Tuesday, September 4, 2007

Author Calls his own CNS Spectrums Article “Ridiculous, Inaccurate, Simplistic”

C. Lindsay DeVane, a Professor of Psychiatry and an author of an ACCME-accredited article published in the journal CNS Spectrums has termed his article a “piece of commercial crap,” and said he had not read the final version before it was published, according to an e-mail he sent to this writer (read his e-mail here).

DeVane, who is Professor of Psychiatry and Behavioral Sciences and Vice Chair for Research at the Medical University of South Carolina, is one of three authors listed for an “Expert Roundtable Supplement” published with the May 2007 issue of CNS Spectrums. The supplement was accredited and produced by i3 CME, a medical education company owned by Ingenix, and was funded by Bristol-Myers Squibb.

Responding in an e-mail to questions I had about the accuracy of the article (read this e-mail here), Dr. DeVane said that he had originally been approached by Dr. Charles Nemeroff to participate in a videotaped discussion to be held at a psychiatric meeting in Hawaii. The discussion was to be funded by Bristol-Myers Squibb, which recently released the antidepressant patch, EMSAM. DeVane initially declined Dr. Nemeroff’s invitation, saying that he did not want to participate in a “circus debate for the sake of selling CME time.” However, he eventually changed his mind and participated in a discussion of antidepressant drug-drug interactions with Nemeroff and Sheldon Preskorn, another high-profile academician who often consults and speaks for drug companies.

After the broadcast, the CME company, i3 CME, presented DeVane with an article based on the discussion, apparently ghost-written by a medical writer hired by the company. DeVane called this a “ridicuous text… parts of it were inaccurate, simplistic, and [contained] over-generalizations.” It is not clear whether DeVane insisted that editorial changes be made. He had not read the final version, and advised that the article be ignored “for purposes of interpreting my research and views.”

The controversy involves a seemingly arcane topic in psychopharmacology, the issue of how drugs interact with other drugs in the bloodstream. In an earlier article in a different journal, published without pharmaceutical funding, Dr. DeVane had argued that these drug-drug interactions were rarely significant when prescribing antidepressants. According to DeVane’s e-mail, that article “represents my summary of the field and opinions.”

The CNS Spectrums article, however, claims that these interactions are often significant when certain antidepressants are used. The article also points out that EMSAM, the drug made by the article’s sponsor, has the advantage of not sharing these drug interaction liabilities. If DeVane’s earlier statements had been used as the basis for the article, then EMSAM could not have been claimed to have this competitive advantage.

In response to inquiries about the discrepancies in DeVane’s earlier article and the newer article, CNS Spectrums and i3 CME did not comment on specifics, but denied any irregularities regarding the planning or writing of the article. According to their written statement, “the faculty [referring to Nemeroff, Preskorn, and DeVane] remains comfortable with the positions they have taken in this CME activity….”

File article under: Corruption in High Places

10 comments:

Anonymous said...
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Anonymous said...

4 September 2007

Daniel Carlat, MD
Editor-in-Chief
The Carlat Psychiatry Report
42 Pleasant Street
P.O. Box 626
Newburyport MA 01950

Dear Dr. Carlat:

I have read with great fascination your recent criticism of the educational credibility (or lack thereof) of industry-sponsored CME activities, most particularly, CNS Spectrums: "A Piece of Commercial C__p" (Tuesday, August 14, 2007). This was especially interesting in light of author Lindsey DeVane's blanket 10-count of the BMS-sponsored project, in which he, too, referred to the published article as "a piece of commercial crap."

As the original publisher of CNS Spectrums, which we started in 1997 and sold to the present publisher in 2003, I might be able to lend some insight into a specific part of the debate; that is—the relationship between publishers, industry, and the ACCME.

I first asked Charles Nemeroff to write a piece on psychotropic drug/drug interactions for CNS Spectrums 10 years ago, when the subject was more noteworthy than, perhaps, it is today. (Remember the CYP 450 debate...?) After the article was published in the journal, we were approached by a sponsoring company who asked if they could license the piece for their use WITHOUT ANY CHANGES TO THE MATERIAL. Nemeroff consented. We were paid for the license and, thus, paid the authors. Commercial interests aside, it was important to me (as a journalist and editor with many science-related bylines) to first have the article independently published. If the article was subsequently sponsored by industry, we were confident that it would pass scientific scrutiny and we would retain the most important qualification of any publisher: Third party credibility. Thus, it was highly critical that we monitored ourselves very carefully. There was never any question of whether the article needed CME accreditation to validate its independence.

Here's the rub: Publisher's have First Amendment rights to publish, virtually, anything they want. This luxury has given journals the ability to go directly to a given pharma company to produce sponsored, customized projects BEFORE publication—becoming, in effect, a private content supplier for industry.

Industry does not enjoy the publisher's First Amendment protection. Consequently, the medical-legal division of these companies have, universally, adopted the rules and regulations of the ACCME in order for sponsored material to pass FDA muster. Ironically, Pharma may not be solely at fault since the FDA has clearly endorsed ACCME-like standards. (See, attached, Final Guidance on Industry-Supported Scientific and Educational Activities. Federal Register; Vol. 62, No. 232. 64073-64092.)

What we are witnessing is that publishers of advertising-generated publications (in all fairness, you could have included me in that category once) bang the same drum over and over again for the simple reason that it is easy. So, it is not a stretch to believe that you are all sick and tired of this, which your blog seems to confirm. In truth, the CME business has become rotten to the core.

The authors of these industry-sponsored "projects" are not solely to blame. (Though you can blame the editors who should know better...) The galley proofs are thrown at them with such velocity that they have little time for review. The authors are no longer on their own timetable, but that of the sponsor and publisher.

One last thing for the record. DeVane's denial of responsibility for the CNS Spectrums debacle is not altogether fair. I am willing to bet dollars to doughnuts that Nemeroff never saw proofs of the article either. While it might be fashionable to throw barbs at the big-money speakers, guys like Nemeroff have made a significant contribution to the field.


Yours truly,


James M. La Rossa Jr.
Editorial Director & Publisher
MedWorks Media Global, LLC.

Philip Dawdy said...

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