Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag A top FDA appointee who doesn’t think patients can be trusted to make their own healthcare decisions.
  Meet Vinay Prasad, a young disciple of Bernie Sanders who ranks as one of the most powerful officials in the federal government. He determines whether patients get access to many life-saving medicines. Or not. Think of him as a one-man death panel.
  Dr. Prasad was named by Marty Makary, the Food and Drug Administration commissioner, as head of the agency’s biologics division in May, and last month as its chief medical and scientific officer. More on why he was tapped to these posts later. But it isn’t an exaggeration to say that Dr. Prasad wields more power than Anthony Fauci ever did at the National Institutes of Health.
 
  Vinay Prasad. Photo: Food and Drug Administration Like Dr. Fauci, Dr. Prasad thinks he knows what’s best for people, and that it’s government’s job to make it happen. “I favor a strong regulatory state,” he proudly professes. And just as Dr. Fauci slowed experimental HIV treatments during the 1980s by rigidly adhering to strict trial protocols, Dr. Prasad is now scuttling potentially life-saving therapies.
  In recent weeks, the FDA has rejected three therapies for debilitating diseases that have shown promise in clinical trials. The agency has also forced off the market a gene therapy that can slow the degenerative loss of muscular function in young boys with certain genetic mutations. Behold America’s strong and arbitrary regulatory state at work.
  If you read Dr. Prasad’s paper—or follow his smash-mouth Substack and X.com feeds—the FDA’s recent actions are no surprise. Dr. Prasad has long criticized the FDA for approving too many treatments that, in his view, provide only marginal benefits. He’s also lambasted President Trump’s first-term “right to try” law, which lets terminally ill patients try experimental drugs not yet approved by the FDA.
  “It is crucial to question whether non-curative therapies . . . are worth it,” Dr. Prasad wrote in a 2021 paper about an FDA-approved cell therapy for multiple myeloma. The therapy reduced disease progression or death by half in patients with advanced cancers who hadn’t responded to already approved therapies. Impressive.
  But Dr. Prasad complained that the treatment was pricey (then $419,500 for a course) and may “only delay inevitable progression” in some patients. In other words, sick patients should just give up and die. Got that?
  In 2016 he wrote an op-ed titled “The case for rationing: Why we should limit public spending on cancer drugs.” He exalted the United Kingdom’s socialized health system for restricting access to new treatments until they demonstrate a high degree of efficacy in multiple trials and that their benefits—as determined by the government—exceed their costs.
  Such government rationing is why survival rates for hard-to-treat cancers are much lower in the U.K. than in America—and why British patients with the financial means cross the pond to receive innovative and often life-saving treatments. Tough luck to Brits of average means.
  Of course, Dr. Prasad insists he really has patients’ best interests at heart. Why would terminally ill patients want to waste their precious remaining time on earth schlepping to hospitals for treatments that may not cure them when they could be preparing for their deaths?
  That’s the gist of his 2022 paper, which estimated patients with advanced cancers spend 16 more hours a month accessing and receiving novel treatments than if they accepted hospice or home palliative care. “Time is a valuable resource for people who have cancer,” the paper noted. Yes, and that’s why they want to continue living.
  He has also argued that “genome-informed cancer medicine”—treatments targeted based on a patient’s genes or tumor mutations—“is mostly hype,” no matter that such treatments have produced most recent improvements in cancer survival.
  Take CAR T-Cell therapies that re-engineer a patient’s immune cells to target proteins on tumor cells. Such therapies can cure aggressive cancers that not long ago carried a death sentence, though Dr. Prasad has hyped their side effects. He has done the same for  Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy, which the agency this month forced off the market after two patients in the advanced stages of the disease died from apparent side effects.
  The deaths look to have been a pretext for Dr. Prasad to deep-six the drug, which he had previously criticized as too costly for its benefits. Most treatments carry rare, life-threatening side effects, but doctors and patients can weigh their risks against their benefits. Perhaps Dr. Prasad doesn’t trust people to do so any more than Dr. Fauci did.
  Dr. Prasad found common cause with Dr. Makary and conservatives in opposing paternalistic Covid policies including vaccine mandates and school shutdowns. But his other positions are at odds with Dr. Makary’s stated support for more flexible reviews of drugs that treat rare and deadly diseases and the MAHA ethos of patient empowerment.
  Dr. Makary in spring 2021 lambasted the FDA for using the “eternal excuse of safety” to pause the  Johnson & Johnson Covid vaccine after a rare blood-clotting side effect cropped up, mostly in middle-aged women. “This is a life-saving medication,” he then wrote. “What ever happened to giving people the data and letting them make their own health decisions?” |