Journalists question the safety and effectiveness of the new Alzheimer's drug

A report published on Wednesday in The BMJ questioned the safety and effectiveness of the Alzheimer's drug Kisunla (donanemab).

Jeanne Lenzer and Shannon Brownlee, independent journalists who published the report, raised concerns about deaths among people taking the drug as well as the financial ties of the drugmakers on the panel that approved the drug.

The anti-amyloid drug developed by Eli Lilly delivers antibodies against the protein thought to cause Alzheimer's disease.

The Food and Drug Administration denied drug approval in January 2023, citing a lack of data and safety concerns. The agency found a higher rate of treatment discontinuations due to adverse events such as brain bleeding and swelling in patients taking the drug compared to placebo. There is an imbalance in the total number of deaths, the FDA said. Specifically, 2.7% of people died in the group that took donanemab and 1.4% in the placebo group. The drug was later approved in July this year.

After the FDA's denial, Lilly admitted that there were three deaths in patients taking donanemab and then hired an outside company to search public records and databases to find the missing data. That information included two additional deaths among those taking donanemab and five deaths among those taking placebo, reducing the imbalance, according to the FDA.

In the new report, Steven Goodman, an expert in clinical trial design at Stanford University, said scientists cannot assess the reliability of the new data without more details about the outside company's methods. Lilly declined to name the outside party, the authors noted.

“Furthermore, there was no information on the health outcomes of these patients other than death, nor on the causes of death,” he says, adding that “the failure to formally follow patients who discontinued treatment represented a significant design flaw , particularly if this termination occurred partly due to adverse drug reactions.”

Seven of the eight doctors hired by the FDA to review donanemab received direct payments from drug companies, the authors said. Three of them had financial ties to Lilly and two had ties to Roche (Lilly's development partner in developing a blood test for Alzheimer's disease). In addition, two others have patents on amyloid antibodies, and the eighth doctor received research funding from Janssen for another Alzheimer's drug.

Lilly said donanemab slowed the progression of Alzheimer's disease by 22%, but touted that it slowed the progression by 35%.

“This is a misleading statement,” Alberto J. Espay, a neurologist and specialist in clinical epidemiology and health research at the University of Cincinnati, was quoted as saying BMJ Report. “This is a relative difference that converts a very small absolute difference into a number that seems impressive.”