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HC70A & SAS70A Winter 2011 Genetic Engineering in Medicine, Agriculture, and Law Professors Bob Goldberg & John Harada Lecture 9 Science & The Constitution: Regulating Science & Genetic EngineeringTEXT READING Chapters 12 & 13SELECTED REFERENCES 1. Cloning & The Constitution, By I.H. Carmen (1985) 2. A Practical Companion To The Constitution, By J.K. Lieberman (1999) 3. The Recombinant DNA Controversy: A Memoir, By D. S. Fredrickson (2001) 4. Genetics: Ethics, Law, and Policy, By Lori B. Andrews et al. (2002) 5. Stem Cell Century, By Russell Korobkin (2007) 6. Biotechnology and The Law, By H.B. Wellons et al. (2007) 7. A Guide to Biotechnology Law & Business, By Robert A. Bohrer (2007) 8. The Role of Science in The Law, By Robin Feldman (2009) 9. Patent, Copyright, & Trademark, By R. Stim (2010) 10. Patents in Genomics and Human Genetics, By Robert Cook-Deegan & Christopher Heaney, Annu. Rev. Human Genetics, 11, 383-425 (2010)THEMES 1. History of Genetics & Law in the US 2. Inborn Errors & Eugenics 3. Evolution and the Law 4. Historical Attempts to Regulate Science-The Genetic Engineering & Stem Cell Controversies 5. Examples of Regulating Science at the Federal and State Levels 6. Patenting Your Genes 7. Government of the United States 8. What is in the Constitution About Science-Directly & Indirectly? 9. Can Scientific Inquiry and Research Be Regulated? 10. Can Experimentation Be Regulated Directly? 11. Case Studies in Regulating Science Directly 12. Can Science Be Regulated Indirectly? 13. Regulating Science-A Summary“Laws and institutions must go hand in hand with the progress of the human mind. As that becomes more developed, more enlightened, as new discoveries are made, new truths disclosed, and manners and opinions change with the change of circumstances, institutions must advance also, and keep pace with the times.” Thomas Jefferson, July 12, 1810What is the History of The Relationship Between Genetics & the Law in the United States?Garrod Discovered That Some Human Metabolic Diseases Have a Genetic Basis And Follow Mendelian Rules of InheritanceInborn Errors of Metabolism - Defects in Phenylalanine Breakdown A. GarrodInborn Errors in the HDG Gene Leading to Alkaptonuria Chromosome 3 55 kb in length 445 aa protein1883 • Regression Line • Standard Deviation • Correlation • Fingerprint Patterns Darwinʼs Cousin Francis Galton Invented the Term Eugenics F. GaltonState Sterilization Laws 1921 64,000 Forced Sterilizations in US - Last one in Oregon in 1981“Pedigree” of Carrie Buck State of Virginia Colony For Epileptics & Feebleminded- 1924The ruling was written by Justice Oliver Wendell Holmes. In support of his argument that the interest of the states in a "pure" gene pool outweighed the interest of individuals in their bodily integrity, he argued in 1927: “We have seen more than once that the public welfare may call upon the best citizens for their lives. It would be strange if it could not call upon those who already sap the strength of the State for these lesser sacrifices, often not felt to be such by those concerned, in order to prevent our being swamped with incompetence. It is better for all the world, if instead of waiting to execute degenerate offspring for crime, or to let them starve for their imbecility, society can prevent those who are manifestly unfit from continuing their kind. The principle that sustains compulsory vaccination is broad enough to cover cutting the Fallopian tubes.” Holmes concluded his argument with the infamous phrase "Three generations of imbeciles are enough."The Law Impacts Science in Many Ways………John Scopes Scientific American, February, 2011Attempts to Regulate Science Are Not New! Trial of Galileo - 1633Lysenko and Genetics in Soviet Union 1930-1950sAttempts to Regulate Genetic Engineering at the Local, State, & Federal Levels The Genetic Engineering Controversy: 1974-1986Cohen-Boyer-1973 Berg Letter (1974), Asilomar (1975), NIH Guidelines & Recombinant DNA Advisory Committee (RAC) (1976)The Berg Letter: Science, July, 1974 The Catalyst For the Asilomar Conference & NIH Recombinant DNA GuidelinesUCLA Biohazard Committee Approvals 19785/24/772/20/771/17/77 Threats of diseases and monsters that could be brought about by recombinant DNA…..gene splicing should be banned within the city limits.2/7/7710/25/77 Congress Has Never Passed a Law Regulating Genetic Engineering- State, City, and County Laws Do Exist, however (e.g., Mendicino County)2/8/77 1/12/78 Allows P1, P2, & P3 Research Following NIH Guidelines Allows Research Following NIH GuidelinesShould There Be Laws Regulating Science? a. Yes b. NoAttempts to Regulate Human Cloning and Stem Cell Research at the Local, State, & Federal Levels? The Stem Cell Funding Wars - 1998 to Present • President Clinton s NIH Advisory Panel Recommended That Federal Funds Be Used For Research on Human Embryos Discarded From In Vitro Fertilization -1995 • Dickey-Wicker Amendment Prohibited Federal Funding For Research in Which Human Embryos Are Destroyed - 1995 • Human Embryonic Stem Cells Discovered (hESC) -1998 • President Bush Announced That Federal Funds Could Be Used For the First Time on Exisiting hESC Lines, but Not on Newly Established hESC lines - 2001 • President Bush Vetoes a Bill Passed by Congress Allowing Federal Funding of hESC Research - 2006 • Present Obama Announced That Federal Funds Could Be Used for hESC Research Consistent with the Dickey-Wicker Amendement- 2009 • US District Court Halts Federally Funded hESC research Under Obama Guidelines -2010• US Appeals Court Allows Federally Funded hESC Research Until it Reviews District Court Case Appeal by Obama Administration - 2010There is No Federal Human Cloning Law. HR4808, 2010 (Pending), Prohibition Against Funding For Human Embryo Cloning. Fifteen States, Including California, Have Laws Dealing With Human Cloning -- From Banning Both Reproductive andTherapeutic Cloning to only Reproductive Cloning (E.G., California).There is No Federal Stem Cell Research Law One is Being Considered in Current CongressDickey-Wiker AmendmentLaws Exist That Regulate Science at the Federal and State Levels Some Examples(GINA) Federal Law on Genetic DiscriminationLaws Exist That Regulate Science at the State Level State Laws on DNA Data BanksState Laws on BiotechnologyGloFish Fluorescing


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UCLA HNRS 70A - Lecture 9

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