Unproven stem cell-based interventions & physicians’ professional obligations; a qualitative study with medical regulatory authorities in Canada

Abstract

BackgroundThe pursuit of unproven stem cell-based interventions (“stem cell tourism”) is an emerging issue that raises various concerns. Physicians play different roles in this market, many of which engage their legal, ethical and professional obligations. In Canada, physicians are members of a self-regulated profession and their professional regulatory bodies are responsible for regulating the practice of medicine and protecting the public interest. They also provide policy guidance to their members and discipline members for unprofessional conduct.MethodsWe conducted semi-structured telephone interviews with representatives from six different provincial Colleges of Physicians and Surgeons in Canada to discuss their experiences and perspectives regarding stem cell tourism. Our focus was on exploring how different types of physician involvement in this market would be viewed by physicians’ professional regulatory bodies in Canada.ResultsWhen considering physicians’ professional obligations, participants drew analogies between stem cell tourism and other areas of medical tourism as well as with some aspects of complementary alternative medicine where existing policies, codes of ethics and regulations provide some guidance. Canadian physicians are required to act in the best interests of their patients, respect patient autonomy, avoid conflicts of interest and pursue evidence-based practice in accordance with accepted standards of care. Physicians who provide unproven treatments falling outside the standard of care, not in the context of an approved research protocol, could be subject to professional discipline. Other types of problematic conduct include referrals involving financial conflict of interest and failure to provide urgent medically necessary care. Areas of ambiguity include physicians’ obligations when asked for information and advice about seeking unproven medical treatments, in terms of providing non-urgent follow-up care, and when asked to support efforts to go abroad by providing tests or procedures in advance that would not otherwise be medically indicated.ConclusionsSpecific policy guidance regarding the identified areas of tension or ambiguity may prove helpful for physicians struggling with these issues. Further consideration of the complex interplay of factors at issue in how physicians may (should) respond to patient demands related to unproven medical interventions while meeting their professional, legal and ethical obligations, is warranted.

Vision Loss after Intravitreal Injection of Autologous “Stem Cells” for AMD

“…8 The need for oversight of such clinics and for the education of patients by physicians and regulatory bodies is paramount to protecting patients while advancing proper research and innovation. 22–24 …”

A Dichotomy of Information-Seeking and Information-Trusting: Stem Cell Interventions and Children with Neurodevelopmental Disorders

“…Respondents stressed the importance of healthcare provider communication, openness and honesty and were hesitant about approaching their child's physician about stem cell interventions when these qualities were lacking. Barriers to communication have been identified in previous research including the concern that dissuading patients or their families from seeking medical services abroad may harm the physician-patient relationship [43][44][45][46]. Furthermore, physicians often lack adequate information about interventions in a field that is continuously changing [43,45] and may prefer that patients take the lead in their medical care [23,44,47].…”

“…Barriers to communication have been identified in previous research including the concern that dissuading patients or their families from seeking medical services abroad may harm the physician-patient relationship [43][44][45][46]. Furthermore, physicians often lack adequate information about interventions in a field that is continuously changing [43,45] and may prefer that patients take the lead in their medical care [23,44,47]. These factors can contribute to a reluctance to discuss stem cell interventions that might result in the perception of physician indifference [18,45], or in the case of one of our respondents, as arrogance, potentially damaging trust in the patient-physician relationship.…”

“…Finally, given the difficulties physicians can face in staying up to date on the latest developments in stem cells [43,45] and their concerns about damaging the doctor-patient relationship, another avenue of proactive engagement with parents lies in Scott's [53] call for stem cell counsellors. These counsellors, akin to genetic counsellors with psychosocial training and a focus on non-directive communication, could work alongside physicians to connect with parents seeking treatment for their child abroad in person or over the Internet and provide guidance about the potential risks of unproven therapies to facilitate informed decision-making.…”

Australasian College of Sports Physicians—position statement: the place of mesenchymal stem/stromal cell therapies in sport and exercise medicine

“…Australasian College of Sports Physicians (ACSP) members need to be cognisant of these concerns and to the pressures this activity may place on them 74 101…”