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Vinay Prasad, a critic of the Food and Drug Administration, has been tapped as the agency's top regulator of vaccines, gene therapies and the blood supply.
Prasad, a University of California at San Francisco professor and epidemiologist, will replace Peter Marks, whom the Trump administration forced out in late March. Prasad, who is also a hematologist and oncologist, is the latest vocal critic of pandemic-era policies to join the administration.
"He brings a great set of skills, energy, and competence to the FDA," Marty Makary, the FDA commissioner, wrote Tuesday in an email to staff obtained by The Washington Post.
Prasad championed Makary as a great choice to lead the FDA, the sprawling agency charged with overseeing the safety of vaccines, drugs, the bulk of the nation's food supply, tobacco products and more. The appointment of Prasad comes at a key time for vaccine policy in the United States. Public health experts and Democrats have raised concerns over the future of vaccines with Robert F. Kennedy Jr., the founder of a prominent anti-vaccine group, at the helm of the Department of Health and Human Services. Kennedy has called for changes in how to test vaccines for safety. And public trust in vaccines continues to decline amid a growing measles outbreak.
In recent weeks, the Trump administration has questioned the safety testing of coronavirus vaccines, injecting uncertainty over whether an updated shot would be available in the fall when they're traditionally offered.
Prasad did not respond to requests for comment.
In an April episode of his "The VPZD Show" podcast with Zubin Damania, Prasad laid out a vision for vaccine makers to run a randomized clinical trial for annual coronavirus vaccines. It's an approach the Trump administration has signaled it would take, but some public health experts have described it as impractical and setting an unreasonably high bar.
Prasad said the pharmaceutical companies could have leeway to decide which strains to target, instead of the FDA dictating it, and run a trial involving older adults and examining whether those who receive an updated formula have lower rates of hospitalization.
"That's the scientific way. Like for all drug products, you run a trial," Prasad said. "If the trial meets a clinically relevant endpoint, you get drug approval."
Regulators currently take an approach similar to flu shots, approving an updated formula for an existing vaccine technology.
Prasad has also criticized the recommendation of annual coronavirus vaccinations for children and welcomed news that federal health officials are weighing limiting the recommendations to older adults.
"I was like, oh you f---ing moron. We've been saying that for years and now finally they're going to change," Prasad said in the April podcast.
In an early April episode featured on his YouTube show, Prasad said the media uncritically reported the ouster of Marks as unfair. Prasad described Marks as unqualified for the FDA when he first joined the agency and touted his own academic credentials as superior. "Peter Marks is a reckless, reckless vaccine promoter," Prasad said. "He is not a scientific vaccine promoter. That's a misnomer. He is a pro-pharmaceutical company, low regulatory barrier, excessive promoter."
Marks was offered the choice to resign or be fired, The Post previously reported, and wrote in a resignation letter that he was leaving his position with a "heavy heart" and rebuked Kennedy for seeking "subservient confirmation of his misinformation and lies" about vaccines.
Marks declined to comment. HHS did not respond to a request for comment.
Kennedy's allies touted Prasad as a well-credentialed pick, while some vaccine experts raised concerns about his past statements on the coronavirus vaccine for young kids, such as his concerns that vaccination may represent "a net harm," as well as his criticism of other pandemic-era policies.
"He represents another giant step backward in the world of public health, but he fits the zeitgeist," said Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia.
Biotech stocks started dropping Tuesday shortly after news of Prasad's selection emerged. Some in the Wall Street world took notice.
"We are surprised by the announcement, because it seems to be in stark contrast to themes and initiatives that have been laid out by Dr. Makary," Matt Phipps, an analyst at financial firm William Blair, wrote in a note to clients, adding that he thought the sell-off in certain oncology companies was overdone.
Geoff Meacham, a Citi Research analyst, wrote that Prasad's appointment isn't necessarily bad news for biopharmaceutical companies, pointing out that his criticisms of the industry "have centered on approvals of expensive treatments with modest/minimal real-world benefits."
In November, Prasad proposed a "simple litmus test" for evaluating Kennedy's ideas: Whether other nations have the same policies as the United States.
"Right now, the media is covering RFK Jr. poorly and unfairly, giving him no credit for ideas that are well within the bounds of discussion," Prasad wrote in The Free Press. "My simple rule makes sense: If other nations are doing it, we should be willing to look into it. And RFK Jr. should not be called a conspiracy theorist for holding that view."
But he also wrote that Kennedy has pushed a debunked link between the MMR vaccine and autism - referring to these statements as "peddling this bunk."
"If RFK Jr. uses his perch as HHS secretary to discourage parents from getting their children inoculated with the MMR vaccine, severe negative repercussions could result, including measles outbreaks and childhood deaths. This is not a good policy," Prasad wrote. "After looking at the whole range of RFK Jr.'s positions, I've come to the view that while some are extreme, others are genuinely worthy of debate - and still others are correct."
In other parts of the FDA's purview, Prasad has long given critiques of the regulatory process for approving cancer drugs. His studies have shown that cancer drugs approved on "surrogate endpoints" - early indicators that they are working, such as evidence that they shrank tumors - may not turn out to extend people's lives.
"I think with the current incentive structure where the sky's the limit [on price], it doesn't matter if you make a great drug or a marginal drug," Prasad told The Post in 2016. "The problem is, I'm certain with the amount we're spending extra, we're not getting the commensurate value with our patients being better off."
During the pandemic, Prasad was critical of policies such as lockdowns and the mask mandates in schools. He also co-wrote an opinion piece in The Post criticizing Trump for taking hydroxychloroquine and zinc to prevent covid-19 after an exposure. Trying therapies without sufficient evidence, he and Ezekiel Emanuel argued, should be undertaken only when the harms outweigh the benefits, giving the example of cancer patients who have no other options. (Emanuel is a bioethicist at the University of Pennsylvania who served as a covid-19 adviser to President Joe Biden's transition team.)
"Is it always wrong to try an unproven therapy? No. We are oncologists. We frequently have tried powerful chemotherapy drugs or other anti-cancer therapies that are being studied and we do not know for sure work. At times, a wise physician must make a calculated gamble," Prasad wrote with Emanuel at the height of the pandemic in May 2020.
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