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FDA approval of Alzheimer’s drug leads to resignation from third adviser



A prominent Harvard drug researcher on Thursday became the third member of an advisory committee of the Food and Drug Administration, who resigned due to the agency’s decision to approve a drug for Alzheimer’s and questioned whether the drug works.

Harvard Medical School professor Aaron S. Kesselheim called the FDA’s approval of Biogen Inc.

drug Aduhelm “probably the worst drug approval decision in recent American history.”

The external advisory committee he worked on – the FDA’s panel on peripheral drugs and the central nervous system – had refused to support the drug, generically known as aducanumab, and said the company should conduct further investigation.

Earlier in the week, David S. Knopman, a neurologist at the Mayo Clinic, and Joel S. Perlmutter, a neurologist at Washington University in St. Louis, pulled out. Louis, out of the advisory committee in protest of the FDA decision. Recommendations from advisory panels composed of recognized experts in their fields are generally accepted by the FDA.

Dr. Perlmutter said in his resignation letter to Stat, a health news organization, that he quit “because of this FDA decision without further discussion with our advisory committee.”

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The layoffs follow criticism of the FDA decision from some Alzheimer’s researchers and doctors. The FDA issued the approval over the doubt among some researchers and doctors who questioned its effectiveness.

The agency said it approved the drug on the grounds that it lowered the levels of a sticky substance in the brain associated with Alzheimer’s called amyloid, which according to critics has not been proven to be a driver of the disease.

The FDA said Monday it gave the green light during the accelerated approval process because Aduhelm is a drug for a “serious or life-threatening illness that provides a meaningful therapeutic benefit over existing treatments.”

The principle behind accelerated approval is that it makes medicines available to seriously ill patients faster, while a company does further research.

The agency said the drug showed benefit in reducing amyloid plaque, which may play a role in Alzheimer’s, which ravages memory and thinking.

But the question over Aduhelm is whether it provides any benefit at all, and the role of amyloid in the disease is not clear.

Dr. Kesselheim said in his resignation letter that the FDA decision was “based on the debatable assumption that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease.”

“This crucial issue was not discussed at the advisory committee meeting, and its premise was specifically excluded from discussion,” he wrote in his resignation letter to FDA Acting Commissioner Janet Woodcock.

Dr. Kesselheim called the agency’s decision a “debacle”, saying the movement “will undermine the care reception for these patients, public confidence in the FDA, the pursuit of useful therapeutic innovation and the affordable price of health care.”

Biogen has set the price of the injectable drug at about $ 56,000 annually, another topic that has contributed to criticism of the drug.

Write to Thomas M. Burton at tom.burton@wsj.com

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