In 2008, the US Senate Finance Committee charged that Stanford University failed to properly monitor alleged conflicts of interest involving Alan Schatzberg, the former chair of its psychiatry department, who owned a substantive amount of stock in Corcept Therapeutics, which was studying the development of mifepristone, or RU-486, for treating psychiatric depression. Beyond his stock holdings, Schatzberg was also listed as 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.

The allegation was part of a lengthy probe into the wider issue of taxpayer-funded research and undisclosed and unmonitored conflicts involving universities, academic researchers and the pharmaceutical industry. The issue generated significant attention because it reflected growing concern over the extent to which such relationships may influence medical research and, subsequently, medical practice. Since then, numerous schools and the NIH have responded by adopting or planning to issue new rules governing conflicts (see here).

As for Stanford, the prestigious university has studiously maintained that conflicts were disclosed and the affair was handled properly, although there were confusing explanations concerning Schatzberg’s role as principal investigator. In any event, the ensuing publicity surrounding the Senate allegation prompted the university to switch principal investigators for the trial. Schatzberg subsequently defended his role (read here) and Stanford created a special web page about the episode to help defend its handling of the situation (back stories here and here and here).

There was one item missing, though, from the Stanford rundown - the university apparently never disclosed that the National Institute for Mental Health’s Data Safety Monitoring Board wanted the trial “terminated immediately and permanently” in May 2009. The reason? An internal NIMH email says the agency’s DSMB wanted the mifrepristone trial closed due to “multiple reasons, including inadequate recruitment to answer study questions, changes in Stanford’s COI policy (which would have halted the trial July 1, 2009, anyway) and concerns about the ability of staff now working on this study to manage such difficult (psychotically depressed) participants.”

In other words, the Stanford trial team was not only unable to find enough of the right participants, but there were concerns in Washington about patient safety. This was a rather embarassing development, given that Stanford is one of the nation’s premier universities and a regular recipient of federal funding. After all, Stanford had its own DSMB and an Investigational Review Board, both of which had opportunities to presumably reach a conclusion similar to the one issued by the NIMH DSMB.

The ongoing omission from the special web page also contradicts the tone set by Stanford general counsel Debra Zumwalt in a February 2009 letter to the editor of The New York Review of Books in which she defended the university’s handling of the affair by stating that “Stanford’s reviews and management of the potential conflict were extensive and well documented.” By the way, she also noted “the integrity and safety of the research were assured by the Data Safety Management Board at both Stanford and the NIMH.”

Why is this coming up now? The Stanford web page does an admirable job offering a chronology and documents, which offer needed perspective on the matter. But the failure to acknowledge that the NIMH wanted the trial ended for sobering reasons, beyond a conflict of interest, raises a question about the willingness to publicly disclose all pertinent details surrounding taxpayer-funded research. This speaks to a basic bargain - a university gets federal funds to do work, all details about the work should be known. Certainly, important details.

For its part, a Stanford med school spokeswoman writes us this: “In June 2008, we posted selective materials on the web to facilitate communication to the media and the public about Senator Charles Grassley’s inquiries regarding Dr. Alan Schatzberg. These web pages are not - and they were not intended to be - a repository of all documents involving the School of Medicine’s conflict of interest policy and/or Dr. Schatzberg, nor were they intended to hold all communications between Stanford and the federal government regarding this matter. These postings were done as a service to reporters and other interested parties who requested information following the publication of Senator Grassley’s letters to Stanford with questions on this subject.”

As an aside, Schatzberg was reinstated as principal investigator on the NIMH grant on July 23, 2009, shortly after the NIMH DSMB made its decison (which you can read here). Although there is no indication this move was ever announced publicly and, by then, the research no longer included the mifrepristone component.