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Vagus Nerve Stimulation and Depression: Conflict of Interest's "Perfect Storm"?

Vagus Nerve Stimulation and Depression: Conflict of Interest's "Perfect Storm"?

A controversial treatment, an industry-funded article with no financial disclosures, a ghostwriter, a lead author who is editor-in-chief of the journal and who is later hired by the company funding the article, and a lucrative order of 10,000 reprints—these were the potent ingredients of what the New York Times recently termed an "egregious set of events" that involved the journal Neuropsychopharmacology.1

In July 2005, the FDA approved a new type of therapy for treatment-resistant depression: vagus nerve stimulation (VNS). However, the approval process incited controversy because the scientific team that was assigned to review the device rejected its approval unanimously 3 separate times. The reviewers were unimpressed with the efficacy research underlying the device, since the only reported placebo-controlled trial showed no significant difference between active and sham VNS. In each case, however, the director of devices for the FDA overruled the review teams' decision. The ultimate approval of VNS became so controversial within the FDA that the Senate Finance Committee investigated the process and published a highly critical report in
February 2006.2

Given the already controversial background, one might have thought that Neuropsychopharmacology would have been particularly cautious about reporting industry disclosures in a recent review article on VNS.3 The article, which listed 9 coauthors, reviewed the evidence regarding VNS and concluded that it was "a promising and well-tolerated intervention" for treatment-resistant depression; the review made no mention of the FDA controversy.3

After the article was published, The Wall Street Journal broke the story that 8 of the 9 contributing authors were paid consultants for Cyberonics, the maker of VNS.4 This story and other media reports5,6 revealed a series of other embarrassing pieces of information:

  • The lead author, Dr Charles Nemer-off, was also the editor-in-chief of Neuropsychopharmacology.
  • Shortly after the article was published, Nemeroff was hired by Cyberonics to chair its new VNS Therapy Mechanism of Action Advisory Board, the purpose of which is to seek FDA approval for new indications for VNS.7
  • Cyberonics purchased 10,000 reprints of the article from Neuropsychopharmacology.
  • The first draft of the article was not written by any of the authors listed, but was ghostwritten by a medical writer hired by Cyberonics.

When interviewed by newspaper reporters about the lack of disclosure, the journal's publisher (Nature Publishing Group) said that those relationships had, in fact, been disclosed to the journal and that it was the editors who were at fault, rather than the authors. However, since the lead author was also the editor-in-chief, it appeared that the authors could not be fully absolved of responsibility for the error.

Dr Nemeroff responded to reporters' questions by saying that he had "recused" himself from the review process; however, he acknowledged having read the final draft before publication. About a month later, he resigned as editor-in-chief of Neuropsychopharmacology.8

Lessons learned?
This unfortunate controversy drives home the point that the relationship between academic psychiatry and industry has become alarmingly incestuous. When an influential psychiatrist is simultaneously a journal editor, an industry advisory board chairman, and the first author of an industry-funded article published in his own journal, there must be something wrong with the system.

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