Healthy Skepticism Library item: 17445

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Stanford Researcher, Accused of Conflicts, Steps Down as NIH Principal Investigator
The Chronicle of Higher Education 2008 Aug 1
http://chronicle.com/article/Stanford-Researcher-Accused/41395/

Full text:

Alan F. Schatzberg, a Stanford University researcher under fire for a possible financial conflict of interest, is stepping down temporarily as principal investigator on his grant from a division of the National Institutes of Health. Notice of the decision, an agreement between the university and the researcher, was sent yesterday by letter and e-mail to that division, the National Institute of Mental Health.

Dr. Schatzberg, a psychiatrist, had drawn the scrutiny of Sen. Charles E. Grassley, the top Republican on the Senate Finance Committee, who during the last year has been investigating possible financial conflicts of interest by scientific researchers.

Senator Grassley had focused on Mr. Schatzberg’s financial connection to Corcept Therapeutics, a drug-development company that the psychiatrist had helped create and in which he had several millions of dollars’ worth of stock. Dr. Schatzberg was leading an NIH-financed investigation of the biology of psychotic depression. The project included studies of the effectiveness of mifepristone – a controversial drug that is used to induce abortions – as an antidepressant.

Senator Grassley sent two letters of inquiry to Stanford this week. In a letter on Thursday, he pointed out that the researcher’s stock holding “could grow dramatically if the results of Dr. Schatzberg’s government-sponsored research find that mifepristone could be used to treat psychotic major depression.”

In its letter to the mental-health institute, the university said that the psychiatrist “appropriately disclosed any potential financial conflict of interest.” Further, the university said, someone else directed research for the portion of the grant that involved the mifepristone trials, “so that [Dr. Schatzberg] was not involved.”

But because Dr. Schatzberg remained listed as principal investigator of the grant, Senator Grassley has asked the university to explain how, if the psychiatrist didn’t play any role in the recruitment, assessment, or follow-up of subjects involved in the mifepristone trials, he could monitor the research as the NIH asks principal investigators to do.

“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, 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,” the letter from Stanford reads. The university will appoint another faculty member with no financial ties to Corcept Therapeutics as interim principal investigator on the grant.

Senator Grassley has also asked Stanford to explain its own financial ties with the drug-development company. The senator, who has given Stanford until August 14 to answer his questions, says the university had licensing agreements with Corcept for mifepristone. -Maria José Viñas