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Joint issues--conflicts of interest, the ASR hip and suggestions for managing surgical conflicts of interest
1Department of Philosophy, Macquarie University, Sydney, NSW 2109, Australia. jane.johnson@mq.edu.au.
Insights
Conflicts of interest in surgery can harm patients, as seen with the Articular Surface Replacement (ASR) hip. Improved strategies beyond disclosure are needed to manage these conflicts and protect patient well-being.
Area of Science:
- Medical ethics
- Surgical innovation
- Patient safety
Background:
- Financial and nonfinancial conflicts of interest (COI) pose risks to patient care and surgical decision-making.
- The Articular Surface Replacement (ASR) hip case exemplifies detrimental COI effects in surgery.
Purpose of the Study:
- To identify COI in the ASR hip case involving surgeons, hospitals, and regulators.
- To analyze the impact of COI on surgical advice, decision-making, and evidence regarding the ASR prosthesis.
- To explore limitations of current COI management strategies (disclosure, recusal) and propose enhanced remedies.
Main Methods:
- Case study analysis of the Articular Surface Replacement (ASR) hip.
- Identification and categorization of financial and nonfinancial conflicts of interest.
- Evaluation of standard COI responses: disclosure and recusal.
- Development of alternative mitigation strategies.
Main Results:
- Multiple COI were identified among stakeholders in the ASR hip case.
- COI potentially influenced surgical recommendations and patient outcomes.
- Disclosure alone is insufficient for effective COI management.
- Recusal-based remedies like second opinions and third-party consent present implementation challenges.
Conclusions:
- The ASR hip serves as a cautionary example of surgical innovation with poorly managed COI.
- Existing COI management in surgery requires improvement.
- Proactive strategies are essential to minimize COI risks in surgical innovation and safeguard patient interests.
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.
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