Last year, we examined Alzheimer’s disease in detail. In June 2021, there seemed to be a treatment breakthrough. However, as of now, we see very disturbing news about a new Alzheimer’s drug.


Benefits Versus Risks: Disturbing News About New Alzheimer’s Drug

As reported by Pam Belluck, Sheila Kaplan, and for the New York Times

On June 7, the FDA. greenlighted the Alzheimer’s drug. A decision met with a scathing rebuke from many Alzheimer’s experts and other scientists. As well as calls for investigations into how the agency approved a treatment that has little evidence it helps patients.

How and why the F.D.A. went ahead and approved the Aduhelm-branded drug remains the subject of intense scrutiny. The intravenous infusion is priced at $56,000 a year. Two congressional committees are investigating the approval and the price. Much is still unknown. But an examination by The Times has found that the process leading to approval took several unusual turns. Including a decision for the FDA to work far more closely with Biogen than is typical in a regulatory review. Allegations about the collaboration prompted the F.D.A. to conduct an internal inquiry after a consumer advocacy group called for an inspector general’s investigation, according to documents reviewed by The Times. The agency has not disclosed the inquiry.

While some Alzheimer’s experts did support the drug’s approval given the dearth of treatment choices for patients. Many say it was a mistake to approve a medication with such unclear evidence of benefit and that trials showed can cause brain swelling or brain bleeding.

Furthermore, earlier this month, two leading hospital groups — the Cleveland Clinic and Mount Sinai — announced that they would not administer Aduhelm to patients.

To read more from the NYT article, click the image.
Even some former employees at Biogen involved in earlier phases of the work on Aduhelm did not agree with the F.D.A.’s approval of the drug. Credit: CJ Gunther/EPA, via Shutterstock


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