Alzheimer's patients are desperate for treatment. But the FDA can't throw out its standards.

From Yahoo, written by Holly Fernandez Lynch, Emily A. Largent, and Andrew Peterson:

Like many government agencies, the Food and Drug Administration is at its best when no one notices it, quietly helping us avoid unsafe and ineffective products. Unfortunately, the agency keeps making decisions that garner front-page news.

In June, the FDA approved Aduhelm (generic name aducanumab), the first new treatment for Alzheimer’s disease in two decades. As bioethicists who work in the areas of Alzheimer’s disease and pharmaceutical policy, we can attest that this decision has generated more controversy than enthusiasm – and for good reasons.

The drug has questionable benefits, substantial risks, a prescription label that remains overbroad and a hefty price tag.

The FDA’s cozy interactions with pharmaceutical company Biogen, and its use of the accelerated approval pathway without consulting its committee of independent advisers, also raises concerns.

But there’s one especially challenging issue in the Aduhelm saga that hasn’t received adequate attention: the central role that patient desperation played in the FDA’s decision-making. In justifying Aduhelm’s approval, FDA leadership asserted that patients and families “made it clear that they are willing to accept the trade-off of some uncertainty about clinical benefit in exchange for earlier access to a potentially effective drug.”