#5SmartReads - June 9, 2021

On the risks of Aduhelm's approval, the future of democracy, and who we still follow

Experts question FDA standards with Aduhelm approval (Axios)

Here’s the recap - the FDA approved an Alzheimer’s drug developed by Biogen and Eisai. It’s the first Alzheimer’s drug to be approved in a while - most noticeably, the first after the FDA issued guidance to ease the standards for drugs treating Alzheimer’s.

The decision to approve Aduhelm, which doesn’t show any significant benefit over the placebo, gives me a lot of pause. Approval before the confirmatory trial’s protocol and study timeline concern me. And while the FDA has no control over pricing, that the drug is extremely expensive is another cause of concern.

The FDA’s standards of safety and effectiveness of the drugs they approve has always been extremely high. I worry this is setting a bad precedent, at a time when public trust in the FDA is polarized.