June 16, 2021 ~ MedPage Today ~ by Vinay Prasad, MD, MPH 

The FDA Is Failing the American People

— The agency’s recent decision to approve aducanumab offers

FDA’s recent approval of a controversial drug — aducanumab (Aduhelm) — to treat people living with Alzheimer’s disease shows just how broken the agency is, and reminds us that we all have to pay for it.

A series of events that has unfolded since January tells the story.

In late April, the FDA’s Oncologic Drugs Advisory Committee reviewed six accelerated approvals — a provisional pathway — involving a group of cancer immunotherapies where clinical trials had failed to confirm that the drugs extended survival or improved quality of life. Yet, in four of the six cases, the advisory committee voted to keep the accelerated approvals intact. The lesson was painfully clear: once the toothpaste is out of the tube it is hard to get it back in. Once doctors get used to using a therapy, pulling a drug from the market or in this case, revoking indications, is hard — even after the drugs fail to confirm benefit.

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