Alarming Concerns Raised About New Alzheimer’s Drug Donanemab

A recent investigation published in The BMJ has uncovered critical flaws in the safety and efficacy of donanemab, an Alzheimer’s drug recently approved by the FDA. The probe raises questions about the drug’s approval due to:

1. Increased Mortality Rates: Higher death rates among patients taking donanemab.
2. Absent Safety Records: Incomplete safety data and dubious efficacy claims.
3. Financial Conflicts: Seven of eight FDA advisory panel members received payments from drug manufacturers.

Initial FDA Rejection and Concerns

The FDA initially rejected donanemab in January 2023 due to:

1. High rate of missing data.
2. Questionable long-term safety.
3. Higher treatment discontinuation rates due to adverse events (brain hemorrhage and swelling).

Investigation Findings

1. Three deaths acknowledged by Lilly; two additional deaths discovered by an outside company.
2. Lack of information on health outcomes and causes of deaths.
3. Significant design flaw in trial design.

Financial Ties Among FDA Advisors

1. Seven of eight advisors received direct payments from drug companies.
2. Three had ties to Lilly; two to Roche, Lilly’s development partner.
3. Two advisors held patents on amyloid antibodies.

Misleading Claims

1. Lilly changed primary trial outcome measure.
2. Results failed to show clinically meaningful difference.
3. Company promoted donanemab as slowing decline by 35%, deemed misleading.

Expert Insights

“The failure to formally follow patients who stopped treatment was a significant design flaw.” – Steven Goodman, Stanford University

“That’s a misleading statement… a very tiny absolute difference.” – Alberto J. Espay, University of Cincinnati

Reference

“Donanemab: Conflicts of interest found in FDA committee that approved new Alzheimer’s drug” (BMJ, 2024)

Share Your Thoughts

What do you think about these alarming concerns? Share your insights in the comments below!