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Regulating the Future of Preimplantation Genetic Screening Jaime S University of California, Hastings College of the Law UC Hastings Scholarship Repository Faculty Scholarship 2008 Predicting Probability: Regulating the Future of Preimplantation Genetic Screening Jaime S. King UC Hastings College of the Law, [email protected] Follow this and additional works at: http://repository.uchastings.edu/faculty_scholarship Part of the Health Law and Policy Commons Recommended Citation Jaime S. King, Predicting Probability: Regulating the Future of Preimplantation Genetic Screening, 8 Yale Journal of Health Policy 283 (2008). Available at: http://repository.uchastings.edu/faculty_scholarship/329 This Article is brought to you for free and open access by UC Hastings Scholarship Repository. It has been accepted for inclusion in Faculty Scholarship by an authorized administrator of UC Hastings Scholarship Repository. For more information, please contact [email protected]. Faculty Publications UC Hastings College of the Law Library King Jaime Author: Jaime S. King Source: Yale Journal of Health Policy, Law, & Ethics Citation: 8 Yale J. Health Pol'y L. & Ethics 283 (2008). Title: Predicting Probability: Regulating the Future of Preimplantation Genetic Screening Originally published in YALE JOURNAL OF HEALTH POLICY, LAW, & ETHICS. This article is reprinted with permission from YALE JOURNAL OF HEALTH POLICY, LAW, & ETHICS and Yale Law School, Yale School of Medicine, Yale School of Public Health. Predicting Probability: Regulating the Future of Preimplantation Genetic Screening Jaime King* INTRODUCTION .............................................................................................................. 285 I. PREIMPLANTATION GENETIC DIAGNOSIS AND SCREENING ..................................... 290 A . C URREN T PG S U SE ............................................................................................... 29 1 1. C HROM OSOM AL A NALYSIS ................................................................................ 292 2. G EN ETIC A NA LYSIS ........................................................................................... 295 B. LIMITATIONS ON CURRENT PG S USE .................................................................... 296 C . FUTURE C APABILITIES OF PG S .............................................................................. 298 II. Is PGS OVERSIGHT NECESSARY? ................................ .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 301 A. THE AUTHORITY OF SOCIETY OVER THE INDIVIDUAL ............................................ 301 B . R ISKS A SSOCIATED W ITH PG S ............................................................................... 303 1. RISKS TO O FFSPRING BORN VIA PG S ................................................................. 303 2. RISKS TO THE PROSPECTIVE PARENTS ............................................................... 308 3. R ISKS TO SO CIETY ............................................................................................. 3 12 C. WHY HAS THE UNITED STATES NOT REGULATED PGS? ....................................... 321 III. WHO SHOULD OVERSEE PGS? ............................................ .. .. .. .. .. .. .. .. .. .. .. ... .. .. .. .. 323 A . PROFESSIONAL SOCIETIES ..................................................................................... 324 B. STATE AND FEDERAL GOVERNMENTS ................................................................... 326 1. STATE G OVERNM ENT ........................................................................................ 329 2. FEDERA L G OVERNM ENT .................................................................................... 331 IV. How SHOULD THE UNITED STATES OVERSEE THE USE OF PGS? ........................ 338 A . FACTORS To C ONSIDER ......................................................................................... 339 1. PROTECTING INDIVIDUAL HEALTH AND WELL-BEING ....................................... 339 2. PROTECTING SOCIETY ....................................................................................... 340 * J.D., Ph.D., Associate Professor of Law, University of California, Hastings College of the Law. The author would like to thank Hank Greely, Elizabeth Bartholet, Norman Daniels, Amitai Aviram, Andrew Bonnes, James King, Ben Moulton, Emily Murphy, Barry Staples, and Kristen Underhill for their helpful comments on earlier versions of this draft. HeinOnline -- 8 Yale J. Health Pol'y L. & Ethics 283 2008 YALE JOURNAL OF HEALTH POLICY, LAW, AND ETHICS VIII:2 (2008) 3. PROTECTING REPRODUCTIVE AUTONOMY ......................................................... 341 4. PRACTITIONERS' INTERESTS .............................................................................. 342 B . POLICY D EVELOPM ENT .......................................................................................... 343 1. A LIGNING SIM ILAR INTERESTS ....................................... ....................... 343 2. BALANCING CONFLICTING INTERESTS ............................................................... 346 C. ASSISTED REPRODUCTIVE TECHNOLOGY AUTHORITY ........................................... 354 1. PROCEDURAL REGULATIONS ............................................................................. 354 2. SUBSTANTIVE R EGULATIONS ............................................................................. 356 C ONCLUSION ................................................................................................................. 357 284 HeinOnline -- 8 Yale J. Health Pol'y L. & Ethics 284 2008 PREDICTING PROBABILITY INTRODUCTION At the intersection of two rapidly developing areas of biotechnology, a revolution is about to take place. Although this revolution involves reproduction, it will not be sexual. A medical procedure, known as preimplantation genetic diagnosis (PGD), combines genetic testing and assisted reproductive technology (ART) to enable parents to screen their potential children before implantation for genetic or chromosomal characteristics. The technology has been a godsend to couples with family histories of genetic disorders and chromosomal mutations causing infertility. However, expanding its use to permit prospective parents to select embryos based on a wide array of genetic characteristics presents substantial risks to individuals involved in the procedure and to society as a whole. Although PGD use has remained extremely limited due to technological constraints, expense, and moderate success rates, recent advances in genetic testing procedures will remove many of these obstacles and significantly increase the benefits of its use. Better tests, providing better information, will expand the use of this technology from embryos known to be at risk for serious disease - preimplantation genetic diagnosis - to the testing of all or almost all in vitro embryos for multiple genetic characteristics - preimplantation genetic screening (PGS).1 Future couples might select their potential children based on knowledge of their genetic susceptibility to serious diseases, like breast cancer 2 and Alzheimer's disease;3 their propensity for cardiac arrhythmia; 4 the probability that they will develop more common diseases, like diabetes;5 the probability that they will have childhood asthma;6 their sex; 7 their likely body-mass index and 1. Throughout the paper, preimplantation genetic diagnosis (PGD) will refer to genetic and chromosomal screening for diseases, and preimplantation genetic screening (PGS) will refer to genetic and chromosomal screening for all other conditions. In addition, PGS will be used to encompass both ideas at once. 2. See Rosalind A. Eeles, Future Possibilities in the Prevention of Breast Cancer: Intervention Strategies in BRCAI and BRCA2 Mutation Carriers, 2 BREAST CANCER RES. 283 (2000). 3. See Charles R. Harrington et al., Influence of Apolipoprotein E Genotype on Senile Dementia of the Alzheimer and Lewy Body Types: Significance for Etiological Theories of Alzheimer's Disease, 145 AM. J. PATHOLOGY 1472 (1994). 4. See Daniel J. Gudbjartsson et al., Variants Conferring Risk of Atrial Fibrillation on Chromosome 4q25, 448 NATURE 353 (2007). 5. See Jose C. Florez et al., TCF7L2 Polymorphisms and Progression to Diabetes in the Diabetes Prevention Program,355 NEw ENG. J. MED. 241 (2006). 6. See Miriam F. Moffat et al., Genetic Variants Regulating ORMDL3 Expression Contribute to the Risk of ChildhoodAsthma, 448 NATURE 470 (2007). HeinOnline -- 8 Yale J. Health Pol'y L. & Ethics 285 2008 YALE JOURNAL OF HEALTH POLICY, LAW, AND ETHICS VIII:2 (2008) weight;8 their hair, eye, and skin color;9 their propensity for aggression;"° and their likely height." As our knowledge of genetics expands, geneticists will be 12 able to test embryos for the presence of gene variants, known as alleles, associated with a range of conditions through the use of a DNA microarray, a testing device that can screen for thousands of alleles at one time. Combining these genetic advances with ART procedures3 will permit parents to select embryos based upon their potential future traits.' While scientists and consumers pursue the promise of PGS, we must also acknowledge the potential harms associated with its widespread adoption. Recent studies suggest that while PGS has great potential, its benefits may not always outweigh its risks. A number of variables contribute to the risks associated with PGS. Assisted reproduction procedures performed as part of PGS, such as in vitro fertilization (IVF), 14 intracytoplasmic sperm injection
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