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Choosing the Genetic Makeup of Children: Our Eugenics Past- Present, and Future?

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Choosing the Genetic Makeup of Children: Our Eugenics Past- Present, and Future? Louisiana State University Law Center LSU Law Digital Commons Journal Articles Faculty Scholarship 2003 Choosing the Genetic Makeup of Children: Our Eugenics Past- Present, and Future? Michael J. Malinowski Louisiana State University Law Center, [email protected] Follow this and additional works at: https://digitalcommons.law.lsu.edu/faculty_scholarship Part of the Law Commons Repository Citation Malinowski, Michael J., "Choosing the Genetic Makeup of Children: Our Eugenics Past-Present, and Future?" (2003). Journal Articles. 36. https://digitalcommons.law.lsu.edu/faculty_scholarship/36 This Article is brought to you for free and open access by the Faculty Scholarship at LSU Law Digital Commons. It has been accepted for inclusion in Journal Articles by an authorized administrator of LSU Law Digital Commons. For more information, please contact [email protected]. Choosing the Genetic Makeup of Children: Our Eugenics Past-Present, and Future? MICHAEL J. MALINOWSKI• TABLE OF CONTENTS I. INTRODUCTION ....................................... .126 ll. THE ORIGIN AND 20TH CENTURY POPULARITY OF EUGENICS .... 134 A. Eugenics Before Nuremberg: Improving the Human . ... .. .. .. .. Condition .. .. ... .. .. .. ... 134 B. Eugenics Under German Law . 142 Ill. THE IMPACT OF NAZI MEDICINE ON EUGENICS, RESEARCH, AND MEDICAL ETHICS PRIOR TO NUREMBERG ............... 149 A. TheRole and Prosecution of German Physicians . 150 .. ....... ... ... .. 158 B. Post-WWII "New Eugenics" .... N. NUREMBERG TO THE PRESENT: EVOLUTION OF REGULATIONS TO PROTECT HUMAN SUBJECTS AND MEDICAL ETHICS ........ 160 • J.D. Yale Law Schooll991; B.A., summa cum laude, Tufts University 1987. Ernest R. and Iris M. Eldred Endowed Associate Professor of Law, Paul M. Hebert Law Center, Louisiana State Univer­ sity and Co-Founder and Associate Director, Program in Law, Science, and Public Health. This article was submitted for publication in June 2003and does not necessarily reflect changes thereafter. While writing this article, the author organized and participated in a forum on the topic at the American Bar Association's Midyear Meeting in Seattle, Washington, Febl"l,l8ry.l2, 2003, entitled "New Frontiers: Policy Considerations and Options for Regulation of Assisted Reproduction Technology (ART),'' and the author would like to thank Alexis Hill, Dr. Pat Kuszler, Judge Barbara Rothstein, Dr. Michael Soules, and program attendees for interactions that enriched this manuscript. The article originated as a presentation at a symposi11m conference hosted by Florida State University School of Law on March 4, 2002, entitled "Genes and Disability: Defining Health and the Goal� ·of Medicine,'' and the author would like to thank those conference participants as well, and Professor Larry Palmer in particular. The author owes a special thank you to John Robertson, whose insight, knowledge and generosity enriched this article considerably; the author is solely responsible for the final content. The author also would like to acknowledge the helpful comments and sugg�tions contributed by John Costonis, Lucy McGough, Pat Martin, and Ben Shieber, and to acknowledge the research contributions of Heidi Wil­ liams. 125 126 CONNECTICUT LAWREVIEW [Vol. 36:125 V. CONTEMPORARY GENETICS: EXPANDING SCIENTIFIC CAPABILITIES ............................... .......... 172 VI. REGULATION OF AND TRENDS IN ASSISTED REPRODUCTION TECHNOLOGY {"ART"). ................................ 179 A. Regulation ofART ...... ............................180 B. Trends in ART ................. ................. .. 189 Vll.A PROPOSED ROLE FOR MORE MEANINGFUL REGULATION OF ART ................................................197 A. Recognition and Regulation of Experimentation on Human Subjects . .. .. .. .. .. .. ...217 B. Further Regulation to Ensure the Practice of Good Medicine, and Ongoing Accountability and Public Oversight . .. .. .. .. .. 218 VITI. CONCLUSION ......... ....... ..... ................ .222 "God and Nature first made us what we are, and then out of our own created genius we make ourselves what we want to be . Let the skyand God be our limit and Eternityour measurement."' "Ifyou want to see God smile, tell him your plans."2 "The keenest sorrow is to recognize ourselves as the sole cause of all our adversities."3 I. INTRODUCTION Prior to the advent of amniocentesis in the 1960s, prospective parents' control over the genetic makeup of their children was limited to deciding with whom to procreate. Today, the limits on that control have been re­ duced to the genes of prospective parents or the donors of ova and sperm they deem acceptable, the number of viable embryos produced, the genetic screening available, and the financial resources necessary to put genetic screening and other assisted reproduction technologies to use.4 And ongo­ ing biomedical research promises to further minimize these limitations. An I GREGORY STOCK, REDESIGNING HUMANS I (2002) (quoting Marcus Garvey (1887-1940)). 2 A PRIMER FOR HEALTH CARE ETHICS: EsSAYS FOR A PLURALISTIC SOCIETY 152 (Kevin O'Rourke ed., Georgetown Univ. Press 2d ed. 2000) [hereinafter PRIMER). 3 THE MOST BRILLIANT THOUGHTS OF ALL TIME 9 (John M. Shanahan ed., 1999) (quoting Sophocles (c. 496-406 B.C.)). 4 In fact, as observed by Professor Storrow, today a child could have up to eight "parents"-the egg donor, the sperm donor, their spouses, a surrogate and her husband, and the intending mother and father. Richard F. Storrow, Parenthood by Pure Intention: Assisted Reproduction and the Functional Approach to Parentage, 53 HASTINGS L.J. 597, 602 (2002). 2003] OUR EUGENICS PAST-PRESENT. AND FUTURE? 127 exponential increase in identified gene and protein functions, the capacity to screen for hundreds-eventually for many thousands-of genetic char­ acteristics in a matter of minutes from a single sample and for a fraction of the present costs of running genetic tests5 and, ultimately, the advent of 5 Presently, there are market impediments keeping predictive genetic testing off of the market. See generally Michael J. Malinowski, Separating Predictive Genetic Testing from Snake Oil: Regula­ tion, Liabilities, and Lost Opportunities, 41 JURIMETRICS J. 23 (2000) [hereinafter Snake Oil] (propos­ ing that predictive genetic testing should be introduced on a regulatory framework like other medical technology). Some of the testing that is available is costly and the subject of extensive intellectual property filings, which has been resulting in disputes. For example, Myriad Genetics' test for BRCAl and BRCA2, genetic alleles associated with breast and ovarian cancers, is priced at $3,850, whlch has resulted in a dispute between Myriad and the Canadian provinces of Alberta and Ontario. See Gene­ Patent Policy Review Urgently Needed, EDMONTON J., Jan. 10, 2003, at http://lists.essential.orglpipermaillip-health/2003-January/004055.htrnl (iast visited Sept. 24, 2003) (on file with the Connecticut Law Review). While there is ample recognition that intellectual property rights are a prerequisite for research and development ("R&D") to make genetic tests, some commenta­ tors assert that intellectual property rights in genotype-phenotype linkages impede access to resulting genetic tests for medical use-an argument subStantiated by the Myriad dispute. See Mildred K. Cho et al., Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services, 5 J. MO­ LECULAR DIAGNOSTICS 3, 8 (2003) ("We conclude that patents and licenses have had a significant negative effect on the ability of clinical laboratories to continue to perform already developed genetic tests .... "); Sherizaan Minwalla, A Modest Proposal to Amend the Patent Code 35 U.S.C.§ 287(c) to Allow Health Care Providers to Examine Their Patients' DNA, 26 S. ILL. U. L.J. 471, 473, 503-04 (2002) (proposing to expand the provision in the Patent Act that protects physicians from infringement actions for pei:forming medical procedures to include genetic tests); John A. Robertson, Extending Preimplantation Genetic Diagnosis: The Ethical Debate, 18 HUMAN REPRODUCTION 465, 467 (2003) (discussing Myriad Corp's patent on the BRCAl and 2 genes). However, this awkward period of only a relatively limited number of commercially available genetic tests is giving way to a deluge of genetic screening capabilities based upon the extensive compilations of genetic subtleties and the bioinformat­ ics capabilities---such as cost-effective DNA chip technology-to manage them and to derive medici­ nal meaning, albeit based upon probabilities, meaning an innate element of speculation. See discussion infra Part V. See generally Michael J. Malinowski, Law, Policy, and Mar�t Implications of Genetic Profiling in Drug Development, 2 Hous. J. HEALTH L. & POL'Y 31 (2002) [hereinafter Market Impli­ cations] (discussing the use and implications of genetic profiling in drug development and the delivery of health care); Lars Noah, The Coming Pharmdcogenomics Revolution: Tailoring Drugs to Fit Pa­ tients· Genetic Profiles, 43 JURIMETRICS J. 1, 7-11 (2002) (analyzing the effects genetic research may have in discovering more refined treatments for disease); Snake Oil, supra, at 28-31 (examining the definitional meaning of predictive genetic testing and its emerging significance in the field of medi­ cine). This deluge of genetic information is a predictable byproduct of ongoing pharmaceutical R&D. See Mar�t Implications, supra, at 39-43 (discussing the trends in pharmaceutical R&D that have led to the entrance of genetic testing in the medical setting as
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