A recent article in the Journal of the Society of NeuroInterventional Surgery, published by the British Medical Journal (BMJ), examined the doctor-device industry relationship through the role of the neurointerventionalist and recent developments within the AdvaMed Code of Ethics. The article discusses a reasonable approach to manage conflict of interest while preserving opportunity for innovation with industry.
The authors explain how the specialty of neurointerventional (NI) surgery is one of the “most rapidly advancing and exciting areas of medicine today—in part based on close relationships with industry that ignite rapid advances.” Given these close relationships, they recognized however that there is a potential risk of conflict of interest.
Despite this concern, the authors clearly recognize that “if it were not for the ongoing collaboration between NI surgeons and the medical technology industry, many of the advanced treatments used every day in neurointerventional surgery would not exist.” This would certainly be detrimental to patients, and the training of future neurointerventional surgeons.
Advancing medical technology
The medical device industry, through advances in medical technology, have enabled neurointerventionalists “to treat a wide array of conditions that occur within the vessels of the brain or spinal cavity, such as aneurysms, strokes and spinal compression fractures.” As the authors explain, although NI is a relatively nascent specialty, “the NI field has developed in an era of technological innovation, and inherent in that development are continuing refinements in the tools used to image and treat patients with these technologies.” According to the authors, these advances in the NI field have emerged “alongside developments by a vibrant and intellectually active medical device industry,” that has thrived due to industry-physician collaboration.
Historically, “NI physicians have often worked collaboratively with their industry partners to help move the field forward to the benefit of patients.” For example, the authors cite Guglielmi detachable coils, an innovation that has led to significant improvements in care and quality of life for patients. Yet the authors note that the medical device industry presents “unique conflicts-of-interest considerations based on product complexity and constant product evolution,” in comparison with other life sciences sectors.
One of the reasons why the device industry-physician relationship is unique is because “neuroIntervention has at its core some of the most life-threatening disease states and high-risk treatment options.” To address these disease states, nuroIntervention involves a “dynamic process of innovation and factors such as product delivery technique refinement, education, testing and clinical trials, and product support, which all make it necessary for ongoing and close collaboration between neurointerventionalists and the device industry.”
As a results, the authors acknowledge that those “in healthcare understand how valuable these relationships are for continued innovation and also for patient safety.” Accordingly, they assert that it is “essential for the NI community and the device industry to proactively manage the potential for conflicts of interest while promoting the highest ethical standards.”
Increasing scrutiny
One of the reasons the authors address this potential for conflict of interest is “in part because the competing pressures from the multiple, overlapping roles as clinician/care giver/investigator/ innovator/customer are significant.” They recognize that “the structure and execution of various industry–physician interactions—such as consulting arrangements, CME funding, clinical trials, research grants, and other arrangements—possess the potential to alter prescription or device usage patterns.”
However, this “potential” has become more like a “perceived” conflict of interest because of recent “prosecutors’ activity and media scrutiny in the area” that makes the “mere suggestion of a conflict of interest alarming to the public, which expects a doctor–patient relationship based on objectivity and transparency.” The increased scrutiny also comes in light of companies posting payments to physicians, and the future disclosure of such payments through the Physician Payment Sunshine Provisions.
To address the potential damage to the public’s trust by physicians working with industry, the authors discuss the important role the device industry has played to ensure an ethical relationship between physicians and industry and the standards they have set. The elimination of such relationships, as some critics and proposals suggest, are not an option to the authors because they assert that “the physician community and industry must work together to seek a balanced approach and resist any one-size-fits-all conflicts-of-interest solution.” Otherwise, the beneficial collaborations that advance technology may be threatened.
Understanding the AdvaMed code
It is because these critical relationships are too often misunderstood that the Advanced Medical Technology Association (AdvaMed), the largest American medical technology association representing medical device and diagnostics companies, strongly encourages both industry and physicians to commit to openness and high ethical standards in the conduct of their business interactions. AdvaMed’s Code of Ethics, most recently revised in July of 2009, deals with new issues and provides guidance tailored to the unique collaborations in device development.
The authors explain that by “adhering to the AdvaMed Code, manufacturers are supporting physicians’ obligation to ensure each patient is provided with the highest level of care, by receiving the treatment option most beneficial to their individual needs.”
The AdvaMed Code clarifies and distinguishes appropriate and inappropriate activity between healthcare professionals and manufacturers of medical devices. It is important to note, as the authors do, that because of this code and its many revisions, medical technology companies and their representatives no longer engage in activities that people once believed were customary. Changes to the Code include:
- Royalty arrangement guidelines with healthcare professionals (HCPs) in exchange for substantial contributions that improve medical technologies.
- Rules for providing no-charge products intended to educate both HCPs and patients receiving newer or improved medical technologies.
- An explicit prohibition on providing entertainment, recreation, and gifts of any type—including all non-educational branded promotional items—of any value.
- Objective reimbursement, coverage, and health economics information provided to HCPs in order to improve patient access to medical technologies.
Training and education
Additionally, AdvaMed has revised code sections to provide greater clarity and rigor in areas such as company-conducted training and education for physicians. These revisions mandate that educational programs for HCPs be conducted in clinical or educational settings that are conducive to exchange of information. The code requires that “Hands-on” training be held at facilities suitable for the type of training to be conducted, and instructors should be qualified and have the technical expertise to conduct the training. To appropriately facilitate exchange of information and product training some companies may have on their campus state-of-the art cadaver laboratories or other specialized training and education facilities to ensure the proper handling and use of these products.
The authors recognize that “because of the way in which medical device technologies are used, industry has a responsibility to make available to physicians education and training on the safe and effective use of their products.” This education and training is critical considering “the FDA mandates training and education to facilitate the safe and effective use of certain medical technologies.”
Going global
Another important development that emphasizes the need for physician-device industry collaboration is the fact that NI professionals are increasingly global. One of the factors contributing to this change is that many of the NI device companies with headquarters in the US are conducting testing abroad and American specialists travel as advisers on their behalf to foreign lands. Given new laws, disclosure, regulations, and reporting, the authors recognized the potential for “confusion that might impede collaboration beneficial to patients and medical technology advancements.”
To address the international nature of NI and the device industry, AdvaMed, and the European Medical Technology Industry Association (Eucomed), the voice of the medical technology industry in the European Union, developed what is now known as the Joint Trans-Atlantic Statement on Ethical Interactions between Medical Technology Companies and Healthcare Professionals. The authors acknowledged that this statement “shows the device industry’s unwavering commitment to develop a cohesive international approach to ethical interactions between medical technology companies and HCPs,” while emphasizing transparency. Many of the provisions in this statement are similar to those in the AdvaMed Code of Ethics.
Conclusion
The authors in this editorial clearly highlight the importance of preserving industry-physician collaboration, and recognize the potential harm for hindering these relationships. While there is no doubt that transparency in such relationships is crucial, sacrificing progress and innovation in technology and patient care is not justified simply because of the “potential” for conflicts-of-interest or that such conflicts can be complex. Additionally, the authors recognize that “many specialty societies have active ethics committees of their own and have taken significant steps to provide meaningful and specialized guidance to their members,” further demonstrating the importance of physician-industry collaboration.
Given that the leadership of the Society of NeuroInterventional Surgery “believes that robust, ethical industry–healthcare professional interactions further patient safety and medical innovation,” and the numerous measures in place by AdvaMed and other specialty societies, it is clear that “physician–industry interaction is critical for continued innovation by our specialties.”