BMC Medical Ethics | |
Unproven stem cell-based interventions & physicians’ professional obligations; a qualitative study with medical regulatory authorities in Canada | |
Marianne Clark1  Amy Zarzeczny2  | |
[1] Health Law Institute, University of Alberta, Edmonton, Canada;Johnson-Shoyama Graduate School of Public Policy, University of Regina, Regina, Canada | |
关键词: Ethics; Policy; Professional discipline; Professional regulation; Medical tourism; Stem cell tourism; | |
Others : 1090014 DOI : 10.1186/1472-6939-15-75 |
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received in 2014-07-16, accepted in 2014-10-07, 发布年份 2014 | |
【 摘 要 】
Background
The 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.
Methods
We 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.
Results
When 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.
Conclusions
Specific 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.
【 授权许可】
2014 Zarzeczny and Clark; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
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20150128153533292.pdf | 228KB | download |
【 参考文献 】
- [1]Snyder J, Crooks V, Johnston R, Kingsbury P: What do we know about Canadian involvement in medical tourism? A scoping review. Open Med 2011, 5(3):e139-e148.
- [2]Levine A: Stem cell tourism: assessing the state of knowledge. SCRIPTed 2010, 7:274-282.
- [3]Lau D, Ogbogu U, Taylor B, Stafinski T, Menon D, Caulfield T: Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell 2008, 3:591-594.
- [4]Regenberg A, Hutchinson L, Schanker B, Matthews D: Medicine on the fringe: stem cell-based interventions in advance of evidence. Stem Cells 2009, 27:2313-2319.
- [5]Ryan K, Sanders A, Wang D, Levine A: Tracking the rise of stem cell tourism. Regen Med 2010, 5:27-33.
- [6]Ogbogu U, Rachul C, Caulfield T: Reassessing direct-to-consumer portrayals of unproven stem cell therapies: is it getting better. Regen Med 2013, 8:361-369.
- [7]Zarzeczny A, Rachul C, Nisbet M, Caulfield T: Stem cell clinics in the news. Nat Biotechnol 2010, 28:1243-1246.
- [8]Dobkin B, Curt A, Guest J: Cellular transplants in China: observational study from the largest human experiment in chronic spinal cord injury. Neurorehabil Neural Repair 2006, 20:5-13.
- [9]Amariglio N, Hirshberg A, Scheithauer B: Donorderived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient. PLoS Med 2009, 6(2):e1000029.
- [10]Thirabanjasak D, Tantiwongse K, Thorner P: Angiomyeloproliferative lesionsfollowing autologous stem cell therapy. J Am Soc Nephrol 2010, 21:1218-1222.
- [11]Mendick R, Hall A: Europe’s Largest Stem Cell Clinic Shut Down After Death of Baby. The Telegraph 2011. http://www.telegraph.co.uk/news/worldnews/europe/germany/8500233/Europes-largest-stem-cell-clinic-shut-down-after-death-of-baby.html webcite
- [12]Song P: Biotech pilgrims and the transnational quest for stem cell cures. Med Anthropol 2010, 29(4):384-402.
- [13]Lysaght T, Kerridge I, Sipp D, Porter G, Capps B: Oversight for clinical uses of autologous adult stem cells: lessons from international regulations. Cell Stem Cell 2013, 13(6):647-651.
- [14]Medical Board of California: The Matter of the Accusation Against: Darryl Matthew See, M.D., Physicians and Surgeon’s Certificate No. G 61569, File No. 04-2004-161179. 2007. http://www.casewatch.org/board/med/see/accusation.shtml webcite; http://www.casewatch.org/board/med/see/surrender.pdf webcite
- [15]General Medical Council, Fitness To Practice Panel: RE Dr. Robert Theodore Henri Kees Trossel, Reg. No. 6049460. 2010. http://www.casewatch.org/foreign/trossel/sanction.pdf webcite
- [16]Singapore Medical Council (SMC): Press Release: Disciplinary Inquiry for Dr. Wong Yoke Meng. 2011. http://www.healthprofessionals.gov.sg/content/dam/hprof/smc/docs/press_releases/Press%20Release%28Dr%20Wong%20Yoke%20Meng_2%29_15Apr11.pdf webcite
- [17]Levine A, Wolf L: The roles and responsibilities of physicians in patients’ decisions about unproven stem cell therapies. J Law Med Ethics 2012, 40:122-134.
- [18]Bell E, Wallace T, Chouinard I, Shevell M, Racine E: Responding to requests of families for unproven interventions in neurodevelopmental disorders: Hyperbaric oxygen “treatment” and stem cell “therapy” in Cerebral Palsy. Dev Dis Res Rev 2011, 17:19-26.
- [19]Johnston R, Crooks V, Snyder J, Dharamsi S: Canadian family doctors’ roles and responsibilities toward outbound medical tourists. Can Fam Physician 2013, 59:1314-1319.
- [20]Johnston R, Crooks B, Snyder J: “I didn’t even know what I was looking for”: a qualitative study of the decision-making processes of Canadian medical tourists. Glob Health 2012, 8:23-35. BioMed Central Full Text
- [21]Howlett K: Two Provinces Moving on Follow-up Care for MS Liberation Therapy. Globe and Mail 2011. http://www.theglobeandmail.com/life/health-and-fitness/two-provinces-moving-on-follow-up-care-for-ms-liberation-therapy/article572477/ webcite
- [22]College of Physicians and Surgeons of Alberta (CPSA): Managing Patients With Multiple Sclerosis After out-of-Country Endovascular Treatment for “CCSVI”. 2011. http://www.cpsa.ab.ca/Libraries/Res/Managing_patients_with_MS_after_out-of-country_endovascular_treatment_for_CCSVI.pdf webcite
- [23]Saskatchewan: Medical Profession Act, 1981. ch. M-10.1, S.S. 1980–81.
- [24]Patton M (Ed): Qualitative Research and Evaluation Methods 3rd Ed. Thousand Oaks, CA: Sage Publications; 2002.
- [25]Fereday J, Muir-Cochrane E: Demonstrating rigor using thematic analysis: a hybrid approach of inductive and deductive coding and theme development. Int J Qual Meth 2006, 5:80-92.
- [26]Chirba MA, Garfield SM: FDA oversight of autologous stem cell therapies: legitimate regulation of drugs and devices or groundless interference with the practice of medicine. J Health Biomed Law 2011, 7:33-272.
- [27]Sipp D, Turner L: U.S. regulation of stem cells as medical products. Science 2012, 338:1296-1297.
- [28]Munsie M, Hyun I: A question of ethics: selling autologous stem cell therapies flaunts professional standards. Stem Cell Res 2014. doi:10.1016/j.scr.2014.04.014
- [29]College of Physicians and Surgeons of Nova Scotia (CPSNS): Policy and Guidelines on Complementary and Alternative Medicine. 2014. http://www.cpsns.ns.ca/PhysicianGuidelinesandPolicies.aspx?EntryId=136 webcite
- [30]College of Physicians and Surgeons of Ontario (CPSO): Policy Statement #3-11; Complementary/Alternative Medicine. 2011. https://www.cpso.on.ca/uploadedFiles/policies/policies/policyitems/complementary_med.pdf webcite
- [31]College of Physicians and Surgeons of Nova Scotia (CPSNS): Policy Regarding Care of Patients Who Have Received Treatment Outside Canada. 2011. http://www.cpsns.ns.ca/PhysicianGuidelinesandPolicies.aspx?EntryId=27 webcite
- [32]Snyder J, Crooks V, Johnston R, Dharamsi S: “Do your homework … and then hope for the best”: the challenges that medical tourism poses to Canadian family physicians’ support of patients’ informed decision-making. BMC Med Ethics 2013, 14:37-47. BioMed Central Full Text
- [33]Zarzeczny A, Caulfield T: Stem cell tourism and doctors’ duties to minors – A view from Canada. AJOB 2010, 10:3-15.