Cyberonics involved in med journal scandal

NEWS Journal editor quits in conflict scandal

Neuropsychopharmacology’s chief steps down after a paper
he co-authored omitted significant financial disclosures

By Stephen Pincock

[Published 28th August 2006 05:28 PM GMT]

The editor of a leading psychiatry journal announced last Friday (August 25) that he was stepping down after he published a paper about a treatment for depression without disclosing that eight of nine authors–including himself–had financial ties to the company that makes the device.

Charles B. Nemeroff, editor in chief of Neuropsychopharmacology, a publication of the American College of Neuropsychopharmacology (ACNP), will not serve another term as editor, the college told its members in an Email. The decision was made “in part, based on the recent adverse publicity to the journal and the ACNP,” the Email said.

That publicity arose after the journal’s July issue carried a positive review of a vagus nerve stimulation (VNS) device made by Cyberonics, Inc, of Houston, Texas. Nemeroff was the lead author for the paper, which described VNS as a “promising and well-tolerated intervention that is effective in a subset of patients with treatment-resistant depression.”

The article acknowledged funding from Cyberonics, and listed coauthor Stephen Brannan as an employee of Cyberonics. But it did not reveal that the eight other academic co-authors were all consultants for the firm.

The story, one of several recent conflict-of-interest cases, first made news in July, prompting the journal to print a correction

This isn’t the first time that Nemeroff has hit the headlines for undisclosed financial ties. In 2003, a review he coauthored in Nature Neuroscience neglected to mention significant financial interests in three therapies that were reviewed favorably (including owning the patent on one of the treatments), prompting the Nature Publishing Group to widen its disclosure policies. At the time, Nemeroff and his co-author Michael Owens said: “Going forward, we intend to provide all financial disclosure information, even if it is not requested by the journal editor.”

Clare Stanford, past president of the British Association for Psychopharmacology and an editor at several journals in the field, said Nemeroff was an influential researcher in his field who was unlikely to have been swayed by the Cyberonics money.

“I don’t believe for a minute that the fact the paper was funded by a company would have influenced his conclusions,” she told The Scientist. “It is unfortunate that he has had to stand down over this incident which is largely a reflection of the scientific community’s paranoia rather than any failing of his professional integrity.”

Not everyone shares her view, however. In a blog entry posted earlier this month on the Health Care Renewal blogspot, Bernard Carroll, scientific director of the Pacific Behavioral Research Foundation, called the incident a “slick, coordinated, public relations-disinformation campaign in which ACNP and its journal were exploited by paid consultants of the corporation.”

Nemeroff, chairman of psychiatry and behavioral sciences at the Emory University School of Medicine, told The Scientist in an Email that the financial disclosures of all authors were submitted to the journal, but due to an “oversight,” were not included in the print version. “There was absolutely no intent to withhold any information concerning financial disclosures.”

He added that he has served as the journal’s chief editor for five years, during which time the journal has “improved in all objective indices including manuscripts submitted, ISI rankings … I feel that we have accomplished our goals and I have opted not to accept the ACNP Council’s invitation to serve another three years.”

The group Alliance for Human Research Protection, meanwhile, has raised concerns that a professional writer paid by Cyberonics wrote the first draft of the paper. The writer was not listed as an author but was thanked in the acknowledgements.

Ronnie Wilkins, executive director of ACNP, told The Scientist that Nemeroff would serve out the rest of his current term as editor in chief, which ends in December. Earlier this year, he had been voted in for another term.

Meanwhile, the college wants to ensure the same thing doesn’t happen again, Wilkins said. “The council met on August 23 … and one of the things we asked the publication committee was to look at our policies and procedures to make sure that we have a checklist to avoid this kind of oversight happening again,” he said.

Stephen Pincock
spincock@the-scientist.com

Links within this article

Charles B. Nemeroff

http://www.psychiatry.emory.edu/NeuropsychopharmacologyLaboratory/Charles%20Nemeroff.htm

Neuropsychopharmacology

http://www.nature.com/npp/index.html

American College of Neuropsychopharmacology

http://www.acnp.org/default.aspx?Page=Home

C. Nemeroff, et al, “VNS Therapy in Treatment-Resistant Depression: Clinical Evidence and Putative Neurobiological Mechanisms,” Neuropsychopharmacology (2006) 31, 1345-1355.
PM_ID: 16880768

Cyberonics

http://www.cyberonics.com/

A. McCook, “Conflicts of interest at Federal agencies,” The Scientist, July 24, 2006.

http://www.the-scientist.com/news/display/24056/#24128

D. Armstrong, “Medical Reviews Face Criticism Over Lapses,” Wall Street Journal, July 19, 2006.

http://www.postgazette.com/pg/06200/706933-114.stm

B. Carey, “Correcting the errors of disclosure,” New York Times, July 25, 2006.

http://www.nytimes.com/2006/07/25/health/25news.html?ei=5070&en=794c681583ce7296&ex=1156910400&adxnnl=1&adxnnlx=1156760425-D1Sb+JF5FgICzW9qEslWjQ

“Corrigendum: VNS Therapy in Treatment-Resistant Depression: Clinical Evidence and Putative Neurobiological Mechanisms,” Neuropsychopharmacology advance online publication, 31 July 2006; doi: 10.1038/sj.npp.1301190

http://www.nature.com/npp/journal/vaop/ncurrent/full/1301190a.html

S. Pincock, “Full disclosure?” The Scientist, October 1, 2003.

http://www.the-scientist.com/article/display/21640/

Clare Stanford

http://www.ucl.ac.uk/Pharmacology/Research/scs.html

B. Carroll, “Money and Medical Journals,” Health Care Renewal, August 8, 2006.

http://hcrenewal.blogspot.com/2006/08/money-and-medical-journals.html

“ACNP journal editor quits amid exposure of conflicts of interest,” AHRP, August 27, 2006. http://www.ahrp.org/cms/content/view/327/55/stating the authors had submitted disclosures in accordance to journal policy, but that the information simply had not been included in the acknowledgement section of the published paper.

Comments (5)

Nancy E. BowlingApril 11th, 2009 at 10:38 am

That vagal nerve stimulator is a piece of crap It destroys lives. My sister had one put in to control her seizures but it made her so ill she not only had an increase in seizure activity, but they even became more intense and more severe. To this day she remains in a psychiatric hospital suffering from a severe psychosis and increased seizure activity. those are both documented side effects of a vagal nerve stimulator.Try explaining that to her precious little ten year old daughter who can’t understand why her mom is so ill. She has lost everything. She will never be a registered nurse agian after being in a mental institution and for the rest of her life, both her and her little girl will be on social csecurity, medicaid, medicare, food stamps and every other assistance this government will have to give. President Obabma, if you really wany ypo improve the economy, make these corporations resonsible for the travesty and destruction their devices cause, Reverse Reigel Vs. Medtronics and make the people responsible for this misscarraige of justice, not the American people who had noyhing to do with it.
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buy deca durabolinMarch 3rd, 2011 at 8:54 am

What a nice post. I really love reading these types or articles. I can?t wait to see what others have to say.

Nancy BowlingMarch 3rd, 2011 at 10:10 am

This is an update on my sister, and her experience with the Cyberonics vns device. Ibegan doing some very extensive research on this device and discovered that psychosis and worsening seizures are two documented possible side effects of this device. I immediately contacted her neurologist, surgeon and the doctor treating her at the hospital she was in. We also contacted a lawyer, and you would be amazed how quickly doctors move when they get a phone call from a lawyer. They quickly removed the device and of course, the psychosis seemed to miraculously disappear. the seizures which had become life-threatening with the device implanted, seem to be ‘all of a sudden’ controllable with medicine. Since then, she is home, but because of the device and what it did to her she is permanetly disabled, but alive. Now I am on a mission to see that something is done about this device. When a Class III medical device is given ‘Conditions of Approval’ then not only doesn’t complete them in a timely fashion, but submits a proposal to the FDA to have those conditions changed when they were actually almost due, and the FDA accepts, there’s something wrong. Our government should reverse Reigel vs. Medtronics, so that people who are injured, or killed by these devices can sue the companies involved. If all these companies would have a threat of a lawsuit hanging over their heads, I bet alot of them would make a much stronger effort to ensure that their products are safe.

DianaMarch 14th, 2012 at 3:25 am

Yeah, and when one of the guys from Slate attempted to point out that they were both a bit wrong on her fbocaoek page it was deleted by moderators twice. Classy.

[...] new boss; she had recently moved to Emory from Toronto), was the journal’s top editor and had been involved in other failures to disclose. Nemeroff indeed did have a history of failure to disclose. And the [...]

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