Dr. Peter Marks was once a respected figure by both Democrats and Republicans. For 13 years, he served at the FDA, most notably as director of the Center for Biologics Evaluation and Research. In this role, Marks supervised the crucial assessment and approval of vaccines, including those for COVID-19, and biologic treatments, such as gene and cell therapies.
Marks gained the confidence of academics and industry scientists alike due to his commitment to strong evidence when assessing new treatments and his support for innovative technologies.
However, his tenure was cut short during the Trump Administration. Marks states that on March 28, he resigned after facing pressure from HHS officials to align with vaccine skepticism or face termination. He also claims that HHS requested his team to share sensitive health data from the FDA’s database, which is used with the CDC to monitor vaccine adverse reactions. Marks, concerned about the potential misuse of this data, refused and resigned. (HHS has yet to respond to requests for comments on this matter.)
Now, he is cautioning against a significant shift within HHS and the FDA, a change he fears is already proving harmful. “I noticed a growing anti-vaccine sentiment within the agency,” he told TIME on April 8. “I had hoped to address it, but it became clear that they were unwilling to do so.”
A clash about vaccines
Since the appointment of Robert F. Kennedy Jr., a long-standing vaccine critic, as head of HHS, the agency has made by the CDC, and it to decide whether or not to approve a COVID-19 vaccine from Novavax.
Marks, understanding Kennedy’s views on vaccines, began drafting a plan in November to address concerns raised by anti-vaccine groups. “I’ve been trying to reach out and say ‘I’m willing to meet you halfway,'” Marks states.
He proposed a four-point strategy for the FDA. First, the agency would re-evaluate vaccine labeling. “Over time, vaccine labeling has become complicated,” he says. “The information provided to patients is not as clear as it could be. This is a valid point. We would explore ways to simplify and clarify labels.”
The FDA would also conduct listening sessions to hear public concerns regarding vaccine components like thimerosal. Thimerosal was removed from the MMR (measles) vaccine and other childhood vaccines in 2001 but is still in some flu shots. The sessions would also address overall vaccine safety and efficacy. The FDA already utilizes this process when reviewing significant drugs and vaccines, inviting public comment before its advisory committee of experts votes on approval.
Marks suggested the FDA commission the National Academy of Medicine, a nonprofit, non-partisan organization that analyzes scientific issues to advise policy and improve public health, to examine Kennedy’s vaccine-related concerns, such as the function of adjuvants, which are components that enhance the body’s immune response.
Additionally, the FDA suggested improving the existing system for reporting vaccine-related side effects or adverse events to enhance transparency in evaluating them and determining their potential link to vaccines.
However, Marks reports that he received no feedback on these proposals before his departure. Dr. Marty Makary, nominated by President Trump, was appointed as the new FDA director on the day Marks resigned and on Marks’ departure shortly after taking office.
The measles fallout
The shift in tone within leading U.S. health agencies has coincided with an ongoing measles outbreak, which has resulted in two child fatalities and . “I was deeply disturbed upon learning of the second measles-related death in a child, to the point of unintentionally using inappropriate language with a reporter,” Marks recalls. “Those who know me understand that this is highly unusual for me. I was and remain deeply troubled because this is entirely preventable.”
As the head of the FDA division responsible for reviewing vaccine manufacturers’ data for approval, Marks emphasizes the strong and clear data supporting the safety and effectiveness of the measles vaccine. “The measles vaccine is among the safest and most effective vaccines available,” he asserts. “Unlike other vaccines where the necessity of vaccination may be debated, the measles vaccine saves lives. Measles can be fatal to one in 1,000 children, and another one in 10,000 to 20,000 may die years later from a persistent brain infection caused by measles. Thus, the vaccine is life-saving. The measles vaccine is not linked to death, encephalitis, autism, or lasting side effects.”
Nevertheless, Kennedy has supposedly David Geier, whose research linking vaccines to autism has been discredited by judges and medical experts, to analyze MMR vaccine safety data and a possible autism connection, despite scientific consensus debunking this link for decades.
