CME, Key Opinion Leaders, and Responsibility

Continuing medical education continues to get slammed (1, 2), and somehow the name of Charles Nemeroff keeps finding its way into these incidents. I wrote last week that Nemeroff co-authored a CME piece, on which he failed to disclose a conflict of interest regarding CeNeRx, for whom he co-chairs the scientific advisory board. The conflict of interest that was not disclosed was quite relevant, as the CME article was a cheer piece for MAOI's, and it just so happens that CeNeRx is in the MAOI business.

Daniel Carlat noted that another CME article upon which Nemeroff was an author has been criticized harshly; this one was dissed by one of its own authors. C. Lindsay DeVane, a coauthor, called it "a commercial piece of crap." Let me state this ever-so-clearly: An author called his own article a commercial piece of crap. This should send shivers up and down your spine -- if authors can't even trust the work upon which their name appears, how the hell are physicians supposed to trust it? Taking it a logical step further, how are patients supposed to trust their physicians if M.D.'s are receiving "education" that is "commercial crap."

I should mention that to Nemeroff's credit, on the "crap" article, he discloses an interest in CeNeRx.

What is authorship, anyway? Everyone knows that CME articles are quite often ghostwritten to reflect key marketing points. It's actually fairly comical that a lot (perhaps virtually all?) of the CME litter-ature is written by ghostwriters, and then key opinion leaders such as Nemeroff, DeVane, Keller, et al sign off on them. To be fair, it's not necessarily all that different from clinical trial literature, which is also frequently ghostwritten by industry-friendly writers (1, 2 ).

So we're left with a new definition of "author" on a scientific paper or CME piece:

Author: Someone who stamps his/her name on a paper to lend extra scientific credibility to the marketing of whatever product is discussed most positively in the manuscript. Having read the paper, written the paper, or having anything to do with the paper/study whatsoever is entirely optional.

Time: Some have said that the "authors" of these CME pieces are not to blame because those mean CME outfits send the proofs of the articles to be approved by the authors so quickly that the authors don't have time to review them. That is perhaps the WORST argument I've heard in a while. If that happens to an author once, I can understand...

Perhaps you're a well-meaning scientist who is hoping to provide something of value to educate your colleagues in a CME piece. Great. Then the ghostwriters throw together something that might be described as, um, "a piece of commercial crap," email you the manuscript to approve in 24 hours or else their version stands as the final version. At that point, you have hopefully learned your lesson. If you are repeatedly performing this exercise, lending your name to commercials passing for education, in which your own scientific views are not represented by the CME pieces, then you have nobody to blame but yourself.

Of course, there may be some whose views are accurately represented in CME pieces. Good for them. Have dozens of CME articles under your name, by all means. But, by God, let's not have any more statements like "the article with my name on it does not reflect my own views." I sincerely applaud Dr. DeVane for admitting that the CME article in CNS Spectrums is a joke. Now let's hope that he never finds himself in such a position again. Fool me once, shame on you; fool me twice... The worst forms of CME, which are marketing points covered with a very thin veneer of science, can only exist so long as "key opinion leaders" continue to sign their names on such pieces.

On a final note, I'd like to know if Nemeroff and Preskhorn, the other two authors on the CNS Spectrums piece likewise view the article as "crap" and if they would be willing to disavow themselves of the study. Here's betting they will have not a word to say on the topic.

Also read Pharmalot's great piece on the topic.

Uh-Oh Chuck, What About the Disclosure? OR Go Team MAOI!

Introduction: As longtime readers can surmise from the headline, this post is about Dr. Charles Nemeroff. And the Dalai Lama. Let's start from the beginning. Nemeroff was featured in a CME activity on Medscape. To view it, you'll need to complete a free registration at Medscape. For those new to the wonderful world of CME, note that while CME stands for continuing medical education, it is more accurate to refer to it as commercial medical education -- it's paid advertising, dare I say cheerleading. It is rather disheartening that physicians who wish to keep their licenses must sit through a bunch of advertisements as opposed to less biased, more educational forms of training. For more on CME in general, read my earlier posts here and here, or check out Daniel Carlat's excellent work (1, 2, 3, 4, 5 ).

The Present Story: Nemeroff, in the aforementioned CME activity, discusses the transdermal patch for selegiline, a monoamine oxidase inhibitor (MAOI) and how it may serve as a good treatment option for people with depression. Here are a couple of quotes from Nemeroff:

The limited use of oral monoamine oxidase inhibitors (MAOIs) over the past decade or so has been driven largely by physicians' concerns that they might potentiate hypertensive reactions when they interact with tyramine in foods. A new transdermal system is currently available that enables the MAOI to avoid first-pass metabolism by bypassing the gut, thereby reducing the chance of hypertensive reactions caused by tyramine.

The Pande study, which I believe was done when Pande was at Lilly, compared 20 patients with atypical depression treated with fluoxetine and 20 treated with the nonselective irreversible MAOI, phenelzine. Efficacy was about equal. Certainly other data and my own experience would suggest that MAOIs are superior to SSRIs and TCAs [for atypical depression].

A case that is treated successfully (of course) with transdermal selegiline is discussed during the activity in some depth. All's well that ends well. Clearly, the CME activity backs the use of transdermal selegiline. While it discusses some of the risks associated with MAOI treatment, the program states that the transdermal system avoids many of these issues.

Chuck's Conflicts: Nemeroff lists the following disclosures in the CME activity:

Reunette W. Harris Professor and Chairman, Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia

Disclosure: Grants: AstraZeneca Pharmaceuticals, LP, Bristol-Myers Squibb Company, Forest Laboratories, Janssen Pharmaceutica, National Institute for Mental Health, Pfizer Inc, Wyeth-Ayerst Laboratories, Consultant: Abbott Laboratories, Acadia Pharmaceuticals, Bristol-Myers Squibb Company, Concept Pharmaceuticals, Ltd, Cypress Bioscience, Inc, Cyberonics, Inc, Eli Lilly and Company, Entrepreneur Fund Inc, Forest Laboratories, GlaxoSmithKline, H. Lundbeck A/S, Ingenix i3 DLN, Janssen Pharmaceutica, Otsuka America Pharmaceutical, Inc, Pfizer Inc, Quintiles Transnational Corporation, UCB Pharma, Wyeth-Ayerst Laboratories; Speaker: Abbott Laboratories, GlaxoSmithKline, Janssen Pharmaceutica, Pfizer Inc.; Stockholder—Acadia Pharmaceuticals; Corcept Therapeutics, Inc; Cypress Biosciences; NovaDel Pharma Inc.; Board of Directors: American Psychiatric Institute for Research and Education, NovaDel Pharma Inc, National Foundation for Mental Health

As you can gather, Nemeroff is a busy guy! According to the above, he is a consultant for 18 drug companies and a speaker for four companies. The plot is about to thicken (or, perhaps, sicken) notably...

The Missing Disclosure: Remember how the above CME was all about pushing a newer, safer MAOI drug for depression? Well, it just so happens that Nemeroff is the co-chair of the Scientific Advisory Board for CeNeRx, a company that is developing a (you guessed it) newer, safer MAOI drug for depression! Note that Nemeroff did not mention his position with CeNeRx in his disclosure for the Medscape CME activity. Here's what the CEO of CeNeRx had to say about the MAOI they are testing:

In contrast to other MAO inhibitors, our third generation RIMA series is designed to bind selectively and reversibly, with the goal of significantly reducing the cardiovascular risks and other side effects typically associated with the MAOI class. These safety results, along with the high plasma levels and favorable pharmacokinetics demonstrated in the study, support advancing Tyrima into a multiple dose safety study in late spring.

Note the similarity to what was being said about the MAOI patch in the Medscape CME. Let me put this plainly: Nemeroff stumps for an MAOI in a CME activity, yet does not disclose that he is being paid by a company which also manufactures an MAOI. Can you say "hiding a blatant conflict of interest?"

The Dalai Lama: Nemeroff is appearing with His Holiness the Dalai Lama for a presentation on depression at Emory University. Thankfully, Nemeroff is not scheduled to speak about MAOI's. He is actually scheduled to speak about the relationship between early life experience and depression, about which the research is quite interesting and important. However, given the history of Nemeroff's scientifically questionable behavior (read a summary here, which has links to more detailed stories), it strikes me as strange that he'll be presenting alongside the Dalai Lama.

Golden Goblet: Does this earn Nemeroff a nomination for a Golden Goblet ? I believe so.