The Wall Street Journal’s editorial board tore to shreds the Trump Food and Drug Administration’s move to block lifesaving cancer research — a move so indefensible, they noted, that even Health and Human Services Secretary Robert F. Kennedy Jr. had no good answers for the Senate when asked.
“The Food and Drug Administration rejection of Replimune’s life-saving treatment for metastatic melanoma is so dubious that even Health and Human Services Secretary Robert F. Kennedy Jr. is distancing himself from it,” the board wrote. “During a hearing Wednesday, Nevada Sen. Catherine Cortez Masto asked Mr. Kennedy about our recent editorial that noted criticisms from oncologists about the FDA rejection of Replimune’s RP1 immunotherapy. ‘First of all, I had nothing to do with this decision,’ he replied.”
Kennedy went on to claim that FDA commissioner Marty Makary told him “every panel” that examined the research voted against it — but this isn’t true, said the board.
“As we wrote, the first FDA panel to review the drug supported its approval but was overruled by biologics chief Vinay Prasad. We’re also told that staffers who recommended approval were sidelined. Retaliation?”
Additionally, the board continued, “Mr. Kennedy said he was told FDA staff ‘voted against it because it does not appear to work, because the trial was a one-armed trial when the company was asked to do a two-armed trial.’ That’s more misinformation. As oncologists explained to us and in letters to the FDA, it would have been unethical to do a trial with patients in a control arm receiving a drug on which their cancers would get worse.”
Ultimately when pressed by Cortez Masto, the board said, Kennedy vowed that “If the drug works, we’re going to approve it.”
“That’s a message to Dr. Makary,” wrote the board. “If the FDA doesn’t reverse course, Congress would do a public service by investigating and demanding the Commissioner testify under oath. Who’s afraid of a little radical transparency?”
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