11/11/2024
In a Grumpy Old Herbalist video this year I grumped about how the mainstream media, medical media and many researchers were drinking the big pharma Kool-Aid by describing the amyloid-plaque-dissolving drug donanemab (recently approved by the FDA) as a groundbreaking development in the treatment of Alzheimer dementia.
Now it turns out that donanemab is under scrutiny due to concerns about its effectiveness and safety. This recent study published in the British Medical Journal (BMJ) highlights the multiple patient deaths during trials, trial design flaws, absent safety records and the financial ties of panelists who recommended the drug’s approval.
The investigation revealed that seven of the eight doctors appointed by the FDA to review donanemab received direct payments from drug companies. Three had financial ties to Lilly (the developer of donanemab), two had ties to Roche, Lilly’s development partner in creating a new blood test for Alzheimer disease, and two others have patents on amyloid antibodies, and the eighth doctor had research funding from Janssen for another Alzheimer drug.
The BMJ paper also describes how the main (primary) outcome of the donanemab trials was changed during the trial from the widely accepted “clinical dementia rating scale—sum of boxes” (CDR-SB) to Lilly’s own integrated Alzheimer’s disease rating scale (iADRS).
And despite results failing to show a clinically meaningful difference between patients on the drug and placebo, Lilly stated that donanemab slowed progression of Alzheimer’s by 22%. The company has also promoted donanemab as “slowing decline by 35%.”
“That is a misleading statement,” says Alberto J Espay, a neurologist and specialist in clinical epidemiology and healthcare research at the University of Cincinnati. “That’s a relative difference that transforms a very tiny absolute difference into a number that seems impressive.”
For more information see:
https://neurosciencenews.com/donanemab-efficacy-concern-27688/
https://scitechdaily.com/critical-flaws-new-alzheimers-drug-could-actually-be-a-safety-risk/
