A University of Cincinnati researcher lured into town by a million-dollar private grant is under scrutiny by university and federal officials, dogged by charges that he failed to disclose a lucrative financial relationship with a medical device manufacturer. As a result of the controversy the researcher, Dr. Randall Wolf, has stepped down from his post as principal investigator of the heart device research program.
Dr. Wolf says that a recent FDA warning was triggered by confusion over two research projects, both which involved a procedure Wolf invented using a device created by manufacturer AtriCure. Wolf and his colleagues initiated one of the studies, which looked at how patients did after they received Wolf's procedure, while the other was a clinical trial sponsored directly by AtriCure. Wolf has substantial ties to AtriCure, which pays him royalties of $200,000 per year, plus providing him with stock options and monthly consulting fees. The FDA warning contends that Wolf failed to adequately disclose these ties during his retrospective study of patient outcomes.
OK, let me get this straight. So it's fine to have a researcher with stock in the company conduct a clinical trial of that company's device, but not to look into outcomes for patients he treated? Isn't something wrong with this picture?
Get more information on the conflict-of-interest issue:
- read this article from The Cincinnati Enquirer