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Jan 13, 2011

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Bernard Carroll

Dr. Nardo’s comment is on target.

Stanford’s dancing around legalistic nuances regarding conflict of interest and transparency succeeds in obfuscating the low quality of the science. The tragedy of the mifepristone hypothesis for psychotic depression is that we still don’t have an answer. Why? Because the clinical trials were so poorly designed and executed, both at Stanford and at Corcept Therapeutics, the company Dr. Schatzberg founded. The drug might very well be effective, which would be a service for some of psychiatry’s sickest patients, but the track record of these people suggests that someone else will have to do the definitive study.

But in the meantime, these Stanford-associated people have a lock on the drug for use in depression. Stanford actually owns the use patent, which they licensed to Corcept. So, the definitive study may never be done. That is not the way clinical science is supposed to work at academic institutions with taxpayer funding through NIMH.

John M. Nardo MD

Why wouldn’t Stanford publicly disclose this? If there were potential concerns about patient safety in the clinical trial... In an email to POGO, Ms. Zumwalt denied that Stanford did anything wrong in not publicly disclosing the information contained in the NIMH DSMB emails.

We didn't do "anything wrong" has been a standard refrain in the defense of the conflict of interest epidemic in academic psychiatry. For starters, for a Principle Investigator of a government funded study to hold a patent on the drug being studied and own shares valued at six million dollars in the company applying to get it approved by the FDA is certainly not something right. Nor is Stanford's web site's page leaving out the fact that the NIMH DSMB recommended that the study be immediately terminated on other grounds [inadequate recruitment to answer the research question and insufficient staff to manage the subjects], particularly when Stanford had touted the NIMH DSMB review in their own defense.

So in this study, the PI had a symphonic Conflict of Interest, the study was badly designed to answer the question asked, and the staff allocated was not capable of managing the impaired subjects being studied. Stanford's response [web site] documented the tit-for-tat with congressional investigators, but failed to post the substantive criticism of the study itself. Unmentioned is the fact that Stanford's own oversight system failed to detect any of these obvious black holes in the study.

This blog post gets to the heart of the current complaints about deterioration of the time-honored scientific method in medical research. The method requires doing a lot of "things right", not limp excuses that "we didn't do anything wrong". Scientific research holds us to a different standard than our everyday criminal law. The onus is on the scientist to prove innocence up front by full disclosure and pristine adherence to the rigors of the scientific method. A Conflict of Interest automatically places one in the category of "guilty until proven innocent," and in this case, neither Schatzberg nor Stanford has come close to doing that, and both are guilty of sanitizing their disclosures. Receiving generous government funding to pursue medical research is a privilege and an honor, not a right - even for Stanford.

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