Physician Interactions With Industry: Striking the Right Balance

Authors: Cory L. Anand JD and Raed A. Dweik MD, MBA
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See related article at: 10.6004/jnccn.2021.7024.

The Open Payments database, required pursuant to the Physician Payment Sunshine Act (Sunshine Act), was created as part of the passing of the Patient Protection and Affordable Care Act implemented in 2010.1 The Open Payments database is the most comprehensive source of industry payments to physicians to date. Prior to the first Open Payments data being reported for a portion of calendar year 2013, and annually thereafter, several drug and device manufacturers reported these payments and other transfers of value either voluntarily, under court order, or under state-specific legislation.2 Under the Sunshine Act, manufacturers of covered drugs, devices, biologics, and medical supplies must report payments and other transfers of value to physicians and teaching hospitals to the Centers for Medicare & Medicaid Services (CMS). CMS provides teaching hospitals and physicians the opportunity to review and dispute the data, and thereafter makes it publicly available via the Open Payments site.

Many published reports trend this publicly available data, both before and following the first report of the Open Payments data. These analyses show that physician characteristics associated with higher payments have been identified, and include gender,35 years in practice,5 medical school,5 institution,3 and specialty.4,5 Furthermore, with these data and other publicly available data sources, such as Medicare Part D prescribing data, many researchers have been able to identify associations between payments and prescribing patterns.6,7 Other analyses conclude that industry payments are associated with more favorable publications of research results and editorials.8,9

Prior to the passing of the Sunshine Act, some people speculated and hoped that publishing the payment and other transfers of value data would cause a decrease in payments or other transfers of value from industry. That objective of the law’s enactment has not come to fruition. Each year, with the explainable exception of the calendar year 2020 due to COVID-19, the total amount of general payments to physicians has increased. It is largely assumed that the decrease in 2020 was associated with less travel and fewer meals and events due to the COVID-19 pandemic.

In evaluating payments to oncologists and internists from 2014 through 2017, Rahman et al10 add to this growing body of literature with a novel examination of industry payments associated with PD-1 and PD-L1 immunotherapy drugs. The recent approval of these products allows for the unique opportunity to evaluate the initial payment pattern for a new and expensive class of drugs. This evaluation by Rahman et al provides several novel and useful insights. They identify a 165% increase in payments to physicians from companies marketing PD-1 or PD-L1 drugs during the study period, compared with a 31% increase from benchmark companies not marketing those drugs. Interestingly, the authors hypothesized that there may be higher payments associated with the annual meeting of the specialty, but that was not substantiated in the data. Lower payments were identified in the summer and the first and last weeks of the year, likely correlating with common vacation times. The authors also found that there was no decrease in the willingness of more recent medical school graduates to accept payments from industry. This demonstrates that the Sunshine Act did not have the intended effect of reducing these relationships. The authors also confirm differences in the number of payments based on physician specialty, years in service, and gender, which have previously been identified in the literature.

The study had a few limitations, and some conclusions may have alternative explanations not directly addressed. The authors indicate that they selected internists for the control group because they would be unlikely to receive payments related to cancer drugs. However, given the known differences in payment associated with specialty and between internists and subspecialists, it may have been more appropriate to use another subspecialty for comparison instead of general internists. In 2017, the authors report that 67.3% of oncologists received a payment or other transfer of value from industry with a mean value of $5,854, whereas 44.1% of internists received a payment with a mean value of $450. In practice, an oncologist’s salary is also generally higher than that of an internist. During the reporting period, the authors found that payments to oncologists increased more dramatically than payments to internists. The authors ascribe the greater increase in payments to a potentially higher return to pharmaceutical companies given the price of oncology drugs compared with drugs an internist may prescribe. Although this may be one reason for the difference, another may be associated with physician collaboration and research required as new cancer drugs are developed and brought forward for approval. The authors identified that physicians who serve on NCCN Guidelines panels during the relevant period of 2014–2017 received more payments and other transfers of value from industry than other oncologists during this period, and the increase in payments over the time period was greater than that of other oncologists. Notably, the median increased by 173% for NCCN Guideline contributors compared with 31% for other oncologists. Based on these data, the authors concluded that drug companies intentionally target guideline contributors due to their ability to influence use of the companies’ products. An alternative possibility not credited is that certain oncologists, due to their leadership and expertise in the field, are sought after by companies as well as to serve as guideline developers. The authors did recognize that these NCCN Guideline panelists are more likely to be academic oncologists involved in research, which is associated with consulting and other ancillary payments.

It may be important to take this opportunity to acknowledge that physician relationships with industry are not inherently good or bad. There are positive interactions between physicians and industry that help advance medical breakthroughs with input by physicians. Physicians are and should be compensated for this work, but such relationships certainly create the potential for bias. This is why these relationships need to be appropriately structured and managed. In addition, there are inappropriate relationships and payments that should be monitored and eliminated. Rahman et al11 focus on the negative aspects of relationships with industry and eventually conclude that action should be taken to reduce and eventually eliminate acceptance of payments by physicians. A more balanced approach could recognize beneficial collaborations between physicians and industry while eliminating inappropriate relationships such as sham payments, promotional activities, industry representative–provided meals, and speakers’ bureau activities.

References

  • 1.

    Patient Protection and Affordable Care Act. Pub L No. 111–148, 124 Stat 119–1025 (2010).

  • 2.

    Chimonas S, Rozario NM, Rothman DJ. Show us the money: lessons in transparency from state pharmaceutical marketing disclosure laws. Health Serv Res 2010;45:98114.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 3.

    Rose SL, Sanghani RM, Schmidt C, et al. Gender differences in physicians’ financial ties to industry: a study of national disclosure data. PLoS One 2015;10:e0129197.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4.

    Tringale KR, Marshall D, Mackey TK, et al. Types and distribution of payments from industry to physicians in 2015. JAMA 2017;317:17741784.

  • 5.

    Inoue K, Blumenthal DM, Elashoff D, et al. Association between physician characteristics and payments from industry in 2015–2017: observational study. BMJ Open 2019;9:e031010.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6.

    Perlis RH, Perlis CS. Physician payments from industry are associated with greater Medicare Part D prescribing costs. PLoS One 2016;11:e0155474.

  • 7.

    Rhee TG, Ross JS. Association between industry payments to physicians and gabapentinoid prescribing. JAMA Intern Med 2019;179:14251428.

  • 8.

    Kaestner V, Edmiston JB, Prasad V. The relation between publication rate and financial conflict of interest among physician authors of high-impact oncology publications: an observational study. CMAJ Open 2018;6:E5762.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9.

    Fugh-Berman A, McDonald CP, Bell AM, et al. Promotional tone in reviews of menopausal hormone therapy after the Women’s Health Initiative: an analysis of published articles. PLoS Med 2011;8:e1000425.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 10.

    Rahman M, Trivedi N, Bach P, Mitchell A. Increasing financial payments from industry to medical oncologists in the United States, 2014–2017 [published online December 28, 2021]. J Natl Compr Cancer Netw, doi: 10.6004/jnccn.2021.7024

    • Search Google Scholar
    • Export Citation
  • 11.

    Tokar D. Health-care industry faces greater scrutiny around payments to doctors to promote products. Wall Street Journal. December 3, 2020. Accessed September 10, 2021. Available at: https://www.wsj.com/articles/health-care-industry-faces-greater-scrutiny-around-payments-to-doctors-to-promote-products-11606991402

    • Search Google Scholar
    • Export Citation

CORY L. ANAND, JD

Cory L. Anand, JD, is Director, Conflict of Interest, Cleveland Clinic Health System's Innovation Management and Conflict of Interest Program. Ms. Anand is responsible for drafting conflict of interest management plans, proposing and drafting conflict of interest policy, analyzing conflict of interest-related guidelines, and overseeing the day-to-day activities of the Innovation Management and Conflict of Interest Office. She also collaborates on conflict of interest research projects. Ms. Anand graduated from Case Western Reserve University School of Law magna cum laude with a concentration in health law. She received her bachelors degree from the University of Wisconsin-Madison in Entomology and Zoology.

RAED A. DWEIK, MD, MBA

Raed A. Dweik, MD, MBA, is the Chair of the Innovation Management and Conflict of Interest Committee for the Cleveland Clinic Health System. He is also the Chairman of the Respiratory Institute at Cleveland Clinic and holds the E. Tom and Erika Meyer endowed chair in pulmonary disease. Dr. Dweik is Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and maintains an active practice in pulmonary and critical care medicine. He has been listed in the Best Doctors in America since 2005. He was the recipient of the Cleveland Clinic Outstanding Innovation in Translational Medicine Award, and a Third Frontier award from the state of Ohio for his pioneering work in exhaled breath analysis for the identification of lung and systemic disease. He has published more than 250 peer reviewed manuscripts and book chapters and serves on several journal editorial boards. Dr. Dweik serves on NIH, American Heart Association, Association of American Medical Colleges, and several other national review panels and committees. Dr. Dweik is a Fellow of the American College of Physicians (FACP), the Royal College of Physicians of Canada (FRCPC), the American College of Chest Physicians (FCCP), the Society of Critical Care Medicine (FCCM), the American Heart Association (FAHA), and the American Thoracic Society (ATSF).

Disclosures: The authors have disclosed that they have no financial interests, arrangements, or affiliations with the manufacturers of any products discussed in this article or their competitors.

Correspondence: Raed A. Dweik, MD, MBA, Innovation Management and Conflict of Interest Program, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195. Email: dweikr@ccf.org
  • 1.

    Patient Protection and Affordable Care Act. Pub L No. 111–148, 124 Stat 119–1025 (2010).

  • 2.

    Chimonas S, Rozario NM, Rothman DJ. Show us the money: lessons in transparency from state pharmaceutical marketing disclosure laws. Health Serv Res 2010;45:98114.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 3.

    Rose SL, Sanghani RM, Schmidt C, et al. Gender differences in physicians’ financial ties to industry: a study of national disclosure data. PLoS One 2015;10:e0129197.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4.

    Tringale KR, Marshall D, Mackey TK, et al. Types and distribution of payments from industry to physicians in 2015. JAMA 2017;317:17741784.

  • 5.

    Inoue K, Blumenthal DM, Elashoff D, et al. Association between physician characteristics and payments from industry in 2015–2017: observational study. BMJ Open 2019;9:e031010.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6.

    Perlis RH, Perlis CS. Physician payments from industry are associated with greater Medicare Part D prescribing costs. PLoS One 2016;11:e0155474.

  • 7.

    Rhee TG, Ross JS. Association between industry payments to physicians and gabapentinoid prescribing. JAMA Intern Med 2019;179:14251428.

  • 8.

    Kaestner V, Edmiston JB, Prasad V. The relation between publication rate and financial conflict of interest among physician authors of high-impact oncology publications: an observational study. CMAJ Open 2018;6:E5762.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9.

    Fugh-Berman A, McDonald CP, Bell AM, et al. Promotional tone in reviews of menopausal hormone therapy after the Women’s Health Initiative: an analysis of published articles. PLoS Med 2011;8:e1000425.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 10.

    Rahman M, Trivedi N, Bach P, Mitchell A. Increasing financial payments from industry to medical oncologists in the United States, 2014–2017 [published online December 28, 2021]. J Natl Compr Cancer Netw, doi: 10.6004/jnccn.2021.7024

    • Search Google Scholar
    • Export Citation
  • 11.

    Tokar D. Health-care industry faces greater scrutiny around payments to doctors to promote products. Wall Street Journal. December 3, 2020. Accessed September 10, 2021. Available at: https://www.wsj.com/articles/health-care-industry-faces-greater-scrutiny-around-payments-to-doctors-to-promote-products-11606991402

    • Search Google Scholar
    • Export Citation
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