Harvard professor of medicine Aaron Kesselheim, a former member of the Food and Drug Administration’s (FDA) advisory committee who left after a controversial new Alzheimer’s disease drug was approved, spoke out Monday, saying research on the medicine “showed no good evidence that it worked.”
Kesselheim was the third member of the FDA’s advisory committee to resign earlier in June after Aduhelm was approved for the treatment of Alzheimer’s, becoming the first new drug to be approved for the disease in almost 20 years.
“It had important side effects,” Kesselheim said while speaking to CBS News medical correspondent Tara Narula. “The FDA’s totally switching gears over the last six months, and approving this drug on the basis of a theory relating to the surrogate marker of amyloid plaques that we, as an advisory committee back in November, were told to not consider.”
Aduhelm, made by American biotech company Biogen, has been shown to reduce the levels of amyloid plaques, which are believed to be behind symptoms of Alzheimer’s, collecting between the brain’s neurons and disrupting cell function.
However, despite these findings, there was no clear evidence that the drug actually works in preventing or improving symptoms of Alzheimer’s.
“If the FDA allows companies to get drugs approved on the basis of trials that are stopped early, trials that are reanalyzed, that sets a precedent because it tells other companies, ‘Well … I don’t need to run a rigorous trial either,'” Kesselheim said.
“Patients and physicians really do depend on the FDA maintaining reasonable standards for the drugs it provides. In the, you know, majority of cases I like to think the FDA makes the right decision,” he added.
Kesselheim said an explanation is needed for the FDA’s decision in approving Aduhelm.
Narula noted that it is uncommon for the FDA to go against the advisory committee’s recommendations, agreeing with them about 80 percent of the time. The times when they disagree usually involve the committee recommending a drug, but the FDA deciding against it, according to Narula.
In a statement, FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni said the benefits offered by Aduhelm outweighed the risks.
“At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward,” Cavazzoni said. “We examined the clinical trial findings with a fine-tooth comb, we solicited input from the Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data.”
Apart from the controversy surrounding its approval, the drug has also been criticized for its hefty price tag, running $56,000 a year per patient.
After Aduhelm was approved, Biogen CEO Michel Vounatsos said the cost was “fair” and vowed to not raise the price of the drug for at least four years.