With the accusation, “Never mind if patients die in the interim,” the editorial board of the conservative Wall Street Journal expressed frustration at how the Food and Drug Administration (FDA) is being run by Commissioner Marty Makary.
In a harsh editorial late Wednesday, the editors noted that, under Makary’s watch, approval of drugs has slowed considerably and unreasonably in the past few months as Makary has asserted himself after being appointed by Donald Trump.
Makary, who has previously been criticized for claiming on TV, medical professionals need “to treat more diabetes with cooking classes, not just throwing insulin at people," is now being accused of “torpedoing of an immunotherapy shot for advanced melanoma and slow-rolling a treatment for a rare disease” which should be “raising big questions.”
The therapy for melanoma was singled out by the editors who explained, “A case in point is Replimune’s melanoma treatment, which the FDA rejected last month. About a third of patients who hadn’t responded to prior immunotherapy showed a strong response to Replimune’s in a clinical trial.”
Noting that oncologists have been enthusiastic about the trials, the editors pointed out, “Tumors shrank in nearly all patients, and responses proved durable over three years,” and then added, “Yet the FDA said the trial was ‘not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.’”
The FDA is now facing criticism from doctors with Vishal Patel, a dermatology oncologist at George Washington University Cancer Center, complaining directly to Makary, “Physicians urgently want and need this agent based on the data they have seen,” and “The world looks for leadership from the FDA based on rationality, science and evidence,” coming from Melanoma World Society president Axel Hauschild.
“The buck stops with Dr. Makary,” editors wrote. “The finger-pointing and his continued support for [head of the biologics division] Dr. Prasad is creating tremendous uncertainty for pharmaceutical developers. If Dr. Makary really wants to make drug approvals for deadly and rare diseases faster and more flexible, he’d send a signal by ordering the FDA to reconsider Replimune’s treatment."
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