January 3

Surgery Journal to Ban Authors Who Fail to Disclose Conflicts of Interest

Just before the closing days of 2005, the Wall Street Journal reported (below):
The Journal of Thoracic and Cradiovascular Surgery has taken a major step toward full disclosure of authors’ conflicts of interest.
The crackdown means that neither scientists found violating disclosure requirements, nor their institutions will be allowed to publish their findings in the journal.

Disclosing industry connections is critical because many physicians make treatment decisions based on data published in medical journals, and need to be able to evaluate their credibility.

The decision follows the discovery by the journal’s editor, Dr. Andrew Wechsler, that the authors (from Cleveland Clinic and University of Cincinnati) in two cases failed to reveal their financial ties toAtriCure Inc, a Cincinnati company that makes a system to treat atrial fibrillation, an abnormal heart rhythm.

The Journal is to be applauded for its unambiguous policy–which we hope will prompt other medical journals to follow suit.
If they don’t their credibility will evaporate.

 Contact: Vera Hassner Sharav

Surgery Journal Threatens Ban For Authors’ Hidden Conflicts
December 28, 2005; Page B1

With conflicts of interest increasingly casting doubt on the credibility of medical research, a leading surgery journal is cracking down on authors who fail to disclose links to industry, threatening to temporarily blacklist them.

The surgical society that owns the journal approved the penalties for "future violations" after learning that researchers for two studies it published this year didn’t reveal financial ties to the maker of heart-surgery equipment that they evaluated favorably.

Andrew Wechsler, editor of the Journal of Thoracic and Cardiovascular Surgery, says the publication plans to issue corrections in the two cases to reveal the financial ties of the researchers to AtriCure Inc., a Cincinnati company that makes a system to treat atrial fibrillation, an abnormal heart rhythm.

Prompted by the AtriCure revelations, the American Association of Thoracic Surgery, which owns the journal, decided that a published correction of a conflict of interest — a common remedy when authors fail to disclose industry links — doesn’t go "far enough," Dr. Wechsler says. He says the tougher sanctions approved by the surgery society will include barring those individuals and their institutions from publishing in the journal for "some period of time."

The action comes as many medical journals struggle with the burgeoning links between researchers and industry. While some of the major medical journals started requiring financial disclosures in the 1980s, most publications didn’t begin to ask about potential conflicts until the past decade. Some editors have complained it is hard to find reviewers and study authors who don’t have potential conflicts of interest. Last year, the British medical journal Lancet said undisclosed conflicts of interest undermined a study it published that suggested childhood vaccinations could cause autism. Lancet said the study’s lead author didn’t disclose he was working on a study for lawyers considering legal action against vaccine makers.

Disclosing industry connections is critical because many physicians make treatment decisions based on data published in medical journals, and need to be able to evaluate their credibility. "Even though we believe the information in the study is sufficiently well-documented, they need to know that the person who authored the article may have a relationship with the company," says Catherine DeAngelis, editor in chief of the Journal of the American Medical Association. "I want you to make the decision on how trustworthy that information is."

The banning of authors who fail to disclose conflicts is "pretty unusual," says Kevin Schulman, a professor of medicine and business administration at Duke University who has studied conflict policies at institutions and medical journals. At the same, Dr. Schulman says, the harsher sanction is "part of the maturation of the relationship between industry, academia and the journals. Basically there has been a constant movement over the last several years to really improve disclosure and to really improve independence."

Dr. DeAngelis says the new policy by the surgery journal is "pretty severe, but not outlandish." At JAMA, authors who fail to disclose relationships are not barred from publication, but their work receives extra scrutiny, she says.

The New England Journal of Medicine says it has "not had occasion to penalize an author for failure to disclose a conflict of interest in recent years." The journal says it would handle any failures to disclose conflicts on a case-by-case basis, and that it expects that few researchers would risk the "professional and personal stigma that forever would be attached to such an incident."

Dr. Wechsler, the surgery-journal editor, says there will be a third correction relating to another study of the AtriCure system because the journal mistakenly failed to note that the authors were consultants to the company even though they had informed editors before publication.

The studies generally praised the AtriCure system, and the company has highlighted two of them in regulatory filings as "independent" clinical studies that "demonstrate the efficacy, ease of use and safety of our system."

In a paper Cleveland Clinic heart surgeon Marc Gillinov co-wrote in the journal in September, his role as a paid consultant to AtriCure wasn’t disclosed. AtriCure highlighted the 27-patient study, which found that 91% of patients were free from fibrillation three months after surgery, in a U.S. Securities and Exchange Commission filing as part of a recent public offering.

The lead author of that study, University of Cincinnati surgeon Randall K. Wolf, has lucrative ties to AtriCure. Dr. Wolf helped develop a surgical cutting device that AtriCure sells and says he was a key player in the early development of the AtriCure surgical procedure.

Before the surgery journal announced the correction, Dr. Wolf said he is a consultant to AtriCure, the holder of AtriCure stock options and is paid by the company to proctor other surgeons learning the AtriCure operation. An AtriCure filing with the SEC in August reports Dr. Wolf owns 18,402 shares of company stock and has warrants or options to purchase 13,913 additional shares of stock. In November, AtriCure reported a four-year royalty agreement with Dr. Wolf that will pay him a minimum of $200,000 a year up to a total of $2 million over the entire length of the agreement.

E. William Schneeberger, a University of Cincinnati surgeon who is another of the study’s authors, is listed as having options for 14,500 shares of AtriCure stock.

When the AtriCure study was submitted to the cardiovascular journal, Dr. Wechsler says Dr. Wolf included a disclosure indicating "Drs. Schneeberger, Gillinov, and I receive educational grants from AtriCure Inc. These grants were not used to fund this research." The stock options and consulting arrangements weren’t disclosed, Dr. Wechsler says.

Dr. Wechsler recently sent a letter to Dr. Wolf saying the journal planned "to publish a correction as soon as possible concerning the disclosures relating to this manuscript" and saying it held the surgeon "responsible for obtaining for us all pertinent relations for all authors."

Dr. Wolf didn’t respond to telephone and email messages seeking comment on the journal’s letter. Dr. Schneeberger, before the correction was announced, said he had "no idea" the financial ties weren’t disclosed. Dr. Gillinov, through a spokeswoman at the clinic, said he didn’t see a final draft of the study turned in by Dr. Wolf. The spokeswoman, Eileen Sheil, says Dr. Gillinov didn’t intend to hide his relationship with the company and has disclosed the link in other forums.

Among the early investors in AtriCure was a venture-capital fund founded by the Cleveland Clinic, a world-renowned heart hospital. The clinic is also one of the leading practitioners of the AtriCure surgery and its doctors have promoted the operation at major medical meetings, in company news releases and in surgery journals.

Dr. Gillinov was the lead author of another AtriCure study, this one published in June and co-written with colleagues from the clinic. One of those authors was Delos "Toby" Cosgrove, a noted heart surgeon who is now the clinic’s chief executive. This study concluded that 72% of the patients were free of atrial fibrillation a year after surgery.

The article, however, failed to note that Dr. Cosgrove was on the AtriCure board during the time the research was conducted. Dr. Cosgrove previously said the failure to disclose his relationship was an oversight. Dr. Gillinov did disclose his consulting relationship when submitting this study.

Ms. Sheil says Dr. Gillinov is in the process of responding to a letter from the medical journal asking why, as the lead author, he didn’t disclose Dr. Cosgrove’s relationship to AtriCure. "He apologizes for the oversight," she says. In the future, she added, "we need to do a better job of making sure" industry relationships are disclosed.

A third study was conducted by surgeons at Washington University in St. Louis and published in the journal’s October 2004 issue. It concluded that 91% of the patients who underwent the AtriCure procedure were free of atrial fibrillation after six months.

The study was written by at least two surgeons with financial ties to AtriCure that weren’t disclosed in the journal. Dr. Wechsler says that Richard Schuessler and Ralph Damiano reported that they were consultants to AtriCure and that the journal mistakenly failed to disclose those ties.

The study’s medical findings were later challenged by doctors in England. In a letter to the editor of the medical journal, the British researchers pointed out that there was no six-month follow-up data for 17 of the 40 patients so that the results were based only on a subset of those who underwent the operation. They argue it was likely that some of the missing patients still had atrial fibrillation and that the "true estimate" of the cure rate was less than 91% and as low as 53%.

Write to David Armstrong at david.armstrong@wsj.com

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