An investigation has uncovered alarming issues including increased mortality rates, absent safety records, dubious efficacy, and financial connections between expert advisors and pharmaceutical companies. It was found that seven out of the eight doctors on the review panel had received payments directly from drug manufacturers.
An investigation published by The BMJ raises concerns about the safety and effectiveness of donanemab, an Alzheimer’s drug recently approved by the US Food & Drug Administration (FDA).
Journalists Jeanne Lenzer and Shannon Brownlee explore concerns not only about its effectiveness and the number of deaths among patients taking the drug, but also about financial ties to drug makers among the “independent” advisory panelists who recommended approval.
Donanemab, developed by Eli Lilly, is the latest in a new class of anti-amyloid drugs that deliver antibodies to target beta-amyloid, a protein believed to cause Alzheimer’s disease.
Initial FDA Rejection and Concerns
In January 2023, the FDA denied approval of donanemab, citing a “high rate” of missing data and questioning the drug’s long-term safety. The agency noted a higher rate of treatment discontinuation due to adverse events (frequently brain hemorrhage and swelling) among patients on donanemab compared with placebo, and an “imbalance” in overall deaths.
Lilly acknowledged three deaths in patients on donanemab, and an outside company it hired to obtain the missing data found two additional deaths among patients in the donanemab arm and five deaths in the placebo arm.
But Steven Goodman, an expert in clinical trial design at Stanford University, says it is not possible to assess the reliability of the new data without more details of the outside company’s methods.
“There was also no information on health outcomes in those patients other than death, nor the causes of the deaths,” he says, adding that the “failure to formally follow patients who stopped treatment was a significant design flaw, particularly when that discontinuation was partly due to adverse drug effects.”
Financial Conflicts Among FDA Advisors
The investigation also reveals 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, two had ties to Roche, Lilly’s development partner in creating a new blood test for Alzheimer’s disease, and two others have patents on amyloid antibodies, and the eighth doctor had research funding from Janssen for another Alzheimer’s drug.
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.
Asked about the extensive financial conflicts among the physician advisors found by The BMJ, the agency stated, “The FDA does not comment on matters related to 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 results failing to show a clinically meaningful difference between patients on the drug and placebo, Lilly stated that donanemab slowed the 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.”
Reference: “Donanemab: Conflicts of interest found in FDA committee that approved new Alzheimer’s drug” by Jeanne Lenzer and Shannon Brownlee, 25 September 2024, BMJ.
DOI: 10.1136/bmj.q2010
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4 Comments
Medicine is corrupted. It operates as a business, with money as the desired outcome, not health. They make money when you are sick, so they never try to prevent illness, in order to get paid to detect and treat disease. And they use animal research to simulate human disease and develop drugs, which is bad science and bad ethics. But it keeps the money coming in for endless research, so they don’t care. It’s about money, not health. And whenever a lifestyle cause of disease is discovered, which people can try for themselves without a prescription, the medical industry suppresses and censors the information, and attacks the discoverer. Medicine is more like politics than science. And like politicians, doctors lie. At least politics is honest about politicians lying. Medicine acts like they have ethics, but they don’t, really, as this article proves.
Warped perspective of medical science. Fact is, for people, enough is never enough. Man is not good. But, if man thought he was in charge his arrogance is husband downfall. Man is not good!
When was the last time a pharmaceutical giant cared about their customers’ safety?
Their business model is: rush the medicine to the market, reap earnings in billions, get sued for causing harm, pay fines in millions, pocket the difference, move on.
Not even the billion dollar fines have managed to deter the Big Pharma from nefarious practices. Their revenue is just so insanely big, it pays off to just pay the fine and go back to business as usual.