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.
The study was conducted by the UCI Institute for Memory Impairments and Neurological Disorders, known as UCI MIND. It appears in the Journal of Alzheimer’s Disease.
The UCI team performed the survey in tandem with the FDA’s spring 2021 consideration of aducanumab. The monoclonal antibody reduces brain plaques, an Alzheimer’s hallmark, in people with the condition. A panel of outside experts advised the FDA against approval, saying aducanumab’s ability to decrease plaques hadn’t shown an impact on the disease’s clinical progression. The agency’s controversial go-ahead and further disaccord over the drug’s labeling and price captured widespread media attention.
The UCI MIND researchers conducted their study among people aged 50 to 79 who had expressed willingness to take part in drug research. Two weeks before the FDA’s decision, UCI MIND asked respondents if they would be interested in enrolling in a hypothetical four-year study of a plaque-reducing monoclonal antibody and a plaque-preventing drug known as a BACE inhibitor. Eight days after the FDA gave aducanumab the green light, UCI MIND sent survey participants a similar questionnaire with a new section about the monoclonal antibody and its approval.
“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 & behavior graduate student Marina Ritchie, corresponding author of the paper. “The people who learned about it from our materials demonstrated absolutely no change in their willingness.”
