FDA approval of Alzheimer’s disease drug aducanumab – Inspector General may investigate

Alzheimer's disease drug

Last week, the US Food and Drug Administration (FDA) approved the first new drug, Aduhelm (aducanumab), for Alzheimer’s disease in 18 years. The new drug is manufactured by Biogen, a US-based pharmaceutical company, and if you read the news reports and social media posts, you’d think the new drug is a miracle.

Given that Alzheimer’s disease afflicts over six million Americans each year, we wanted to celebrate aducanumab as a miracle. Except, there’s really nothing to celebrate here.

The FDA ignored the advice of its own expert advisory committee, which voted overwhelmingly (eight against approval, one for, and two abstained) to not recommend the drug because, according to the FDA’s own analyses, the drug failed to show that it can do anything to treat Alzheimer’s devastating cognitive decline. Plus aducanumab costs $56,000 per year (yes, $56,000) and comes with a relatively high risk for brain swelling and bleeding.

In response to the outcry, Acting FDA Commissioner Janet Woodcock wrote a letter to the acting inspector general of the Department of Health and Human Services, acknowledging that there has been “significant attention and controversy” surrounding the approval of Aduhelm. In particular, Woodcock said, concerns continue to be raised about the agency’s contacts with Biogen, including “some that may have occurred outside of the formal correspondence process.”

So we have to ask why would the FDA approve this new drug for Alzheimer’s disease, even though aducanumab is expensive, has serious side effects, and probably doesn’t do anything to improve the outcomes of Alzheimer’s patients? And because the drug is so expensive and everyone will demand the drug for the disease, this could add hundreds of billions of dollars to the cost of healthcare in the USA and across the world (don’t believe for a second that this possibly worthless drug is going to cost only $5.00 in Denmark, because it won’t).

The answers to these questions are complicated, and I’ll try to explain. But I think what happened here is disturbing and tragic. And it could have implications for any new drug approved by the FDA.

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