Presented By: Center for Bioethics and Social Sciences in Medicine (CBSSM)
CBSSM Seminar featuring Leigh Turner, PhD (March 10th
Announcing our next CBSSM seminar for Tuesday, March 10th. (Please note the different date and location):
U.S. Clinics Marketing Unlicensed and Unproven “Stem Cell” Interventions: Ethical Concerns and Regulatory Challenges
Leigh Turner, PhD, Associate Professor, Center for Bioethics, School of Public Health, and College of Pharmacy, University of Minnesota
Tuesday, March 10, 2015
3:00-4:00 pm
Center for Bioethics and Social Sciences in Medicine
University of Michigan
2800 Plymouth Road
NCRC, Building 16, B001E
Ann Arbor, MI 48109-2800
Abstract: Clinics advertising “stem cell” interventions are proliferating across the U.S. These businesses market putative “stem cell therapies” for ALS, MS, Parkinson’s disease, spinal cord injuries, muscular dystrophy, and many other diseases and injuries. Physicians at such clinics typically claim that they are engaged in the practice of medicine. They deny that they are promoting and administering biological drugs that are supposed to go through regulatory review and receive approval from the FDA before entering the marketplace. In many cases, available evidence suggests that this “practice of medicine” rationale is incorrect. Rather, by advertising unproven and unlicensed biological drugs, U.S. clinics appear to violate regulatory standards, ethical norms, and guidelines for the responsible conduct of research. It is understandable that patients are drawn to such businesses by powerful rhetorical claims, dramatic testimonials, and persuasive company websites. However, the advertisement, manufacture, and administration of unproven and unlicensed stem cell interventions generates many ethical, legal, and scientific concerns.
Refreshments will be provided!
You can find the complete list of CBSSM seminars on the CBSSM website.
U.S. Clinics Marketing Unlicensed and Unproven “Stem Cell” Interventions: Ethical Concerns and Regulatory Challenges
Leigh Turner, PhD, Associate Professor, Center for Bioethics, School of Public Health, and College of Pharmacy, University of Minnesota
Tuesday, March 10, 2015
3:00-4:00 pm
Center for Bioethics and Social Sciences in Medicine
University of Michigan
2800 Plymouth Road
NCRC, Building 16, B001E
Ann Arbor, MI 48109-2800
Abstract: Clinics advertising “stem cell” interventions are proliferating across the U.S. These businesses market putative “stem cell therapies” for ALS, MS, Parkinson’s disease, spinal cord injuries, muscular dystrophy, and many other diseases and injuries. Physicians at such clinics typically claim that they are engaged in the practice of medicine. They deny that they are promoting and administering biological drugs that are supposed to go through regulatory review and receive approval from the FDA before entering the marketplace. In many cases, available evidence suggests that this “practice of medicine” rationale is incorrect. Rather, by advertising unproven and unlicensed biological drugs, U.S. clinics appear to violate regulatory standards, ethical norms, and guidelines for the responsible conduct of research. It is understandable that patients are drawn to such businesses by powerful rhetorical claims, dramatic testimonials, and persuasive company websites. However, the advertisement, manufacture, and administration of unproven and unlicensed stem cell interventions generates many ethical, legal, and scientific concerns.
Refreshments will be provided!
You can find the complete list of CBSSM seminars on the CBSSM website.
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