November 6

Psychiatry News: High Cost of Nondisclosure

A guest editorial in Psychiatry News, by the two psychiatrists who first blew the whistle on an egregious example of undisclosed financial conflicts of interest involving Dr. Charles Nemeroff, a ghostwritten favorable review of vagus nerve stimulation (VNS) to which he and eight others penned their name. The review was published in the journal of the American College of Neuropsychopharmacology (ACNP), whose editor he was at the time.

We called it  “a perfect storm” see: Wall Street Journal report:  See: New York Times editorial, and more: 

VNS is the latest controversial device for the treatment of depression lacking in scientific evidence of efficacy. It carries a hefty price tag to ensure profits for Cyberonics and its academic marketing collaborators. The undisclosed financial relationship between Dr. Nemeroff and the 8 other academics who penned their name to the ghostwritten review has stirred a hornet's nest.

The importance of  this case is that the it provides a road map for citizens to gain insight about how biotech / pharmaceutical corporations use academic experts to push their products.  Furthermore, such conflicts of interest are anything but rare–they permeate the entire field of psychiatry.  The professional and moral integrity of its research and journal reports are corrupted because psychiatry's institutional framework–its leading academic-based researchers and professional associations–are paid promoters who serve as covert marketers for industry.

Indeed, the only "author" of the ACNP review of VNS who openly declared his relationship with Cyberonics, is an employee. The academic-based "authors" failed to disclose their financial ties to the company.

Because the practice of psychiatry lacks a scientific base–it is shaped by pharmaceutical industry marketing objectives.  Though drugs are the mainstay of current treatment, in this case, psychiatrists promoted a device as marketers for Cyberonics.  A similar cottage industry  promotes the business interests of electroshock manufacturers.

 Dr. Bernard Carroll* and Dr. Robert Rubin,* are independent minded psychiatrists who swam against the tide and persevered, as few others do. Their message to their colleagues is clear:
 "When the leaders of professional societies lose their ethical compass, individual members can exert moral suasion by speaking out."

Unfortunately, a two man posse can't cleanse the stench in psychiatry.
It will require setting tight limits on the nature and scope of financial ties between psychiatrists and drug / device companies. The nature of any ties will have to be explicitly and fully disclosed–not just in obscure journals– but wherever public statements about the product are made.

Legislation is needed to ensure that conflicts of interest rules in medicine are enforced. One method for reigning in the abuse is to prohibit government grant awards to any researcher who violates financial conflict of interest rules.

Contact: Vera Hassner Sharav
Psychiatry News
The High Cost of Nondisclosure
O c t o b e r 2 0 0 6
•   Opinion 27

The July 2006 issue of the journal N e u r o p s y – chopharmacology featured a lead review article on the supposed mechanism of action of vagus nerve stimulation therapy for refractory depression (Neuropsychopharmacology 2006;31:1345-55).The lead author was Dr. Charles B. Nemeroff, who also served as the journal’s editor-in-chief. On July 7, Cyberonics Inc., the corporation that markets VNS therapy, issued a press release touting the article in the peer-reviewed publication. Those two developments would soon provoke a storm of controversy.
After critical articles appeared in the Wall Street Journal, the New York Times, and Science, as well as on Internet blogs, Dr. Nemeroff resigned as editor. At the same time, the Council of the American College of Neuropsychopharmacology (ACNP), the prestigious professional society that publishes the journal, did an about-face by ceasing to defend its editor’s actions.

What led to those events?
ACNP Members Raise Objections The primary cause was the widening outrage of ACNP members at the apparent exploitation of their journal by commercial interests. ACNP members recognized
that the review article was a “stealth infomercial” drafted by a professional writer hired by Cyberonics, and that the academic authors were paid consultants to Cyberonics.
ACNP members were also well aware that, as a New England Journal of Medicine editorial has stated, “For private companies, publication and a positive press have cash value. … ” Essentially, the members declared that ACNP and its journal were not for sale.

An unrestricted educational grant from Cyberonics was acknowledged, but the article failed to disclose that the eight university- based authors were all paid consultants to Cyberonics.
Compounding the appearance of impropriety, the press release issued by Cyberonics failed to disclose the company’s financial support for the preparation of the article and the ongoing paid-consultant status of the eight authors.  In addition, Dr. Nemeroff was featured in the press release praising the value of VNS therapy.

Outrage increased when it became known that Cyberonics had ordered 10,000 reprints of the article. Here, then, was a case of double concealment. The review article was 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.

Word Spreads About Improprieties
We 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. This incident resonated with the press because similar instances of nondisclosure by academic authors in the Journal of the American Medical Association had recently come to light. Recruiting support from key ACNP members, we urged the ACNP Council to withhold the reprints from Cyberonics until the disclosures required by ACNP and journal policy could be inserted.

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. No one was held accountable.
The executive committee’s statement avoided any criticism of Cyberonics (which is a supporting corporation of ACNP), and Dr. Nemeroff repeatedly dismissed the problem as “a simple oversight.”
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.

Take-Home Message
Several lessons can be learned from these events:
_ Transparency matters, and academic authors—however senior—will be held accountable for nondisclosure.
_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.

_On the issue of ghostwriting, Dr. Drummond Rennie, past editor of the British Medical Journal, stated in the Aug. 4 commentary in Science, “It is very bad scientific and ethical practice to have a non author write the first draft” of a published article.
_ The review acknowledged an “unrestricted educational grant” from the corporation. Given that the professional writer was already being paid by the corporation, several questions arise, such as:
Who was the grantee, and where did the money end up?
_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. â– 

*DR. CARROLL is scientific director, Pacific Behavioral Research Foundation, Carmel, Calif.
*DR. RUBIN is vice chair of the department of psychiatry and biobehavioral sciences at the University of California, Los Angeles, and chief of psychiatry and mental health, Veterans Affairs Greater Los Angeles  Healthcare System.

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