UPDATED: In highly unusual op-ed, 3 aducanumab adcomm members again call on FDA to reject Biogen's Alzheimer's drug
Typically, when the FDA convenes advisory committees for drugs or vaccines, the outside experts offer their perspective, vote, and then the agency either listens to them or not. And that’s where it ends. But the review of Biogen’s Alzheimer’s drug aducanumab has been anything but typical.
In a highly unusual op-ed in JAMA, three members of the adcomm that reviewed the drug last November again laid out their case for why the FDA should reject aducanumab. Johns Hopkins epidemiologist Caleb Alexander, University of Washington biostatistician Scott Emerson and Harvard bioethicist Aaron Kesselheim spotlighted the conflicting results between Biogen’s two pivotal trials, the potential safety concerns those studies turned up, and allegations that regulators may have compromised their objectivity by working too closely with the company.
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