Response to Allegations and Call for Open Discussion of Pharmaceutical Funding

I am writing to address briefly the misperceptions and false statements about my research and ethics that have circulated in various forums. I have posted a more complete response on the Member-to-Member Listserv.

My integrity is important to me, and I have always taken steps to report and avoid any potential conflict throughout my career. Moreover, I have never improperly used my position at Stanford or my involvement with various research studies for my personal gain. I have tried to fairly and honestly report on all my research and subjected all the studies at issue to peer review.

Let me also assure everyone that I did not conceal any pertinent information during the recent APA election process. It was several months after I was recruited to run and the slate was announced that Sen. Charles Grassley first wrote to the president of Stanford University seeking information. Sen. Grassley never contacted me, and to this date has not contacted me, seeking any information or clarification. It was my understanding that Stanford had provided all the requested information and was dealing with the senator to clarify any issues. I did not become aware of any specific concerns until late June of this year, over four months after the APA election results were announced, when the senator publicly questioned Stanford about my disclosures.

The senator's initial contentions were based on some confusion regarding the information we provided. For example, the senator contended that I had not reported payments from Johnson & Johnson, not realizing that my disclosures had specified payments from the company's subsidiary, Janssen.

The senator also alleged that I had failed to report the extent of my holdings in Corcept Therapeutics, a company I co-founded. This allegation was based on reviewing an annual disclosure form that I had correctly filled out but does not provide specificity on stock above $100,000. Other forms, providing more detailed descriptions, were available and were provided once Sen. Grassley raised the issue. In addition, my Corcept stock holdings have been publicly available on financial Web sites for several years.

Over the past 25 years, my colleagues and I have studied psychotic major depression and developed a hypothesis that excessive activity of the hypothalamic-pituitary axis plays a role in the development of psychosis of this often lethal illness. We hypothesized that blocking cortisol activity in the brain could produce relief and, from 1995 to 1997, we studied mifepristone, a progesterone and glucocorticoid receptor antagonist. In accord with the Bayh-Dole Act, Stanford applied for a use patent for the use of mifepristone in psychotic depression, which was issued at the end of 2000. When the university was unable to license the drug to any pharmaceutical companies, my colleagues and I founded a biotech company, Corcept Therapeutics, to develop mifepristone to help treat psychotic depression.

We informed NIMH of a possible conflict of interest on a grant on which I had been the principal investigator and agreed that I would abstain from involvement with the conduct of the mifepristone component of the grant. I am one of the authors on the NIMH-sponsored study that was reported in 2006 because I was instrumental in the study design before the conflict, in obtaining the funding, and in helping to write the paper. Moreover, the results of all of our mifepristone studies have been published in peer-reviewed publications in a totally transparent manner for others to review. Stanford double-blind data are totally independent of Corcept and will not be used for an FDA submission for approval. The plan for dealing with the conflict of interest, including my involvement with Concept Therapeutics, had been agreed to by NIMH and had been audited independently by NIH pursuant to its “Targeted Site Review for Financial Conflict of Interest.” Nonetheless, Stanford and I have agreed that I would temporarily withdraw my involvement in the entire NIMH study given the concern recently raised by Sen. Grassley.

I remain proud of my efforts to develop a new treatment for a lethal disorder that has no approved pharmacological therapy and remain hopeful that this treatment will be effective. Patients, their families, and practitioners may all benefit from a dramatically innovative therapy. That is my goal and one shared by all psychiatrists who treat such patients.

I am also proud of what APA does to defend the rights of psychiatric patients and the professional interests of its members. APA takes pride in allowing all of its members to voice their opinions and is currently addressing the very complex issues regarding pharmaceutical funding. This issue will require all interested parties and all views to be expressed and considered, whether they believe that all funding from the pharmaceutical industry should be banned and the government should fund all research, that such funding is essential to continuing development and research, or that limits need to be imposed on the funding. I share the belief that all voices need to be heard to address these issues, and I look forward to working with you all as your president-elect and next year's president. ▪