An investigation published in The BMJ has raised alarming issues regarding the newly approved Alzheimer's drug, donanemab, by the U.S. Food & Drug Administration (FDA). The report highlights patient fatalities during the trials, significant design flaws in the study, and financial conflicts of interest among panelists involved in its approval. These findings cast doubt on the safety and efficacy of the drug.
Manufactured by Eli Lilly (LLY), donanemab belongs to a new class of anti-amyloid drugs that deliver antibodies targeting beta-amyloid, a protein associated with Alzheimer's disease.
Initially, in January 2023, the FDA rejected the drug's approval, citing a "high rate" of missing data and concerns regarding its long-term safety. Officials pointed to a higher incidence of adverse events, including brain hemorrhage and swelling, which led to more frequent discontinuations of treatment among those receiving donanemab compared to the placebo group.
In response to the FDA's concerns, Eli Lilly engaged an external company to search publicly available records, databases, social media, and traditional media to recover the missing data. This search uncovered two additional deaths in the donanemab group and five deaths in the placebo group.
However, Steven Goodman, a clinical trial design expert at Stanford University, questioned the reliability of this data due to a lack of transparency regarding 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," Goodman noted. He emphasized that the failure to formally follow patients who discontinued treatment was a significant design flaw, especially since some discontinuations were due to adverse drug effects.
The investigation also revealed that seven out of the eight FDA-appointed doctors who reviewed donanemab had received direct payments from pharmaceutical companies. These payments included up to $62,000 for consulting and speaking fees, and research grants amounting to as much as $10.5 million from 2017 to 2023.
As donanemab awaits regulatory approval in the UK, these revelations have raised serious concerns about its potential to gain approval in other jurisdictions.
