The Commentary published Jan. 10 criticizing the new drug, Aduhelm (aducanumab) just approved by the FDA for Alzheimer’s disease was timely and important (“Medicare needs to test the new Alzheimer’s drug before paying”).
As a retired geriatrician, with a family history of Alzheimer’s disease I am deeply disturbed by this decision by the FDA.
The American Geriatrics Society (AGS) has just published a tipsheet on their HealthInAging website (www.healthinaging.org/) which offers some helpful guidance as noted below.
The AGS emphasizes:
1. Aducanumab is only to be used in patients with Mild Cognitive Impairment (MCI) or mild Alzheimer’s Disease. MCI may not progress to Alzheimer’s disease. Alzheimer’s disease is not the only cause of dementia and distinguishing it at an early stage can be challenging.
2. The only evidence available is that aducanumab can reduce an abnormal protein called amyloid which accumulates in the brain of a person with Alzheimer’s disease.
3. There is no proof that this reduction of amyloid will improve an individual’s status or slow progression.
4. There are side effects with unknown consequences.
5. The study only included healthy people and excluded people over 85 years old. This Is clearly a very highly selected population relative to the number of people affected by this disease.
6. The FDA is requiring the manufacturer to proceed with a clinical trial that will likely take 9 years.
The AGS recommends:
1. Solid confirmation of the diagnosis. That would ideally include the same testing that was performed in the study,
2. Be informed and ensure your provider talks with you openly about the potential benefits and harms of this drug.
There may be opportunities to enter studies on this medication if you are so moved. There are no guarantees of any benefit from this drug. Be well informed.
Roger Renfrew, M.D., MACP
Skowhegan
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