The "debacle" over an Alzheimer's drug recently approved by the Food and Drug Administration continues, or at least that's how the commotion is being described by a third adviser to the agency who's now quit over it. Mayo Clinic neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter—experts who were on an advisory panel that voted in November that the FDA shouldn't give the green light to Aduhelm (Biogen's brand name for aducanumab)—resigned earlier this week, upset that the agency ignored the panel's recommendation. Now Harvard Medical School professor Aaron S. Kesselheim is also stepping down, calling the FDA's decision on Monday to OK Aduhelm "probably the worst drug approval decision in recent US history," reports the Wall Street Journal.
Kesselheim's resignation letter touches on a "pivotal question": the "debatable premise" that Aduhelm's ability to reduce harmful amyloid beta proteins in the brain would have any real effect on Alzheimer's patients. That premise "was specifically excluded from discussion," Kesselheim notes. Bloomberg reports that two major clinical trials involving the drug produced unclear results on whether it could actually slow cognitive decline. Late last month, before the FDA approved the drug, Kesselheim told the Washington Post that "the worst thing for people with Alzheimer's would be to put out a product that doesn't work." In his resignation letter, Kesselheim notes that the FDA's decision to move ahead with Aduhelm "will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system." (More Alzheimer's disease stories.)
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