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Conflicts of Interest in Spine Surgery
Summary of Key Points
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A conflict of interest is defined as “a set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain).”
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Spinal surgeon relations with implant manufacturers are especially prone to conflicts of interest because of rapid industry growth, declining reimbursements, and the role of surgeon implant preference in driving market share.
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Disclosures are the primary means by which patients are informed of any potential conflicts of interest that may affect the decision making of their practitioner. However, these conflicts are frequently underreported or omitted by surgeons and other healthcare professionals.
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Significant evidence exists that demonstrates a propensity toward publication of positive results in industry-funded studies.
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Bone morphogenetic protein–2 and lumbar artificial disc replacement, among other technologies in spine and orthopedic surgery, are case studies of technologies whose adoption outpaced quality outcome data. Many of these failed technologies resulted in patient harm and involved advocacy by conflicted surgeons.
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Constant awareness and adjudication of potential conflicts of interest by physicians, universities, hospitals, institutions, and other entities that have a connection to patient care should be rigorously observed to mitigate the potential for patient harm.
A conflict of interest is defined as “a set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain).” Manifestations of conflicts of interest can range from direct payments to consulting agreements, stock options, venture capital investments, research grants, intellectual property, royalties from implants, golf outings, dinners, or gifts including logo merchandise and pens. Strategies to mitigate the potentially deleterious effects of conflict of interest on medical decision making include removal, disclosure, or recusal of relationship, third party evaluations, and adherence to a strong code of ethics.
Spinal surgeon relations with implant manufacturers are especially prone to conflicts of interest because of rapid industry growth, declining reimbursements, and the role of surgeon implant preference in driving market share. In 2010 the U.S. spinal implant market exceeded $6.8 billion, a 30-fold increase compared with 1994. This figure is projected to exceed $19.5 billion by 2024. Meanwhile, average Medicare reimbursement for all spine surgeries has decreased by 25.8% from 2000 to 2018, or an average of 1.7% per year when adjusted for inflation. Market share in the spinal implant industry is largely driven by surgeon implant preference. These circumstances may create an environment that could foster unethical collaboration between spinal surgeons and industry, which could ultimately compromise patient safety.
Surgeon–Industry Collaboration
Collaboration between surgeons and industry is necessary and fundamental to support innovation and ultimately provide better patient care. By virtue of using equipment in the operating room on a daily basis, practicing surgeons are best suited to evaluate and identify methods by which spinal instruments and implants can be improved. Industry support is required to research and develop these ideas to allow for their clinical translation. Many reputable academic institutions have long benefitted from industry support of training, education, and translational research. Examples of positive industry collaboration in spinal surgery include the works of Dr. Paul Harrington and Dr. Raymond Roy-Camille in developing metal rods and pedicle screws, respectively. These pioneers profited from their ingenuity that advanced the field of spine surgery.
Relationships between surgeons and industry are not a problem in principle, as long as they are fully disclosed and the parties follow ethical rules of behavior. However, these collaborations may become dangerous when physician judgment is compromised by financial conflicts, leading to unethical behavior and potentially resulting in harm to the patient.
Importance of Disclosure
Disclosures are the primary means by which patients are informed of any potential conflicts of interest that may affect the decision-making of their practitioner. However, these conflicts are frequently underreported or omitted by surgeons and other healthcare professionals. The rate of disclosure of industry payments from five prominent orthopedic implant manufacturers to presenters at the 2008 American Academy of Orthopaedic Surgeons Annual Meeting was 79.3% for payments directly related to the presentation topic and 50.0% for indirectly related payments. Discrepancy rates between surgeon-reported disclosures and company-reported disclosures at the North American Spine Society’s 2011 Annual meeting ranged from 30% to 52.4%, depending on the manufacturer.
Failure to disclose or incomplete disclosure of industry relations also permeates academic medicine far beyond orthopedic and spine surgery. An analysis of 160 deans of allopathic medical schools in the United States found that nine of these deans held directorships in private health corporations, with a median compensation of $217,454. Of these nine directorships, four were undisclosed, two were not reported as being associated with any compensation, and the compensation for the remaining three was underreported by 39% to 80%.
There also seems to be a lack of enforcement for full disclosure of conflicts and, in many instances, there are no consequences to those who underreport or fail to report any conflicts at all. Oftentimes, the lay press is the first to expose such conflicts (when harm comes to a patient), to the embarrassment of the institutions and the healthcare professionals.
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