Safety concerns are being raised after the recent controversy surrounding the FDA approval of a new Alzheimer’s treatment. There are questions about the standards that should be used to evaluate investigational drugs and the side effects caused by those drugs. The drug in question is aducanumab (brand name, Aduhelm).
A virtual discussion titled “The Alzheimer’s Treatment Controversy: Implications of Accelerated Drug Approvals” was recently co-hosted by The Forum at the Harvard University T.H. Chan School of Public Health and Reuters.
Researchers said Aduhelm received FDA approval despite an independent advisory committee nearly unanimously rejecting the drug. Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, served on the panel that advised against the drug, which was tested and recently approved for patients with early signs of Alzheimer’s.
“I, too, was waiting for a treatment for Alzheimer’s disease,” said Kesselheim, who treats patients suffering the disease that has no known cure. “But I think there was a problem with the decision-making and a problem with the decision itself.”
Additionally, researchers said there was a lack of convincing evidence that Aduhelm actually slowed the progression of cognitive dysfunction in patients with Alzheimer’s.
“There’s a substantial risk with this drug,” Kesselheim said. “I think there’s also harm for patients that will be spending a lot of money on this drug… They could be spending that on home health aids to live better lives.”
Medical experts also believe the drug presents important safety concerns. Meanwhile, Kesselheim said one out of every three trial patients had side effects that included brain swelling and bleeding.
“I think that the benefits are potential benefits,” Kesselheim continued. “It has substantial risks and substantial costs.”
The cost of the drug in question is at a minimum, $56,000 a year, which would likely be partially paid by Medicare and the rest by individuals and their families.
Kesselheim shared his perspective during a live online Q&A with Julie Steenhusysen, a journalist with Reuters. He also discussed possible reforms to the FDA’s accelerated approval pathway, which is a program that is intended to facilitate faster drug approvals based on indirect measures of benefits.
“I think we should be investigating all interactions along the way… ultimately what happens with that investigation I don’t really know,” Kesselheim added. “We will have to see what the investigation undercovers.”