Draft:Eisai's Alzheimers Trial
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According to the Alzheimer Association, 6.9 million Americans will struggle with Alzheimer’s disease in 2024 (“Alzheimer’s Disease Facts and Figures.”). This disease affects more than just the individual. It has an expansive reach touching everyone who knows the person. I like many others learned this lesson firsthand. My grandmother, Freddie, suffered from Alzheimer’s. One day I went to visit her and she no longer knew who I was. She didn’t recognize any of her family. She didn’t know anyone that loved her. The person I knew was gone. No one wants to lose their identity and self-awareness. For this reason when researchers revealed a new experimental drug, BAN2401 (Leqembi), for Alzheimer’s, thousands volunteered to test the drug without realizing that manufactures hid crucial information from them about the risks associated with the drug study.
Alzheimer’s is an insidious disease. Dr. Howard Fillit who is involved in Alzheimer’s research explains that Alzheimer’s deprives you of your humanity: “ ‘[you] can’t dress yourselves. Can’t go to the bathroom. Forget how to walk. Forget how to swallow. They’re like infants in a human body” (7). Researchers have worked for over 25 years, searching for a cure. The focus has been on amyloids. Amyloids are proteins that make plaque in the brain and has been thought to be a primary cause of Alzheimer’s (3). The amyloid research has had consistent side effects of brain injuries. The problem for researchers is that they need volunteers with a specific gene APOE4 because people with this gene are more likely to have Alzheimer’s (12). The issue that arose with regard to the Leqembi study is that the pharmaceutical company, Eisai, did not fully disclose the dangers to the participants.
Eisai ran a drug trial, but did not tell the volunteers that they were personally at high risk for brain injuries. They had them sign consent forms, sharing that a genetic test would be run, but that the results would not be shared with anyone including the participants (12-13). The pharmaceutical company was specifically seeking volunteers that had the genetic profile more likely to suffer from Alzheimer’s, even knowing that this profile also was more likely to have brain bleeds or micro hemorrhaging (12).
During the course of the study, several participants were injured. Genevie Lane died as a result of the drug.She was recruited by a research company targeting residents of The Village, a well-known retirement community in Florida. They held a number of social events and held a discussion about Alzheimer’s (8-9).. Lane had started to realize that she was having mental issues so she signed up for the trial without any understanding of her risk. Lane had the specific gene that made her more genetically prone for Alzheimer’s and also more likely to get micro hemorrhages (14). The action of Eisai created an ethical issue as to whether they have a duty to share the dangers to the participants.
The decision to keep the information from the case members was defended by a neurologist who argued that the decision to share information is case dependent (13). The information is not shared if it is felt that it would negatively impact the study. It is recognized that “ ‘[r]esearchers have an inherent conflict if interest…They want people to be in their study, and there are researchers who feel, if I tell people the full facts and risks, they may not want to be in the study’ “ (12). Essentially, the argument is that the benefits to society and close to seven million people outweighs the individual risks.
However, the purpose of drug trials is to reveal risks regarding the drugs (3). A general rule for volunteers is that they should be informed of potential personal risk (3). In the Eisa trials, the volunteer signed a consent form that shared that people were specific genetic results had more risk of brain injuries and participants would not be told the results (3). The action in these trials was unusual. George Perry, editor of the Journal of Alzheimer’s Disease, called “ ‘the decision not to disclose the genetic results, certainly troubling and ‘ethically fraught’” (3). The failure to disclose relevant information about the safety of the participants is particularly troubling, especially since the risk of amyloid drug trials was well known.The failure to disclose risks to the volunteers was also an unusual act.
The Federal drug administration raised concerns about Amyloid drugs years before (5). It wanted to limit people who could volunteer to those who had only a handful of prior brain bleeds (10). Researchers fought back and talked the FDA into expanding the definition to those who had had at least four prior brain bleeds because they felt it would limit the study too much (10). The overall feeling was that the benefit to society outweigh the risk to the participants even though the drugs did not prevent cognitive decay and did not heal any brain damage (4). The amount of money involved in drug trials should also not be ignored. Billions of dollars is at play with regard to successful implementation of drugs for Alzheimer’s (1).
“Alzheimer’s Disease Facts and Figures.” Alzheimer’s Disease and Dementia, www.alz.org/alzheimers-dementia/facts-figures. Accessed 5 Nov. 2024.
Bogdanich, Walt, and Carson Kessler. “What Drugmakers Did Not Tell Volunteers in Alzheimer’s Trials.” The New York Times, The New York Times, 23 Oct. 2024, www.nytimes.com/2024/10/23/health/alzheimers-drug-brain-bleeding.html.