Abstract
Hundreds of businesses and clinics in the United States are engaged in direct-to-consumer marketing of unproven and unlicensed stem cell-based interventions. This essay provides an overview of this marketplace, examines advertising techniques companies use to draw clients and legitimate marketing claims, and summarizes the roles the Food and Drug Administration (FDA) and other agencies are supposed to play in regulating the direct-to-consumer marketplace for stem cell interventions. The essay also reviews federal regulations, describes how many businesses selling purported “stem cell treatments” appear to violate these standards, and considers ethical issues and harms associated with widespread promotion of unapproved stem cell products.
Original language | English (US) |
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Pages (from-to) | 7-24 |
Number of pages | 18 |
Journal | Perspectives in Biology and Medicine |
Volume | 61 |
Issue number | 1 |
DOIs | |
State | Published - Dec 1 2018 |
Bibliographical note
Funding Information:The paper was originally presented at a research symposium on “Autologous Cellular Therapies: Defining the Scope and Obligations of Clinical Innovation” in Singapore on May 24, 2017. This symposium was supported with funding from the National University of Singapore Office of the Deputy President (Research and Technology)–Humanities and Social Sciences Research Fund (WBS: R-171-000-055-646) and the Stem Cell Society, Singapore. Professor Alastair Campbell, National University of Singapore Centre for Biomedical Ethics, provided an oral commentary on the paper at the symposium, and the paper was revised following review from the guest editors and Professor Campbell.
Funding Information:
The paper was originally presented at a research symposium on “Autologous Cellular Therapies: Defining the Scope and Obligations of Clinical Innovation” in Singapore on May 24, 2017. This symposium was supported with funding from the National University of Singapore Office of the Deputy President (Research and Technology)-Humanities and Social Sciences Research Fund (WBS: R-171-000-055-646) and the Stem Cell Society, Singapore. Professor Alastair Campbell, National University of Singapore Centre for Biomedical Ethics, provided an oral commentary on the paper at the symposium, and the paper was revised following review from the guest editors and Professor Campbell.
Publisher Copyright:
© 2018 by Johns Hopkins University Press.