Why Did The FDA Hide Vaccine Injuries?

How Peter Marks' role in the COVID vaccine debacle exposed the flaws in America's toxic health bureaucracy

A frequent criticism of corporations (which I believe also applies to governmental bureaucracies) is that their organizational structure encourages sociopathic behavior. This is because members of these entities are shielded from legal or personal accountability for their actions, with any wrongdoings being attributed to the corporation as a whole. In contrast, the main form of accountability most members face is the pressure to advance the institution’s mission (e.g., make more money), leading to the proliferation of increasingly unethical methods to achieve that goal.

To illustrate, consider this quote from Peter Rost, a former executive at Pfizer and one of the few pharmaceutical leaders to speak out against the industry:

It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry … The difference is, all these people in the drug industry look upon themselves – well, I’d say 99 percent, anyway – look upon themselves as law-abiding citizens, not as citizens who would ever rob a bank … However, when they get together as a group and manage these corporations, something seems to happen … to otherwise good citizens when they are part of a corporation. It’s almost like when you have war atrocities; people do things they don’t think they’re capable of. When you’re in a group, people can do things they otherwise wouldn’t, because the group can validate what you’re doing as okay.

In looking through what went awry with the COVID-19 response, while Fauci was commonly blamed for all that went amiss, I kept running into another less-known individual who, while hidden within the FDA bureaucracy, I believe was directly responsible for many of the mishaps that happened

This was because Peter Marks was:

•The primary person who covered up the reports of COVID vaccine injuries (and instead repeatedly told the world they were “safe and effective”).

•Kept on pushing the FDA’s chief vaccine scientists (who were very pro-vaccine) to accelerate and condense the approval timelines for the COVID vaccines (as those approvals were needed to legally implement Biden’s vaccine and booster mandates). Eventually, Gruber and Krause reported their were no more corners they could cut to further accelerate the COVID vaccine approvals, at which point they were removed from the COVID vaccine approval process and Marks took it over (at which point the unjustifiable approvals and mandates quickly followed).

As such, I felt Marks should not be in the agency and four weeks ago put together a detailed summary of his gross malfeasance at the FDA throughout COVID-19 in the hopes his abhorrent conduct could become widely known.

Last week, Marks announced his resignation in a spiteful letter that concluded with:

I was willing to work to address the Secretary’s concerns regarding vaccine safety and transparency…However, it has become clear that truth and transparency are not
desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.

This, in turn, prompted Robert Redfield (Trump’s 2018-2021 CDC director) to make a Twitter account to state:

Secretary Kennedy and Commissioner MartyMakary have the responsibility to build their own team at the FDA to move our nation forward. It was extremely disappointing to see Dr Peter Marks’ vindictive comments towards Secretary Robert Kennedy Jr. in his resignation letter. I firmly believe RFK will be the most consequential Health Secretary in our nation’s history.

Note: Redfield, to my knowledge, is the only CDC director who went into private practice (he treats long COVID) after leaving the CDC (whereas in contrast most directors accept lucrative or prestigious positions following their tenure).

Following Mark’s resignation (which many news outlets claimed was forced), many news outlets attempted to paint him as saint and a victim of RFK’s “war against science”

This gushing coverage of Marks, in turn, I would argue was due to his background. Specifically:

•Prior to joining the FDA, Marks was an academic hematologist and oncologist with an “average and unimpressive publication history” (none of which related to vaccines, but one of which extensively discussed the global need for fully informed consent and stated “those that have only pretended to move [towards informed consent] will have the greatest difficulty”).

•Prior to joining the FDA, he’d also worked for several years the pharmaceutical industry (although oddly, no information exists online as to which companies he worked for—although one was likely Novartis).

•While at the FDA, he prioritized pushing through extremely expensive gene therapies (22 in total—most of which cost over half a million dollars), including some highly questionable ones (e.g., he overruled three FDA review teams and two top officials to push through a failed muscular dystrophy treatment which subsequently killed a patient).
Note: Robert Malone recently showed that Peter Marks was not qualified to be a senior regulator and had minimal knowledge or background in molecular biology, immunology or vaccinology (and worse still, repeatedly chose to overrule the FDA scientists who did).

•Marks was seen as a global leader in commercializing this field (e.g., he helped direct Germany’s national program to develop gene therapies, his resignation shook the entire sector, and following his resignation, large drops occurred in the stocks of key gene therapy companies).

Fake Empathy

Roughly a century ago, a new industry which combined propaganda, marketing and the emerging science of psychology was created by Freud’s nephew and rapidly took off because of how effectively it shifted public opinion. Since that time Public Relations (PR) has been continuously refined and this invisible industry has gradually gained a monopoly over pubic discourse and gotten a stranglehold on our society.

Since so many backwards policies (e.g., medical ones) originate from PR campaigns, I’ve thus tried to expose the common tactics this industry uses (e.g., having “experts” spam a persuasive soundbite across every media platform), as when you can’t see it, those tactics exert a powerful subconscious pull on the listener, but once you are able to see them, they become immensely transparent and you begin to see through so many of the lies that are fed to us.

Note: I have long found it immensely aggravating how often public figures (e.g., politicians) will successfully repeat PR lines you can tell they clearly do not believe what they are saying as there is no conviction behind their words and frequently they will subsequently say or do things which clearly demonstrate they did not mean what they’d said at the time). Likewise, I have always greatly disliked how when corporations do something evil and get caught, and it will puts out a statement which begins with “we are deeply saddened by …” and then somehow are absolved of their culpability for what happened

In my eyes, one of the most critical points to understand about PR is that the industry has made it much easier (and cheaper) to create a positive perception by paying a PR firm to do that than it is to earn the positive perception through one’s actions. Similarly, public policy has shifted towards policies being determined by whether or not a PR firm can sell them to the public rather than if the electorate supports them.

Note: much of the PR apparatus depends upon having a total monopoly over information (so that nothing can challenge the absurd narratives millions are spent to make be entrenched in our society). One of most profound shifts in our society has been the ability of information to freely diffuse across social media, thereby breaking the monopoly on truth which used to be afforded to those PR campaigns and allow contrary narratives which challenge the absurdity of many of these PR campaigns to rapidly disseminate and dispel those campaigns (e.g., I’ve had numerous times where this Substack successful dispelled a multi-million dollar propaganda campaign and since I am just one of many people doing that, it’s not financially feasible for traditional PR campaigns to continue to control the narrative).

Within medicine, one of the most common complaints patients have is that their doctors “don’t show empathy” towards them—a situation I believe ultimately results from the fact doctors have so little time with all the patients they see that the fundamental human capacity to be present to another’s experience gets overloaded and they instead default to interacting with their patient’s through an abstract script to get through the day.

In turn, while I sometimes come across individuals (e.g., doctors or politicians) who have the capacity to quickly be present to large numbers of people, normally the only viable solution to this problem is to spend more time with each person. Unfortunately, the current insurance payment scheme incentivizes those short visits (which I believe is incredibly shortsighted as many chronic issues can only be solved with longer visits that cost much less than the innumerable short visits that take their place).

As such, the medical industry chose to address this lack of empathy not by giving patients what they wanted (a doctor they felt connected to) but rather by creating the facade of empathy. This for example was accomplished by training medical students to robotically repeat “empathy statements” (e.g., repeating back what the patient said or stating “I’m sorry to hear that”), as in many cases, that indeed works.

Note: due to how profitable medical students are, there has been a proliferation of medical schools which has required gradually dropping the standards for admission (as our declining education standards has led to a lack of qualified college graduates). Because of this, the profession recently relaxed some of core graduation requirements such as their first board exams being switched to pass/fail and the pass/fail in-person basic assessment of clinical skills (where physician “empathy” was evaluated) being permanently cancelled due to COVID social distancing.

Most recently, I saw this on display in a viral video where a popular YouTube doctor (who’s taken a lot of pharmaceutical money) “debated 20 anti-vaxxers” and then received many variants of these two responses:

•"I am deeply impressed by the incredible empathy and compassion Dr. Mike gave these people."

•"I cannot believe how moronic and misinformed those people were; Dr. Mike is a saint for talking to them the way he did."

Conversely, after I watched it the following points jumped out at me:

1. Many of the people selected to appear challenged vaccination by promoting extreme and hard to defend views, thereby making it possible to make viral clips of their statements to smear all criticism of vaccines (whereas in contrast individuals with extensive familiarity on many of the topics were not invited so that Dr. Mike’s “expertise” could go unchallenged).

2. His responses typically were a mixture of standard vaccine talking points (e.g, all evidence of vaccine injury presented to him did not count because “correlation is not causation”) followed by “empathetic” statements.

3. Because of the smooth hypnotic pace he used, false statements that went unchallenged were peppered in such as:

•He asserted VAERS overreports vaccine injuries when in reality less than 1% of injuries make it into VAERS (as the government never wanted a publicly available injury database and once a law forced its creation, the government has worked for decades to undermine VAERS).

•He “compassionately” claimed the Federal vaccine injury compensation program existed to help individuals injured by vaccines and that they could sue a vaccine manufacturer if they were unsatisfied with the verdict—when in reality it is nearly impossible to have most injuries be acknowledged by that program and even harder to be able to sue a manufacturer outside of it).

•He argued that “vaccine immunity is superior to natural immunity” (which is false as vaccine immunity often creates a very narrow immunity pathogens rapidly evolve a resistance to). Then as people started to point that out, he pivoted to stating “vaccines do not put you at risk of infection like an actual infection so they are superior due to the lower risk entailed in become immune” and was not called out for moving the goalpost from efficacy to safety.
Note: there is also strong evidence vaccine side effects are often much greater than those from a natural infection (best demonstrated by how many more people have permanent complications from the vaccines than a COVID infection.

In short, his actions were a classic example of the (incredibly cruel) gaslighting many patients experience when, after being injured by a pharmaceutical, they are told the injury is entirely in their head. In some cases that’s done in a rude and confrontational way, but in many others, it’s instead done in a deceptive and compassionate manner which still traps you in the same box.

Note: one noteworthy fact about this doctor is that in addition to “combating misinformation” throughout COVID, he also used his large platform to repeatedly advocate for social distancing and mask wearing—but like many other proponents of that doctrine, subsequently got caught flagrantly violating it (in his case at his birthday party where he was maskless and tightly packed amongst women he’d invited—after which he essentially refused to apologize for his hypocrisy).

Mark’s “Empathy”

At React19’s request (an organization which advocates for the vaccine injured), I went through hundreds of pages of meetings and emails React19 had with the FDA. Many of these were with Peter Marks or his staff and occurred at the same time Marks was aggressively pushing FDA scientists to expedite approving the COVID vaccines so they could be mandated (e.g., military mandates began the day after his approval) and telling everyone the vaccine was safe and effective.

Throughout these documents, I noticed a few consistent patterns.

First, Marks would frequently not respond to queries or data demonstrating any issues with the vaccine.

Second, he would always stall and claim the FDA needed more time to conduct an analysis to determine if there was a specific safety issue with the vaccine (even though many of them were exceedingly obvious and could be definitely proven in less than a day).

Third, when directly presented with data he could not run away from (e.g., because he was in a live meeting) he would continually come up with excuses to explain why the data did not count (some of which matched Dr. Mike’s) and hence could not be linked to the COVID vaccines. As you can imagine, this was extremely frustrating for the React19 members (which included physicians), and they spent a lot of time trying to find something that could get through to him.

Fourth, he would repeatedly blame the serious issues the vaccine injured were having on medical system failing patients (but deflect when it was pointed out that those failures were due to a lack of injury acknowledgment or treatment guidelines from the NIH or FDA and that doctors who nonetheless treated injuries being targeted by medical boards).

Fifth, when pressed to define what would constitute acceptable proof of vaccine harm, Marks dodged the question.

Sixth, Marks (especially in meetings), whenever confronted with the horrendous experiences vaccine injured individuals went through used a large number of empathy statements to indicate that he “deeply cared” about the immense suffering those with COVID-19 vaccine injuries were going through.

In short, within ten minutes of the first meeting I watched that he had with React19, it was clear to me that Marks viewed those injured by the vaccines as acceptable collateral damage and that his only goal in dealing with them was to do whatever he could to make them go away so he wouldn’t have to deal with them or have them derail his vaccine campaign.

I believe this was demonstrated by one of their final [4/15/23] emails with him which went:

Hi Dr Marks and team. 

We received alarming news that the FDA participated in a multi-day event with a significant focus of dismantling the “anti-vax movement” instead of fully evaluating the safety and efficacy of vaccination. You are quoted as saying you can’t believe the vaccines aren’t seen as anything but safe. 

(After the honest conversation Germany’s government is having about Covid vaccine side effects nonetheless) 

Is this true??

The lives and livelihoods sacrificed by the Covid vaccine program are the legs of which the Covid vaccine program stands. If you cannot properly support this population, the program will not succeed as you desire. 

Of all the takeaways your team could have from the last two years is that this is all the “anti-vax movement’s fault?” 

Imagine the GOOD you could have done to help ALL Americans, not just those who suffer from diseases that are politically convenient. After two long years of illness these families are physically, emotionally and financially decimated. 

Dr Marks, Dr Richards, Ms McNeil, Dr Nair, Dr Woodcock: I can’t believe I trusted you to do the right thing. 

Brianne Dressen 

Co-Chair | React19.org

This email was in reference to a major vaccine conference (on April, 4, 2023) where Marks was a keynote speaker (as were other well-known figures like Peter Hotez). To quote a report from an undercover attendee, during a panel where Marks spoke with one of England’s chief regulators (alongside top scientists from Moderna and J&J):

Poland set the tone for the four-day conference in the first 10 minutes. In his mind, the COVID-19 pandemic was halted through the hard work of our regulatory agencies and the remarkable products borne of the mRNA platform.

The only failure came in the form of “inexplicable” vaccine hesitancy, a phenomenon driven by anti-vax pseudoscientists who are profiting from spreading baseless, fear-driven propaganda.

Combatting vaccine hesitancy, he said, is as big a challenge as protecting the world from the next deadly pathogen. Indeed, a significant portion of the events focused on strategies to dismantle the troubling “anti-vaxxer” movement.

Marks supported Poland’s position that the vaccine-hesitant are irrational, “It’s crazy that they don’t get how great vaccines are,” he said. “I am past trying to argue with people who think that vaccines are not safe.”

Note: during the React19 zoom meetings, Marks repeatedly implied otherwise (e.g., he stated “nobody is denying vaccine injuries may occur,” “nobody is denying adverse events can occur…nobody is denying the symptoms of what’s going on here,” “no-one is denying there are vaccine injury here. Nobody is denying that” “no-one is denying there are reports of neuropathy or potential of vaccine injury here. Nobody is denying that. But that vs a safety signal, that’s what we’re asking about”). Likewise, he repeatedly assured React19 they could trust the FDA (e.g., “We don’t have any secrets here.” “There is nothing I care about more than safe vaccines. No-one is trying to stonewall you…We don’t want to spread misinformation.” “Nobody is saying they’re not real it’s just saying that making definitive associations is very challenging.”).

In short, Marks provided a perfect illustration of the fake empathy that has infected medicine (and of course subsequently denied making these conference remarks).

Note: being a keynote speaker at the major conference for a pharmaceutical sector virtually guarantees the industry believes you will push along their products to the best of your ability. Similarly, I previously covered how Califf (Biden’s second FDA chief who was notorious for his pharmaceutical conflicts of interest) was the key note speaker at the annual invite-only conference JP Morgan Chase hosted for pharmaceutical investors (making it arguably the most important conference of the year). At that conference, Chase proclaimed that Ozempic and the new Alzheimer’s drugs would be some of the most lucrative drugs in history, and remarkably, immediately beforehand, Calif back-doored the approval of a highly controversial Alzheimer’s drug, while afterwards, the FDA began aggressively promoting Ozempic’s use in every age group.

Regulatory Blindness

The full report of that conference gives a fascinating perspective into the cult-like mentality of vaccine proponents. For instance, most of the attendees were convinced anti-vaxxers were a grave danger to humanity that had no rational basis for their beliefs (and hence must be censored). Yet simultaneously, most of the vaccine proponents (including prominent regulators) had no familiarity with most of basic data on COVID vaccines or any ability to address basic questions any reasonable person would ask.

Note: this is very similar to how an investigative journalist interviewed numerous subsequent leaders of the FDA during its war on DMSO and discovered each of them was essentially clueless on the existing science about DMSO (rather they mindlessly and aggressively regurgitated the FDA’s erroneous positions), which he found quite remarkable given both that they were expected to be the most knowledge scientists in America and that DMSO was by far the most controversial topic the FDA had to handle (and hence the one thing its leader should be informed about).

Most remarkably, the undercover attendees discovered that asking basic and reasonable questions pro-vaccine individuals would be expected to ask red-pilled many other (vaccine supporting) attendees. Put differently, like many other cults, the logical inconsistencies in many of their viewpoints were so extreme they could not standup to gentle scrutiny (and as such the moderators always terminated those dialogs).

This thus touches upon two important points.

First, in the 1970s and 1980s, the pharmaceutical industry had not yet bought out the mainstream media (as it was not until 1997 that the FTC decided to legalize pharmaceutical television advertisements) and as a result, national news programs that highlighted serious issues with the American vaccine program were aired (all of which I compiled here). Initially, government and industry tried to address the rising vaccine skepticism by debating it, but before long, they realized all that accomplished was reducing trust in vaccines (as many of their positions were indefensible and thus could not stand up to public scrutiny). As such, to combat this, alongside a newly minted media embargo on any questioning of vaccines, a decision was made going forward to never debate knowledgeable vaccine skeptics under the rationale “their viewpoints are so abhorrent giving them a platform endangers public health.” Fortunately,

Note: Peter Hotez (one of the world’s leading vaccine proponents) epitomizes this as his statements in favor of vaccination are so unconvincing and ridiculous (e.g., consider this infamous Joe Rogan exchange) they actively reduce trust in vaccination, and conversely, Hotez has adamantly refused to ever debate a vaccine skeptic, even when he was offered over 2.5 million dollars to.

Secondly, it helps clarify why the FDA, NIH, and CDC were unable to acknowledge any vaccine-related injuries, offering crucial context to their otherwise surreal, Kafkaesque struggle to have these injuries recognized.

For reference, an abridged timeline of what transpired is as follows:

December (2020): The NIH confirms both mRNA vaccines can cause complex non-anaphylactic reactions.

January: The NIH begins studying complex neurological issues that have been reported following vaccination.

March: The NIH study begins and officials at the NIH, CDC, and FDA acknowledge over 1,000 neurological injuries have been reported.

April: Vaccine injured patients are requested by the NIH and FDA to not publicly report their injuries so it will not interfere with the publication of the study (and thus preparing the medical community to treat them).

May: The NIH denies the study exists but partially admits injuries have been reported.

June: The FDA chief responds to a desperate May plea by the vaccine injured for help, promising to do whatever she can to help them, while the NIH determines that the neurologic injuries can be treated (if treated early). Since nothing was done, Senator Mike Lee sends a letter to the FDA and CDC about the vaccine injuries (which neither agency responded to).

July: The NIH publishes a rushed study claiming the neurological symptoms were due to FND (which essentially argues they are from stress), while the FDA (including Marks) responds to the mounting issues raised by vaccine injured patients by asking for more time.

August: The NIH study begins cancelling follow-up appointments with participants, but continues promising to help the vaccine injured, and when formally approving the COVID vaccines, commits to following up on each report vaccine injury (which is never done).

September: The NIH closes the vaccine injury study (and stops communicating with participants in October), while the FDA continues to ask for more time to do something and Marks refers the vaccine injured to the NIH (as they are more qualified to assess and help them).

October: Marks has a zoom meeting with React19 where he states none of the adverse reaction data they presented can be linked to the vaccine but promises the FDA will thoroughly examine everything for any potential safety signal.

November: NIH denies their study occurred, ceases providing private care to the injured and refers them to the private sector. Senator Ron Johnson also holds a roundtable on vaccine injuries which the FDA, CDC and NIH refuse to attend.

January: Marks cuts off and leaves a React19 meeting, and later commits to reviewing a doctor’s vaccine injury (but never does).

March: Marks meets with React19 where he again blames their situation on doctors failing to treat them and comes up with a variety of excuses to deny the strong evidence linking the COVID vaccines to a variety of unusual conditions.

April: Marks assures React19 that progress is being made and the FDA will be able to do something for them soon.

May: Marks continues to stall and downplay vaccine injuries.

September: The FDA cancels an in person meeting at the last minute with React-19 (after they came to Washington DC) and instead conducts a zoom meeting, where Marks again stalls and downplays the immense consequences of the FDA’s inaction being raised to him by React19 members.

December (2022): The FDA confirms receiving requested data from React19 and then completely ceases replying to them.

Note: a more detailed summary of those events can be read here.

React19 Memo Executive Summary

360KB ∙ PDF file

Download

Download

Likewise, this 10/04/21 meeting (which was one of seven Zoom calls React19 had with the FDA) for example illustrates Mark’s evasive behavior throughout the process:

Finally, React19’s experiences were not an isolated event. For example after Dr. Patricia Lee (a California ICU doctor and surgeon) witnessed a series of alarming and highly unusual incidents following vaccination such as AIDS like illnesses, a young woman who's pregnant becoming paraplegic (who lived just long enough to have her baby and died a month later) and two young women who lost most of their small intestines), she reported them to VAERS.

Since she was not followed up with, had Lawyer Aaron Siri send an official notice to the FDA (specifically Peter Marks) of the injuries she was observing and eventually got a meeting with Marks and the FDA.

The most incredible part of that meeting is after Dr. Patricia Lee relayed the stories in detail that would bring tears to most folks' eyes, she asked Dr. Marks[6] and the other 5 representatives from the FDA and CDC, do you have any questions?

[Aaron Siri pauses]

Exactly. That's exactly what she got. The silence that you hear. Until eventually, Dr. Marks did begin to speak and explained to her, VAERS is a wonderful system, and we're not seeing safety signals, everything's fine.

Likewise, to quote Robert Malone:

I met with [Marks] via zoom on June 03, 2021 to discuss the Pfizer Japanese regulatory submission documents that Dr. Byran Bridle had discovered on a Japanese regulatory affairs server. These documents clearly documented that Pfizer had failed to meet both FDA and worldwide regulatory norms with their non-clinical studies concerning the mRNA COVID vaccine, and yet FDA/CBER/Marks was proceeding with Emergency Use Authorization. My belief at the time was that FDA was acting in good faith, but lacked the specialized experience required to see through the misleading information that Pfizer had submitted (particularly regarding the biodistribution and toxicities of the injected product and resulting genetic transfer). In that meeting, which was also attended by an FDA PR representative, Dr. Marks indicated that he had seen additional data from Pfizer (what is now commonly referred to as the “Pfizer Papers”,) and that there was nothing there that “concerned” him. Furthermore, Dr. Marks asked me - as an expert in the area- to withhold public criticism until he could release the supporting data.

This was a manipulative ruse and a lie, and I hate being lied to and manipulated. He had no intention of releasing the data to the public, which data eventually required court action for release. Were it not for this like and misdirection, I would have spoken out earlier and more forcefully, but I acted to withhold my criticism out of respect for what I believed was an honest colleague.

Similarly, when Marks was confronted with data showing the COVID vaccines were contaminated with synthetic DNA fragments, rather than address a major quality control issue, he simply chose to launch a media campaign to suppress that concern.

Note: the above quote was from a comprehensive summary of Peter Marks surprising lack of competency Robert Malone recently published.

The Curious Case of FDA's Dr. Peter Marks

Mark’s Resignation

Frequently when dishonest people get called out, rather than apologize for their behavior, they will double-down on it. As such, I hope this article provides some helpful context to full appreciate Mark’s resignation letter.

Dear Dr. Brenner:

It is with a heavy heart that I have decided to resign from the FDA and retire from federal service as Director of the Center for Biologics Evaluation and Research, effective April 5, 2025. I leave behind a staff of professionals who are undoubtedly the most devoted to protecting and promoting the public health of any group of people that I have encountered during my four decades working in the public and private sectors. I have always done my best to advocate for their well-being, and I would ask that you do the same during this very difficult time, during which their critical importance to the safety and security of our nation may be underappreciated.

Over the past years, I have been involved in enhancing the safety of our nation’s blood supply, advancing the field of cell and gene therapy, and responding to public health emergencies. In the last of these, during the COVID-19 pandemic, I had the privilege of watching the vision that I conceived for Operation Warp Speed in March 2020 in collaboration with Dr. Robert Kadlec become a reality under the leadership of HHS Secretary Azar and President Trump due to the unwavering commitment of public servants at FDA and elsewhere across the government.

To be clear, Marks is taking credit here for rushing along the COVID vaccines (which was arguably the greatest regulatory mistake in history).

At FDA, the tireless efforts of staff across the agency resulted in remarkably expediting the development of vaccines against the virus, meeting the standards for quality, safety, and effectiveness expected by the American public. The vaccines undoubtedly markedly reduced morbidity and mortality from COVID-19 in the United States and elsewhere. Many of these same individuals applied learnings from the pandemic during a flawless response, helping to facilitate the rapid control of the mpox epidemic in the United States during 2022. Individuals who participated in these responses remain at the ready to address the infectious threats that undoubtedly will confront us in the coming years, including H5N1, which is now on our threshold.

Note: monkeypox was never a threat to public health because it was incredibly difficult to transmit.

Efforts currently being advanced by some on the adverse health effects of vaccination are concerning. The history of the potential individual and societal benefits of vaccination is as old as our great nation. George Washington considered protecting his troops in Cambridge, Massachusetts against smallpox early in the Revolutionary War so that they would not be susceptible to infection by British troops infiltrating the ranks. Later in the war, in February 1777, while encamped in Morristown, NJ, he went on to have the courage and foresight to sign an order requiring inoculation of his troops against smallpox. Subsequently, refinement of the smallpox vaccine, combined with a widespread vaccination campaign, resulted in the eradication of smallpox from the globe. The application of the remarkable scientific advances of Drs. Salk and Sabin’s vaccines led to the elimination of polio in the United States. And these are just effects of two of the vaccines that have been associated with saving millions of lives.

Note: the false mythology behind the smallpox and polio vaccines is covered here.

The ongoing multistate measles outbreak that is particularly severe in Texas reminds us of what happens when confidence in well-established science underlying public health and well-being is undermined. Measles, which killed more than 100,000 unvaccinated children last year in Africa and Asia owing to pneumonitis and encephalitis caused by the virus, had been eliminated from our shores.

Note: in addition to the relatively small increase in measles this year, unlike Africa, measles deaths are almost unheard of in the United States (e.g., in 2019 a 37-year old man died from measles, and this year, a child with measles died from an erroneously untreated bacterial pneumonia).

The two-dose measles, mumps, rubella vaccine regimen (MMR) used over the past decades has a remarkably favorable benefit-risk profile. The MMR vaccine is 97% or more effective in preventing measles following the two-dose series, and its safety has been remarkably well studied. Though rarely followed by a single fever-related seizure, or very rarely by allergic reactions or blood clotting disorders, the vaccine very simply does not cause autism, nor is it associated with encephalitis or death. It does, however, protect against a potentially devastating consequence of prior measles infection, subacute sclerosing panencephalitis (SSPE), which is an untreatable, relentlessly progressive neurologic disorder leading to death in about 1 in 10,000 individuals infected with measles. Undermining confidence in well-established vaccines that have met the high standards for quality, safety, and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety, and security.

Given that roughly 200 cases of measles occur each year in the United States, it would take approximately 50 years for a case of SSPE to emerge here.

In the years following the pandemic, at the Center for Biologics Evaluation and Research, we have applied the same unwavering commitment to public health priorities to the development of cell and gene therapies to address both hereditary and acquired rare diseases.

Note: one of the particularly frustrating decisions the FDA made in 2021 (and which Marks took credit for) was to cut off most of the human use of umbilical cord blood stem cells (that when applied correctly, were immensely useful for a variety of challenging illnesses), which effectively killed that industry.

During my tenure as Center Director, we have approved 22 gene therapies, including the first gene therapy ever to be approved in the United States. However, we know that we must do better to expedite the development of treatments for those individuals suffering from any one of the thousands of diseases potentially addressable by the advances in molecular medicine over the past decades. Drawing from learnings of the pandemic, the staff at the Center for Biologics Evaluation and Research are implementing best practices learned during the pandemic, such as increased communication with product developers, to further expedite bringing needed treatments to those in need. They have also been exploring the dramatic transformation of our regulatory approach to expedite the delivery of directly administered genome editing products. If thoughtfully approached and further developed and refined, these treatments have the potential to transform human health over the coming years.

Over the past 13 years, I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health. As you are aware, I was willing to work to address the Secretary’s concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine. However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.

My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end, so that the citizens of our country can fully benefit from the breadth of advances in medical science. Though I will regret not being able to be part of future work at the FDA, I am truly grateful to have had the opportunity to work with such a remarkable group of individuals as the staff at FDA and will do my best to continue to advance public health in the future.

Sincerely,
Peter Marks, MD, PhD

Note: the key point I cannot sufficiently emphasize in all of this was the degree of suffering and desperation in the vaccine injured patients who Marks “empathetically” stonewalled as he continued to push the COVID vaccines.

Conclusion

In 1906, the FDA (with the full support of Congress) was created in response to massive public protests against adulterated food and drugs (e.g., rotting food partially preserved with food additives or counterfeit consumer products). The first head of agency, Harvey Wiley, was an extremely dedicated public servant who did everything he could to protect America’s health.

However, despite initially having the full backing of the president and the courts, food industry lobbyists attempted every tactic imaginable, eventually taking over the Department of Agriculture and in time forcing Wiley to quit (as he felt he could do more for America’s health through public advocacy outside of the government).

To my knowledge, Secretary Kennedy is the first public servant to be in a similar position to Wiley, but unfortunately, the corruption (which was in its bare infancy during Wiley’s time) has exponentially grown. As such, despite having both a political mandate and the president’s support, RFK Jr. still faces an uphill battle to Make America Healthy Again.

Fortunately, a lot is going on behind the scenes and RFK is gradually untying the vast Gordian knot of corruption with in the H.H.S. (e.g., since it’s an exercise in futility to work against thousands of bureaucrats who actively try to sabotage you, he recently began letting go of 10,000 H.H.S. personnel who had not been serving America’s interests such as Anthony Fauci’s wife who remarkably served as America’s chief bioethicist during the unconscionable COVID vaccine mandates). Likewise, he is gradually addressing many longstanding issues every other regulator has passed on such as being the first Secretary in fifty years to clean up our unhealthy infant formula supply and closing the “generally recognized as safe” (GRAS) loophole many use to put toxic substances in our food (which came about after Wiley proved the toxicity of those additives, then fought for years to take those additives off the market but instead they were eventually given “GRAS” status).

Like Wiley, RFK Jr. is opposed by vast entrenched interests, and as such it is important to remember Wiley’s prescient warning that policies which bring health back to America can only be implemented if the public also advocates for them. We now have a once in a lifetime opportunity to do this, and I hope this article helps to illustrate a bit of what RFK is working against to Make America Healthy Again and create a system where our healthcare system is restructured to genuinely care about the people it serves. I thus sincerely thank each of you for what you’ve done to make this moment possible and the support you’ve given me which has allowed me to also be an advocate for a healthier world.

To learn how other readers have benefitted from this publication and the community it has created, their feedback can be viewed here. Additionally, an index of all the articles published in the Forgotten Side of Medicine can be viewed here.