\n<\/p>\n
Vinay Prasad, until Tuesday one of the country\u2019s 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\u2014a 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.<\/p>\n
We don\u2019t know the exact reason behind Prasad\u2019s departure. According to a Department of Health and Human Services spokesperson, he resigned to \u201cspend more time with his family.\u201d (Neither Prasad nor HHS responded to my request for comment.) Politico<\/em> 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\u2019s sudden need for a better work-life balance suggests the administration is following a time-honored approach to medical regulation: Business comes first.<\/p>\n Prasad\u2019s troubles began in the first weeks of his tenure at the FDA, when he overruled the agency\u2019s own scientific reviewers by limiting the use of COVID vaccines. In doing so, he managed to anger the country\u2019s pro- and anti-vaccine factions at the same time. While many public-health experts criticized the decision to limit access to the shots, Kennedy\u2019s allies in the \u201cMake America healthy again\u201d movement felt betrayed by the fact that the government had allowed mRNA shots to remain available at all.<\/p>\n 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\u2019s 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 \u201csabotaging Trump\u2019s deregulatory agenda,\u201d and an opinion writer for The<\/em> Wall Street Journal<\/em> declared him a \u201cone-man death panel.\u201d<\/p>\n I know Prasad a bit: I\u2019ve twice been a guest on his podcast, and I\u2019ve 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\u2019ve 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. \u201cThe American economy can handle a great deal of wasteful health-care spending,\u201d Prasad told me in an interview in 2021. \u201cBut it can\u2019t tolerate an infinite number.\u201d<\/p>\n 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\u2019 livers. Worryingly, it also appears to be related to a pair of deaths. Prasad\u2019s 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\u2019s uncertainty about its benefit. (Marks was forced out by Kennedy this spring, after the two clashed over access to vaccine-safety data.)<\/p>\n 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\u2019 ability to obtain still-unproven therapies. During Trump\u2019s first term, the president signed into law the \u201cRight to Try Act,\u201d which expanded access to experimental drugs. That law was championed by Republican Senator Ron Johnson, who, according to reporting from STAT<\/em>, may have been instrumental in Prasad\u2019s ouster.<\/p>\n One might have guessed that things were different now in Washington\u2014that Kennedy\u2019s eccentric philosophy had ushered in a novel form of conservative leadership, in which business interests didn\u2019t 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\u2019ve 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 \u201csock puppet of industry\u201d from which Prasad himself would provide a \u201cwelcome reprieve,\u201d while also championing the public\u2019s right to choose its food and drugs (even as they interfere with the distribution of some vaccines).<\/p>\n 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\u2019t rigorous evidence of benefit? For years, Prasad has been clear on where he stands in that regard. \u201cIt is not a case of patients who crave risk facing off with regulators who abhor it,\u201d he wrote in a medical journal in 2019. Rather, the current system, in which \u201creliable data are inconsistently generated,\u201d has failed patients who wish to make informed decisions about their care.<\/p>\n 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\u2019s 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 \u201cmarket solutions\u201d over \u201cprescriptive regulation.\u201d Indeed, even as the news of Prasad\u2019s firing was coming out, Makary was promoting his \u201cnational listening tour\u201d of private interests. \u201cLooking forward to hearing from more pharma and biotech CEOs!\u201d he wrote on X.<\/p>\n 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. (\u201cAs readers know, my philosophy is RCT or STFU,\u201d 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. \u201cRandomized controlled trials are not always necessary, and when they are done, they are not always informative,\u201d he reportedly said on May 7, his second day on the job.<\/p>\n 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\u2019s drug companies and medical-device makers.<\/p>\n","protected":false},"excerpt":{"rendered":" Vinay Prasad, until Tuesday one of the country\u2019s 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<\/p>\n","protected":false},"author":1,"featured_media":13411,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[794,2002,7087,81,7086],"class_list":{"0":"post-13410","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-social-issues","8":"tag-administration","9":"tag-maha","10":"tag-prasad","11":"tag-trump","12":"tag-vinay"},"_links":{"self":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/13410","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=13410"}],"version-history":[{"count":0,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/13410\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/media\/13411"}],"wp:attachment":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=13410"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=13410"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=13410"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}