Unproven "Stem Cell" Interventions in the U.S.: Ethical, Scientific, & Regulatory Concerns
Mini Bioethics Academy:
Health researchers have studied “stem cell tourism” to clinics in countries such as China, India, Mexico, Thailand, and the Ukraine but more recently, studies have found hundreds of clinics here in the U.S. selling unapproved and unproven stem cell interventions. Many of these clinics do not sell FDA-approved stem cell products or have credible evidence supporting their marketing claims.
This direct-to-consumer approach to selling unproven and unlicensed cell-based products prompts troubling concerns about patient safety, the manipulation of hope in advertising, and the gap between the current state of stem cell research and the purported therapies these clinics market.
In this talk, the speaker describes the U.S. direct-to-consumer marketplace for stem cell interventions and explore ethical issues related to the increase in U.S. clinics selling stem cell treatments. The presentation also covers regulation of stem cell-based products, FDA enforcement activity, and lawsuits filed by former patients of U.S. stem cell clinics.
Leigh Turner, PhD, Associate Professor, Center for Bioethics, Associate Professor, Dept of Pharmaceutical Care & Health Systems, Associate Professor, School of Public Health | With co-editors Jill Hodges and Ann Marie Kimball, Turner edited Risks and Challenges in Medical Tourism: Understanding the Global Market for Health Services (Praeger, 2012). With Raymond De Vries, Kristina Orfali, and Charles Bosk, Turner edited The View from Here: Bioethics and the Social Sciences (Wiley-Blackwell, 2007). Turner’s research addresses ethical, legal, and regulatory issues associated with clinics engaged in direct-to-consumer marketing of unproven and unlicensed cell-based interventions. Turner is also the author of numerous publications examining ethical issues related transnational medical travel (also known as “medical tourism”) and globalization of health care.