COVID-19 vaccine architect lands major role with pharma giant
Peter Marks, the former FDA official instrumental in the rollout of COVID-19 mRNA shots, has landed an executive role at pharmaceutical giant Eli Lilly.
Marks played a key role in Operation Warp Speed, the first Trump administration’s initiative to develop the experimental mRNA shots. He was part of the team that rushed the authorization for the injections, which have cratered public trust in vaccines and public health officials. Until April, Marks served as director of the Center for Biologics Evaluation and Research (CBER), the FDA unit that oversees vaccines, gene therapies, and blood products. He was forced to resign after he reportedly refused “to get behind restoring science to its golden standard and promoting radical transparency,” a senior HHS official said.
Starting this month, Marks will oversee molecule discovery and infectious disease at Eli Lilly. The drugmaker told Reuters that his “expertise strengthens our abilities across multiple areas.”
When he led Operation Warp Speed—which Marks himself named—Marks was described as “the single most critical figure in the vaccine decision.” The Washington Post called him “the most important government employee most people have never heard of.”
As the FDA official charged with regulating vaccines, it was Marks’ job to ensure the safety and efficacy of the mRNA shots. The vaccine was a failure on both counts, a fact that Marks knew at the time but withheld from the public.
In June 2022, Marks acknowledged a fivefold increase in myocarditis among vaccinated children 12-17 but downplayed the danger by suggesting the vaccine was not to blame.
“[Myocarditis] is a known phenomena in the 12-17 year-old age range,” said the CBER director. “And the rate that it was seen in the 12-17 year-olds who are vaccinated seem to be fivefold higher than the baseline rate that we would expect. And that’s why this is not a slam dunk.”
“Here, it’s very challenging. When something’s only three to five times more common in a vaccinated population, you don’t know whether it’s cases that would have been there, that aren’t really associated with the vaccine that have come up, or how much actually the vaccine has increased that risk,” he added.
Marks emphasized that he was not denying that the vaccine has a myocarditis safety signal, but he also tried to suggest that the jump in myocarditis was normal.
“I’m not trying to deny that there’s some signal here. I’m just trying to say the magnitude of this over what we might be seeing is baseline, summertime, viral myocarditis is hard to know exactly. But just to give you an idea of the order of magnitude, we’re seeing about fivefold more than you might expect if this were normal summertime.”
The Big Pharma-Government ‘revolving door’
Marks is the latest public health official to snag an executive role in the drug industry, a “revolving door” trend that many say invites regulatory corruption.
In February, Pfizer named former senior FDA official Patrizia Cavazzoni as its chief medical officer. Until this year, Cavazzoni headed the FDA’s Center for Drug Evaluation and Research (CDER), which regulates drugs sold to the American public. She resigned from the agency in January.
Both Marks and Cavazzoni worked in the drug industry before and after serving as regulators of that same industry.
Every FDA commissioner since 2000 has found top spots in the pharmaceutical industry. Robert Califf, the most recent commissioner, secured leadership roles at Verify Life Sciences and Google Health between his two terms. Former commissioner Scott Gottlieb sits on the board of directors of Pfizer and Illumina. Andrew von Eschenbach served on the boards of BioTime and Viamet Pharmaceuticals, Mark McClellan joined the boards of Johnson & Johnson and Cigna, and Jane Henney secured a spot on the board of AstraZeneca. Margaret Hamburg joined the board of Alnylam Pharmaceuticals after she left the FDA in 2015. During her tenure as commissioner, Hamburg held financial interests in FDA-regulated drug companies through an exclusive hedge fund managed by her husband’s company.
This revolving door is not exclusive to the FDA. A study found that a third of the 78 presidential appointments to the Department of Health and Human Services (HHS) between 2004 and 2020 later secured private industry jobs that raised concerns about conflicts of interest.
The federal government has been slow to take measures against these conflicts of interest, if at all. During the first Trump administration, FDA appointees were required to sign ethics pledges that they would not engage in Big Pharma lobbying for five years after leaving their government roles, though it did not forswear employment in the industry. That pledge requirement was terminated on January 19, 2021, Trump’s last day in office.
Kennedy vows change
HHS Secretary Robert F. Kennedy, Jr. has repeatedly vowed to “shut the revolving door.”.
“We will remove conflicts of interest from the committees and research partners whenever possible or balance them with other stakeholders,” Kennedy said shortly after assuming office. “We will shut the revolving door.”
