Psychiatry Prof. and Department Chair Alan Schatzberg has stepped down from his position as principal investigator on a federal research grant, following what has now been six months of Congressional scrutiny regarding the professors financial ties to the drug industry.
The move deemed temporary by Stanford officials comes after half a year of communications between the University and Sen. Chuck Grassley (R-IA), who has been unearthing details of Schatzbergs financial relationship with Corcept Therapeutics, a public company specializing in depression treatment. Schatzberg co-founded Corcept in 1998 and now owns more than $6 million in the companys stock.
Schatzberg, who is also the president-elect of the American Psychiatric Association, served as principal investigator of research that was being funded by a grant from the National Institutes of Health (NIH). The research centered on the biology of psychotic depression involved the drug mifepristone, which has been used since 1988 to induce abortions but has recently been tested by Corcept as an anti-depressant.
In a July 31 letter from Grassley to University President John Hennessy, Grassley noted a potential conflict of interest between the professors research on mifepristone and his equity in Corcept.
This equity could grow dramatically if the results of Dr. Schatzbergs government-sponsored research find that mifepristone could be used to treat psychotic major depression, the Iowa senator wrote.
In a July 31 letter from the University to the National Institute of Mental Health (NIMH), Stanford General Counsel Debra Zumwalt stressed that appropriate steps were taken to prevent bias or actual conflict of interest. Zumwalt noted that other faculty members, who had no financial interest in the results of the research, assumed responsibility for the mifepristone trials.
Michelle Brandt, senior media relations manager of the School of Medicine, said in an email to The Weekly that Medical School Prof. Charles DeBattista oversaw the initial mifepristone trials in place of Schatzberg, followed by several other doctors.
Dr. Schatzberg did not select or screen the participants, treat the participants or consult on the treatment they received, collect the data from the participants visits or analyze the data, Brandt said. It would not have been appropriate for him to do so.
Still, Grassley noted in his letter to Hennessy that, according to NIH grant policy, the primary investigator of an NIH grant is responsible for scientific or technical aspects, as well as day-to-day management of the project.
So, the question arises: How could Dr. Schatzberg monitor the research funded with his NIH grants if he was not involved closely in the study? Grassley asked.
Grassley also pointed to several other NIH-funded mifepristone trials listed on Stanfords Web site and ClinicalTrials.gov next to Schatzbergs name. In response, Stanford Vice Provost and Dean of Research Ann Arvin explained in a July 31 letter to Grassley the progression of doctors who assumed responsibility for the mifepristone trials, and she told the senator that Schatzberg will step down from his role as principal investigator.
Despite our belief that Stanford, NIMH and Dr. Schatzberg have handled this grant in accordance with the regulations and applicable policies and with due regard for the integrity of the research, Arvin wrote, we can see how having Dr. Schatzberg continue as the principal investigator on the grant can create an appearance of conflict of interest.
And we want to eliminate that concern, Zumwalt added to the same statement in her letter to the NIMH.
According to Brandt, School f Medicine Prof. Fredric Kraemer will temporarily replace Schatzberg as principal investigator on the grant.
In Grassleys most recent letter to Stanford officials, the senator also probed the Universitys financial ties to Corcept. Claiming Stanford may have a conflict of interest similar to Schatzbergs, Grassley has given the University until today (Aug. 14) to officially respond.