Following the Food and Drug Administration's polarizing authorization of the Alzheimer's therapy Aduhelm on Monday, a member of an agency advisory committee that recommended against the drug's approval has resigned.
Neurologist Joel Perlmutter of Washington University in St. Louis, a member of the FDA's expert panel for nervous system therapies, told STAT in an email that he had quit the committee on Monday "due to this ruling by the FDA without further discussion with our advisory committee."
The advisory committee, which convened in November, couldn't have been more openly skeptical of the drug, also known as aducanumab. Ten of the 11 panelists found that there was not enough evidence to show it could slow cognitive decline. The 11th voted "uncertain."
Less than five weeks after granting a highly controversial approval for the Alzheimer's drug Aduhelm, the Food and Drug Administration has updated its recommendation for who should receive the drug. The update narrows the recommended patient pool from all those with Alzheimer's disease to only those with mild forms of the disease.
The FDA's initial sweeping recommendation was a highly contentious aspect of the drug's approval, because it wasn't backed by any data. Aduhelm's developer, Biogen, had only included people with mild disease in its clinical trials. The numerous critics of the approval raised immediate questions as to why the drug would be open to all.
[...] Critics quickly called the approval "disgraceful" and "dangerous." Three members of the agency's advisory panel resigned in protest. Watchdog group Public Citizen called for the ouster of three top FDA officials.
Adding fuel to the fiery criticism is Biogen's decision to price Aduhelm at $56,000 for a year's supply. One analysis estimated that if the country's 5.8 million Medicare-eligible adults with Alzheimer's began taking Aduhelm, it could cost the federal insurance program $334.5 billion a year. In 2019, Medicare spent a total $37 billion for all drugs in the same category as Aduhelm, which is a doctor-administered drug. And the eye-popping cost estimate does not include additional, pricy brain scans and safety monitoring that taking the drug would require. While Aduhelm's efficacy is uncertain, the drug's known side effects include dangerous brain swelling and bleeding.