12:56:43 PM PDT - Sunday, July 25th, 2021

Why We May Never Know Whether the $56,000-a-Year Alzheimer’s Drug Actually Works  

By Editor - Mon Jul 12, 2:53 am

The Food and Drug Administration’s approval in June of a drug purporting to slow the progression of Alzheimer’s disease was widely celebrated, but it also touched off alarms. There were worries in the scientific community about the drug’s mixed results in studies — the FDA’s own expert advisory panel was nearly unanimous in opposing its approval. And the annual $56,000 price tag of the infusion drug, Aduhelm, was decried for potentially adding costs in the tens of billions of dollars to Medicare and Medicaid. But lost in this discussion is the underlying problem with using the FDA’s “accelerated” pathway to approve drugs for conditions such as Alzheimer’s, a slow, degenerative disease. Though patients will start taking it, if the past is any guide, the world may have to wait many years to find out whether Aduhelm is actually effective — and may never know for sure. The accelerated approval process, begun in 1992 , is an outgrowth of the HIV/AIDS crisis.

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Why We May Never Know Whether the $56,000-a-Year Alzheimer’s Drug Actually Works

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