The Wall Street Journal editorial board slammed a key subordinate of Health and Human Services Secretary Robert F. Kennedy Jr. on Monday, calling him a "grim reaper" over his efforts to stop what could well be lifesaving research into melanoma, a deadly form of skin cancer.
This comes as Kennedy held an announcement with President Donald Trump that the administration is endorsing a hypothesis linking autism to Tylenol use during pregnancy, which has very little scientific evidence backing it.
Dr. Vinay Prasad, the board noted, "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," wrote hte board. "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."
However, Prasad moved to reject the treatment on the grounds that the clinical trials didn't include a placebo group — even though doctors note running a placebo group in a terminal disease that has other forms of treatment available is considered unethical. This mirrors similar unethical demands the Trump administration is making on approval for reformulating vaccines.
"This is part of Mr. Kennedy’s anti-pharma agenda, and Dr. Prasad is his point of the spear," wrote the board. "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."
What all this shows, the board concluded, is that "the biggest danger to public health these days is regulators like Dr. Prasad who loathe drug makers more than they care about helping patients."