The Controversy Over the FDA ’s Approval of The First Alzheimer’s Treatment Keeps Growing

“The whole thing is befuddling, and a series of inexplicable surprises,” says Dr. Caleb Alexander, professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health. Alexander is a member of the U.S. Food and Drug Administration’s advisory committee that provided recommendations to the agency on whether or not to approve the Alzheimer’s drug aducanumab. On June 7, the FDA did approve the drug (under the brand name Aduhelm), in a highly controversial decision that continues to divide the Alzheimer’s community. Patients and advocacy groups, including the Alzheimer’s Association, support the approval, noting that the drug is the first to address the underlying causes of Alzheimer’s disease. While it’s not a cure or a home run therapy, they say, it’s a needed start. [time-brightcove not-tgx=”true”] Neurology and dementia experts, as well as statisticians who have looked at the data the drug makers submitted for approval are more skeptical. They note that the two large studies of the drug were hardly convincing in showing effectiveness. One study showed no significant benefit among people who received the drug compared to those getting a placebo, while the other showed only marginal improvement in cognitive tests among people getting the drug. Adding to the contention around the FDA decision is the way the agency made it. Before approving a drug, the FDA conducts a thorough review of the ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Source Type: news