Last month, the US Senate Finance Committee charged that Stanford University failed to properly monitor alleged conflicts of interest involving Alan Schatzberg, who chairs the psychiatry department and owns about $6 million in stock in Corcept Therapeutics, which is studying the development of mifepristone, or RU-486, for treating psychotic depression.

In addition to his stock holdings, Schatzberg is also a co-patent holder for the drug, which is best known for inducing abortion, and he received a grant from the National Institutes of Health 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.

Schatzberg “has not had responsibility for any aspect of the conduct of the grant’s research related to mifespristone. He remains the principal investigator on the original NIMH grant, which has been extended through the years and covers a range of issues involved in the biology of psychotic depression…We would like to underscore that Dr. Schatzberg has not been involved in managing or conducting any human subjects research involving mifepristone, a pharmaceutical that Corcept licenses for the treatment of psychotic major depression.”

In addition, a 2006 paper in Neuropsychopharmacology indicates several NIH grants funded research into mifepristone and depression, but declared Schatzberg “played no direct role in the recruitment, assessment, or follow-up of subjects enrolled in this study. Dr Schatzberg was not directly involved in the analysis of data stemming from this research.”

Yet, the NIH grants policy statement says that a principal investigator “is the individual, designated by the grantee, responsible for the scientific or technical aspects of the grant and for day-to-day management of the project or program.” And the corresponding NIH info for one of the supporting grants, which was noted in the 2006 paper, states that Schatzberg was the principal investigator. Please look here.

We understand that grants can be structured in a complex manner and day-to-day responsiblities can have different meanings in different situations. But Stanford insists Schatzberg had no role in dealing with patients or analyzing data, even though NIH rules maintain a principal investigator has broad and deep responsibilities that would appear to extend to such activities. So how do Stanford and Schatzberg reconcile what appears to be a disconnect?

In response, a Stanford spokesman sent us a statement saying Schatzberg transferred some responsibilities and the NIH approved the move…

“We managed the conflict of interest in a customary manner, and Dr. Schatzberg notified NIH that he had transferred the protocol director responsibilities on Mifepristone research for this grant to another scientist. This was disclosed repeatedly to NIH, and it approved of Stanford’s and Dr. Schatzberg’s handling of this matter. In addition to that approval, an NIH Targeted Site Review on Financial Conflict of Interest was conducted in 2006 of Stanford COI management that included Dr. Schatzberg, and it identified no problems.”

We checked with the NIH and this is what came back from a spokesman: “NIH may consider, on a case by case basis, a grantee institution’s request to modify the PI duties. Grantee institutions may propose such a modification to deal with a conflict of interest, illness, performance issue, or staff departure, for example. Before approving such requests, the NIH must carefully consider the effect of proposed changes on the grant.”

We then asked if, in fact, the NIH took this step regarding Stanford and Schatzberg. We received this statement: “The NIH policy applies to all grantee institutions – each case is unique and we apply the policy accordingly.” The implication is, most likely, yes, but it is not an explicit response, which we again requested. Nor does this explain why the NIH would agree in this instance.

We can guess, however, that the NIH agreed to the changes involving Schatzberg’s grant in an effort to keep the research on track. However, the circumstances in which the research originated harks back to the problem highlighted by Grassley - the ability of the NIH and a university to properly monitor conflicts and grants in order to avoid compromising or hindering research.

For another look at this issue, Health Care Renewal had an interesting post the other day.