Professional Regulation: A Potentially Valuable Tool in Responding to “Stem Cell Tourism”

•Stem cell tourism is a complex and growing phenomenon that raises various concerns•Physicians play important roles in this market and are often professionally regulated•Key features of professional regulation make it well placed to respond•It is appropriate to use available tools to mitigate risks of stem cell tourism The growing international market for unproven stem cell-based interventions advertised on a direct-to-consumer basis over the internet (“stem cell tourism”) is a source of concern because of the risks it presents to patients as well as their supporters, domestic health care systems, and the stem cell research field. Emerging responses such as public and health provider-focused education and national regulatory efforts are encouraging, but the market continues to grow. Physicians play a number of roles in the stem cell tourism market and, in many jurisdictions, are members of a regulated profession. In this article, we consider the use of professional regulation to address physician involvement in stem cell tourism. Although it is not without its limitations, professional regulation is a potentially valuable tool that can be employed in response to problematic types of physician involvement in the stem cell tourism market. The growing international market for unproven stem cell-based interventions advertised on a direct-to-consumer basis over the internet (“stem cell tourism”) is a source of concern because of the risks it presents to patients as well as their supporters, domestic health care systems, and the stem cell research field. Emerging responses such as public and health provider-focused education and national regulatory efforts are encouraging, but the market continues to grow. Physicians play a number of roles in the stem cell tourism market and, in many jurisdictions, are members of a regulated profession. In this article, we consider the use of professional regulation to address physician involvement in stem cell tourism. Although it is not without its limitations, professional regulation is a potentially valuable tool that can be employed in response to problematic types of physician involvement in the stem cell tourism market. There is a growing international market for unproven stem cell-based interventions advertised on a direct-to-consumer basis primarily over the internet, a phenomenon often referred to as “stem cell tourism” (Ryan et al., 2010Ryan K.A. Sanders A.N. Wang D.D. Levine A.D. Tracking the rise of stem cell tourism.Regen. Med. 2010; 5: 27-33Crossref PubMed Scopus (95) Google Scholar, Levine and Wolf, 2012Levine A.D. Wolf L.E. The roles and responsibilities of physicians in patients’ decisions about unproven stem cell therapies.J. Law Med. Ethics. 2012; 40: 122-134Crossref PubMed Scopus (44) Google Scholar, Regenberg et al., 2009Regenberg A.C. Hutchinson L.A. Schanker B. Mathews D.J. Medicine on the fringe: stem cell-based interventions in advance of evidence.Stem Cells. 2009; 27: 2312-2319Crossref PubMed Scopus (103) Google Scholar). Studies have established that clinics around the world are offering unproven stem cell-based interventions for a vast array of diseases and conditions, in the absence of robust evidence of the safety or efficacy of these procedures (Lau et al., 2008Lau 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: 591-594Abstract Full Text Full Text PDF PubMed Scopus (254) Google Scholar, Ogbogu et al., 2013Ogbogu U. Rachul C. Caulfield T. Reassessing direct-to-consumer portrayals of unproven stem cell therapies: is it getting better?.Regen. Med. 2013; 8: 361-369Crossref PubMed Scopus (63) Google Scholar). Engagement in this market does not always involve patients traveling out of country, and, as is discussed more below, countries such as the United States are seeing a growing market and push for use of autologous stem cell therapies (Munsie and Hyun, 2014Munsie M. Hyun I. A question of ethics: Selling autologous stem cell therapies flaunts professional standards.Stem Cell Res. (Amst.). 2014; https://doi.org/10.1016/j.scr.2014.04.014Crossref PubMed Scopus (36) Google Scholar, Bianco and Sipp, 2014Bianco P. Sipp D. Regulation: sell help not hope.Nature. 2014; 509: 336-337Crossref Scopus (39) Google Scholar). Patients generally pay for these treatments directly, without support from public or private health insurance. Concerns associated with the stem cell tourism market are numerous and include physical risks to patients (Amariglio et al., 2009Amariglio N. Hirshberg A. Scheithauer B.W. Cohen Y. Loewenthal R. Trakhtenbrot L. Paz N. Koren-Michowitz M. Waldman D. Leider-Trejo L. et al.Donor-derived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient.PLoS Med. 2009; 6: e1000029Crossref PubMed Scopus (733) Google Scholar, Thirabanjasak et al., 2010Thirabanjasak D. Tantiwongse K. Thorner P.S. Angiomyeloproliferative lesions following autologous stem cell therapy.J. Am. Soc. Nephrol. 2010; 21: 1218-1222Crossref PubMed Scopus (163) Google Scholar, Dobkin et al., 2006Dobkin B.H. 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: 5-13Crossref PubMed Scopus (193) Google Scholar, Jabr, 2012Jabr, F. (2012). In the flesh: the embedded dangers of untested stem cell cosmetics. Scientific American, December 17, 2012. http://www.scientificamerican.com/article/stem-cell-cosmetics/.Google Scholar), financial exploitation of patients and their supporters (Zarzeczny et al., 2010Zarzeczny A. Rachul C. Nisbet M. Caulfield T. Stem cell clinics in the news.Nat. Biotechnol. 2010; 28: 1243-1246Crossref PubMed Scopus (52) Google Scholar), and reputational risks for the field of legitimate stem cell science (Wilson, 2009Wilson J.M. Medicine. A history lesson for stem cells.Science. 2009; 324: 727-728Crossref PubMed Scopus (91) Google Scholar). There are also financial and other implications for patients’ home health care systems when patients return from receiving treatment abroad—or merge back into publicly funded medical systems after pursuing care in the private market—and require follow-up care that may prove complex and/or expensive (Snyder et al., 2011Snyder J. Crooks V.A. Johnston R. Kingsbury P. What do we know about Canadian involvement in medical tourism? A scoping review.Open Med. 2011; 5: e139-e148PubMed Google Scholar, Snyder et al., 2012Snyder J. Crooks V. Johnston R. Perceptions of the ethics of medical tourism: comparing patient and academic perspectives.Public Health Ethics. 2012; 5: 38-46Crossref Scopus (32) Google Scholar). These concerns have not gone unanswered. Responses include patient education efforts (ISSCR, 2008aISSCR (International Society for Stem Cell Research) (2008a). Patient handbook on stem cell therapies; Appendix I of the guidelines for the clinical translation of stem cells. http://www.isscr.org/home/publications/patient-handbook.Google Scholar, Master and Caulfield, 2014Master, Z., and Caulfield, T. (2014). Patient Booklet: What you need to know about stem cell therapies. http://www.hli.ualberta.ca/Research/Public_Outreach_Award.aspx.Google Scholar), guidance focused on stem cell scientists (ISSCR, 2008bISSCR (International Society for Stem Cell Research) (2008b). Guidelines for the clinical translation of stem cells. http://www.isscr.org/home/publications/ClinTransGuide.Google Scholar, Master and Resnik, 2011Master Z. Resnik D.B. Stem-cell tourism and scientific responsibility. Stem-cell researchers are in a unique position to curb the problem of stem-cell tourism.EMBO Rep. 2011; 12: 992-995Crossref PubMed Scopus (49) Google Scholar), resources for clinicians (Caulfield et al., 2012Caulfield T. Zarzeczny A. Toronto Stem Cell Working GroupStem cell tourism and Canadian family physicians.Can. Fam. Physician. 2012; 58 (e182–e185): 365-368PubMed Google Scholar), tightening of national regulation (e.g., in Germany [Stafford, 2009Stafford N. Germany tightens law on stem cell treatments.BMJ. 2009; 339: b2967Crossref PubMed Scopus (12) Google Scholar] and China [Cyranoski, 2009Cyranoski D. Stem-cell therapy faces more scrutiny in China.Nature. 2009; 459: 146-147Crossref PubMed Scopus (39) Google Scholar]), and stronger enforcement of existing regulatory regimes (FDA, 2011FDA (U.S. Food and Drug Administration). (2011). Owner of Arizona company charged and convicted of introducing an unapproved new drug—stem cells—into interstate commerce [U.S. Department of Justice Press Release]. http://www.fda.gov/ICECI/CriminalInvestigations/ucm268867.htm.Google Scholar). However, recent data indicate that notwithstanding these efforts, the number of clinics and jurisdictions in which they operate continues to grow (Ogbogu et al., 2013Ogbogu U. Rachul C. Caulfield T. Reassessing direct-to-consumer portrayals of unproven stem cell therapies: is it getting better?.Regen. Med. 2013; 8: 361-369Crossref PubMed Scopus (63) Google Scholar). Perhaps this result is unsurprising given the challenges inherent in regulating and responding to online markets that tend to be very fluid, and more time is required to see the long-term effects of these efforts. However, given the potential risks involved, it seems worthwhile to simultaneously consider more direct avenues of response to stem cell tourism. Physicians play a variety of roles in the stem cell tourism market and in many jurisdictions around the world are members of a regulated profession. Here, we propose that professional regulation may be well placed to respond to some of the key concerns associated with the challenging phenomenon of stem cell tourism. Physicians are involved in stem cell tourism in various capacities, which may trigger professional discipline, although some types of conduct are more direct and potentially egregious than others. For example, physicians may provide unproven stem cell-based interventions, own and/or operate a clinic, refer patients to providers located in other jurisdictions, advertise unproven stem cell-based interventions offered elsewhere, sit as an advisor or member of a clinic’s medical board, provide information and advice to patients, provide preprocedure testing and/or follow-up, and/or, in a research capacity, share stem cell lines with providers of the unproven therapies. There are examples from jurisdictions around the world where physicians have been sanctioned by professional regulatory bodies for providing unproven stem cell-based interventions. For example, Dr. Robert Trossel was a physician licensed in the United Kingdom who provided stem cell therapy to a number of patients suffering from multiple sclerosis at a clinic he was associated with in Rotterdam. A panel of the General Medical Council (GMC) found his fitness to practice was impaired due to his misconduct in relation to his treatment of these patients and directed his name be erased from the Medical Register (GMC, 2010). The Medical Board of California similarly disciplined a physician, Dr. Darryl See, who treated a number of patients (including a quadriplegic patient, a patient with neck pain, and a patient with spinal cord injury) with stem cells. There were various causes for discipline in that case including gross negligence, repeated negligent acts, incompetence, and false representations (MBC, 2007Medical Board of California (MBC). (2007). In the Matter of the Accusation against Darryl Matthew See, M.D. Division of Medical Quality, Medical Board of California, Department of Consumer Affairs, State of California. Case No. 04-2004-161179. http://www.casewatch.org/board/med/see/surrender.pdf.Google Scholar). In another instance, an Australian physician, Dr. Harvey Tarvydas, was sanctioned by the Medical Board of Queensland for purporting to treat a patient suffering from arachnoiditis with an experimental treatment intended to stimulate the growth of stem cells. His conduct was found to contravene the policy regarding unconventional medical practice in a number of respects including failure to obtain properly informed consent and failure to properly assess the patient (MBQ, 2010Medical Board of Queensland (MBQ). (2010). Re Dr. Harvey Tarvydas Medical Board of Queensland v. Tarvydas [2010]. http://www.austlii.edu.au/cgi-bin/sinodisp/au/cases/qld/QCAT/2010/246.html?stem=0&synonyms=0&query=Tarvydas#fn4.Google Scholar). In other cases, physicians have been sanctioned for less direct involvement, such as advertisement or pre- or posttreatment interventions. For example, Dr. Wong Yoke Meng was a licensed physician in Singapore and owner of two clinics when he was convicted of professional misconduct for misleading advertisements suggesting he was a specialist in stem cell treatments that were recognized, effective treatments for arthritis, hypertension, diabetes, Parkinson’s disease, and cancer (SMC, 2010aSMC (Singapore Medical Council). (2010a). Disciplinary Inquiry for Dr. Wong Yoke Meng. November 3, 2010. http://www.healthprofessionals.gov.sg/content/dam/hprof/smc/docs/press_releases/14.Press%20Release_Dr%20Wong%20Yoke%20Meng_3Nov10.pdf.Google Scholar). In another instance, he was convicted of professional misconduct for advertising stem cell skin therapy and stem cell therapy for facial and body rejuvenation. The services offered included escorted tours to foreign clinics as well as pre- and posttreatment care (SMC, 2010bSMC (Singapore Medical Council). (2010b). Press Release: Disciplinary inquiry for Dr. Wong Yoke Meng. November 9, 2010. http://www.healthprofessionals.gov.sg/content/dam/hprof/smc/docs/press_releases/15.Press%20Release_Dr%20Wong%20Yoke%20Meng4_9Nov10.pdf.Google Scholar). Although there may be exceptions (e.g., Munro, 2005Munro, M. (2005). Authorities probe B.C. doctor who gave stem-cell injections. Times–Colonist, Victoria, BC, Canada, June 25, 2005. A5.Google Scholar), at present it seems physicians in jurisdictions such as Canada are perhaps most likely to be involved in more peripheral capacities than as direct providers of unproven stem cell-based interventions. In a recent series of by of the with physicians and from of Physicians and in Canada, the two following types of involvement as most on with of medical tourism and and information and advice to patients and/or and preprocedure testing and/or a research study the of Canadian medical patients their physicians for medical or in for treatment which the physicians provided et al., R. Crooks V.A. Snyder J. know I was A study of the of Canadian medical 2012; 8: PubMed Scopus Google Scholar). study health policy implications for patients’ home health care systems, where such services are by a public health (e.g., in also raises regarding this conduct on the of physicians be or as support for or of the at Levine and Wolf, 2012Levine A.D. Wolf L.E. The roles and responsibilities of physicians in patients’ decisions about unproven stem cell therapies.J. Law Med. Ethics. 2012; 40: 122-134Crossref PubMed Scopus (44) Google present data on the of in the United States who an unproven stem cell-based for or for their a of patients and their including and advice and Wolf, 2012Levine A.D. Wolf L.E. The roles and responsibilities of physicians in patients’ decisions about unproven stem cell therapies.J. Law Med. Ethics. 2012; 40: 122-134Crossref PubMed Scopus (44) Google Scholar). In of the physicians to their patients (Zarzeczny and Caulfield, 2010Zarzeczny A. Caulfield T. 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D. of autologous cell J. 2014; PubMed Scopus Google Scholar). been that the of autologous stem cell therapies professional and and that regulation of this may be appropriate (Munsie and Hyun, 2014Munsie M. Hyun I. A question of ethics: Selling autologous stem cell therapies flaunts professional standards.Stem Cell Res. (Amst.). 2014; https://doi.org/10.1016/j.scr.2014.04.014Crossref PubMed Scopus (36) Google Scholar). However, regarding the and of regulatory also and jurisdictions, which the of new policy in this potential concern is that in regulatory and enforcement to by clinics for the most regulatory For example, robust enforcement efforts in clinics into less regulated there is some evidence to this of is in the stem cell tourism following to this market (e.g., R. (2012). Stem cell clinic that on the The 2012. Scholar, its stem cell to Scholar). 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