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How an Unproven Alzheimer’s Drug Got Approved
Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.
Pam Belluck, Sheila Kaplan and
Two months before the Food and Drug Administration’s deadline to decide whether to approve Biogen’s controversial Alzheimer’s drug, aducanumab, a council of senior agency officials resoundingly agreed that there wasn’t enough evidence it worked.
The council, a group of 15 officials who review complex issues, concluded that another clinical trial was necessary before approving the drug. Otherwise, one council member noted, approval could “result in millions of patients taking aducanumab without any indication of actually receiving any benefit, or worse, cause harm,” according to minutes of the meeting, obtained by The New York Times.
“It is critical that the decision be made from a place of certainty,” the minutes said.
The session, whose details have not been reported before, represented at least the third time that proponents of approving aducanumab in the F.D.A. had received a clear message that the evidence did not convincingly show the drug could slow cognitive decline.
On June 7, the F.D.A. greenlighted the drug anyway — a decision that has been met with scathing rebuke from many Alzheimer’s experts and other scientists and calls for investigations into how the agency approved a treatment that has little evidence it helps patients.
How and why the F.D.A. went ahead and approved the drug — an intravenous infusion, marketed as Aduhelm, that the company has since priced at $56,000 a year — has become the subject of intense scrutiny. Two congressional committees are investigating the approval and the price. Much is still unknown, but an examination by The Times has found that the process leading to approval took several unusual turns, including a decision for the F.D.A. to work far more closely with Biogen than is typical in a regulatory review.
Allegations about the collaboration prompted the F.D.A. to conduct an internal inquiry after a consumer advocacy group called for an inspector general’s investigation, according to documents reviewed by The Times. The agency has not disclosed the inquiry.
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