Corrupt and Unethical Leadership at the FDA
There is a particular kind of government betrayal that arrives not with a bang, but with an obscure bureaucratic memo. No dramatic announcement, no press conference, no honest accounting to the public.
Just a directive, handed down through internal channels, instructing scientists to withdraw publication of their work — work they spent years producing; that taxpayers spent millions funding; that concluded, simply and clearly, that FDA-approved vaccines are safe.
That is what has been happening at the FDA. And it should disgust and anger every American who has ever trusted a public health institution.
FDA officials withdrew or blocked publication of studies that found no new safety concerns in widely used COVID-19 vaccines and reinforced the known safety profile of Shingrix, the shingles vaccine. Two COVID vaccine studies — both accepted for publication in medical journals— were withdrawn, allegedly after government scientists were directed in October by their bosses to pull them. And in February, agency officials refused to sign off on abstracts for two studies of Shingrix, the shingles vaccine, preventing them from being presented at a major drug safety conference.
The research simply disappeared into a bureaucratic void.
The FDA’s explanation, offered through a Department of Health and Human Services spokesman, was that the studies drew “broad conclusions that were not supported by the underlying data.” This defense doesn’t hold up. Independent experts who reviewed the withdrawn studies were clearly disgusted by the intrusion of politics into public health. Dr. Caleb Alexander of Johns Hopkins, a drug safety and methodology specialist, found “nothing inherently problematic” about the research; Dr. Jeffrey Morris, director of the University of Pennsylvania’s biostatistics division, called the studies generally well done; and Dr. Aaron Kesselheim of Harvard, who has collaborated with the FDA extensively, said the agency’s work met “the highest standards of scientific investigation” and called the withdrawal “censorship.”
These are not partisan voices or vaccine activists. These are accomplished scientists evaluating their peers’ methodology. Their verdict is clear and correct: this is censorship. The stated justification is not.
Consider what these studies found. One examined 7.5 million Medicare beneficiaries who received COVID vaccines. Of 14 potential adverse outcomes studied — including heart attacks, strokes, and Guillain-Barré syndrome — only one elevated risk appeared: a severe allergic reaction affecting roughly one in a million recipients of the Pfizer vaccine.
Another study of 4.2 million vaccine recipients found rare cases of fever-related seizures and myocarditis, both already known to be associated with COVID vaccines, and concluded that “the benefits of vaccination outweigh the risks.” That finding is consistent with FDA-approved labeling: Myocarditis and pericarditis are real but rare risks, with the highest rates among young men. The Shingrix safety study found results consistent with what was already in the vaccine’s labeling. Again, the benefits outweigh the risks. CDC likewise says Shingrix is more than 90 percent effective in healthy adults over 50 and was not associated with serious adverse events in clinical trials, while noting that Guillain-Barré syndrome has been reported very rarely. Again, the benefits outweigh the risks.
In other words, the data supported the vaccines’ safety. So, for reasons the agency still has not persuasively explained, as appeasing the anti-vaccine lobby is the most likely reason, the data had to go.
What makes this especially damning is the selective standard being applied. While rigorous, peer-reviewed safety studies are being buried, other information — unvetted, alarming, and of dubious provenance — flows freely. A striking example was a memo by Dr. Vinay Prasad — who recently departed as head of the FDA center that oversees research on vaccines — that provoked widespread criticism when he claimed COVID vaccines were linked to the deaths of “at least 10 children.” The agency has never substantiated or explained that claim. An internal review later reported by Inside Medicine classified zero cases as “certain” vaccine-caused deaths, while the FDA’s own guidance warns that VAERS reports generally cannot establish causation.
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The claim provoked widespread criticism and became central to the erosion of Prasad’s credibility; he recently departed the agency amid widespread speculation that he was fired. The double standard could not be more stark: Scientific evidence supporting vaccines is suppressed while unsupported claims casting doubt on them are amplified. Nor is this an isolated case: The CDC also declined to publish a report showing last winter’s COVID vaccine reduced emergency visits and hospitalizations, after officials cited methodological objections that other experts disputed.
This is not scientific caution. It is bureaucratic corruption dressed in the language of rigor. “Gold-standard science” may be their mantra, but it isn’t reality.
Dr. Jeanne Marrazzo, the former director of the National Institute of Allergy and Infectious Diseases at NIH, bluntly called the FDA’s actions an “active act of sabotage.” Dr. Helen Chu, an infectious disease specialist who was fired from the CDC’s Advisory Committee on Immunization Practices last summer, has publicly explained why large post-market surveillance studies are so critical: They examine millions of patients, far beyond the numbers in pre-approval clinical trials. Doctors, patients, and policymakers rely on them. Suppressing them does not protect public safety; it endangers it.
There is a downstream cost to this malfeasance that extends far beyond any individual vaccine or study. Public trust in health institutions is not abstract — it determines whether people get vaccinated, whether they take their children to the doctor, and whether they will believe what scientists tell them during the next pandemic. Every suppressed study, withdrawn paper, and government scientist whose work is buried for political reasons damages the credibility built over decades.
The FDA was created to protect Americans from unsafe medicines and other products — not to protect itself from inconvenient data. When it begins to suppress its own scientists’ findings because those findings are politically incorrect, it has abandoned its fundamental mission.
Dr. Kesselheim put it succinctly: “At any other time in history, this would be a major scandal that would lead to congressional hearings and resignations of leadership.”
He’s right. The question is whether this moment will be treated with the seriousness and response it demands — or whether the censorship will continue, the science will keep disappearing, and no one will be held to account.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Scholar at the Science Literacy Project. He was the founding director of the FDA’s Office of Biotechnology. Find Henry on his website: henrymillermd.org
