The involvement of Canadian physicians in promoting and providing unproven and unapproved stem cell interventions

Ogbogu, Ubaka; Du, Jenny; Koukio, Yonida

doi:10.1186/s12910-018-0273-6

Cited by 24 publications

(16 citation statements)

References 22 publications

(28 reference statements)

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“…Earlier analyses indicated that unproven SCI clinics were predominately located in countries considered to have less regulatory enforcement over drugs and biologics. Since 2014, clinics marketing purported SCIs have emerged in countries with robust regulatory infrastructure within Europe, North America, Australia, and Southeast Asia ( Berger et al., 2016 ; Connolly et al., 2014 ; Knoepfler, 2019d ; Munsie et al., 2017 ; Ogbogu et al., 2018 ; Turner and Knoepfler, 2016 ). Based on online advertising, the unproven SCI market is estimated at US$2.4 billion impacting 60,000 patients annually ( International Society Cell and Gene Therapy (ISCT), 2018 ) with documented clinics in Australia, Austria, Canada, China, Colombia, Costa Rica, Dominican Republic, Germany, India, Israel, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Panama, Philippines, Portugal, Russia, Spain, Thailand, Turkey, UK, US, and Ukraine.…”

Section: Main Textmentioning

confidence: 99%

Unproven stem cell interventions: A global public health problem requiring global deliberation

2021

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Section: Main Textmentioning

confidence: 99%

Unproven stem cell interventions: A global public health problem requiring global deliberation

2021

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“…This means that any cord blood therapies used by banks or their partners in the future would need to complete the clinical trial process and be approved by Health Canada. Institutions wishing to perform treatments in the future would be limited to approved therapies, and would not be able to perform unproven or unapproved therapies in the manner private clinics recently have in the context of stem cell therapies [45][46][47].…”

Section: Health Canadamentioning

confidence: 99%

The law and problematic marketing by private umbilical cord blood banks

2020

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Background: Private umbilical cord blood banking is a for-profit industry in which parents pay to store blood for potential future use. Governments have noted the tendency for private banks to oversell the potential for cord blood use, especially in relation to speculative cell therapies not yet supported by clinical evidence. We assessed the regulatory landscape governing private cord bank marketing in Canada. Main body: Because the problematic marketing of private cord blood banking for future use often relates to speculative future cell therapies that do not exist and are not being advertised for current clinical use, most private blood bank marketing seems to fall outside Health Canada's regulatory scope. However, this problematic marketing is regulated by the Competition Bureau pursuant to the Competition Act. While representations relating to future hypothetical treatments may not always be subject to the legal requirement for claim substantiation, the law also prohibits individuals and companies from knowingly or recklessly making representations that are "false or misleading in a material respect." A representation is materially false or misleading when it could "influence a consumer's behavior or purchasing decisions," and consumers are likely to be considered to be "credulous and inexperienced" for the purposes of assessing an advertisement's general impression. Because all of the potential benefit of the banking is derived from the potential future use of the biological material for health interventions directed toward the customers and their relatives, and because we know the best available medical evidence indicates a very low probability of utility in this context, we can say with confidence that some private cord blood banking claims are materially misleading. Moreover, to the extent that medical professionals are involved in private bank interactions with customers or hold ownership stakes in private banks, they are subject to professional codes, standards of practice, and potentially fiduciary obligations that further prohibit misleading marketing. Conclusions: Private cord blood bank marketing that advertises hypothetical future treatments can be misleading and may influence consumer behaviour. This marketing may breach existing advertising law. Regulatory bodies should enforce the law in order to help prevent public health and personal financial harm.

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“…Despite possibilities for vast improvements that might be introduced into such frameworks, current regulatory pathways remain the best guarantee for both quality and safety of newly approved products to protect patients from potential harm. Most importantly, physicians who are involved in offering or providing unproven SCIs which lack the appropriate scientific evidence, are violating the trust of their patients and subjecting them to unjustifiable risks .…”

Section: Factors Contributing To the Emergence And Global Rise Of Unpmentioning

confidence: 99%

Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions

Bauer

Elsallab

Abou‐El‐Enein

2018

Stem Cells Translational Medicine

126

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The promise of stem cell (SC) therapies to restore functions of damaged tissues and organs brings enormous hope to patients, their families, loved ones, and caregivers. However, limits may exist for which indications SC therapies might be useful, efficacious, and safe. Applications of innovative therapies within regulatory boundaries and within the framework of controlled clinical trials are the norm in the scientific and medical community; such a system minimizes patient risk by setting a clear and acceptable safety and efficacy profile for new therapeutics before marketing authorization. This careful clinical validation approach often takes time, which patients suffering from terminal or debilitating diseases do not have. Not validated, unproven stem cell interventions (SCI) that promise a working treatment or cure for severe diseases have therefore found their way into the patient community, and providers of such treatments often take advantage of the public's willingness to pay large amounts of money for the misguided hope of a reliable recovery from their illnesses. We conducted a review of scientific publications, clinical case reports, and mass media publications to assess the reported cases and safety incidents associated with unproven SCI. The review also analyzes the main factors that were identified as contributing to the emergence and global rise of the “stem cell tourism” phenomenon. stem cells translational medicine 2018;1–10

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The involvement of Canadian physicians in promoting and providing unproven and unapproved stem cell interventions

Cited by 24 publications

References 22 publications

Unproven stem cell interventions: A global public health problem requiring global deliberation

Unproven stem cell interventions: A global public health problem requiring global deliberation

The law and problematic marketing by private umbilical cord blood banks

Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions

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