Three scientists on the Food and Drug Administration’s independent panel of drug safety advisers have resigned over the agency’s decision to approve an Alzheimer’s drug they argue has not been proven to benefit patients.
“Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval,” said Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, on Monday after the drug was approved.
Kesselheim resigned from his position on the FDA’s Peripheral and Central Nervous System Advisory Committee on Thursday, which voted against approval of the intravenous drug Aducanumab in November 2020 — 10 members objected to approval, while one person abstained. Members of the panel argued the drug’s clinical trial results produced flimsy evidence that it would slow cognitive decline seen in patients with the degenerative disease.
The FDA’s Monday approval of Aducanumab, christened Aduhelm by biotech giant Biogen, is considered “accelerated,” meaning the company will have to produce results from a post-market study to prove efficacy. The treatment is a monoclonal antibody taken intravenously every month. It clears a “sticky” plaque in the brain made up of the protein beta-amyloid, which accumulates in the brains of Alzheimer’s patients and is believed to cause memory and cognitive problems. However, trial results did not provide proof of a clear benefit against the progression of the disease.
It is the first Alzheimer’s treatment to be approved by federal regulators in 18 years, and doctors are eager to have another available treatment for their patients. Still, scientists are doubtful that it can produce results.
Kesselheim was the third member of the panel to resign after Mayo Clinic neurologist Dr. David Knopman quit Wednesday and Washington University neurologist Dr. Joel Perlmutter on Tuesday, Reuters reported.
“I was very disappointed at how the advisory committee input was treated by the FDA,” Knopman told Reuters on Wednesday. “I don't wish to be put in a position like this again.”
The treatment’s high price tag of $56,000 per year would drive up Medicare premiums across the board. The cost is also a sticking point for seniors covered by the government health plan, who could face copayments of up to $11,500 annually, according to the Associated Press.
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Original Author: Cassidy Morrison