title: Are stem cells drugs? The regulation of stem cell research and development.
abstract: Stem cell research and its clinical application have become political, social, and medical lightning rods, polarizing opinion among members of the lay community and among medical/scientific professionals. A potpourri of opinion, near-anecdotal observation, and scientifically sound data has sown confusion in ways rarely seen in the medical arts and sciences. A major issue is regulation, with different aspects of stem cell research falling within the purview of different government agencies and local offices. An overarching clearinghouse to review the field and recommend policy is lacking. In the following pages, I touch on the societal framework for regulation, the known and potential risks and benefits of cardiovascular stem cell therapies, whether stem cells should be regulated as drugs or in analogy to drugs, and if there is to be regulation, then by whom. In so doing, I refer to the stem cell literature only as it relates to the discussion of regulation because this is not a review of stem cell research; it is an opinion regarding regulation.
authors.affiliation: College of Physicians and Surgeons of Columbia University, Department of Pharmacology, 630 W 168 St, PH 7West-321, New York, NY 10032, USA. mrr1@columbia.edu
authors.forename: Michael R
authors.initials: MR
authors.lastname: Rosen
mesh_terms: D035843:Biomedical Research; D016026:Bone Marrow Transplantation / Q000266:history; D033041:Embryo Research / Q000331:legislation & jurisprudence; D006331:Heart Diseases / Q000628:therapy*; D049673:History, 20th Century; D006801:Humans; D009316:National Institutes of Health (U.S.); D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000941:ethics / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration