The ethics of Alzheimer's trials: more to the story
Companies, academics, advocates push back on claims they should have disclosed genotype to Alzheimer's trial participants
New York Times reporters have trained a retrospectroscope onto Alzheimer’s disease trials and concluded that drug companies and academic researchers, enabled by a commercial institutional review board, unethically withheld important information from trial participants.
The Times article asserted that Eisai Co. Ltd. (Tokyo:4523) and Eli Lilly and Co. (NYSE:LLY), along with some of the world’s leading Alzheimer’s investigators, should have disclosed the results of APOE4 genotype testing to clinical trial participants. The article implies that the companies held onto the information to prevent patients from learning they were at an increased risk of brain swelling and bleeding, commonly referred to as amyloid-related imaging abnormalities (ARIA) based on how they are measured. That knowledge may have led some patients to decline to participate in trials. ...