The Wall Street Journal editorial board continued on Tuesday to express its rage at the Trump FDA for blocking experimental treatments.
Specifically, the board took aim at efforts by regulators to stifle new therapies for late-stage melanoma and Duchenne muscular dystrophy.
"President Trump pushed out Marty Makary and his deputy Vinay Prasad this spring in large part because they had scuttled treatments for life-threatening and rare diseases," noted the board, something they have been covering for months. That should have been the end of it, and for a while, it appeared it was, the board continued.
"The FDA under acting Commissioner Kyle Diamantas in recent months appeared to be turning around," the board wrote. "The agency is reconsidering many treatments rejected by the previous regime and has scheduled public hearings with outside experts to review medicines."
But now, FDA staff have once again advanced the same arguments that Makari and Prasad's deputies used to block Replimune's cancer therapy and Capricor Therapeutics' cell therapy to treat Duchenne. Trials of these drugs have already shown promising results, but Makari and Prasad, allies of anti-vaccine conspiracy theorist Health and Human Services chief Robert F. Kennedy Jr., have had it out for these drugs as part of their demands for control groups, even though there are more ethical ways of testing such treatments.
"The panel ... concocted pretexts to kill the treatment — for instance, the staff opined that maybe biopsies had zapped the tumors. If only biopsies had such miraculous effects," the board wrote. "This week’s briefing document repeats such absurdities and manipulates the data to claim the drug doesn’t work."
The FDA, lamented the board, has had its "bureaucratic culture of control" worsened by Prasad, who "[drove] out division leaders and staffers who didn’t share his anti-industry dogmatism," creating a "leadership vacuum." They concluded: "We hope the experts this week aren’t swayed by the bureaucracy’s kill shots, which underscore why the FDA needs permanent leaders who share the President’s right-to-try principles."
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