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In October 2024 a New York Times investigative report revealed that during clinical trials of two recently approved drugs for Alzheimer’s disease, participants were not told whether their genetic profiles increased their risks of brain injuries.[1] According to the article, in trials of lecanemab (LEQEMBI) and donanemab (KISUNLA), “volunteers first had to sign consent forms that said people with certain genetic profiles faced higher risks of brain injuries from receiving the drugs, and that...
In October 2024 a New York Times investigative report revealed that during clinical trials of two recently approved drugs for Alzheimer’s disease, participants were not told whether their genetic profiles increased their risks of brain injuries.[1] According to the article, in trials of lecanemab (LEQEMBI) and donanemab (KISUNLA), “volunteers first had to sign consent forms that said people with certain genetic profiles faced higher risks of brain injuries from receiving the drugs, and that participants would be tested for them — but not told the results.”
The FDA approved lecanemab in 2023 and donanemab in 2024. Public Citizen’s Health Research Group opposed the approval of both drugs because their modest clinical benefits in temporarily slowing the rate of cognitive decline in patients with Alzheimer’s disease do not outweigh their substantial safety risks. As discussed in previous issues of Worst Pills, Best Pills News, neither drug reverses the brain damage from Alzheimer’s disease; they may slow the rate of cognitive decline for a period, which is usually measured in months.[2],[3]
Both medications carry boxed warnings that monoclonal antibodies directed against aggregated forms of beta-amyloid, including lecanemab and donanemab, can cause amyloid-related imaging abnormalities (ARIA).[4],[5] ARIA are associated with brain swelling and brain bleeding and are more common in people with the genetic profiles that were tested for in the trials. The serious adverse events associated with this class of Alzheimer’s disease drugs include serious intracerebral hemorrhage (bleeding), some cases of which have been fatal.
After the Times article was published, Public Citizen’s Health Research Group called on the Food and Drug Administration and the Office for Human Research Protections to investigate the two trials and the actions of the institutional review boards that approved the secrecy provisions.[6] Under federal regulations, a fundamental protection for subjects is the requirement to obtain informed consent before involving individuals in research. If subjects had known that they were at higher risk of brain injuries, they might have decided not to participate in the trials. Because the results of genetic risk testing are information potential participants would want to know, the revelations about the secrecy provisions in the Alzheimer’s disease trials signify that the principle of informed consent was undermined.
As the Times article noted, “Drug trials are in part designed to illuminate risks, which is why volunteers are routinely informed of potential dangers before joining.”[7] The informed consent failure in the Alzheimer’s disease trials is a wake-up call for clinical investigators and institutional review boards to exercise sound judgment and assure that research subjects are fully informed about their risks.
References
[1] Bogdanich W, Kessler C. What drugmakers did not tell volunteers in Alzheimer’s trials. New York Times. October 23, 2024. https://www.nytimes.com/2024/10/23/health/alzheimers-drug-brain-bleeding.html. Accessed November 4, 2024.
[2] Worst Pills, Best Pills News. Lecanemab for Alzheimer’s disease: do not use. October 2023.
[3] Worst Pills, Best Pills News. Donanemab (Kisunla): a bad choice for Alzheimer’s disease. November 2024.
[4] Prescribing information: Leqembi. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s001lbl.pdf. Accessed November 5, 2024.
[5] Prescribing information: Kisunla. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf. Accessed November 5, 2024.
[6] Public Citizen. Federal officials should investigate conduct of Alzheimer’s disease trials. October 23, 2024. https://www.citizen.org/news/federal-officials-should-investigate-conduct-of-alzheimers-disease-trials/. Accessed November 5, 2024.
[7] Bogdanich W, Kessler C. What drugmakers did not tell volunteers in Alzheimer’s trials. New York Times. October 23, 2024. https://www.nytimes.com/2024/10/23/health/alzheimers-drug-brain-bleeding.html. Accessed November 5, 2024.
