Analysis of Transparency in Journal Disclosures
Although it is standard practice for medical journals to require authors to disclose industry relationships, the requirements vary among journals and are often not specific, according to researchers. Authors themselves are sometimes left to determine the appropriate period for disclosure or the relevance of a financial relationship to a submitted article. Thus, the reviewers and readers may not be fully informed of the connections between the authors and the industry. The researchers continued by stating that full disclosure in medical journals of industry relationships is critical because the articles form a permanent scientific record used by clinicians, guidelines committees, purchasers, and patients to evaluate treatment options. Full disclosure allows editors, reviewers, and readers to be fully informed about authors’ industry relationships to consider potential for bias. To evaluate the transparency provided by the current journal disclosure system, researchers recently examined 2007 physician payment data from 5 orthopedic device companies. The 5 companies included in the analysis were Biomet, DePuy Orthopedics, Smith & Nephew, Stryker, and Zimmer. Results of the analysis were reported in a recent issue of Archives of Internal Medicine [2011;171(1):81-86]. The analysis compared company payment information for recipients of ≥$1 million with disclosures in the recipients’ journal articles. Payments were made to company consultants—the category included individuals, hospitals, academic medical centers, professional medical associations, foundations, and corporations that received payments for “services relating to hip or knee reconstruction and replacement.” The disclosures used in the analysis were obtained in the acknowledgments section, conflict of interest statements, and financial disclosures of published articles authored by the recipients. In aggregate, the 5 companies made 1654 direct payments in 2007, for a total of $248 million. Mean payment to all consultants was $150,000 (median, $13,850). Of the total funds distributed, 81% ($184 million) were paid to individuals. The mean payment to individuals was $187,000 (median, $17,500). The disparity between the mean and the median variables suggests that a few very high payments skewed the distribution. Forty individuals (38 physicians and 2 researchers with PhDs) received at least $1 million from a single manufacturer; 1 physician received >$1 million from each of 2 companies. These 41 recipients received $114 million (mean $2,781,866; median, $2,187,500). The researchers focused on this cohort of recipients. Of the 41 individuals who received ≥$1 million, 32 published a total of 151 articles on orthopedics between January 1, 2008, and January 15, 2009. The average number of articles published by each author was 5; 1 author published 11 articles. After applying inclusion criteria, the examination included 95 articles, ranging from clinical studies and literature reviews to meta-analyses and evaluations of device materials. The researchers found considerable variation in published disclosures of company payments. Of the 95 articles analyzed, 46% (n=44) disclosed a financial relationship between the author and the orthopedic manufacturer. Seven of the 95 articles provided information on the amount of money received; all 7 were published in a journal whose disclosure guidelines requested disclosures of payments “in excess of $10,000.” Three other articles were in the same journal, but did not disclose the payment. Of the 27 authors with >1 article in the sample, 15% (n=4) consistently mentioned the company name, 52% (n=14) were inconsistent in mentioning the company name, and 33% (n=9) did not mention the company payment at all. In 26% of the articles (n=25), the recipients of ≥$1 million were first or sole authors, 36% (n=34) were middle authors, and 38% (n=36) appeared as senior authors. There were no statistically significant differences among the 3 authorship categories, but when the researchers combined the first/sole and senior categories into a measure of authorship prominence, there were significant variations. The rate of disclosure was 54% when the payment recipient was the first, sole, or senior author, versus 32% when the payment recipient was a middle author (P=.03). Articles in journals with stricter disclosure policies were not more likely to reveal the author’s industry relationship. In conclusion, the researchers stated that “current journal disclosure practices do not yield complete or consistent information regarding authors’ industry ties. Medical journals, along with other medical institutions, should consider new strategies to facilitate accurate and complete transparency.”