In a letter sent to the acting Commissioner of the U.S. Food and Drug Administration this week, the man who was leading a unit of the agency that oversees vaccines resigned.
This letter was first reported by the Wall Street Journal.
Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research (CBER), said that he made the decision with a “heavy heart” and that his final day would be April 5. During more than a decade with CBER, one of Marks notable achievements was developing “Operation Warp Speed” under the first administration of President Donald Trump during the COVID-19 pandemic.
“One of the very best examples of ‘America can still do hard things’ was Operation Warp Speed,” said Dr. Ashish Jha, who served as the White House COVID-19 response coordinator during former President Joe Biden’s administration. “[Its] chief scientific architect was Peter Marks. Peter was pushed out of the FDA by RFK Jr. yesterday,” Jha added, referring to Health and Human Services Secretary Robert F. Kennedy Jr.
After receiving his graduate degree in cell and molecular biology and his medical degree at New York University, Marks completed an Internal Medicine residency and Hematology/Medical Oncology fellowship at Brigham and Women's Hospital in Boston, Mass., where he then joined the attending staff as a clinician-scientist. Eventually, he went on to serve as Clinical Director of Hematology at the hospital.
Marks also worked for several years in the pharmaceutical industry, on the clinical development of hematology and oncology products. Then, he returned to academic medicine at Yale University where he led the Adult Leukemia Service and served as Chief Clinical Officer of Smilow Cancer Hospital. In 2012, he joined the CBER and in 2016 he became the center director.
Marks noted in his letter that Kennedy – known to be skeptical of vaccines – was one of the main reasons why he decided to leave his post.
“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 said. “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.”
This isn’t the first time that Kennedy has been criticized for his stance on vaccines. During the Senate hearings regarding his appointment to the HHS position, Republican Sen. Bill Cassidy (R-La.) admitted that he was reluctant to approve it, though he ultimately did.
In his letter to Dr. Sarah Brenner, acting commissioner of the FDA, Marks went back to efforts of first U.S. President George Washington to inoculate soldiers and the work of Jonas Salk in favor of vaccines and said that the COVID-19 shots “markedly reduced morbidity.” He said that vaccination has the potential to be important as cases of H5N1 flu (also known as bird flu) increase.
“Efforts currently being advanced by some on the adverse health effects of vaccination are concerning. The history of the potential individual and societal benefits of vaccination is as old as our great nation,” Marks said. He also mentioned concerns about the ongoing multi-state measles outbreak and said that measles vaccines are safe and do not cause autism.
FactCheck.org said this February that Kennedy has “refused to say that vaccines do not cause autism, despite a large body of evidence showing that there is no link” and that the Secretary “pointed to a flawed paper to suggest there is credible evidence to claim that vaccines cause autism,” during his confirmation hearings. Earlier this month, HHS asked the CDC to study vaccines and autism, CNN said.
CNN also reported that an HHS official said this in a statement provided to the outlet: “If Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy,” regarding the CBER head’s departure.
Others had a different take on the development.
“This is what happens when you hire a 20-year virulent anti-vaccine activist who continues to deny the science that vaccines don’t cause autism, and put him in a position of influence,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a vaccine adviser to the FDA, told CNN. He expects that new studies will show that vaccines cause autism because Kennedy will “put in place people who will shoehorn data to make it look that way, which will create more fear, will create likely more people who will choose not to be vaccinated, and you’ll just see more and more in the way of these outbreaks.”
According to Biopharma Dive, Marks’ departure “will leave both of the FDA’s principal drug review offices without a permanent leader,” since Patrizia Cavazzoni – formerly head of the other office, stepped down from her role in January. It said that deveral other agency leaders have also left in recent months.
“We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people,” John Crowley, head of the biotech lobbying group BIO, said in a statement cited by Biopharma Dive.
This week, the HHS also announced “a dramatic restructuring” that is expected to include letting go of 10,000 full-time employees. A press release said this overhaul is also going to “implement the new HHS priority of ending America’s epidemic of chronic illness by focusing on safe, wholesome food, clean water, and the elimination of environmental toxins.”
As these changes are on the horizon, Marks said this: “I leave behind a staff of professionals who are undoubtably the most devoted to protecting and promoting the public health of any group of people that I’ve encountered during my four decades working in the public and private sectors.”