The rapid emergency approval of vaccines for COVID-19 put the FDA firmly in the middle of an unexpected political firestorm that had, and continues to have, ramifications for the overall field of science. The COVID-19 pandemic brought misinformation to the general public at a rate perhaps never seen before, leading many to develop a distrust of science and scientists.
Now, a new study from researchers in California shows news coverage of another controversial FDA decision is impacting the public so much that it’s having a negative affect on pharmaceutical trials.
In June 2021, the FDA went against its advisory committee to approve the first Alzheimer’s drug in nearly 20 years. A survey performed in tandem with that decision has found news coverage of the FDA’s decision made the public less willing to volunteer for Alzheimer’s pharmaceutical trials.
The advisory committee did not find aducanumab (brand name Aduhelm) unsafe, but concluded the monoclonal antibody’s ability to decrease brain plaques hadn’t shown an impact on the clinical progression of Alzheimer’s disease. The FDA’s subsequent approval and further disaccord over the drug’s labeling and price captured widespread media attention.
While this situation was playing out in the spring of 2021, University of California, Irvine neuroscientists launched their own study among people aged 50 to 79 who had expressed willingness to take part in drug research.
Two weeks before the FDA’s decision, the UCI team asked survey 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 Institute for Memory Impairments and Neurological Disorders (MIND) sent survey participants a similar questionnaire with a new section about the monoclonal antibody and its approval.
According to the study, published in Journal of Alzheimer’s Disease, the respondents who heard about the FDA decision before the follow up survey were less willing to take part in a drug trial. Conversely, those who learned about the approval from UCI’s follow up survey materials showed no change in their willingness to participate.
UCI Mind Director Joshua Grill says the researchers believe the difference in attitudes could be evidence of the influence of media coverage of science.
“It 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,” said Grill. “Alzheimer’s is the most important medical condition society faces and we need an army of citizen volunteers to participate in drug trials. 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.”
Grill’s point is an interesting one as an unrelated study also from spring 2021 found a changing landscape surrounding Alzheimer’s clinical trials and drug development. In that study—based on data from clinicaltrials.gov, the U.S. National Library of Medicine and 5 years of annual Alzheimer's pipeline reviews—researchers saw a retreat of pharmaceutical companies from Alzheimer's clinical trials, especially early phase human trials. In their place, federal agencies and nonprofit organizations have become the primary drivers of growth and innovation in the Alzheimer’s drug development space.
Jeffrey Cummings, UNLV School of Integrated Health Sciences research professor said that’s one reason why the FDA’s decision regarding aducanumab was so important.
"If pharmaceutical companies do not see a clear path to FDA approval, they will continue not to invest in Alzheimer's," said study author Jeffrey Cummings, UNLV School of Integrated Health Sciences research professor. "If new therapies are approved by regulatory authorities, more sponsors and more funding may be attracted to Alzheimer's research with accelerated innovation.”
The UCI MIND team plans to conduct further research, with emphasis on the diversity of participants in current Alzheimer’s clinical trials.
“It’s crucial for trial participants to reflect the scope of people affected by the disease,” concluded the study authors. “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. We need to understand what barriers to trust may exist and overcome them so our research is inclusive and applicable to everyone.”