BMC Medical Ethics | |
Joint issues – conflicts of interest, the ASR hip and suggestions for managing surgical conflicts of interest | |
Wendy Rogers2  Jane Johnson1  | |
[1] Department of Philosophy, Macquarie University, Sydney, NSW 2109, Australia;Department of Philosophy and Australian School of Advanced Medicine, Macquarie University, Sydney, NSW 2109, Australia | |
关键词: Surgical innovation; Recusal; Disclosure; Conflicts of interest; ASR hip; | |
Others : 1090106 DOI : 10.1186/1472-6939-15-63 |
|
received in 2014-03-17, accepted in 2014-07-16, 发布年份 2014 | |
【 摘 要 】
Background
Financial and nonfinancial conflicts of interest in medicine and surgery are troubling because they have the capacity to skew decision making in ways that might be detrimental to patient care and well-being. The recent case of the Articular Surface Replacement (ASR) hip provides a vivid illustration of the harmful effects of conflicts of interest in surgery.
Discussion
We identify financial and nonfinancial conflicts of interest experienced by surgeons, hospitals and regulators in the ASR case. These conflicts may have impacted surgical advice, decision-making and evidence gathering with respect to the ASR prosthesis, and contributed to the significant harms experienced by patients in whom the hip was implanted. Drawing on this case we explore shortcomings in the standard responses to conflicts of interest – disclosure and recusal. We argue disclosure is necessary but by no means sufficient to address conflicts of interest. Using the concept of recusal we develop remedies including second opinions and third party consent which may be effective in mitigating conflicts, but their implementation introduces new challenges.
Summary
Deployment of the ASR hip is a case of surgical innovation gone wrong. As we show, there were multiple conflicts of interest involved in the introduction of the ASR hip into practice and subsequent attempts to gloss over the mounting body of evidence about its lack of safety and effectiveness. Conflicts of interest in surgery are often not well managed. We suggest strategies in this paper which can minimise the conflicts of interest associated with surgical innovation.
【 授权许可】
2014 Johnson and Rogers; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20150128154226207.pdf | 235KB | download |
【 参考文献 】
- [1]Lo B, Field MJ (Eds): Conflict of Interest in Medical Research, Education and Practice. Washington DC: The National Academies Press; 2009.
- [2]Thompson D: Understanding financial conflicts of interest. N Engl J Med 1993, 329:573-576.
- [3]Katz D, Caplan AL, Merz JF: All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift giving. Am J Bio 2010, 10:11-17.
- [4]deGara CJ, Rennick KC, Hanson J: Perceptions of Conflict of Interest: Surgeons, Internists, and Learners Compared. Am J Surgery 2013, 205:541-546.
- [5]Mirza SK: Accountability of the accused: facing public perceptions about financial conflicts of interest. Spine J 2004, 4:491-494.
- [6]Hockenberry JM, Weigel P, Auerbach A, Cram P: Financial payments by orthopedic device makers to orthopedic surgeons. Arch Intern Med 2011, 171(19):1759-1765.
- [7]Joint Reaction: Four Corners. 2011. [http://www.abc.net.au/4corners/content/2011/s3218266.htm webcite] [Accessed 18 May 2011]
- [8]Crawford R, Ranawat CS, Rothman RH: Metal on metal: is it worth the risk? J Arthroplasty 2010, 25:1-3.
- [9]Cohen D: Out of joint: the story of the ASR. BMJ 2011, 342:1-9.
- [10]The Senate Community Affairs References Committee: The Regulatory Standards for the Approval of Medical Devices in Australia. Canberra: Senate Printing Unit; 2011.
- [11]Steinbrook R: Industry payments to physicians: lessons from orthopedic surgery. Arch Intern Med 2011, 171(19):1765-1766.
- [12]Cohen D: How safe are metal-on-metal hip implants? BMJ 2012, 344:1-5.
- [13]Lieberman JR, Pensak MJ, Kelleher MS, Leger RR, Polkowski GG: Disclosure of financial conflicts of interest: an evaluation of orthopaedic surgery patients’ understanding. Clin Orthop Relat Res 2013, 471:472-477.
- [14]Morreim H, Mack MJ, Sade RM: Surgical innovation: too risky to remain unregulated? Ann Thoracic Surg 2006, 82:1957-1965.
- [15]Lemmens T: Conflict of Interest in Medical Research: Historical Development. In The Oxford Textbook of Clinical Research Ethics. Edited by Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D. New York: Oxford University Press; 2008:747-757.
- [16]Camp MW, Mattingly DA, Gross AE, Nousiainen MT, Alman BA, McKneally MF: Patients’ views on surgeons’ financial conflicts of interest. J Bone Joint Surg Am 2013, 95:e9. 1–8; A.S
- [17]Kesselheim AS, Maisel WH: Managing financial and nonfinancial conflicts of interest in healthcare delivery. Am J Therapeutics 2010, 17:440-443.
- [18]Loewenstein G, Sah S, Cain DM: The unintended consequences of conflict of interest disclosure. JAMA 2012, 307:669-670.
- [19]Cain DM, Loewenstein G, Moore DA: The dirt on coming clean: perverse effects of disclosing conflicts of interest. J Legal Stud 2005, 34:1-25.
- [20]Thagard P: The moral psychology of conflicts of interest: insights from affective neuroscience. J Appl Philos 2007, 24:367-380. 378
- [21]Barkun JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg M: Surgical innovation and evaluation 1: Evaluation and stages of surgical innovations. Lancet 2009, 374:1089-1096.
- [22]Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien P-A, Reeves BC, Seiler CM: Surgical innovation and evaluation 2: Challenges in evaluating surgical innovation. Lancet 2009, 374:1097-1104.
- [23]McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J: Surgical innovation and evaluation 3: No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009, 374:1097-1104.
- [24]Rogers W, Johnson J: Addressing within-role conflicts of interest in surgery. Journal of Bioethical Inquiry 2013, 10:219-225.
- [25]Rogers WA, Lotz M, Hutchison K, Pourmoslemi A, Eyers A: Identifying surgical innovation: a qualitative study of surgeons’ views. Ann Surg 2014, 259(2):273-278.