The trial data for Aduhelm was “a little questionable” says Dung Trinh, MD, founder of the Healthy Brain Clinic. One trial suggested it slowed patients’ memory decline, but another showed no difference compared with a placebo. Prior to the drug’s approval, an independent FDA advisory committee, a group made up of experts and consumer representatives who review clinical trial data and vote on whether to recommend that the FDA approves the medicine, unanimously voted against Aduhelm’s approval. The FDA is not bound to the advisory committee’s opinion, and it went ahead and approved Aduhelm anyway. The approval gave Biogen, Aduhelm’s manufacturer, another nine years to continue collecting data to prove that the drug not only reduces amyloid plaques, but actually slows memory decline in Alzheimer’s patients. MedShadow’s founder, Suzanne Robotti, wrote about how unusual this move was back in 2021. She wasn’t the only one with suspicions about the approval.  Later, Medicare refused to pay for the drug. The controversy led scientists to conduct a study on how the FDA treats advice from its advisory boards, which found that the FDA was far more likely to follow advisory board recommendations when those recommendations were to approve a drug than when they suggested rejecting it. Congress also investigated, and found serious irregularities in the Aduhelm’s approval specifically, including excessive collaboration between the drug’s manufacturer, Biogen, and the FDA. For example, the FDA helped Biogen develop a presentation about the drug to be given to the independent advisory committee. The FDA met with Biogen 55 times or more, and many of the meetings were not documented. As Robotti wrote in 2021, “Eventually, Aduhelm may be proven effective at slowing the progression of Alzheimer’s,” but right now, we just don’t know. Robotti said the approval hinged on two studies, one of which suggested the drug slightly slowed memory decline and another which didn’t. “There’ve been so many controversies that it just flopped and died.” Despite the fact that it’s still on the market, Trinh says, it’s not being used very much. “Really, Aduhelm died last year, because it was controversial. It was very expensive. And it’s very controversial. The data was iffy.”