President Donald Trump’s administration got another tongue-lashing by the conservative Wall Street Journal editorial board, as yet another Health and Human Services official moves to obstruct groundbreaking cancer research.
“Food and Drug Administration biologics chief Vinay Prasad is stepping down at the end of this month after torpedoing breakthrough rare disease treatments,” wrote the board, referencing a controversial figure who has been responsible for shutting down a number of promising therapies. “The grim reaper can’t leave soon enough, but he’s not leaving without kicking patients with late-stage melanoma on his way out.”
Specifically, the board wrote, he and FDA commissioner Marty Makary rejected an experimental melanoma immunotherapy for a second time — cutting off a potential treatment avenue for people suffering from a lethal form of skin cancer.
“Some 8,500 Americans die every year of melanoma, many of whom could be saved by Replimune’s RP1. But Dr. Prasad and Commissioner Marty Makary have decided that for whatever reason they aren’t worth saving,” wrote the board. “RP1 is an oncolytic virus therapy that turbo-charges the immune response in people resistant to other immunotherapies. A modified herpes virus is injected into tumors, which causes cancer cells to burst and release flares that activate and train the immune system to attack cancer cells throughout the body.”
Nearly all patients responded to this treatment, and a third went into remission — a massive deal for a particularly dangerous form of cancer that typically kills patients who stop responding to other immunotherapies within a year. However, Prasad and Makary rejected approval because there was no control group — even though control groups are never used in trials for this type of deadly disease because leaving some patients with zero treatment whatsoever is considered unethical.
“Drs. Makary and Prasad may not care if they kill a company, but what about the patients who will die as a result?” wrote the board. “The rejection will have a chilling effect on drug development by signaling that the FDA is slamming the door on accelerated approvals and requiring a level of evidence of efficacy that fewer cancer drugs could meet.”
This comes after Medicare and Medicaid administrator Dr. Mehmet Oz revealed that President Donald Trump thinks his diet soda habit prevents cancer because pouring diet soda on grass causes it to die.
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