Joint issues--conflicts of interest, the ASR hip and suggestions for managing surgical conflicts of interest

BMC Med Ethics. 2014 Aug 15:15:63. doi: 10.1186/1472-6939-15-63.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Arthroplasty, Replacement, Hip* / adverse effects
  • Arthroplasty, Replacement, Hip* / ethics
  • Conflict of Interest*
  • Decision Making
  • Disclosure*
  • Hip Joint / surgery
  • Hip Prosthesis* / adverse effects
  • Hip Prosthesis* / ethics
  • Humans
  • Informed Consent*
  • Patient Care / ethics
  • Referral and Consultation*
  • Third-Party Consent*