Summarize this content to 100 words Peter Marks, the top Food and Drug Administration official who oversaw vaccines, gene therapies, and the blood supply, resigned Friday after being told by Trump administration officials he would be fired if he did not step down, according to people familiar with the situation.
In his resignation letter, which was obtained by STAT, Marks said that he had attempted to answer the concerns of Health and Human Services Secretary Robert F. Kennedy Jr., regarding the safety of common childhood vaccinations.
“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,” Marks wrote. “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.”
The news was first reported by The Wall Street Journal.
Former FDA commissioners, as well as experts in public health, oncology, and the practice of medical research instantly criticized the move.
“His letter raises uniquely serious concerns for the community who care about the health of our people,” said Robert Califf, who served as FDA commissioner under two presidents. “I hope the biomedical community will speak with conviction. I don’t use the word uniquely lightly. This is a point in American history that is truly unique.”
Scott Gottlieb, who served as FDA commissioner during the first Trump Administration, told the Washington Post that Marks deserved particular credit for his work in regulating gene therapy.
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“Peter has presided over an extraordinary period of medical progress, spearheading breakthroughs in cell and gene therapy that helped transform the treatment of pediatric leukemia, sickle cell disease, and certain forms of blindness,” Gottlieb said.
The public’s immediate concern will not be Marks’ long work in gene therapy, but the questions he raised in his resignation letter about the integrity of the U.S. process for regulating vaccines.In the month and a half since he was sworn in as HHS Secretary Kennedy has moved swiftly to enact his anti-vaccine agenda. A meeting of the Centers for Disease Control and Prevention’s expert vaccine panel, the Advisory Committee on Immunization Practices was postponed and a meeting of the FDA’s vaccine advisers, the Vaccines and Related Biological Products Advisory Committee was canceled.
Kennedy demanded that a new study looking for a link between vaccines and autism be conducted, work CDC scientists initially thought they were to conduct. But the agency was instead told to share the raw data of four previously published studies with HHS. A stalwart of the anti-vaccine movement, David Geier, has been hired as a “senior data analyst” working in the office of the Secretary. Geier, who has only a bachelor’s degree, was once disciplined for practising medicine without a license.
And Thursday, Kennedy announced in an interview on News Nation that he was creating an agency within the CDC to study vaccine injuries.
In his resignation letter, Marks raised concerns about the burgeoning measles outbreaks in the country, which have already claimed two lives. The CDC reported Friday that there have been nearly 500 confirmed cases to date in 19 states; experts believe many parents are not seeking tests for infected children and the actual figure may be considerably higher.
In normal times, measles outbreaks trigger strong and frequent calls from public health leaders for parents of unvaccinated children to get their children inoculated. But Kennedy, who believes there is a link between vaccinations and autism, despite mountains of evidence disproving the claim, has only said that vaccination is a personal choice. Rather than urging parents to help their children avoid infection, he has emphasized questionable approaches to treating children while they are ill; some parents have given such high doses of the vitamin A that Kennedy espouses to prevent measles that their children have incurred liver damage.
“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,” Marks wrote in his resignation letter.
“I worry that his loss to FDA, and, more generally, meddling with the US government’s most talented scientific leaders and staff, will slow the availability of new cures, hurt our economy, put public safety at risk, and discourage scientists from careers in public service where they are so needed,” Jesse Goodman, director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University told STAT. Goodman previously served in the role at FDA that Marks held.
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Marks was one of the architects of Operation Warp Speed, the $18 billion U.S. effort to speed development of Covid-19 vaccines. The undertaking was one of the signature accomplishments of the first Trump administration, leading to the deployment of two vaccines within a mere 11 months of the publication of the first genetic sequence of the new virus.
In an interview with STAT shortly before the election, Marks made clear his views that vaccines were safe, rigorously tested, and necessary to ensure public health. There is no skimping on safety in the vaccine world,” he said.
In November, shortly after President Donald Trump was elected, Marks spoke at a health care conference in London and said he thought the scientific community would have to make the case for the value of vaccines to the incoming anti-vax administration, but said “I have to believe that some degree of moderation will prevail.”
He said he knew there was dialogue to come but said, “My hope is that through an open dialogue, we will get to the right place.”
He made it clear he hoped to keep his job, saying: “I will stay around as long as I’m considered to be welcome to stay around.” That turned out to be just over two months.
The resignation was met with disappointment by researchers working on new cancer immunotherapies such as CAR T-cell therapy. ”This is so incredibly sad for cancer and specifically cell and gene therapy,” Krishna Komanduri, physician-in-chief at the Helen Diller Comprehensive Cancer at the University of California, San Francisco Cancer Center, posted on social media in response to Mark’s departure. “CAR-T therapies would not be where they are without his efforts.”
Eric Topol, chair of the department of translational medicine at Scripps Research was blunt: “A huge loss for FDA,” he posted on social media shortly after the news broke.
Even some conservatives were concerned about Marks’ resignation. Peter Pitts, a former FDA associate commissioner under President George W. Bush, told STAT: “Peter Marks was willing to work with the new Administration — but there was no appetite on the part of Mr. Kennedy to agree to disagree. Bad decision. Get your vaccinations and hold on to your principles.”
Ashish Jha, dean of the school of public health at Brown University and Biden’s Covid czar, considers Marks “one of the most brilliant, dedicated scientists and public servants,” he said in a social media post. “This is not,” he said, “how we make America healthy.”
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