Amy Zarzeczny

Stem Cell Tourism and Doctors' Duties to Minors—A View From Canada

While the clinical promise of much stem cell research remains largely theoretical, patients are nonetheless pursuing unproven stem cell therapies in jurisdictions around the world—a phenomenon referred to as “stem cell tourism.” These treatments are generally advertised on a direct-to-consumer basis via the Internet. Research shows portrayals of stem cell medicine on such websites are overly optimistic and the claims made are unsubstantiated by published evidence. However, anecdotal evidence suggests that parents are pursing these “treatments” for their children, despite potential physical and financial risk. Physicians are in a unique position as they can be expected to be involved in, or privy to, such decisions. In this paper, we consider what duties physicians may have toward minor patients whose parents/guardians wish to engage in stem cell tourism on their behalf. We use the Canadian perspective to address the broadly relevant issues raised by this trend.

iPS Cells: Mapping the Policy Issues

Given the explosion of research on induced pluripotent stem (iPS) cells, it is timely to consider the various ethical, legal, and social issues engaged by this fast-moving field. Here, we review issues associated with the procurement, basic research, and clinical translation of iPS cells.

Stem cell clinics in the news

1243 respect, diagnostics are unusual compared with other domains where patent exclusivity has a role. We agree the evidence of harms from exclusive licensing is not systematic, but the evidence of benefit from patents in genetic diagnostics historically is even weaker. Finally, we appreciate there are indeed limits to BIO’s actions when questions of antitrust would arise in enforcing the existing norms on patenting and licensing genomic inventions. The licensing norms developed by the Organization for Economic Cooperation and Development2 (Paris), the US National Institutes of Health3 and the ‘Nine Points’ document on university technology licensing4 are all pro-competitive however, not anti-competitive. If a company is deviating from those norms, therefore, antitrust concerns would not arise; quite the reverse. We don’t suggest BIO act when antitrust would loom as an issue, but commenting on policies—such as enforcing patents when no test is available to patients— would rarely confront antitrust policy. The main underlying point is that problems with patents and exclusive licensing distinctive to diagnostics can be identified and dealt with, but only if the problems are acknowledged and acted upon. If BIO is turning its attention to these issues, then we will all benefit.

Emerging Ethical, Legal and Social Issues Associated with Stem Cell Research & and the Current Role of the Moral Status of the Embryo

Since its early days, stem cell research, particularly human embryonic stem cell research, has been the focus of intense social debate, and the question of the moral status of the embryo has been a central issue in the controversy. Despite this friction, and while it has yet to obtain widespread success in clinical applications, stem cell research remains a great hope for future advances in healthcare. In this paper, we will discuss the results of our systematic literature review in which we examined recent social science, legal and biomedical discourse, as well as Canadian print media discourse, associated with stem cell research in order to assess the role the question of the moral status of the embryo currently plays in these forums, and to identify what other issues are emerging and receiving attention. This analysis will assist with recognizing the issues which are likely to inform future policy and will facilitate forecasting the probable direction of the continually developing social discourse surrounding stem cell research.

Marketing of unproven stem cell–based interventions: A call to action

Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that should be addressed by coordinated approaches at the national and international levels. Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that has proven resistant to regulatory efforts. Here, we suggest a coordinated approach at the national and international levels focused on engagement, harmonization, and enforcement to reduce the risks associated with direct-to-consumer marketing of unproven stem cell treatments.

The Stem Cell Research Environment: A Patchwork of Patchworks

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a ‘patchwork of patchworks’. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.

“Media, politics and science policy: MS and evidence from the CCSVI Trenches”

BackgroundIn 2009, Dr. Paolo Zamboni proposed chronic cerebrospinal venous insufficiency (CCSVI) as a possible cause of multiple sclerosis (MS). Although his theory and the associated treatment (“liberation therapy”) received little more than passing interest in the international scientific and medical communities, his ideas became the source of tremendous public and political tension in Canada. The story moved rapidly from mainstream media to social networking sites. CCSVI and liberation therapy swiftly garnered support among patients and triggered remarkable and relentless advocacy efforts. Policy makers have responded in a variety of ways to the public’s call for action.DiscussionWe present three different perspectives on this evolving story, that of a health journalist who played a key role in the media coverage of this issue, that of a health law and policy scholar who has closely observed the unfolding public policy developments across the country, and that of a medical ethicist who sits on an expert panel convened by the MS Society of Canada and the Canadian Institutes of Health Research to assess the evidence as it emerges.SummaryThis story raises important questions about resource allocation and priority setting in scientific research and science policy. The growing power of social media represents a new level of citizen engagement and advocacy, and emphasizes the importance of open debate about the basis on which such policy choices are made. It also highlights the different ways evidence may be understood, valued and utilized by various stakeholders and further emphasizes calls to improve science communication so as to support balanced and informed decision-making.

Professional Regulation: A Potentially Valuable Tool in Responding to “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.

Stem cell research policy and iPS cells

The field of induced pluripotent stem cells (iPSCs) will be subject to a wide range of laws and research ethics policies, many of which exist as a result of the controversies associated with research on human embryonic stem cells. Understanding this potentially complex regulatory environment will help iPSC research move forward and will inform future policy.

The Evolution of Policy Issues in Stem Cell Research: An International Survey

Stem cell research remains a tremendously promising yet controversial field of study. It continues to attract considerable public interest and generate discussion and debate. However, while the high profile of this field has endured, the tone and nature of the discourse that drives this profile appears to be changing. In order to get a better sense of how these potential shifts are perceived by individuals directly embedded in the field, we conducted an international internet survey of members of the stem cell research community. Our participants included individuals publishing on both scientific and ethical, legal and social issues topics. We explored the degree to which participants perceived that key policy issues were becoming more or less contentious over time. We queried views regarding the effect of regulatory frameworks on emerging stem cell research technologies and the extent to which participants experience pressure related to clinical translation. We also explored participants’ relationships with industry, experience with patents and perceptions regarding the emphasis placed on the potential economic benefits of stem cell research. Our results suggest that while traditional debates such as those surrounding the moral status of the embryo remain, other issues more closely associated with clinical translation and commercialization are perceived as becoming increasingly contentious. This survey provides useful insight into the perspectives of a sample of active researchers working in countries around the world as well as an opportunity to reflect on the likely direction of future stem cell policy debates.