In June 2021, the FDA approved Aduhelm (aducanumab), a drug designed to help treat Alzheimer’s disease. But, was that decision too hasty?
That’s the question two House committees recently explored during an 18-month investigation of the drug’s approval process. The members found that the FDA went against scientific advisors to pass the drug, which had shown little effectiveness in its initial trials. Studies of the drug didn’t show benefits until later studies when the dosages were raised.
The FDA, however, responded in a statement that the approval was “based on our scientific evaluation of the data.”
Biogen, the drug’s creator, also responded in a statement: “Alzheimer’s is a highly complex disease, and we have learned from the development and launch of Aduhelm. … Biogen stands by the integrity of the actions we have taken.”
Investigators also found the price of Aduhelm to be “unjustifiably high”, at an initial $56,000 a year, which Medicare refused to cover even after the price was dropped to $28,000. Medicare only agreed to cover Aduhelm if patients participated in a trial to prove the drug slowed their cognitive decline.
There are also speculations that communications between Biogen and the FDA did not follow typical protocol. The investigation report reveals the two had 115 exchanges, which was reported in an internal FDA review to exceed the norm.
At an advisory committee meeting in November 2020, no members voted to confirm confidence in Aduhelm’s effectiveness. However, former FDA adviser Aaron Kesselheim, MD, told CNN this did not match up with the FDA’s backing of the drug.
“There was a strange dynamic compared to the other advisory committee meetings I’ve attended,” Kesselheim said. “Usually, there’s some distance between the FDA and the company, but on this one, the company and the FDA were fully in line with each other in support of the drug.”
CNN reported that Kesselheim resigned in protest after the drug’s approval—even calling the process “probably the worst drug approval decision in recent U.S. history.”
Although the FDA initially approved the drug for anyone living with Alzheimer’s, it later recommended the drug only be used by patients with early-onset forms of the disease, similar to those who participated in the clinical trials.
Speculations about the legitimacy of Aduhelm have raised worries about the approval of future Alzheimer’s drugs.
“[The] FDA must take swift action to ensure that its processes for reviewing future Alzheimer’s disease treatments do not lead to the same doubts about the integrity of FDA’s review,” the congressional report read.
Despite the controversy, Aduhelm is nevertheless currently available, with out-of-pocket costs for adults with insurance varying depending on coverage.
