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.
The turmoil has had significant repercussions for aducanumab’s rollout. Some major medical institutions have already 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, patient advocacy, and research group, on the other hand, stands by the support 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 “aduhelm.” After reports that members of Biogen allegedly met with members of the FDA outside of their formal regulatory capacity, the agency announced on July 9 that it would investigate how the drug was approved. Following that announcement, the Cleveland Clinic, the Mount Sinai Health System in New York, and Providence, a health care system based in Renton, Wash., all decided that they would not carry the drug.
At least until the results of the investigation are complete. A handful of Blue Cross Blue Shield plans have also said that for the time being, they would not reimburse the drug, which is expected to cost $56,000 a year. It’s a blow to the more than 6 million Americans currently living with Alzheimer’s, a neurodegenerative disorder that primarily affects memory and cognitive function. For decades, their hopes have been raised and dashed as new drug candidates after they failed to show much benefit. Given the lack of available options, aduhelm’s approval was, unsurprisingly, a new source of optimism.