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Forget future medicines – dementia patients need better care now In terms of quality of life for the foreseeable future, social care will be more important to people with Alzheimer’s than any medication 14 June 2021 • 5:00am US regulatory bodies have approved the use of aducanumab for patients with early onset Alzheimer’s Credit: Shutterstock An old friend and veteran of the psychiatry of older people tells me he experienced a feeling of déjà vu over celebrations of the latest ‘extraordinary breakthrough’ in the treatment of Alzheimer’s disease. These reports greeted the preliminary approval by the US regulatory authorities of aducanumab, a monoclonal antibody that targets the amyloid-beta proteins that are deposited in the destructive plaques in the brain that cause the inexorable cognitive decline of Alzheimer’s. ....
Food and Drug Administration (FDA) drew criticisms after granting Alzheimer’s disease drug Aduhelm a conditional approval. It allows the drug scientifically known as aducanumab to be prescribed and used while its maker Biogen conducts a post-marketing, phase 4 confirmatory study that could take years to complete. Aduhelm is the first Alzheimer’s medication approved by the FDA since 2003. According to the influential Institute for Clinical and Economic Review (ICER), the FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Aduhelm. ICER questions Aduhelm’s effectiveness The FDA, which announced the approval on June 7, said that the drug was the first to treat the underlying mechanism in Alzheimer’s. But ICER didn’t see it that way. ....