Tuesday, September 26, 2006

VNS, Chuck, and Conflicts of Interest

Nemeroff Part 2

Suppose you are the paid chairman of the “Mechanism of Action Advisory Board” for a company that markets a device (vagus nerve stimulation or VNS) which treats depression. Is it ethical to slap your name on a very favorable journal article related to VNS without indicating that you (and several of your coauthors) have a substantial conflict of interest?

How about having a ghostwriter make substantial contributions to the aforementioned paper? And what do you think about making sure that this “scientific review” of VNS overlaps carefully with the marketing used for the device? At this point, I’ll quote directly from Health Care Renewal’s excellent post:

“There is no discernible difference between the corporation's press releases and the text of the review article on these topics. The review did not address the controversy surrounding the FDA approval process. In these respects, the review has the hallmarks of a ghostwritten article. As described by Leemon McHenry, who has written on conflict of interest issues in medicine, "I have ... seen contracts between the pharmaceutical companies and the ghostwriting companies with the plan of production and the budget. What is particularly interesting about these is the fact that it is clear that the company owns the manuscript until it is released to the "authors." The company's legal department reviews the manuscript and releases it at the end of the process. The first draft isn't even reviewed by the "authors." This is all internal until the second draft." It appears very likely that the VNS review was carefully screened by the corporation to ensure that the first draft was "on message" before being released to the "authors" for them to strengthen the hard science surrounding the stealth infomercial.”

Should your allegedly detached and scientific review skirt around any issues about the controversy of the device’s FDA approval for treating depression? To quote the NY Times: “…in the most carefully controlled trial, a group that had the device implanted but not turned on fared nearly as well as the group being stimulated. Critics also pointed out that long-term results indicated that 30 percent of the patients reported worsening depression similar to Ms. Coram’s, creating unanswered questions about potential harm.Yeah, certainly don't mention any controversy!

As the lead author of the study, should you bother to mention that you are the chair of the Advisory Board for the corporation?

Better yet, should you publish this article in the journal where you are editor in chief? To top it off, make sure to be quoted in a press release by the VNS manufacturer, in which you describe how the latest article shows VNS is super-duper wonderful:

"After reviewing all the available data, taken together, it is clear that VNS Therapy is a promising treatment for patients living with TRD. Given the nature of TRD, it is exceptional that the antidepressant effect of VNS Therapy has been shown to improve over time and is sustained long-term for patients with TRD. Results of ongoing clinical and imaging studies will be critical to increasing our understanding of the mechanisms of action that mediate the beneficial effects of VNS Therapy for TRD.”

So, to summarize, a ghostwriter hired by Cyberonics pens a draft of an article (or at least writes quite a bit of an initial working draft) favorable to VNS therapy for depression. Eight academics, including Nemeroff, sign their names to it after perhaps adding some substantive content. The article is then sent to Neuropsychopharmacology, where Nemeroff is editor in chief, resulting in likely disproportionately favorable reviews and a relatively easy publication. In this publication, the financial conflict of interest of Nemeroff and colleagues is not mentioned. To celebrate this great triumph of marketing, er, science, Cyberonics issues a press release discussing how this “peer-reviewed” article provides support for their product. To top it off, Cyberonics reportedly ordered 10,000 reprints of this so-called study. Friendly representatives will be visiting a psychiatrist near you with this ironclad evidence of efficacy!

For more details, read Health Care Renewal’s post on the topic.

Is this a fluke for Dr. Nemeroff, a one-time occurrence. We’ll see…

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