Undoubtedly you've heard about the latest on childhood and Covid vaccinations, along with Tylenol and related recommendations. But, as this WSJ piece explains, things are actually getting worse than they appear on the health front. 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.
[EOP]
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