The past month has seen exposés of authors who failed to disclose financial interests in JAMA and in Neuropsychopharmacology, the official journal of the American College of Neuropsychopharmacology (ACNP). As noted today by Catherine DeAngelis, editor of JAMA, the press gave wide exposure to these incidents. The specifics of the ACNP incident went well beyond a procedural failure to disclose. The publication in question was a major review of a new treatment for refractory depression, known as vagus nerve stimulation (VNS). Evidence for the efficacy of this treatment is modest at best: when the FDA approved it recently for the depression indication, the decision was made over the strenuous objections of FDA staffers, and it triggered an inquiry by Sen. Charles Grassley in the Senate Finance Committee, which issued a scathing report on the process.
The review article, published in the July 2006 issue of Neuropsychopharmacology, dealt with the purported mechanism of action of VNS in depression. The substantive ethical concerns with this publication are as follows. First, all 8 academic authors are members of the Mechanism of Action Advisory Board of the corporation that markets VNS. These affiliations were not revealed. In addition, some authors are recipients of research grants from the corporation, which also was not disclosed. Second, the article acknowledged "editorial support" from a professional writer, who acknowledged to the Wall Street Journal that she was employed by the corporation for the task of writing a first draft. Although the authors claimed they provided substantive input after the first draft, it is ethically dubious to use a hired writer for a first draft. As Drummond Rennie, past editor of BMJ, commented in Science this week, "It is very bad scientific and ethical practice to have a nonauthor write the first draft." When senior academics behave in this way, it sets a poor example for junior faculty and trainees.
Third, the review went beyond a discussion of the putative mechanism of action of VNS by summarizing the regulatory status and evidence of efficacy of this treatment. In presenting this summary, the review carefully followed the corporation's marketing message and branding language. 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.
Fourth, the review acknowledged an "unrestricted educational grant" from the corporation. As the professional writer was already being paid by the corporation, the question arises, who was the grantee and where did the money end up? Does not this euphemism, now so common, hijack the original meaning of the term, to serve as a cover for a corporate payment to the authors?
Fifth, the lead author of the review, Charles Nemeroff, is chair of the Advisory Board for the corporation. This circumstance was not disclosed.
Sixth, the same individual is also editor-in-chief of the journal in which the review appeared, an arrangement that a recent New York Times editorial called "incestuous."
Seventh, the corporation issued a coordinated press release in early July 2006, calling attention to the newly published, favorable review article. This press release featured Charles Nemeroff shilling for the corporation's product, but it did not disclose the consultant status of Dr. Nemeroff and the other authors.
Overall, the appearance here is of a slick, coordinated, public relations-disinformation campaign in which ACNP and its journal were exploited by paid consultants of the corporation. The double non-disclosure is especially revealing. Oh, and by the way, should there be any lingering doubt about the careful planning of this incident, we should note that the corporation ordered 10,000 reprints of the article. So much for this being an independent review, conceived and executed by dispassionate and disinterested senior academic authors.
Lessons to Learn
In light of these events, here are some lessons for all concerned with quality in medical journals. First, find an editor possessed of trustworthy ethical instincts, who will respect the boundary between personal agendas and institutional priorities.
Second, create a firewall against corporate marketing tactics designed to buy influence. Chief among these is acknowledgement of an “unrestricted educational grant” from a corporation. Everybody knows this is code for a payoff to the authors. Another tactic is designation of the group as some b.s. term like “International Consensus Group for Anxiety and Depression.” It is not hard to find examples of such "key opinion leader" fictions, funded by Pharma to meet at junkets in congenial resorts with the support of “unrestricted educational grants.” Legitimate journals like Neuropsychopharmacology should not allow themselves to be co-opted by these deceptive marketing tactics.
Likewise, acknowledgement of “editorial support” should trigger some inquiry as to the exact arrangements, including who paid for it. Whenever an “unrestricted educational grant” is acknowledged, an honest broker needs to verify the money trail and auditing process. Who paid what to whom and where did the money end up? Members of ACNP would do well to insist that articles featuring these marketing tactics should be routinely rejected by Neuropsychopharmacology. Let the marketeers go to some other journal. It is a sad sign of the corruption of standards nowadays that one even needs to make these points.
Larry Husten, Writing For Forbes, Nicely Summarizes TECOS: Lightens Merck's Januvia Load - Well, this likely just means that Merck may pick up some of the slack spooling at AZ's feet, now -- related to its Onglyza diabetes medication. But the la...
1 hour ago