title: Displaced agendas: current regulatory strategies for germline gene therapy.
abstract: Recent developments in biotechnology are radically affecting the nature of reproduction and the manner in which we approach disease. In particular, germline gene therapy, or the insertion of genetic material into cells while they are developing and dividing, offers the promise of eradicating genetic defects in humans during embryonic development. In this article, the authors argue that the social and ethical implications of the developments in the field of germline gene therapy have not yet received adequate consideration. Unlike previous technologies which targeted already-developed cells, germline gene therapy can potentially correct and eliminate genetic deficiencies at the developmental stages of a cell. This raises issues of genetic enhancement beyond the therapeutic applications of this technology. However, the authors submit that an established pattern of subordinating social and ethical issues to technical and scientific debate in the regulatory arena is repeating itself in the case of discussions over germline gene therapy. The authors suggest that the American scientific regulatory process fails to fully meet the challenges of this technology, particularly because social and ethical issues are not formally considered in the existing process. They therefore suggest that American regulatory agencies should look to the approach taken by Europe with regard to germline gene therapy as an emerging technology, and that it may be necessary to incorporate effective public debate over social and ethical concerns into a regulatory process which is primarily concerned only with the efficacy of new technologies.
authors.affiliation: Sidley and Austin, Washington, DC, USA.
authors.forename: E
authors.initials: E
authors.lastname: Marden
authors.forename: D
authors.initials: D
authors.lastname: Nelkin
mesh_terms: D001709:Biotechnology / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003132:Commerce; D005053:Eugenics; D005060:Europe; D005315:Fetal Diseases / Q000628:therapy; D024861:Genetic Enhancement; D015316:Genetic Therapy / Q000191:economics / Q000941:ethics* / Q000331:legislation & jurisprudence*; D005854:Germ Cells; D033161:Government Regulation; D006801:Humans; D009316:National Institutes of Health (U.S.); D011640:Public Policy; D012926:Social Control, Formal; D014481:United States; D014486:United States Food and Drug Administration