Healthy Skepticism Library item: 17442

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: Electronic Source

Silverman E
Grassley Intensifies Probe Into NIH & Stanford
Pharmalot 2008 Aug 1
http://www.pharmalot.com/2008/08/grassley-intensifies-probe-into-nih-stanford/

Full text:

The Senate Finance Committee is intensifying its investigation into research grants and conflicts of interest are managed by the National Institutes of Health and universities, whose academic researchers receive both NIH funding and have ties to drugmakers. Yesterday, though, Stanford University and its psychiatry department chair, Alan Schatzberg, came under special scrutiny – again.
You may recall Schatzberg owns about $6 million in stock in Corcept Therapeutics, which is studying the development of mifepristone for treating psychotic depression. He is also a co-patent holder for the drug and he received an NIH grant to oversee the research. In response to the charges that Schatzberg failed to properly disclose this tangled web, Stanford issued a statement defending Schatzberg by saying, among other things, that all conflicts were properly disclosed.
And as we noted here earlier this week, Stanford insists Schatzberg had no role in dealing with patients or analyzing data in mifepristone research, even though he is listed as a primarly investigator on several grants and papers, and NIH rules maintain a principal investigator is responsible “for the scientific or technical aspects of the grant and for day-to-day management of the project or program.” The NIH told us that it modifies an investigator’s duties, by request, on a case-by-case basis, in order to deal with issues such as conflicts.
However, the Congressional Record from July 31 shows that Chuck Grassley, the ranking Republican on the committee, wants Stanford and the NIH to explain the conundrum. “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?” In other words, Grassley wants the NIH to explain why an exception was made involving such a convulated situation.
Moreover, another focus of this widening inquiry is a conflict involving the university itself, since Stanford has a licensing agreement with Corcept and paid $10,000 in royalties to Schatzberg over the past few years. Grassley wants to know how Stanford can manage Schatzberg’s apparent conflict when it has one of its own, and whether the NIH was notified of the conflicts. Bottom line: we can’t help but wonder if the NIH funding for this research will somehow be jeopardized.
Want to read Grassley’s letters to Stanford and the NIH? Go here and type in ‘Schatzberg.’