AAOS Now

Published 4/1/2019
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Gregory A. Brown, MD, PhD; Kevin G. Shea, MD; Kaitlyn S. Sevarino, MBA

The Integrity of Scientific Work Relies on Transparency of Financial Conflicts

In 2007, Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) introduced the Physician Payments Sunshine Act to increase transparency of the relationships between physicians and medical product manufacturers. Although initial attempts to pass the bill failed, it was enacted as part of the Affordable Care Act in 2010. To further promote transparency in medicine, the Centers for Medicare & Medicaid Services (CMS) began reporting physician payments on its Open Payments website in 2013. ProPublica has independently analyzed the CMS Open Payments data and reports the same information on its Dollars for Docs website.

The resignation of José Baselga, MD, as chief scientific officer at Memorial Sloan Kettering Cancer Center due to his repeated failure to properly disclose millions of dollars in industry payments is a recent example of the fallout that a lack of transparency can create. His departure highlights the importance of continuously vetting financial conflicts of interest (FCOIs). An editorial in The New York Times reported that “nearly 70 percent of oncologists who speak at national meetings, nearly 70 percent of psychiatrists on the task force that ultimately decides what treatments should be recommended for … mental illnesses, and a significant number of doctors on Food and Drug Administration advisory committees have financial ties to the drug and medical device industries.”

Because orthopaedics is a medical specialty with one of the highest average incomes, we need to be able to withstand the scrutiny placed on other areas of medicine and proactively prevent any FCOIs from presenting bias in the Academy’s evidence-based clinical practice guideline (CPG) workgroups.

Even when FCOIs are disclosed, the presentation of the information can be biased, and the audience may not be aware that the evidence is being manipulated. Thus, is transparency enough?

An example of transparency not being enough to prevent bias in CPGs is the use of aspirin for venous thromboembolism (VTE) prophylaxis. For the past decade, the use of aspirin for VTE prophylaxis after total hip replacement (THR) and total knee replacement (TKR) surgery has been one of the most contentious issues in orthopaedics. Aspirin was removed from Medicare’s Surgical Care Improvement Project (SCIP) list of approved agents for VTE prophylaxis after THR or TKR because of a CPG from the American College of Chest Physicians (ACCP). In 2004, ACCP released Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines, and six of the seven writing panel members disclosed FCOIs with Sanofi-Aventis, a manufacturer of a low-molecular-weight heparin, an injectable agent for VTE prophylaxis. The guideline stated, “We recommend against the use of … aspirin” for elective hip arthroplasty, elective knee arthroplasty, and hip fracture surgery. After much controversy, ACCP convened a new workgroup that did not have those FCOIs, and the new CPG included aspirin as an acceptable option for VTE prophylaxis. This change aligned AAOS and ACCP recommendations, and effective Jan. 1, 2014, aspirin became an acceptable VTE prophylaxis treatment that met SCIP measures for orthopaedic surgery.

The authors operated under the false assumption that if we did not have any consulting contracts with pharmaceutical or orthopaedic implant manufacturers, we did not need to review the CMS Open Payments or ProPublica websites. However, this is another form of online presence of which we must be aware. The results were eye opening! For example, the only listing for Gregory A. Brown, MD, PhD, orthopaedic surgery, on the CMS Open Payments website was for his first hospital practice in Minnesota (1999–2006). In 2014, Dr. Brown moved to Washington state, yet the query for Washington found no matches. Data were provided for 2013–2017 but did not link any of the payments to specific topics. ProPublica’s Dollars for Docs website provided more detail about the payments, including the companies and topics for each payment, but lagged one year behind CMS Open Payments on the reporting.

The granular data provided by ProPublica can be helpful for the evaluation of potential/perceived conflicts of interest. The AAOS Conflict of Interest policy specifies that to preclude participation on a CPG project or appropriate use criteria voting panel, an applicant’s financial conflicts must be both relevant to the topic and significant in nature. For example, Dr. Brown’s payment from Smith & Nephew for teaching orthopaedic trauma implants (from New Zealand and Australia while he was working in Auckland, New Zealand) was deemed not relevant to the Surgical Management of Osteoarthritis (OA) of the Knee CPG. (He represented the American Orthopaedic Society for Sports Medicine on the CPG work group.) Dr. Brown disclosed the relationship and payment through the AAOS Disclosure Program and was able to participate on the CPG workgroup.

An example of lack of transparency is the ongoing controversy in orthopaedic surgery regarding the use of hyaluronic acid (HA) injections for the treatment of knee OA. FCOIs can impart biases and affect the conduct of effectiveness analyses. The AAOS “Treatment of OA of the Knee: Evidence-based Guideline” (second edition) (OAK2) says that the workgroup “cannot recommend using HA for patients with symptomatic OA of the knee,” based on strong evidence remaining after the group eliminated randomized, controlled trials with a high risk of bias. Other meta-analyses supporting the use of HA injections have been published, and the authors of those reports have included biased clinical trials that were excluded from the AAOS OAK2 CPG meta-analyses. Some meta-analyses
supporting HA injections have been published by authors acknowledging FCOIs in other publications. For example, payments from Canadian companies are not listed in CMS Open Payments or ProPublica’s Dollars for Docs.

Lack of transparency also is present in letters to the editors of orthopaedic surgery journals. Because the letters are not peer-reviewed publications, there are no FCOI disclosures. Some letters have criticized the AAOS CPG development process without reporting relevant FCOIs. Thus, readers are advised to review reported FCOIs on the CMS Open Payments or ProPublica’s Dollars for Docs websites for authors of such letters.

To maintain the credibility of AAOS, the Evidence-based Quality and Value (EBQV) Committee will continue to manage FCOIs in the CPG development process. Members review the CMS Open Payments and ProPublica websites to assess possible FCOIs for workgroup applicants. The committee is broadening the diversity of the workgroups and including four Board of Councilors Research and Quality Committee members on the next three CPG workgroups. Committee members promise to continually improve the transparency of CPG development.

Gregory A. Brown, MD, PhD, is the former CPG section leader of the AAOS Committee on EBQV. He can be reached at brown061@gmail.com.

Kevin G. Shea, MD, is chair of the AAOS Committee on EBQV. He can be reached at kgshea@stanford.edu.

Kaitlyn S. Sevarino, MBA, is senior manager in the AAOS Department of Clinical Quality and Value.

References:

  1. The New York Times: Medicine’s Financial Contamination. Available at: https://www.nytimes.com/2018/09/14/opinion/medicines-financial-contamination.html. Accessed January 21, 2019.
  2. Geerts WH, Pineo GF, Heit JA, et al: Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126(suppl 3):S338-400.
  3. Jevsevar DS, Brown GA, Jones DL, et al: The American Academy of Orthopaedic Surgeons Treatment of Osteoarthritis of the Knee: Evidence-based Guideline, second edition. J Bone Joint Surg Am 2013;95:1885-6.