Consumer Group Calls FDA Approval of New Alzheimer’s Drug “Reckless”

The prominent consumer watchdog group Public Citizen is sharply criticizing federal drug regulators for approving a new Alzheimer’s disease drug, which many say has not been proven to be effective.

Public Citizen issued a statement on June 7, claiming the U.S. Food and Drug Administration (FDA) inappropriately approved the drug Aduhelm (aducanumab) to treat Alzheimer’s patients.

The group claims the FDA “inappropriately collaborated with Biogen” to rush out what Public Citizen says is an unproven treatment, and may be ineffective or dangerous.

The drug is the first novel therapy approved for the treatment of Alzheimer’s since 2003, and is designed to reduce the presence of amyloid beta plaques in the brain, which are believed to be linked to the progression of the disease. However, in a November 2020 meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, eight of the 11 members voted that one of the major clinical trials supporting approval of the drug did not provide strong evidence of Aduhelm’s effectiveness. Only one member of the committee voted “Yes” and two others were uncertain.

The committee voted similarly on another study’s findings, which looked at the drug’s effectiveness, with seven members voting the evidence was not convincing, four voting they were uncertain, and none of the members voting they were convinced the study showed Aduhelm actually works.

A third vote on the overall evidence resulted in a 10-0 vote against whether there was primary evidence of Aduhelm’s effectiveness, with one member voting they were uncertain.

“The FDA’s decision shows a stunning disregard for science and eviscerates the agency’s standards for approving new drugs,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in the group’s statement. “Because of this reckless action, the agency’s credibility has been irreparably damaged.”

He claims the FDA worked too closely and collaboratively with Biogen before and after the drug approval was submitted, which Carome said dangerously compromised the integrity of the agency’s review process.

Even the FDA itself indicated it anticipated criticism of its decision in its announcement of the drug’s approval, saying the data was not straightforward, but that the agency followed its usual decision-making process.

“There has been considerable public debate on whether Aduhelm should be approved,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research said in the agency’s press release. “As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.”

The FDA used its Accelerated Approval Program to rush the drug through, claiming it meets an unmet medical need. Cavazzoni noted that if the drug shows no benefits in post-approval studies, it could face removal from the market.