Dr. Prasad, the FDA’s Grim Reaper
S E E D E D C O N T E N T
Robert F. Kennedy Jr. is disrupting the Health and Human Services Department in nearly all the wrong ways. See how Vinay Prasad, his left-hand man at the Food and Drug Administration, is killing life-saving experimental cancer treatments and undercutting biotech innovation.
Dr. Prasad is back running the FDA’s biologics division after a short resignation amid controversy over his role in killing a drug for a rare muscular dystrophy disease. RFK Jr. got him reinstated, and he’s now following through on his campaign to block a Replimune Group immunotherapy for patients with advanced melanoma. It’s a scandal that will cost many lives.
Career FDA staff supported the RP1 therapy for approval, as did oncologists who described the trial results as unprecedented. Tumors shrank in nearly all patients, and one-third went into remission. One in six saw their tumors vanish. Patients with metastatic melanoma who don’t respond to other treatments typically don’t live much more than a year. The FDA designated RP1 as a “breakthrough therapy” last November to expedite its review.
Enter Dr. Prasad in May. The agency a couple of months later rejected the treatment and changed the standard for approval, quibbling that its trial lacked a placebo group. Running a control arm would have been unethical in terminal patients. Oncologists from around the world urged the FDA to reconsider.
Dr. Prasad didn’t listen. The company issued a statement on Thursday indicating that the FDA isn’t budging. Oncologists tell us the Replimune rejection is a portent for how the agency will review experimental treatments going forward. That may be Dr. Prasad’s goal.
A Bernie Sanders acolyte, Dr. Prasad has long criticized the FDA for approving too many cancer drugs based on trials that lack placebo groups. He wants drug makers to run bigger and longer trials to demonstrate with 100% certainty that medicines work, even if this means patients die because of the FDA’s delay.
Dr. Prasad supports single-payer government healthcare and drug price controls, which may explain his hostility to new drugs that may be costly. The FDA under the law may only review medicines for efficacy and safety, not price. But Dr. Prasad’s motivation may be to block experimental medicines to ration care.
The FDA’s unexpected rejection of RP1 is creating enormous uncertainty in the biotech industry and causing some companies to reconsider investments. Krystal Biotech last month halted a trial into an experimental melanoma treatment, saying “a recent decision by the regulatory agency has signaled a shift in their approach to drug approvals.”
This is part of Mr. Kennedy’s anti-pharma agenda, and Dr. Prasad is his point of the spear. The campaign could also enrich Mr. Kennedy’s trial-lawyer friends. Several plaintiff firms have sued Replimune for allegedly deceiving shareholders about its medicine’s prospects for approval. In fact, the FDA misled Replimune.
Meanwhile, Dr. Prasad is threatening drug makers over TV ads that he claims are misleading because their visuals are too attractive. Seriously. He wants to force ads off the air to reduce sales. This includes AstraZeneca ’s self-administered nasal vaccine for the flu that the FDA approved last year.
“Compelling and attention-grabbing visuals” and “frequent scene changes, compete for the viewers’ attention and make it difficult for the viewer to adequately process and comprehend the risk information,” Dr. Prasad wrote to AstraZeneca. The health risks from its nasal spray are slight, but who knew one of Dr. Prasad’s skills is drama criticism?
The biggest danger to public health these days is regulators like Dr. Prasad who loathe drug makers more than they care about helping patients.
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Yikes, nutcases on every side of the political spectrum.
Just what kind of doctor is he? Did he take the Hippocratic Oath?
He likely only signed up for the 'Hypocritical oath' under Donald Trump. It's the oath that pledges loyalty to Trump above all else. Trump loyalists thought they were going to become doctors and use their knowledge to help people?
When these fuckwads run out of excuses they always fall back on the "Well we shouldn't have to pay anything for the care received by that lgtbq platform.