Medical Journal to Issue Correction
On Review of Depression Treatment
By DAVID ARMSTRONG
July 18, 2006 11:43 a.m.
BOSTON -- A review of a new depression treatment published in a medical journal failed to disclose that the authors are consultants to the company that sells the treatment.
An official of the medical society that publishes the journal Neuropsychopharmacology says a correction will be issued soon.
The review piece in this month's Neuropsychopharmacology comes to favorable conclusions about the treatment, called vagus nerve stimulation. The treatment involves the implanting of a small device just under the skin. Electrodes attached to the device are wrapped around the vagus nerve in the neck. The Food and Drug Administration approved the treatment for use in depression last year.
Of the nine authors, eight are academic researchers who are consultants for Cyberonics Inc., which makes the vagus nerve device. The ninth author is an employee of the company, which was disclosed.
In the conclusions of the review article, the authors write that vagus nerve stimulation is "a promising and well-tolerated intervention that is effective in a subset of patients with treatment-resistant depression." (See the review article.)
Ronnie Wilkins, the executive director of the medical society that publishes Neuropsychopharmacology, says that the consulting arrangements should have been disclosed and that a correction will be published as soon as possible. He says the authors did report their financial relationships with the company in forms they are required to fill out as part of the publication process. However, he says the consulting information was not included in the manuscript of the review piece as required.
The first author of the article, Charles B. Nemeroff of Emory University, is also the editor of Neuropsychopharmacology. Mr. Wilkins says Dr. Nemeroff recused himself from the editing of the review. Dr. Nemeroff, however, did see an edited version of the review article before it was published, Mr. Wilkins says.
Dr. Nemeroff, chairman of the department of psychiatry and behavioral sciences at the Emory school of medicine, did not respond to telephone messages left at his office.
While the acknowledgements section of the review article says "preparation of this report was supported by an unrestricted educational grant from Cyberonics Inc.," it does not disclose that the academic authors are company consultants. The acknowledgements also thank Sally Laden for "editorial support in developing early drafts of this manuscript."
Ms. Laden is a professional medical writer who was hired by Cyberonics to help compile the review article. She said the company provided her with materials from the company's advisory board meetings to help draft the review article. Ms. Laden said she prepared the first draft of the review piece which then went through many revisions based on edits and suggestions by the listed authors. All of the authors were involved in preparing the final version of the review article, she said.
"This was not a ghostwritten project," Ms. Laden said. "I was just a facilitator."
Ms. Laden declined to say how much she was paid by the company for her work. A Cyberonics spokeswoman said the company would have no comment on the review article. |
