Dr. Peter Marks Was a Hero to Biotech Investors, Not Patients and Public Health

A series of poor decisons that ignored FDA staff and outside experts marked Dr. Marks for government termination.

8 minute read

Unless you lack access to the Internet or electricity, you likely caught a headline noting that Dr. Peter Marks resigned from the FDA last Friday, sending a vengeful letter condemning Secretary Kennedy. Reports of Marks’ departure rocketed all the way to India and Australia, but headlines in the New York Times (Top F.D.A. Vaccine Official Resigns, Citing Kennedy’s ‘Misinformation and Lies’) and the Washington Post (RFK Jr. forces out Peter Marks, FDA’s top vaccine scientist) should give you a flavor for the narrative legacy media is feeding us: RFK Jr’s misinformation and lies drove vaccine expert Peter Marks from public service.

But Peter Marks is no vaccine expert, and his own history of misinformation and lies led to his dismissal to protect both the public and science from his poor decisions.

Dr. Marks served as the FDA’s Director of CBER (Center for Biologic Evaluation and Research), and during the Biden administration he disregarded the opinions and expert advice of long-time career scientists to advance his own dangerous agenda on at least 4 documented occasions. Dr. Marks seized control of COVID vaccine decision-making in late 2021, ousting the FDA’s top vaccine scientists—Drs. Marion Gruber and her deputy Philip Krause—because they had voiced concerns about COVID-19 vaccine boosters, pitting themselves in opposition to Biden administration’s vaccine agenda.

Prior to forcing out the FDA’s vaccine experts, BioPharma Dive reported that Marks overruled FDA career scientists in the summer of 2021 to support the approval of Biogen’s Alzheimer’s drug ADUHELM or aducanumab; a decision that later turned sour. He then overruled his own staff scientists concerns in June 2023 and those raised by an FDA Advisory Board to grant approval of Sarepta’s ELEVIDYS, a gene therapy treatment for Duchenne muscular dystrophy (DMD). Last summer, Marks expanded the approval of ELEVIDYS despite FDA staff objections and without FDA Advisory Committee input.

The media proclamation that Dr. Marks’ is “FDAs top vaccine scientist” is ironic because that’s a position he gave to himself after pushing out the FDA’s real vaccine experts: Drs. Gruber and Krause. Marks is a physician but he has no clinical or scientific training in vaccines nor immunology. He’s actually an oncologist, a field far from the complex area of vaccine biology. When Dr. Marks removed the FDA’s top career vaccine scientists in 2021, he did so not to advance science, but to force through the approval of the COVID vaccine boosters to meet an arbitrary Biden administration deadline.

Weeks after Dr. Marks pushed them out of the FDA, Drs. Gruber and Krause co-published a viewpoint in The Lancet that questioned the safety to patients of COVID-19 vaccine booster:

Although the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines). If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate.

The House Judiciary Committee outlined much of these events in a report that found the Biden administration pressured the FDA to cut corners, and lower agency standards to approve the Pfizer COVID-19 vaccine and authorize boosters, allowing mandates. Marks approved the use of the vaccine in children despite the known fact that children have an extremely low risk of serious health effects of COVID-19 infection and a known significant increased risk of serious vaccine related toxicity.

Appearing on a podcast just a few days ago, Dr. Krause said that Dr. Marks and the Biden administration promoted COVID-19 mandates despite evidence, causing some people to lose their jobs or be kicked out of the military.

“Mandating a vaccination to protect other people was really based solely on speculation,” Dr. Krause said. “My sense is that this speeding up of the approval came about as this part of a push for mandates. And to me that’s one of the things that led to the greatest loss of confidence in the public health system.”

Dr. Marks also failed to protect public health when he overruled career FDA scientists and supported the approval of the Alzheimer’s treatment AUDHELM, a controversial approval that was subsequently overturned. ADUHELM was approved in June 2021 despite strident objections from FDA staff and against the recommendations of an Advisory Board. Critics said the approval was a dangerous lowering of drug approval standards for a medication that Biogen planned to price at $56,000 per patient a year.

The Washington Post reported that 2 prominent members of that advisory board resigned to protest the decision, with Washington University in St. Louis neurologist Joel S. Perlmutter saying he quit “due to this ruling by the FDA without further discussion with our advisory committee.”

David S. Knopman, a neurologist at the Mayo Clinic, emailed the Post that he did not “wish to be part of a sham process.”

House investigators released a report that found FDA's interactions with Biogen were atypical and failed to follow protocol and that the agency inappropriately collaborated with Biogen on a joint briefing document for a key advisory committee. FDA’s approval of ADUHELM, congressional investigators found, happened despite lack of clinical data.

Biogen decided to remove ADUHELM from the market, in January 2024, after confirmatory trials failed to show patient benefit and Medicare limited coverage. Essentially, Dr. Marks again supported an ineffective therapy that gave patients false hope, eroded trust in the regulatory process for bringing new medicines to market, and provided nothing but risk and cost to Americans.

Further evidence of Dr. Marks’ failed judgement came to light just 2 weeks ago when Sarepta reported that a Duchenne muscular dystrophy (DMD) patient treated with their gene therapy ELEVIDYS died of fulminant liver failure. Despite concerns of many career FDA scientists, Dr. Marks pushed ELEVIDYS in both in the 2023 initial approval and in 2024 expanded approval.

Reporting on the death of the 16 year-old boy, Fierce Pharma noted:

“You haven’t delivered any of this evidence you’re supposed to have for your $3.2 million drug,” Catherine Collins, mother of a DMD patient, was recorded telling a Sarepta exec at a Parent Project Muscular Dystrophy event last year.

“We’re the people who give you the millions of dollars but you’re not giving us anything back, which is facts, data and science,” Collins said, as quoted by Stat.

Marks overruled his own career staff and experts in order to drive through a risky and unproven therapy. While advocates point to the need for new therapies in severe debilitating diseases such as DMD, giving patients and families hope with a toxic therapy that does not provide a clinical benefit rises beyond simple incompetence. A patient died needlessly and others have been harmed due to this incompetence.

Both the ADUHELM initial approval and the ELEVIDYS approvals demonstrate that Marks endangers patients, gives false hope to those in desperate need, and his decisions cost vast amounts of money that our health system can ill afford.

We still have yet to determine the harm caused by Dr. Marks decision to remove the most experienced and trusted vaccine scientists who simply wanted more time to understand the, now proven, risks of the COVID vaccine. But it cannot be overstated how destructive Dr. Mark’s decisions have been to drug development. His uneven application of basic clinical trial data interpretation calls into question the impartiality and credibility of the FDA. This is particularly relevant now as a young patient who could have lived many more years died from an expected toxicity.

Dr. Marks may try to claim that differences with Secretary Kennedy on vaccines caused his termination, and the legacy media may try to paint Dr. Marks as the FDA hero, but the real reason he was terminated from public service is that he made bad decisions contrary to FDA policies and he ignored professional career staff at FDA. Thanks to Dr. Marks’ terrible decisions, we are left with a gene therapy that has no proven benefit and that just killed a young patient, as well as a COVID-19 vaccine now recommended for children who have no significant risk of harm from the underlying infection.

Advocates for Dr. Marks claim that he has acted to help patients with life-threatening conditions which have no alternative treatments. We should strive to advance safe and effective therapies for such illnesses but we should not approve ineffective and dangerous therapies simply to put something out on the market and reward investors.

Dr. Marks has repeatedly disregarded long-held FDA policies to side with industry over patient safety with Investor’s Business Daily applauding him as “key proponent for regulatory flexibility.” Proof of this can be found in a series of stories in recent days noting that biotech stocks dropped after he was removed from government service.

That is not heroism. That is malpractice.

Dr. George Tidmarsh is a physician and research scientist currently serving as Adjunct Professor of Pediatrics and Neonatology at Stanford University. He has spent over 30 years in biotechnology drug development, helping bring numerous new therapies through FDA approval while serving in various capacities, including company CEO.