Controversial Alzheimer’s drug approval sparks surprising impact in US
When the U.S. Food and Drug Administration gave controversial accelerated approval to the first Alzheimer’s drug in nearly 20 years, it had a surprising impact on attitudes about research into the disease. A survey by University of California, Irvine neuroscientists has found news coverage of the FDA’s decision made the public less willing to volunteer for Alzheimer’s pharmaceutical trials.
California [US], December 1 (ANI): When the Food and Medicine Administration granted fast approval to the first Alzheimer’s drug in nearly 20 years, it had an unexpected impact on attitudes toward Alzheimer’s research.
According to a poll conducted by neuroscientists at the University of California, Irvine, news coverage of the FDA’s decision made the public less likely to volunteer for Alzheimer’s pharmacological studies.
The UCI Institute for Memory Impairments and Neurological Disorders, or UCI MIND, conducted the research. The project’s study was published in the Journal of Alzheimer’s Disease.
The UCI team conducted the survey in conjunction with the FDA’s review of aducanumab in spring 2021. The monoclonal antibody decreases brain plaques, a characteristic of Alzheimer’s disease, in patients.
A team of outside experts advised the FDA to reject approval, claiming that aducanumab’s capacity to reduce plaques had not been demonstrated to have an influence on the disease’s clinical course. The agency’s contentious approval, as well as ongoing disagreements over the drug’s labelling and pricing, drew extensive media attention.
The UCI MIND researchers conducted their study on adults aged 50 to 79 who expressed an interest in participating in pharmacological research. Two weeks before the FDA’s decision, UCI MIND asked respondents if they would be interested in participating in a hypothetical four-year research of a plaque-reducing monoclonal antibody and a BACE inhibitor, a plaque-preventing medicine.
UCI MIND sent survey participants a comparable questionnaire with a new component concerning the monoclonal antibody and its approval eight days after the FDA approved aducanumab.
“We found those who had heard about the FDA decision before our follow-up became less willing to take part in a drug trial,” said neurobiology and behaviour graduate student Marina Ritchie, first and corresponding author of the paper. “The people who learned about it from our materials demonstrated absolutely no change in their willingness.”
UCI MIND Director, Professor Joshua Grill said: “This is surprising because it goes against some of our previous data showing people are generally more willing to take part in studies involving approved drugs compared to investigational ones. We believe it could be evidence of the powerful influence of media coverage of science.” Professor Grill is a UCI professor of neurobiology and behaviour and of psychiatry and human behaviour.
The survey’s findings may offer important insights for Alzheimer’s disease researchers. “Alzheimer’s is the most important medical condition society faces and we need an army of citizen volunteers to participate in drug trials,” Professor Grill said. “Anything that diminishes credibility in scientific research impedes our progress. Media coverage has the potential to influence people’s choices. That can hold us back or push us forward.”
The findings also show researchers need to be aware of sample bias. It occurs when people with certain characteristics participate in a study at a higher rate than others without those traits or if some research population segments are not fairly represented. “It’s crucial for trial participants to reflect the scope of people affected by the disease,” Ritchie said. “One thing we don’t know is whether the impact of media attention may be more or less important for particular groups, especially groups underrepresented in research.”
The UCI MIND team plans to conduct further research into the issue, with an emphasis on learning how to better ensure diverse populations are part of Alzheimer’s clinical trials. “We need to understand what barriers to trust may exist and overcome them so our research is inclusive and applicable to everyone,” Professor Grill said. (ANI)