SCRC

Turner, Leigh, Ph.D.

Section 1

Leigh Turner, Ph.D.

Professor and Executive Director, UCI Bioethics Program

Biography

Leigh Turner is Executive Director of the University of California, Irvine Bioethics Program and a Professor in the Program in Public Health’s Department of Health, Society, and Behavior. His primary research program addresses ethical, legal, and social issues related to stem cells and regenerative medicine products. In particular, he uses approaches from bioethics and the social sciences to study businesses and clinics engaged in direct-to-consumer marketing of unproven and unlicensed cell-based interventions. Professor Turner’s research in this area is funded by the Pew Charitable Trusts. He also studies ethical issues related to such topics as pay-to-participate clinical studies, crowdfunding for medical care, and cross-border health-related travel. Turner is a co- editor of Risks and Challenges in Medical Tourism: Understanding the Global Market for Health Services and The View from Here: Bioethics and the Social Sciences.

Turner was previously an Associate Professor at the University of Minnesota Center for Bioethics and School of Public Health; Associate Professor and William Dawson Scholar at McGill University’s Biomedical Ethics Unit and Department of Social Studies of Medicine; Clinical Assistant Professor at the University of Toronto Joint Centre for Bioethics and Clinical Ethicist at Baycrest Centre for Geriatric Care and Sunnybrook Health Sciences Centre; and a Research Associate at The Hastings Center. He has been a Visiting Fellow at the Brocher Foundation in Hermance, Switzerland; Erasmus Mundus Visiting Scholar, Radboud University Nijmegen, the Netherlands; Distinguished Visiting Fellow, Comparative Program on Health and Society, University of Toronto Munk School of Global Affairs, Toronto, Ontario, Canada; Member, School of Social Science, Institute for Advanced Study, Princeton, New Jersey, USA; National Endowment for the Humanities/Sealy & Smith Foundation Visiting Scholar, University of Texas Medical Branch Institute for the Medical Humanities, Galveston, Texas; and Ryan Bioethicist in Residence, Southern Illinois University, Carbondale, Illinois, USA.

Professor Turner is a member of the International Society for Stem Cell Research’s Ethics Committee and Membership Committee, the International Society for Cell & Gene Therapy’s Presidential Task Force on the Use of Unproven and/or Unethical Cell and Gene Therapies, and the National Institutes of Health’s Novel and Exceptional Technology and Research Advisory Committee.

Research in Lay Terms

"My research addresses ethical, legal, and social issues related to U.S. businesses and international companies engaged in direct-to-consumer marketing of unlicensed and unproven stem cell interventions. Using research methods drawn from the social sciences, I investigate the claims such businesses make about where they are located, what diseases and injuries they purport to treat, what types of cell-based interventions and other regenerative medicine products they sell, and how much such procedures cost. This empirical approach is integrated with ethical analysis of the marketing claims, commercial practices, and clinical activities of such businesses. My research explores the implications inaccurate marketing representations have for informed consent, patient safety, public health, and public understanding of stem cell research and regenerative medicine."

Research Focus

"My primary research program addresses ethical, legal, and social issues related to stem cell research and the field of regenerative medicine. My work provides an empirical analysis and ethical critique of businesses engaged in advertising and administering unlicensed and unproven stem cell interventions. I have examined direct-to-consumer marketing by such businesses in Canada and the United States, addressed various ethical issues related to such commercial and clinical activity, explored legal and policy environments for stem cell interventions and other regenerative medicine products, identified and critiqued ‘’pay-to-participate” stem cell studies, worked with Professor Jeremy Snyder to analyze crowdfunding campaigns established by individuals seeking unproven stem cell interventions, considered how “right-to-try” legislation might change access to stem cell products, and tracked changes in marketing representations as some companies have claimed to offer treatments, preventive interventions, or “immune boosters” in response to the COVID-19 pandemic. Funded by the Pew Charitable Trusts, my research team and I are proceeding from this existing body of research to examine understudied features of the U.S. marketplace for unlicensed and unproven stem cell interventions."

Research Details

In the United States and elsewhere around the world, hundreds and possibly thousands of businesses are selling purported stem cell treatments that are not approved by national regulators and are unsupported by convincing evidence of safety and efficacy. Businesses advertise putative stem cell therapies for amyotrophic lateral sclerosis, autism spectrum disorder, cerebral palsy, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson’s disease, osteoarthritis, spinal cord injuries, sports- related musculoskeletal injuries, and many other diseases and injuries. Some patients have suffered serious injuries after being administered such unproven and unapproved products. Other patients have experienced substantial financial losses after being subjected to “hard sell” sales tactics by such businesses. In addition to posing risks to individual patients, some companies selling unproven stem cell products engage in activities with harmful collective consequences, such as circulating health-related misinformation on corporate websites and social media platforms, making misleading claims about the Food and Drug Administration and other regulators, blurring important distinctions between treatment and research, diverting individuals from opportunities to participate in well-designed and carefully conducted clinical trials, and claiming to reduce transmission of SARS-CoV-2 and prevent COVID-19 by selling supposedly “immune-boosting” stem cell products that in reality are not backed by convincing evidence of safety and efficacy.

Using empirical research methods from the social sciences and methods and theories from bioethics, my research addresses ethical, legal, and social issues related to direct-to- consumer marketing of unlicensed and unproven stem cell products. My research explores marketing claims made by such businesses and the personal and collective consequences of what often are inaccurate and misleading advertising claims. Over the next two years, my research team and I will pay particular attention to the U.S. direct-to- consumer marketplace for putative stem cell treatments. We will identify and address ethical issues related to such commercial and clinical practices, examine laws and regulations that incentivize or constrain problematic marketing practices and clinical activities, consider how regulators such as the Food and Drug Administration, Federal Trade Commission, state medical boards, and state attorneys general offices should respond to such business operations, and explore what can be done to increase the likelihood that when patients are administered stem cell products they are provided interventions backed by convincing evidence of safety and efficacy. This research program is supported by funding from the Pew Charitable Trusts.

Publications Addressing Ethical, Legal, and Social Issues Related to Stem Cell Research and Regenerative Medicine

Leigh Turner, The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions, Cell Stem Cell, Volume 28, Issue 11, 2021, Pages 1891-1895, ISSN 1934-5909, https://doi.org/10.1016/j.stem.2021.10.008 November 4, 2021.

Leigh Turner. 2021. U.S. Businesses Selling Unproven and Unlicensed Stem Cell Interventions: Ethical, Legal, and Social Issues. Pennsylvania State University Bioethics Colloquium. November 1.

Leigh Turner, Co-chair, with Laertis Ikonomou, Co-chair, Farzana Akkas, Presenter, Jaime Imitola, Presenter. 2021. Adverse Effects of Unproven Cell-based Products. International Society for Cell & Gene Therapy Webinar. October 21. 

Leigh Turner, Megan Munsie, Aaron D. Levine, Laertis Ikonomou. 2021 Ethical and public communication in the development of cell-based treatments for COVID-19: Lessons from the pandemic. Stem Cell Reports. Published online October 14 with publication in print issue to follow.

Quoted in: Anna Merlan, A Controversial Autism Treatment is About to Become a Very Big Business. Vice, October 6, 2021. 

Quoted in: Matthew Perrone, US stem cell clinics boomed while FDA paused crackdown. Associated Press, September 30, 2021 (Published in Los Angeles Times, Washington Post, etc.) 

Anthony Atala; Panelists: Arthur L. Caplan, Nancy M.P. King, Susan Kornetsky, Leigh Turner. Stem Cell Research and Pay-to-Participate Trials Webinar, September 22, 2021. 

Turner L. 2021. Hope, hype, cures, and persons with cerebral palsy. Developmental Medicine and Child Neurology Published online September 18.

Invited September 16, 2021 to serve on the NIH Novel and Exceptional Technology and Research Advisory Committee’s new Working Group on Data Science and Emerging Technology. 

Turner L., Snyder J. 2021. Ethical issues concerning a pay-to-participate stem cell study. Stem Cells Translational Medicine 10: 815-819.

Leigh Turner. 2021. U.S. Marketplace for Unlicensed and Unproven Stem Cell Interventions. Orthobiologics and Regenerative Medicine Webinar Series, Alliance for Regenerative Rehabilitation Research and Training. August 17.

Turner L. 2021 ISSCR’s Guidelines for Stem Cell Research and Clinical Translation: Supporting development of safe and efficacious stem cell-based interventions. Stem Cell Reports 16: 1394-1397.

Lovell-Badge R., Anthony A., Barker R., Bubela T., Brivanlou A., Carpenter M., Charo, A., Clark A., Clayton E., Cong Y., Daley G., Fu J., Fujita M., Greenfield A., Goldman S., Hill L., Hyun I., Isasi R., Kahn J., Kato K., Kim, J-S., Kimmelman J., Knoblich J., Mathews D., Montserrat N., Mosher J., Munsie M., Nakauchi H., Naldini L., Naughton G., Niakan K., Ogbogu U., Pedersen R., Rivron, N., Rooke H., Rossant J., Round J., Saitou M., Sipp D., Steffann J., Sugarman J., Surani A., Takahashi J., Tang F., Turner L., Zettler P., Zhai X. ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update. Stem Cell Reports 16: 1398-1408.

Snyder J., Turner L. 2020. Crowdfunding, stem cell interventions and autism spectrum disorder: comparing campaigns related to an international “stem cell clinic” and US academic medical centerCytotherapy 23, 3: 198-202.

Snyder J., Bateman-House A., Turner L. 2020. Is right to try being tried? Using crowdfunding data to better understand usage of nontribal pre-approval access pathways. Regenerative Medicine 15, 8: 1979-1985.

Turner L. 2020. Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed “Stem Cell Treatments” for COVID-19. Cell Stem Cell 26 (6): 806-810.

Smith C., Martin-Lille C., Higano J., Turner L., Phu S., Arthurs J., Nelson T., Shapiro S., Master Z. 2020. Challenging misinformation and engaging patients: characterizing a regenerative medicine consult service. Regenerative Medicine 15 (3): 1427-1440.

Sipp D., Turner L., Rasko, J. 2019 Stem Cell Businesses and Right to Try Laws. Cell Stem Cell 25 (3): 304-305.

Snyder J., Turner L. 2019. Crowdfunding for Stem Cell Based Interventions Intended to Treat Neurological Diseases and Injuries. Neurology 93, 6: 1-7. 

Fu W., Smith C., Turner L., Fojtik J., Pacyna J., Master Z. 2019. Characteristics and Scope of Training of Clinicians Participating in the US Direct-to-Consumer Marketplace for Unproven Stem Cell Interventions. Journal of the American Medical Association 321, 24: 2463-2464.

Ikonomou L., Wagner DE., Turner L., Weiss DJ. 2019. Translating Basic Research into Safe and Effective Cell-based Treatments for Respiratory Diseases. Annals of the American Thoracic Society 16, 6: 657-668. 

Tanner C, Munsie M, Sipp D, Turner L, Wheatland C. 2019. The politics of evidence in online illness narratives: an analysis of crowdfunding for purported stem cell treatments. Health: An Interdisciplinary Journal for the Social Study of Health, Illness and Medicine 23, 4: 436-457.

Zarzeczny A., Atkins H., Illes J., Kimmelman J., Master Z., Robillard J., Snyder J., Turner L., Zettler P., Caulfield P. 2018. The stem cell market and policy options: a call for clarity. Journal of Law and the Biosciences, 1-16.

Turner L. 2018. Direct-to-consumer marketing of stem cell interventions by Canadian Businesses. Regenerative Medicine 13 (6): 643-658.  

Sipp D., Robey, P., and Turner L. 2018. Clear up this stem-cell mess. Nature 561 (7724): 455-457.    

Wagner D., Turner L., Panoskaltsis-Mortari A., Weiss D., Ikonomou L. 2018. Co-opting of ClinicalTrials.gov by patient-funded studies. The Lancet Respiratory Medicine 6 (8): 579-581.  

Turner L. 2018. The U.S. Direct-to-Consumer Marketplace for Autologous Stem Cell Interventions. Perspectives in Biology and Medicine 61, 1: 7-24.

Snyder J., Turner L. 2018. Selling stem cell ‘treatments’ as research: prospective customer perspectives from crowdfunding campaigns. Regenerative Medicine 13 (4): 375-384.

Snyder J, Turner L, Crooks V. 2018. Crowdfunding for Unproven Stem Cell-Based Interventions. Journal of the American Medical Association 319, 18: 1935-1936.

Knoepfler P., Turner L. 2018. The FDA and the US direct-to-consumer marketplace for stem cell interventions: a temporal analysis. Regenerative Medicine 13 (1): 19-27.   

Weiss D., Turner L., Levine A., Ikonomou L. 2018. Medical Societies, Patient Education Initiatives, Public Debate, and the Marketing of Unproven Stem Cell Interventions. Cytotherapy 20 (2): 165-168.

Turner L. 2017. ClinicalTrials.gov, Stem Cells, and “Pay-to-Participate” Clinical Studies. Regenerative Medicine. 12 (6): 705-719.

Martins Martinho A., Turner L. 2017. Stem Cells in Court: Historical Trends in U.S. Legal Cases Related to Stem Cells. Regenerative Medicine 12 (4): 419-430. 

Turner L., Knoepfler P. 2016. Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry. Cell Stem Cell 19 (2): 154-157.

O’Donnell L., Turner L, Levine, A. 2016. The role of communication in better understanding unproven cellular therapies. Cytotherapy 18, 1: 143-148. 

Dominici M., Nichols K., Srivastava A., Weiss D., Eldridge P., Cuende N., Deans R., Rasko J., Levine A., Turner L., Griffith D., O’Donnell L., Forte M., Mason C., Wagena E., Janssen W., Norton R., Wall, D., Ho H., Ruiz M., Wilton S., Horwitz E., Gunter K. 2015. Positioning a scientific community on unproven cellular therapies: The 2015 International Society for Cellular Therapy Perspective. Cytotherapy 1: 1663-1666.   

Turner L. 2015. Federal Regulatory Oversight of U.S. Clinics Marketing Adipose-derived Autologous Stem Cell Interventions: Insights from Three New FDA Draft Guidance Documents. Mayo Clinic Proceedings 90, 5: 567-571.

Turner L. 2015. U.S. Clinics Marketing Unproven and Unlicensed Adipose-derived Autologous “Stem Cell” Interventions. Regenerative Medicine 10, 4: 397-402. 

Turner L. 2015. U.S. Stem Cell Clinics, Patient Safety, and the FDA. Trends in Molecular Medicine 21, 5: 271-273.

Sipp D, and Turner L. 2012. U.S. Regulation of Stem Cells as Medical Products. Science 338: 1296-1297.

Related Links

Leigh Turner, UCI Faculty Profile

Noncompliant-a podcast about neurodiversity and human rights, 2021; Stem Cells for Autism

MinnPost, 2020; Unproven stem cell products are being peddled as COVID-19 ‘therapies’

Critically Speaking, 2020; Stem Cells for COVID-19?

Critically Speaking, 2019; Part I: Beware: Stem Cell Direct-to-Consumers and Part II: Dangerous?: Listen Before Getting Stem Cell Therapy

RegMedNet, 2018; Understanding the landscape of direct-to-consumer marketing in Canada

The Stem Cell Podcast, 2017: Episode 106: Ethical Concerns

RegMedNet, 2017; “Pay-to-participate stems cells studies”

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Email: leigh.turner@uci.edu 

Twitter: @LeighGTurner

Department Affiliations:

Program in Public Health, Department of Health, Society, and Behavior Institute for Clinical and Translational Science