Frustrating Drug Advancement
By David Henderson
David Kessler, who was FDA commissioner under both presidents George H. W. Bush and Bill Clinton, confidently stated, “When the industry sells a drug, the drug works, and it does what it says on the label. Take that away and we go back to snake oil.”
Not quite. Does helping 10 percent of patients show that “the drug works”?
This is from David R. Henderson and Charles L. Hooper, “Standing Between You and COVID-19 Relief: The FDA,” Goodman Institute, Brief Analysis No. 137, April 20, 2020.
Merck’s Keytruda has recently become one of the hottest drugs on the market. It received favorable press coverage when Jimmy Carter reported that he was cancer free after therapy with Keytruda. But Carter was lucky. In one clinical trial, Keytruda destroyed or reduced the tumors in only 34 percent of patients. Keytruda—which was the fourth biggest-selling drug globally in 2018 and brought in worldwide revenues of $11.1 billion last year—is far from a sure thing.
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