Biogen’s Aduhelm, or aducanumab, was cleared by the F.D.A., despite the fact that some of its senior officials believed it was unlikely to benefit patients. The Food and Drug Administration’s advisory council has resoundingly agreed that aducanumab does not have enough evidence to push for its approval two months before the deadline for deciding whether to approve it.
Alzheimer’s Drug Approved Despite Unproven Claims
Before the drug could be approved, the Clinical Trials Advisory Council, made up of 15 officials, decided that another study was necessary. The New York Times obtained minutes of the meeting and notes that one council member noted that approval could “lead millions of patients to take aducanumab without any indication that it actually helps, or worse, it could cause harm”, according to the minutes. According to the minutes, certainty is essential for the decision to be made.
Aducanumab developers were clearly told in the FDA session, with its details unknown before, that there was insufficient evidence showing the drug slows cognitive decline for the third time in a row. The F.D.A. approved the drug anyway on June 7 – a decision that has drawn scathing criticism from Alzheimer’s experts and other scientists who say the agency should be investigated over the approval of a treatment that has little proof that it works.
In recent years, there has been intense scrutiny surrounding the FDA’s approval of a drug marketed under the brand name Aduhelm, which is marketed for $56,000 per year. The approval and price of this project are under investigation by two congressional committees. Several unusual decisions led to approval, including a decision by the Food and Drug Administration to work with Biogen far more closely than is typical in a regulatory review, according to The Times investigation of the process.
An advocacy group asked for an inspector general’s investigation after allegations about the collaboration prompted the Food and Drug Administration to ask for an internal investigation. According to the report, no public report has been released regarding the investigation.
Despite it being one of the most controversial and consequential decisions in the agency’s history, acting commissioner Dr. Janet Woodcock did not participate in the decision-making process and left the final decision in the hands of the director of the drug applications center, according to an agency spokesperson. The Drug Enforcement Agency defended its approval of the drug – which is the first for Alzheimer’s in 18 years – in a written response to questions from The Times.
According to the agency, the decision was made after weighing logic, science, medicine, policy, and judgment. Biogen responded that the company “stands 100 percent behind its approval and the clinical data that underpins that decision.”
The agency’s approval process has been the subject of mounting pressure, which led Dr. Woodcock to ask the inspector general to look into it. “Process problems,” according to Dr. Woodcock have not been specifically described.
In his book about the agency, former senior official Wayne Pines says that this incident has significantly damaged agency integrity. In order for the F.D.A. to ensure that the official decision was made based on science, all avenues must be pursued until all stones have been turned over and all avenues explored.”
Even though some Alzheimer’s experts strongly supported the drug’s approval, given that there are few options for those with the disease, many believe it was a mistake to approve it with such unclear evidence that it can cause bleeding or swelling in the brain.
As a result of an independent monitoring committee’s findings that aducanumab is not helping patients, two nearly identical late-stage clinical trials were stopped in 2019. Biogen found that participants receiving aducanumab in the highest dose in one trial slowed cognitive decline slightly, but participants in another trial did not see any benefit.
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