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Medical Industry Ties Often Undisclosed in Journals

Twenty-five out of 32 highly paid consultants to medical device companies in 2007, or their publishers, failed to reveal the financial connections in journal articles the following year, according to a study released on Monday.

The study compared major payments to consultants by orthopedic device companies with financial disclosures the consultants later made in medical journal articles, and found them lacking in public transparency.

“We found a massive, dramatic system failure,” said David J. Rothman, a professor and president of the Institute on Medicine as a Profession at Columbia University, who wrote the study with two other Columbia researchers, Susan Chimonas and Zachary Frosch.

The study, published on the Web site of The Archives of Internal Medicine, focused on 32 medical doctors and doctoral researchers who were each paid at least $1 million in 2007 and published one or more journal articles the next year.

Most of the doctors and most of the orthopedic journal articles did not disclose their financial relationships with companies, the study found.

Professor Rothman called for stricter disclosure policies, including precise amounts of consulting payments. He said journal readers needed the information to consider the potential for bias.

Dr. Marcia Angell, a former editor of The New England Journal of Medicine, who was not involved with the study, called it “an ingenious study, with unsurprising results.” She added, “It is one more indication of the widespread corruption of the medical profession by industry money.”

“The journals’ lax enforcement of disclosure policies probably reflects the fact that journals, too, are dependent on industry support,” Dr. Angell said in an e-mail to a reporter after reviewing the study.

The International Committee of Medical Journal Editors, responding to criticism, has proposed better disclosure policies in the last two years. But each journal sets its own policy, and critics say many of them have still not gone far enough.

The Journal of Arthroplasty lacked disclosures in 17 of 24 articles in the study. Glen Campbell, head of health sciences journals for the publisher Elsevier, said it required disclosure. “We’re impressed with the quality of research here which clearly shows a collective need for greater adherence by authors and encouragement by publishers to comply,” he wrote in an e-mail.

The Journal of Bone and Joint Surgery, which disclosed the financial ties in seven of 10 articles in the study, said in a statement on Monday that it agreed on the need for improvement and planned to announce tighter policies next year.

“It is important to us that the readers of our research work are fully aware of the sources of support for this innovative research,” the journal editor, Dr. Vernon T. Tolo, director of the orthopedic center at Children’s Hospital Los Angeles, wrote.

The study was based on disclosures by five medical device companies, mostly forced by government investigations. The companies paid about $250 million to consultants in 2007, including royalties, the study says. Zimmer paid $87 million; DePuy Orthopaedics, $63 million; Stryker, $45 million; Biomet, $27 million; and Smith & Nephew, $24 million.

Of that total, $114 million went to 41 doctors, the study said, of whom 32 wrote or were co-authors on orthopedic journal articles the next year. The study focused on a representative sample of 95 of those articles. It said 51 of them, or 54 percent, did not mention the financial relationship with a company. It showed that 25 of the 32 authors did not disclose some or all of the time.

The study does not identify individual doctors or their journal articles. Professor Rothman said he did not know how often the journals required disclosures in 2008, but he said the lack of results showed “a broken system” regardless of who was to blame.

Representatives from Stryker, Zimmer and DePuy had no immediate comment on Monday.

The research focused on doctors paid more than $1 million because that seemed a significant conflict-of-interest that should have been disclosed the next year, Professor Rothman said.

In a further criticism, he said none of the medical journals required authors to disclose exactly how much they had received, making it impossible to distinguish between payments ranging from $10,000 to $8.8 million.

“We’ve got accurate data out there,” he said. “Why aren’t we using it?”

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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