Archives of Internal Medicine: Soros Funded Study on Disclosure Skirts the Facts

In October 2009, the International Committee of Medical Journal Editors (ICMJE) recommended a new “Uniform Format for Disclosure of Competing Interests in ICMJE Journals.” One of the main reasons for adopting this uniform format was because there was no uniform vehicle for the disclosure of financial associations among ICMJE member journals. Since there was no consistent format for authors to use, each journal had their own disclosure or transparency form and publication rules, which created a wide variation in disclosure.

 While it has become standard practice in medical journals over the past 25 years to require authors to disclose relationships with industry, those requirements have varied “across journals and often lack specificity.” Moreover, journals often leave it “to authors to determine the appropriate period for disclosure or the relevance of a financial relationship to a submitted article.” Given these unspecified and indeterminate requirements, disclosures have been inconsistent, ^“with neither reviewers nor readers fully informed of the ties between authors and industry.”

 Consequently, as disclosure and transparency have gained attention over the past several years, there have been a number of instances where the media or the medical journals themselves have pointed to doctors failing to properly disclose their financial interests in journal articles they author or co-author. In doing so, the media has portrayed the problem of disclosure and transparency as if it was the author or researchers fault. In fact, in response to a recent article published in the Archives of Internal Medicine, numerous mainstream media sources have painted this issue with broadly negative strokes.

 One article asserts that “Docs failed to disclose big ties,” and another stated that “Surgeons routinely fail to disclose financial ties,” as if this were a widespread practice plaguing medical journals. These sensationalist titles, and the article from the Archives itself, underscore the fact that at the time of the study there was no uniform reporting established for medical journals, and there was a large amount of confusion on the part of doctors authoring and publishing articles. In other words, while the media has chosen to put the blame on doctors for failing to disclose such payments, the reality is, the confusing, unorganized, wide-ranging, and inconsistent policies of journals are what caused such failures.

 The authors noted that full disclosure in medical journal articles is of great concern because “these articles constitute a permanent scientific record that is used by practicing physicians, guideline committees, purchasers, and patients to evaluate treatment options.” As a result, it is crucial that “journal editors, reviewers, and readers are fully informed about authors’ industry relationships to consider the potential for bias”

 Accordingly, the study examined the 2007 physician payment information from 5 orthopedic device companies: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer. The authors compared company payment information for recipients of $1 million or more with disclosures in the recipients’ journal articles. Disclosures were obtained in the acknowledgments section, conflict of interest statements, and financial disclosures of recipients’ published articles. The authors also assessed variations in disclosure by authorship position, payment-article relatedness, and journal disclosure policies.

The study found 41 individuals who received $1 million or more in 2007, of which 32 had published 151 articles relating to orthopedics between January 1, 2008, and January 15, 2009. Findings included:

–  Fewer than half of the journal articles (46%) disclosed a financial relationship between the author and the orthopedic device manufacturer from which an author received at least $1 million;

–  Disclosures of company payments varied considerably;

–  In no article could readers know how substantial the company payment to an author was;

–  More stringent journal policies were not associated with greater transparency;

–  Prominent authorship position and article-payment relatedness were associated with greater disclosure;

–  Nondisclosure rates remained high: even when the recipient of company funds was the first, sole, or senior author, only 54% of the articles mentioned the company tie;

–  Even among articles directly or indirectly related to payments, the disclosure rate was only 50%

The authors explained that “there are many possible explanations for this lack of full and consistent disclosure.” For example, they noted that “journals may not solicit—or may not publish—complete financial disclosures.” Another explanation was that “authors may believe that payments from orthopedic device manufacturers are not relevant to research reports in orthopedics that do not specifically evaluate the company’s products.” In both situations, the study recognized that “it is likely that both journals and authors contribute to the lack of full transparency in published articles.”

One weakness from the study was that the companies specified only whether payments were direct or “in-kind” (reimbursements), not what service the direct payment was for (eg, consulting, royalties, honoraria). This is problematic because the authors just lumped together totals, instead of breaking down exactly what work and services these doctors were providing, for example, if they received royalties from an invention or if they spoke at an educational seminar.  Another weakness was that the study used a limited sample of articles and authors in a single year, which led the authors to recognize the need for further research on more representative groups.

Discussion

David J. Rothman, a professor and president of the Institute on Medicine as a Profession at Columbia University, who wrote the study, and is largely funded by liberal billionaire George Soros still believes the payments are “clear conflicts of interest.” Despite his broad generalization of such payments, Dr. Rothman and his colleagues recognized however that, payments don’t mean an article “shouldn’t be published,” it means that readers “should know that the author has a real stake in this game.”

Dr. Rothman’s comment however, completely ignores the fault of journals for having unclear policies that make it confusing for authors to disclose. Doctors are not consciously failing to disclose their relationships; they are reading unclear policies and making decisions about what to report without any clear guidance from the journals.  Many of these authors are uniquely qualified to conduct such research and publish their results because they are often the inventors of such devices or have mastered the techniques for using such devices. They are not out to hide their success collaborating between academia and industry.

But critics of such payments, such as Arnold Relman, a former editor of the New England Journal of Medicine, believe this “kind of money compromises the doctors who take it and should be eliminated from the practice of medicine.” He further asserted that “When you take money from the company that makes the product, you clearly undermine the ethical relationship between doctor and patient.” Dr. Relman believes that because orthopedic surgeons make a lot of money, to make more “is greed and nothing more.”

 What Dr. Relman ignores, is that in many situations, the doctors receiving such payments are the ones who developed the innovation, and are the only individuals truly qualified to train physicians in the earliest stage of adoption of a new medical device, technique, or technology. It is only by principle of the significant risk these doctors took to research and develop such devices that they be rewarded, and that is how all business models work.

 

Conclusion

 

Given these findings, the authors asserted that “current journal disclosure practices do not yield complete or consistent information regarding authors’ industry ties.” As a result, they recommended that “medical journals, along with other medical institutions, should consider new strategies to facilitate accurate and complete transparency.”

 

With 15 pharmaceutical and medical device companies now publicly reporting data about their payments to physicians and health care organizations, an updated ICJME form, and newly enacted health care reform legislation requiring the same companies to report all such payments, transparency of such payments will likely be increased. Once the public realizes these doctors are hiding nothing and they begin to understand the impact and importance such relationships play, doctors can continue focusing again on improving patient outcomes with the devices they helped create.