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Thursday, October 14, 2021
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Dr. Aaron Kesselheim had been on an advisory committee for the US Food and Drug Administration for a half-dozen years, but he had never been to a meeting like this one. The FDA establishes advisory committees to assist the federal agency with one of its most important duties: deciding whether to approve the distribution of new drugs. The stakes of these decisions are enormous. Based on the outcome of the FDA's deliberations, patients may gain access to lifesaving medicines, and manufacturers may reap billions in profits. Kesselheim, a professor at Harvard Medical School, was one of the members of this committee because of his expertise on pharmaceuticals that address diseases of the brain, including Alzheimer's, the irreversible, progressive brain disorder that destroys memory and thinking skills, and eventually causes death. Alzheimer's is the sixth leading cause of death in the United States. The public meeting, conducted as an all-day video call on November 6, 2020, concerned the application for aducanumab, a drug that would be marketed under the name Aduhelm by the company Biogen, which is based in Cambridge, Massachusetts. Aduhelm, if effective, would address one of the most pressing needs in modern medicine: to slow the symptoms of Alzheimer's disease. Research into Alzheimer's treatments has long been an exercise in frustration, with no new drugs approved since 2003. The field of Alzheimer's research had proved so difficult that it was dubbed by some with the macabre nickname of the "Valley of Death." In light of this record, and the need to improve it, Kesselheim was looking forward to examining the prospects for Biogen's new drug. "The great thing about advisory committees is that they are independent, and they don't have a stake in the outcome," he said. "We were just an independent group providing their opinion." As in all advisory committee meetings, this one included several representatives of the FDA and of the applying pharmaceutical company. Dr. Billy Dunn, the director of neuroscience at the FDA, spoke at length on the call, and Samantha Budd Haeberlein, a senior vice president of Biogen, led the representatives for the company. What was unusual about this meeting, though, according to Kesselheim, was the apparent relationship between the FDA and company representatives. "There was a strange dynamic, compared to the other advisory committee meetings I've attended," Kesselheim said. "Usually there's some distance between the FDA and the company, but on this one the company and the FDA were fully in line with each other in support of the drug."