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Invited Commentary
Gastroenterology and Hepatology
December 28, 2018

The Call for Greater Transparency in Conflicts of Interest

Author Affiliations
  • 1Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas
  • 2Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
JAMA Netw Open. 2018;1(8):e186342. doi:10.1001/jamanetworkopen.2018.6342

Physicians, according to the age-old ideal, are professionals who always hold their patients’ interests above their own. However, modern medicine poses ever-present financial conflicts of interest that challenge this ideal for physicians of all stripes, whether through the push for positive findings to fuel research grants, the desire for excellent teaching evaluations to spur promotion, or the reality that treatment decisions for individual patients influence physicians’ collections from payers. More recently, attention has focused on another such conflict: payments to physicians from pharmaceutical and device companies, about which Nusrat et al1 report. Conflicts of interest, including relationships of all sorts with pharmaceutical and device companies, are an ever-evolving issue that requires more rigorous attention by medical societies.

Nusrat et al focus on payments to gastroenterologists. They queried the Centers for Medicare & Medicaid Services (CMS) Open Payments database and found that more than $67 million was paid to gastroenterologists in 2016. Of this amount, 62.7% was spent on consulting, speaking, or other services, and most of the remainder was divided between food and beverage expenditures, royalty and licensing fees, and travel and lodging expenses. The authors estimate that 88.9% of adult gastroenterologists and 66.7% of pediatric gastroenterologists received payments of some kind in 2016, and around 13% of gastroenterologists received funds for consultative or other services, with approximately 6% receiving more than $10 000. However, the vast majority of payments, nearly 90%, were for food and beverages.

Such payments are by no means unique to gastroenterology—indeed, the receipt of these payments is nearly universal across specialties2—however, the high-cost medications gastroenterologists use to treat conditions like hepatitis C and inflammatory bowel disease make gastroenterologists a rational choice for pharmaceutical spending; therefore, the specialty is an illustrative case study.

The authors’ source of data, the CMS Open Payments database, tracks the congressionally mandated reporting of payments from drug and device manufacturers to physicians. Although it is the largest and most reliable source of such data, the specifics of its reporting requirements should be noted. As anyone who has attended a large medical convention recently might attest, gifts as small as $10 are required to be reported, and still smaller gifts like coffee often are as well. This may explain why the vast majority of gastroenterologists had some sort of payment reported in the database.

Although the authors did not report on them, the CMS database also includes funds paid to physicians for research, which may be used to generate or augment the salaries of both academic and community physicians. There is a clear discordance between what is reported in the CMS database and what is self-reported by authors of medical articles.3 However, journals set their own standards for conflict of interest disclosure, and some journals may not require disclosure of conflicts considered irrelevant to the topic at hand, even if they are listed in the CMS database. Conversely, some conflicts may not be reported in the CMS database, but their disclosure may be required by some journals. Unfortunately, this discrepancy in reporting can lead to questions of bias, intended or unintended, and a lack of transparency surrounding conflicts of interest.

Importantly, financial conflicts of interest have the potential to negatively affect physicians’ care of patients. A physician who receives consulting fees, research funding, or food or travel expenses from a drug or device company may subconsciously or consciously develop a bias for that company’s products. As a result, that physician may oversell the products’ effectiveness to patients or recommend the product when it is not a patient’s best option. This may occur even with seemingly insignificant payments, as social science research suggests that even small financial transfers may influence physician decision making.4 Furthermore, irrespective of physicians’ ability to separate their financial conflicts from their day-to-day treatment recommendations, payments from for-profit enterprises may engender a lack of trust from patients and the public at large.

It follows that larger payments have the potential to be more influential. The physicians who receive these substantial payments are often thought leaders, and their expertise is valued not only by industry but also by committees drafting clinical guidelines. Nusrat et al also report that of 36 clinical practice guidelines published by 4 of the major gastroenterology societies in 2016 to 2017, 29 included authors who had payments listed in the Open Payments database. These 99 authors included 32 who received more than $10 000 in 2016 and 7 who collected more than $100 000. In addition, Khan et al5 recently reported on clinical guidelines involving the top 10 medications by revenue in 2016 and showed that about half of guideline authors had received payments from companies making those drugs.

Clinical guidelines exert an enormous effect on prescribing patterns, so it can be concerning that physicians with financial conflicts of interest are helping pen them. However, completely excluding these physicians may also result in exclusion of experts who provide valuable insight. Thus, creating a transparent and consistent process to determine who may be included in guideline-writing committees and what must be disclosed is key. To this end, the Institute of Medicine6 has outlined standards for guideline development and recommendations on how to manage potential conflicts among guideline panelists.

The Institute of Medicine guidelines dictate that conflicts must be declared, and, reassuringly, Nusrat et al report that all but 1 of the guidelines they examined had conflicts disclosed. It is also vital that guidelines be developed in a systematic fashion (for example, using the Grading of Recommendations Assessment, Development and Evaluation system) and include the participation of experts in methodology. In line with the Institute of Medicine guidelines, a minority of members on a guideline panel may have conflicts of interest, allowing for the inclusion of some experts with financial conflicts while ensuring they do not have undue voting power.

Physician-industry relationships are vital for the development of new drugs and devices, and the findings by Nusrat et al show that such relationships are common. Without these, experts could not lend their advice regarding drug development and front-line clinicians could not enroll their patients in clinical trials. However, it is imperative that medical societies and health care organizations create well-defined processes to address these potential conflicts so that health care development and delivery remain a transparent, unbiased process.

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Article Information

Published: December 28, 2018. doi:10.1001/jamanetworkopen.2018.6342

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2018 Fudman D et al. JAMA Network Open.

Corresponding Author: Joseph D. Feuerstein, MD, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215 (jfeuerst@bidmc.harvard.edu).

Conflict of Interest Disclosures: None reported.

References
1.
Nusrat  S, Syed  T, Nusrat  S, Chen  S, Chen  W-J, Bielefeldt  K.  Assessment of pharmaceutical company and device manufacturer payments to gastroenterologists and their participation in clinical practice guideline panels.  JAMA Netw Open. 2018;1(8):e186343. doi:10.1001/jamanetworkopen.2018.6343Google ScholarCrossref
2.
Tringale  KR, Marshall  D, Mackey  TK, Connor  M, Murphy  JD, Hattangadi-Gluth  JA.  Types and distribution of payments from industry to physicians in 2015.  JAMA. 2017;317(17):1774-1784. doi:10.1001/jama.2017.3091PubMedGoogle ScholarCrossref
3.
Cherla  DV, Olavarria  OA, Holihan  JL,  et al.  Discordance of conflict of interest self-disclosure and the Centers of Medicare and Medicaid Services.  J Surg Res. 2017;218:18-22. doi:10.1016/j.jss.2017.05.037PubMedGoogle ScholarCrossref
4.
Sah  S, Fugh-Berman  A.  Physicians under the influence: social psychology and industry marketing strategies.  J Law Med Ethics. 2013;41(3):665-672. doi:10.1111/jlme.12076PubMedGoogle ScholarCrossref
5.
Khan  R, Scaffidi  MA, Rumman  A, Grindal  AW, Plener  IS, Grover  SC.  Prevalence of financial conflicts of interest among authors of clinical guidelines related to high-revenue medications.  JAMA Intern Med. 2018. doi:10.1001/jamainternmed.2018.5106PubMedGoogle Scholar
6.
Institute of Medicine. Clinical practice guidelines we can trust. http://www.nationalacademies.org/hmd/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx. Published March 23, 2011. Accessed November 5, 2018.
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