Dr. Prasad, the FDA's Grim Reaper - WSJ Editorial

Robert F. Kennedy Jr. is disrupting the Health and Human Service 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.

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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.

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