Elsevier

The Spine Journal

Volume 13, Issue 12, 1 December 2013, Pages 1780-1788
The Spine Journal

Clinical Study
Discrepancies in spine surgeon conflict of interest disclosures between a national meeting and physician payment listings on device manufacturer web sites

https://doi.org/10.1016/j.spinee.2013.05.032Get rights and content

Abstract

Background context

Previous studies have identified inconsistencies in physician conflict-of-interest disclosures at academic meetings. The Physician Payment Sunshine Act (PPSA) will require industry to disclose anything of value given to physicians by 2014. In preparation, some spine device companies have begun reporting payments online.

Purpose

To evaluate potential inconsistencies between physician disclosures and payments reported by industry before the PPSA implementation.

Study design

Comparison of publically available disclosure/payment data.

Patient sample

Physicians participating in the 2011 North American Spine Society (NASS) annual meeting and physicians listed on the 2010 physician payment web sites of Medtronic and Depuy Spine.

Methods

Disclosures of participants at NASS were compared with the published Medtronic and Depuy Spine physician payments. The periods reflected by the disclosures compared should have coincided (except the Depuy site, which was only listed for one quarter of the NASS disclosure period). Discrepancies were noted whenever participant disclosures and company listings did not match as well as whenever payment ranges did not overlap. Fisher's exact test was used to compare disclosure discrepancy rates based on Medtronic payment size. No funding was received for this work. The authors report no conflicts of interest directly related to this study; however, one of the authors does do consulting unrelated to this study.

Results

Medtronic and Depuy Spine were disclosed by 12.1% and 8.75% of NASS participants, respectively. Based on NASS disclosures, 52.4% of NASS participants affiliated with Medtronic had their disclosures inaccurately reflected on the Medtronic web site. Based on Medtronic payment postings, 45.7% of NASS participants listed on Medtronic's webpage had discrepancies in their NASS disclosures. Those who received payments <$100,000 from Medtronic were more likely to have discrepancies in their disclosures than those who received payments >$100,000 (p=.009). Based on Depuy Spine payment postings, 30% of NASS participants listed on Depuy Spine's site had discrepancies in their NASS disclosures.

Conclusions

Discrepancy rates between what spine surgeons disclosed at NASS 2011 and what companies reported for their consultants were high. This is concerning given the passage of the PPSA as well as the increased public visibility of potential discrepancies. More uniform practices will certainly be necessary.

Introduction

Evidence & Methods

Financial conflicts of interest can bias presented and published research. Thus, accurate disclosure is vital so that the audience (ie, listeners at a conference, readers of journal articles) can consider this information when analyzing the results.

The authors found that about half of the time there were significant discrepancies in the reporting of conflicts when comparing NASS disclosures from the annual meeting with published reports from two device manufacturers.

The information is important given recent concerns about conflicts of interest and reported research results in spine surgery literature. That said, there may be valid reasons for discrepancies, such as timing of disclosure and undefined dollar amounts depending on when consulting or royalty payments are received. Beyond this, there is limited literature to suggest that the amount of money received holds a linear relationship with potential bias. Clearly, however, given the increased and justified scrutiny of sponsored authors, aiming for accuracy in reporting is an important goal.

On March 23, 2010, Congress passed into law the Physician Payment Sunshine Act (PPSA). The originally proposed act aimed to require manufacturers of pharmaceuticals, medical devices, biological products, and medical supplies to report all payments to physicians worth more than $10 by 2013 [1], [2], but the final ruling has now delayed the reporting to early 2014 [3]. This information will eventually be available online and searchable by the public [4]. In preparation for the implementation of the PPSA, some medical device companies have begun to voluntarily report payments to their physician consultants.

Although these payments to physicians by medical industries affect all areas of medicine, the field of orthopedic surgery and spine surgery are of special relevance given their well-established physician-industry relationships [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15]. The concerns about physician relationships with industry include potential financial conflicts of interest that may impact research, medical decision-making, and patient care. Consequently, financial relationships and interactions between orthopedic surgeons and medical device manufacturing companies are drawing greater attention [16], [17]. To increase transparency, disclosure of physician relationships with industry has become standard practice in medical journals and academic society meetings [11]. However, the definition of what constitutes appropriate disclosure continues to evolve [18].

Although few question the importance of increased financial transparency in the medical arena, the implementation of such disclosure reporting is complex and fraught with potential errors and inconsistencies. This has been highlighted in recent studies demonstrating that significant variability exists in the reporting of financial conflicts of interest by individual surgeons presenting in the same year at different spine surgery society meetings [10] and sports medicine society meetings [9]. In fact, in a separate study, Jegede et al. identified that surgeons had a difficult time simply deciphering what financial information was being asked for disclosure when reviewing instructions from journal or society meetings [8]. Other studies have also found inconsistencies between company payments and physician disclosures but these were done in the time before the passing of the PPSA and stricter disclosure guidelines [7], [11].

The purpose of the current study was to evaluate the accuracy of physician's self-reported, conflict-of-interest disclosures with the posted payments to these same physicians on the web sites of spine implant manufacturers in the period preceding the implementation of the PPSA. To this end, we analyzed payments to physicians that were made in 2010 by two large spine implant manufacturers, Medtronic and Depuy Spine Inc., and compared these with the monetary conflict-of-interest disclosures made by physicians who were participants at the 2011 annual meeting of the North American Spine Society (NASS). This conference and companies were chosen as the periods for disclosure reporting and posted payments were overlapping and should have been comparable.

Section snippets

2011 NASS Annual Meeting

The 46th annual NASS meeting was held November 2–5, 2011, in Chicago, IL. The meeting's disclosure policy [19] required its participants to disclose in estimated dollar amounts all financial relationship(s) greater than $100 that occurred between January 1, 2010, and December 31, 2010, regardless of relevance to the author's presentation (global disclosure). The NASS disclosure index [20] indicated the name of the medical device company with whom the participant had relationship(s), the type of

NASS 2011 Annual Meeting

Disclosure information was available for 1,100 participants at NASS 2011. A total of 677 (61.5%) participants disclosed no relationships with industry, whereas 133 (12.1%) disclosed relationships with Medtronic and 96 (8.75%) disclosed relationships with Depuy Spine. Of these participants 36 (3.3%) disclosed relationships with both companies. The remaining 230 (20.9%) participants had disclosures other than Medtronic or Depuy Spine. The minimum summed disclosed Medtronic and Depuy Spine

Discussion

In this observational study of conflict-of-interest disclosures by participants at NASS 2011, we found that the physicians' self-reported disclosures were quite different from what the companies posted online regarding payments made to these same physicians. First, assuming the NASS participants were accurate in their disclosures, then Medtronic had discrepancies for 52.4% of NASS participants with Medtronic affiliations. On the other hand, assuming that Medtronic was accurate in its payment

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    FDA drug/device status: Not applicable.

    Author disclosures: RAB: Nothing to disclose. MCF: Nothing to disclose. JNG: Consulting: Affinergy (D), Alphatec (E), Depuy (C), Harvard Clinical Research Institute (D), Medtronic (B), Powered Research (A), Stryker (E); Grants: Smith and Nephew (no salary support, paid directly to institution).

    The disclosure key can be found on the Table of Contents and at www.TheSpineJournalOnline.com.

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