Johnson Jane, Rogers Wendy
Department of Philosophy, Macquarie University, Sydney, NSW 2109, Australia.
BMC Med Ethics. 2014 Aug 15;15:63. doi: 10.1186/1472-6939-15-63.
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.
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.
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.
医学和外科领域中经济利益冲突和非经济利益冲突令人担忧，因为它们有能力以可能损害患者护理和福祉的方式扭曲决策。最近的人工关节表面置换（ASR）髋关节案例生动地说明了外科手术中利益冲突的有害影响。
我们识别了ASR案例中外科医生、医院和监管机构所经历的经济利益冲突和非经济利益冲突。这些冲突可能影响了关于ASR假体的手术建议、决策和证据收集，并导致了植入该髋关节的患者遭受重大伤害。基于此案例，我们探讨了对利益冲突的标准应对措施——披露和回避——的不足之处。我们认为披露是必要的，但绝不足以解决利益冲突。利用回避的概念，我们提出了包括寻求第二意见和第三方同意在内的补救措施，这些措施可能有效地缓解冲突，但其实施带来了新的挑战。
ASR髋关节的应用是一个手术创新失败的案例。正如我们所表明的，在将ASR髋关节引入实践以及随后试图掩盖大量关于其缺乏安全性和有效性的证据的过程中，存在多重利益冲突。外科手术中的利益冲突往往管理不善。我们在本文中提出了一些策略，这些策略可以将与手术创新相关的利益冲突降至最低。
