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Genome Editing and the Jurisprudence of Scientific Empiricism

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Genome Editing and the Jurisprudence of Scientific Empiricism Vanderbilt Journal of Entertainment & Technology Law Volume 19 Issue 3 Issue 3 - Spring 2017 Article 5 2017 Genome Editing and the Jurisprudence of Scientific Empiricism Paul Enriquez Follow this and additional works at: https://scholarship.law.vanderbilt.edu/jetlaw Part of the Health Law and Policy Commons, Law and Society Commons, and the Science and Technology Law Commons Recommended Citation Paul Enriquez, Genome Editing and the Jurisprudence of Scientific Empiricism, 19 Vanderbilt Journal of Entertainment and Technology Law 603 (2020) Available at: https://scholarship.law.vanderbilt.edu/jetlaw/vol19/iss3/5 This Article is brought to you for free and open access by Scholarship@Vanderbilt Law. It has been accepted for inclusion in Vanderbilt Journal of Entertainment & Technology Law by an authorized editor of Scholarship@Vanderbilt Law. For more information, please contact [email protected]. Genome Editing and the Jurisprudence of Scientific Empiricism Paul Enriquez* ABSTRACT Humankind has reached, in tow by the hand of a scientific breakthrough called CRISPR, the Rubicon of precise genetic manipulation first envisioned over fifty years ago. Despite CRISPR's renown in science and its power to transform the world, it remains virtually unaddressed in legal scholarship. In the absence of on-point law, the scientific community has attempted to reach some consensus to preempt antagonistic regulation and prescribe subjective standards of use under the guise of a priori scientific empiricism. Significant and complex legal issues concerning this technology are emerging, and the void in legal scholarship is no longer tolerable. This Article shrinks the scholarly gap, and it is the first to introduce CRISPR to legal literature. By providing a resource for jurists, scholars, and practitioners, it challenges conventional notions concerning the false dichotomy frequently associated with mutually exclusive normative roles for science and law. The Article makes two independent contributions. First, it lays a robust and comprehensive epistemic foundation of genome editing suitable for legal audiences. This element is descriptive, but essential because a detailed and coherent understanding of the nuts and bolts of the science is requisite for a discussion of law and policy. Second, it advocates for a jurisprudence of scientific empiricism, namely, a normative legal framework that consolidates empiricism and technological-e.g., genome editing-applications into a uniform doctrinal structure unencumbered by common substantive impediments to constructive debate. These impediments consist of impractical and often J.D., LL.M., Ph.D. Candidate, Structural and Molecular Biochemistry. I am indebted to Michael Byrne, Terri Beiner, and Sean Murphy for their generous comments and thoughtful suggestions. 603 604 VAND. J. ENT. & TECH. L. [Vol. XIK:3:603 sensationalist claims about issues raised by technological advances and are collectively characterized as "deceptive simplicity." The proposed paradigm, which lays a blueprint for the legal community to combat the deleterious effects of scientific illiteracy, flows from the Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics and is broadly adaptable to addressing questions of science in law. Applying this framework, the Article reconsiders Buck v. Bell and argues that, contrary to long-held views, Buck is not a direct product of false science, but of unbridled deceptive simplicity. Lastly, the Article sets the stage for a series of forthcoming works that will analyze genome editing from regulatory, constitutional, international, egalitarian, ethical, and policy standpoints, which highlight pivotal synergistic roles for law, science, and public policy in the development of this remarkable nascent biotechnology. TABLE OF CONTENTS I. INTRODUCTION ................................. ..... 605 II. GENOME EDITING-A SYNOPSIS .................... .... 617 A. The Rise of Recombinant DNA .............................. 621 III. THE GENOME EDITING TOOLBOX ................... ..... 622 A. Chemistry-Based Synthetic DNA Scission ...... ....... 622 B. Viral-Based Editing ......................... ...... 623 C. Nuclease Genome Editing Based on Protein-DNA Interactions ................................ ..... 624 1. Meganucleases ....................... ............. 624 2. Zinc Finger Nucleases ........................ 626 3. TALENs...................................... 627 D. Programmable, RNA-guided, DNA Nuclease Genome Editing ............................ ..... 628 IV. CURRENT AND PROSPECTIVE APPLICATIONS OF GENOME EDITING ......................................... 633 A. Editing to Target Somatic Cells and Stem Cells ................. 633 B. Gene Drives............ .................... ..... 638 C. Transgenic Animals for Translational and Basic Research 644 1. Mouse Pre-Clinical Models of Disease.............. 645 2. Large Animal Pre-Clinical Models on the Rise.............. 647 3. Xenotransplantation-A Case Study ............... 650 D. Agriculture...................................... 654 1. Crops and Biofuels.. ................................ 654 2017] GENOME EDITING 605 2. Animals ...................................... 661 E. Human Germline Editing .................. ......... 664 V. SCIENTIFIC EMPIRICISM AS A BEDROCK FOR GENOME EDITING JURISPRUDENCE. ................................... ..... 672 A. The Exorcism of Designer Baby's Specter .. .............. 673 B. Dispelling the Myth of IQ Heritability-A Case Study....... 679 C. Buck v. Bell-The Prototypical Fruit of Deceptive Simplicity ................................. ..... 685 D. Forging a Path Forward............................ 691 VI. CONCLUSION ..................................... ...... 694 I. INTRODUCTION The most significant technological breakthrough of this generation, namely, a genome editing tool called "CRISPR," has inconspicuously arrived. Only on rare occasions does a technology with such far-reaching implications lightly knock to announce its arrival while holding the power to forever change the world and humankind. The world has heard that sporadic light knock before. Nearly eight decades ago, scientific inquiry conceptualized nuclear fission' as a theoretical explanation for the recondite empirical evidence that 239U, an isotope of uranium produced by the neutronic irradiation of 2 238U, could have its nucleus split into highly radioactive fragments. That theory was ultimately supported by experimental observations showing the enormous release of ionization energy resulting from nuclear fragmentation, 3 thereby confirming a decades-old relationship between mass and energy-E = mc 2 -first formulated by Albert Einstein. 4 With remarkable speed, the newfangled knowledge covertly 1. Lise Meitner & O.R. Frisch, Disintegrationof Uranium by Neutrons: A New Type of Nuclear Reaction, 143 NATURE 239, 239 (1939). 2. Von 0. Hahn & F. Strassmann, Uber den Nachweis und das Verhalten der bei der Bestrahlung des Urans Mittels Neutronen Entstehenden Erdalkalimetalle [Concerning the Existence of Alkaline Earth Metals Resulting from Neutron Irradiation of Uranium], 27 DIE NATURWISSENSCHAFTEN 11 (1939), translatedin Hans G. Graetzer, Discovery of Nuclear Fission, 32 AM. J. PHYSICS 9, 10 (1964). 3. O.R. Frisch, Physical Evidence for the Division of Heavy Nuclei Under Neutron Bombardment, 143 NATURE 276, 276 (1939). 4. A. Einstein, Ist die Trdgheit Eines Korpers von Seinem Energieinhalt abhdngig? [Does the Inertia of a Body Depend upon its Energy-Content?], 18 ANNALEN DER PHYSIK 639 (1905), translated in THE COLLECTED PAPERS OF ALBERT EINSTEIN, VOL. 2, THE SWISS YEARS: WRITINGS, 1900-1909, at 172 (Anna Beck trans., Princeton University Press 1989), 2 http://einsteinpapers.press.princeton.edu/vol -trans/1?ajax [https://perma.cclK6TE-UP3M]. 606 VAND. J. ENT. & TECH. L. [Vol. XIX:3:603 served as the basis for the Manhattan Project, the research program that ultimately developed the atomic bomb through nuclear fission.5 The scientific breakthrough modus operandi is, to a certain extent, wholly universal. The genesis of modern computing had its principles neatly packaged in a seminal paper authored by the mathematician Alan Turing.6 The revolutionary notion that a machine could imitate computations performed by humans spawned the first "Turing-complete," programmable, general-purpose, Electronic Numerical Integrator and Computer (ENIAC). 7 Unpredictably, the technology evolved into personal computers and smartphones, and enabled the ensuing development of the Internet.8 Other fundamental discoveries over the past few centuries-in mathematics, physics, chemistry, and biology-have facilitated our ability to harness the power of natural phenomena in space travel, wireless communications, medicine, and a myriad other applications. The technological breakthrough of this generation, unlike many of its predecessors, holds the power to alter humankind from 5. For a historical account of the origins and development of the US atomic bomb program of World War II, see generally F.G. GOSLING, THE MANHATTAN PROJECT: MAKING THE ATOMIC BOMB (U.S. Dep't of Energy ed. 1999). 6. A.M. Turing, On Computable Numbers, with an Application to the Entscheidungsproblem,42 PROC. LONDON MATHEMATICAL SOC'y 230, 230 (1937). 7. Electronic Numerical Integrator and Computer, U.S. Patent No. 3,120,606 (filed June 26, 1947) (issued Feb. 4, 1964). To this day, debate exists concerning whether the first modern computer was the Atanasoff-Berry Computer (ABC)
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