Senate GOP Rams Through Plan to Cut Out Democrats and Bankroll ICE
“This decision comes out of FDA, and we trust the process there. And I’ve been told by Marty Makary that every panel that looked at that drug unanimously voted against it … because it does not appear to work,” Kennedy said to the Senate Finance Committee.
This is disputed by many oncologists, who pointed out in a Wall Street Journal op-ed this week that an initial panel approved the drug before being overruled by the head of biologics, Dr. Vinay Prasad. They also disputed Kennedy’s claim at a House hearing last week that Replimune did a “one arm trial, and all the people who were tested also received a chemotherapy drug, so we don’t know what the effect was.”
In reality, none of the patients in the trial received chemotherapy; instead they received a different form of immunotherapy, the oncologists noted. A longtime melanoma researcher who worked on the trial, Dr. Anna Pavlick, told the Journal, “Honestly, there was no doubt in our minds whatsoever when we completed this study and we saw the results, that this was going to be approved as a wonderful alternative for our patients because they have no options.
