The Man Who Was Too MAHA for the Trump Administration

The Atlantic

6 days ago

Vinay Prasad, until Tuesday one of the country's top medical regulators, just got a bitter taste of what it means to have real power. In recent months, the academic hematologist-oncologist, medical contrarian, and polemic podcaster had become a central figure at the U.S. Food and Drug Administration. In May, he was chosen to lead its Center for Biologics Evaluation and Research—a position that gave him authority over vaccines and gene therapies. In June, Marty Makary, who is currently the FDA commissioner, bestowed upon him an even more important role: chief medical and scientific officer of the entire agency. This week, Prasad abruptly departed.
We don't know the exact reason behind Prasad's departure. According to a Department of Health and Human Services spokesperson, he resigned to 'spend more time with his family.' (Neither Prasad nor HHS responded to my request for comment.) Politico reports that President Donald Trump ordered his removal this week over the objections of Makary and Health and Human Services Secretary Robert F. Kennedy Jr. Whatever the particulars, Prasad's sudden need for a better work-life balance suggests the administration is following a time-honored approach to medical regulation: Business comes first.
Prasad's troubles began in the first weeks of his tenure at the FDA, when he overruled the agency's own scientific reviewers by limiting the use of COVID vaccines. In doing so, he managed to anger the country's pro- and anti-vaccine factions at the same time. While many public-health experts criticized the decision to limit access to the shots, Kennedy's allies in the 'Make America healthy again' movement felt betrayed by the fact that the government had allowed mRNA shots to remain available at all.
Prasad also faced a blitz from the pharmaceutical industry and patient-advocacy groups after the FDA tried to suspend distribution of a gene therapy for Duchenne muscular dystrophy called Elevidys, over safety concerns. For those affected by this rare, incurable condition, the move was seen as an outrageous denial of their right to weigh the drug's risks and benefits for themselves, and an extinguishing of what had been at least a glimmer of hope. Two days later, the right-wing provocateur Laura Loomer publicly accused Prasad of 'sabotaging Trump's deregulatory agenda,' and an opinion writer for The Wall Street Journal declared him a 'one-man death panel.'
I know Prasad a bit: I've twice been a guest on his podcast, and I've followed his prolific academic work and public commentary about evidence-based medicine since about 2016, when he was a young professor at Oregon Health & Science University working to identify low-value medical practices. We've had our disagreements over the years. But with respect to Elevidys and drugs like it, our views are in alignment. We share the worry, for example, that the FDA keeps lowering its approval standards for drugs that keep getting more expensive. 'The American economy can handle a great deal of wasteful health-care spending,' Prasad told me in an interview in 2021. 'But it can't tolerate an infinite number.'
His skepticism of Elevidys, in particular, is both long-standing and well-founded. The therapy has not been conclusively shown to slow the progression of the muscle-wasting disease it targets, but it does often induce vomiting and damage patients' livers. Worryingly, it also appears to be related to a pair of deaths. Prasad's predecessor in his role at CBER, Peter Marks, approved the drug, which costs $3.2 million per course of treatment, in spite of his own staff's uncertainty about its benefit. (Marks was forced out by Kennedy this spring, after the two clashed over access to vaccine-safety data.)
Read: The sanewashing of RFK, Jr.
That Prasad should take a tough line on drug regulation was perfectly in keeping with his history. He rose to prominence on that basis: To his many fans, he was a dogged and courageous industry watchdog; to his many critics, a self-righteous pharma scold. That mainstream Republicans should balk at this approach, and strive to undo it, was equally predictable. Politicians, particularly those on the right, have for years supported patients' ability to obtain still-unproven therapies. During Trump's first term, the president signed into law the 'Right to Try Act,' which expanded access to experimental drugs. That law was championed by Republican Senator Ron Johnson, who, according to reporting from STAT, may have been instrumental in Prasad's ouster.
One might have guessed that things were different now in Washington—that Kennedy's eccentric philosophy had ushered in a novel form of conservative leadership, in which business interests didn't always lead the way. Thus far, however, the MAHA movement has done little to adjust the status quo. Instead, it has mostly wallowed in its own contradictions. We've been told that cooking with seed oils is toxic but that treating measles with cod-liver oil is great; and that both deworming pills and microbe-laden raw milk are good for you. MAHA leaders have declared the FDA a ' sock puppet of industry ' from which Prasad himself would provide a ' welcome reprieve,' while also championing the public's right to choose its food and drugs (even as they interfere with the distribution of some vaccines).
So which is it? Should people have easy access to almost any health-care intervention, or should the government protect vulnerable patients from drugs for which there isn't rigorous evidence of benefit? For years, Prasad has been clear on where he stands in that regard. 'It is not a case of patients who crave risk facing off with regulators who abhor it,' he wrote in a medical journal in 2019. Rather, the current system, in which 'reliable data are inconsistently generated,' has failed patients who wish to make informed decisions about their care.
Whenever this tension has been tested in the Trump administration, MAHA leaders have almost always seemed inclined to move the other way. A recent op-ed by the FDA's Makary and Mehmet Oz, the head of the Centers for Medicare & Medicaid Services, summed up the current regulatory approach as follows: Agency bureaucrats should cooperate with industry leaders instead of antagonizing them, and the government should favor 'market solutions' over 'prescriptive regulation.' Indeed, even as the news of Prasad's firing was coming out, Makary was promoting his 'national listening tour' of private interests. 'Looking forward to hearing from more pharma and biotech CEOs!' he wrote on X.
Prasad himself appeared to recognize which way the wind was blowing. From the moment he took office, he was tempering his point of view. Before he became a political appointee, Prasad was dogmatic in his dismissal of evidence that did not emerge from large, randomized clinical trials. ('As readers know, my philosophy is RCT or STFU,' he wrote in his newsletter in 2023.) But Prasad seemed to back away from this idea even in his opening remarks to his new colleagues and staffers. 'Randomized controlled trials are not always necessary, and when they are done, they are not always informative,' he reportedly said on May 7, his second day on the job.
Such appeasement efforts proved insufficient to protect him from rival forces in the Republican Party, if not also in the MAHA movement itself. For the moment, Prasad has been replaced at CBER by the wealthy biomedical entrepreneur George Tidmarsh. Surely that will come as a relief to a constituency that seems to hold immense sway with this administration: America's drug companies and medical-device makers.