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Old 07-19-2006, 03:41 PM   #1
scotty
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Medical Reviews Face Criticism Over Lapses

WSJ.com - Medical Reviews Face Criticism Over LapsesURL for this article:
http://online.wsj.com/article/SB115322997681109756.html

Medical Reviews
Face Criticism
Over Lapses

By DAVID ARMSTRONG
July 19, 2006; Page B1

Charles Nemeroff, one of the nation's most prominent psychiatrists, edits the journal Neuropsychopharmacology, which this month favorably reviewed a controversial new treatment for depression.

But yesterday, the journal said it plans to publish a correction because it failed to cite the ties of the article's eight academic authors to the company that makes the treatment, including the article's lead author: Dr. Nemeroff.

The journal's nondisclosure of the financial ties of its own editor as well as those of the other authors highlights the failure of many respected medical journals to identify relationships between academic researchers and medical companies that may benefit from positive research reports. A spate of recent lapses is prompting calls for more journals to ban offending authors from publication. In addition, medical schools are being urged to regulate relationships between their researchers and industry more closely.

Last week, the Journal of the American Medical Association published a correction indicating that seven authors of a February paper on depression during pregnancy failed to reveal they were paid by the makers of antidepressants. It was the third such incident at JAMA this year.

"If journals are going to have ethical standards and if those ethical standards are going to mean anything, there has to be sanctions associated with them," says Sheldon Krimsky, a Tufts University professor who has studied conflict-of-interest policies of medical journals. Most policies require authors to report financial ties, but don't include any punishment if they fail to do so.

The science journal Environmental Health Perspectives added penalties to its disclosure policy in 2004 after several authors failed to note industry relationships. The new policy calls for a three-year ban on publication for authors who willfully fail to disclose financial links. In addition, the journal said it would retract studies if it determined that the unreported conflicts would have prompted it to initially reject the manuscript.

Last December, the Journal of Thoracic and Cardiovascular Surgery said it would start to ban for "some period of time" authors who fail to disclose conflicts. The journal's editor said the common remedy for disclosure failures -- a published correction -- doesn't go far enough.

Most journal editors, however, are reluctant to ban authors, partly out of concern these researchers will shop their work to a different publication. The editor in chief of JAMA, Catherine DeAngelis, takes another approach. She asks medical school deans employing the researchers to investigate. She says sanctions, which she didn't specify, have resulted against authors each time she has asked for such an investigation.

Jerome P. Kassirer, a former editor of the New England Journal of Medicine, says medical schools need "more stringent policies" limiting financial relationships between researchers and industry. "These faculty members are just up to their ears in financial conflicts and academic medical centers are just not doing anything about it," he says.

In the latest case, Neuropsychopharmacology published a review of a new treatment for depression in which a small device is implanted in the chest to deliver mild electrical pulses to the vagus nerve in the neck. The Food and Drug Administration approved the device, made by Cyberonics Inc. of Houston, for use in treating depression last year. The authors conclude 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 article1.)

Concerns about the treatment have been raised elsewhere. In congressional testimony this year, U.S. Sen. Charles Grassley (R., Iowa) said FDA reviewers opposed use of the device for depression because Cyberonics didn't demonstrate reasonable assurances of safety and effectiveness.

Of the nine authors of the review, eight are academic researchers who serve as consultants to the company, according to Ronnie Wilkins, executive director of the American College of Neuropsychopharmacology, which publishes Neuropsychopharmacology. The ninth author is an employee of Cyberonics, which was reported in the review article.

Mr. Wilkins says the academic authors revealed their relationships with the company in disclosure forms required by the journal. However, he says the authors didn't report the financial ties in the manuscript submitted to the journal as required. He says the journal is reviewing its procedures "to prevent similar omissions in the future," and a correction will be issued soon.

Dr. Nemeroff, chairman of psychiatry and behavioral sciences at the Emory University School of Medicine, says there was "no intent whatsoever on my part or any of my co-authors to hide the fact we were working in collaboration with Cyberonics."

He also says the identification of one author as a Cyberonics employee as well as a notation that the report was supported by a Cyberonics grant made clear the review was connected to the company. Dr. Nemeroff says he serves on two Cyberonics advisory boards but declined to say how much he was paid. Mr. Wilkins says Dr. Nemeroff recused himself from the editing and peer review. He was shown an edited version before it was published.

The article acknowledges Sally Laden for "editorial support in developing early drafts of this manuscript," without citing her ties to Cyberonics. Ms. Laden, a professional medical writer hired by Cyberonics to help compile the review, said the company provided her with materials from its advisory board meetings. Ms. Laden says 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 the authors were involved in preparing the final version, she says.

A Cyberonics spokeswoman declined to comment. The company issued a press release this month announcing publication of the review. The press release quoted Dr. Nemeroff as saying, "It is clear VNS therapy is a promising treatment." His consulting work was not mentioned. The company also ordered 10,000 reprints of the article.

Write to David Armstrong at david.armstrong@wsj.com4
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Old 07-19-2006, 08:29 PM   #2
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Re: Medical Reviews Face Criticism Over Lapses

ethical standards in psychiatry without collusion with big pharma?....
Now that will be the day...
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Old 07-19-2006, 09:01 PM   #3
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Re: Medical Reviews Face Criticism Over Lapses

Yeah.... I with you on that statement Redking!!
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Old 07-20-2006, 06:08 AM   #4
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Re: Medical Reviews Face Criticism Over Lapses

Me too!!
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