Concerns About Potential Conflicts of Interest, Patient Safety Cited in Shut Down of Stanford Clinical Trial, According to Emails

A National Institutes of Health (NIH) oversight committee voted unanimously in 2009 to shut down a clinical trial run by Stanford University, citing concerns about potential problems with patient safety and conflicts of interest, as well as other issues, according to internal emails acquired by the Project On Government Oversight (POGO).

“It’s heartening to see that the NIH is more seriously scrutinizing conflicts of interest and taking action,” POGO Investigator Paul Thacker said. “When it comes to federal research, patients and the interest of taxpayers need to come first.”

Over the past several years, the NIH has come under increasing pressure to guard against conflicts of interest in taxpayer funded studies; the agency plans to release new guidelines soon.

The clinical trial had been run by Stanford Professor Alan Schatzberg, who had an NIH grant to study mifepristone as a possible treatment for depression. While overseeing this research, Dr. Schatzberg owned millions of shares in Corcept Therapeutics, a company that was attempting to get mifepristone approved by the FDA to treat depression. Stanford later shifted the oversight of the study from Schatzberg to another professor.

According to the emails obtained by POGO, an NIH Data Safety Monitoring Board met in May 2009 and voted unanimously that the clinical trial component of the grant “should be terminated immediately and permanently.” Among other things, the board cited conflicts of interest concerns and potential problems with patient safety. The NIH Board eventually determined that a portion of the study—the portion not involving drugs and patients—would be allowed to continue. The continuation of this portion was allowed to proceed after the NIH Board was satisfied that “the original potential COI [conflict of interest] has been managed by Stanford University,” according to an NIH email.