Clinics Won ’t Provide It. Insurers Won’t Cover It. So Will the First Alzheimer’s Drug Make a Difference?

In theory, the approval of the first drug to treat Alzheimer’s disease would be cause for universal celebration. But from the moment the U.S. Food and Drug Administration (FDA) approved aducanumab on June 7, the drug has been beset by controversy about whether the drug is actually effective—and if the agency bent to pressure from maker Biogen. The conflict came to a head Wednesday when the agency watchdog, the U.S. Department of Health and Human Services Inspector General, announced that it would look into the drug’s accelerated approval, including allegations that the FDA had an “inappropriately close relationship” with the pharmaceutical industry. However, the agency will not reexamine the science behind the approval. [time-brightcove not-tgx=”true”] The turmoil has had major repercussions for aducanumab’s rollout. Already, some major medical institutions have said they will not provide it, doctors don’t feel comfortable prescribing it, and members of the FDA advisory committee resigned in protest over the approval. The Alzheimer’s Association, a patient advocacy and research group, on the other hand, stands by the approval and says that patients should have the option of deciding whether or not they want to try it. Doctors take issue with the quality of the data on which the FDA’s decision was based, and they are also criticizing how the agency reviewed the drug, which will be marketed under the brand name &...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Drugs healthscienceclimate Source Type: news