‘People are desperate’: FDA-approved Alzheimer's drug, Aduhelm, causes worry for doctors
- Three experts even resigned from an FDA committee over the agency’s decision to approve a medicine that only slowed the mental decline in one study that was marred by hard-to-interpret results.
The US Food and Drug Administration’s (FDA) approval of a new Alzheimer's drug has left doctors worried as patients are “desperate” to know the effectiveness of the medicine. Hopeful patients have bombarded doctors with their queries after FDA approved Biogen’s Aduhelm for Alzheimer’s disease, an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks. Alzheimer’s patients want to know whether the drug might be right for them.
“It's not a simple yes or no,” said Dr Alireza Atri, a neurologist at the Banner Sun Health Research Institute in Arizona.
Doctors are still trying to figure out who should receive the drug which does not reverse mental decline but, at best, slows the disease marginally. The approval of Aduhelm itself was controversial and triggered a swift backlash from many experts. Three experts even resigned from an FDA committee over the agency’s decision to approve a medicine that only slowed the mental decline in one study that was marred by hard-to-interpret results.
Aduhelm is the first Alzheimer's medication in nearly 20 years and has been granted conditional approval based on its ability to get rid of harmful clumps of plaque in the brains of patients with early forms of the disease. The approval, however, isn't limited to those early patients and anyone with Alzheimer's, at least theoretically, could get prescribed the drug.
“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s," Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement after the approval.
Many providers have said that it will take weeks or months before they are ready to give the drug as insurers still need to determine which patients to cover for the expensive treatment that could cost more than $50,000 a year. Doctors worry that emotions will affect decisions by patients and families in seeking the drug.
“People are desperate. It's a really horrible disease,” said Stanford University's Dr Michael Greicius, but added that he has no plans to prescribe Aduhelm.
“I don't think there's sufficient evidence that it works, and there's plenty of evidence that it can harm patients,” he said, questioning the efficacy of the FDA-approved medicine.
Greicius said he plans to lay out a “compelling and compassionate” case for not providing the drug to his patients but he worries that some patients may simply turn to other doctors to get the prescription.
Apart from the side effects of Aduhelm, doctors worry that an earlier diagnosis combined with the drug's incremental benefit may simply prolong the hardships of those caring for someone with Alzheimer's.
“It could turn out that it actually increases your caregiver burden if it's just slowing things down a little bit,” said Dr Suzanne Schindler of Washington University in St. Louis. “I think it's going to be really disappointing for a lot of people.”
(With AP inputs)