The American Journal of Bioethics

respected. However, there may be cases in which the wishes of the adult patients while competent cannot be obtained. It is worth noting that elder abuse legislation exists in some jurisdictions to parallel the child welfare legislation mentioned by Zarzeczny and Cauleld. For example, Nova Scotias Adult Protection Act imposes on everyone a duty to report information that an adult is in need of protection to the Minister of Community Services. One key difference between this particular statute and the child welfare legislation mentioned by Zarzeczny and Cauleld is that the Adult Protection Act denes adults in need of protection as those who are (1) incapable of protecting or caring for themselves and (2) are victims of abuse and/or are not receiving adequate care and attention. The child welfare legislation imposes a duty to intervene before injury has occurred, and so requires a doctor to report a child where there is a substantial risk of physical injury. The distinction is in whether the duty requires a doctor to report present mistreatment or likely future mistreatment. On a strict interpretation, the decision to take an incompetent patient abroad for risky stem cell therapy looks less like present mistreatment than possible future mistreatment. Nonetheless, a court may choose to interpret such legislation broadly so as to read in a duty to intervene before harm arises, and other jurisdictions may have different statutes that do in fact explicitly impose a duty of intervention before harm occurs. As a result, physicians should perhaps consider the possibility that obligations similar to those discussed by Zarzeczny and Cauleld in the context of minor patients may also arise with their adult incompetent patients. Another relevant consideration is the possibility of legal consequences for failing to discharge the duty to report under child welfare legislation and elder abuse legislation. The child welfare legislation cited by Zarzeczny and Cauleld

provides that the failure to report as required by the statute constitutes a criminal offence (Child, Youth and Family Enhancement Act, section 4(6)). In addition, the courts may impose a common law duty giving rise to a possible claim for compensation. For example, in one 1997 case, a radiologist was held liable for the subsequent abuse of a child where he did not inform a pediatrician that a computed tomography (CT) scan indicated a possible case of child abuse (Brown v. University of Alberta Hospital 1997). It is important to stress that liability in negligence for failure to report depends upon that failure being unreasonable in the courts view. In the case of unproven stem cell therapies, there is considerable uncertainty about their pros and cons, so it is less likely that a failure to report will be viewed as unreasonable than in a case where harm is substantially likely to occur.

REFERENCES
Adult Protection Act, R.S.N.S. 1989, c.2. Brown (next friend of) v. University of Alberta Hospital [1997] A.J. No. 298 (Alta. Q.B.). Child, Youth and Family Enhancement Act, R.S.A. 2000, c. C-12. Lau, D., U. Ogbogu, B. Taylor, T. Stanski, D. Menon, and T. Cauleld. 2008. Stem cell clinics online: The direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell 3: 591594. Regenberg, A., L. Hutchinson, B. Schanker, and D. Matthews. 2009. Medicine on the fringe: Stem cell-based interventions in advance of evidence. Stem Cells 27(9): 23122319. Zarzecny, A., and T. Cauleld. 2010. Stem cell tourism and doctors duties to minorsA view from Canada. American Journal of Bioethics 10(5): 315.

Insights from Patients Blogs and the Need for Systematic Data on Stem Cell Tourism
Aaron D. Levine, Georgia Institute of Technology
Patient pursuit of unproven stem-cell-based interventions has raised important questions about physicians obligations to their patients, particularly those too young to make fully informed decisions about their medical care. Unfortunately, as Zarzeczny and Cauleld (2010) articulate in the target article exploring these duties, there are few broadly applicable answers to this question. Rather physicians obligations vary on a case-by-case basis, depending on the severity of their patients conditions, the likely risks and benets, if any, of the treatment, and a number of other factors. In this commentary, I suggest that in addition to these important legal obligations, the pragmatic question of what advice physicians should offer their patients (or their

Address correspondence to Aaron D. Levine, Assistant Professor, School of Public Policy, Georgia Institute of Technology, 685 Cherry Street, Atlanta, GA 30332-0345, USA. E-mail: aaron.levine@pubpolicy.gatech.edu 28 ajob May, Volume 10, Number 5, 2010

Stem Cell Tourism and Doctors Duties

patients parents) about these unproven stem cell therapies also deserves attention. As a step toward addressing these related questions, I provide preliminary insight into the types of patients pursuing unproven stem cell therapies and the interactions they have with their physicians. This effort makes use of a recently described data set of blogs maintained by patients (or the caretakers of patients) undergoing unproven stem cell therapies (Ryan et al. 2010). One of the biggest surprises in the analysis of the blogs of patients undergoing unproven stem cell therapies was the frequency with which the patients were minors. Indeed, more than 40% of the patients in the dataset were under the age of 18 years. In some cases, these patients were teenagers who had the ability to participate, at least to some degree, in decisions about their medical care. In many other cases, however, the patients were no more than a few years old and clearly reliant on their parents to make decisions about their medical treatment. In these latter cases, in particular, the questions of how physicians should respond to parents inquiring about unproven stem cell therapies and what obligations they owe their minor patients are crucial. The specic condition for which an unproven stem cell treatment is sought is an important factor shaping physicians obligations and responses. Our analysis documented children receiving unproven stem cell treatments for a variety of different conditions. These included typically fatal diseases, such as spinal muscular atrophy and Battens disease, as well as disabling but nonfatal conditions such as cerebral palsy, optic nerve hypoplasia, and autism. As physicians obligations to a minor patient with an untreatable fatal condition may differ from their obligations to a minor with a chronic but potentially manageable disease, the range of patients observed supports Zarzeczny and Caulelds conclusion that these duties vary from case to case. Because objective data about stem-cell-based interventions offered in clinics around the world are extremely limited, physicians who are asked to provide advice about these treatments are placed in a difcult position. In particular, the absence of clinical trial data and the lack of relevant preclinical studies in animal models for most of the treatment modalities used in these clinics leave doctors unable to comment knowledgeably about either the safety or efcacy of these treatment options. Doctorpatient discussions about unproven stem cell therapies were recounted in a number of patient blogs and several physician communication approaches emerged. In the rst approachthe strong rejection strategydoctors strongly advised against the therapy under consideration. In a typical example, a doctor would argue both that the unproven therapy was unlikely to be effective and that it posed potentially serious risks. In the second approachthe skeptical ambivalence strategydoctors declined to make denitive recommendations, indicating that they had insufcient information on which to base advice. These doctors often expressed skepticism about the proposed treatment, however. A physician following this strategy might,

for instance, indicate that she or he couldnt rule out the possibility that the treatment might work although there was no medical reason to think that it should. A small number of doctorpatient interactions were recounted in which the doctor could be characterized as at least partially supportive of the stem-cell-based therapy. These typically occurred when the patient was an adult suffering from an incurable degenerative disease, such as amyotrophic lateral sclerosis, and the reasoning appeared to focus more on the lack of other options for the patient than on any real benet offered by the unproven therapy. The nature of the sample of patient blogs studied precludes any conclusions about the impact of these various physician communication strategies on patients choices, but it seems likely that the strong rejection strategy would more effectively steer patients away from these treatments than the other communication approaches. The lack of systematic knowledge about these unproven stem cell therapies is a fundamental problem for patients considering their treatment options, as well as physicians advising these patients. It also poses challenges for policymakers seeking to regulate the development of new therapies or aiming to encourage their peers in other countries to clamp down on clinics offering unapproved medical interventions. Unfortunately, few of the clinics offering unproven stem cell therapies have expressed any serious interest in conducting randomized double-blind clinical trials (perhaps because a failed trial might jeopardize their current income streams). In some cases, a patients physician, regardless of the advice she or he gave about the unproven therapy, will conduct detailed pre- and post-treatment studies to help assess its effectiveness. This is a useful exercise, particularly when the results are shared with other patients and physicians, but it cannot replace larger, more systematic approaches. While this lack of information leaves the duties of physicians to their minor patients unresolved in most cases and the advice they should offer unclear, the obligations for other groups are more straightforward. Biomedical research funding agencies, scientic societies, disease advocacy groups, and others concerned with the risks that stem cell tourism poses to individual patients and the broader eld of stem cell science are obligated to establish processes to collect rigorous, objective, empirical data about patients experiences with unproven stem cell therapies. Such a step would inform medical care, help clarify doctors obligations, and facilitate ongoing policy efforts to mitigate the risks associated with unproven stem cell therapies. REFERENCES
Ryan, K. A., A. N. Sanders, D. D. Wang, and A. D. Levine. 2010. Tracking the rise of stem cell tourism. Regenerative Medicine 5(1): 2733. Zarzeczny, A., and T. Cauleld. 2010. Stem cell tourism and doctors duties to minors: A view from Canada. American Journal of Bioethics 10(5): 315.

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