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.

The future of artificial intelligence in medicine: Medical-legal considerations for health leaders.

Artificial Intelligence (AI) is becoming increasingly common in healthcare and has potential to improve the efficiency and quality of healthcare services. As the utility of AI expands, medical-legal questions arise regarding the possible legal implications of incorporating AI into clinical practice. Particularly, the unique black box nature of AI brings distinct challenges. There is limited guidance addressing liability when AI is used in clinical practice, and traditional legal principles present limitations when applied to novel uses of AI. Comprehensive solutions to address the challenges of AI have not been well established in North America. As AI continues to evolve in healthcare, appropriate guidance from professional regulatory bodies may help the medical field realize AI's utility and encourage its safe use. As the options for AI in medicine evolve, physicians and health leaders would be prudent to consider the evolving medical-legal context regarding use of AI in clinical practices and facilities.

Artificial intelligence-based imaging analytics and lung cancer diagnostics: Considerations for health system leaders.

Lung cancer is a leading cause of cancer death in Canada, and accurate, early diagnosis are critical to improving clinical outcomes. Artificial Intelligence (AI)-based imaging analytics are a promising healthcare innovation that aim to improve the accuracy and efficiency of lung cancer diagnosis. Maximizing their clinical potential while mitigating their risks and limitations will require focused leadership informed by interdisciplinary expertise and system-wide insight. We convened a knowledge exchange workshop with diverse Saskatchewan health system leaders and stakeholders to explore issues surrounding the use of AI in diagnostic imaging for lung cancer, including implementation opportunities, challenges, and priorities. This technology is anticipated to improve patient outcomes, reduce unnecessary healthcare spending, and increase knowledge. However, health system leaders must also address the needs for robust data, financial investment, effective communication and collaboration between healthcare sectors, privacy and data protections, and continued interdisciplinary research to achieve this technology's potential benefits.

The Future of Stem Cell Research and its Clinical Translation in Canada: Exploring Questions of Governance and Policy Options.

Stem cell research is a promising area of biomedical research with tremendous potential for increasing our understanding of human development and for improving clinical treatment options across a range of serious conditions. However, it has historically also been a complex field, both scientifically and ethically. It raises numerous policy tensions including those related to the acceptability of different forms of research in the field and, more recently, regarding how to respond to the rapidly growing private market for clinical applications that lack broadly accepted forms of evidence of safety and efficacy. Using the Canadian market for unproven stem cell interventions as a case study, this review paper identifies questions of governance and policy options as they relate to the future of stem cell research and its clinical translation in Canada. Key areas of inquiry include the roles and influence of evidence, scientific and clinical imperatives, and public pressure on policy decisions, as well as the role of regulation in managing risks and uncertainty in fast moving fields of biomedicine. Examining these questions in a Canadian context is particularly timely at present given the emerging domestic private market for stem cell-based interventions coupled with scientific developments in the field that are highlighting ambiguities and other challenges with our current regulatory framework.

Medical tourism and national health care systems: an institutionalist research agenda.

Although a growing body of literature has emerged to study medical tourism and address the policy challenges it creates for national health care systems, the comparative scholarship on the topic remains too limited in scope. In this article, we draw on the existing literature to discuss a comparative research agenda on medical tourism that stresses the multifaceted relationship between medical tourism and the institutional characteristics of national health care systems. On the one hand, we claim that such characteristics shape the demand for medical tourism in each country. On the other hand, the institutional characteristics of each national health care system can shape the very nature of the impact of medical tourism on that particular country. Using the examples of Canada and the United States, this article formulates a systematic institutionalist research agenda to explore these two related sides of the medical tourism-health care system nexus with a view to informing future policy work in this field.

Defining 'medical necessity' in an age of personalised medicine: A view from Canada.

The concept of medical necessity plays a central role in many healthcare systems, including Canada's, by helping determine which healthcare services will receive funding. Despite its significance in health policy frameworks, medical necessity has proven to be notoriously difficult to define and operationalise. A shift toward a more personalised and genetically-informed approach to the provision of healthcare seems likely to heighten associated policy challenges. One of the stated goals of personalised medicine is to save healthcare systems money by facilitating the use of less and more effective treatments. However, any cost saving potential may ultimately be thwarted by physicians' legal and ethical obligations, given that physicians will inevitably be required to implement and define the bounds of genetically-informed medical necessity for their patients.

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

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.

"Media, politics and science policy: MS and evidence from the CCSVI Trenches".

BACKGROUND: In 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. DISCUSSION: We 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. SUMMARY: This 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.

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 pursuing 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.

Contact us for more information: an analysis of public enquiries about stem cells.

Aim: This study examines online enquiries received by two prominent stem cell science initiatives operating in different geographical jurisdictions. Materials & methods: Combined quantitative and qualitative analysis undertaken of internet-based queries (n = 1047) received by Stem Cells Australia and EuroStemCell from members of the public over a two-year period (May 2014-2016). Results: Findings reveal striking similarities between the two datasets and highlight the range of uncertainties, priorities and needs of those seeking information about stem cells online. Conclusion: Sustained and in-depth tailored guidance is needed to effectively meet the diverse stem cell-related information-based needs of communities internationally. Such efforts should be prioritized by regenerative medicine research initiatives and organizations, given the trust and hope diverse publics appear to place in these groups.

How to Peddle Hope: An Analysis of YouTube Patient Testimonials of Unproven Stem Cell Treatments.

Providers capitalize on patient testimonials to market unproven stem cell treatments (SCTs). We evaluated 159 YouTube videos and found patients discussed health improvements (91.2%), praised providers (53.5%), and recommended SCTs (28.9%). In over a third of the videos, providers posed questions to patients, thereby directing narratives and making them a powerful marketing tool.

Canada's Assisted Human Reproduction Act: Pragmatic Reforms in Support of Research.

Canada's Assisted Human Reproduction Act is long overdue for Parliamentary review. We argue that the current regulation of research using human reproductive materials is not proportionate, not responsive to the uncertain threats posed to human and environmental health and safety, and is not considerate of diverse values in a democratic society. We propose tailored regulatory carve-outs for in vitro research for currently prohibited activities, such as gene editing, and for the exercise of Ministerial Discretion for access by Canadians to experimental in vivo interventions that are currently prohibited, such as mitochondrial replacement therapy. Our recommendations are bounded by constitutional constraints that recognize political and practical challenges in keeping oversight of this research under Federal jurisdiction, whether conducted in academic or private sectors. The proposed nuanced regulatory scheme should be overseen by a new national Agency, modeled on a blend of the Canadian Stem Cell Oversight Committee and Assisted Human Reproduction Canada.

Exploiting science? A systematic analysis of complementary and alternative medicine clinic websites' marketing of stem cell therapies.

OBJECTIVE: To identify the frequency and qualitative characteristics of stem cell-related marketing claims made on websites of clinics featuring common types of complementary and alternative medicine practitioners. The involvement of complementary and alternative medicine practitioners in the marketing of stem cell therapies and stem cell-related interventions is understudied. This research explores the extent to which they are involved and collaborate with medical professionals. This knowledge will help with identifying and evaluating potential policy responses to this growing market. DESIGN: Systematic website analysis. SETTING: Global. US and English-language bias due to methodology. MAIN OUTCOME MEASURES: Representations made on clinic websites in relation to practitioner types, stem cell therapies and their targets, stem cell-related interventions. Statements about stem cell therapies relating to evidence of inefficacy, limited evidence of efficacy, general procedural risks, risks specific to the mode of therapy, regulatory status, experimental or unproven nature of therapy. Use of hype language (eg, language that exaggerates potential benefits). RESULTS: 243 websites offered stem cell therapies. Many websites advertised stem cell transplantation from multiple sources, such as adipose-derived (112), bone marrow-derived (100), blood-derived (28), umbilical cord-derived (26) and others. Plant stem cell-based treatments and products (20) were also advertised. Purposes for and targets of treatment included pain, physical injury, a wide range of diseases and illnesses, cosmetic concerns, non-cosmetic ageing, sexual enhancement and others. Medical doctors (130), chiropractors (53) and naturopaths (44) commonly work in the clinics we found to be offering stem cell therapies. Few clinic websites advertising stem cell therapies included important additional information, including statements about evidence of inefficacy (present on only 12.76% of websites), statements about limited evidence of efficacy (18.93%), statements of general risks (24.69%), statements of risks specific to the mode(s) of therapy (5.76%), statements as to the regulatory status of the therapies (30.86%) and statements that the therapy is experimental or unproven (33.33%). Hype language was noted (31.69%). CONCLUSIONS: Stem cell therapies and related interventions are marketed for a wide breadth of conditions and are being offered by complementary and alternative practitioners, often in conjunction with medical doctors. Consumer protection and truth-in-advertising regulation could play important roles in addressing misleading marketing practices in this area.

Research on Human Embryos and Reproductive Materials: Revisiting Canadian Law and Policy.

Research involving human embryos and reproductive materials, including certain forms of stem cell and genetic research, is a fast-moving area of science with demonstrated clinical relevance. Canada's current governance framework for this field of research urgently requires review and reconsideration in view of emerging applications. Based on a workshop involving ethics, legal, policy, scientific and clinical experts, we present a series of recommendations with the goal of informing and supporting health policy and decision-making regarding the governance of the field. With a pragmatic and principled governance approach, Canada can continue its global leadership in this field, as well as advance the long-term health and well-being of Canadians.

Leveraging social media in the stem cell sector: exploring Twitter's potential as a vehicle for public information campaigns.

AIM: Our aim in this project was to explore Twitter's potential as a vehicle for an online public information campaign (PIC) focused on providing evidence-based information about stem cell therapies and the market for unproven stem cell-based interventions. METHODS: We designed an online, Twitter-based PIC using classic design principles and identified a set of target intermediaries (organizations with online influence) using a network governance approach. We tracked the PIC's dissemination over a 2-month period, and evaluated it using metrics from the #SMMStandards Conclave. RESULTS: Participation was limited but the PIC achieved some reach and engagement. CONCLUSION: Social media based online PICs appear to have potential but also face challenges. Future research is required to better understand how to most effectively maximize their strengths.