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

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.

The medical ecoculture at work: the case of the metal-on-metal hip.

The United States has the most expensive, technologically intensive system of medical care in the world, but not the most effective. Reforming health care will require understanding the interactions among the many individuals and institutions that collectively constitute the health-care ecoculture, an ecosystem with a major human component. Because technology is a key driver of health-care costs and a critical component of the patient's experience of American medicine, it is fruitful to consider an example of a particular technology: why it was embraced, who benefited from its use, and the response of the ecoculture when a critical flaw in the technology emerged. The case of the introduction, diffusion, and withdrawal of metal-on-metal hip prostheses will be discussed from the perspective of patients, physicians, device manufacturers, regulators, and the legal system. Each of these groups responded to external stimuli by adaptation in an attempt to maximize its own interests. Interactions between the groups served as a further mechanism of maintaining the status quo within medicine. A single change, such as modification of the payment system or incentivizing patients, is thus unlikely to be effective in transforming health care; instead, a multi-pronged approach, along with reforms outside medicine, will likely be necessary.