On June 7th, the FDA approved a drug manufactured by Biogen. The brand name of the drug is Aduhelm. The generic name is aducanumab. The drug allegedly slows the onset of symptoms of dementia by targeting a protein that creates plaque. Whether this actually slows dementia onset is unclear.
The approval was based on an accelerated process that can allow a drug to enter the market if it is shown to meet some intermediate goals in the treatment process, but not the overall final objective. Thus if a drug can be shown to stop creation of plaque, it could be approved even if there is no proof that it helps dementia symptoms.
The approval is controversial for the following reasons:
- Two clinical trials of Aduhelm were stopped early because an independent data monitoring committee found that the drug didn’t appear to help patients.
- Roughly 40% of trial participants developed brain bleeding or swelling, in a few cases serious.
- The FDA Advisory Committee reviewing data on the drug recommended against approval.
Biogen has set an annual cost for this drug of $56,000.
Two major medical systems have now announced that they will not offer this drug to patients, regardless of the FDA’s approval: the Cleveland Clinic and the Mount Sinai Health System. They don’t believe the drug works and executives of the Cleveland Clinic are questioning the approval process and the decision to override that Advisory Committee.
After the missteps in 2020 with COVID, this problem poses a threat to the FDA’s reputation as an authority on drug issues. Will people treat FDA announcements with the same respect going forward, or will this encourage more lawsuits to challenge those decisions?