Abstract
BackgroundDirect to consumer offerings of unproven stem cell interventions (SCIs) is a pressing scientific and policy issue. According to media reports, providers of SCIs have emerged in Canada. This study provides the first systematic scan of Canadian providers and associated trends and claims.MethodsThe study sample consisted of 15 websites retrieved from a Google™ keyword search. The websites were assessed by a rater using a peer-reviewed coding frame that queried treatment location, stem cell offerings, treatment claims, supporting evidence, and legal and regulatory compliance. A second rater reviewed a subset of the websites for purposes of inter-rater reliability. Disagreements between raters were resolved by consensus. Data collected by the raters was analyzed in SPSS.ResultsPhysicians are the dominant treatment providers in Canada. Providers operate in urban and semi-urban areas in the most populous provinces. SCIs provided are mainly autologous adult stem cells for multiple conditions including musculoskeletal disorders, spinal cord injury (SCI) and diabetes. Efficacy and benefits of treatment are prominently and positively portrayed, while risks are not mentioned or portrayed as trivial. Regulatory concerns are not discussed.ConclusionsThe involvement of physicians in promoting and providing unproven and unapproved SCIs raises significant ethical, legal and regulatory concerns. Treatment claims and trends appear to contravene applicable professional standards, statutory obligations, and consumer protection laws. While the number of providers observed is still marginal, urgent and proactive regulatory response is needed to prevent proliferation of a potentially exploitative and harmful market for unproven SCIs in Canada.
Highlights
Direct to consumer offerings of unproven stem cell interventions (SCIs) is a pressing scientific and policy issue
Twelve (12) of the 15 websites in the study feature Stem Cell Interventions (SCIs) provided by physicians
Thirteen (13) providers use adult stem cells for the clinical interventions promoted on their websites, while 2 providers do not specify the type of stem cells used
Summary
Direct to consumer offerings of unproven stem cell interventions (SCIs) is a pressing scientific and policy issue. Providers of SCIs have emerged in Canada. Stem cell interventions (SCIs) offered to the public in advance of clinical testing and regulatory approval is a pressing scientific, health policy and patient/public welfare issue [1,2,3,4,5,6,7]. The only SCIs approved for clinical use by Health Canada are hematopoietic stem cell transplants from bone marrow, umbilical cord and peripheral. Our findings show that Canadian physicians are the dominant players in the online promotion and provision of unproven and unapproved SCIs and suggest an urgent need for policy action and response from both within and outside the profession
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