They Know How to Work It,That’s Their Focus in Life: The Complex Role of Industry Representatives in Surgical Innovation

Abstract

Relationships between health care providers and industry can generate conflicts of interest with their attendant harms. However, the types of relationships that involve conflicts of interest have often been understood narrowly as material ones between individual clinicians and industry. In research we undertook with surgical teams, we found the role of industry representatives has become normalized in the context of surgical innovation. In this article, we report the findings of our study and unpack the features of both surgery and innovation which contribute to the scope and normalization of industry involvement. We argue that these relationships generate significant ethical challenges and conclude by commenting on how our conceptualization of the situation might inform change.

Keywords

bioethics conflicts of interest/bias in-depth interviews philosophy surgery surgical innovation device industry representatives

Get full access to this article

View all access options for this article.

References

American College of Surgeons. (2009). Statement on guidelines for collaboration of industry and surgical organizations in support of continuing education. Retrieved from https://https://www.facs.org/about-acs/statements/36-collaboration-industry-surgical

Brännström

Johannesson

Dahm-Kähler

Enskog

Mölne

Kvarnström

. . . Gäbel

(2014). First clinical uterus transplantation trial: A six-month report. Fertility and Sterility, 101, 1228-1236.

Brody

(2011). Clarifying conflict of interest. The American Journal of Bioethics, 11(1), 23-28.

Camp

M. W.

Mattingly

D. A.

Gross

A. E.

Nousiainen

M. T.

Alman

B. A.

McKneally

M. F.

(2013). Patients’ views on surgeons’ financial conflicts of interest. The Journal of Bone and Joint Surgery, 95(2), e9.

Dana

(2009). Appendix D: How psychological research can inform policies for dealing with conflict of interest in medicine. In Lo

Field

M. J.

(Eds.), Conflict of interest in medical research, education, and practice (pp. 358-374). Washington, DC: The National Academies Press.

de Gara

C. J.

Rennick

K. C.

Hanson

. (2013). Perceptions of conflict of interest: Surgeons, internists, and learners compared. The American Journal of Surgery, 205, 541-546.

DiCicco-Bloom

Crabtree

B. F.

(2006). The qualitative research interview. Medical Education, 40, 314-321.

DiPaola

C. P.

Dea

Noonan

V. K.

Bailey

C. S.

Dvorak

M. F.

Fisher

C. G.

(2014). Surgeon-industry conflict of interest: Survey of North Americans’ opinions regarding surgeons consulting with industry. The Spine Journal, 14, 584-591.

Grundy

(2016). “Whether something cool is good enough”: The role of evidence, sales representatives and nurses’ expertise in hospital purchasing decisions. Social Science & Medicine, 165, 82-91.

10.

Hutchison

Rogers

Eyers

Lotz

(2015). Getting clearer about surgical innovation: a new definition and a new tool to support responsible practice. Annals of surgery, 262, 949-954.

11.

Jacobs

J. J.

Galante

J. O.

Mirza

S. K.

Zdeblick

(2006). Relationships with industry: Critical for new technology or an unnecessary evil? The Journal of Bone and Joint Surgery, 88, 1650-1663.

12.

Johnson

Rogers

(2012). Innovative surgery: The ethical challenges. Journal of Medical Ethics, 38, 9-12.

13.

Johnson

Rogers

Lotz

Townley

Meyerson

Tomossy

(2010). Ethical challenges of innovative surgery: A response to the IDEAL recommendations. The Lancet, 376, 1113-1115.

14.

Katz

Caplan

A. L.

Merz

J. F.

(2003). All gifts large and small: Toward an understanding of the ethics of pharmaceutical industry gift giving. The American Journal of Bioethics, 3, 39-46.

15.

Kuzel

A. J.

(1992). Sampling in qualitative inquiry. In Crabtree

B. F.

Miller

W. L.

(Eds.), Doing qualitative research (pp. 31-44). Newbury Park, CA: SAGE.

16.

Langreth

(2013). Intuitive robosurgery training seen lacking in lawsuits. Bloomberg. Retrieved from https://www.bloomberg.com/news/articles/2013-03-21/intuitive-robosurgery-training-seen-lacking-in-lawsuits

17.

Liamputtong

(2013). Qualitative research methods (4th ed.). South Melbourne, Australia: Oxford University Press.

18.

Field

M. J.

(Eds.). (2009). Conflict of interest in medical research, education, and practice. Washington, DC: The National Academies Press.

19.

Mastroianni

A. C.

(2006). Liability, regulation and policy in surgical innovation: The cutting edge of research and therapy. Health Matrix: The Journal of Law-medicine, 16(2), 351-442.

20.

McCulloch

Altman

D. G.

Campbell

W. B.

Flum

D. R.

Glasziou

Marshall

J. C.

. . . Balliol Collaboration. (2009). No surgical innovation without evaluation: The IDEAL recommendations. The Lancet, 374, 1105-1112.

21.

McKneally

M. F.

(2007). Beyond disclosure: Managing conflicts of interest to strengthen trust in our profession. The Journal of Thoracic and Cardiovascular Surgery, 133, 300-302.

22.

McKneally

M. F.

(2011). The ethics of innovation: Columbus and others try something new. The Journal of Thoracic and Cardiovascular Surgery, 141, 863-866.

23.

Miller

W. L.

Crabtree

B. F.

(1992). Primary care research: A multimethod typology and qualitative road map. In Crabtree

F. B.

Miller

W. L.

(Eds.), Doing qualitative research (pp. 3-28). Newbury Park, CA: SAGE.

24.

Mirza

S. K.

(2004). Accountability of the accused: Facing public perceptions about financial conflicts of interest in spine surgery. The Spine Journal, 4, 491-494.

25.

Morgan

M. A.

Dana

Loewenstein

(2006). Interactions of doctors with the pharmaceutical industry. Journal of Medical Ethics, 32, 559-563.

26.

Morreim

Mack

M.J.

Sade

R.M.

(2006). Surgical innovation: too risky to remain unregulated? The Annals of Thoracic Surgery, 82(6), 1957-1965.

27.

O’Connor

Pollner

Fugh-Berman

(2016). Salespeople in the surgical suite: Relationships between surgeons and medical device representatives. PLoS ONE, 11(8), e0158510.

28.

Oxford Radcliff Hospitals NHS Trust Memorandum (PS 102). (2009). Document tabled for the UK house of commons health committee report into patient safety. Retrieved from http://www.publications.parliament.uk/pa/cm200809/cmselect/cmhealth/151/151we49.htm

29.

Pradarelli

J. C.

Campbell

D. A.

Dimick

J. B.

(2015). Hospital credentialing and privileging of surgeons: A potential safety blind spot. Journal of the American Medical Association, 313, 1313-1314.

30.

Pronin

Lin

D. Y.

Ross

(2002). The bias blind spot: Perceptions of bias in self versus others. Personality and Social Psychology Bulletin, 28, 369-381.

31.

Rabin

R. C.

(2013). Salesmen in the surgical suite. The New York Times. Retrieved from http://www.nytimes.com/2013/03/26/health/salesmen-in-the-surgical-suite.html

32.

Relman

A. S.

(2001). Separating continuing medical education from pharmaceutical marketing. Journal of the American Medical Association, 285, 2009-2012.

33.

Rodwin

M. A.

(2010). Drug advertising, continuing medical education, and physician prescribing: A historical review and reform proposal. The Journal of Law, Medicine & Ethics, 38, 807-815.

34.

Rogers

W. A.

Johnson

(2013). Addressing within-role conflicts of interest in surgery. Journal of Bioethical Inquiry, 10, 219-225.

35.

Rogers

W.A.

Lotz

Hutchison

Pourmoslemi

Eyers

(2014). Identifying surgical innovation: a qualitative study of surgeons’ views. Annals of surgery, 259, 273-278.

36.

Rothman

D. J.

McDonald

W. J.

Berkowitz

C. D.

Chimonas

S. C.

DeAngelis

C. D.

Hale

R. W.

. . . Wofsy

(2009). Professional medical associations and their relationships with industry: A proposal for controlling conflict of interest. Journal of the American Medical Association, 301, 1367-1372.

37.

Royal Australasian College of Surgeons. (2017). Position paper: Interactions with the medical industry. Retrieved from https://www.surgeons.org/media/306202/2017-06-27_pos_fes-pst-021_interactions_with_the_medical_industry.pdf

38.

Schwaitzberg

S. D.

Godinez

Kavic

S. M.

Sutton

Worthington

R. B.

Colburn

Park

(2009). Training and working in high-stakes environments: Lessons learned and problems shared by aviators and surgeons. Surgical Innovation, 16, 187-195.

39.

Schwartz

(2015). Innovation in pediatric surgery: The surgical innovation continuum and the ETHICAL model. Journal of Pediatric Surgery, 49, 639-645.

40.

Schwarze

M. L.

(2009). Conflict of interest with industry and the challenges for surgical education. Journal of the American College of Surgeons, 209, 766-768.

41.

Steinbrook

(2008). Financial support of continuing medical education. Journal of the American Medical Association, 299, 1060-1062.

42.

Stolfi

V. M.

Milsom

J. W.

Lavery

I. C.

Oakley

J. R.

Church

J. M.

Fazio

V. W.

(1992). Newly designed occluder pin for presacral hemorrhage. Diseases of the Colon & Rectum, 35, 166-169.

43.

Taylor v. Intuitive Surgical Inc. (2013). Case number 09-2-03136-5, in the Superior Court of the State of Washington, Kitsap County. Decided 23rd May.

44.

Taylor v. Intuitive Surgical Inc., (2015). Case number 45052-6-II. Washington Court of Appeal. Decided 7th July.

45.

Taylor v. Intuitive Surgical Inc. (2017). Case number 92210-1. Washington Supreme Court. Decided 9th February.

46.

Thompson

(1993). Understanding financial conflicts of interest. The New England Journal of Medicine, 329, 573-576.

47.

Wall

L. L.

Brown

(2010). The perils of commercially driven surgical innovation. American Journal of Obstetrics & Gynecology, 202(1), e1-e30.

48.

Zipkin

D. A.

Steinman

M. A.

(2005). Interactions between pharmaceutical representatives and doctors in training. Journal of General Internal Medicine, 20, 777-786.