More accusations and revelations about the drug industry’s influence on research are under way. In the June 23 Congressional Record, Sen Grassley said that he has sent letters to almost 2 dozen research universities across the United States asking questions about the COI disclosure forms signed by some of their faculty.
At the same time, he raised questions about Alan Schatzberg, MD, Psychiatric Times’s editorial board member and APA’s president-elect. Grassley contended that there was a “lack of consistency” between what was reported in financial disclosures to Stanford University, where Schatzberg is professor and chair of the department of psychiatry and behavioral sciences, and what the drug companies said he was paid. The discrepancies total about $70,000. Stanford immediately responded that there was no reporting error by Dr Schatzberg. The university said that Schatzberg—contrary to Sen Grassley’s claim—did disclose to the university a $22,000 payment from Johnson & Johnson in 2002. The payment came from Janssen—the wholly owned subsidiary of Johnson & Johnson.
In addition, Sen Grassley claimed that in 2004, Schatzberg reported to Stanford that he received between $10,000 and $50,000 from Eli Lilly, but Eli Lilly’s reports showed $52,000. Stanford responded that Schatzberg disclosed 3 different sources of compensation from Lilly: less than $10,000 for being on the advisory board, $10,000 to $50,000 for consultation, and $10,000 to $50,000 for honoraria; “together, this disclosure fully accounts for the 2004 payments from Lilly.”
Other discrepancies cited by Sen Grassley most likely resulted from differences in record-keeping and fiscal years, Stanford said.
The ranking Republican on the Senate Finance Committee also questioned the thoroughness of Stanford’s COI guidelines.
Stanford responded in a June 25 press statement: “Based on our extensive investigation to date, we believe Schatzberg has fully complied with the University’s rigorous conflict of interest policy.”
As described in the statement, Schatzberg was the original principal investigator on a NIMH grant exploring the biology of psychotic depression in the 1990s. That work led to Stanford’s receiving a patent for certain uses of the drug mifepristone(Drug information on mifepristone) (known as Corlux). When Stanford received the patent, it licensed it to Corcept Therapeutics, a company engaged in developing medications for treating severe psychiatric and metabolic diseases. Mifepristone is in Phase 3 trials for psychotic depression and has received the FDA’s fast-track status. Stanford received a small amount of equity in Corcept under a technology license but later divested the stock in order to adhere to its policy on institutional COI.
Schatzberg, a cofounder of Corcept Therapeutics in 1998, served as a member of its board of directors through 2007, and now chairs its scientific advisory board.
“Before the patent was issued, Dr Schatzberg did not have any financial interest in this drug. Once he was aware he was going to have a financial interest in mifepristone, he disclosed it, and Stanford University managed the conflict of interest,” Stanford responded.
While acknowledging that Schatzberg “appropriately disclosed to Stanford that his [Corcept] stock shares were valued at over $100,000,” Sen Grassley complained that amount did not capture the stock’s true value—some $6 million for the 2,738,749 shares Schatzberg beneficially owned as of January 31. Sen Grassley expressed concern about Stanford’s ability to adequately monitor Schatzberg’s COI with its current disclosure policies and called for a re-examination of them.
Stanford University responded that it was “fully aware” of the extent of Schatzberg’s stake in Corcept Therapeutics and managed the COI to ensure it did not influence the research he was conducting. According to the university, Schatzberg consistently discloses that his ownership of equity in Corcept is in excess of $100,000 (the highest dollar category on the university’s COI form), and that he further disclosed in writing his ownership of the Corcept stock and its actual value during reviews conducted by the Conflict of Interests Committee at the School of Medicine as well as the Institutional Review Board.
Stanford’s statement went on to emphasize that “Schatzberg has not been involved in managing or conducting any human subjects research involving mifepristone” and that “Stanford and Dr Schatzberg disclosed this conflict and the fact that Stanford was managing the conflict to NIH.”
Sen Grassley’s concerns about Schatzberg’s disclosures of drug company payments were also addressed in Stanford’s response.