I have obviously been stirred up by the re-emergence of the story of Dr. Charlie Nemeroff who became Chairman of Psychiatry at Emory several years after I left the Department over 20 years ago:
I blog for a number of reasons, but one of them is to "get things off my chest," and it’s obvious that this had weighed heavily for a long time. Something I’ve learned in writing these posts should’ve been apparent way back when, but it wasn’t. Dr. Nemeroff rode into Emory during a wave of "brain psychology" in Psychiatry that swept away many more "mind psychology" types than just me. What I realize is that the psychoanalysts and psychotherapists of the 50’s, 1960’s , and 70’s had been as imperious as the Nemeroffs that replaced them – occupying the Chairmanships, dominating the government grants, presiding over the American Psychiatric Association, just as the biologists have done for the last thirty years ["bipartisanship" is as elusive in scientific disciplines as it is in Congress]. The pendulum probably needed to swing when it did. So in part, I was caught up in a big paradigm shift that I didn’t recognize at the time. And I didn’t realize that the "mind" people had historically demeaned the "brain" people, and earned some of the wrath that came their way as the pendulum swung the other way.
So what else is there to say more about the controversy surrounding Dr. Nemeroff’s moving to Miami’s Department of Psychiatry? There are, actually, several other things. While the issue on the table is Conflict of Interest [COI], the term doesn’t do justice to what actually happened. It does seem that the case that got Dr. Nemeroff demoted, raking in speaker fees from GlaxoSmithKlein Pharmaceuticals and serving on some of their boards while being a Principle Investigator of a large NIMH grant studying their products, is obviously a COI. But there were cases that more directly spoke to his lack of integrity, though they seems to have escaped as much notoriety.
Dr. Nemeroff is the co-author of a popular textbook, The Textbook of Psychopharmacology [$228.00], with the Chairman of Psychiatry at Stanford, Dr. Alan Schatzberg [the outgoing president of the American Psychiatric Association]. They were jointly autographing the new edition of their book at the recent APA convention in New Orleans earlier this year. Well it seems that they were more than just two Department Chairman who as friends and colleagues authored a textbook together. They are also business associates in a company called Corcept, and they are both also targets of a Congressional Investigation by Senator Chuck Grassley into a Conflict of Interest.
It’s a complex story that involves the drug Mifepristone [RU-486]. If you’ve heard of it, it’s because it’s the "abortion pill," often in the news as the abortion debate has raged on in America. The drug is an antagonist to Progesterone and Glucocorticoids. Corcept was formed by Dr. Schatzberg and a colleague in 1998 with the idea of using it in Psychotic Depression, based on their hypothesis that Cortisol has something to do with that. This became one of the big Conflict of Interest Cases looked at by Senator Grassley, in that Schatzberg did not reveal his involvement with Corcept, yet was the Primary Investigator in an NIMH funded drug trial. The drug has never been introduced and probably never will be [because it doesn’t work]. Meanwhile, Dr. Schatzman made plenty of money on the deal. Here’s the story:
How does that relate to Dr Nemeroff [from the second link]?
Dr. Schatzberg is not the only academic to benefit from Corcept. Dr. Charles Nemeroff, a member of Corcept’s scientific advisory board, also did well. He exercised options to buy 60,000 shares on joining the board in 1998. Dr. Nemeroff diligently promoted Corcept’s drug. Following the style documented for Dr. Schatzberg, Dr. Nemeroff emphasized weak positive trends in the data while suppressing inconvenient negative analyses. In the fall of 2002, Dr. Nemeroff referred to the Stanford-NIH trials as “impressive studies indicating that … [mifepristone]…is very effective in the treatment of psychotic depression.” The claims “impressive” and “very effective” are indefensible, and may even be fraudulent. Dr. Nemeroff’s exaggerated promotion occurred while the company prepared for its IPO, but he did not disclose his financial stake. Right after the 6-month SEC-mandated lockup period expired, Dr. Nemeroff sold 20,000 shares for $137,500. His cost was $6.60. Help me, what is the right term for this behavior?
And then there was this:
After Revelations of Undisclosed Conflicts of Interest, a Journal Editor Steps Down
HealthcareRenewal
by Roy M. Poses, MD
August 30, 2006
In July, we briefly posted about several cases in which articles published in prominent journals were discovered to have been written by authors who had relevant, but undisclosed conflicts of interest. One of those cases we summarized thus:An article was published in Neuropyschopharmacology in July about vagus nerve stimulation as a treatment for depression [Nemeroff CB, Mayberg HS, Krahl SE. VNS therapy in treatment-resistant depression: clinical evidence and neurobiological mechanisms. Neuropsychopharmacology 2006; 31, 1345–1355.] The Wall Street Journal discovered that eight of the article’s nine authors had financial ties to Cyberonics Inc, the manufacturer of the device. The ninth author is an employee of the company, which was disclosed." [See previous post on Cyberonics here.]
In August, Bernard Carroll posted in more detail. He noted that the case involved more than the failure to disclose possible conflicts of interest, but also that one of the authors of the first draft the article was a hired writer, whose role was not fully disclosed; that "the review carefully followed the corporation’s marketing message and branding language"; and that Cyberonics produced a press release touting VNS therapy featuring Nemeroff, but without revealing his financial relationships with the company.Now the Wall Street Journal, and The Scientist reported that Nemeroff, who not only wrote the article in question, but was the Editor of Neuropsychopharmacology, will be stepping down from that role in December, "in part, based on the recent adverse publicity to the journal and the ANCP [American College of Neuropsychopharmacology]."
The Scientist also noted that "This isn’t the first time that Nemeroff has hit the headlines for undisclosed financial ties. In 2003, a review he coauthored in Nature Neuroscience neglected to mention significant financial interests in three therapies that were reviewed favorably [including owning the patent on one of the treatments], prompting the Nature Publishing Group to widen its disclosure policies"…
So there it is. It’s more than just Conflict of Interest, it’s a broad pattern of recommending treatments for disease based on his personal financial interest, without revealing that financial interest, treatments that are either unproven or ineffective, multiple instances even in the face of previous censure. It’s more than just his lightweight research or political hutzfa that accounts for the outrage, it’s something much more sinister.
Physicians, Psychiatrists only have two things to bring to the table – integrity and an old oath [Do no harm]. The first one is sometimes hard, and the second one is impossible to live up to 100% of the time. But to consciously recommend a treatment because you own stock in the company and you don’t yet even know that the treatment is effective, and to do it repeatedly. That seems to me to be a deal-breaker – certainly a deal-breaker for someone in a position of power in charge of training other physicians. In my mind, that is an absolute truth…
Addendum: I said above, "While the issue on the table is Conflict of Interest [COI], the term doesn’t do justice to what actually happened."
A conflict of interest [COI] occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other. A conflict of interest can only exist if a person or testimony is entrusted with some impartiality; a modicum of trust is necessary to create it. The presence of a conflict of interest is independent from the execution of impropriety. Therefore, a conflict of interest can be discovered and voluntarily defused before any corruption occurs. Examples of some occupations where a conflict of interest is most likely to be encountered or discovered include: policeman, lawyer, judge, insurance adjuster, politician, engineer, executive, director of a corporation, medical research scientist, physician, writer, and editor.
So the next step is impropriety? That term seems a too soft as well. Looking over the AMA Principles of Medical Ethics, ethical violation [at best], profiteering, fraud [more like it] are the terms that come to mind…
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