‘This was the first time nobody voted for approval of a drug’: Neurologist on FDA panel that negatively evaluated controversial Alzheimer’s drug aducanumab resigns after agency pushes through approval

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Credit: Aerogondo/iStock
Credit: Aerogondo/iStock

Neurologist Joel Perlmutter of Washington University in St. Louis, a member of the FDA’s expert panel for nervous system therapies, told STAT in an email that he had quit the [Alzheimer’s therapy Aduhelm] committee on [June 7] “due to this ruling by the FDA without further discussion with our advisory committee.”

The advisory committee, which convened in November, couldn’t have been more openly skeptical of the drug, also known as aducanumab. Ten of the 11 panelists found that there was not enough evidence to show it could slow cognitive decline. The 11th voted “uncertain.”

But the FDA still approved the treatment on [June 7]. On top of the potentially massive implications for patients, clinicians, and health care spending, the decision also raised questions about the role of the advisory committees — and what it meant that the agency, in its final adjudication, bucked the very panel it had convened.

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“This isn’t the first time when I was on a committee where the committee voted one way and the FDA decided another,” said biostatistician Scott Emerson… “This was the first time that nobody voted for approval of this drug — nobody — and they went against that.”

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