In the waning days of his tenure, the leading U.S. vaccine regulator stood firm against granting the team of Health Secretary Robert F. Kennedy Jr. unqualified access to a closely guarded vaccine safety database. The former chief of vaccines at the Food and Drug Administration (FDA), Dr. Peter Marks, expressed concerns that the sensitive data could be altered or eliminated.
In a revealing discussion, Dr. Marks mentioned the lengths he went to in order to placate Kennedy, including creating a comprehensive “vaccine transparency action plan” to tackle the perennial worries about vaccine safety. Although Dr. Marks consented to permit Kennedy’s team to review a significant amount of data from the Vaccine Adverse Event Reporting System (VAERS), he drew the line at allowing them to directly modify the information.
“If they had access, we couldn’t trust them not to manipulate the data,” Dr. Marks stated, punctuating his point with a strong expletive. His comments come in the wake of another measles-related death in an unvaccinated child in Texas, the second such occurrence this year. Dr. Marks linked the tragedy to the U.S. Department of Health and Human Services’ (HHS) indecisive stance, balancing between promoting vaccines and endorsing alternative treatments like vitamin A supplements.
During Senate hearings, Kennedy insisted he wasn’t inherently anti-vaccine, yet his actions in office have suggested otherwise. He vowed to scrutinize childhood vaccinations, halting vaccine research, and bringing back outdated debates regarding vaccines’ ties to conditions like autism—a connection long disproven by scientific evidence.
According to Dr. Marks, “Mr. Kennedy has accelerated efforts to reduce vaccine usage nationwide.” Kennedy, through social media, paid homage to vaccine efforts claiming it as the most effective deterrent against disease spread, even while simultaneously extolling alternative remedies from the Mennonite community.
Despite Dr. Marks’ respected standing among former FDA leaders and industry figures, his methods drew mixed reviews. His balancing act during the COVID-19 pandemic attracted criticism for both hesitation and hastiness in greenlighting vaccines across different administrations.
In a bid to work harmoniously with Kennedy, Dr. Marks pushed for more transparency concerning vaccine constituents, safety, and side effects. The keystone of this push was an extensive overhaul of the VAERS system, historically susceptible to misinterpretation by anti-vaccine factions due to its inclusion of unverified reports.
Dr. Marks’ initiative involved a clear mandate: ensuring detailed scrutiny of serious side-effect reports by governmental scientists to correct inaccuracies. Often these investigations reveal that reported deaths were attributable to unrelated events. While much of the verification process is withheld for privacy reasons, his office was eager to enhance transparency.
“We must make the VAERS data process more comprehensible,” Dr. Marks professed, emphasizing the importance of clarity to assuage public distrust. But his proposed reforms were left unanswered by the FDA’s acting commissioner.
With pressure mounting from the Trump administration staffers wanting full VAERS access, Dr. Marks insisted on the data’s sensitive nature, underscoring the confidentiality of included medical and corporate details. Despite assertions from HHS that Kennedy’s team should analyze the data independently, Dr. Marks lamented his inability to gain direct communication with Kennedy.
As his resignation loomed, Dr. Marks recounted being invited to HHS headquarters, where he received confirmation of his departure sparked by Kennedy’s influence. Reluctantly, Dr. Marks complied, pointing to Kennedy’s perpetuation of “misinformation and lies” about vaccines as the catalyst.
Despite Kennedy’s proclaimed goals to address public health crises, Dr. Marks urged a focus on increasing vaccination rates to prevent avoidable fatalities, especially among children.
Preventative vaccinations remain crucial, Dr. Marks stressed. “These outbreaks could be prevented,” he insisted, “if vaccination efforts are prioritized to protect children against diseases like measles.”