Summary: The FDA-approved Alzheimer’s medicine donanemab is under scrutiny due to concerns about its effectiveness and safety, according to an inspection. The study identifies numerous patient deaths reported during investigations, design defects, and participants ‘ financial ties to the drug’s approval.
Reviewers question the data used to analyze donanemab, pointing to a false representation of the medication’s impact on Alzheimer’s development. Moreover, the record calls attention to unknown financial issues among the FDA-appointed experts.
Important Information:
- Donanemab has been linked to adverse side effects and individual deaths during testing.
- Financial disagreements were discovered between FDA reviewers and their staff members.
- Utilizing equivalent differences, claims of success may have been exaggerated.
Origin: BMJ
The safety and effectiveness of donanemab – an Alzheimer’s drug recently approved by the US Food &, Drug Administration ( FDA ) – is called into question in an investigation published by , The BMJ , today.
Reporters Jeanne Lenzer and Shannon Brownlee raise questions about the drug’s potency and how many people die when taking it, as well as about the economic ties to the “independent” expert panellists who gave the recommendation for approval.
Donanemab, developed by Eli Lilly, is the latest in a new class of anti-amyloid medicines that deliver antibodies to target experimental amyloid, a proteins believed to cause Alzheimer’s disease.
In January 2023, the FDA denied acceptance of donanemab, citing a “high level” of missing information and questioning the product’s long term health. The organization noted a higher rate of treatment discontinuation due to adverse events ( frequently brain hemorrhage and swelling ) among donanemab patients as opposed to placebo, as well as an “imbalance” in overall deaths.
Lilly acknowledged three donanemab deaths in people, and an outside firm it hired to obtain the missing information discovered two more deaths in the donanemab shoulder and five deaths in the sham arm.  ,
However, according to Steven Goodman, a Stanford University professional on clinical trial design, it is impossible to determine the accuracy of the new data without providing more information about the methods employed by the outside company.
According to him,” There was also no information on health outcomes in those patients who stopped care, nor the causes of the deaths,” adding that the “failure to formally adopt patients who stopped therapy was a major style weakness, especially when that discontinuation was partially due to adverse drug effects.”
Additionally, according to the research, seven of the eight doctors who were hired by the FDA to examine donanemab received clear obligations from drug companies.  ,
Three had economic relations to Lilly, two had ties to Roche, Lilly’s development companion in creating a new blood test for Alzheimer’s disease, and two some have patents on amyloid antibodies, and the seventh doctor had research funding from Janssen for another Alzheimer’s medication.  ,
Using the public database OpenPayments, members ‘ CVs, disclosures in published articles, and the Google patent ownership database, The BMJ found that individual advisers received up to$ 62 000 ( £47 000, €56 000 ) for consulting and speaking fees and up to$ 10.5m in research grants from 2017 through 2023.
The BMJ inquired about the extensive financial conflicts among the physician advisors, stating that” The FDA does not comment on matters involving individual members of an advisory committee.”
Lenzer and Brownlee also describe 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 the results showing no clinically significant difference between the drug’s and placebo patients, Lilly claimed that donanemab reduced Alzheimer’s progression by 22 %. Donanemab is also being promoted as” slowing decline by 35 %” by the company.
Alberto J. Espay, a neurologist and expert in clinical epidemiology and healthcare research at the University of Cincinnati, calls that a “misleading statement.” That’s a relative difference that turns a tiny absolute difference into a figure that seems impressive, according to the statement.
About this Alzheimer’s disease and Donanemab research news
Author: BMJ Group Media Relations
Origin: BMJ
Contact: BMJ Group Media Relations – BMJ
Image: The image is credited to Neuroscience News
Original Research: The findings will appear in BMJ
