It’s no secret that money changes hands between healthcare professionals and the biopharma and medtech industries. It can take the form of gifts, travel and lodging, meals or, of course, speaker fees. The International Committee of Medical Journal Editors (ICMJE) requires that all study authors disclose any potential conflicts of interest, but whether they actually do so has been difficult to track, at least until the Sunshine Act came into effect in 2010.
The Centers for Medicare & Medicaid Services set up the Open Payments Database (OPD) in 2013 to collect data from the mandatory reporting of any and all payments made to physicians through surgical and medical device, pharmaceutical, and technology companies. A new study looking specifically at physicians who had received payments from surgical and medical device makers didn’t have encouraging results. It found that, of 100 doctors receiving payments from 1 of 10 selected companies declared their conflict of interest only 37% of the time.
“When evaluating published works, it is important to assess the integrity and academic credentials of the authors, who serve as putative experts. A relationship with a relevant manufacturer may increase the potential risk for bias in relevant studies. Research has shown that as many as 94% of physicians in the United States receive a form of benefit from an external company, with food and beverage being the most common,” the authors wrote. The study was conducted by a team in the Department of Surgery at the University of California, Irvine’s School of Medicine. It appears in JAMA Surgery.
The researchers looked at papers authored by the physicians who, based on OPD data, received the 10 highest payments from the following 10 companies in 2015: Medtronic, Stryker, Intuitive Surgical, Edwards Lifesciences, Ethicon, Olympus, W. L. Gore, LifeCell, Baxter and Covidien, whose merger with Medtronic closed in January 2015. While general payments included “food and beverage, consulting fees, nonpublicly traded ownership interests, honoraria, gifts, travel and lodging, entertainment, royalty or license,” and serving as faculty or as a speaker in various settings, the study excluded royalty or license payments from its analysis.
In general, Medtronic paid the most to physicians ($187,446,743 in total), with Stryker ($61,956,819) and Intuitive ($25,643,935) coming in a distant second and third. The mean value per payment didn’t differ too widely between Medtronic and Stryker: $712 and $693. As for payments to the 100 doctors in the sample population, Stryker came out tops, with Intuitive in second and Medtronic in fourth.
The researchers searched Pubmed for articles by each doctor published in 2016. They recorded the total number of publications and the number of articles published during that period, whether the doctor disclosed funding by one of the companies and whether the articles were relevant to the funding. If a device was directly or indirectly used, tested, investigated or discussed in an article, a payment from its manufacturer was considered relevant.
None of the doctors were among the top 10 recipients for more than one of the 10 evaluated companies. And 36 of them did not publish an article in 2016 and so, were excluded from the analysis. The 100 physicians in the sample population received nearly $12,447,000 in total payments, with a median payment of $95,993. Of the 225 publications that were deemed relevant, the doctors only declared their conflict of interest in 84 of them (37.3%). Of the 64 authors who published in 2016, 86% of them had at least one paper in which they did not declare a conflict of interest.
“This high rate of discordance raises concern regarding the accuracy and credibility of self-declared COI,” the researchers wrote. And their findings are in line with data from other studies using OPD data from 2013 and 2014.
The researchers wrote that the discordance rate could be due to differences in conflict-of-interest disclosure policies at different journals, meetings and institutions. And authors may have different ideas of what constitutes a conflict of interest. In their study, they call for a single standardized disclosure process to be used for “all scholarly activities,” the implementation of a conflict-of-interest statement in article abstracts and full disclosure of all financial ties, relevant or not.