Friday, November 03, 2006

More on the Nemeroff Saga

Well, well, well. Another chapter in the Nemeroff saga is upon us. A brief but fabulous article in Clinical Psychiatry News (CPN) provides an excellent summary. You really should follow the link here after you read the current post. Let’s start with some background…

In July 2006, the journal Neuropsychopharmacology published an article ostensibly focusing on the purported mechanism of action for vagus nerve stimulation therapy (VNS) for treatment resistant depression. To summarize, Nemeroff was lead author of the review article (which was at least partially ghostwritten), editor of the journal in which it appeared, and a paid consultant to Cyberonics, the manufacturer of the VNS device. To top it off, all of the co-authors were also paid consultants to Cyberonics. It is tough to match that for conflicts of interest! The article contained a disclosure of funding from Cyberonics to write the article, but nothing was written indicating that all authors were paid consultants to the company.

On July 7, not wasting much time, Cyberonics issued a press release extolling the aforementioned review article as proof that VNS is a most excellent treatment for depression. Of course, Cyberonics did not bother to mention that the authors of this allegedly scientific review were all on the Cyberonics payroll! Nor did the press release (or the original article) mention that much of the article was drafted by a ghostwriter hired by Cyberonics. To ice the cake, Nemeroff is featured praising VNS in the press release. See my earlier post here for a longer rant and a few more details.

Cyberonics ordered 10,000 reprints of the Neuropsychopharmacology article. Mind you, this article was (quoting from the CPN editorial) “viewed as an infomercial because it followed the Cyberonics public relations message and branding language on the modest efficacy of VNS therapy. No mention was made of the controversy surrounding the Food and Drug Administration's approval of VNS therapy or the Senate Finance Committee's scathing report on the approval.”

Modest efficacy, you wonder? 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.” Nemeroff et al’s review was much more positive, stating that: “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.”

So, to the aftermath we go, from the CPN piece. Drs. Bernard Carroll and Robert Rubin “sent the ACNP Council a notification of these problems on July 11, 4 days after the Cyberonics press release appeared. When, after almost a week, we got no response, we shared the information with several journalists.” What did the ACNP do in response?

“In response to the widening controversy, ACNP began damage control. Initially, ACNP proposed simply to publish a corrigendum in a future issue of the journal. In response to member feedback, ACNP then acted on the urgent need to correct the 10,000 reprints.

On July 25, the executive committee (ACNP president, past-president, and president-elect) issued a statement to members aimed at casting the events in the least unfavorable light. Their conclusion? The use of a professional writer did not amount to “ghostwriting” in this case [Hmmm -- I'm not sure in WHICH case one would find a verdict of ghostwriting according to ACNP]. No one was held accountable.

The executive committee's statement avoided any criticism of Cyberonics (which is a supporting corporation of ACNP) [Hey, someone has to pay the bills!], and Dr. Nemeroff repeatedly dismissed the problem as “a simple oversight.” [If this is an oversight, there is a disturbing trend of oversight on Nemeroff’s part, as can be seen here]

“A second wave of negative feedback from members to ACNP Council came after the executive committee's statement. Also on July 25, the New York Times cited the Cyberonics case as exemplary of how corporations use academic experts to push their products.

By Aug. 3, ACNP President Kenneth Davis issued a second communication to the membership, very different in tone from the initial executive committee statement. This message intimated that individuals would indeed be held accountable. The next day, an unflattering news item appeared in Science.

By Aug. 25, ACNP announced to members that Dr. Nemeroff was resigning his editorial position. At press time, a search for a new editor was in progress.”


“Omnibus disclosure forms, which the authors said they had sent to the journal for the editors to review, often serve to obfuscate the compromised status of authors vis-à-vis specific publications. In the case of the Cyberonics-funded VNS therapy review, the only relevant disclosure that by ACNP policy should have been included in the article for readers to see was the paid Cyberonics-consultant status of the academic authors, not their many relationships with other corporations. All eight have been members of the Cyberonics Mechanism of Action Advisory Board since 2003.

When the leaders of professional societies lose their ethical compass, individual members can exert moral suasion by speaking out.

Physicians associated with professional journals should insist that articles featuring such marketing tactics be routinely rejected. Stanford University's School of Medicine has led the way by announcing a ban on faculty members placing their names on ghostwritten articles.” [Great idea, but I wonder if they will just a) not acknowledge that their articles are ghostwritten or b) take the position that having someone else write your articles is not ghostwriting, such as the ACNP]

My View: It’s nice to see someone blowing the whistle in a widely read trade publication! Their speaking out did appear to help chase Nemeroff from his editorial position and really helped to bring a spotlight to a situation that desperately called for public notice. Indeed, I find these stories highly motivational -- vigilance can indeed yield results!

One point that bears emphasis is that the omnibus conflict of interest statements serve to better cover up relevant conflicts of interest than to clarify them. Reading many psychiatry journal articles, one sees that an author will acknowledge research funding from six companies, unrestricted grants from two or three, paid speaker status for five, and so forth. What is relevant is who paid for this particular article. I want to know if the authors were funded to conduct this study by the drug or device manufacturer, not whether the authors spoke to a group of physicians about some other product made by a different company. I’d also like to know if the authors serve on an advisory board for the company whose product they are pimping.

I agree that journals should toss out ghostwritten infomercial articles. One does not have to look far in many psychiatry journals to see junk “review” or “mechanism of action” articles that are clearly nothing more than infomercials. It’s predictable. If a new product is coming out or an existing product is trying to expand into a new indication, watch for so-called scientific journals (and especially journal supplements) to be flooded with cheap toilet paper-quality articles talking about how this treatment will help to improve outcomes for an undertreated or treatment resistant population. Given how few actual advances have been made in treating psychiatric conditions in the past few decades, readers are well advised to wait until sufficient data have been collected prior to showing anything other that skepticism toward these corporate propaganda pieces, er, review/theoretical mechanism of action articles. Carroll and Rubin are absolutely correct to call for journals to not publish them, yet they bring in revenue as either supplement fodder (as we know, supplements are generally funded by drug or device companies), or they are purchased en masse as reprints ($$$ for the journal publisher) so I am afraid that their suggestion will not be taken seriously. Another post on that topic to come sometime in the near future...

1 comment:

Anonymous said...

You are frequently critical of Nemeroff. Not sure yet if you're being fair or not, but regardless thought you may be interested in this article. Your thoughts?