Major medical centers reject Aduhelm (aducanumab)

Crushed · July 2021

from today's new York Times

Cleveland Clinic and Mount Sinai Won’t Administer Aduhelm to Patients

The rejection of the new Alzheimer’s drug by the two major medical centers is one of the starkest signs of concern over its approval by the F.D.A.

In a striking reflection of concern over the approval of the controversial new Alzheimer’s drug Aduhelm, two major American health systems have decided that they will not administer it to patients.

The Cleveland Clinic, one of the largest and most respected medical centers in the country, said in a statement that a panel of its experts had “reviewed all available scientific evidence on this medication,” which is also called aducanumab.

“Based on the current data regarding its safety and efficacy, we have decided not to carry aducanumab at this time,” the statement said.

A spokeswoman for the clinic said that individual physicians there could prescribe Aduhelm to patients, but those patients would have to go elsewhere to receive the drug, which is administered as a monthly intravenous infusion.

Mount Sinai’s Health System in New York City has also decided not to administer Aduhelm, said Dr. Sam Gandy, director of the Mount Sinai Center for Cognitive Health.

Quilting brings calm · July 2021

Saw an article in our local paper that Medicare is only covering this drug on a case by case basis while they review it. Personally, I don’t want that drug anywhere near me or my LOs. My Mom is too far gone for it and has had a previous brain injury with swelling.

loveskitties · July 2021

Crushed,

Thank you so much for posting this. I was unaware of any issues.

As a result of your post, I went on the web to find out just what the problem was, and boy was it a shocker. In one major news feed it stated that there was major concern that the "fix was in" between top FDA official and drug developer, and that members of the FDA panel had resigned due to their issues with the approval.

Even FDA approval, does not mean a drug is safe for our LO, or ourselves for that matter.

Crushed · July 2021

My field is science based safety regulation. There is no "corruption" in the financial sense. What there was was a clash of world views, just like the TITANIC not having enough lifeboats.

The approval was based on "well we don't have anything for Alzheimer's and this MIGHT repeat MIGHT be something so lets give it a shot"

Very narrow silo thinking without regard to the special problems of Alzheimer's. We don't have either good biomarkers or good symptomatic tests. The uncertainties in the measurements DWARF the purported benefit. But they bright lined the purported benefit WHICH MAY NOT EXIST. Think of a benefit of 8 units plus or minus 10

In 1977 was offered the job at FDA of working on developing the Science Court which was supposed to answer such questions in a formal way. They never developed it. Instead they use expert advisory panels. but in this case they absolutely ignored the experts.