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New Alzheimer's Drug Spurs Big Concerns, an Investigation

2 House committees launch inquiry into approval, cost of Biogen's Aduhelm
By Jenn Gidman,  Newser Staff
Posted Jun 30, 2021 6:35 AM CDT

(Newser) – It was supposed to have been a "cause for celebration," but instead, it's become a "catastrophe in the making." That's Axios' recent take on Aduhelm, the costly new Alzheimer's drug that was approved by the Food and Drug Administration despite major reservations from its own advisory panel. Now, two House committees have launched a probe into how and why the go-ahead from the FDA came to be, reports Reuters. Citing "serious concerns" about both the $56,000-per-year price tag of Aduhelm (Biogen's brand name for aducanumab) and the FDA approval process itself, Rep. Carolyn B. Maloney, who heads up the Committee on Oversight and Reform, and Rep. Frank Pallone Jr., chair of the Committee on Energy and Commerce, said in a Friday letter that the investigation will look into not only those two issues, but also "what impact this will have on research for future Alzheimer's treatments and federal health care programs."

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An opinion piece earlier this month in the Annals of Internal Medicine journal tried to tackle that last question, with Dr. G. Caleb Alexander and Dr. Jason Karlawish noting that the FDA's decision to greenlight Aduhelm—which went through an FDA "accelerated approval" process, despite a lack of evidence for its efficacy—will "reverberate for years." "Persons living with [Alzheimer's] disease may choose to drop out of or not enroll in clinical trials and instead take Aduhelm," the authors write, per CNN, adding that would potentially hold up progress on more beneficial drugs. Axios also notes the "false hope" that could prove devastating to families. In response to the lawmakers' investigation, Biogen tells CNN in an email, "We will of course cooperate with any inquiry we may receive from these committees." Meanwhile, documents released by the FDA on Monday show its statisticians were "highly concerned" about the "inconsistency" of Biogen's phase 3 clinical trials, per Politico. (Read more Aduhelm stories.)

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