On Friday, Dr. Peter Marks introduced his resignation from the U.S. Meals and Drug Administration (FDA) as Director of CEBR (Heart for Biologics Analysis and Analysis) citing variations with Well being and Human Companies (HHS) Secretary Kennedy relating to vaccines. The New York Occasions, Washington Submit, and different media retailers similar to STAT Information breathlessly reported that “FDA’s high vaccine scientist had been pushed out.” We’ve got been informed that science is in danger. The irony of those experiences is that Marks didn’t resign and isn’t a vaccine scientist. Dr. Marks was requested to depart after which subsequently wrote that he didn’t wish to develop into “subservient to (Secretary Kennedy’s) misinformation and lies.”
Peter Marks just isn’t a hero of the resistance however as an alternative has been subverting the scientific course of at FDA for years.
The media proclamation that Dr. Marks’ is “FDA’s high vaccine scientist” is ironic as a result of he determined to offer himself that place. Marks is a doctor however has no medical or scientific coaching in vaccines or immunology. Dr. Marks skilled as an oncologist, a subject removed from the essential and sophisticated space of vaccine biology. At FDA in 2021, Dr. Marks eliminated high profession vaccine scientists so he might drive by means of the approval of the COVID vaccine to satisfy an arbitrary Biden administration deadline. He additionally declined to convene the FDA Vaccine Advisory Committee to evaluation his resolution. These occasions are clearly outlined within the June 2023 Home Judiciary Hearings. Marks ousted Dr. Gruber and Dr. Krause, the highest scientists on the Workplace of Vaccine Analysis, on account of “intransigence” of those actual vaccine consultants to not ram by means of the approval of the vaccine. Drs. Gruber and Krause had voiced issues that they wanted extra time to know the protection of the vaccine particularly because it pertains to irritation of the center, now a well-known and accepted toxicity of the COVID vaccine. Marks authorized using the vaccine in kids regardless of the identified indisputable fact that kids have an especially low threat of great well being results of COVID-19 an infection and but a identified important elevated threat of great vaccine associated toxicity.
On at the least three extra, documented events throughout the Biden administration as Director of CBER, Marks disregarded the opinions and knowledgeable recommendation of long-time profession scientists to advance his personal harmful agenda. Along with ignoring and overruling FDA’s high vaccine scientists throughout the pandemic, Marks additionally overruled FDA profession scientists and supported the approval of the Alzheimer’s drug ADUHELM; a choice later overturned. In 2023, he overruled his personal workers scientists amid their issues and people raised by an FDA Advisory Board to grant approval of ELEVIDYS, a gene therapy for Duchenne muscular dystrophy (DMD). Moreover, in 2024 Marks expanded the approval of ELEVIDYS regardless of FDA workers objections and with out FDA Advisory Committee enter.
As tragic proof of Marks’ failed judgement, simply 2 weeks in the past, the corporate that markets the remedy ELEVIDYS introduced {that a} handled affected person died of fulminant liver failure. Marks overruled his personal profession workers and consultants to drive by means of a dangerous and unproven remedy that has now killed a affected person. This tragedy mustn’t have occurred. After the preliminary FDA approval, the corporate carried out a subsequent trial which did not meet the first efficacy endpoint. On high of that, ELEVIDYS has confirmed toxicity together with liver failure (22% of sufferers) and enhance in severe adversarial occasions. Regardless of the dearth of confirmed efficacy and the regarding toxicity profile, Dr. Marks rammed by means of the preliminary ELEVIDYS approval and the complete approval in June of 2024 towards the counsel of his workers and the knowledgeable panel. Whereas advocates level to the necessity for brand spanking new therapies in extreme debilitating illnesses similar to DMD, giving sufferers and households hope on a poisonous remedy that doesn’t present a medical profit rises past easy incompetence. A affected person died needlessly, and others have been harmed on account of this incompetence.
Dr. Marks additionally failed to guard public well being when he overruled profession FDA scientists and supported the approval of the Alzheimer’s therapy AUDHELM, a controversial approval that was subsequently overturned. ADUHELM was authorized in June 2021 regardless of strident objections from FDA workers and towards the suggestions of an Advisory Board. The truth is, two distinguished members of that advisory board resigned in protest of the choice. These members cited a scarcity of clear efficacy and the chance of great toxicity together with mind swelling and bleeding that may be life threatening. These occasions led to a congressional investigation which discovered that FDA had “unusually shut” interactions with Biogen, the AUDHELM sponsor and applicant. In January 2024, Biogen determined to take away ADUHELM from the market after confirmatory trials failed to point out affected person profit. So, Dr. Marks once more supported a harmful and ineffective remedy that cruelly gave sufferers hope and offered nothing however threat and price to Individuals.
Each the ADUHELM preliminary approval and the ELEVIDYS approvals exhibit that ignoring fundamental tenants of the use and interpretation of medical trial knowledge might be very damaging to public well being. By ignoring these well-tested tenants of FDA evaluation and approval, Marks endangered sufferers, gave false hope to these in determined want and price huge quantities of cash that our well being case system can in poor health afford. It can’t be overstated how damaging this follow is to drug growth. This uneven utility of fundamental medical trial knowledge interpretation calls into query the impartiality and credibility of the FDA. That is significantly related now as a affected person who in any other case might have lived many extra years died from an anticipated toxicity. And we have now but to totally decide the hurt brought on by Dr. Marks resolution to take away probably the most skilled and trusted vaccine scientists that merely wished extra time to know the, now confirmed, dangers of the COVID vaccine.
Whereas Dr. Peter Marks might attempt to declare variations with Secretary Kennedy on vaccines and the legacy media attempt to paint Marks because the FDA hero, the true cause he was terminated is that he made dangerous choices that had been opposite to FDA long-standing insurance policies and which ran counter to the evaluations {of professional} profession workers at FDA. Because of Dr. Marks’ horrible choices, we’re left with a drug that has no confirmed profit and that simply killed a younger affected person, a vaccine that isn’t utterly protected is being administered to kids that don’t have any important threat of hurt from the underlying an infection, and an overburdened healthcare system that needed to pay billions for an additional unproven, dangerous remedy. Advocates for Dr. Marks declare that he has acted to assist sufferers with life-threatening situations which don’t have any various remedies. However in actuality, he catered to business and damage sufferers. After all, we should always try to advance protected and efficient therapies for such situations, however we should always not approve ineffective and harmful therapies merely to place one thing out in the marketplace. Sadly, Dr. Marks has repeatedly disregarded long-held FDA coverage that’s in place to guard sufferers. That’s malpractice not heroism.
George F. Tidmarsh, MD, PhD, Stanford College College of Drugs, Adjunct Professor, Pediatrics and Neonatology.
