The recent snafu regarding Eli Lilly's experimental Alzheimer's drug is causing some researchers to take a hard second look at how they communicate with people who sign up for drug trials. Do future participants in Alzheimer's studies need to be told about the new data indicating that patients who took the Lilly drug got worse?
The New York Times' Gina Kolata discussed the issue with a few different ethicists who specialize in clinical trials. "We realize drugs can cause side effects and that sometimes they don't work but we don't think they can make conditions worse," said Dr. John Ennever, a VP with the Western Institutional Review Board, which does ethical reviews on trials. "We are dealing with humans who have hopes and aspirations. The whole idea of research is a difficult concept. We all forget that if we knew the answer we wouldn't be doing the research."
Elan's CSO, Dr. Dale Schenk, works in the field. And he isn't all that worried by the Lilly data. "To be fair, this is the first anti-amyloid drug that has demonstrated a negative effect," Dr. Schenk said. "I'm not worried about the class."
But Baruch Brody, director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine, sees some big concerns. "The companies and, even more so, the institutional review boards need to take this to heart. They need to make sure the consent forms say, ‘You may not benefit and may be harmed.'"
- here's the NYT article