By Andrew Joseph
\nSTAT<\/p>\n
A <\/span><\/span>third member of a Food and Drug Administration expert panel has resigned over\u00a0the agency\u2019s contentious approval<\/a>\u00a0of an Alzheimer\u2019s therapy this week, a sign of a growing backlash over the decision.<\/p>\n In a letter to acting FDA Commissioner Janet Woodcock on Thursday, Aaron Kesselheim, who had served on the FDA\u2019s advisory committee for nervous system therapies since 2015, wrote that the approval of Biogen\u2019s Aduhelm \u201cwas probably the worst drug approval decision in recent U.S. history.\u201d<\/p>\n \u201cIt is clear to me that FDA is not presently capable of adequately integrating the Committee\u2019s scientific recommendations into its approval decisions,\u201d wrote Kesselheim, the director of Brigham and Women\u2019s Hospital\u2019s Program on Regulation, Therapeutics, and Law. He also cited the FDA\u2019s decision to approve Sarepta Therapeutics\u2019 eteplirsen for Duchenne muscular dystrophy in 2016 over the recommendation of the advisory committee in his decision to quit.<\/p>\n Kesselheim\u2019s resignation follows those of neurologist David Knopman of the Mayo Clinic and neurologist Joel Perlmutter of Washington University in St. Louis. Perlmutter wrote in an email to STAT Tuesday\u00a0his decision to quit the panel<\/a>\u00a0was \u201cdue to this ruling by the FDA without further discussion with our advisory committee.\u201d<\/p>\n Knopman, whose resignation\u00a0was first reported<\/a> Wednesday by Business Insider, was recused from the aducanumab panel because he had been a trial investigator.<\/p>\n But during the panel\u2019s\u00a0November hearing<\/a> on the therapy, 10 of the 11 members voted that there was not enough evidence to show Aduhelm, also known as aducanumab, could slow cognitive decline, recommending against its approval. The 11th voted \u201cuncertain.\u201d<\/p>\n On Monday, however, the FDA granted Aduhelm an accelerated approval based on the drug\u2019s ability to clear toxic protein plaques in patients\u2019 brains \u2014 a regulatory route that FDA officials told the advisory committee in November was not being considered. In explaining the approval, the FDA acknowledged Aduhelm had not demonstrated a clear clinical benefit in terms of slowing disease progression, but argued that by removing the plaques, Aduhelm \u201cis reasonably likely to predict a clinical benefit to patients.\u201d<\/p>\n The FDA also told the chair of the panel Monday that \u201cfurther discussions\u201d within the agency after the panel\u2019s hearing led to the decision to use the accelerated approval pathway.<\/p>\n The FDA does not have to follow the recommendations of its advisory committees, and researchers have found that\u00a0it has gone against<\/a>\u00a0the votes about 1 in 5 times in recent years. But generally, such overrulings occur when the votes are much closer.<\/p>\n Nicholas Florko contributed reporting.\u00a0<\/em><\/p>\n ___ Third member of FDA expert committee resigns over controversial Alzheimer\u2019s therapy decision By Andrew Joseph STAT A third member of a Food and Drug Administration expert panel has resigned over\u00a0the agency\u2019s contentious approval\u00a0of an Alzheimer\u2019s therapy this week, a sign … Continue reading
\nhttps:\/\/www.statnews.com\/2021\/06\/10\/third-member-of-fda-expert-committee-resigns-over-controversial-alzheimers-therapy-decision\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"