Today's New York Times includes an article entitled "What Drugmakers Did Not Tell Volunteers in Alzheimer’s Trials" (LINK) and it's a long and disappointing article to read. Most of the article focuses on trials for biological medicines marketed by Eli Lilly and Eisai. Biogen, Novartis and Amgen are also mentioned. These drugs target beta amyloid protein using monoclonal antibodies. There are numerous areas of concern noted.
Ethical concerns were raised that certain patients were not informed that they might be at higher risk of significant side effects, namely brain injury. These patients carry copies of a gene know as APOE4.
Patients in the Eisai and Lilly trials were given genetic tests and the results were not shared with them during the trial. Those whose genetics put them at higher risk for having brain injury were not informed of this added risk.
Eisai did not provide a response to the authors of the article and cancelled an interview.
The currently approved drugs, Leqembi and Kisunla, do not stop cognitive decline.
The European Union and Australia have not approved Leqembi.
With the participation of the Alzheimer's Association, an advocacy group that accepts industry funding, a group of researchers with close ties to drugmakers, played down the severity of the brain injuries, by renaming them under a term called ARIA, instead of by calling them micro-hemorrhages or vasogenic edema.
Over 90% of drug trials are reviewed by only two institutional review boards, both owned by private-equity firms. The authors suggest that this compromises safety.
While the chief scientific representative of the Alzheimer's Association sees these treatments as "transformational," experts raised concerned that brain injuries associated with these new treatments will increase.
Companies like Eisai state "We give our first thought to patients, their families, and caregivers." The New York Times article suggests that there's more to it than that.
Comments