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

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Surgery Journal to Ban Authors Who Fail to Disclose Conflicts of

Interest

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

FYI

Just before the closing days of 2005, the Wall Street Journal

reported (below):

" 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 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.

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

212-595-8974

veracare@...

http://online.wsj.com/article_email/SB113573949963432737-

lMyQjAxMDE1MzI1ODcyMzg5Wj.html

THE WALL STREET JOURNAL

Surgery Journal Threatens Ban For Authors' Hidden Conflicts

By DAVID ARMSTRONG

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.

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 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 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. 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 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 Armstrong at david.armstrong@...

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