Follow the science: Why Peter Marks was asked to leave the FDA

On Friday, Dr. Peter Marks announced his resignation from the U.S. Food and Drug Administration (FDA) as Director of CEBR (Center for Biologics Evaluation and Research) citing differences with Health and Human Services (HHS) Secretary Kennedy regarding vaccines. The New York Times, Washington Post, and other media outlets such as STAT News breathlessly reported that “FDA’s top vaccine scientist had been pushed out.” We have been told that science is at risk. The irony of these reports is that Marks didn’t resign and is not a vaccine scientist. Dr. Marks was asked to leave and then subsequently wrote that he did not want to become “subservient to [Secretary Kennedy’s] misinformation and lies.”

Peter Marks is not a hero of the resistance but instead has been subverting the scientific process at FDA for years.

The media proclamation that Dr. Marks’ is “FDA’s top vaccine scientist” is ironic because he decided to give himself that position. Marks is a physician but has no clinical or scientific training in vaccines or immunology. Dr. Marks trained as an oncologist, a field far from the important and complex area of vaccine biology. At FDA in 2021, Dr. Marks removed top career vaccine scientists so he could force through the approval of the COVID vaccine to meet an arbitrary Biden administration deadline. He also declined to convene the FDA Vaccine Advisory Committee to review his decision. These events are clearly outlined in the June 2023 House Judiciary Hearings. Marks ousted Dr. Gruber and Dr. Krause, the top scientists at the Office of Vaccine Research, due to “intransigence” of these real vaccine experts to not ram through the approval of the vaccine. Drs. Gruber and Krause had voiced concerns that they needed more time to understand the safety of the vaccine especially as it relates to inflammation of the heart, now a well known and accepted toxicity of the COVID vaccine. 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 yet a known significant increased risk of serious vaccine related toxicity.

On at least three additional, documented occasions during the Biden administration as Director of CBER, Marks disregarded the opinions and expert advice of long-time career scientists to advance his own dangerous agenda. In addition to ignoring and overruling FDA’s top vaccine scientists during the pandemic, Marks also overruled FDA career scientists and supported the approval of the Alzheimer’s drug ADUHELM; a decision later overturned. In 2023, he overruled his own staff scientists amid their concerns and those raised by an FDA Advisory Board to grant approval of ELEVIDYS, a gene treatment for Duchenne muscular dystrophy (DMD). Furthermore, in 2024 Marks expanded the approval of ELEVIDYS despite FDA staff objections and without FDA Advisory Committee input.

As tragic evidence of Marks’ failed judgement, just 2 weeks ago, the company that markets the therapy ELEVIDYS announced that a treated patient died of fulminant liver failure. Marks overruled his own career staff and experts to drive through a risky and unproven therapy that has now killed a patient. This tragedy should not have happened. After the initial FDA approval, the company conducted a subsequent trial which failed to meet the primary efficacy endpoint. On top of that, ELEVIDYS has proven toxicity including liver failure (22% of patients) and increase in serious adverse events. Despite the lack of proven efficacy and the concerning toxicity profile, Dr. Marks rammed through the initial ELEVIDYS approval and the full approval in June of 2024 against the counsel of his staff and the expert panel. While advocates point to the need for new therapies in severe debilitating diseases such as DMD, giving patients and families hope on 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.

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. In fact, two prominent members of that advisory board resigned in protest of the decision. These members cited a lack of clear efficacy and the risk of serious toxicity including brain swelling and bleeding that can be life threatening. These events led to a congressional investigation which found that FDA had “unusually close” interactions with Biogen, the AUDHELM sponsor and applicant. In January 2024, Biogen decided to remove ADUHELM from the market after confirmatory trials failed to show patient benefit. So, Dr. Marks again supported a dangerous and ineffective therapy that cruelly gave patients hope and provided nothing but risk and cost to Americans.

Both the ADUHELM initial approval and the ELEVIDYS approvals demonstrate that ignoring basic tenets of the use and interpretation of clinical trial data can be very damaging to public health. By ignoring these well-tested tenets of FDA review and approval, Marks endangered patients, gave false hope to those in desperate need and cost vast amounts of money that our health case system can ill afford. It cannot be overstated how destructive this practice is to drug development. This 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 patient who otherwise could have lived many more years died from an expected toxicity. And we have yet to fully determine the harm caused by Dr. Marks decision to remove the most experienced and trusted vaccine scientists that simply wanted more time to understand the, now proven, risks of the COVID vaccine.

While Dr. Peter Marks may try to claim differences with Secretary Kennedy on vaccines and the legacy media try to paint Marks as the FDA hero, the real reason he was terminated is that he made bad decisions that were contrary to FDA long-standing policies and which ran counter to the evaluations of professional career staff at FDA. Thanks to Dr. Marks’ terrible decisions, we are left with a drug that has no proven benefit and that just killed a young patient, a vaccine that is not completely safe is being administered to children that have no significant risk of harm from the underlying infection, and an overburdened healthcare system that had to pay billions for another unproven, harmful therapy. Advocates for Dr. Marks claim that he has acted to help patients with life-threatening conditions which have no alternative treatments. But in reality, he catered to industry and hurt patients. Of course, we should strive to advance safe and effective therapies for such conditions, but we should not approve ineffective and dangerous therapies simply to put something out on the market.  Unfortunately, Dr. Marks has repeatedly disregarded long-held FDA policy that is in place to protect patients. That is malpractice not heroism.

George F. Tidmarsh, MD, PhD, Stanford University School of Medicine, Adjunct Professor, Pediatrics and Neonatology.