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New Alzheimer’s Drug is Controversial

By Dr. David E. Marcinko MBA CMP®

SPONSOR: http://www.CertifiedMedicalPlanner.org

It seemed too good to be true—on June 7, the FDA approved a breakthrough medication for Alzheimer’s disease. At the time, the drug “could mark a new era in treating the leading cause of dementia and the sixth leading cause of death in the US”, according to some experts.

–OR NOT–

The FDA’s approval of the drug was met with widespread criticism. And the ensuing scandal has undermined the integrity of the agency’s approval process for new treatments.  

Backlash to Aduhelm continued to escalate last week. On Thursday, influential hospitals Cleveland Clinic, NYC’s Mount Sinai Health System, and Providence in Washington State said they wouldn’t administer Aduhelm, citing concerns over its effectiveness and safety. 

Review 

According to Morning Brew, the FDA approving Aduhelm was like you deciding to watch a movie knowing that it had a 47% rating on Rotten Tomatoes. In November 2020, an expert panel advised the FDA against approving the drug after a pair of studies showed conflicting results about its effectiveness. 

Instead the agency fast-tracked it, arguing that the benefits of treating a devastating disease like Alzheimer’s outweigh the risks. An Alzheimer’s drug hadn’t been approved by the FDA in 18 years. 

Some experts who helped the FDA evaluate Aduhelm protested the decision. Harvard Medical School Professor Dr. Aaron Kesselheim, the third member of the 11-person advisory panel to resign in the wake of the FDA’s approval, said it was “probably the worst drug approval decision in recent U.S. history.”

Effectiveness is one concern around Aduhelm. Side effects, which include brain swelling and brain bleeding, are another. The final issue is the price tag: $56,000. That’s a lot, but it could cost even more since patients might have to pay for periodic tests that look for side effects.

A study by the healthcare nonprofit Altarum concluded that by the mid-2020s, Aduhelm would account for more than 1% of all national health spending, and that’s on the low end of projections. 

Looking Ahead … the blowback has been so bad that the acting FDA chief has ordered a federal investigation to explore the perhaps too-cozy relationship between the scientists who approved the drug and the drug-maker, Biogen. 

Still, “once the product is approved, the cat’s out of the bag, the horse is out of the barn,” Johns Hopkins Drug Safety Expert Dr. G. Caleb Alexander told the NYT. More than 600 sites across the US are getting ready to administer Aduhelm, and they’re expecting high demand.

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Approval VERSUS Authorization: https://www.theverge.com/22189236/fda-approval-authorization-difference-clearance-vaccines

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Filed under: Alerts Sign-Up, Drugs and Pharma, Ethics | Tagged: Aaron Kesselheim, Aduhelm, Alzheimer's disease, Biogen, FDA, G. Caleb Alexander | 1 Comment »