On Friday, Dr. Peter Marks resigned from his position as Director of the Center for Biologics Evaluation and Research (CBER) at the FDA. His departure stemmed from severe disagreements with Health and Human Services Secretary Kennedy over the vaccine agenda. The media rushed to label Marks as “FDA’s top vaccine scientist” who was wrongfully ousted. This characterization is not only misleading but completely wrong. Marks didn’t resign out of principle; he was given an ultimatum, revealing his unwillingness to adhere to facts in favor of political expediency.
Dr. Marks is no champion of scientific integrity. His background in oncology does not qualify him as an expert in vaccines or immunology—fields that require specialized knowledge and experience. During his tenure, he systematically sidelined reputable vaccine scientists to enforce a rapid approval of the COVID vaccine that was driven more by political pressure than by scientific rigor. He ignored the concerns of seasoned professionals who understood the risks associated with the vaccine, particularly in children, who face more danger from the vaccine than the virus itself.
Evidence has stacked against Marks as he made decisions based on a dangerous agenda. He overruled the FDA’s own vaccine scientists, such as Dr. Gruber and Dr. Krause, forcing the approval timeline to align with arbitrary deadlines set by the Biden administration. This included bypassing the essential review process with the FDA Vaccine Advisory Committee. The ramifications of these decisions are now painfully clear, as they have compromised public safety and risked lives.
Consider the approval of the gene therapy ELEVIDYS for Duchenne muscular dystrophy. Marks ignored the strong objections from his own team after a treated patient tragically died from liver failure. This reckless approval, lacking proven efficacy and fraught with severe adverse effects, exemplifies the danger of his leadership. The technology’s risks were highlighted in subsequent trials, yet Marks pushed forward, resulting in unnecessary harm to families counted on hope—a hope he irresponsibly offered.
Similarly, Marks’ support for the Alzheimer’s drug ADUHELM revealed a troubling disregard for established protocols. Despite overwhelming evidence against its efficacy and the potential for catastrophic side effects, he pushed for its approval. This decision not only wasted taxpayer money but also led to a public outcry, culminating in an investigation that uncovered troubling ties between the FDA and the drug’s manufacturer.
The American public deserves better than reckless policies that disrupt the balance between innovation and safety. Marks’ oversight and misjudgment have not only wasted resources but also harmed patients. His approach has tarnished the credibility of the FDA, raising serious questions about the integrity of our drug approval process. As we move forward, our focus must remain on ensuring that drug safety is not sacrificed for speed or pressure from industry.
In truth, Dr. Marks has betrayed the principles intended to protect patient health, leaving behind a legacy of incompetence and danger. This isn’t heroism; it’s a gross miscalculation that has cost lives and damaged the trust of the American people. It’s time to hold those in power accountable, ensuring that safety and efficacy are never compromised in favor of political gain.
