeria, 11 of the 200 children with meningitis who were studied died [most of whom should not have with proper care], and later the highly toxic antibiotic they tested was subsequently pulled from the market.

One of the doctors at Pfizer’s research center tried to warn them about the trial but was ignored and eventually fired despite being a whistleblower (all of the events and the whistleblower lawsuit are summarized here and here). In addition to the trial being conducted in a reprehensible way (and was thought to have inspired the Constant Gardener), evidence also emerged that Pfizer bribed the Nigerian government to conduct the trial, and falsified documentation to appease the regulatory authorities.

John Kopchinski

Pfizer is also notorious for being greedy enough with their sales practices to be repeatedly fined for their criminal conduct (sadly this is not a complete list of Pfizer’s criminal settlements):

The 2.3 billion dollar settlement was for Bextra. Bextra was Pfizer’s version of Vioxx, and, like Vioxx, was aggressively promoted for off-label uses, and eventually was pulled from the market for causing too many fatal heart attacks and strokes (Bextra was pulled in 2005, Vioxx in 2004).

The whistleblower who helped initiate the lawsuit, John Kopchinski, was a sales rep who was recruited by Pfizer’s CEO during his early 1990s acquisition of veterans. In early 2003, Kopchinski raised concerns over Bextra, and instead of being listened to, was summarily dismissed from the company and left jobless. A few excerpts from his story mirror the experiences of many other Pfizer whistleblowers:

“Particularly in pharma, it’s no secret that it’s an industry that can blackball former employees,” Kelton [Kopchinski’s attorney] said, “so the reward is important both to encourage people to step forward and to recognize that their contributions are huge.”

[Less than a year after being hired by Pfizer], Kopchinski was selling the epilepsy drug Neurontin when a previous whistleblower’s suit was unveiled against [Pfizer] over similar illegal promotion tactics that led to stiff penalties and a form of corporate probation [Pfizer has been repeatedly forced to sign a corporate integrity agreements with the U.S. government].

At the time, [Kopchinski] was told by managers that the Neurontin suit would be in the news and any physicians who asked questions should be told it was just complaints from a disgruntled former employee, Kopchinski said. Ironically, after filing the Bextra suit, “I was the disgruntled former employee,” he said. [

In both the Bextra case (detailed here) and the Neurontin case (detailed here), Pfizer followed a fairly similar pattern. They aggressively pushed their sales reps to prescribe as many drugs as possible (and provided bonuses for doing so), and they used an elaborate scheme of bribes to incentivize doctors to prescribe these drugs. Most of the uses Pfizer made up for the drugs had nothing to do with the drug’s intended use, and in many cases, these reckless uses were quite dangerous to patients.

Note: Another drug in the same class as Bextra, Celebrex, was also aggressively promoted by Pfizer (and sold by reps like James Reidy). Instead of being pulled from the market, it received a black box warning from the FDA. Later in 2016, Pfizer was forced to pay 406 million dollars to shareholders because of the losses they incurred from Pfizer concealing the harms of Bextra and Celebrex.

Jamie Reidy

Most of the pharmaceutical employees who worked on the retail end of the business have come forward with similar stories of their sales culture. The below video, although not from Pfizer, gives one of my favorite windows into this world (I hope you liked the ending I added to it):

This circa 2000 clip shows how Pharma sales reps are trained behind the scenes. Like Pfizer, GSK aggressively and illegally promotes drugs (like this one) and has received billions in fines. I can't even imagine how much wilder the industry has become since this was filmed.

Jamie Reidy was one of the many veterans picked up in Pfizer’s recruitment drive for ex-military in the early 1990s, and his story mirrored what other former Pfizer representatives have told me—they were an ideal demographic because Pfizer wanted a pool of candidates who would follow corporate’s sales scripts and not deviate from them. Reidy eventually published his experiences within a comical memoir released while Rost was making waves in the national press (Rost likewise helped Reidy on the national PR front). Reidy’s self-deprecating memoir was later adapted into a popular romantic comedy, Love and Other Drugs, so his story is one of the better-known peeks inside Pfizer (it also resulted in him immediately being fired by the new pharmaceutical company employing him).

Since Pfizer established their dominance in the market through the success of their sales division, I was quite interested to hear Reidy’s perspective on the the nuts and bolts of the operation.

Pfizer being Pfizer, however, it didn’t have to resort to trolling college campuses; Pfizer could pick and choose its sales force from candidates who got their start at other companies.

Pfizer’s approach was built around utilizing algorithms their marketing research team had developed, which identified the most effective scripts for each stage of the sales process (from opening the encounter through closing the deal). Pfizer essentially practiced evidence-based sales and had the results to validate their model. Many of these scripts are quite interesting to read through. Each illustrates how each pharmaceutical company would twist the data to support their drug, and how much of a doctor’s education and comprehension of the drugs they prescribed resulted from what the sales reps primed them to focus on (note: so much of human behavior is explained by what people have been primed to focus on).

Pfizer’s model thus required inspiring zealotry and standardization in its salesforce (as Rost detailed in the first half of this series, Pfizer reps were well known for this tactic):

From Day One, people told us how great we were. “Pat yourselves on the back,” our first speaker said, “because you are the cream of the crop.” I had already noticed that our class did not lack confidence, and the knowing grins on people’s faces confirmed my perception.

“Any drug rep from any company will tell you that he left initial training thinking that his drugs were the best in the industry, such was the power of pharmaceutical brainwashing [I wonder if this also applies to Jordan Walker’s department]. Pfizer reps departed training with a “Pass me the Kool-Aid” conviction that not “only were our drugs the best in the industry, but also that our company was the best in the world. Doctors and competing reps alike routinely commented on a “Pfizer attitude,” a tangible vibe suggesting we were intrinsically better than any other salespeople. Interestingly, army trainees emerge from boot camp with a similar sense of indestructibility, an unshakable belief that there could not be a more prepared soldier on earth. The key to creating this self-confidence [bravado] in both arenas was the same: an endless repetition of messages and tasks [Note: Pfizer would also frequently tell reps in service about how wonderful Pfizer was].”

“The brainwashing was not limited to our view of ourselves, however. Rather, the Pfizer training staff instilled within us indelibly negative impressions of our competitors, creating a hatred for people we had yet to compete against, let alone meet”

“They lied. They cheated. Their women dressed slutty. They bought physicians’ love with extravagant dinners and golf at Pebble Beach, instead of earning it through ethical practices. (I later learned that every company told its reps that they did things the “right way,” while the other companies cheated.) ”

Although Pfizer had been repeatedly fined for criminal sales activity, I didn’t see anything within Reidy’s memoir that was clearly illegal. Much to the disdain of the sales reps, although headquarters was always pushing the reps to sell more, headquarters was also shutting down any plan reps implemented which was potentially illegal (bribes to prescribe or promoting a drug for uses it was not approved for—known as off-label marketing).

The only cases I found in his book where the sales reps employed external incentives to influence a physician to prescribe their drug was through utilizing their sex appeal (and sometimes seducing either the physician or their staff). However, unlike monetary bribes, this is nearly impossible to outlaw so it has never been made illegal.

At the time Viagra came out, because no reasonable treatments for erectile dysfunction existed, everyone was clamoring for it (to the point that Viagra samples were regularly stolen). Not surprisingly, it was soon sought out by individuals beyond those it had been approved for (old men with poor circulation impeding erections). As a result, some off-label marketing to women and younger men for increased sexual performance did eventually occur (even though Pfizer at the start told its reps not to do this, because the accelerated approval of the then-novel drug put them in a precarious position with the FDA).

In summary, I do not believe Reidy provided any concrete proof of illegal activity within Pfizer, so he is not technically a whistleblower. However, he did provide an invaluable window into the corporate culture of Pfizer which also helps put their behavior into context.

Note: Ever since its approval, a variety of side effects (including heart attacks, strokes, blindness, hearing loss, or melanoma) have been attributed to Viagra. As Reidy detailed, many of these were known from the start by Pfizer. Many lawsuits have been thus filed for these injuries. Unfortunately, the legal system rarely supports these types of lawsuits, so Pfizer (along with subsequent manufacturers of similar drugs) have been able to dodge most of them and settle the rest.

Allen Jones

I mention this story last because it is potentially the most important one in this series (and resulted in him being named whistleblower of the year in 2012). Jones initially worked at Pennsylvania’s Office of the Inspector General (PA’s OIG) for 5 years (1986-1991), retired to be closer to his family, and then returned 11 years later in 2002, once his situation changed.

When he returned, he was assigned to investigate PA’s chief pharmacist, who Jones found was managing an unregistered bank account into which Johnson and Johnson (J&J) was essentially depositing illegal bribes. Additionally, some of that money was then transferred to the Director of Texas’s Department of Mental Health and Mental Retardation. In return for these funds, state officials traveled across the country to promote switching large numbers of patients to J&J’s new antipsychotic medication (which cost ten times as much as other similar drugs, and frequently created significant side effects).

Jones reported the case to his boss, and was told to drop the case as it was “too political” to touch. Since Jones did not comply, he was taken off the case. Then in 2003, he found out that J&J’s bribery lobbying was successful and everyone in PA would soon be switched to J&J’s drugs, regardless of their medical needs or background. Given that many of the people subject to this edict cannot oppose it (e.g., prisoners with mental illnesses or the many children who are pushed into the state mental health system), there were significant ethical issues with allowing it to proceed, which led to Jones deciding to risk his livelihood to stop it.

Note: I know a few people in foster care who were forcefully medicated with psychiatric drugs and had terrible experiences from them. To appreciate the full human cost of this greedy industry’s initiative to push their dangerous anti-psychotics on children, please read this article.

Jones filed a first amendment suit to protect himself, reported what was happening to the New York Times, and then was fired. Jones then filed suit against PA and set off a series of lawsuits (some of which were pursued by state Attorney Generals) and J&J ultimately had to pay billions of dollars in fines for their conduct. PA’s state Pharmacist was also convicted, but I feel his ultimate punishment was relatively minor. His conviction, however, is important to the current story because he was convicted of taking bribes from J&J and Pfizer.

Like Pfizer and J&J, AstraZeneca has also been fined billions for off-label-marketing, bribing physicians to prescribe their drugs, and was involved in the initiative to bribe state officials to push these medications on mental health patients. This bribery was not exclusive to the United States either; these three companies are currently being tried in court for bribing terrorists within the Iraqi government to coerce their Ministry of Health into using their products, and a few years ago, AstraZeneca was fined for bribing state health care providers in Russia and China to push their products.I hold the opinion that once the corruption of this industry is understood (which will probably always exist because of how much money there is to be made in medicine), the best path forward is to prohibit mandating of their products. If a product is safe and effective, it will sell itself and does not need to be forced on people.Unfortunately, the systemic fraud within this industry regularly brings bad pharmaceuticals to market that are neither safe nor effective.

As the examples with the state psychiatric programs show, this is a longstanding issue. It is my hope that bringing the public’s attention to the unjustifiable COVID-19 vaccine mandates can help bring about critical changes for medical autonomy that are needed throughout medicine.

Note: Since Moderna is a much newer company, an equivalent track record does not exist for them. I also believe this accounts for why they had a much less elaborate system in place to gaslight the participants in their clinical trials compared to the other COVID-19 vaccine manufacturers.

Conclusion

Pfizer eventually got fed up with Rost humiliating them on national television. He was fired and entered a protracted legal battle with Pfizer that eventually concluded in 2013 with an undisclosed settlement. At the time this happened, Pfizer made a point to widely publicize his termination in the national media. In Rost’s own words:

There is no question in my mind that Pfizer's [illegal] termination of whistleblowers [highlighted through this article] sends chilling signals to honest employees within the company. The media campaign they unleashed when they fired me served the same purpose. Pfizer’s outrage was apparent.

I hope that this article has made the case that Pfizer has a culture of corruption and a sociopathic leadership that has absolutely no problem with harming people or breaking the law to drive up sales. Assuming you accept that premise, I would argue that that means Pfizer was probably the worst party that could have been given a blank check by the government for the purpose of forcing an extremely dangerous experimental vaccine gene therapy onto the American people. Just think—if Pfizer already was that bad with government oversight--how bad do you think they would be once the government actively conspired to conceal their criminal activity and the harms of their product?

Similarly, if we consider the plight of many of the recent whistleblowers like Brook, the degree to which the government has chosen to ignore their claims is truly incredible. Similarly, nine months ago I covered an investigation by one of the less corrupt agencies of the government into HHS’s COVID-19 response, where they essentially concluded corruption trumped sound scientific policy (because employees in each department confided this in private interviews).

One of the most interesting things I discovered in it was just how hostile the U.S. Health and Human Services department (HHS,e.g., the CDC, NIH, and FDA) was to whistleblowers. None of the typically required safeguards existed to support employees blowing the whistle, and when queried, officials in each department could not cite a specific reason for why they had never gotten around to creating those safeguards.

Additionally, most of the employees felt that their leadership was already aware of the issues (and to some extent complicit in them), and they feared retaliation if they complained. Not surprisingly, between 2010-2021, there were zero cases where misconduct was officially reported by an employee of the HHS, and when asked, officials in each department interpreted this as a sign that no problems requiring reporting existed.

Sadly, corruption is not unique to the pharmaceutical industry, and many of the experiences shared by the brave whistleblowers in this series are mirrored by those outside of the medical industry. As you might expect, Pfizer and many of the other pharmaceutical companies involved in the COVID-19 vaccines (along with many defense contractors and other members of the medical industrial complex), have lobbied aggressively to restrict the ability of whistleblowers to uncover and correct their misdeeds. For example, consider what they did at the end of 2021, a year after their vaccines had entered the market.

As I look at how things have transpired decade by decade, it never ceases to amaze me how much more corrupt our government (and media) have become in a relatively short period of time. At the same time though, I believe Team Humanity still wins, because the internet has made it impossible to prevent the general public from becoming aware of these misdeeds.

As I end this series, I would like to share one of Rost’s concluding remarks which, like many other things he has shared, is just as true now as it was twenty years ago:

I didn’t always think this way. I didn’t want to become a whistleblower. I didn’t want to write this book. But in the end, I had to; I just couldn’t let the crooks win. The fact that you have just read this book means—to me—that I have won my fight against an overpowering opponent.

I for one, decades later, am profoundly grateful for the odd quirks of fate that led Rost to speak out against Pfizer.

I hope this article has provided some valuable context to fully appreciate Jordan Walker’s previous remarks to Project Veritas and his new ones today:

“If something were to happen downstream and it was, like, really bad? I mean, the scale of that scandal would be enormous.”

What goes on inside Pfizer and the pharmaceutical industry is surreal, and I hope the window opened for you by these whistleblowers will allow you to draw your own conclusions about Pfizer’s culture and what really goes on behind the scenes. I admit I avoided discussing much of what jumped out to me from their testimonies (and those of whistleblowers from other pharmaceutical companies) since this series was already pushing the limit of how much people will read.

I thank each of you for the time you took to read this article and those who shared the series with the audience that needed to hear it.

Postscript: I meant to include this but completely forgot to. One of my colleagues occasionally saw a patient who was a vaccine sales rep for Pfizer that would actively boast about how often their entire family was vaccinated. In the middle of the vaccine roll-out, that patient showed up asking for a medical exemption from their vaccine.

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 following book represents an extraordinary historical achievement in the reporting of events in science and medicine.

It also appears to be a record of a great crime against humanity.

In 2022, the Pfizer documents, a tranche of 55,000 documents, many of them thousands of pages long, were released via a court order. This was due to a successful lawsuit by attorney Aaron Siri. The US Food and Drug Administration had asked the court to keep these documents hidden for 75 years — until after most of us alive now would be dead and gone.

Luckily, the court did not concur.

We at DailyClout.io, a website devoted to civic transparency, realized that the raw documents were impossible to cover in normal journalistic ways. One reason was the massive scope of the documentation. But another reason was that the documents are written for scientists and medical researchers, in language that only specialists in those fields could really understand properly or explain.

We sent out a call for expert volunteers from those fields on our own platforms, and we did so also on the video and podcast platform, War Room Pandemic, hosted by Stephen K. Bannon. A global audience thus recognized how important it was for an informed public — who had been harried, bullied, and “mandated” to receive Pfizer’s and Moderna’s mRNA injections in 2021-2022 — to understand what was really revealed inside of the Pfizer documents.

As a result of our calls for expert help, we received 2000, then 2500, and finally 3500 responses from volunteers, many of whom are experts in their fields. Biostatisticians, lab clinicians, pathologists, anesthesiologists, sports medicine physicians, cardiologists, research scientists, RNs, and many other related disciplines are represented among these decent, highly-skilled people who offered to read through these difficult, technical documents — pro bono, as a service to humanity (and out of respect as well, in many cases, for their own lifelong commitment to real science, real medicine, and truth in general). Many of them were not only published, peer-reviewed academic authors in their fields, but some were peer reviewers themselves. There was no way, with a group this distinguished in science and medicine doing the labor, that the interpretation of these documents could be dismissed as “fringe,” subjective, or as the work of “conspiracy theorists.”

Of course, managing a project in which 3500 highly trained specialists from all over the world work together virtually on unpacking and reporting on such a massive trove of material, would have been impossible for mere mortals.

At first, indeed, we did not know how to organize the thousands of specialists who offered their help.

Enter Amy Kelly, who is also a heroine of this story. She is a talented project manager, and now DailyClout’s COO; and she has a distinguished background in complex organizational projects in various fields.

Ms. Kelly managed, seemingly effortlessly, to organize the volunteers into six working teams, with subcommittees of expert readers. Under her extraordinary leadership, the thousands of specialists around the globe started to communicate with one another, share their findings, and draft their reports. I trained the volunteers in writing for a general audience, and I also trained our DailyClout editors in editing what was often dense medical language, but with extremely important findings, into accessible reports that anyone with any level of education could follow and understand.

For all of us, but mostly for the volunteers and Ms. Kelly, the next year represented a Herculean effort to turn this material, that one of the most powerful companies in the world trusted would never be made public, into fifty readable reports sharing the most urgent headlines of all — the reports that are now in your hands.

You will see that the 46 reports document what may be a massive crime against humanity. You will see that Pfizer knew, as it appears, that the mRNA vaccines did not work. You will see that the ingredients, including lipid nanoparticles, in the mRNA injections bio-distributed throughout the body in a couple of days, accumulating in the liver, adrenals, spleen — and ovaries. You will see that Pfizer and the FDA knew that the injections damaged the hearts of minors — and yet waited months to inform the public. You will see that Pfizer sought to hire over a thousand new staffers simply to manage the flood of “adverse events” reports that they were receiving and that they anticipated receiving. You will see that 61 people died of stroke — half of the stroke adverse events being within a couple of days after injection — and that five people died of liver damage with, again, many of the liver damage adverse events sustained shortly after the injection. You will see neurological events, cardiac events, strokes, brain hemorrhages, and blood clots, lung clots and leg clots at massive scale. You will see that headaches, joint pain, and muscle pain are rampant as adverse events, though these are not disclosed as routine side effect warnings by our agencies.

Most seriously of all, you will see a 360-degree attack on human reproductive capability: with harms to sperm count, testes, sperm motility; harms to ovaries, menstrual cycles, placentas; you will see that over 80 per cent of the pregnancies in one section of the Pfizer documents ended in spontaneous abortion or miscarriage. You will see that 72 per cent of the adverse events in one section of the documents were in women, and that 16 percent of those were “reproductive disorders,” in Pfizer’s own words. You will see a dozen or more names for the ruination of the menstrual cycles of women and teenage girls. You will see that Pfizer defined “exposure” to the mRNA vaccine as including skin contact, inhalation and sexual contact, especially at the point of conception.

History has not yet concluded its assessment of what Pfizer — and the FDA, who were in custody of all of these documents — has done. We are at the very start of that assessment.

But to me it is clear that the following documents, written by impeccably skilled experts, and linked to primary sources, show that a crime has likely been committed against humanity that is unprecedented in its scale.

We owe the War Room/DailyClout Pfizer Documents Research Volunteers — some named, most of them unnamed — who labored for a year, and do so to this day, and for nothing more than the privilege of serving humanity, science, medicine and the actual truth — a tremendous debt. We thank Mr. Bannon and his team for so often supporting our call for experts and for helping us to announce the results in real time, as the reports came in. We thank all of the other news outlets, of all kinds, who risked reprisals from Big Pharma or even from the government — which recent lawsuits have shown allied with Big Pharma — who have also showcased the work of the Volunteers, in an effort truly to inform their viewers.

Please share this document with your loved ones if you also find it to be important.

Everyone by law deserves informed consent when it comes to medical interventions — it is actually a crime to withhold it (really many crimes appear to be represented here, but history will sort that out as well).

It has been a privilege to report on this team’s work, and to do all I can as CEO of DailyClout, to help sustain their, and the remarkable Ms. Kelly’s, work on humanity’s behalf.

Sincerely,

Dr. Naomi Wolf
CEO, DailyClout.io
March 21, 2023
Salem, Massachusetts

An anonymous tip from December of 2020 aged exceptionally well, with bad repercussions for the female fertility in girls born to both Covid-19 vaccinee parents.

Although it has been reported on by Igor Chudov a few days ago, I would like to add a bit more beef to this uncorroborated (so far) information, as it is the news no one wants to believe, but it deserves further investigation for the reasons outlined below.

The original Moderna insider tip from Dec. 2020, from two anonymous engineers working there, goes like this:

I'm an industrial engineer at Moderna and the other one of us is a process development engineer. I'm sure the same thing is happening with Pfizer-BioNTech. It was hard to put things together based on the small quantities of additions happening in manual step (highly unorthodox for a continuous process production). The explanation we got was highly sensitive trade secret adjuvants being added. Digging in deeper showed how sensitive it actually was. Most people's understanding of this novel vaccine type is that it works as follows:`

1. Make mRNA coding for S protein
2. Make lipid nanoparticle delivery system
3. Profit

How it actually works from what we've uncovered:

1. Make mRNA coding for S protein
2. Make mRNA coding for mutant versions of CYP19A1 and CDKN1B in smaller amounts
3. Make sure that while delivery system for (1) mostly ends up in liver, most of (2) ends up in the gonads
4. Make sure form and quantity of additive upregulating LINE-1 reverse transcription activity makes it hard to detect among legit adjuvants
5. Effects from (2) integrated by (4) are recessive; mildly oncogenic effects in vaccine recipients unlikely to be noticed for many years
6. (5) recessive but since most of population vaccinated, in next generation female offspring have premature ovarian failure

The beef of this tip is that, in addition to the mRNA code for S spike, the vaccine vials will contain additional mRNA that codes both for a mutant version of CYP19A1 and a mutant version of CDKN1B. Both these mutant proteins are implicated in the female infertility issues. From the advantage of hindsight in March 2022, this information is credible for the following reasons:

• The pharmacokinetics information of the LNPs in mRNA vaccines has been spilled by the Japanese only in May 2021. As it turned out, the LNPs with the mRNA in them do not stay at the injection site, as CDC and other agencies postulated. Instead, they accumulate in the liver and the gonads of the vaccinees in high concentrations. Surprise! So, the tipsters have been confirmed correct in this regard.

• The studies regarding LINE-1 enzymes being able to reverse transcribe the vaccine mRNA back into human DNA appeared much later as well:

  1. Reverse-transcribed SARS-CoV-2 RNA can integrate into the genome of cultured human cells and can be expressed in patient-derived tissues ( Jaenisch et al., 2021.05.21)
  2. Coronavirus gene findings are no cause for alarm, says leading scientist (ABS-CBN, 2021.01.30): The discovery by Professor Rudolf Jaenisch and researchers at the Massachusetts Institute of Technology, stirs up a hornet's nest because mRNA vaccines, including those made by Pfizer/ BioNTech and Moderna, operate in similar ways to the virus to trigger an immune response.
  3. Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line (Aldn et al., 2022.02.25).
  4. Moderna finally cracks into gene editing with Metagenomi pact thanks to 'irresistible' data (Fierce Biotech, 2021.11.02): We finally know who Moderna has been courting behind the scenes to make the big jump into gene editing. The famed biotech has signed a research partnership with CRISPR gene editing company Metagenomi. Metagenomi will offer up access to its gene editing tools. The company recent unveiled data on its CRISPR-associated transposases system that can be used to "precisely integrate large DNA fragments into genomes", allowing for new editing techniques beyond the currently available technology.
  5. Metagenomi Presents New Findings on CRISPR-associated Transposases (CAST) that Allow for Targetable Genomic Integration of Large DNA Fragments (Metagenomi.co, 2021.05.14): Our research presented at ASGCT describes how our first-in-class programmable CAST gene editing system can be used to precisely integrate large fragments of DNA into target genomes and the potential of these systems in the development of both ex vivo and in vivo gene therapies. CRISPR-associated transposases can be reprogrammed to integrate at specific genomic sites using guide RNAs. Target genomes, eh? Transhumans, anyone? A.k.a. mutants?

  Another solid confirmation that the tipsters knew what they were talking about way before this information went public.

• As the reader Jeff C pointed out (and I quote verbatim from here on), the tipsters not only said that LINE-1 could facilitate reverse transcription but that the vaxx has a hidden additive that specifically upregulates LINE-1 (point #4)). The Aldn et al. paper using the BioNTech vaxx clearly showed a high presence of LINE-1 when the vaxx was added that was not there in the control. So something about the vaxx significantly increases LINE-1 just like the tipster said. The fact that the tipster knew this before any of this was publicly known is pretty impressive. If you look back at the Covid virus reverse transcription study (Jaenisch et al - looked at Covid itself, not the vaxx) they artificially increased LINE-1 in the cells via transfection [To increase the likelihood of detecting rare integration events, we transfected HEK293T cells with LINE1 expression plasmids prior to infection with SARS-CoV-2]. That was a key criticism of the study in that it wasn't a real world case. This is in stark contrast to the vaxx study where LINE-1 increased solely due to the vaxx itself. Wasn't that the role of one of the "highly sensitive trade secret adjuvants being added", as hinted by the tipster?

• In Oct. 2021, a former Pfizer quality control manager and a whistleblower, Melissa Strickler, spilled beans on the unusual manufacturing process at the Pfizer Covid-19 vaccine plant in a series of interviews. Pfizer's processes for its vaccine are strangely deviating from usual norms. The compounding room has no idea what are the components they are mixing into the product. This secrecy about what goes into the vials is unprecedented. Furthermore, the vaccine manufacturers are not controlled by any independent bodies as to the quality control, the vials being shipped directly to the vaccine administration locations. This lends credence to the assertion that the mRNA vaccines may contain undisclosed constituents.

• The leak of EMA-Pfizer correspondence in Nov.-Dec. 2020, when EMA was working on Pfizer's vaccine authorization, revealed that EMA was concerned that the mRNA in the vaccine vials contains only 55% of the intended S spike code, the rest being truncated species blamed on the faults in the manufacturing process. Pfizer placated these concerns by pushing the S spike code proportion up to 75%, at least for the time being. After that, EMA stopped looking and declared the jabs kosher. More on this in my post Zeroing in on Gifts from Science to Humanity from Nov. 2021. So, another score for the tipsters - the jabs do contain some exogenous mRNA code that no one analyses or scrutinizes.

• If that is not enough, BigPharma, in collaboration with WHO and NIH, has a long tradition of adding undisclosed ingredients harming female fertility into the vaccines going all the way back to 1970s:

2017: HCG Found in WHO Tetanus Vaccine in Kenya Raises Concern in the Developing World. Baby-Killing Vaccine: Is It Being Stealth Tested?: During the early 1990s, the World Health Organization (WHO) has been overseeing massive vaccination campaigns against tetanus in a number of countries, among them Nicaragua, Mexico, and the Philippines. In October 1994, Human Life International (HLI) received a communication from its Mexican affiliate, the Comite Pro Vida de Mexico, regarding that country's anti-tetanus campaign. Suspicious of the campaign protocols, the Comite obtained several vials of the vaccine and had them analyzed by chemists. Some of the vials were found to contain human chorionic gonadotrophin (hCG), a naturally occurring hormone essential for maintaining a pregnancy. Here are the known facts concerning the tetanus vaccination campaigns in Mexico and the Philippines:

• Only women are vaccinated, and only the women between the ages of 15 and 45. (In Nicaragua the age range was 12-49).
• Human chorionic gonadotrophin (hCG) hormone has been found in the vaccines.
• The vaccination protocols call for multiple injections-three within three months and a total of five altogether. But, since tetanus vaccinations provide protection for ten years or more, why are multiple inoculations called for?

Allied with the WHO in the development of an anti-fertility vaccine (AFV) using hCG with tetanus and other carriers have been UNFPA, the UN Development Programme (UNDP), the World Bank, the Population Council, the Rockefeller Foundation, the All India Institute of Medical Sciences, and a number of universities, including Uppsala, Helsinki, and Ohio State.[5] The U.S. National Institute of Child Health and Human Development (part of NIH) was the supplier of the hCG hormone in some of the AFV experiments.

Again, a corroboration of the thrust of the allegations by the Moderna insiders.

• The strange, irrational drive to vaccinate every last person on Earth, especially children and pregrant women, with the untested and clearly dangerous injections is another huge red flag as to the true goals of the Covid-19 vaccination of the world population. Especially that the population control has been a holy grail for the eugenicist cabal since the 19th century, and in the form of vaccines, no less. Read my post Going for Jugular Take 2 - All Ducks in Row (Dec. 2021) for complete, more or less, disclosure.

• The new plant-based Canada-made non-mRNA vaccine still contains LNP material, for some inexplicable reason. Or should we suspect that it will also contain fertility-harming mRNA?

So, lots of indirect evidence that the Moderna insiders are trustworthy and that their whistle blowing deserves all the attention it can garner. In the form of vial analysis and vaccinee testing, for starters.

In the meantime, this post should serve as a fair warning and one of the elements on which to base your informed decision as to whether to accept any vaccine in 2022 and going onward. Or any injection, for that matter, from your caring health authorities and governments.

Continued in How Will We Know?

The COVID-19 pandemic is one of the most manipulated infectious disease events in history, characterized by official lies in an unending stream lead by government bureaucracies, medical associations, medical boards, the media, and international agencies.[3,6,57] We have witnessed a long list of unprecedented intrusions into medical practice, including attacks on medical experts, destruction of medical careers among doctors refusing to participate in killing their patients and a massive regimentation of health care, led by non-qualified individuals with enormous wealth, power and influence.

For the first time in American history a president, governors, mayors, hospital administrators and federal bureaucrats are determining medical treatments based not on accurate scientifically based or even experience based information, but rather to force the acceptance of special forms of care and “prevention”—including remdesivir, use of respirators and ultimately a series of essentially untested messenger RNA vaccines. For the first time in history medical treatment, protocols are not being formulated based on the experience of the physicians treating the largest number of patients successfully, but rather individuals and bureaucracies that have never treated a single patient—including Anthony Fauci, Bill Gates, EcoHealth Alliance, the CDC, WHO, state public health officers and hospital administrators.[23,38]

The media (TV, newspapers, magazines, etc), medical societies, state medical boards and the owners of social media have appointed themselves to be the sole source of information concerning this so-called “pandemic”. Websites have been removed, highly credentialed and experienced clinical doctors and scientific experts in the field of infectious diseases have been demonized, careers have been destroyed and all dissenting information has been labeled “misinformation” and “dangerous lies”, even when sourced from top experts in the fields of virology, infectious diseases, pulmonary critical care, and epidemiology. These blackouts of truth occur even when this information is backed by extensive scientific citations from some of the most qualified medical specialists in the world.[23] Incredibly, even individuals, such as Dr. Michael Yeadon, a retired ex-Chief Scientist, and vice-president for the science division of Pfizer Pharmaceutical company in the UK, who charged the company with making an extremely dangerous vaccine, is ignored and demonized. Further, he, along with other highly qualified scientists have stated that no one should take this vaccine.

Dr. Peter McCullough, one of the most cited experts in his field, who has successfully treated over 2000 COVID patients by using a protocol of early treatment (which the so-called experts completely ignored), has been the victim of a particularly vicious assault by those benefiting financially from the vaccines. He has published his results in peer reviewed journals, reporting an 80% reduction in hospitalizations and a 75% reduction in deaths by using early treatment.[44] Despite this, he is under an unrelenting series of attacks by the information controllers, none of which have treated a single patient.

Neither Anthony Fauci, the CDC, WHO nor any medical governmental establishment has ever offered any early treatment other than Tylenol, hydration and call an ambulance once you have difficulty breathing. This is unprecedented in the entire history of medical care as early treatment of infections is critical to saving lives and preventing severe complications. Not only have these medical organizations and federal lapdogs not even suggested early treatment, they attacked anyone who attempted to initiate such treatment with all the weapons at their disposal—loss of license, removal of hospital privileges, shaming, destruction of reputations and even arrest.[2]

A good example of this outrage against freedom of speech and providing informed consent information is the recent suspension by the medical board in Maine of Dr. Meryl Nass’ medical license and the ordering of her to undergo a psychiatric evaluation for prescribing Ivermectin and sharing her expertise in this field.[9,65] I know Dr, Nass personally and can vouch for her integrity, brilliance and dedication to truth. Her scientific credentials are impeccable. This behavior by a medical licensing board is reminiscent of the methodology of the Soviet KGB during the period when dissidents were incarcerated in psychiatric gulags to silence their dissent.

OTHER UNPRECEDENTED ATTACKS

Another unprecedented tactic is to remove dissenting doctors from their positions as journal editors, reviewers and retracting of their scientific papers from journals, even after these papers have been in print. Until this pandemic event, I have never seen so many journal papers being retracted— the vast majority promoting alternatives to official dogma, especially if the papers question vaccine safety. Normally a submitted paper or study is reviewed by experts in the field, called peer review. These reviews can be quite intense and nit picking in detail, insisting that all errors within the paper be corrected before publication. So, unless fraud or some other major hidden problem is discovered after the paper is in print, the paper remains in the scientific literature.

We are now witnessing a growing number of excellent scientific papers, written by top experts in the field, being retracted from major medical and scientific journals weeks, months and even years after publication. A careful review indicates that in far too many instances the authors dared question accepted dogma by the controllers of scientific publications—especially concerning the safety, alternative treatments or efficacy of vaccines.[12,63] These journals rely on extensive adverting by pharmaceutical companies for their revenue. Several instances have occurred where powerful pharmaceutical companies exerted their influence on owners of these journals to remove articles that in any way question these companies’ products.[13,34,35]

Worse still is the actual designing of medical articles for promoting drugs and pharmaceutical products that involve fake studies, so-called ghostwritten articles.[49,64] Richard Horton is quoted by the Guardian as saying “journals have devolved into information laundering operations for the pharmaceutical industry.”[13,63] Proven fraudulent “ghostwritten” articles sponsored by pharmaceutical giants have appeared regularly in top clinical journals, such as JAMA, and New England Journal of Medicine—never to be removed despite proven scientific abuse and manipulation of data.[49,63]

Ghostwritten articles involve using planning companies whose job it is to design articles containing manipulated data to support a pharmaceutical product and then have these articles accepted by high-impact clinical journals, that is, the journals most likely to affect clinical decision making of doctors. Further, they supply doctors in clinical practice with free reprints of these manipulated articles. The Guardian found 250 companies engaged in this ghostwriting business. The final step in designing these articles for publication in the most prestigious journals is to recruit well recognized medical experts from prestigious institutions, to add their name to these articles. These recruited medical authors are either paid upon agreeing to add their name to these pre- written articles or they do so for the prestige of having their name on an article in a prestigious medical journal.[11]

Of vital importance is the observation by experts in the field of medical publishing that nothing has been done to stop this abuse. Medical ethicists have lamented that because of this widespread practice “you can’t trust anything.” While some journals insist on disclosure information, most doctors reading these articles ignore this information or excuse it and several journals make disclosure more difficult by requiring the reader to find the disclosure statements at another location. Many journals do not police such statements and omissions by authors are common and without punishment.

As concerns the information made available to the public, virtually all the media is under the control of these pharmaceutical giants or others who are benefitting from this “pandemic”. Their stories are all the same, both in content and even wording. Orchestrated coverups occur daily and massive data exposing the lies being generated by these information controllers are hidden from the public. All data coming over the national media (TV, newspaper and magazines), as well as the local news you watch every day, comes only from “official” sources—most of which are lies, distortions or completely manufactured out of whole cloth—all aimed to deceive the public.

Television media receives the majority of its advertising budget from the international pharmaceutical companies—this creates an irresistible influence to report all concocted studies supporting their vaccines and other so-called treatments.[14] In 2020 alone the pharmaceutical industries spent 6.56 billion dollars on such advertising.[13,14] Pharma TV advertising amounted to 4.58 billion, an incredible 75% of their budget. That buys a lot of influence and control over the media. World famous experts within all fields of infectious diseases are excluded from media exposure and from social media should they in any way deviate against the concocted lies and distortions by the makers of these vaccines. In addition, these pharmaceutical companies spend tens of millions on social media advertising, with Pfizer leading the pack with $55 million in 2020.[14]

While these attacks on free speech are terrifying enough, even worse is the virtually universal control hospital administrators have exercised over the details of medical care in hospitals. These hirelings are now instructing doctors which treatment protocols they will adhere to and which treatments they will not use, no matter how harmful the “approved” treatments are or how beneficial the “unapproved” treatments are.[33,57]

Never in the history of American medicine have hospital administrators dictated to its physicians how they will practice medicine and what medications they can use. The CDC has no authority to dictate to hospitals or doctors concerning medical treatments. Yet, most physicians complied without the slightest resistance.

The federal Care Act encouraged this human disaster by offering all US hospitals up to 39,000 dollars for each ICU patient they put on respirators, despite the fact that early on it was obvious that the respirators were a major cause of death among these unsuspecting, trusting patients. In addition, the hospitals received 12,000 dollars for each patient that was admitted to the ICU—explaining, in my opinion and others, why all federal medical bureaucracies (CDC, FDA, NIAID, NIH, etc) did all in their power to prevent life- saving early treatments.[46] Letting patients deteriorate to the point they needed hospitalization, meant big money for all hospitals. A growing number of hospitals are in danger of bankruptcy, and many have closed their doors, even before this “pandemic”.[50] Most of these hospitals are now owned by national or international corporations, including teaching hospitals.[10]

It is also interesting to note that with the arrival of this “pandemic” we have witnessed a surge in hospital corporate chains buying up a number of these financially at-risk hospitals.[1,54] It has been noted that billions in Federal Covid aid is being used by these hospital giants to acquire these financially endangered hospitals, further increasing the power of corporate medicine over physician independence. Physicians expelled from their hospitals are finding it difficult to find other hospitals staffs to join since they too may be owned by the same corporate giant. As a result, vaccine mandate policies include far larger numbers of hospital employees. For example, Mayo Clinic fired 700 employees for exercising their right to refuse a dangerous, essentially untested experimental vaccine.[51,57] Mayo Clinic did this despite the fact that many of these employees worked during the worst of the epidemic and are being fired when the Omicron variant is the dominant strain of the virus, has the pathogenicity of a common cold for most and the vaccines are ineffective in preventing the infection.

In addition, it has been proven that the vaccinated asymptomatic person has a nasopharyngeal titer of the virus as high as an infected unvaccinated person. If the purpose of the vaccine mandate is to prevent viral spread among the hospital staff and patients, then it is the vaccinated who present the greatest risk of transmission, not the unvaccinated. The difference is that a sick unvaccinated person would not go to work, the asymptomatic vaccinated spreader will.

What we do know is that major medical centers, such as Mayo Clinic, receive tens of millions of dollars in NIH grants each year as well as monies from the pharmaceutical makers of these experimental “vaccines”. In my view, that is the real consideration driving these policies. If this could be proven in a court of law the administrators making these mandates should be prosecuted to the fullest extent of the law and sued by all injured parties.

The hospital bankruptcy problem has grown increasingly acute due to hospitals vaccine mandates and resulting large number of hospitals staff, especially nurses, refusing to be forcibly vaccinated.[17,51] This is all unprecedented in the history of medical care. Doctors within hospitals are responsible for the treatment of their individual patients and work directly with these patients and their families to initiate these treatments. Outside organizations, such as the CDC, have no authority to intervene in these treatments and to do so exposes the patients to grave errors by an organization that has never treated a single COVID-19 patient.

When this pandemic started, hospitals were ordered by the CDC to follow a treatment protocol that resulted in the deaths of hundreds of thousands of patients, most of whom would have recovered had proper treatments been allowed.[43,44] The majority of these deaths could have been prevented had doctors been allowed to use early treatment with such products as Ivermectin, hydroxy-chloroquine and a number of other safe drugs and natural compounds. It has been estimated, based on results by physicians treating the most covid patients successfully, that of the 800,000 people that we are told died from Covid, 640,000 could have not only been saved, but could have, in many cases, returned to their pre-infection health status had mandated early treatment with these proven methods been used. This neglect of early treatment constitutes mass murder. That means 160,000 would have actually died, far less than the number dying at the hands of bureaucracies, medical associations and medical boards that refused to stand up for their patients. According to studies of early treatment of thousands of patients by brave, caring doctors, seventy-five to eighty percent of the deaths could have been prevented.[43,44]

Incredibly, these knowledgeable doctors were prevented from saving these Covid-19 infected people. It should be an embarrassment to the medical profession that so many doctors mindlessly followed the deadly protocols established by the controllers of medicine.

One must also keep in mind that this event never satisfied the criteria for a pandemic. The World Health Organization changed the criteria to make this a pandemic. To qualify for a pandemic status the virus must have a high mortality rate for the vast majority of people, which it didn’t (with a 99.98% survival rate), and it must have no known existing treatments—which this virus had—in fact, a growing number of very successful treatments.

The draconian measures established to contain this contrived “pandemic” have never been shown to be successful, such as masking the public, lockdowns, and social distancing. A number of carefully done studies during previous flu seasons demonstrated that masks, of any kind, had never prevented the spread of the virus among the public.[60]

In fact, some very good studies suggested that the masks actually spread the virus by giving people a false sense of security and other factors, such as the observation that people were constantly breaking sterile technique by touching their mask, improper removal and by leakage of infectious aerosols around the edges of the mask. In addition masks were being disposed of in parking lots, walking trails, laid on tabletops in restaurants and placed in pockets and purses.

Within a few minutes of putting on the mask, a number of pathogenic bacteria can be cultured from the masks, putting the immune suppressed person at a high risk of bacterial pneumonia and children at a higher risk of meningitis.[16] A study by researchers at the University of Florida cultured over 11 pathogenic bacteria from the inside of the mask worn by children in schools.[40]

It was also known that children were at essentially no risk of either getting sick from the virus or transmitting it.

In addition, it was also known that wearing a mask for over 4 hours (as occurs in all schools) results in significant hypoxia (low blood oxygen levels) and hypercapnia (high CO2 levels), which have a number of deleterious effects on health, including impairing the development of the child’s brain.[4,72,52]

We have known that brain development continues long after the grade school years. A recent study found that children born during the “pandemic” have significantly lower IQs—yet school boards, school principals and other educational bureaucrats are obviously unconcerned.[18]

TOOLS OF THE INDOCTRINATION TRADE

The designers of this pandemic anticipated a pushback by the public and that major embarrassing questions would be asked. To prevent this, the controllers fed the media a number of tactics, one of the most commonly used was and is the “fact check” scam. With each confrontation with carefully documented evidence, the media “fact checkers” countered with the charge of “misinformation”, and an unfounded “conspiracy theory” charge that was, in their lexicon, “debunked”. Never were we told who the fact checkers were or the source of their “debunking” information—we were just to believe the “fact checkers”. A recent court case established under oath that facebook “fact checkers” used their own staff opinion and not real experts to check “facts”.[59] When sources are in fact revealed they are invariably the corrupt CDC, WHO or Anthony Fauci or just their opinion. Here is a list of things that were labeled as “myths” and “misinformation” that were later proven to be true.

• The asymptomatic vaccinated are spreading the virus equally as with unvaccinated symptomatic infected.

• The vaccines cannot protect adequately against new variants, such as Delta and Omicron.

• Natural immunity is far superior to vaccine immunity and is most likely lifelong.

• Vaccine immunity not only wanes after several months, but all immune cells are impaired for prolonged periods, putting the vaccinated at a high risk of all infections and cancer.

• COVID vaccines can cause a significant incidence of blood clots and other serious side effects

• The vaccine proponents will demand numerous boosters as each variant appears on the scene.

• Fauci will insist on the covid vaccine for small children and even babies.

• Vaccine passports will be required to enter a business, fly in a plane, and use public transportation

• There will be internment camps for the unvaccinated (as in Australia, Austria and Canada)

• The unvaccinated will be denied employment.

• There are secret agreements between the government, elitist institutions, and vaccine makers

• Many hospitals were either empty or had low occupancy during the pandemic.

• The spike protein from the vaccine enters the nucleus of the cell, altering cell DNA repair function.

• Hundreds of thousands have been killed by the vaccines and many times more have been permanently damaged.

• Early treatment could have saved the lives of most of the 700,000 who died.

• Vaccine-induced myocarditis (which was denied initially) is a significant problem and clears over a short period.

• Special deadly lots (batches) of these vaccines are mixed with the mass of other Covid-19 vaccines

Several of these claims by those opposing these vaccines now appear on the CDC website—most still identified as “myths”. Today, extensive evidence has confirmed that each of these so-called “myths” were in fact true. Many are even admitted by the “saint of vaccines”, Anthony Fauci. For example, we were told, even by our cognitively impaired President, that once the vaccine was released all the vaccinated people could take off their masks. Oops! We were told shortly afterward— the vaccinated have high concentrations (titers) of the virus in their noses and mouths (nasopharynx) and can transmit the virus to others in which they come into contact—especially their own family members. On go the masks once again— in fact double masking is recommended. The vaccinated are now known to be the main superspreaders of the virus and hospitals are filled with the sick vaccinated and people suffering from serious vaccine complications.[27,42,45]

Another tactic by the vaccine proponents is to demonize those who reject being vaccinated for a variety of reasons. The media refers to these critically thinking individuals as “anti-vaxxers”, “vaccine deniers”, “Vaccine resisters”, “murders”, “enemies of the greater good” and as being the ones prolonging the pandemic. I have been appalled by the vicious, often heartless attacks by some of the people on social media when a parent or loved one relates a story of the terrible suffering and eventual death, they or their loved one suffered as a result of the vaccines. Some psychopaths tweet that they are glad that the loved one died or that the dead vaccinated person was an enemy of good for telling of the event and should be banned. This is hard to conceptualize. This level of cruelty is terrifying, and signifies the collapse of a moral, decent, and compassionate society.

It is bad enough for the public to sink this low, but the media, political leaders, hospital administrators, medical associations and medical licensing boards are acting in a similar morally dysfunctional and cruel way.

LOGIC, REASONING, AND SCIENTIFIC EVIDENCE HAS DISAPPEARED IN THIS EVENT

Has scientific evidence, carefully done studies, clinical experience and medical logic had any effect on stopping these ineffective and dangerous vaccines? Absolutely not! The draconian efforts to vaccinate everyone on the planet continues (except the elite, postal workers, members of Congress and other insiders).[31,62]

In the case of all other drugs and previous conventional vaccines under review by the FDA, the otherwise unexplained deaths of 50 or less individuals would result in a halt in further distribution of the product, as happened on 1976 with the swine flu vaccine. With over 18,000 deaths being reported by the VAERS system for the period December 14, 2020 and December 31st, 2021 as well as 139,126 serious injuries (including deaths) for the same period there is still no interest in stopping this deadly vaccine program.[61] Worse, there is no serious investigation by any government agency to determine why these people are dying and being seriously and permanently injured by these vaccines.[15,67] What we do see is a continuous series of coverups and evasions by the vaccine makers and their promoters.

The war against effective cheap and very safe repurposed drugs and natural compounds, that have proven beyond all doubt to have saved millions of lives all over the world, has not only continued but has stepped up in intensity.[32,34,43]

Doctors are told they cannot provide these life-saving compounds for their patients and if they do, they will be removed from the hospital, have their medical license removed or be punished in many other ways. A great many pharmacies have refused to fill prescriptions for lvermectin or hydroxy- chloroquine, despite the fact that millions of people have taken these drugs safely for over 60 years in the case of hydroxy chloroquine and decades for Ivermectin.[33,36] This refusal to fill prescriptions is unprecedented and has been engineered by those wanting to prevent alternative methods of treatment, all based on protecting vaccine expansion to all. Several companies that make hydroxy chloroquine agreed to empty their stocks of the drug by donating them to the Strategic National Stockpile, making this drug far more difficult to get.[33] Why would the government do that when over 30 well-done studies have shown that this drug reduced deaths anywhere from 66% to 92% in other countries, such as India, Egypt, Argentina, France, Nigeria, Spain, Peru, Mexico, and others?[23]

The critics of these two life-saving drugs are most often funded by Bill Gates and Anthony Fauci, both of which are making millions from these vaccines.[48,15]

To further stop the use of these drugs, the pharmaceutical industry and Bill Gates/Anthony Fauci funded fake research to make the case that hydroxy chloroquine was a dangerous drug and could damage the heart.[34] To make this fraudulent case the researchers administered the sickest of covid patients a near lethal dose of the drug, in a dose far higher than used on any covid patient by Dr. Kory, McCullough and other “real”, and compassionate doctors, physicians who were actually treating covid patients.[23]

The controlled, lap-dog media, of course, hammered the public with stories of the deadly effect of hydroxy- chloroquine, all with a terrified look of fake panic. All these stories of ivermectin dangers were shown to be untrue and some of the stories were incredibly preposterous.[37,43]

The attack on Ivermectin was even more vicious than against hydroxy-chloroquine. All of this, and a great deal more is meticulously chronicled in Robert Kennedy, Jr’s excellent new book—The Real Anthony Fauci. Bill Gates, Big Pharma, and the Global War on Democracy and Public Health.[32] If you are truly concerned with the truth and with all that has occurred since this atrocity started, you must not only read, but study this book carefully. It is fully referenced and covers all topics in great detail. This is a designed human tragedy of Biblical proportions by some of the most vile, heartless, psychopaths in history.

Millions have been deliberately killed and crippled, not only by this engineered virus, but by the vaccine itself and by the draconian measures used by these governments to “control the pandemic spread”. We must not ignore the “deaths by despair” caused by these draconian measures, which can exceed hundreds of thousands. Millions have starved in third world countries as a result. In the United States alone, of the 800,000 who died, claimed by the medical bureaucracies, well over 600,000 of these deaths were the result of the purposeful neglect of early treatment, blocking the use of highly effective and safe repurposed drugs, such as hydroxy-chloroquine and Ivermectin, and the forced use of deadly treatments such as remdesivir and use of ventilators. This does not count the deaths of despair and neglected medical care caused by the lockdown and hospital measures forced on healthcare systems.

To compound all this, because of vaccine mandates among all hospital personnel, thousands of nurses and other hospital workers have resigned or been fired.[17,30,51] This has resulted in critical shortages of these vital healthcare workers and dangerous reductions of ICU beds in many hospitals. In addition, as occurred in the Lewis County Healthcare System, a specialty-hospital system in Lowville, N.Y., closed its maternity unit following the resignation of 30 hospital staff over the state’s disastrous vaccine mandate orders. The irony in all these cases of resignations is that the administrators unhesitatingly accepted these mass staffing losses despite rantings about suffering from short staffing during a “crisis”. This is especially puzzling when we learned that the vaccines did not prevent viral transmission and the present predominant variant is of extremely low pathogenicity.

DANGERS OF THE VACCINES ARE INCREASINGLY REVEALED BY SCIENCE

While most researchers, virologists, infectious disease researchers and epidemiologists have been intimidated into silence, a growing number of high integrity individuals with tremendous expertise have come forward to tell the truth—that is, that these vaccines are deadly.

Most new vaccines must go through extensive safety testing for years before they are approved. New technologies, such as the mRNA and DNA vaccines, require a minimum of 10 years of careful testing and extensive follow-up. These new so-called vaccines were “tested” for only 2 months and then the results of these safety test were and continue to be kept secret. Testimony before Senator Ron Johnson by several who participated in the 2 months study indicates that virtually no follow-up of the participants of the pre-release study was ever done.[67] Complains of complications were ignored and despite promises by Pfizer that all medical expenses caused by the “vaccines” would be paid by Pfizer, these individuals stated that none were paid.[66] Some medical expenses exceed 100,000 dollars.

As an example of the deception by Pfizer, and the other makers of mRNA vaccines, is the case of 12-year-old Maddie de Garay, who participated in the Pfizer vaccine pre-release safety study. At Sen. Johnson’s presentation with the families of the vaccine injured, her mother told of her child’s recurrent seizures, that she is now confined to a wheelchair, must be tube fed and suffers permanent brain damage. On the Pfizer safety evaluation submitted to the FDA her only side effect is listed as having a “stomachache”. Each person submitted similar horrifying stories.

The Japanese resorted to a FOIA (Freedom of Information Act) lawsuit to force Pfizer to release its secret biodistribution study. The reason Pfizer wanted it kept secret is that it demonstrated that Pfizer lied to the public and the regulatory agencies about the fate of the injected vaccine contents (the mRNA enclosed nano-lipid carrier). They claimed that it remained at the site of the injection (the shoulder), when in fact their own study found that it rapidly spread throughout the entire body by the bloodstream within 48 hours.

The study also found that these deadly nano-lipid carriers collected in very high concentrations in several organs, including the reproductive organs of males and females, the heart, the liver, the bone marrow, and the spleen (a major immune organ). The highest concentration was in the ovaries and the bone marrow. These nano-lipid carriers also were deposited in the brain.

Dr. Ryan Cole, a pathologist from Idaho reported a dramatic spike in highly aggressive cancers among vaccinated individuals, (not reported in the Media). He found a frighteningly high incidence of highly aggressive cancers in vaccinated individuals, especially highly invasive melanomas in young people and uterine cancers in women.[26] Other reports of activation of previously controlled cancers are also appearing among vaccinated cancer patients.[47] Thus far, no studies have been done to confirm these reports, but it is unlikely such studies will be done, at least studies funded by grants from the NIH.

The high concentration of spike proteins found in the ovaries in the biodistribution study could very well impair fertility in young women, alter menstruation, and could put them at an increased risk of ovarian cancer. The high concentration in the bone marrow, could also put the vaccinated at a high risk of leukemia and lymphoma. The leukemia risk is very worrisome now that they have started vaccinating children as young as 5 years of age. No long-term studies have been conducted by any of these makers of Covid-19 vaccines, especially as regards the risk of cancer induction. Chronic inflammation is intimately linked to cancer induction, growth and invasion and vaccines stimulate inflammation.

Cancer patients are being told they should get vaccinated with these deadly vaccines. This, in my opinion, is insane. Newer studies have shown that this type of vaccine inserts the spike protein within the nucleus of the immune cells (and most likely many cell types) and once there, inhibits two very important DNA repair enzymes, BRCA1 and 53BP1, whose duty it is to repair damage to the cell’s DNA.[29] Unrepaired DNA damage plays a major role in cancer.

There is a hereditary disease called xeroderma pigmentosum in which the DNA repair enzymes are defective. These ill-fated individuals develop multiple skin cancers and a very high incidence of organ cancer as a result. Here we have a vaccine that does the same thing, but to a less extensive degree.

One of the defective repair enzymes caused by these vaccines is called BRCA1, which is associated with a significantly higher incidence of breast cancer in women and prostate cancer in men.

It should be noted that no studies were ever done on several critical aspects of this type of vaccine.

• They have never been tested for long term effects

• They have never been tested for induction of autoimmunity

• They have never been properly tested for safety during any stage of pregnancy

• No follow-up studies have been done on the babies of vaccinated women

• There are no long-term studies on the children of vaccinated pregnant women after their birth (Especially as neurodevelopmental milestone occur).

• It has never been tested for effects on a long list of medical conditions:

  • Diabetes

  • Heart disease

  • Atherosclerosis

  • Neurodegenerative diseases

  • Neuropsychiatric effects

  • Induction of autism spectrum disorders and schizophrenia

  • Long term immune function

  • Vertical transmission of defects and disorders

  • Cancer

  • Autoimmune disorders

Previous experience with the flu vaccines clearly demonstrates that the safety studies done by researchers and clinical doctors with ties to pharmaceutical companies were essentially all either poorly done or purposefully designed to falsely show safety and coverup side effects and complications. This was dramatically demonstrated with the previously mentioned phony studies designed to indicate that hydroxy Chloroquine and Ivermectin were ineffective and too dangerous to use.[34,36,37] These fake studies resulted in millions of deaths and severe health disasters worldwide. As stated, 80% of all deaths were unnecessary and could have been prevented with inexpensive, safe repurposed medications with a very long safety history among millions who have taken them for decades or even a lifetime.[43,44]

It is beyond ironic that those claiming that they are responsible for protecting our health approved a poorly tested set of vaccines that has resulted in more deaths in less than a year of use than all the other vaccines combined given over the past 30 years. Their excuse when confronted was—“we had to overlook some safety measures because this was a deadly pandemic”.[28,46]

In 1986 President Reagan signed the National Childhood Vaccine Injury Act, which gave blanket protection to pharmaceutical makers of vaccines against injury litigation by families of vaccine injured individuals. The Supreme Court, in a 57-page opinion, ruled in favor of the vaccine companies, effectively allowing vaccine makers to manufacture and distribute dangerous, often ineffective vaccines to the population without fear of legal consequences. The court did insist on a vaccine injury compensation system which has paid out only a very small number of rewards to a large number of severely injured individuals. It is known that it is very difficult to receive these awards. According to the Health Resources and Services Administration, since 1988 the Vaccine Injury Compensation Program (VICP) has agreed to pay 3,597 awards among 19,098 vaccine injured individuals applying amounting to a total sum of $3.8 billion. This was prior to the introduction of the Covid-19 vaccines, in which the deaths alone exceed all deaths related to all the vaccines combined over a thirty-year period.

In 2018 President Trump signed into law the “right-to-try” law which allowed the use of experimental drugs and all unconventional treatments to be used in cases of extreme medical conditions. As we have seen with the refusal of many hospitals and even blanket refusal by states to allow Ivermectin, hydroxy-chloroquine or any other unapproved “official” methods to treat even terminal Covid-19 cases, these nefarious individuals have ignored this law.

Strangely, they did not use this same logic or the law when it came to Ivermectin and Hydroxy Chloroquine, both of which had undergone extensive safety testing by over 30 clinical studies of a high quality and given glowing reports on both efficacy and safety in numerous countries. In addition, we had a record of use for up to 60 years by millions of people, using these drugs worldwide, with an excellent safety record. It was obvious that a group of very powerful people in conjunction with pharmaceutical conglomerates didn’t want the pandemic to end and wanted vaccines as the only treatment option. Kennedy’s book makes this case using extensive evidence and citations.[14,32]

Dr. James Thorpe, an expert in maternal-fetal medicine, demonstrates that these covoid-19 vaccines given during pregnancy have resulted in a 50-fold higher incidence of miscarriage than reported with all other vaccines combined.[28] When we examine his graph on fetal malformations there was a 144-fold higher incidence of fetal malformation with the Covid-19 vaccines given during pregnancy as compared to all other vaccines combined. Yet, the American Academy of Obstetrics and Gynecology and the American College of Obstetrics and Gynecology endorse the safety of these vaccines for all stages of pregnancy and among women breast feeding their babies.

It is noteworthy that these medical specialty groups have received significant funding from Pfizer pharmaceutical company. The American College of Obstetrics and Gynecology, just in the 4th quarter of 2010, received a total of $11,000 from Pfizer Pharmaceutical company alone.[70] Funding from NIH grants are much higher.[20] The best way to lose these grants is to criticize the source of the funds, their products or pet programs. Peter Duesberg, because of his daring to question Fauci’s pet theory of AIDS caused by HIV virus, was no longer awarded any of the 30 grant applications he submitted after going public. Prior to this episode, as the leading authority on retroviruses in the world, he had never been turned down for an NIH grant.[39] This is how the “corrupted” system works, even though much of the grant money comes from our taxes.

HOT LOTS—DEADLY BATCHES OF THE VACCINES

A new study has now surfaced, the results of which are terrifying.[25] A researcher at Kingston University in London, has completed an extensive analysis of the VAERs data (a subdepartment of the CDC which collects voluntary vaccine complication data), in which he grouped reported deaths following the vaccines according to the manufacturer’s lot numbers of the vaccines. Vaccines are manufactured in large batches called lots. What he discovered was that the vaccines are divided into over 20,000 lots and that one out of every 200 of these batches (lots) is demonstrably deadly to anyone who receives a vaccine from that lot, which includes thousands of vaccine doses.

He examined all manufactured vaccines—Pfizer, Moderna, Johnson and Johnson (Janssen), etc. He found that among every 200 batches of the vaccine from Pfizer and other makers, one batch of the 200 was found to be over 50x more deadly than vaccines batches from other lots. The other vaccine lots (batches) were also causing deaths and disabilities, but nowhere near to this extent. These deadly batches should have appeared randomly among all “vaccines” if it was an unintentional event. However, he found that 5% of the vaccines were responsible for 90% of the serious adverse events, including deaths. The incidence of deaths and serious complications among these “hot lots” varied from over 1000% to several thousand percent higher than comparable safer lots. If you think this was by accident—think again. This is not the first time “hot lots” were, in my opinion, purposefully manufactured and sent across the nation—usually vaccines designed for children. In one such scandal, “hot lots” of a vaccine ended up all in one state and the damage immediately became evident. What was the manufacture’s response? It wasn’t to remove the deadly batches of the vaccine. He ordered his company to scatter the hot lots across the nation so that authorities would not see the obvious deadly effect.

All lots of a vaccine are numbered—for example Modera labels them with such codes as 013M20A. It was noted that the batch numbers ended in either 20A or 21A. Batches ending in 20A were much more toxic than the ones ending in 21A. The batches ending in 20A had about 1700 adverse events, versus a few hundred to twenty or thirty events for the 21A batches. This example explains why some people had few or no adverse events after taking the vaccine while others are either killed or severely and permanently harmed. To see the researcher’s explanation, go to https://www.bitchute.com/video/6xIYPZBkydsu/ In my opinion these examples strongly suggest an intentional alteration of the production of the “vaccine” to include deadly batches.

I have met and worked with a number of people concerned with vaccine safety and I can tell you they are not the evil anti-vaxxers you are told they are. They are highly principled, moral, compassionate people, many of which are top researchers and people who have studied the issue extensively. Robert Kennedy, Jr, Barbara Lou Fisher, Dr. Meryl Nass, Professor Christopher Shaw, Megan Redshaw, Dr. Sherri Tenpenny, Dr. Joseph Mercola, Neil Z. Miller, Dr. Lucija Tomjinovic, Dr. Stephanie Seneff, Dr. Steve Kirsch and Dr. Peter McCullough just to name a few. These people have nothing to gain and a lot to lose. They are attacked viciously by the media, government agencies, and elite billionaires who think they should control the world and everyone in it.

WHY DID FAUCI WANT NO AUTOPSIES OF THOSE WHO DIED AFTER VACCINATION?

There are many things about this “pandemic” that are unprecedented in medical history. One of the most startling is that at the height of the pandemic so few autopsies, especially total autopsies, were being done. A mysterious virus was rapidly spreading around the world, a selected group of people with weakened immune systems were getting seriously ill and many were dying and the one way we could rapidly gain the most knowledge about this virus—an autopsy, was being discouraged.

Guerriero noted that by the end of April, 2020 approximately 150,000 people had died, yet there were only 16 autopsies performed and reported in the medical literature.[24] Among these, only seven were complete autopsies, the remaining 9 being partial or by needle biopsy or incisional biopsy. Only after 170,000 deaths by Covid-19 and four months into the pandemic were the first series of autopsies actually done, that is, more than ten. And only after 280,000 deaths and another month, were the first large series of autopsies performed, some 80 in number.[22] Sperhake, in a call for autopsies to be done without question, noted that the first full autopsy reported in the literature along with photomicrographs appeared in a medico-legal journal from China in February 2020.[41,68] Sperhake expressed confusion as to why there was a reluctance to perform autopsies during the crisis, but he knew it was not coming from the pathologists. The medical literature was littered with appeals by pathologist for more autopsies to be performed.[58] Sperhake further noted that the Robert Koch Institute (The German health monitoring system) at least initially advised against doing autopsies. He also knew that at the time 200 participating autopsy institutions in the United States had done at least 225 autopsies among 14 states.

Some have claimed that this dearth of autopsies was based on the government’s fear of infection among the pathologists, but a study of 225 autopsies on Covid-19 cases demonstrated only one case of infection among the pathologist and this was concluded to have been an infection contracted elsewhere.[19] Guerriero ends his article calling for more autopsies with this observation: “Shoulder to shoulder, clinical and forensic pathologists overcame the obstructions of autopsy studies in Covid-19 victims and hereby generated valuable knowledge on the pathophysiology of the interaction between the SARS-CoV-2 and the human body, thus contributing to our understanding of the disease.”[24]

Suspicion concerning the worldwide reluctance of nations to allow full post mortem studies of Covid-19 victims may be based on the idea that it was more than by chance. There are at least two possibilities that stand out. First, those leading the progression of this “non-pandemic” event into a perceived worldwide “deadly pandemic”, were hiding an important secret that autopsies could document. Namely, just how many of the deaths were actually caused by the virus? To implement draconian measures, such as mandated mask wearing, lockdowns, destruction of businesses, and eventually mandated forced vaccination, they needed very large numbers of covid-19 infected dead. Fear would be the driving force for all these destructive pandemic control programs.

Elder et al in his study classified the autopsy findings into four groups.[22]

1. Certain Covid-19 death
2. Probably Covid-19 death
3. Possible Covid-19 death
4. Not associated with Covid-19, despite the positive test.

What possibly concerned or even terrified the engineers of this pandemic was that autopsies just might, and did, show that a number of these so-called Covid-19 deaths in truth died of their comorbid diseases. In the vast majority of autopsy studies reported, pathologists noted multiple comorbid conditions, most of which at the extremes of life could alone be fatal. Previously it was known that common cold viruses had an 8% mortality in nursing homes.

In addition, valuable evidence could be obtained from the autopsies that would improve clinical treatments and could possibly demonstrate the deadly effect of the CDC mandated protocols all hospitals were required to follow, such as the use of respirators and the deadly, kidney-destroying drug remdesivir. The autopsies also demonstrated accumulating medical errors and poor-quality care, as the shielding of doctors in intensive care units from the eyes of family members inevitably leads to poorer quality care as reported by several nurses working in these areas.[53-55]

As bad as all this was, the very same thing is being done in the case of Covid vaccine deaths—very few complete autopsies have been done to understand why these people died, that is, until recently. Two highly qualified researchers, Dr. Sucharit Bhakdi a microbiologist and highly qualified expert in infectious disease and Dr. Arne Burkhardt, a pathologist who is a widely published authority having been a professor of pathology at several prestigious institutions, recently performed autopsies on 15 people having died after vaccination. What they found explains why so many are dying and experiencing organ damage and deadly blood clots.[5]

They determined that 14 of the fifteen people died as a result of the vaccines and not of other causes. Dr. Burkhardt, the pathologist, observed widespread evidence of an immune attack on the autopsied individuals’ organs and tissues— especially their heart. This evidence included extensive invasion of small blood vessels with massive numbers of lymphocytes, which cause extensive cell destruction when unleashed. Other organs, such as the lungs and liver, were observed to have extensive damage as well. These findings indicate the vaccines were causing the body to attack itself with deadly consequences. One can easily see why Anthony Fauci, as well as public health officers and all who are heavily promoting these vaccines, publicly discouraged autopsies on the vaccinated who subsequently died. One can also see that in the case of vaccines, that were essentially untested prior to being approved for the general public, at least the regulatory agencies should have been required to carefully monitor and analyze all serious complications, and certainly deaths, linked to these vaccines. The best way to do that is with complete autopsies.

While we learned important information from these autopsies what is really needed are special studies of the tissues of those who have died after vaccination for the presence of spike protein infiltration throughout the organs and tissues. This would be critical information, as such infiltration would result in severe damage to all tissues and organs involved—especially the heart, the brain, and the immune system. Animal studies have demonstrated this. In these vaccinated individuals the source of these spike proteins would be the injected nanolipid carriers of the spike protein producing mRNA. It is obvious that the government health authorities and pharmaceutical manufacturers of these “vaccines” do not want these critical studies done as the public would be outraged and demand an end to the vaccination program and prosecution of the involved individuals who covered this up.

CONCLUSIONS

We are all living through one of the most drastic changes in our culture, economic system, as well as political system in our nation’s history as well as the rest of the world. We have been told that we will never return to “normal” and that a great reset has been designed to create a “new world order”. This has all been outlined by Klaus Schwab, head of the World Economic Forum, in his book on the “Great Reset”.[66] This book gives a great deal of insight as to the thinking of the utopians who are proud to claim this pandemic “crisis” as their way to usher in a new world. This new world order has been on the drawing boards of the elite manipulators for over a century.[73,74] In this paper I have concentrated on the devastating effects this has had on the medical care system in the United States, but also includes much of the Western world. In past papers I have discussed the slow erosion of traditional medical care in the United States and how this system has become increasingly bureaucratized and regimented.[7,8] This process was rapidly accelerating, but the appearance of this, in my opinion, manufactured “pandemic” has transformed our health care system over night.

As you have seen, an unprecedented series of events have taken place within this system. Hospital administrators, for example, assumed the position of medical dictators, ordering doctors to follow protocols derived not from those having extensive experience in treating this virus, but rather from a medical bureaucracy that has never treated a single COVID-19 patient. The mandated use of respirators on ICU Covid-19 patients, for example, was imposed in all medical systems and dissenting physicians were rapidly removed from their positions as caregivers, despite their demonstration of markedly improved treatment methods. Further, doctors were told to use the drug remdesivir despite its proven toxicity, lack of effectiveness and high complication rate. They were told to use drugs that impaired respiration and mask every patient, despite the patient’s impaired breathing. In each case, those who refused to abuse their patients were removed from the hospital and even faced a loss of license—or worse.

For the first time in modern medical history, early medical treatment of these infected patients was ignored nationwide. Studies have shown that early medical treatment was saving 80% of higher number of these infected people when initiated by independent doctors.[43,44] Early treatment could have saved over 640,000 lives over the course of this “pandemic”. Despite the demonstration of the power of these early treatments, the forces controlling medical care continued this destructive policy.

Families were not allowed to see their loved ones, forcing these very sick individuals in the hospitals to face their deaths alone. To add insult to injury, funerals were limited to a few grieving family members, who were not allowed to even sit together. All the while large stores, such as Walmart and Cosco were allowed to operate with minimal restrictions. Nursing home patients were also not allowed to have family visitations, again being forced to die a lonely death. All the while, in a number of states, the most transparent being in New York state, infected elderly were purposefully transferred from hospitals into nursing homes, resulting in a very high death rates of these nursing home residents. At the beginning of this “pandemic” over 50% of all death were occurring in nursing homes.

Throughout this “pandemic” we have been fed an unending series of lies, distortions and disinformation by the media, the public health officials, medical bureaucracies (CDC, FDA and WHO) and medical associations. Physicians, scientists, and experts in infectious treatments who formed associations designed to develop more effective and safer treatments, were regularly demonized, harassed, shamed, humiliated, and experience a loss of licensure, loss of hospital privileges and, in at least one case, ordered to have a psychiatric examination.[2,65,71]

Anthony Fauci was given essentially absolute control of all forms of medical care during this event, including insisting that drugs he profited from be used by all treating physicians. He ordered the use of masks, despite at first laughing at the use of masks to filter a virus. Governors, mayors, and many businesses followed his orders without question.

The draconian measures being used, masking, lockdowns, testing of the uninfected, use of the inaccurate PCR test, social distancing, and contact tracing had been shown previously to be of little or no use during previous pandemics, yet all attempts to reject these methods were to no avail. Some states ignored these draconian orders and had either the same or fewer cases, as well as deaths, as the states with the most strictly enforced measures. Again, no amount of evidence or obvious demonstration along these lines had any effect on ending these socially destructive measures. Even when entire countries, such as Sweden, which avoided all these measures, demonstrated equal rates of infections and hospitalization as nations with the strictest, very draconian measures, no policy change by the controlling institutions occurred. No amount of evidence changed anything.

Experts in the psychology of destructive events, such as economic collapses, major disasters and previous pandemics demonstrated that draconian measures come with an enormous cost in the form of “deaths of despair” and in a dramatic increase in serious psychological disorders. The effects of these pandemic measures on children’s neurodevelopment is catastrophic and to a large extent irreversible.

Over time tens of thousands could die as a result of this damage. Even when these predictions began to appear, the controllers of this “pandemic” continued full steam ahead. Drastic increases in suicides, a rise in obesity, a rise in drug and alcohol use, a worsening of many health measures and a terrifying rise in psychiatric disorders, especially depression and anxiety, were ignored by the officials controlling this event.

We eventually learned that many of the deaths were a result of medical neglect. Individuals with chronic medical conditions, diabetes, cancer, cardiovascular disease, and neurological diseases were no longer being followed properly in their clinics and doctor’s offices. Non-emergency surgeries were put on hold. Many of these patients chose to die at home rather than risk going to the hospitals and many considered hospitals “death houses”.

Records of deaths have shown that there was a rise in deaths among those aged 75 and older, mostly explained by Covid-19 infections, but for those between the ages of 65 to 74, deaths had been increasing well before the pandemic onset.[69] Between ages of 18 and aged 65 years, records demonstrate a shocking hike in non-Covid-19 deaths. Some of these deaths were explained by a dramatic increase in drug-related deaths, some 20,000 more than 2019. Alcohol related deaths also increased substantially, and homicides increased almost 30% in the 18 to 65-year group.

The head of the insurance company OneAmerica stated that their data indicated that the death rate for individuals aged 18 to 64 had increased 40% over the pre-pandemic period.[21] Scott Davidson, the company’s CEO, stated that this represented the highest death rate in the history of insurance records, which does extensive data collections on death rates each year. Davidson also noted that this high of a death rate increase has never been seen in the history of death data collection. Previous catastrophes of monumental extent increased death rates no more than 10 percent, 40% is unprecedented.

Dr. Lindsay Weaver, Indiana’s chief medical officer, stated that hospitalizations in Indiana are higher than at any point in the past five years. This is of critical importance since the vaccines were supposed to significantly reduce deaths, but the opposite has happened. Hospitals are being flooded with vaccine complications and people in critical condition from medical neglect caused by the lockdowns and other pandemic measures.[46,56]

A dramatic number of these people are now dying, with the spike occurring after the vaccines were introduced. The lies flowing from those who have appointed themselves as medical dictators are endless. First, we were told that the lockdown would last only two weeks, they lasted over a year. Then we were told that masks were ineffective and did not need to be worn. Quickly that was reversed. Then we were told the cloth mask was very effective, now it’s not and everyone should be wearing an N95 mask and before that that they should double mask. We were told there was a severe shortage of respirators, then we discover they are sitting unused in warehouses and in city dumps, still in their packing crates. We were informed that the hospitals were filled mostly with the unvaccinated and later found the exact opposite was true the world over. We were told that the vaccine was 95% effective, only to learn that in fact the vaccines cause a progressive erosion of innate immunity.

Upon release of the vaccines, women were told the vaccines were safe during all states of pregnancy, only to find out no studies had been done on safety during pregnancy during the “safety tests” prior to release of the vaccine. We were told that careful testing on volunteers before the EUA approval for public use demonstrated extreme safety of the vaccines, only to learn that these unfortunate subjects were not followed, medical complications caused by the vaccines were not paid for and the media covered this all up.[67] We also learned that the pharmaceutical makers of the vaccines were told by the FDA that further animal testing was unnecessary (the general public would be the Guinea pigs.) Incredibly, we were told that the Pfizer’s new mRNA vaccines had been approved by the FDA, which was a cleaver deception, in that another vaccine had approval (comirnaty) and not the one being used, the BioNTech vaccine. The approved comirnaty vaccine was not available in the United States. The national media told the public that the Pfizer vaccine had been approved and was no longer classed as experimental, a blatant lie. These deadly lies continue. It is time to stop this insanity and bring these people to justice.

Footnotes

How to cite this article: Blaylock RL. COVID UPDATE: What is the truth? Surg Neurol Int 2022;13:167.

Disclaimer

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Journal or its management.

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Articles from Surgical Neurology International are provided here courtesy of Scientific Scholar

"If the radiance of a thousand suns were to burst at once into the sky, that would be like the splendor of the mighty one." "Now I am become Death, the destroyer of worlds”.

J. Robert Oppenheimer, Scientific director of the Manhattan Project (quoting from the Bhagavad Gita)

by Robert W. Malone MD, MS

Last January, Stew Peters decided to roll out the thesis that I have personal responsibility for the morbidity and mortality associated with the COVID-19 mRNA vaccines consequent to my pioneering work in developing the ideas and reduction to practice of using synthetic mRNA as a transient “gene therapy” method, with the entry level application being for vaccine purposes. This has been echoed by many angry social media detractors seeking to find someone to blame for the lies and adverse events that have been associated with these mRNA vaccines. Mindful of those critics, this Substack essay focuses on some of the differences between what was originally envisioned and the current molecules that are being injected into our bodies. The first section of the essay sets the stage by summarizing (for a general readership) how the whole idea of gene therapy was developed, and then describing how and why this lead to the idea of mRNA as a drug and as a method of generating a vaccine response. The second section gets quite technical, and provides detailed information intended for a scientific audience. The conclusion is written for a general audience.

Gene Therapy, Transhumanism, and the origins of mRNA as a drug or vaccine

The core idea captured in the original nine patents which stem from my work between 1987 and 1989 was that there are multiple key problems with the idea of permanent “gene therapy” as originally envisioned by Richard Roblin, PhD and academic Pediatrician Dr. Theodore Friedman in 1972. The modern embodiment of this concept can be found in the many writings from the WEF and others concerning “Transhumanism” and use of CRISPR/Cas9 gene editing technology. To really understand all of this requires a brief journey through the history and logic of “gene therapy”.

The January 2015 UC San Diego News center piece entitled “Friedman Recognized for Pioneering Gene Therapy Research: School of Medicine professor receives prestigious Japan Prize” nicely summarizes the underlying logic of “Gene Therapy” as envisioned by Friedman and Roblin.

“Though posed as a question, Friedmann and Roblin firmly believed the answer was yes, citing emergent thinking, new studies and growing data that suggested “good DNA” could be used to replace defective DNA in people with inherited conditions.

“In our view,” they wrote, “gene therapy may ameliorate some human genetic diseases in the future. For this reason, we believe that research directed at the development of techniques for gene therapy should continue.”

Though Friedmann said initial response to the paper was “not overwhelming,” it’s now commonly cited as a major milestone in the scientific beginnings of gene therapy research, though Friedmann said it was the Asilomar conference three years later (scientists set safety standards for recombinant DNA technology) where interest really “exploded.”

The idea of gene therapy, which quickly captured the public imagination, was fueled by its appealingly straightforward approach and what Friedmann has described as “obvious correctness”: Disarm a potentially pathogenic virus to make it benign. Stuff these viral particles with normal DNA. Then inject them into patients carrying abnormal genes, where they will deliver their therapeutic cargoes inside the defective target cells. In theory, the good DNA replaces or corrects the abnormal function of the defective genes, rendering previously impaired cells whole, normal and healthy. End of disease.”

Nice theory, what could possibly go wrong? The article continues-

“In 1968, Friedmann, working at the National Institutes of Health in Bethesda, Maryland with the late Jay Seegmiller (a founding faculty member of the School of Medicine) and others, showed that by adding foreign DNA to cultured cells from patients with Lesch-Nyhan syndrome, they could correct genetic defects that caused the rare but devastating neurological disorder. The condition was first described by William Nyhan, MD, a UC San Diego professor of pediatrics, and medical student Michael Lesch in 1964.

The feat was a powerful proof-of-concept, but subsequent efforts to advance the work to human clinical trials stalled. “We began to realize that it would be very complicated to take this idea and make it work in people,” Friedmann said, who joined the School of Medicine faculty in 1969.

In 1990, a 4-year-old girl with a congenital disease called adenoside deaminase (ADA) deficiency, which severely affects immunity and the ability to fight infections, became the first patient treated by gene therapy. White blood cells were taken from her, the normal ADA gene was inserted into them using an engineered and disabled virus and the cells re-injected. Despite initial claims of success, Friedmann said the experiment was eventually deemed a failure. The girl’s condition was not cured, and the research was found wanting.

A report commissioned by National Institutes of Health director Harold Varmus, MD, was highly critical of the entire gene therapy field and the ADA effort in particular, chiding investigators for creating a “mistaken and widespread perception of success.” Friedmann says he took the Varmus report “personally. I felt awful. It almost made me feel like I had been deceiving myself and my colleagues for more than two decades about the promise of gene therapy.” But he also knew there were “many more good people doing gene therapy research than rogues” and continued diligently and conscientiously to pursue his own research.

Nonetheless, media attention and hype about gene therapy continued to be rampant, fueled in part by over-enthusiastic opinions by some scientists. Things crashed in 1999 when an 18-year-old patient named Jesse Gelsinger, who suffered from a genetic disease of the liver, died during a clinical trial at the University of Pennsylvania. Gelsinger’s death was the first directly attributed to gene therapy. Subsequent investigations revealed numerous problems in the experimental design.”

The history of the Varmus report provides an early glimpse of the way things work at NIH and the US HHS. The Scientist appointed to head up the commission to review the science of “Gene Therapy” was none other than my graduate mentor Dr. Inder Verma, who had long been one of the leading proponents of gene therapy, and was subsequently forced to resign from the Salk Institute over a decades long record of what might most gently be called ethical lapses. But this was the scientist appointed by the overall Director of the NIH to “independently” investigate the scientific rigor and merits of the field. One hand washes the other.

What is awry with the original “gene therapy” concept? There are multiple issues, and here are a few-

1) Can you efficiently get genetic material (“polynucleotides”) into the nucleus of the majority of cells in the human body so that any genetic defects (or transhuman genetic improvements) can be made? In short, no. Human cells (and the immune system) have evolved many, many different mechanisms to resist modification by external polynucleotides. Otherwise we would already be overrun by various forms of parasitic DNA and RNA- viral and otherwise. This remains a major technical barrier, one which the “transhumanists” continue to overlook in their enthusiastic but naïve rush to play god with the human species. What are polynucleotides? Basically, the long chain polymers composed of four nucleotide bases (ATGC in the case of DNA, AUGC in the case of RNA) which carry all genetic information (that we know of) across time.

2) What about the immune system? Well, this was one of my breakthroughs way back in the late 1980s. What Ted (Friedman) originally envisioned was the simple idea that if a child had a genetic birth defect causing the body to produce a defective or not produce a critical protein (such as Lesch-Nyhan syndrome or Adenosine Deaminase Deficiency), this could be simply corrected by providing the “good gene” to complement the defect. What was not appreciated was that the immune systems of these children were “educated” during development to either recognize the “bad protein” as normal/self, or to not recognize the absent protein as normal/self. So, introduction of the “go od gene” into a person’s body would cause production of what was essentially a “foreign protein”, resulting in immunologic attack and killing of the cells which now have the ‘good gene”.

3) What happens when things go wrong and the “good gene/protein” is toxic? Well, in the current vaccine situation this is essentially the “Spike protein” problem. I get asked all the time “what can I do to eliminate the RNA vaccines from my body”, to which I have to answer – nothing. There is no technology that I know of which can eliminate these synthetic “mRNA-like” molecules from your body. The same is true for any of the many “gene therapy” methods currently being used. You just have to hope that your immune system will attack the cells that have taken up the polynucleotides and degrade (chew up) the offending large molecule that causes your cells to manufacture the toxic protein. Since virtually all current “gene therapy” methods are inefficient, and essentially deliver the genetic material randomly to a small subset of cells, there is no practical way to surgically remove the scattered, relatively rare transgenic cells. Clearance of genetically modified cells by the cellular immune system (T cells) is the only currently viable method to remove cells that have taken up the foreign genetic information (“transfection” in the case of mRNA or DNA, or “transduction” in the case of a viral vectored gene).

4) What happens if the “good gene” lands in a “bad place” in your genome? It turns out that the structure of our genome is highly evolved, and we are still relative neophytes in our current level of understanding. Despite having sequenced the human genome. The method of “insertional mutagenesis” (sticking genetic information in the form of viral DNA or other ways) has long been one of the leading methods to generate new insights into genetics – from fruit flies to frogs to fish to mice. When new DNA is inserted into chromosomes it can cause many unexpected things to happen. Like development of cancers, for example. This is why there is so much concern about the possibility that the mRNA-like polynucleotides used in the “RNA vaccines” may travel into the nucleus (where the DNA chromosomes reside) and insert or recombine with a cellular genome after reverse transcription (RNA-> DNA). Normally, with DNA-based gene therapy technologies, the FDA requires genotoxicity studies for this reason, but the FDA did not treat the “mRNA vaccine” technology as a gene therapy product.

Based on these risk considerations, the original idea behind using mRNA as a drug (for genetic therapeutic or vaccine purposes) was that mRNA is typically degraded quite rapidly once manufactured or released into a cell. mRNA stability is regulated by a number of genetic elements including the length of the “poly A tail”, but typically ranges from ½ to a couple of hours. Therefore, if natural or synthetic mRNA which is degraded by the usual enzymes is introduced into your body, it should only last for a very short time. And this has been the answer which Pfizer, BioNTech and Moderna have provided to physicians when asked “how long does the injected mRNA last after injection”.

But now we know that the “mRNA” from the Pfizer/BioNTech and Moderna vaccines which incorporates the synthetic nucleotide pseudouridine can persist in lymph nodes for at least 60 days after injection. This is not natural, and this is not really mRNA. These molecules have genetic elements similar to those of natural mRNA, but they are clearly far more resistant to the enzymes which normally degrade natural mRNA, seem to be capable of producing high levels of protein for extended periods, and seem to evade normal immunologic mechanisms for eliminating cells which produce foreign proteins which are not normally observed in the body.

Key findings from this seminal work by Katharina Röltgen et al include the following:

Regarding pseudouridine and mRNA

What is pseudouridine (shorthand symbol Ψ)? Pseudouridine is a modified nucleotide mRNA subunit that is prevalent in natural human mRNAs, and the biologic significance and regulation of the modification process is still being determined and understood. This modification occurs naturally in the cells of our body, in a highly regulated manner. This is in sharp contrast to the random incorporation of synthetic pseudouridine which occurs with the manufacturing process used for producing the Moderna and Pfizer/BioNTech (but not CureVac) COVID-19 “mRNA” vaccines. The “state of the art” of understanding of the biology of natural pseudouridine modifications is summarized circa late 2020 in this excellent review published in the journal Annual Review of Genetics by Erin K Borchardt et al. The open source version (not paywall protected) can be found here. Hang on, because we are about to dive into some serious immunology, molecular and cell biology.

Abstract as follows:

“Recent advances in pseudouridine detection reveal a complex pseudouridine landscape that includes messenger RNA and diverse classes of noncoding RNA in human cells. The known molecular functions of pseudouridine, which include stabilizing RNA conformations and destabilizing interactions with varied RNA-binding proteins, suggest that RNA pseudouridylation could have widespread effects on RNA metabolism and gene expression. Here, we emphasize how much remains to be learned about the RNA targets of human pseudouridine synthases, their basis for recognizing distinct RNA sequences, and the mechanisms responsible for regulated RNA pseudouridylation. We also examine the roles of noncoding RNA pseudouridylation in splicing and translation and point out the potential effects of mRNA pseudouridylation on protein production, including in the context of therapeutic mRNAs.”

A more recent (peer reviewed) publication in the journal Molecular Cell has shed light on some of the mechanisms of action associated with natural pseudouridine modification. It appears that, in the natural context, various highly regulated cellular enzymes (for example PUS1, PUS7, and RPUSD4) act on specific mRNAs and specific locations within those mRNAs while they are being made in the cell to modify the normal uridine nucleotide subunit to form pseudouridine. These modifications occur at locations associated with alternatively spliced RNA regions, are enriched near splice sites, and overlap with hundreds of binding sites for RNA-binding proteins. Latest data indicate that pre-mRNA pseudouridylation is used by human cells to regulate human gene expression via alternative pre-mRNA processing.

Relevant to the “mRNA” vaccines, the Borchardt review makes the following surprising statement, which is consistent with the Cell paper cited above which demonstrates that the synthetic “mRNA” being used for these vaccines persists in patient lymph node tissue for 60 days or longer-

“An exciting possibility is that regulated mRNA pseudouridylation controls mRNA metabolism in response to changing cellular conditions.”

That is a technically precise way of saying that incorporation of pseudouridine is one factor that controls how long an mRNA stays around in your body.

The review proceeds with the following alarming (from the context of the unregulated incorporation of Ψ into the molecules used for vaccine purposes) statement:

“The biological effects of Ψ must originate in chemical differences between U and Ψ, which primarily affect RNA backbone conformation and the stability of base pairs. Because Ψ can form stable pairs with G, C and U in addition to A, it has been proposed as a “universal” base pairing partner. Despite intensive study of the structural effects of Ψ on short, synthetic RNA oligos, it is currently impossible to predict the structural outcome of site-specific RNA pseudouridylation in longer RNAs. The systematic investigation of sequence-context effects on the stability of Ψ-containing duplexes is an important step towards accurate predictions. It will be important to determine the structural consequences of RNA pseudouridylation in cells, which is possible using improved methods to probe RNA structure in vivo.”

Furthermore,

“The effect of Ψ on the yield of functional protein depends strongly on the specific codons used. The mechanisms underlying this sequence dependence are unknown, highlighting how much remains to be understood about the translational consequences of mRNA pseudouridylation in cells.”

Finally, relevant to the immunosuppression being observed after multiple mRNA vaccine boosters (which is increasingly referred to as an acquired immunodeficiency syndrome or AIDS disease), Borchardt et al teach the following:

“Innate Immunity

Cells are equipped with innate immune sensors, including various Toll-like receptors (TLRs), retinoic acid inducible protein (RIG-I), and protein kinase R (PKR), which detect foreign nucleic acid. RNA modifications have been thought to provide a mechanism for discerning “self” RNA from non-self RNA, and indeed, incorporating RNA modifications, including pseudouridine, in foreign RNA allows for escape from innate immune detection. This makes RNA modification a powerful tool in the field of RNA therapeutics where RNAs must make it into cells without triggering an immune response, and remain stable long enough to achieve therapeutic goals. In addition, the presence of modified nucleosides in viral genomic RNA could contribute to immune evasion during infection.

TLRs Toll-Like Receptors (TLRs) are membrane-associated proteins which detect various pathogen associated molecular patterns (PAMPS) and subsequently stimulate production of proinflammatory cytokines. The RNA-sensing TLRs, TLR3, TLR7 and TLR8 reside within endosomal membranes. TLR3 recognizes dsRNA, while TLR7 and TLR8 recognize ssRNA. Upon target recognition, TLRs activate a signaling cascade that results in the expression of proinflammatory cytokines and interferon. In vitro transcribed RNA is immunostimulatory when transfected into HEK293 cells engineered to express either TLRs and inclusion of Ψ in the RNA suppressed this response (most pronounced for TLR7 and TLR8).

RIG-I Retinoic Acid Inducible Protein (RIG-I) is a cytosolic innate immune sensor responsible for detecting short stretches of dsRNA or ssRNA with either a 5′-triphosphate or 5′-disphosphate group (a feature common to various RNA viruses). Activation of RIG-I relieves its autoinhibition, releasing its CARD domains to interact with MAVS and set off a signaling cascade that ultimately results in expression of immune factors. Inclusion of Ψ in a 5′-triphosphate capped RNA abolishes activation of RIG-I, providing another mechanism for pseudouridine-mediated suppression of innate immune activation. Further, the polyU/UC region of the HCV genome is also potent activator of RIG-I and complete replacement of U with Ψ in this RNA fully abrogates downstream IFN-beta induction, despite RIG-I still binding to the modified RNA, but with reduced affinity. Durbin et al present biochemical evidence that RIG-I bound to pseudouridylated polyU/UC RNA fails to undergo the conformational changes necessary to activate downstream signaling.

PKR RNA-dependent Protein Kinase (PKR) is a cytosolic resident innate immune sensor. Upon detection of foreign RNA, PKR represses translation through phosphorylation of translation initiation factor eIF-2alpha. Molecules which activate PKR are varied, but include dsRNA formed intra- or inter-molecularly, and 5′ triphosphate groups. Inclusion of Ψ in various PKR substrates reduces PKR activation and downstream translation repression relative to unmodified RNAs. For example, a short 47-nt ssRNA potently activates PKR when synthesized with U but not with Ψ (~30-fold reduction with Ψ). Ψ also modestly reduced PKR activity when this short RNA was annealed to a complementary unmodified RNA 170. Likewise, in vitro transcribed, unmodified tRNA acted as much more potent activator of PKR than tRNAs transcribed with pseudouridine. It should be noted that it is unclear whether a fully pseudouridylated tRNA adopts canonical folding and what impact this may have on PKR recognition of this substrate. Finally, transfection of an unmodified mRNA caused a greater reduction in overall cellular protein synthesis in cell culture compared to the same mRNA fully pseudouridylated. Consistent with this result, fully pseudouridylated mRNA reduced PKR activation and subsequent phosphorylation of eIF-2alpha.”

Regarding the consequences for the use of mRNA as a drug for therapeutic or vaccine purposes, Borchardt et al conclude that

“Pseudouridine likely affects multiple facets of mRNA function, including reduced immune stimulation by several mechanisms, prolonged half-life of pseudouridine-containing RNA, as well as potentially deleterious effects of Ψ on translation fidelity and efficiency.”

Conclusion

Based on this information, it appears to me that the extensive random incorporation of pseudouridine into the synthetic mRNA-like molecules used for the Pfizer/BioNTech and Moderna SARS-CoV-2 vaccines may well account for much or all of the observed immunosuppression, DNA virus reactivation, and remarkable persistence of the synthetic “mRNA” molecules observed in lymph node biopsy tissues by Katharina Röltgen et al. Many of these adverse effects were reported by Kariko, Weissman et al in their 2008 paper “Incorporation of pseudouridine into mRNA yields superior nonimmunogenic vector with increased translational capacity and biological stability” and could have been anticipated by regulatory and toxicology professionals if they had bothered to consider these findings prior to allowing emergency use authorization and widespread (global) deployment of what is truly an immature and previously untested technology. Therefore, neither the FDA, NIH, CDC, nor BioNTech (which employs Dr. Kariko as a Vice President) nor Moderna can claim true ignorance. To my eyes, what we have seen is more appropriately classified as “willful ignorance”.

In conclusion, based on these data it is my opinion that the random and uncontrolled insertion of pseudouridine into the manufactured “mRNA”-like molecules administered to so many of us creates a population of polymers which may resemble natural mRNA, but which have a variety of properties which distinguish them in a variety of aspects which are clinically relevant. These characteristics and activities may account for many of the unusual effects, unusual stability, and striking adverse events associated with this new class of vaccines. These molecules are not natural mRNA, and they do not behave like natural mRNA.

The question that most troubles and perplexes me at this point is why the biological consequences of these modifications and associated clinical adverse effects were not thoroughly investigated before widespread administration of random pseudouridine-incorporating “mRNA”-like molecules to a global population. Biology, and particularly molecular biology, is highly complex and matrix-interrelated. Change one thing over here, and it is really hard to predict what might happen over there. That is why one must do rigorously controlled non-clinical and clinical research. Once again, it appears to me that the hubris of “elite” high status scientists, physicians and governmental “public health” bureaucrats has overcome common sense, well established regulatory norms have been disregarded, and patients have unnecessarily suffered as a consequence.

When will we ever learn.

Vaccine spike antigen and mRNA persist for two months in lymph node germinal centers... protein production of spike is higher than those of severely ill COVID-19 patients!

Immune imprinting, breadth of variant recognition and germinal center response in human SARS-CoV-2 infection and vaccination Cell. Published:January 24, 2022DOI:https://doi.org/10.1016/j.cell.2022.01.018

Highlights (per the journal)

• Vaccination confers broader IgG binding of variant RBDs than SARS-CoV-2 infection
• Imprinting from initial antigen exposures alters IgG responses to viral variants
• Histology of mRNA vaccinee lymph nodes shows abundant germinal centers
• Vaccine spike antigen and mRNA persist for weeks in lymph node germinal centers

The hidden highlight (lede) buried in this peer reviewed paper is that protein production of spike in people vaccinated with the Moderna or Pfizer vaccine is higher than those of severely ill COVID-19 patients! A person might ask, “How could that be?” In order to understand this, we must carefully analyze what the study shows.

This study asserts that the mRNA and the spike protein produced persists for weeks in lymph node germinal centers in human patients. Having worked with mRNA for decades, I can attest that this is highly unusual.

One very real hypothesis is that the substitution of pseudouridine for uridine to avoid the immune response is working so well that the mRNA is completely evading the normal clearance/degradation pathways. Hence, mRNA that is not being incorporated into cells at the injection site, is migrating to the lymph nodes (and throughout the body as the non-clinical Pfizer data suggest?) and continuing to express protein there. In this case, the cytotoxic protein antigen is spike. Spike protein can be detected for at least 60 days after administration of dose. Note that the duration of the protein expression was only tested for 60 days.

The spike protein, let’s review what it is and how it is being used (from the Daily Skeptic):

These new gene-based ‘vaccines’ are working in a completely novel way – nothing remotely resembling that of traditional vaccines. Given that pharmaceutical companies work competitively it was also somewhat of a surprise they took the same approach of targeting what has been termed the ‘spike protein’ of the SARS-CoV-2 virus.

This (spike) protein is nasty – sometimes being referred to as a ‘pathogenic protein’ – and is recognised as causing many of the awful pathologies associated with the disease of COVID-19. Logically you would inactivate or at least attenuate this nasty spike protein and develop a vaccine around the attenuated virus. But that’s not what was done. These ‘vaccines’ do not contain any of the offending virus at all but rather the gene sequence that causes the nasty spike protein to be made in the body. We have little idea how much of this nasty protein is produced or for how long it lasts after an injection of the gene sequence. Furthermore, stimulating the body’s own complex biological systems to produce the spike protein will mean that the amount of protein produced will vary from person to person. The idea is that the spike protein produced by the gene encoding it elicits a response by our immune system to produce antibodies directed against the spike. When the wild virus comes along and infects us the antibodies recognise the spike protein and attack it thus preventing its nasty effects. And it does, though as we have since learnt this approach isn’t very good at preventing infection or stopping its transmission. Are we perhaps clutching at straws too in claiming that these ‘vaccines’ are preventing serious disease and death? Have we not learnt anything over the past two years in treating Covid symptoms with conventional therapeutic drugs?

Knowing what we know about the spike protein in these vaccines, the study quantitatively measured spike protein levels in plasma after vaccination. Which, it turns out, are higher than the levels observed in a person with a severe COVID-19 infection. Just to write it, the fact that this only now being discovered or it it was known, released to the public is criminal in my opinion. This should have been characterized long ago, including prior to beginning human clinical trials.

That this has not been published or investigated more demonstrates the gross regulatory dereliction of duty by Pfizer, Biointech, Moderna, NIAID VRC and that whole crew. Using these vaccines, which include pseudouridine without fully understanding the implications and without the FDA requiring a complete pre-clinical toxicology regulatory package, including long-term follow-up, as is done with any other unique chemical or adjuvant additive is shocking. Then there is the novel use of the unique nano particles being used in these vaccines, which also were only marginally assessed, as shown by the Japanese Pfizer data.

Protein expression is not being turned off, because the immune response against the mRNA/pseudouridine complex is either not happening or is ineffective. It may also be that the mRNA/pseudouridine complex has a longer half-life than normal mRNA. The In either case, this is regulatory nightmare.

I do not know how to write this more strongly. This technology is immature. The WHO has approved six, more traditional vaccines, all of which the US government could license. These genetic vaccines are not the only option.

To note: The use of pseudouridine in these mRNA vaccines is not the only option. It has often been hypothesized that the reason Dr. Kariko added pseudouridine to the mRNA vaccine was to make an improvement to the original mRNA patents that I was an inventor on. An improvement to an existing patent allows commercialization of that patent. It is an old trick. Remember, that Curevac does not use pseudouridine in its formulation and it is not required or necessary for a significant immune response. In the next generation of mRNA vaccine experiments (hopefully done in an animal model), it is clear that the issues of adding pseudouridine need to be addressed prior to any more of these vaccines going into humans.

I know the following from the paper is long, but it is very important.

Prolonged detection of vaccine mRNA in LN GCs, and spike antigen in LN GCs and blood following SARS-CoV-2 mRNA vaccination

The biodistribution, quantity and persistence of vaccine mRNA and spike antigen after vaccination (with the Pfizer vaccine), and viral antigens after SARS-CoV-2 infection, are incompletely understood but are likely to be major determinants of immune responses. We performed in situ hybridization with control and SARS-CoV-2 vaccine mRNA-specific RNAScope probes in the core needle biopsies of the ipsilateral axillary LNs that were collected 7-60 days after 2nd dose of mRNA-1273 or BNT162b2 vaccination, and detected vaccine mRNA collected in the GCs of LNs on day 7, 16, and 37 post vaccination, with lower but still appreciable specific signal at day 60 (Figures 7A -7E). Only rare foci of vaccine mRNA were seen outside of GCs. Axillary LN core needle biopsie of non-vaccinees (n = 3) and COVID-19 patient specimens were negative for vaccine probe hybridization. Immunohistochemical staining for spike antigen in mRNA vaccinated patient LNs varied between individuals, but showed abundant spike protein in GCs 16 days post-2nd dose, with spike antigen still present as late as 60 days post-2nd dose. Spike antigen localized in a reticular pattern around the GC cells, similar to staining for follicular dendritic cell processes (Figure 7B). COVID-19 patient LNs showed lower quantities of spike antigen, but a rare GC had positive staining (Figure 7F). Immunohistochemical staining for N antigen in peribronchial LN secondary and primary follicles of COVID-19 patients (Figures 7F - 7I) was positive in 5 of the 7 patients, with a mean percentage of nucleocapsid-positive follicles of more than 25%.

Discussion One of the positive developments amid the global calamity of the SARS-CoV-2 pandemic has been the rapid design, production and deployment of a variety of vaccines, including remarkably effective mRNA vaccines encoding the viral spike (Baden et al., 2021; Polack et al., 2020). We find that BNT162b2 vaccination produces IgG responses to spike and RBD at concentrations as high as those of severely ill COVID-19 patients and follows a similar time course. Unlike infection, which stimulates robust but short-lived IgM and IgA responses, vaccination shows a pronounced bias for IgG production even at early time point

Read that again: Protein production of spike is higher than those of severely ill COVID-19 patients!

The paper also notes that the antibody response is IgG, not IgA or IgM. IgA and IgM antibodies produce a strong mucosal immune response needed for respiratory diseases, unlike IgG.

This Substack article has only skimmed the surface of the implications of this paper in terms of both the science and the malfeasance on the part of our government and pharmaceutical corporations. There is more to come on this issue.

To get to the full paper to download, click here.

Why Weren’t These Vaccines Put Through the Proper Safety Trials For Gene Technology, Asks a Former Pharmaceutical Research Scientist The Daily Skeptic 7 February 2022 by Dr. John D. Flack

This article by the daily skeptic does a great job at documenting that appropriate studies have not been done and even attempts to answer the question why:

Are we perhaps clutching at straws too in claiming that these ‘vaccines’ are preventing serious disease and death? Have we not learnt anything over the past two years in treating Covid symptoms with conventional therapeutic drugs?

Perhaps this has driven Big Pharma to pursue a new more profitable model based on protecting the healthy rather than treating the sick? Enter the era of the gene-based ‘vaccines’. The new technologies have had a long and difficult gestation period with several stillbirths. But perhaps their time had come with the ‘unprecedented’ virus from the East. A declared worldwide health emergency demanded a technological response, and it was there in waiting. But have we been blinded and duped by technology and lost sight of the end game of providing safe and effective medicines? Was it a judicious use of the PCR, rapid antigen test technology and information APP technology to drive the test and trace fiasco?

Was the gene technology ready to be used in a mass world-wide vaccination programme without a thorough examination of the potential problems of short- and long-term safety of this previously untested technology?

In my view, technocracy has trumped the sound principles, established over decades and centuries, of basic medical practice, immunology, virology, pharmaceutical sciences and public health generally. In the process, political democracy, personal freedoms, free speech and choice have been dangerously sidelined and even censored.

1. Peter Doshi, senior editor,

2. Fiona Godlee, former editor in chief,

3. Kamran Abbasi, editor in chief

4. The BMJ, London, UK

5. Correspondence to: P Doshi Pdoshi{at}bmj.com

Data should be fully and immediately available for public scrutiny

In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.1234

The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data.56 Public battles for drug company data,78 transparency campaigns with thousands of signatures,910 strengthened journal data sharing requirements,1112 explicit commitments from companies to share data,13 new data access website portals,8 and landmark transparency policies from medicines regulators1415 all promised a new era in data transparency.

Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come.16 This is morally indefensible for all trials, but especially for those involving major public health interventions.

Unacceptable delay

Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data.17 And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023 (NCT04368728).

The lack of access to data is consistent across vaccine manufacturers.16 Moderna says data “may be available … with publication of the final study results in 2022.”18 Datasets will be available “upon request and subject to review once the trial is complete,” which has an estimated primary completion date of 27 October 2022 (NCT04470427).

As of 31 December 2021, AstraZeneca may be ready to entertain requests for data from several of its large phase III trials.19 But actually obtaining data could be slow going. As its website explains, “timelines vary per request and can take up to a year upon full submission of the request.”20

Underlying data for covid-19 therapeutics are similarly hard to find. Published reports of Regeneron’s phase III trial of its monoclonal antibody therapy REGEN-COV flatly state that participant level data will not be made available to others.21 Should the drug be approved (and not just emergency authorised), sharing “will be considered.” For remdesivir, the US National Institutes of Health, which funded the trial, created a new portal to share data (https://accessclinicaldata.niaid.nih.gov/), but the dataset on offer is limited. An accompanying document explains: “The longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives.”

We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymised individual participant data from clinical trials must be made available for independent scrutiny.

Journal editors, systematic reviewers, and the writers of clinical practice guideline generally obtain little beyond a journal publication, but regulatory agencies receive far more granular data as part of the regulatory review process. In the words of the European Medicine Agency’s former executive director and senior medical officer, “relying solely on the publications of clinical trials in scientific journals as the basis of healthcare decisions is not a good idea ... Drug regulators have been aware of this limitation for a long time and routinely obtain and assess the full documentation (rather than just publications).”22

Among regulators, the US Food and Drug Administration is believed to receive the most raw data but does not proactively release them. After a freedom of information request to the agency for Pfizer’s vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete, arguing in court that publicly releasing data was slow owing to the need to first redact sensitive information.23 This month, however, a judge rejected the FDA’s offer and ordered the data be released at a rate of 55 000 pages a month. The data are to be made available on the requesting organisation’s website (phmpt.org).

In releasing thousands of pages of clinical trial documents, Health Canada and the EMA have also provided a degree of transparency that deserves acknowledgment.2425 Until recently, however, the data remained of limited utility, with copious redactions aimed at protecting trial blinding. But study reports with fewer redactions have been available since September 2021,2425 and missing appendices may be accessible through freedom of information requests.

Even so, anyone looking for participant level datasets may be disappointed because Health Canada and the EMA do not receive or analyse these data, and it remains to be seen how the FDA responds to the court order. Moreover, the FDA is producing data only for Pfizer’s vaccine; other manufacturers’ data cannot be requested until the vaccines are approved, which the Moderna and Johnson & Johnson vaccines are not. Industry, which holds the raw data, is not legally required to honour requests for access from independent researchers.

Like the FDA, and unlike its Canadian and European counterparts, the UK’s regulator—the Medicines and Healthcare Products Regulatory Agency—does not proactively release clinical trial documents, and it has also stopped posting information released in response to freedom of information requests on its website.26

Transparency and trust

As well as access to the underlying data, transparent decision making is essential. Regulators and public health bodies could release details27 such as why vaccine trials were not designed to test efficacy against infection and spread of SARS-CoV-2.28 Had regulators insisted on this outcome, countries would have learnt sooner about the effect of vaccines on transmission and been able to plan accordingly.29

Big pharma is the least trusted industry.30 At least three of the many companies making covid-19 vaccines have past criminal and civil settlements costing them billions of dollars.31 One pleaded guilty to fraud.31 Other companies have no pre-covid track record. Now the covid pandemic has minted many new pharma billionaires, and vaccine manufacturers have reported tens of billions in revenue.32

The BMJ supports vaccination policies based on sound evidence. As the global vaccine rollout continues, it cannot be justifiable or in the best interests of patients and the public that we are left to just trust “in the system,” with the distant hope that the underlying data may become available for independent scrutiny at some point in the future. The same applies to treatments for covid-19. Transparency is the key to building trust and an important route to answering people’s legitimate questions about the efficacy and safety of vaccines and treatments and the clinical and public health policies established for their use.

Twelve years ago we called for the immediate release of raw data from clinical trials.1 We reiterate that call now. Data must be available when trial results are announced, published, or used to justify regulatory decisions. There is no place for wholesale exemptions from good practice during a pandemic. The public has paid for covid-19 vaccines through vast public funding of research, and it is the public that takes on the balance of benefits and harms that accompany vaccination. The public, therefore, has a right and entitlement to those data, as well as to the interrogation of those data by experts.

Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims.33 The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it is to protect the health of their populations. We need complete data transparency for all studies, we need it in the public interest, and we need it now.

Footnotes

• Competing interests: We have read and understood BMJ policy on declaration of interests and declare that The BMJ is a co-founder of the AllTrials campaign. PD was one of the Cochrane reviewers studying influenza antivirals beginning in 2009, who campaigned for access to data. He also helped organise the Coalition Advocating for Adequately Licensed Medicines (CAALM), which formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). PD is also a member of Public Health and Medical Professionals for Transparency, which has sued the FDA to obtain the Pfizer covid-19 vaccine data. The views and opinions do not necessarily reflect the official policy or position of the University of Maryland.

• Provenance and peer review: Commissioned; externally peer reviewed.

This key post in the Politics of Care series stems from an invite from Norman Fenton to give a lecture on December 6 to a group interested in the evidence swirling around vaccines. It is accompanied by The Handmaid’s Vaccine on RxISK, which gives a video of the talk, whose text and slides are below. The sound effects in the video are slightly mixed at one or two point and you might need the text to clarify the points made.

This talk is for all who are interested in evidence and how we generate it as well as for a group of people who are pro-vaccine, to the point of being volunteers in clinical trials, but who have ended up being harmed by them. They are the ones doing the science and demonstrating what science means – as I’ll explain – but their work is written off as misinformation.

The company handling of SSRI harms shows we came to classify real Evidence as misinformation. Many of the company tricks involved in this effort to persuade us the world is flat will be known to you but the brazenness with which they were deployed and the failure of physicians to spot what was going on may be new.

Slide 2

I have a doctorate in Serotonin Reuptake and was keen to try the SSRIs early on. Two men I put on Prozac became suicidal. Their problems cleared after stopping and re-emerged on starting another serotonin reuptake inhibitor and stopped again after stopping. See Creaney et al.

This is as clear a causal connection as you can get anywhere in science. I sent the cases to Lilly for comment and presented them in forums. No-one offered alternate explanations. Others reported similar cases during the year to publication of this article.

Slide 3

This rash of cases forced FDA to require Lilly to defend their drug. As my article came out, Lilly published this Beasley et al article in the BMJ. It came out on the same day the company presented their case at an FDA hearing – September 20, 1991 – stating:

• The plural of anecdote is not data
• It’s the disease not the drug
• Are you going to believe the misinformation or the science?
• It’s all the fault of the Church of Scientology (1991’s Anti-vaxxers).

The BMJ article shows more suicidal events on Prozac but the paper said these were not statistically significant and so there was no problem. FDA talked about heart-breaking cases reported to them but concluded the science didn’t link Prozac to the problem.

Slide 4

Here is Tony Hill, who created RCTs, saying 20 years later RCTs can help assess one of the 100 things a drug does – something we might be able to use for treatment purposes. This, by definition, means RCTs are not a good way to evaluate a drug. See Clinical Trials are not Safe.

Saying RCTs are not the way the truth and the light, these days, is like saying the Bible, the Koran or the US Constitution aren’t reliable.

Slide 5 Watch this.

Slide 6

In a depression trial, investigators focus intensely on one thing – does Prozac have an effect on mood. Pretty well everything else is ignored. The statistics we use don’t work unless there is an intense effort to collect everything we can about this one outcome.

And so, depression trials miss something that happens to almost everyone who takes an SSRI within 30 minutes of the first pill – your genitals go numb. You can search the RCTs on these drugs and all you will find is that perhaps 5% of people have sexual issues on these drugs.

Emotional numbing is another extremely common effect almost completely missed. This is how these drugs help. This is how these drugs might help someone diagnosed as depressed but the key point is that it is much more common than depression recovery.

Similarly in the vaccine trials, the common thing is a multiplicity of Spike protein effects – doing this we hope might help but if we are hypnotized by what is hoped for we will miss and have missed what these Spike proteins are actually doing.

If we just depend on RCTs, we end up knowing almost nothing about a drug.

The idea that an RCT shows there is a favourable Risk-Benefit ratio for a drug or vaccine can only hold true if the thing we are looking at is the commonest thing this vaccine does – like a parachute for instance. The commonest thing is a life saved and the Risk Benefit is favourable but we don’t need an RCT for parachutes.

If what we are hoping for is pretty rare – as in vaccine or SSRI trials – and in particular if we don’t know what we are missing, such as an obliteration of our ability to make love, perhaps for all time, then claiming a favourable Risk Benefit ratio is psychotic.

Slide 7

The first rating scale for behaviour was the Hamilton Rating Scale for Depression. An aid to make sure physicians checked on most of the things that might be abnormal in depression while they were interviewing a patient. An aid to help a doctor do an interview that would help the patient to live the life they wanted to live.

If you cleave to the checklist you will do very standardized but possibly disastrous interviews. For instance, on the Hamilton Scale, there is an item on suicide which could stem from the illness or from the drug – it needs a judgement call as to which of these is responsible. Ditto for sex, for sleep. Just checking yes for suicidality risks going badly wrong.

Checklists like these however became viewed as scientific instruments. They look better to hospital managers than DH asking about your daughter or partner. Without judgements, in medicine we call these diagnoses, rating scales are meaningless – other than to help a doctor to help you to live the life Pfizer want you to live.

Slide 8

The latest twist on this story are the rating scales for adverse events companies now run electronically which let people rate up to 12 things that happen after the vaccine – such as sore arm, headache, nausea etc. This ensures certain events become statistically significant – and are put forward as a result as the only things we know for sure happen on the vaccine. See Johanna Ryan’s work on Virtual Trials.

There is no area for people to contribute anything else – so reports of other adverse events end up coming from outside the trial and are viewed anecdotes – misinformation. Companies like Pfizer tally anecdotes. What else would you do with misinformation?

Slide 9

Here is Fluvoxamine, an SSRI supposedly good for Covid. There have been lots of dropouts in the trials done on this, enough to invalidate the trial.

Side effects though could be endorsed on pre-populated lists that included cough, fever, nausea etc but not suicidality, homicidality, sexual dysfunction or the other things this drug causes that were likely responsible for the huge dropout rate.

Many look to drugs like this as an alternate to vaccines. Some doctors advocate them as our Hi Tech versus Albert Bourla’s Hi Tech. There are lots of low tech things that might be more helpful like getting you off some of the Tech you’re on rather than throwing more Hi Tech at you.

As we throw Hi Tech at you, we miss the fact that RCTs convert poisons, from whose use we hope to bring some good, into sacraments – something that can only do good. Most believers figure having as many sacraments as you can daily is a good thing where its seems equally obvious to most of us that taking more than one poison at the same time is unlikely to be all that safe.

One more quirk is companies always want their Ugly Ducklings to have an I’m a Swan moment – thalidomide was the fourth most profitable drug in the US last year but will be pushed down to fifth by Albertine this year. Thalidomide is a drug that causes suicidality, sexual dysfunction and birth defects – just like the SSRIs including fluvoxamine.

Slide 10

For drug companies, rating scales ensure you do an interview that produces figures which are the most seductive way to get the patient on their drug. The interview helps you to help them to live the life Pfizer want them to live.

This is not just true for rating scales, it is true for any measure – peak flow rates, bone densities, blood pressure or lipids, or sugar. It may be important to do something about some figures, but the goal is to help people to live the life they want to live – not the life Pfizer want them to live.

A stopwatch can be a wonderful motivator to achieve a dream – it provides data from one fraction of our lives. If we remain on top of that fine – but what about weighing scales? Just after they were introduced we got the first descriptions of anorexia nervosa. In the 1920s, they had norms for ideal weight attached to them and eating disorders mushroomed. They migrated into our homes in the 1960s and eating disorders became epidemic.

It’s very difficult to ignore figures for weight. Without data from every other aspect of our lives at the same time, we risk being trapped by this one data source. We become neurotic.

Can we let bone densities remain thin, or lipid levels remain high? Yes, we can. You think of post-mortems as something that reveal what we died from – they more often reveal what we can live with.

Slide 11

Figures create risks and pharma makes money from treating risks rather than diseases. We are seduced into taking drugs when we are healthy.

The Covid dashboards are a great mechanism to generate perceptions of risk and fear. The vaccines of course treat risks – not disease.

The Meatloaf title Paradise by the Dashboard Light is what Pfizer sees but its Hell by the Dashboard Light for us – this now extends to the evaluation of lectures and ensures we pander to people rather than challenge them.

It’s extraordinary how little we have put into treating SARS-Cov, the disease in this case and its associated pneumonia. Curing diseases is not a good business model.

Slide 12 As Peter Drucker, the Guru of Marketing Science put it 50 years ago:

The goal of marketing is to make selling superfluous. The aim is to know and understand the customer so well that the product or service fits and sells itself.

Slide 13

Imipramine was the first antidepressant. It beats the later SSRIs in RCTs. It treats melancholia – they can’t. They are useless for severe depression. Melancholia comes with a high risk of suicide.

Imipramine was launched in 1958. A year later at a meeting in England, Danish psychiatrists made it clear that while it was a wonderful treatment it made some people suicidal.

Let’s do a thought RCT of imipramine versus placebo in melancholia. Even though it can cause suicide, we would expect it to reduce the number of suicides because it treats the condition. This RCT would be great evidence antidepressants do not cause suicide.

Slide 14

Here is the data on the trials in mild depression that brought the SSRIs to market – a doubling of suicidal events compared to placebo.

Slide 15

Imipramine looks the same in mild depressions. Now it too causes suicides. So RCTs tell us nothing about cause and effect – they can give us diametrically opposite answers. This is because these aren’t drug trials. They are Treatment Trials and in any clinical Trial, the condition confounds the effects of the drugs.

People evaluating drugs pre-RCTs knew this. When a patient becomes suicidal in a trial you have to use your judgement to work out what has happened but you are told not to.

Slide 16

This is true in every clinical situation where drugs and conditions cause superficially similar effects – diabetes and glitazones both cause heart failure, osteoporosis and bisphosphonates both cause fractures – and this makes it impossible for an algorithmic exercise as most RCTs are to establish what is happening.

Slide 17

Here is what a real drug trial looks like. Companies ran these studies in the 1980s and found that SSRIs make healthy volunteers suicidal, cause dependence and sexual dysfunction but we heard nothing about this when the drugs launched. These Trials enabled companies to game their Treatment Trials to hide these problems.

Vaccine trials are healthy volunteer trials.

Slide 18

This slide shows data straight from a 2006 GlaxoSmithKline paper. GSK’s SSRI paroxetine was in trouble – the RCTs data for Major Depressive Disorder seem to show paroxetine causes suicidal events. The real data are likely worse that GSK admit to here.

Slide 19

But never fear RCTs come to the rescue. GSK also did trials in people with Intermittent Brief Depressive Disorders – IBDD. These are borderline personality disorder to most people – patients who have suicidal events much more often than anyone else. But these patients can meet criteria for depression and could be entered into Depression RCTs.

Slide 20

Prozac in these patients didn’t work. Paroxetine didn’t either and had a 3-fold higher suicidal act rate than placebo. GSK then did another trial in a similar group of patients. Why?

The answer is here. Here are IBDD data from the two GSK trials. I have seen other data for these two trials which make paroxetine look worse but let’s stick with GSK’s story. We could even add 16 more events to the paroxetine arm and still get the same magical outcome

When you add the IBDD data to the MDD data – all of a sudden paroxetine doesn’t cause suicidal events it protects against them.

Something like this must happen in every treatment trial with heterogenous patients – back pain, breast cancer, diabetes, hypertension, osteoporosis, parkinson’s disease. We can use an effect a drug causes to hide an effect a drug causes.

RCTs are not a way to work out what is going on. Back pain trials will insist you use analgesics rather than antibiotics – which is wrong for the 10% of backpains caused by infections.

Slide 21

You’ve seen the son of this slide before. Here are the parents. In all AD RCTs there was a 2-week washout period during which patients were whipped off prior medicines. We now know this was a tricky thing to do – it gives lots of suicides – a bit like the two-week post vaccine period.

But companies argued as the patients were on nothing, all these events should be counted as placebo events – as the diagram here illustrates.

Slide 22

The Prozac 1991 paper had an increased number of suicidal events – but hey not statistically significant. Undo this maneuver –– and they are statistically significant.

Here are the paroxetine data presented to FDA. We’d prefer the figures for paroxetine to be better than placebo but what’s a fraction between friends.

Slide 23

Undo the washout maneuver and this is what the data looked like. FDA knew what was going on and that it breached regulations and did nothing. And these figures don’t look like a drug that should be approved without warnings.

Slide 24

When that was rumbled, companies changed the game. Patients terminated from their SSRI who went into withdrawal and became suicidal were viewed as placebo, while those who stopped placebo and were put on an SSRI and committed suicide were classified as a placebo suicide – on an intention to treat basis. Regulators didn’t ask questions.

Slide 25

Sylvia Plath committed suicide a week into an antidepressant – a common timeframe.

Slide 26

This advert is for the type of antidepressant she was given, an MAOI, featuring a space shuttle, aimed to giving doctors the impression this drug will get their patients into orbit faster.

Slide 27

Here is a space shuttle – the safest transport ever per million miles travelled – but not so safe if expressed in terms of exits from and entries back into earth’s atmosphere.

Rather than express suicidal events per patient exposed companies stuck to events per thousand patient years – having taken care to ensure some patients doing well remained in extended follow-up for months or years.

Slide 28

When the RCT data turned tricky and we got Black Box Warnings – companies turned to Real World Evidence – like national suicide rates. Here you see the claims for Norway which were typical of all Nordic countries – as SSRI use increased suicide rates fell – which is not compatible with the SSRI data.

If you look though suicide rates are going up with pre SSRI AD use until about 1988 – 3-4 years pre SSRI when they begin to fall.

Slide 29

Here is Norway again where you see suicide rates falling from 88 or so and what you see if them rising as autopsy rates rise and then falling in step – as ill-defined deaths fall and rise.

Slide 30 This is true for all the Nordic countries – See Reseland et al.

Slide 31

We routinely hear that SSRI use is escalating. It’s not – the same number of people go on them each year. The increase speaks to the growing numbers who are dependent on them.

Slide 32

This has implications for suicide rates – you are only likely to see an effect on an index like this during the first few years. In the case of vaccines, this years rate of myocarditis and thromboses will become the new normal – See Healy and Aldred 2005.

Slide 33

In 1999 I was asked to participate as a speaking at a company symposium in London – speakers would need to produce articles for a supplement. I said yes and soon after had an email with my article. It was a great Healy article saying the things Healy say in the way he says them with Healy references. No one who knew my stuff would pick it out as not mine.

I emailed back saying I figured on writing my own. There was surprise at the other end but they said okay. I sent it on to them and they said this is rather good but there are some important commercial messages in the other one – we’ll get Siegfried Kasper to put his name on it.

Here it is – only one word changed from the original paper – the name of author Kasper. Everybody in Vienna knows this but its done no harm to SK’s career. You can find materials saying you can trust doctors like Kasper because they have written a 1000 articles or more. Its still a great Healy article etc.

Slide 34

A year later I was in Pfizer’s archive where even the loo-paper was stamped confidential. I came across this working document – which was the articles on Pfizer’s SSRI Zoloft being managed by Current Medical Directions – a medical writing company.

Slide 35

Inside there are pages listing the articles published or in train on Zoloft for the anxious, the depressed, the young, the old etc – here you see the PTSD page.

You will see on the right – the articles were written for these essentially negative studies saying the drug worked wonderfully well. One would go to NEJM – the other to JAMA. And on the left – you see TBD – authors names are To Be Determined. Pfizer’s marketing department will work out who would be the best sales people for the drug.

This is not just a mental health issue. It holds for all treatments across medicine.

Slide 36

Here is the most famous RCT of all time. It has a distinguished authorship line and is in the journal with the highest impact factor in child psychiatry and says paroxetine works wonderfully well and is entirely safe for children who are depressed.

Slide 37

This internal GSK document from 1998 shows the company knew the trial had shown the drug didn’t work and proposed taking out the good bits of the data and publishing those which is the article you have seen. New York State took a fraud action against GSK on this basis who were also fined $3 billion which led to access to the trial data and what you are going to see next.

Slide 38 The full story is on Study329.org

Slide 39

Through this legal action we got access to company data no one ever sees. The efficacy data is pretty irrelevant, but it was still possible to show that no matter which way you cut the data paroxetine was not more efficacious than placebo.

Slide 40

The tricks used to hide the problems were the real interest in these data.

The original article had 10 pages. Regulators see an 800-page Clinical Study Report (CSR) plus nearly 5000 pages of appendices – these are notional they are there but no-one in MHRA or FDA will look at them. We saw these and a further 77,000 Clinical Record Form (CRF) pages.

Point 2 points to data that just didn’t get transcribed from the 77000 pages to the 5000 pages. Point 10 is patients on placebo got SSRIs – I can explain how. But I want to focus on the coding issues.

Slide 41

The psychiatric adverse events all got grouped in CNS or neurological events – into which the groupers also put headaches and dizziness. The dizziness was not neurological – it was cardiovascular because it this case the comparator drug lowers BP especially when used in double or triple the adult dose.

The effect of this was to drown out the signal from psychiatric adverse events. So there is an issue about grouping. We were sensitized to this by Elizabeth Loder, the BMJ editor handling out paper – which took over a year to publish with 7 review rounds and 7 reviewers – who objected to our every mention of headache. As it turned out was a headache-ologist, who was an opinion leader for GSK but above all was the wife of an attorney working in Ropes and Gray who had been the lawyers defending GSK against the $3 billion fine.

Slide 42

So here, leaving out headache and dizziness, in the lower bar you see the number of suicidal events in the Keller paper – once you decode them from emotional lability. In the middle bar, GSK revised this after being asked to do so by FDA when a fuss blew up. In the upper bar you see that we found more again – and there were more than we missed as I’m about to tell you.

Slide 43

How does this fit Co-Vaccines? Well, here you see Pfizer’s report of their adverse event data – a ton of them have disappeared into a higher order coding group called General Disorders. The crimson half of the bar shows you these are serious, potentially lethal. General Disorders is a meaningless group – it needs unpacking.

Slide 44

In a Pfizer trial, one man poured petrol over himself and set a match to it, intending to kill himself. He died 5 days later from his burns. His death was coded as burns. But the company had to write a Serious Adverse Events narrative and if you got to see that you could work out that he should have been coded as suicide.

Slide 45

Companies have found a way to get around this, as found out after Study 329 finished. Here is a young man on a street waving a gun. Its Kyle Rittenhouse. In Study 329 a boy of 15 was picked up out on the street waving a gun around and threatening to kill people. He was hospitalized and should therefore have had an SAE narrative but the company coded him as intercurrent illness.

Four children dropped out of Study 329 coded as intercurrent illness – all were taking paroxetine. Add them into the picture you have just seen and things look a lot worse.

What is intercurrent illness? This was almost certainly an adverse event on paroxetine but invoking an intercurrent illness that means you really should not have been entered into this study means there is no need to write a narrative. This loophole has been there for 25 years and FDA have not moved to close it.

Slide 46

We know Astra-Zeneca broke the blind and got rid of serious adverse events like the ones that happened to Bri Dressen – see New England J of Misinformation. Here you see intercurrent illnesses turning up in this same Astra-Zeneca trial.

Slide 47

Here you have Maddie de Garay who has been tube fed and needs a wheelchair since a few days after the second dose of Pfizer’s vaccine in their trial for 12-15 year olds. But the company says no serious vaccine-related adverse events happened in this trial. They claim she has hysteria and of course that antedates the trial and so the vaccine can’t have caused it.

Slide 48

Few people know that FDA approved paroxetine for children – here is part of FDA’s 2002 letter of approval to GSK. The key bit is typed up so you can read it. The date is important – the Keller paper was 2001.

You can see here GSK told FDA that Study 329 was negative and you see that FDA agreed to approve the drug on the back of three negative studies and also agreed that there was no need to mention this in the labelling. Why would FDA do this?

Slide 49

Here are the published results of adult trials of antidepressants nearly a decade earlier. The picture looks pretty good.

Slide 50

But as Erick Turner has shown, this is how these studies looked to FDA. A different picture. Companies don’t leave negative studies unpublished, they know FDA are happy to let them publish negative studies as positive.

Why? Did GSK tell FDA – if you tell the world Study 329 was negative, we might get sued for fraud – which they did and fined for $3 billion. FDA don’t feel inclined to blow this whistle and MHRA and EMA have even less incentive.

Slide 51

So here is Study 329 again. The author is not listed. In the case of trials done in children, pretty well the entire literature was company written. The mismatch between what articles claim and the data when we see is the greatest known divide in medicine but likely not atypical. Study 329 was a good and ethical trial compared to some of the current vaccine trials.

There are now 45 negative trials for antidepressants in minors – out of 45 trials done. Yet antidepressants appear now to be the second most commonly taken drugs by teenage girls.

Slide 52

In this New England J of Misinformation article, the first thing to note is the author is not listed here. Twenty of the 29 apparent authors are company people. Few are clinicians and none are likely to have seen anyone harmed.

Second the trial was run by I Con rather than Pfizer who subcontracted to Palladium Research, who subcontracted to Ventavia and we know Ventavia ran a shit-show.

Anyone with experience of company trials knows that it is worth looking at the centres involved because for instance in a trial of aripiprazole where there might be 33 centres with 30 producing results for the drug that would not get approval, but perhaps 3 in places FDA won’t visit that found every patient put on the drug did fabulously and every on placebo was seriously injured or died a horrible death and adding both together produces a result that can squeak by FDA.

There is scope to wonder if something similar happened in this trial.

What we do know is that more people died on vaccine than placebo and lots more people disappeared on vaccine and FDA’s current leadership for whatever reason would prefer to be dead before anyone gets access to the data and their correspondence with Pfizer.

Slide 53

Is there a House in the Doctor? The medical drama House was watched and loved by many. Dr House was good at solving puzzling clinical cases by pulling on the thread of some minor detail which led to the answer.

Doctors today have close to lost the ability to say an evident X causes an evident Y – largely down to the mantra that only RCT evidence tells us what a treatment does and we can’t believe the evident anymore. Wife shoots husband point blank in chest – did she kill him? Who knows. In perhaps 1 case in 100 he had a heart attack just beforehand – we need to pass the 100 cases on to those experts in CDC, FDA, EMA etc and let them work it out.

As a result docs report maybe 1 in 10 or 1 in 100 serious side effects to regulators who file these away and do nothing with them.

This is unlike airline pilots who also report near misses and refuse to fly if these reports are not taken into account – after all if the customer dies the pilot does too. This is not true of doctors.

Slide 54

There is a profound misapprehension of the role of a regulator. They are not part of the health apparatus. Their job , perhaps easier to see in the case of food, is to decide if this yellow stuff is butter or lard colored to look like butter. If butter – it is not their job to decide if this is good butter or not or if butter is good for us or not. Ditto with drugs – the role is just to tick a box if certain criteria are met.

They have no abilities to or training in establishing if a drug or vaccine causes a problem.

Slide 55

Here is Walter Raleigh getting his head chopped off. After the fact legal systems recognized the injustice of convicting someone based on hearsay and said cases could only be decided on the basis of evidence in the room that can examined and cross-examined.

The first thing MHRA do with any reports is to remove the names of doctors and patients. This converts them into hearsay, anedcotes, misinformation. It means no-one can decide if there is a link.

MHRA will say till the crack of doom they are looking to find causal needles in the haystack of reports but faced with a needle-stack they can’t seem to spot a needle.

The key to determining cause and effect is an encounter between a doctor and patient. All the data is there. After a first run through there is a chance to follow up when oddities about the data come to mind. Remove the possibility for an ongoing two-way encounter like this and you remove the ability to establish cause and effect.

Slide 56

The one tool regulators have with anonymized drug reports is proportional reporting rates but as Matthew Crawford pointed out you can’t even use this for VAERS because you need lots of drugs in the mix for this to work properly. Besides proportional reporting rates are a cop-out. They might look more scientific than interviewing someone but they aren’t.

Slide 57

If someone commits suicide on an SSRI, their doctor will be advised by their insurer not to say the drug caused it or say anything that might lead to a further legal case. Insurance is supposed to be a business that supports us to take risks but is not doing this here.

If the doctor breaks ranks and blames the drug, a coroner, who can say a street drug caused a death, has no box to tick to implicate a prescription drug in a death.

Media guidance equally ensures journalists cannot say the obvious – the drug caused the suicide if the coroner hasn’t done so – and all this will apply to vaccines also.

If the coroner goes rogue and writes to the regulator and intimates that the evident cause of death was the drug or vaccine, the regulator will check on what the doctor has said and if the doctor didn’t finger the drug or vaccine – they won’t.

If the case is so Evident that both doctor and coroner go rogue, as in the Alana Cutland case, the regulator will respond, as MHRA did, that we only have a handful of reports like this – not enough to let us work out what might have gone on.

Slide 58

In the TV series House, the hero pays heed to tiny things that don’t fit the pattern and after twists and turns finds how it all hangs together.

When a wife shoots her husband in front of Dr House these days he seems unable to work out what’s gone on. Ok the guy may have had a heart attack at the same time and she shot him afterwards out of spite at being cheated out of a pleasant moment but 99 times out a 100 it’s pretty simple, she killed him. House though has lost this plot.

Some great doctors encourage their colleagues to report adverse events to regulators – which makes the problem worse. Regulators will file these reports away until the crack of doom. Unless doctors have the courage to say – look I know what I have seen and the vaccine or the drug killed my patient, they make things worse.

Dr House can’t get his head around the fact that with drugs and vaccines we hope to bring good out of the use of a poison, and sometimes people get poisoned. We and he prefer the idea he is giving sacraments – things that can only do good.

F Scott Fitzgerald once said that a sophisticated mind can hold two contradictory things in mind at the same time and still function – doctors could do this once but can’t now.

Science challenges Muslims and Jews, Xtians and Atheists to leave their biases at the door and come to a consensus about the data. But as in a jury trial, sticking with the data we still have to come to a verdict. A judgement. A diagnosis. It is not the role of a regulator to make diagnoses or deliver verdicts.

A verdict has effects in the real world just as much as shooting someone. There are evident effects from shooting on a husband who dies, and equally evident effects on the wife being tried.

This is important but more important for all of us just now are the effects on the doctor or failing to make any verdict, and just as much failing to make the diagnosis they know or suspect is the right one.

This failure transforms them into Model Doctors – a shrunken replica of the real thing.

When treating a patient, following the evidence can’t mean doing what ghostwritten fraudulent articles say. It has to mean following the person in front of me and coming to a consensus view just as a jury would.

If there is a mismatch between that and the so-called evidence – well all the books say that’s what moves science forward.

Slide 60

See The Handmaid’s Vaccine on RxISK – and its message about Albert and Ursula, the happy couple you see here.

Pfizer/BioNTech’s Comirnaty COVID shot was approved (licensed) by the U.S. Food and Drug Administration in late August 2021, but only for adults, and only when carrying the Comirnaty label. No other COVID shot has been FDA approved. However, Comirnaty is currently not available, and while the experimental, emergency use authorized (EUA) Pfizer shot is substituted for Comirnaty, the two products are clearly legally distinct and not the same

A licensed vaccine is not shielded from liability until or unless it’s added to the recommended childhood vaccination schedule by the CDC. So, if you were injured by Comirnaty, you could sue Pfizer. You cannot sue if injured by the EUA Pfizer shot (or any of the other EUA COVID injections)

Even though several hundred claims have been filed with the Countermeasures Injury Compensation Program (CICP) for injuries resulting from the COVID shots — which is the only possible avenue to obtain damages — not a single claim has been paid out

Natural immunity is much stronger than what you can achieve from the injection, which only provides antibodies against the SARS-CoV-2 spike protein and wanes within a few months. The shots may in fact permanently limit the kind of immune response you would make were you to later be exposed or infected with COVID

Children’s Health Defense has filed a lawsuit arguing you cannot have a vaccine that is both an emergency use product and a licensed product at the same time. That’s against the law, but the government has done it anyway. Remarkably, the request for an injunction was initially thrown out, but the CHD has not given up and is still pursuing the case

In this interview, Dr. Meryl Nass, an internist specializing in toxicology, vaccine-induced illnesses and Gulf War illness, shares her insights into the dangers of the COVID jab, which received an emergency use authorization October 26, 2021, for children as young as 5.

We also discuss the conflicts of interest within the U.S. Food and Drug Administration that seem to be behind this reckless decision, and how the agency pulled the wool over our eyes with its approval of Pfizer/BioNTech’s Comirnaty COVID injection.

Is the COVID Jab Approved or Not?

As explained by Nass:

“All of the COVID ‘vaccines,’ and most of the COVID treatment products, have not been [FDA] approved. Approved means licensed. All except one, which is the Pfizer vaccine for adults, age 16 and up, which got approved, i.e., licensed on August 23 [2021].

But every other vaccine, and for every other age group, including the boosters, have only been authorized under emergency use authorizations (EUAs). There’s a critical difference [between licensing and EUA]. Once a drug is fully licensed, it is subject to liability.

If the company injures you with that product, you can sue them, unless it later gets put on the CDC’s childhood schedule or is recommended by the CDC [U.S. Centers for Disease Control and Prevention] [during] pregnancy, in which case it obtains a different liability shield.

It then becomes part of the National Vaccine Injury Compensation Program (NVICP, established under the 1986 National Childhood Vaccine Injury Act), and 75 cents from every dose of vaccine that is sold in the United States goes into a fund to pay for injuries that way.”

The National Childhood Vaccine Injury Act removed liability for all vaccines recommended by the CDC for children. Since 2016, they’ve also removed liability for vaccines given to pregnant women, a category that has become the latest “gold rush” for vaccines. Naturally, once a company is no longer liable for injuries, the profitability of the product in question increases dramatically.

Countermeasures Injury Compensation Program Is Nearly Useless

Products under emergency use have their own special government program for liability called the Countermeasures Injury Compensation Program (CICP). “It is a terrible program,” Nass says. CICP is an offshoot of the 2005 PREP Act.

“The PREP act enabled the CICP to be created by Congress,” Nass explains. “Congress has to allocate money for it. If you are injured by an emergency use product, you don’t get any legal process. The companies have had all their liability waived. There is a single process that is administered through HHS [Health and Human Services].

Some employees there decide whether you deserve to be compensated or not. The maximum in damages you can obtain is about $370,000 if you’re totally disabled or die, and the money is only to compensate you for lost wages or unpaid medical bills.”

So far, even though several hundred CICP claims have been filed for injuries resulting from the COVID shots, not a single claim has been paid out. This is important, because the statute of limitations is one year. “It’s getting close to running out for people who were vaccinated early,” Nass says.

If you fail to apply in time, you lose the opportunity to get any compensation entirely. “Of course, in fact, it’s really ‘an opportunity’ to apply and get nothing because almost nobody gets paid,” she says. At that point, you have no further recourse. There’s no appeals process to the judicial system.

“You can ask the HHS twice to compensate you, and if they say no, that’s it,” Nass explains. “You can attempt to sue the company that made the product, if you’re convinced it was improperly made, but the secretary of HHS has to give you the permission to sue.

You have to prove that there was willful misconduct and no one has ever reached that bar. So, there has never been a lawsuit under this. Anyway, that’s what you’re looking at. If you get the vaccine under EUA and are injured, you’re on your own. People have no idea about this when they vaccinate themselves or their children.”

Why Were the Shots Mandated?

As you know by now, president Biden decided to mandate the COVID jab for most federal employees (but not all) and private companies with 100 employees or more. “We don’t know why that is,” Nass says. It doesn’t make sense, as large numbers of Americans have already recovered from COVID-19 and have durable, long-lasting immunity already.

As correctly noted by Nass, natural immunity is much stronger than what you can achieve from the injection, which only provides antibodies against the SARS-CoV-2 spike protein and wears off within a few months. The shots “may in fact permanently limit the kind of immune response you would make were you to be infected with COVID later,” Nass says.

For these reasons, there’s absolutely no good reason to vaccinate people who have recovered from the infection and several bad reasons. There’s evidence showing the shot can be more harmful for those with existing immunity.

“But for reasons best known to itself, the Biden administration feels so certain it needs to vaccinate everybody that it has used illegal means to tell employers they will lose federal contracts if they don’t force their employees to be vaccinated immediately, and must fire them — if they’re health care workers, for example, or government employees, or military — if they have not been vaccinated.

Obviously that is creating a great deal of chaos, particularly within the health care industry, particularly in my state, Maine, where these draconian rules have gone into effect and many fire department, police, EMTs, nurses and doctors can no longer work.

The one thing that was necessary to push mandates forward was for the government to be able to say it had a licensed product. Before the emergency use authorization was created in 2005, you had licensed drugs and you had experimental drugs and nothing else.

There was no gray area between them. Any use of a medication or vaccine that is not fully licensed is still experimental, despite the fact that a new category of drugs has been created with emergency use authorizations.

These are still experimental drugs, so under emergency use, you can’t force people [to take them]. You have to offer them options and they have the right to refuse. Since that is part of the statute, the federal government can’t get around it.

Therefore, attorneys in the Biden administration knew they could not legally impose mandates under an EUA, and so they demanded that FDA provide a COVID vaccine full approval, aka, an unrestricted license. This was believed to enable them to impose mandates.

They must have put pressure on the FDA, and FDA gave them what they wanted, which was a license for the Pfizer vaccine called Comirnaty on August 23 [2021].”

Comirnaty Approval Includes Important Caveats

In the documents released August 23, 2021, by the FDA, there were some interesting caveats. They said the Comirnaty vaccine is essentially equivalent to the EUA vaccine and the two vaccines may be used interchangeably. However, they pointed out that the two are legally distinct. Curiously, FDA didn’t specify what these legal distinctions are.

“I concluded that the legal distinctions were the fact that under EUA, there was essentially no manufacturer liability, but once the vaccine got licensed, the manufacturer would be subject to liability claims unless and until the vaccine was placed on the childhood schedule or recommended in pregnancy, in which case it would then fall … under the NVICP,” Nass says.

“Right now, Comirnaty is still not in that injury compensation program, and it’s licensed, so it no longer falls under the CICP. So, it is in fact subject to liability if you get injured with a bottle that says Comirnaty on it. Of course, if you’re Pfizer, what do you want to do?

You don’t want to make that licensed product available until several months have gone by and Comirnaty has been put into the National Vaccine Injury Compensation Program. So, Pfizer and FDA have not made the licensed product available yet.

What has happened instead, in the military, is the FDA has made a secret deal with the military and said, certain emergency use lots can be considered equivalent to the licensed vaccine, and [told military medical staff] which QR codes — which lots can be used. [These specific lots] can then be given to soldiers as if they’re licensed.

Subsequently, we’re told that military clinics are actually putting Comirnaty labels onto bottles that are under EUA. Now, that probably can happen in the military, but only in the military, because there are likely to be memoranda of understanding within the military that we haven’t seen yet that say soldiers cannot sue Pfizer for injuries …

In the military, the government and Pfizer feel like they have set up a situation where nobody can sue, but in the civilian world, that has not happened, and so there is no Comirnaty available.

Yet, on the basis that FDA licensed this product, the federal government is still telling employers that they can mandate it and that they must fire employees that have not taken the vaccine, or they will lose government contracts. We’re in a very interesting situation that is ripe for litigation, and Children’s Health Defense, which is an organization I represent, is litigating some of this.

However, the litigation situation has been very difficult since the pandemic began. Cases that normally would’ve been easy wins are being thrown out by the courts, both in the U.S. and in Europe. Something strange has happened and the judges are looking for any way out, so they don’t have to rule on the merits of these cases.”

The organization Children’s Health Defense has filed a lawsuit arguing you cannot have a vaccine that is both an emergency use product and a licensed product at the same time. That’s against the law, but the federal government did it anyway. Remarkably, the request for an injunction was initially thrown out, but Children’s Health Defense hasn’t given up and is still pursuing that case.

COVID Jab Is Authorized for 5- to 11-Year-Olds in the US

As mentioned, the FDA recently authorized the EUA COVID jab for children between the ages of 5 and 11, which is simply appalling, considering they are at virtually no risk from COVID-19. I’ve not seen a single recorded case in the entire world of anyone in that age group dying of COVID that didn’t have a serious preexisting comorbidity, such as cancer.

If you have a healthy child, they are at no risk from the infection, so there’s only danger associated with this shot, which in this age group would be one-third the adult dose. Typically, when you’re giving a drug to a child, the dose is calculated based on the child’s weight. Here, they’re giving the same dose to a 5-year-old as an 11-year-old, despite there being a significant difference in weight. So, it’s pure guesswork.

Worse yet, the mRNA vaccines produce an unpredictable amount of spike protein, and even if they produce much too much, there is no way to turn off the process once you have been injected.

Despite clear safety signals, the FDA’s advisory committee authorized the Pfizer jab for 5- to 11-year-olds unanimously, 17-to-0 (with one abstaining vote). However, when you look at the roster of the FDA’s committee members1 who reviewed and voted to authorize the Pfizer shot for children as young as 5, the unanimous “yes” vote becomes less of a mystery.

Abhorrent Conflicts of Interest

As reported by National File2 and The Defender,3 the membership of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has had staggering conflicts of interest. Members have included:

In addition to that, former FDA commissioner Scott Gottlieb is currently on Pfizer’s board of directors. As noted by Nass, two of the members, one permanent and one temporary, are also CDC career employees whose job it is to push vaccines at the CDC.

“If they voted against authorizing a vaccine, they would be out of a job,” Nass says. “They have no business on that committee … It’s a very unethical stew of advisory committee members …

What happened is Pfizer delivered a large package of information to the FDA on October 6, 2021. FDA staff had to go through this large packet of information on the 5- to 11-year-olds and produce their own report, which was about 40 pages long, and create talks to give to the advisory committee, and they did all of this in 17 days.

There was apparently very little critical thought that went into their presentations. Before the meeting, Children’s Health Defense, and I was one of the authors, wrote to the committee and to FDA officials saying, ‘Look, there’s all these reasons that don’t make logical or medical sense for vaccinating kids in this age group, because they almost never get very ill or die, and the side effects of the vaccine are essentially unknown.

We know there are a lot of side effects, but the federal government has concealed from us the rate at which these side effects occur. But we know that the rate from myocarditis is very high, probably at least 1 in 5,000 young males … which is a very serious side effect. It can lead, probably always leads, to some scarring. It can lead to sudden death, to heart failure.”

Trials in Young Children Were Insufficient

As explained by Nass, in the clinical trial, there were two groups of children. The first group was enrolled for two to three months, while the second group was enrolled for just 17 days after receiving the second dose. (Pfizer added the second group because FDA claimed there weren’t enough volunteers in the first group.)

These two groups comprised over 3,000 children who got the jab and 1,500 or 2,000 who got a placebo. None suffered serious side effects. This was then translated into the claim that the injection was safe. However, as noted by Nass:

“They didn’t look at safety in all these kids. Even though FDA had said, ‘Add kids to your clinical trial,’ Pfizer created a ‘safety subset’ of one-tenth of the vaccinated subjects.

It was this small number of kids from whom they drew blood to show they had adequate levels of neutralizing antibodies, which was a surrogate for efficacy, because they didn’t have enough cases of COVID in this abbreviated trial to show that the vaccine actually works in this age group.”

Even though the advisory committee acknowledged that the blood test done for efficacy had not been validated, and wasn’t reliable evidence of effectiveness, they still decided that all children, regardless of health status, would benefit from the injection.

They also ignored the fact that at least half the children are already immune, and giving them the injection will provide no additional benefit in terms of immunity, while putting them at increased risk for serious side effects.

“Nobody said, ‘Look, the parents of healthy kids may be dying for a vaccine, but that’s because we haven’t told them the truth about the vaccine. We haven’t told them their kids don’t need it. We haven’t told them it’s going to potentially damage future immunity.

We haven’t told them they’re at higher risk of side effects than if they never had COVID. We’re not allowing them to go get antibody tests to establish that they’re already immune and therefore should be waved from being vaccinated.’

The committee members were aware of all this stuff, but in the end [they voted yes] … apart from one very smart member of the committee who works for the National Institutes of Health. He abstained. He didn’t have the guts to vote no, but he knew this was a bad idea.”

Children Are Being Injected Without Parental Consent

While all of that is bad enough, parents of young children now face the possibility of their children being injected against their will and without their knowledge. Nass comments:

“As I said, we don’t know why the government wants everybody vaccinated, but there’s probably a reason that goes beyond protecting us from COVID.

The government got the FDA to authorize the vaccine for 12- to 15-year-olds on May 10 [2021], and subsequently that group, which is about 6 million kids, has been getting vaccinated across the country. That’s under emergency use so, again, you can’t sue.

But something kind of evil happened, which was many cities began vaccinating 12- to 15-year-olds in the absence of parental permission. So, a child could show up with their friends or a friend’s mother at a vaccine center and get vaccinated with no one asking about their medical history, nobody calling the parents. No notation got entered into the child’s medical record that they were vaccinated.

Vaccinators were told to make their own assessment. If they thought this child could give consent, go ahead and vaccinate. Now, that is a gross violation of our laws, and yet it was happening in Boston, in Philadelphia, in Seattle, in San Francisco, and we have good documentation of it.

The government currently is planning for mobile vaccination clinics for kids and vaccinations in schools, and they may take this program of vaccinating without parental consent down to the 5- to 11-year-olds …

In fact, we may see clinics popping up that don’t require informed consent in the 5- to 11-year-old group. Let me just mention that the chief medical officer in Canada’s British Columbia said they have brought laws that allow children of any age to consent for themselves. Think about that. A baby can consent for vaccinations for itself. It would be funny if it wasn’t so diabolical.”

All of this goes against the most basic concept of medical ethics, which is informed consent. No one has the right to perform a medical procedure on you without your consent, or the consent of a legal guardian. The government, again, without establishing any new laws, is simply bypassing the legal system.

Will Young Children Be at Risk for Myocarditis?

Based on her review of the scientific literature, Nass suspects younger children in the now COVID jab-approved, 5- to 11-year-old age group will be at exponentially higher risk of myocarditis and other side effects compared to the 12- to 15-year group, where we’ve already seen a documented increase.

“In the letter that Children’s Health Defense wrote to the advisory committee for the FDA, we created a graph based on the reporting rate of myocarditis versus age, and we showed there was an exponential curve.

Men aged 65 and up had a rate that was 1/100th the rate of boys aged 12 to 17. If that exponential curve keeps going up, the rate in the 5- to 11-year-olds could be even dramatically higher. In those young men, a 1 in 5,000 rate was reported to VAERS [Vaccine Adverse Events Reporting System]. That’s not a real rate.

That just tells us how many people got diagnosed with myocarditis, and then went to the trouble of reporting it to the FDA. The FDA and CDC have a large number of other databases from which they can gather rates of illness.

VAERS is considered passive reporting. It is not considered fit for purpose to establish illness rates because we don’t know how many people report. Do 1 in 10 report, 1 in 100, 1 in 50? Nobody knows.

However, again, because everything is crazy since the pandemic came in, the CDC has tried to pull the wool over our eyes and has claimed that the rate of anaphylaxis in the population from COVID vaccines is identical to their reporting rate to VAERS. We know that’s not true.

On the CDC’s website, that’s what they have. Elsewhere on the website, they say you can’t take a VAERS rate and call it an actual rate of reactions, but they’ve done that [for anaphylaxis]. And they’re trying to obfuscate the fact that they’re not giving you real rates, and sort of pretending that the myocarditis rate is probably the VAERS reporting rate of myocarditis, although they’re not saying so directly.”

Nass goes on to recount an example from the smallpox vaccine, which also caused myocarditis. A military study that just looked at cases sent to specialists found roughly 1 in 15,000 developed myocarditis. A military immunologist then dug deeper, and drew blood on soldiers before and after vaccination, and found a myocarditis rate of 1 in 220 after receiving the smallpox vaccine.

However, 1 soldier in 30 developed subclinical myocarditis where troponin rose from normal to more than two times the upper limits of normal. While asymptomatic, 1 in 30 had measurable inflammation of the heart. “Right now, in terms of what the rate is for COVID, nobody is looking, no federal agency wants to find out the real rate,” Nass says.

You Can’t Find Problems You Refuse to Look For

A simple study that measures troponin levels — a marker for heart inflammation and damage — before and after each dose, could easily determine what the real rate of myocarditis is, yet that is not being done.

“This is what we’re dealing with,” Nass says. “All these databases, which is about a dozen different databases, that CDC and FDA said they could access to determine the rates of side effects after vaccination with COVID vaccines, they’re either not being used or being used improperly,” Nass says.

“It was discovered that a new algorithm was being used to study the VAERS database that only came into use in January 2021, immediately after the vaccines were authorized, and the algorithm was developed such that you compare two vaccines to each other.

If the pattern of side effects was similar between the two vaccines — which is often the case because there’s a limited number of general vaccine adverse reactions — even if one vaccine has a thousand times more side effects as the one it is being compared to, by using this flawed algorithm, if the pattern of reactions was the same, even though the rates were 1,000 times higher for one, the algorithm would fail to detect a problem.

That is the algorithm they’re using to analyze VAERS [data]. They’re also using bad methods … to analyze the vaccine safety database, which encompasses 12 million Americans who enrolled in HMOs around the country. The CDC pays for access to their electronic medical records and their data.

Somehow when these databases have been looked at carefully, they’re finding very low rates of myocarditis in boys, approximately equal to the VAERS reporting. It was said months ago, ‘We can’t find a safety signal for myocarditis. We’re not finding an anaphylaxis signal. we’re not finding a Bell’s palsy signal.’

The FDA’s and CDC’s algorithms couldn’t pick up for most known side effects. So, there’s something wrong with the analytic methods that are being used, but the agencies haven’t told us precisely what they are. What we do know is that the rates of side effects that are being reported to VAERS are phenomenal.

They’re orders of magnitude higher than for any previous vaccines used in the United States. An order of magnitude is 10-fold, so rates of reported adverse reactions are 10 to 100 times higher than what has been reported for any other vaccine. Reported deaths after COVID in the United States are 17,000+. It’s off the charts.

Other side effects reported after COVID vaccinations total over 800,000. Again, more deaths and more side effects than have ever been reported for every vaccine combined in use in the U.S. cumulatively over 30 years.”

Despite all this shocking data, our federal agencies look the other way, pretending as if nothing is happening, and no matter how many people approach them — with lawsuits, with public comments, reaching out to politicians — they refuse to address blatantly obvious concerns. This is clear evidence that they’re acting with intentional malice.

FDA has become Clown World, and what they do now is to perform a charade of all the normal regulatory processes that they are expected to perform … You’re the guinea pigs, but they’re not collecting the data. Nobody should get these shots. ~ Dr. Meryl Nass

The FDA and CDC are supposed to protect the public. They’re supposed to identify safety concerns. They’re not supposed to act as marketing firms for drug companies, but that’s precisely what they’ve been converted to.

New Formulations Have Never Been Tested

Another truly egregious fact is that Pfizer has altered its formulation, allegedly to make it more stable, but this new formulation has never been included in any of the trials. Nass explains:

“During the October 26, 2021, VRBPAC [Vaccines and Related Biological Products Advisory Committee] meeting, Pfizer said, ‘Look, we want to give the vaccines in doctor’s offices and we’ve found a way to stabilize the vaccine so we don’t need those ultra-cold fridges anymore. We can put these vials in a doctor’s office and, once defrosted, they can sit in a regular fridge 10 weeks and they’ll be fine.’

Some committee members asked, ‘OK, what’d you do? How did you make this marvelous discovery?’ And they said, ‘We went from the phosphate buffered saline buffer to a Tris buffer, and we slightly changed some electrolytes.’ A committee member asked, ‘OK, how did that make it so much more stable?’ And everybody in the meeting from FDA and Pfizer looked at each other and said, ‘We don’t know.’

An hour later, Pfizer had one of their chemists get on the line, but he couldn’t explain how the change in buffer led to a huge increase in stability, either. Then, later in the meeting, one of the members of the committee asked, ‘Did you use this new formulation in the clinical trial?’

And Dr. Bill Gruber, the lead Pfizer representative, said, ‘No, we didn’t.’ In other words, Pfizer plans, with FDA connivance, to use an entirely new vaccine formulation in children, after their clinical trials used the old formulation. This is grossly illegal. They’ve got a new formulation of vaccine. It wasn’t tested in humans. And they’re about to use it on 28 million American kids.”

It’s nothing short of a dystopian nightmare. Completely surreal. You can’t make this stuff up. Yet as shocking as all this is, earlier this year, Dr. Anthony Fauci projected that these COVID jabs would be available for everyone, from infants to the elderly. Now they’ve got the 5-year-olds, and there’s every reason to suspect they’ll go after newborns and infants next.

Whose Babies Will Be Offered Up as Sacrificial Lambs?

According to Nass, Pfizer and the FDA have struck a deal that will allow Pfizer to test on babies even younger than 6 months old, even if there’s no intention to inject infants that young. Those trials may begin as early as the end of January 2022.

“This arrangement between FDA and Pfizer will give Pfizer its extra six months of patent protection, whether or not these vaccines are intended to be used in those age groups. So, you can look at these trials as a way of almost sacrificing little children, because when you start a trial, you don’t know what the dangers are going to be.

I could be wrong, but I doubt we’re going to give these to newborn babies the way we give the hepatitis B vaccine on the date of birth, yet they will be tested in very young babies. The question is, whose babies get tested? In the past, sometimes the babies that got tested were foster children, wards of the state. Sometimes parents offer up their children. But there will be clinical trials.”

When will we get the data from those trials? It turns out that in the agreements reached between Pfizer and the FDA, some of those trials won’t conclude until 2024, 2025 and 2027. The goal here is to vaccinate all Americans, children and adults, within the coming few months or a year, yet it’ll be five years before we actually know from clinical trials what the side effects may be.

We’re Living in Clown World

As noted by Nass, this is yet another crime. It may fulfill the letter of the law, but it doesn’t fulfill the meaning of the law. It makes no sense to run clinical trials that won’t be completed until five years after your mass vaccination program has been completed and the entire population is injected.

“It’s just a joke to do that,” Nass says. “But FDA has become Clown World, and what they do now is to perform a charade of all the normal regulatory processes that they are expected to do, but they’re only doing them in an abbreviated or peculiar manner so that they don’t really collect the important data.

For example, the control group has been vaccinated two months into the Pfizer trials, which effectively obscures side effects that develop after two months. Blood is not tested for evidence of myocarditis or blood clots using simple tests (troponin and D-dimer levels).

For all the Americans out there who haven’t spent 20 years examining the FDA procedures like I have, these FDA advisory committee meetings are it’s designed to make you think a real regulatory process is going on, when it’s not. Instead we are all guinea pigs, but no one is collecting the data that would normally be required to authorize or approve a vaccine. Therefore, in my opinion, nobody should get these shots.“

To make matters even worse, it’s actually illegal to grant EUAs for these vaccines, because there are drugs that can prevent the condition (COVID), as well as treat it. EUAs can only be granted if there are no existing approved, available alternatives to prevent or treat the infection.

The effective drugs most have already heard of are ivermectin and hydroxychloroquine, but there are a number of other drugs that also have profound effects on COVID, Nass says, including TriCor and cyproheptadine (Periactin).

TriCor, or fenofibrate, emulsifies lipid nanoparticles and fatty conglomerations that contain viruses and inflammatory substances. The drug essentially allows your body to break down the viral and inflammatory debris better. As such, it might also help combat complications caused by the nanoliposomes in the COVID shot.

According to Nass, Pepcid at high doses of up to 80 milligrams three times a day is also useful for treatment. Dr. Robert Malone is starting a clinical trial using a combination of Pepcid and celecoxib (brand name Celebrex). Many are also recommending aspirin to prevent platelet activation and clotting.

I believe a far better alternative to aspirin is lumbrokinase, and/or serapeptase. Both are fibrinolytic enzymes that address blood clotting. You can develop sensitivity to them, so I recommend alternating the two on alternate days for about three months if you’ve had COVID.

You could rule out blood clotting by doing a D-dimer test. If your D-dimer is normal, you don’t need an anticlotting agent. If clotting is a concern, you could also use NAC in addition to these fibrinolytic enzymes. It too helps break up clots and prevent clot formation.

NNTV, the standard policy tool that Pharma, the FDA, & CDC no longer want to talk about

A funny thing happened this afternoon. Not funny as in “haha”. More like funny as in, “ohhhhh that’s how the FDA rigs the process.”

I was reading the CDC’s “Guidance for Health Economics Studies Presented to the Advisory Committee on Immunization Practices (ACIP), 2019 Update” and I realized that the FDA’s woeful risk-benefit analysis in connection with Pfizer’s EUA application to jab children ages 5 to 11 violates many of the principles of the CDC’s Guidance document. The CDC “Guidance” document describes 21 things that every health economics study in connection with vaccines must do and the FDA risk-benefit analysis violated at least half of them.

Today I want to focus on a single factor: the Number Needed to Vaccinate (NNTV). In four separate places the CDC Guidance document mentions the importance of coming up with a Number Needed to Vaccinate (NNTV). I did not recall seeing an NNTV in the FDA risk-benefit document. So I checked the FDA’s risk-benefit analysis again and sure enough, there was no mention of an NNTV.

Because the FDA failed to provide an NNTV, I will attempt to provide it here.

First a little background. The Number Needed to Treat (NNT) in order to prevent a single case, hospitalization, ICU admission, or death, is a standard way to measure the effectiveness of any drug. It’s an important tool because it enables policymakers to evaluate tradeoffs between a new drug, a different existing drug, or doing nothing. In vaccine research the equivalent term is Number Needed to Vaccinate (NNTV, sometimes also written as NNV) in order to prevent a single case, hospitalization, ICU admission, or death (those are 4 different NNTVs that one could calculate).

Pharma HATES talking about NNTV and they hate talking about NNTV even more when it comes to COVID-19 vaccines because the NNTV is so ridiculously high that this vaccine could not pass any honest risk-benefit analysis.

Indeed about a year ago I innocently asked on Twitter what the NNTV is for coronavirus vaccines.

Pharma sent a swarm of trolls in to attack me and Pharma goons published hits pieces on me outside of Twitter to punish me for even asking the question. Of course none of the Pharma trolls provided an estimate of the NNTV for COVID-19 shots. That tells us that we are exactly over the target.

Various health economists have calculated a NNTV for COVID-19 vaccines.

• Ronald Brown, a health economist in Canada, estimated that the NNTV to prevent a single case of coronavirus is from 88 to 142.

• Others have calculated the NNTV to prevent a single case at 256.

• German and Dutch researchers, using a large (500k) data set from a field study in Israel calculated an NNTV between 200 and 700 to prevent one case of COVID-19 for the mRNA shot marketed by Pfizer. They went further and figured out that the “NNTV to prevent one death is between 9,000 and 100,000 (95% confidence interval), with 16,000 as a point estimate.”

You can see why Pharma hates this number so much (I can picture Pharma’s various PR firms sending out an “All hands on deck!” message right now to tell their trolls to attack this article). One would have to inject a lot of people to see any benefit and the more people who are injected the more the potential benefits are offset by the considerable side-effects from the shots.

Furthermore, the NNTV to prevent a single case is not a very meaningful measure because most people, particularly children, recover on their own (or even more quickly with ivermectin if treated early). The numbers that health policy makers should really want to know are the NNTV to prevent a single hospitalization, ICU admission, or death. But with the NNTV to prevent a single case already so high, and with significant adverse events from coronavirus vaccines averaging about 15% nationwide, Pharma and the FDA dare not calculate an NNTV for hospitalizations, ICU, and deaths, because then no one would ever take this product (bye bye $93 billion in annual revenue).

Increased all cause mortality in the Pfizer clinical trial of adults

As Bobby Kennedy explains, Pfizer’s clinical trial in adults showed alarming increases in all cause mortality in the vaccinated:

In Pfizer’s 6 month clinical trial in adults — there was 1 covid death out of 22,000 in the vaccine (“treatment”) group and 2 Covid deaths out of 22,000 in the placebo group (see Table s4). So NNTV = 22,000. The catch is there were 5 heart attack deaths in the vaccine group and only 1 in placebo group. So for every 1 life saved from Covid, the Pfizer vaccine kills 4 from heart attacks. All cause mortality in the 6 month study was 20 in vaccine group and 14 in placebo group. So a 42% all cause mortality increase among the vaccinated. The vaccine loses practically all efficacy after 6 months so they had to curtail the study. They unblinded and offered the vaccine to the placebo group. At that point the rising harm line had long ago intersected the sinking efficacy line.

Former NY Times investigative reporter Alex Berenson also wrote about the bad outcomes for the vaccinated in the Pfizer clinical trial in adults (here). Berenson received a lifetime ban from Twitter for posting Pfizer’s own clinical trial data.

Pfizer learned their lesson with the adult trial and so when they conducted a trial of their mRNA vaccine in children ages 5 to 11 they intentionally made it too small (only 2,300 participants) and too short (only followed up for 2 months) in order to hide harms.

Estimating an NNTV in children ages 5 to 11 using Pfizer’s own clinical trial data

All of the NNTV estimates above are based on data from adults. In kids the NNTV will be even higher (the lower the risk, the higher the NNTV to prevent a single bad outcome). Children ages 5 to 11 are at extremely low risk of death from coronavirus. In a meta-analysis combining data from 5 studies, Stanford researchers Cathrine Axfors and John Ioannidis found a median infection fatality rate (IFR) of 0.0027% in children ages 0-19. In children ages 5 to 11 the IFR is even lower. Depending on the study one looks at, COVID-19 is slightly less dangerous or roughly equivalent to the flu in children.

So how many children would need to be injected with Pharma’s mRNA shot in order to prevent a single hospitalization, ICU admission, or death?

Let’s examine Pfizer’s EUA application and the FDA’s risk-benefit analysis. By Pfizer’s own admission, there were zero hospitalization, ICU admissions, or deaths, in the treatment or control group in their study of 2,300 children ages 5 to 11.

So the Number Needed to Vaccinate in order to prevent a single hospitalization, ICU admission, or death, according to Pfizer’s own data, is infinity. ∞. Not the good kind of infinity as in God or love or time or the universe. This is the bad kind of infinity as in you could vaccinate every child age 5 to 11 in the U.S. and not prevent a single hospitalization, ICU admission, or death from coronavirus according to Pfizer’s own clinical trial data as submitted to the FDA. Of course Pfizer likes this kind of infinity because it means infinite profits. [Technically speaking the result is “undefined” because mathematically one cannot divide by zero, but you get my point.]

Estimating an NNTV and risk-benefit model in children ages 5 to 11 using the limited data that are available

Everyone knows that Pfizer was not even trying to conduct a responsible clinical trial of their mRNA shot in kids ages 5 to 11. Pfizer could have submitted to the FDA a paper napkin with the words “Iz Gud!” written in crayon and the VRBPAC would have approved the shot. They are all in the cartel together and they are all looking forward to their massive payoff/payday.

But let’s not be like Pharma. Instead, let’s attempt to come up with a best guess estimate based on real world data. Over time, others will develop a much more sophisticated estimate (for example, Walach, Klement, & Aukema, 2021 estimated an NNTV for 3 different populations based on “days post dose”). But for our purposes here I think there is a much easier way to come up with a ballpark NNTV estimate for children ages 5 to 11.

Here’s the benefits model:

• As of October 30, 2021, the CDC stated that 170 children ages 5 to 11 have died of COVID-19-related illness since the start of the pandemic. (That represents less than 0.1% of all coronavirus-related deaths nationwide even though children that age make up 8.7% of the U.S. population).

• The Pfizer mRNA shot only “works” for about 6 months (it increases risk in the first month, provides moderate protection in months 2 through 4 and then effectiveness begins to wane, which is why all of the FDA modeling only used a 6 month time-frame). So any modeling would have to be based on vaccine effectiveness in connection with the 57 (170/3) children who might otherwise have died of COVID-related illness during a 6-month period.

• At best, the Pfizer mRNA shot might be 80% effective against hospitalizations and death. That number comes directly from the FDA modeling (p. 32). I am bending over backwards to give Pfizer the benefit of considerable doubt because again, the Pfizer clinical trial showed NO reduction in hospitalizations or death in this age group. So injecting all 28,384,878 children ages 5 to 11 with two doses of Pfizer (which is what the Biden administration wants to do) would save, at most, 45 lives (0.8 effectiveness x 57 fatalities that otherwise would have occurred during that time period = 45).

• So then the NNTV to prevent a single fatality in this age group is 630,775 (28,384,878 / 45). But it’s a two dose regimen so if one wants to calculate the NNTV per injection the number doubles to 1,261,550. It’s literally the worst NNTV in the history of vaccination.

If you inject that many children, you certainly will have lots and lots of serious side effects including disability and death. So let’s look at the risk side of the equation.

Here’s the risk model:

• Because the Pfizer clinical trial has no useable data, I have to immuno-bridge from the nearest age group.

• 31,761,099 people (so just about 10% more people than in the 5 to 11 age bracket) ages 12 to 24 have gotten at least one coronavirus shot.

• The COVID-19 vaccine program has only existed for 10 months and younger people have only had access more recently (children 12 to 15 have had access for five months; since May 10) — so we’re looking at roughly the same observational time period as modeled above.

• During that time, there are 128 reports of fatal side effects following coronavirus mRNA injections in people 12 to 24. (That’s through October 22, 2021. There is a reporting lag though so the actual number of reports that have been filed is surely higher).

• Kirsch, Rose, and Crawford (2021) estimate that VAERS undercounts fatal reactions by a factor of 41 which would put the total fatal side effects in this age-range at 5,248. (Kirsch et al. represents a conservative estimate because others have put the underreporting factor at 100.)

• With potentially deadly side effects including myo- and pericarditis disproportionately impacting youth it is reasonable to think that over time the rate of fatal side effects from mRNA shots in children ages 5 to 11 might be similar to those in ages 12 to 24.

So, to put it simply, the Biden administration plan would kill 5,248 children via Pfizer mRNA shots in order to save 45 children from dying of coronavirus.

For every one child saved by the shot, another 117 would be killed by the shot.

The Pfizer mRNA shot fails any honest risk-benefit analysis in children ages 5 to 11.

Even under the best circumstances, estimating NNTV and modeling risk vs. benefits is fraught. In the current situation, with a new and novel bioengineered virus, where Pfizer’s data are intentionally underpowered to hide harms, and the FDA, CDC, & Biden Administration are doing everything in their power to push dangerous drugs on kids, making good policy decisions is even more difficult.

If the FDA or CDC want to calculate a different NNTV (and explain how they arrived at that number) I’m all ears. But we all know that the FDA refused to calculate an NNTV not because they forgot, but because they knew the number was so high that it would destroy the case for mRNA vaccines in children this age. Your move CDC — your own Guidance document states that you must provide this number.

Update: CDC finally mentions NNTV, but . . .

Toward the end of the six-hour CDC’s Advisory Committee on Immunization Practices (ACIP) Nov. 2 meeting where the committee voted to recommend Pfizer’s EUA vaccine for children 5 - 11, there was finally a mention of NNTV. It was on slide 36 of a presentation by CDC official D.r Sara Oliver. Unfortunately the CDC estimate was untethered from reality. I’ll explain:

Oliver claimed the NNTV to prevent a single case is 10, even though the best lower bound estimate is 88 and other estimates are 200 or higher (see calculations here and here).

Then she claimed the NNTV to prevent a single hospitalization is between 2,213 and 8,187. This is dishonest and a violation of scientific norms.

NNTV is calculated by dividing 1 by the Absolute Risk Reduction. There was no Absolute Risk Reduction in hospitalizations in the Pfizer clinical trial in kids 5 to 11, because no one was hospitalized in either the treatment or control group. 1/0 is “undefined” not 8,187.

Oliver made no estimate of NNTV to prevent a single COVID-19-related death because that is also undefined (again, there were no COVID-related deaths in the treatment or placebo group in the trial so the absolute risk reduction was zero).

Oliver also did not model injuries or deaths from the vaccine (she immuno-bridged from an older age group to show benefits but ignored the reported harms from the vaccine in the older age group).

I should also note that my estimates of NNTV were based on CDC data showing 170 deaths from COVID-19-related illness in kids ages 5 to 11 over the last 18 months (I got the number directly from the CDC COVID tracking website).

However at the ACIP meeting, the CDC said the number of children in this age group who have died of COVID-19-related illness is 94.

If 94 is the correct number to use, then the NNTV to prevent a single death from COVID-19 related illness in this age group would be 28,384,878 / 31 = 915,641. But it’s a two-dose regimen, so if one wants to calculate the NNTV-per-injection the number doubles to 1,831,282.

I imagine that at most, half of American parents will be foolish enough to inject this toxic product into their kids. At a 50% uptake rate, the ACIP decision to approve the Pfizer shot will likely kill 2,624 children via adverse reactions in order to potentially save 12 from COVID-19-related illness.

Now you know why the CDC did not release the meeting materials prior to the ACIP meeting — they could not stand up to any public scrutiny.

Update 11/05/21:

I see that El Gato Malo engaged in a similar set of calculations back in September when Pfizer first released its “results.” He faced the same challenges as I did — namely, there is no usable data from Pfizer and so one has to pull from others sources. He builds a steel man case (the most generous possible defense of the Pfizer product) and yet his results are still in line with mine (my numbers are higher though because I use a lower estimate of vaccine effectiveness and correct for VAERS underreporting). So again, even under the most generous assumptions, the Pfizer mRNA shot fails any honest risk benefit assessment in connection with children 5 to 11.

#PR POPULAR RATIONALISM COVID-19 HERO SERIES

Meet Dr. Harvey Risch (Photo: Yale.edu)

Harvey Risch is a brilliant contributor to the knowledge base of biomedical research. Dr. Risch was the first to publish on hydroxychloroquine, very early in the pandemic, summarizing in the American Journal of Epidemiology evidence that hydroxychloroquine (HCQ) was associated with lowered mortality risk in a dose-dependent manner. He advocated very strongly that the world should not wait for the outcome of long-term randomized clinical trials, showing a correct understanding of the level of evidence required for off-label prescription during emergencies. This publication has had more than 140,000 views. You can read his, and the world’s first review of the clinical evidence of hydroxychloroquine here.

Dr. Risch also served as the principal scientist in the large Brazil hydroxychloroquine trial, published in Travel Medicine and Infectious Disease. That study found day 6 use of HCQ, prednisone or both significantly reduced hospitalization risk by 50–60%. It is inconceivable that in the review of the evidence Dr. Risch presented that individuals like Anthony Fauci could not have known about what the studies were truly indicating. You can read the large Brazil HCQ study here.

Dr. Risch has also worked tirelessly to educate the public on hydroxychloroquine and other aspects of COVID-19, such as this piece in Newsweek in July, 2020 “Tireless” does not truly capture his efforts; he has appeared in interviews on television at least 76 times to date, and had provided testimony for important proceedings, giving decision makers no reason not to see and understand the value of HCQ for outpatient care for COVID-19.

It is a near universal truth that academic training, especially in the medical and biological sciences, attempts to force specialization. When individuals in academia continue to gather new skills via formal training, they break the mold. In addition to his medical training, Dr. Risch obtained a PhD in mathematical modeling of infectious epidemics and has actively published on that challenging topic. He is Professor of Epidemiology at Yale School of Public Health, widely recognized as one of the premier public health institutions in this country, and has published over 350 peer-reviewed scientific research papers. His publications have generated over 41,000 citations of those papers in the medical and scientific literature.

One of the distinctions that Dr. Risch carries is that he has no financial conflicts of interest in HCQ or any early treatment for COVID-19. Dr. Risch’s early vision has been supported by the clinical experience of many physicians - and he is co-author on the landmark “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection” with world-renown COVID-19 authority Dr. Peter McCollough.

Critics of Dr. Risch accuse him of weakening the standards for clinical adoption of treatment for COVID-19. These critics are hazards to public health in part because they fail to respect that off-label use is allowed when no standard of care exists (such as with COVID-19), and that Emergency Use Authorization (EUAs) do not require the same high level of evidence that clinical options require for success in translational efforts for medical options during non-emergencies. They apparently are unaware that the rules have changed for COVID-19 related studies: Real World Data and Real World Evidence can now be given full consideration by regulatory agencies (See FDA Guidance, 9/30/2021).

One of Dr. Risch’s interviews was with Dr. Naomi Wolf on The Daily Clout. Co-guests included Dr. Howard Tenenbaum, and Dr. Paul Alexander.

And here is a highly informative academic presentation (aired June 25, 2021) that tells the story of hydroxychloroquine and its abuse by false accusations and fake studies. He also highlights the Bradford-Hill Criteria for causality, a topic we’ll be reviewing in courses at IPAK-EDU.

NIAID Director Anthony Fauci has rejected hydroxychloroquine using language like “all the credible studies”. There are limitations to the available science on hydroxychloroquine, not the least of which have included faked studies conducted and published to cast dispersion on the inexpensive drug. Other limitations include small sample sizes of some studies; however, if Fauci and Francis Collins had prioritized large, well-conducted studies of hydroxychloroquine, this would not be a limiting issue. The massive number of studies to date that find an effect place hydroxychloroquine high among the candidates for likely to succeed in a thorough, objective analysis.

The fact that people are still dying without any ambulatory in-home care is the crime of the century.

Related

Alexander, P et al., Early Multidrug Outpatient Treatment of SARS-CoV-2 Infection (COVID-19) and Reduced Mortality Among Nursing Home Residents

Who Are the World's Leading Authorities in COVID-19 Treatment?

COVID-19 early treatment: real-time analysis of 1,013 studies

Given the ever-changing narrative on COVID-19 vaccines, it is almost impossible for a layperson to understand exactly what is safe and what is part of the ongoing Phase 3 trials. A recent graphic found on the website of the School of Pharmacy at the University of Waterloo adds to that confusion, particularly given that mixing and matching of vaccines was NOT part of the original vaccine program.

Here is the graphic which is supposed to allow vaccine consumers to determine whether they are fully vaccinated:

Basically, the graphic is telling laypeople that they should not be getting the AstraZeneca vaccine as their second dose unless they received it as their first dose and that either the Pfizer or Moderna vaccines are suitable as a second dose if they received the AstraZeneca vaccine as their first dose.

Given that these vaccines are still being rolled out and that the final phase three trials for the stand-alone products (i.e. without mixing and matching) will not end until the following dates:

1.) Pfizer:

2.) AstraZeneca:

3.) Moderna:

...and that the medium- and long-term side effects and efficacy of each of the vaccines on a stand-alone basis have yet to be fully understood and shared with governments, public health officials and consumers, it is concerning that governments are basically allowing Big Pharma to continue their unprecedented vaccine experiment on humanity by both extending the period of time between doses far beyond what the manufacturer recommended and allowing the mixing and matching of COVID-19 vaccines all in the name of vaccinating as much of the world as possible as quickly as possible.

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