The Food and Drug Administration yanked the fight against Alzheimer’s out of the mire with its approval of the first disease-modifying therapy. Although it’s a modest first step, it paves the way for more momentous breakthroughs.
The drug — aducanumab by Biogen and Eisai — is a monoclonal antibody that clears a toxic protein called beta-amyloid from the brain. The drug can’t reverse Alzheimer’s-related damage once amyloid has seized a beachhead and symptoms of the disease emerge. Its promise lies in battling amyloid before it does irreversible harm.
Opponents of approval wanted to see stronger data showing that the drug could slow the progression of Alzheimer’s. But the FDA decided not to make perfect be the enemy of the good. It approved the drug, which will be sold as Aduhelm, on the condition that Biogen complete a large clinical trial to confirm that removing beta-amyloid has cognitive benefits. Meanwhile, the treatment is approved for all patients diagnosed with Alzheimer’s disease, which requires a PET scan or lumbar puncture confirming the presence of beta-amyloid in the brain.
I’ve yet to read a positive take about aducanumab that isn’t followed by a declaration of a relationship with Biogen or the Alzheimer’s Association. This piece particularly feels like propaganda.
Everything in medicine, from individual decisions with patients to regulatory decisions about new drugs, is cost benefit analysis. Conflicts of interest cloud our ability to do that type of analysis objectively.
STAT should protect its credibility by restricting opinion pieces on this controversial decision to those from unconflicted individuals.
Precisely