Tuesday, April 05, 2011

WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE?

Ghostwriting Charges and Stonewalling at the American Psychiatric Association

The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public letter from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the New York Times. The book was Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see here and here. Soon, these allegations were being dissected in the blogosphere, with stellar contributions from Daniel Carlat, 1boringoldman, Ed Silverman, and Alison Bass.

The APA and its publishing arm, known as American Psychiatric Press, Inc. or APPI, came to the defense of the two prominent academic authors over the ghostwriting charge. In particular, an APA employee named Mark Moran authored a denial of the charge in the January 2011 issue of the APA news magazine, Psychiatric News. As the controversy played out, letters from attorneys demanded retractions, and partial qualifications of the original story appeared in the New York Times and on the POGO weblog. There was never any doubt that the heavy lifting was done by a pair of professional writers employed by a medical communications company under a financial grant from a drug company. Nemeroff defended his role by averring that he ‘scrutinized’ the work product of the professional writers. Threatening letters from lawyers for Nemeroff and Schatzberg were publicized, and the APA weighed in.

The coup de grĂ¢ce was administered by blogger Daniel Carlat’s withering review of the book’s artful construction to highlight the use of the sponsoring company’s antidepressant and anti-anxiety drug in primary care, while muting important information about the drug’s liabilities. Nevertheless, the APA held to its legalistic stance in defense of the ‘authors.’ This behavior is counterproductive for professional medical organizations, as I have discussed before, because it misses the ethical forest for the legal trees.

Now comes the good part. In response to the piece by Mark Moran in Psychiatric News, Leemon McHenry prevailed on Robert Rubin and myself to write with him to the magazine’s editors. Leemon is a faculty member in the Department of Philosophy at California State University, Northridge. He also has experience evaluating legal documents arising in litigation over antidepressant drugs. Robert Rubin has partnered with me in outing several notable ethics compromises involving Nemeroff and Schatzberg, going back as far as 2002, though we always call ourselves equal opportunity critics.

Our letter sent in late January to Dr. Carolyn Robinowitz, the Interim Editor of Psychiatric News, has been posted today on the POGO site. In our letter, we challenged much of Mr. Moran’s defense, and we called attention to what WASN’T in the public domain, despite all the claims and counterclaims. Essentially, the partial qualifications of the original reports that appeared in The New York Times and in the letter to NIH from POGO resulted from the inconclusiveness of some of the documents. We called on the APA to come clean with the release of all relevant materials, in the interest of transparency.

For instance, what WASN’T known were the specifics of the contract involving the corporation, the (ahem) authors, the publisher (APPI), and the medical communications company. Or the money flow to the ‘authors’ from the contract in addition to their royalties. Or the legal release form transferring ownership of the work product to the ‘authors’ and APPI. Or the corporation’s planned marketing activities, given that the corporation ordered 10,000 copies of the book. Or the correspondence among all parties that might reveal who actually did what.

Leemon McHenry’s perspective is that this hidden layer of documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not. Here is the curt reply from the Executive Editor Catherine Brown denying publication of our letter after a delay of almost 8 weeks. Now that’s what I call stonewalling.

8 comments:

Anonymous said...

Of all the people one would think would be most attuned to deception and manipulation you would think it would psychiatrist. The level of denial is astounding and brings into question the whole area of study.

Can the whole science of psychiatry be trusted if it is solely based on commercial interest?

Steve Lucas

Anonymous said...

Your letter will reach a far wider audience on this blog than in the journal.

John M. Nardo MD said...

I'm glad to see you're pursuing this inquiry. Drs. Schatzberg and Nemeroff responded to POGO's revelations with great bluster, then backed off. By moving the focus from what they did to trivial details, they hoped to divert our attention. If there's any clear place to focus our attention on right now in Psychiatry, it's on the invasion of our specialty by the Pharmaceutical Industry, and on the Psychiatrists who have become their willing partners. Ghostwriting, CME infomercials, Speaker's Bureaus, "Institutional Grants," etc. have become far too familiar in Psychiatry, and this pair of highly placed Psychiatrists have lead the pack in their inappropriate and unethical associations with the commercial drug industry. Just because Dr. Schatzberg was recently the APA President is no reason for the APA to stonewall an investigation into his improprieties. POGO's evidence was compelling, but if there's more, we deserve to see it...

Afraid said...

Marvelous work Dr. Carroll, thank you. I agree that you should post more here.

Evelyn Pringle said...

I've got a feeling that this whole issue is going to get a lot bigger long before it goes away. I've been working for months putting a timeline together of all the events of the past 25 years, basically focusing on the time since the new generations of psych drugs came on the market and it all fits together like a giant jig-saw puzzle.

I have to give many thanks to the bloggers on this site as well as Dr Nardo's and others for staying with it all. However, if you keep it up, I fear I shall never get it done. LOL.

Great work people!!

Anonymous said...

Where is Senator Grassely when we need him? A subpoena please?

Anonymous said...

I just want to echo Steve Lucas' comment above: "Can the whole science of psychiatry be trusted if it is solely based on commercial interest?"

This is more than just a rhetorical question.

I received my psychiatric residency training in the early- to mid-2000s in one of the fine institutions directed by these two men. My training was almost exclusively psychopharm-based, and as I think back to my years there, I cannot recall a single faculty member who was NOT affiliated with big pharma (as a clinical trial investigator and/or as a paid speaker).

To make matters worse, I distinctly remember very persuasive lectures (in particular, on Abilify, Geodon, and Cymbalta) given by certain faculty members who-- I later learned-- were paid speakers for BMS, Pfizer, and Lilly (and others). Moreover, the slides I remember seeing in residency are the same slides I've seen in dinner talks ever since.

I don't think it's an exaggeration to say that my residency training was bought & paid for by big pharma. And for their money, they effectively "purchased" a whole generation of graduates from one of the nation's top training programs who are now prescribing their drugs for nearly everything they see. (And who were never encouraged to ask why, or analyze the data, as Dr Nardo is doing so expertly on his blog.)

Had I paid a single penny for my training, I'd be demanding a refund today.

Anonymous said...

Its disturbing isnt it. Take what i say as 'far more knowing' in regards to the effect from this industry and the entire pharming disease spreading profits.
Im where i am today without any one giving a damn because the Psychiatrist and Dr claim to know more about me than i do, not only from reading ghost written for cash documents but also because the 'clinical evidence' being nothing like what i state it is, not excluding 1000s of others out there suffering too.
But instead what do we know? We only take the poison, live in a hell of disorientation and mimicking diseases etc, from a little anxiety we did once have, we are now 'bipolar' or an unknown genetic mental disorder. Its so sadistic and twisted, mental disease is a lie, at least to those being medicated. As for realism the man who is happy to chemically poison/with animal dna/on continuum, dose someone by way of 'help/need/care' is the mental and is indeed with a brain unknown to any other human