A version of this piece first appeared in Sensible Medicine. Vinay Prasad, Marty Makary, and Adam Cifu, among others, were founding members of Sensible Medicine.
After news came out that Vinay Prasad would be leaving the Food and Drug Administration, my colleague John M. Mandrola, a cardiologist and contributor to Sensible Medicine, wrote, “Mainly, I am sad.”
I join him in being sad. I am also unsurprised — this administration acted exactly how I expected it would, with cowardice and short-sightedness — and angry.
I share nothing here that is not publicly known, and, as usual, I speak only for myself.
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 — as he and I have done many times on Sensible Medicine — and will change his mind when he is wrong. I am, clearly, not an unbiased reporter.
I do understand that he is … well … 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.
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 Paul Sax wrote in NEJM Journal Watch after his appointment:
“In short, he has made a career challenging dogma and questioning medical practices that are adopted with too little critical scrutiny. These qualities — intellectual sharpness, a relentless drive to improve science — will serve him well in this important job.”
His position at the FDA — leading the Center for Biologics Evaluation and Research and then also becoming chief medical and scientific officer — 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.
Many in the administration, however, probably knew Vinay only for his contrarian (to some) views during the Covid pandemic.
To succeed by what I know to be Vinay’s 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.’s camp, who seem unreasonably skeptical of all vaccines.
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’s not right. To function in his position, he would need to be open to a spectrum of evidence, as all physicians must be — and he is.
I applauded his appointment and his early work. His and Makary’s transparency was especially admirable.
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, that evidence proved was neither safe nor effective. If 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’s very purpose.
I am bewildered by political operatives who demand loyalty over effective work. I am disappointed that Vinay’s superiors apparently 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.
I worry about what comes next. It is hard to imagine someone more equipped and more dedicated to vetting treatments.
But I am proud of my friend for having fought the good fight, however briefly.
Adam Cifu, M.D., is a general internist and professor of medicine at the University of Chicago.
Source link
