Study finds ‘serious gaps’ in medical journals’ disclosure of surgeons' relationships with industry

Nearly half the surgeons who made at least $1 million in payments from orthopedic device companies did not have that relationship published in their scientific articles, according to a recent study in the online edition of the Archives of Internal Medicine.

The findings show that readers are not being adequately informed about conflicts of interest, even when the funds involved are significant.

“The findings raise troubling questions about undisclosed payments or royalties and other fees from medical device companies that could lead to biased scientific conclusions,” stated senior author David J. Rothman, PhD, president of the Institute on Medicine as a Profession (IMAP), in a press release.

‘A stake in transparency’

The study, conducted by researchers at IMAP, is the first of its kind to use company records to check on the accuracy of disclosure information listed in medical journals. The five manufacturing firms investigated in the study – Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer – disclosed in a public database the amounts they paid to consultants. Researchers combed through this database and compared the list to the financial disclosure information – if any – listed in the unnamed journal articles.

IMAP compared 2007 physician payment information from the five orthopedic device companies with the disclosure of company payments in journal articles. These five companies made a total of 1,654 payments amounting to $248 million for consulting, honoraria or other payments for services.

Analysis also found that payments to 41 orthopedic surgeon researchers ranged from just over $1 million to a high of $8.8 million, representing 62% of all company expenditures. Researchers with IMAP focused on these consultants, finding 95 articles published in scientific literature after payments were received. Fewer than half of the published articles disclosed a financial relationship between the author and the company.

Authorship position and disclosure policies

Of 41 individuals who received $1 million or more in 2007, the study found 32 published articles relating to orthopedics between January 1, 2008 and January 15, 2009.

The researchers found prominent authorship position and article-payment relatedness to be associated with greater disclosure, but noted in their study that nondisclosure rates remained high – 46% among first-, sole-, and senior-authored articles and 50% among articles directly or indirectly related to payments. Furthermore, the accuracy of disclosures did not vary with the strength of a journals’ disclosure policies.

“Articles in journals with more stringent policies were no more likely than others to reveal an author’s industry relationship,” the authors wrote.

In no case, the study goes on, did journal articles reveal how substantial the payments were to the authors.

“Patients have a real stake in transparency,” Rothman stated in the release. “You want to make sure that the surgeon is choosing the device that is best for you and that your doctor is not getting biased information.”

Acceleration of the process

The authors noted that journal editors typically do not check multiple databases that are now available, relying more on the honor system. Researchers are expected to disclose all of their conflicts, but this information is not verified to be complete or accurate, they wrote.

“These articles constitute a permanent scientific record that is used by practicing physicians, guideline committees, purchasers and patients to evaluate treatment options,” the authors wrote. “The availability of company data provides an unprecedented opportunity for the medical profession to move to a system of full, verifiable transparency. Medical journals, as gatekeepers of scientific knowledge, should be among the first to use company data, setting the standard for others to follow.”

Rothman added that editors and others need to start using company databases to get information about physician-industry relationships. No less than 15 drug and device companies are now putting payment information on their websites – a practice that will be accelerated by the Patient Protection and Affordable Care Act.

“The next generation of physicians should know that every dollar they take from industry is going to be made public,” Rothman told Orthopedics Today. – by Robert Press

Notes from the editors

None of the journals in the study were identified. SLACK Incorporated, the parent company of Orthopedics Today, also publishes Orthopedics.

See the cover story on surgeon/industry disclosures in the November issue of Orthopedics Today.

References:

• Chimonas S, Frosch Z, Rothman DJ. From disclosure to transparency: The use of company payment data. Arch Intern Med. Published online September 13, 2010. doi:10.1001/archinternmed.2010.341
• www.imapny.org

• David J. Rothman, PhD, received travel reimbursements from IMAP; is a is an ethics consultant (unpaid) to the North American Spine Society, and has received small gifts and travel reimbursements connected to this consulting; received honoraria and travel reimbursements from the Department of Orthopedics at the University of Utah and the Spine Education Summit .

Scholarly medical and scientific publications have been wrestling with the problem of lack of disclosure — lack of transparency of real or apparent conflicts of interest of authors (what is reported, how it’s reported and how much money is involved) — for years. Journals have relied on the honor system with authors asked to voluntarily disclose their conflicts. Most top tier journals … like Journal of Bone and Joint Surgery (JBJS) … have been engaged in activities to improve disclosure for many years, but have a distance to go. This paper clearly demonstrated that our efforts for full transparency of conflicts must continue.

As Chairman of the Board of Trustees of the Journal of Bone and Joint Surgery, I know that our senior management and the trustees have been concerned about incomplete disclosures of conflicts of interest by authors. We currently have an active board (including management) project team that is developing new conflict of interest policies … for authors, the editorial staff, trustees, senior management and staff. We also have been following the development of new disclosure policies by the International Committee of Medical Journal Editors (ICMJE), planning to possibly adopt their new policies. However, I don’t believe that the ICMJE new guidelines go far enough; they do not request that authors report their actual payments (specific amounts) from industry.

This study, I believe, will have a major impact, resulting in journals’ staffs and boards of directors, professional societies (which provide continuing medical education programs and clinical guidelines for patient care), hospitals and academic medical centers and others re-evaluating, even again, their disclosure policies. Each will be influenced to include these more objective disclosures — public reports of payments made to physicians and health care organizations by industry — in their conflict of interest policies.

The newly passed Patient Protection and Affordable Care Act requires that by 2013 all payments to physicians from device and drug companies must be recorded in a national online database. I believe that because all previous attempts at full transparency for authors’ conflicts continue to be a work in progress, journals and the above-mentioned organizations will most likely develop systems that will link this data to specific authors as the authors of this paper recommend.

As the medical historian Ludmeyer stated, “Medicine is, at its center, a moral enterprise grounded in a covenant of trust. Today, this covenant is significantly threatened.” By providing full transparency of any real or perceived conflicts of interest of medical/scientific authors, we will have taken a significant step forward in restoring that trust.

– James H. Herndon, MD, MBA
Chairman of the Board of Trustees of the Journal of Bone and Joint Surgery

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