Marks: RFK Jr. Wants FDA to Support Stem-cell Treatments
One day before his forced resignation took effect 4/5, CBER director Peter Marks alleged in an exclusive interview with the Wall Street Journal that HHS secretary Robert F. Kennedy Jr. not only sought generation of new FDA data to support his antivaccine narratives but also reduction of regulatory safeguards that prevent the proliferation of unproven stem-cell treatments. Marks’ two-page resignation letter noted that he had attempted to address Kennedy’s concerns regarding vaccine safety and transparency but “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.”
Marks said that before his ouster, he was approached by Kennedy’s team who requested that he turn over data on cases of brain swelling and deaths caused by the measles vaccine, which he said do not exist and there are no such confirmed cases in the U.S. “I can only come to a single conclusion that there was not an appreciation for having somebody who was rigorously science-driven within the organization,” Marks told the Journal.
Marks said Kennedy’s team was also interested in relaxing the regulation of unproven stem-cell treatments, which clinics and Web sites sell for diseases ranging from Alzheimer’s to arthritis. He met with senior HHS officials and offered to meet them in the middle by proposing new regulations that would be risk-based — more restrictions for risky treatments but less moderate-risk therapies, he told the Journal. “What they are trying to do is potentially dangerous,” he said. “These stem cells, if they are made improperly, they can harm people.”
Marks also faced backlash from president Trump’s aides who accused Marks of slowing down the authorization of the Covid-19 vaccines so no decision would be known until after the 2020 election, according to the Journal. “I am leaving this job knowing that I always did my best to use the science to do what is right for the American public,” he said. FDA commissioner Marty Makary reportedly supported the decision to force Marks out based on what he felt were irregularities surrounding Covid vaccine boosters during the pandemic, in addition to what he characterized in a 2023 social-media post as spreading “misinformation” about the boosters.
Additionally, Marks’ interview revealed that FDA’s delay earlier in the week in making a review action on Novavax’s BLA seeking full approval for its Covid-19 vaccine, which is currently marketed under an emergency use authorization, was ordered by HHS political appointees and cleared by Makary, according to the Journal. Marks said he would have resigned after FDA missed the deadline for the approval decision, if he hadn’t already resigned. “The politicals shouldn’t have been involved in this,” he said. “There was no controversy. The review staff agreed it was an approval.”