{"id":109238,"date":"2025-08-01T03:36:23","date_gmt":"2025-08-01T03:36:23","guid":{"rendered":"https:\/\/www.europesays.com\/us\/109238\/"},"modified":"2025-08-01T03:36:23","modified_gmt":"2025-08-01T03:36:23","slug":"vinay-prasad-is-divisive-opinionated-and-usually-right","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/109238\/","title":{"rendered":"Vinay Prasad is divisive, opinionated \u2014 and usually right"},"content":{"rendered":"

A version of this piece first appeared in Sensible Medicine<\/a>. Vinay Prasad, Marty Makary, and Adam Cifu, among others, were founding members of Sensible Medicine.<\/p>\n

After news came out that Vinay Prasad would be leaving the Food and Drug Administration<\/a>, my colleague John M. Mandrola, a cardiologist and contributor to Sensible Medicine, wrote<\/a>, \u201cMainly, I am sad.\u201d<\/p>\n

I join him in being sad. I am also unsurprised \u2014 this administration acted exactly how I expected it would, with cowardice and short-sightedness \u2014 and angry.<\/p>\n

I share nothing here that is not publicly known, and, as usual, I speak only for myself.<\/p>\n

I have known Vinay for 16 years. While I once saw him as a student and mentee, I now view him as a colleague and friend who has lapped me in our careers. Vinay is absurdly smart, hardworking, kind, willing to argue points \u2014 as he and I have done many times on Sensible Medicine \u2014 and will change his mind when he is wrong. I am, clearly, not an unbiased reporter.<\/p>\n

I do understand that he is \u2026 well \u2026 divisive. He has strong opinions, and he is not shy about sharing them. On social media, he has at times been brash, nasty, and insulting. Being opinionated and insensitive guarantees enemies, and he made them in spades. I have many colleagues who confide that they greatly respect his intelligence and productivity and agree with him on most issues, while being seriously offended by his style.<\/p>\n

GO DEEPER<\/p>\n

Vinay Prasad\u2019s ouster as top FDA official<\/p>\n

This style, however, brought more attention to the issues he feels strongly about than the scores of sober papers he published. It probably also played a significant role in getting him appointed to a leadership position at the FDA, a role that seemed tailor-made for him. In addition to being a leader, he was rightly put in a position that required a workhorse. As\u00a0Paul Sax wrote in NEJM Journal Watch<\/a> after his appointment:<\/p>\n

\u201cIn short, he has made a career challenging dogma and questioning medical practices that are adopted with too little critical scrutiny. These qualities \u2014 intellectual sharpness, a relentless drive to improve science \u2014 will serve him well in this important job.\u201d<\/p>\n

His position at the FDA \u2014 leading the Center for Biologics Evaluation and Research and then also becoming chief medical and scientific officer \u2014 was always going to be a tough one. The appointment made great sense given his work on evidence-based medicine, especially around waste in oncology. I am sure this is what FDA Commissioner Marty Makary was thinking when he called on Vinay.<\/p>\n

Many in the administration, however, probably knew Vinay only for his contrarian (to some) views during the Covid pandemic.<\/p>\n

To succeed by what I know to be Vinay\u2019s high standards, he was going to need to make difficult and unpopular decisions. The pharmaceutical industry would be angered when therapies with poor evidence bases were withheld or more data were demanded. Any limit to vaccine availability would anger those who already disagreed with him during Covid. Any support for vaccines would anger many in health secretary Robert F. Kennedy Jr.\u2019s camp, who seem unreasonably skeptical of all vaccines.<\/p>\n

Vinay was also guaranteed to be labeled a hypocrite. Although his views on evidentiary requirements have always been nuanced, many critics labeled him as accepting only randomized controlled studies as adequate evidence. But that\u2019s not right. To function in his position, he would need to be open to a spectrum of evidence, as all physicians must be \u2014 and he is.<\/p>\n

I applauded\u00a0his appointment and his early work<\/a>. His and Makary\u2019s transparency was especially admirable.<\/p>\n

\t\t\t\"\"\t\t<\/p>\n

\t\t\t\t\"\"\/
\n\t\t\t\tA running list of senior FDA officials who have left the agency<\/a><\/p>\n

Unfortunately, as difficult decisions were made, politics and pharmaceutical company money seem to have trumped the need to ensure that drugs are safe and effective. It is ironic, or maybe fitting, that his downfall seems related to a drug, Elevidys<\/a>, that evidence proved was neither safe nor effective.\u00a0If anything, the notion that an unsafe (which might be an understatement here) and ineffective drug would require approval solely because it might offer hope is antithetical to the FDA\u2019s very purpose.<\/p>\n

I am bewildered by political operatives who demand loyalty over effective work. I am disappointed that Vinay\u2019s superiors \u00a0apparently bowed to pressure over a drug whose safety is more in question than that of any of the vaccines that the HHS secretary spends so much time criticizing.<\/p>\n

I worry about what comes next. It is hard to imagine someone more equipped and more dedicated to vetting treatments.<\/p>\n

But I am proud of my friend for having fought the good fight, however briefly.<\/p>\n

Adam Cifu, M.D., is a general internist and professor of medicine at the University of Chicago.<\/p>\n","protected":false},"excerpt":{"rendered":"A version of this piece first appeared in Sensible Medicine. Vinay Prasad, Marty Makary, and Adam Cifu, among…\n","protected":false},"author":3,"featured_media":109239,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[150,64,151,67,132,68],"class_list":{"0":"post-109238","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-business","8":"tag-biotechnology","9":"tag-business","10":"tag-fda","11":"tag-united-states","12":"tag-unitedstates","13":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/114951421118557604","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/109238","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=109238"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/109238\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/109239"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=109238"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=109238"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=109238"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}