Researchers, Executives Accountable for Clinical Trial Violations

摘要

Clinical investigators, officials at research institutions and executives of drug companies may all be personally liable for criminal charges and civil lawsuits arising from ethical failures in clinical trials, a panel of experts said. For example, W. Scott Harkonen, former CEO of InterMune, currently faces felony charges of wire fraud and violating the Federal Food, Drug and Cosmetic Act (FDCA) and could spend up to 23 years in prison in a case involving the selective release of clinical trial results for Actimmune (interferon gamma-lb), Barry Pollack, a criminal defense attorney and partner with Kelley, Drye & Warren, said. InterMune was found to have fraudulently promoted Actimmune for unapproved uses through the selective release of favorable data and paid $37 million to settle felony charges of violating the FDCA, Pollack said (WDL, March 24). He spoke Tuesday at a briefing at the National Press Club sponsored by the RxTrials Institute and the HHS Office of Research Integrity (ORI).