Letter to the Editor: Dr. Roberts Responds to Grimaldi’s Column

Dear Editor,

I would like to comment on the front page article in the Saturday 23 April edition of The Paper written by John Grimaldi entitled, “The Truth About Alzheimer’s.” I can’t determine the author’s credentials, but his concern about the “Biden Administration’s Centers for Medicare [CMS]” seeking to limit the availability of aducanamab (Aduhelm) to Medicare beneficiaries is lacking context. It seems he has a political axe to grind rather than providing more details explaining CMS’s decision to limit payment for this biological agent to only patients who are participating in CMS-approved clinical trials designed to assess its clinical benefit.

While the FDA did indeed approve Aduhelm last June, the decision was steeped in significant controversy, not the least of which was that ten out of the eleven neurologists (physicians who care for Alzheimer’s patients) on the FDA advisory panel voted to NOT approve it. Studies conducted by Biogen, the pharmaceutical company that developed Aduhelm, revealed that the monoclonal antibody reduced the presence of amyloid beta protein in the brain. This protein is increased in patients suffering from Alzheimer’s dementia. However, reducing the amount of amyloid beta in the brain has not yet been shown to result in clinical improvement (functioning) of Alzheimer’s patients. This is the critical question that will hopefully be answered by the CMS-approved studies. A biological agent that has an effect on a biomarker but does not result in improving patients’ functioning would not be worth using, particularly with the exorbitant estimated cost of $100,000 per patient per year (Aduhelm cost plus the associated costs of infusing it).

Mr. Grimaldi also failed to mention the significant side effects of Aduhelm that include brain swelling and bleeding that occured in 41% of patients in the high-dose arm of the clinical studies (the dose approved by the FDA). Here are three excellent sources for additional reading, two from the New York Times (nyti.ms/3Ox8Bro and nyti.ms/3OHdyhi) and one from Science Based Medicine (bit.ly/3y2u71g).

Sincerely,

John R. Roberts, MD
Crawfordsville