Biology, Medicine, and the Bill of Rights

September 1988

NTIS order #PB89-136428 Recommended Citation: U.S. Congress, Office of Technology Assessment, Biology, Medicine, and the Bill of Rights-Special Report, OTA-CIT-371 (Washington, DC: U.S. Government Print- ing Office, September 1988).

Library of Congress Catalog Card Number 88-600568

For sale by the Superintendent of Documents U.S. Government Printing Office, Washington, DC 20402-9325 (order form can be found in the back of this report) Foreword

Rapid progress in biological sciences–so dramatic that we now speak of “The New Biology” –has brought in its wake many social, legal, and ethical issues. In research laboratories, medical practice, public health programs, genetic counseling, law enforcement, insurance, the patenting process, agriculture, and many other fields, legal controversies and public policy debates have arisen. Some of these issues, many of which have been probed in recent OTA reports, also entail challenges to traditional interpretations of constitutional principles and precedents. This special report considers the implications of new developments in biological sciences for the freedoms and protections embedded in our Bill of Rights. It is one of a series of publications coming from OTA’s Constitutional Bicentennial Project, begun in 1987 at the request of the House Committee on the Judiciary and its Subcommittee on Courts, Civil Liberties, and the Administration of Jus- tice. Earlier publications include a background paper, Science, Technology, and the Constitution (September 1987), and two special reports: Science, Technology, and the First Amendment (January 1988), and Criminal Justice, New Technol- ogy, and the Constitution (May 1988).

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Biology, Medicine, and the Bill of Rights Project Review Panel

William Carey Monroe Price Advisor to the Carnegie Foundation of Dean New York Benjamin Cardozo Law School Washington, DC New York, NY James Duggan Mark Rothstein Director Director of Health Law New Hampshire Appellate Defender University of Houston Program Houston, TX Concord, NH Thomas Smith, Esquire Judith Lichtenberg Assistant Director Center for Philosophy and Public Policy Criminal Justice Section University of Maryland American Bar Association College Park, MD Washington, DC Peter Low Paul Stephen Hardy Cross Dillard Professor of Law and Professor John V. Ray Research Professor of Law University of Virginia School of Law School of Law University of Virginia Charlottesville, VA Charlottesville, VA Laurence R. Tancredi The Honorable Pauline Newman Kraft Eidman Professor of Medicine and United States Circuit Judge the Law United States Court of Appeals for the Director of the Health Law Program Federal Circuit University of Texas Health Sciences Center Washington, DC Houston, TX

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the reviewers. The reviewers do not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and the accuracy of its contents.

iv Biology, Medicine, and the Bill of Rights OTA Project Staff

John Andelin, Assistant Director, OTA Science, Information, and Natural Resources Division

Fred W. Weingarten, Program Manager Communication and Information Technologies Program

Project Staff Vary T. Coates, Project Director Mary Ann Madison, Research Analyst Benjamin C. Amick III, Analyst

Administrative Staff Liz Emanuel, Administrative Assistant Karolyn Swauger, Secretary Rebecca Battle, Secretary Contents

Page Chapter l. Biology and the Constitution...... 3

Chapter 2. Personal Rights and Technological Might ...... 9

Chapter 4. Human Genetics and the Constitution ...... 39

Chapter 5. Public Health Techniques and Technologies ...... 61

Chapter 6. Medical Interventions: The Beginning and End of Life ...... 89

Appendix. List of OTA Reviewers, Contractors, Workshop Participants, and External Reviewers ...... ~ . . . .117

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Chapter 1 Biology and the Constitution CONTENTS

Page The Constitutional Concept of Mankind ...... 3 Why the “New Biology” Raises Constitutional Issues ...... 4 Chapter 1 Biology and the Constitution

Our laws and institutions must move forward used all means at their disposal to improve with the progress of the human mind. health, extend their life span, increase the qual- —Thomas Jefferson ity and yield of food, have or avoid having children, and enhance their physical and mental A few decades ago, genes and inheritance capabilities. For thousands of years we have were still mysteries to science. The discovery bred cattle and beans, used contraception and of DNA, of how genetic characteristics are fertility enhancers, developed medicines, brewed passed on between generations, and how genetic drugs, and followed social customs thought to information is expressed and modified as a per- produce healthy children. These basic human son matures, opened the door to understand- desires have helped define individual rights ing and manipulating these fundamental bio- within a society. Social custom, law, and gov- logical processes. Today, in many instances, ernment authority have regulated technologies we can modify genes and genetic inheritance in order to help individuals achieve these goals to suit our own ends. Some deadly genetic dis- within the framework of their society. The U.S. eases have been traced to their root causes— Constitution was designed to guarantee indi- making it possible that in the future we will vidual rights and to bound the powers of gov- find a way to cure or avoid them. Genetic engi- ernment, while ensuring a place for societal neering holds out the hope for permanent cures interests. It guides the application of technol- for simple genetic disease, and is already pro- ogies in those murky areas between individ- viding better pharmaceuticals, crops, and in- ual rights and societal interests, between industrial products. Other new biological tech- dividual privacy and freedom and the needs nologies amplify the potential of genetic of government to carry out its duties and en- engineering, and still other biomedical tech- sure the social welfare. New biotechnologies, nologies-computerized sensors, artificial pros- because of their unprecedented power to extend theses, tissue implants-promise powerful new human intervention, raise correspondingly capabilities. unprecedented challenges to the Constitution The application of new biological advances and to the laws built on that constitutional is not new. People have throughout history foundation.

THE CONSTITUTIONAL CONCEPT OF MANKIND The Constitution of the United States em- a large extent his present physical and men- bodies an 18th century view of the nature of tal health were beyond his own power to con- Man: a rational being, possessed of free will trol, or that of the State. And though Man had and amoral sense, endowed by his Creator with a natural right to Life, Liberty, and Property, inalienable rights and inescapable responsibil- in the real world all of those—like health, hap- ities, accountable to the State and to his fel- piness, and the ability to beget children and low men through the implicit contract to which raise them to adulthood—could be seen to de- he consents by continuing to live within a pend on chance, fate, or the incomprehensible democratic republic.l His biological inheri- Will of God. They could be accepted, but sel- tance, his mental competence, and indeed to dom explained by science or controlled by human choice. *Use of the terms “Man” or “mankind” here reflects the 18th century assumption that it was in males that civic author- The common view of the human condition ity and moral responsibility were lodged. is different, now; in some ways it is less clear,

3 4 less satisfying, less firmly grounded in philos- ment and punishment. In some ways, we have ophy and ethics. We may indeed cling to the diminished the scope of accountability embod- ethical and spiritual truth in the constitutional ied in the 18th century political philosophy, assumptions about responsibility. Yet at the but perhaps we have more than compensated same time we often analyze human behavior for this; we have enhanced the 18th century in terms of environment or genes, infantile ex- concept of the fundamental equality of “all periences or biochemical imbalances, socioeco Men” by giving explicit recognition and prac- nomic deficits or neurocortical connections; tical effect to the principle that this includes and we oscillate between education and coer- women, and men and women of all races and cion, rehabilitation and conditioning, treat- all economic classes.

WHY THE “NEW BIOLOGY” RAISES CONSTITUTIONAL ISSUES There are in summary several reasons why 4. The increasing possibility of effective in- advances in biological knowledge and capabil- tervention to prolong life, remove physi- ity to intervene in human biology have impli- cal and mental handicaps, and enhance cations for constitutional rights: physical and mental performance reinforces the growing assertion of a “right to health 1. The capability for biological interventions, care. ” Such assertions may be based on especially with regard to reproduction, the contribution of Federal funding to the bodily health, mental functions, and death, development of new medical capabilities, gives people new choices, and forces them but are also often claimed as a constitu- to make decisions about things that were tional right although no such right has previously beyond our control. The ques- been judicially recognized. tion arises as to whether the State should or constitutionally can regulate such de- 5. Biological knowledge is likely to impinge cisions in the public interest. on formal or informal religious beliefs or 2. Biology-based technology, alone and in at least on traditional formulations of re- combination with other kinds of science ligious doctrine. Because the evolution of and technology, increases the power of the English common law, classical political State to enforce its laws and policies (e.g., philosophy, constitutional government, by screening for drug use, or by using and the doctrines of several European DNA typing for identification). These uses Christian churches are historically inter- may intrude on the constitutionally guar- twined, the constitutional separation of anteed sphere of individual privacy. Church and State requires repeated at- 3. The power to identify biological risks (e.g., tempts to distinguish between religious exposure to infectious disease or genetic values and common cultural values. vulnerability to chemicals in the environment) often outstrips the capability to re- There are strong indications that biological move or reduce those risks. This raises a research will provide increasing evidence for demand for social control measures that a genetic and biochemical basis for variations sometimes impinge on constitutional free- in human abilities and performance and for doms. Some of these are traditional pub- much human behavior, including some behaviors lic health techniques falling under States’ that we now regard as voluntary, and there- “police power” but now often at odds with fore punishable. New pharmaceuticals, psycho- increased public expectations of, and ju- surgery, or other treatments will become avail- dicial affirmation of, the scope of constitu- able to moderate mental functions and modify tional liberties. behavior. Genetic engineering of human germ 5 cells or somatic cells could remove inherited right far outweighed by the contrary interest mental traits. of the State, which is considered to be the public interest? Biology is allowing major human interven- The balancing of the State interest with in- tions at the boundary between life and death. dividual rights is forever going on, and where By resting the definition of death on brain func- the balance is struck often involves two kinds tions, we have raised the question of how much of social change. One frequent factor is new quality or competence in brain functioning is technological capability that gives us new con- necessary for recognition of constitutional trol of natural processes or new power to ma- rights. By making it possible to artificially nipulate our physical and biological environ- maintain bodily functions we have vested in ment. The second is the rising expectation of some people, with or without their willingness, self-determination and privacy. awesome responsibilities for making decisions about life and death for other people who can Some traditional public health techniques, no longer decide for themselves. At the begin- well established in law and in constitutional ning of life, advancing technological capabil- decisions as permissible under State police ities have changed, and may further change, powers, are almost certain to be challenged the point at which a new life is viable outside anew because of today’s broader interpreta- the womb—indeed, gestation from test tube tion of individual rights of privacy and auton- to “birth” may someday be possible in artifi- omy. This is occurring, for example, in the con- cial wombs, reflecting again the question of text of the AIDS epidemic with regard to when constitutional rights begin. techniques of mandatory reporting, contact tracing, mandatory testing, and partial or full Advances in biological sciences and technol- quarantine. As the risks of environmental and ogies are creating choices, in situations where workplace contaminants are increasingly rein the past people had no choice. Or, less posi- vealed, the State could decide to use genetic tively, they force people to make decisions screening technology (now at an early and un- about situations that in the past were beyond satisfactory state of development, but likely human control. Increasingly (though not yet to be made much more effective in the future) always) people can choose whether or not to to write regulations forbidding some groups reproduce, and in the future, they maybe able of people from assuming occupational or envi- routinely to choose the gender of the child they ronmental risks to which they are especially wish to have, to select some of its genetic char- vulnerable. acteristics, to choose to use an embryo from Many kinds of medical and genetic interven- other biological parents, or to donate their own tions raise complementary questions. First, embryos to others. when can the State, in the exercise of its police power, legitimately mandate preventive or New biological knowledge and technologies therapeutic treatment, as it has long mandated give people powers to make critical decisions vaccination, in the public interest? Second, about the life and death of themselves, other should the Courts (or Congress) at some point people, and future generations. When technol- in the future rule that there is a constitutional ogy allows people to make such choices or de- basis for a “right to health” or at least to health cisions, the question arises as to whether the care? If, for example, interventions became State should regulate, or even absolutely con- possible (as a result perhaps of research at the trol, those decisions. Constitutionally, this National Institutes of Health) that would sig- question becomes: would State intervention nificantly control or slow aging and extend nor- impinge on some individual liberty that is mal lifetimes, say by 25 years-would we leave guaranteed by the Bill of Rights? and if so, it to market mechanisms to determine who re- is the individual’s interest in exercising that ceived this “priceless” boon? 6

Decisions about kidney dialysis and organ tissue, patenting of human cell lines and de- transplants have so far obscured and delayed rived biological, the safety of bioengineering rather than answered this question, which is laboratories, and release of engineered organ- already being raised by some public interest isms in the environment, have some common groups not only as a public policy issue but grounds. Is there a constitutional right to do as a constitutional challenge. They argue that research? Should there be areas of “forbidden Americans have an “equal protection” right knowledge?” What values should be reflected to the results of medical research supported in Federal research funding allocation and Fed- by taxpayers. eral guidelines? Recent decisions about the teaching of evo- This introduction to the report on “biology lution or of “creation science” in public schools and the Constitution” contains many questions, have not removed the possibility of further ef- and few answers. Indeed, this is true of the rest forts to restrict either the teaching or the ap- of the report. In looking into the future, much plication of new biological knowledge on reli- can be anticipated but little can be said with gious or quasi-religious grounds. There are certainty. When we consider the triple uncer- strong indications that a major area of con- tainties of rapidly advancing knowledge, stead- stitutional debate in the future will deal with ily rising expectations of civil liberty and self- conflicts between biological research objectives determination, and conflicting value systems and procedures, on the one hand, and religious that are themselves caught in turbulence and or ethical values on the other. The present de- challenge, there are indeed few certain answers bates over animal rights, research using fetal to the troublesome questions raised here. Chapter Personal Rights and Technological Might CONTENTS

Page Technology and Government Power ...... 9 By Popular Demand: The Bill of Rights, 1787-91 ...... 10 Federalism-Dual Citizenship and Constitutional Rights...... 10 Fundamental Rights ...... +.+.++. 12 Molecular Biology and New Technology ...... 16 Chapter 2 Personal Rights and Technological Might

Technology is a powerful force for change. of one’s blood, breath, or genetic code ‘seized’ Law, especially constitutional law, is a power- without a warrant. ful reinforcer of stability and continuity. The In constitutional government, the powers of tension between these two has much to do with the State are limited and the rights of individ- how well a society’s political system can adapt uals are acknowledged and protected. The most to economic and social forces that affect the essential individual rights or civil liberties are, distribution of power and wealth. in modern constitutions, nearly always speci- Between 1787 and 1987, the United States fied in a Bill of Rights.’ The full meaning of evolved from a small agrarian nation, relatively these rights and the strength with which they poor and powerless in the international sys- will be protected become clear only gradually, tem, to a modern industrial world leader. The as statutory laws are written and judicial Constitution has provided the political and le- precedents are set. In the United States, their gal framework for technological change, and scope has been worked out by the courts and it has accommodated both a growth in the role by the political process, often with reference of government and enhanced expectations of to English common law. Even the simple and individual rights. elegant prose of the United States Constitu- tion has required continuing examination, ex- In the face of technological, social, and eco- planation, and interpretation as social insti- nomic change, both Congress and the Supreme tutions, economic forces, and technological Court have repeatedly reexamined the mean- conditions have changed. ing, the intent, and the scope of constitutional provisions. Both, for example, struggled to decide whether the right of people “to be secure IR~ph c, chandler, Rich~d A. Enslen, and peter G. Ren- in their persons, houses, papers, and effects” strom, The Constitutional Law Dictionary (Santa Barbara, CA: does or does not include the right to be secure ABC-CLIO, 1985), vol. 1, Individual Rights, pp. 10-11. Great Britain had no single written “Constitution,” but traditional in one’s electric communications (from wiretap- rights of individuals based on centuries of common law were ping), or protection against having the content put into statutory form in the Bill of Rights Act of 1689.

TECHNOLOGY AND GOVERNMENT POWER A constitution empowers a government by straints on those actions. It also increases the giving legitimate authority to its actions as individual’s power to act in ways that may of- the instrument and agent of the people. At the fend the conscience of the community, or to same time, a constitution, and particularly its create and use technology that may adversely bill of rights, is designed to limit the power affect the welfare of others. Can or should civil of government. Its effectiveness depends on liberties, as defined in 1791, restrain govern- the determination of citizens that government ments in regulating such choices? shall abide by these limits. Opinions on these questions differ dramati- The role that technology plays in the balance cally among citizens, among legal experts, between individual rights and governmental among constitutional scholars, among judges, power to act in the public interest is seldom and among courts. Hence, the questions ad- explicitly discussed. But technical capability dressed in the several reports and papers com- at least partly determines the effectiveness of ing from OTA’s study of “Science, Technol- both government’s actions and the legal re- ogy, and the Constitution” are: what new and

9 10 emerging technological capabilities may stim- turning to this analysis, further discussion of ulate constitutional challenges in the foresee- the basic concepts within the Bill of Rights able future? How may Congress and the Court will be useful. be asked to reconsider the scope of fundamental rights? This report considers these questions in relation to several areas in which basic scientific knowledge and related technological ing (Science, Technology, and the First Amendment, February capability are making rapid advances: bioengi- 1988) and new technologies for law enforcement (Cn”nu”nal Jus- 2 neering, public health and medicine. Before tice, New Technology, and the Constitution, March 1988). See also Science, Technology, and the Constitution–Background ZTwo emlier speci~ reports explored similar questions with Papx, September 1987, for an overview of OTA’S Constitutional regard to new technologies for communication and news report- Bicentennial Project.

BY POPULAR DEMAND: THE BILL OF RIGHTS, 1787-91 In 1787, many State constitutions included on September 25, 1789. Ten were ratified by a Bill of Rights, but no Bill of Rights was writ- the States and added to the Constitution on ten into the national Constitution. Several December 15, 1791.4 Since then, the meaning proposals to add one were voted down in the and scope of these rights has been asserted or closing days of the Philadelphia Convention has been challenged in hundreds of Court cases. with relatively little discussion. Most of the Sometimes the questions raised are directly delegates thought that a national Bill of Rights related to new technological capabilities. Often was unnecessary because the new government they are indirectly related, because they reflect was to have only limited, delegated powers. profound economic, social, and political changes An explicit prohibition against the establish- associated with technological change. ment of religion, for example, might imply that It is not only the Supreme Court that inter- the national government would otherwise have prets constitutional protections, although it the power to regulate the practice of religion. does so most formally and definitively. Both During the critical debate on ratification, a Bill Federal and State courts at all levels repeat- of Rights might thus increase rather than de- edly ponder the rights of citizens, the powers crease the already widespread fears of the 3 of governments, and the nature of due proc- power of a new central government. ess. Congress and 50 State legislatures declare The lack of one however, drew more public their understanding of the Constitution in criticism than any other aspect of the Consti- framing legislation. And Americans are gen- tution. The Constitution was finally adopted erally willing to assert, either in celebration only with the understanding that the first busi- or complaint, their own understanding of their ness of the Congress would be to correct this rights. That is one reason we have been called defect. a litigious society. Twelve amendments to the Constitution were therefore proposed by the First Congress Federalism—Dual Citizenship and Constitutional Rights 3Jmes MacGregor Burns, The American Experiment.’ ‘he Vineyard of Liberty (New York, NY: Alfred A. Knopf, 1982), Even when Americans can quote from the pp. 53-55. Also Chapter 3, “The Experiment Begins, ” pp. 86- Bill of Rights or describe its content, they are 90. See also, Catherine Drinker Bowan, Miracle at Philadelphia (Boston, MA: Little, Brown, 1966). Also Edward S. Corwin and 4Th two that were proposed but not ratified J.W. Peltason, Understandz”ng the Constitution, 4th ed. (New e prescribed the York, NY: Holt, Rinehart& Winston, 1967), p. 104. The Con- ratio of Representatives to population and prohibited any institution already included prohibitions of bills of attainder, and crease in Congressmen’s pay during a term. They were prob- ex post facto laws, and guarantees of the writ of habeas corpus ably perceived as not properly included in a list of the rights and of trial by jury in Federal criminal cases. of individuals. Corwin and Peltason, op. cit., footnote 3, p. 104. 11 often somewhat vague about just whose ac- Court used tortured reasoning to declare that tions they are protected from. Americans of most key civil and political rights were part 1989, unlike those of 1789, usually do not of State citizenship, rather than U.S. citizen- clearly distinguish their rights and duties as ship. The “privileges and immunities of citizens citizens of Virginia, New York, or Massachu- of the United States, ” the Court said, were setts from their rights and duties as American limited to a few rights such as travel between citizens. The consciousness of dual citizenship the States and voting for Federal officials. This has faded. declaration has never been explicitly overturned. The Bill of Rights itself restricted only the Federal Government, as Chief Justice John But the Fourteenth Amendment went onto Marshall ruled in 1833.5 In 1868 the addition say: of the Fourteenth Amendment changed that: . . . nor shall any State deprive any person of it said that all persons born in (or naturalized 6 life, liberty, or property, without due process by) the United States are citizens; and it of law, nor deny to any person within its juris- then continued: diction the equal protection of the laws. (Em- No State shall make or enforce any law which phasis added.) shall abridge the privileges or immunities of It was these two provisions that the Supreme citizens of the United States. . . . Court eventually used to extend to the States This was intended to guarantee the rights of the limitations placed on the Federal Govern- those who had been slaves, and their descen- ment by the first Ten Amendments. The Due dants; it extended the constraints imposed on Process Clause was used until the late 1930s the Federal Government to State governments to strike down State laws aimed at improving as well, on behalf of all citizens.7 the lot of workers through economic regulation; the property rights of “corporate per- Yet only in the last three decades has the sons” were protected through the doctrine of Bill of Rights come to be effectively applied substantive due process. But in a series of to restrain State governments.8 In 1873, in 9 cases after the Second World War, the Court the Slaughterhouse Cases, the Supreme has declared that the Fourteenth Amendment ‘‘incorporates’ most of the protections and ‘BarrorI v. Baltimore, 7 Peters 243 (1833). rights listed in the Bill of Rights. In effect, it ‘This reversed the conclusion of the Dred Scott Case, before the Civil War, that Negroes even if free were not “intended to has said that “due process” includes the fun- be included, under the word ‘citizen’ in the Constitution, and damental concepts of justice and liberty spelled can therefore claim none of the rights and privileges which that out in the first eight Amendments and further instrument provides for and secures to citizens. . . .” Citizen- ship was henceforth based on place of birth, not by parentage strengthened with the Ninth Amendment or race. By statutory law, Congress has also conferred citizen- declaration that their enumeration does not ship on those born outside of the United States to U.S. citizens. ". . . deny or disparage others retained by the ?The States, of course, had their own Bills of Rights, but people.” In the discussion that follows, there- Federal courts cannot enforce those protections if the State courts do not. fore, note is often made that a particular right ~Three ~endments were added immediately after the Civil has been incorporated by the Supreme Court War, the Thirteenth, Fourteenth, and Fifteenth Amendments. The Thirteenth prohibited forever the institution of slavery; the into the Due Process Clause of the Fourteenth Fifteenth assured slaves and their descendants of the right to Amendment, and therefore is binding on the vote. The Eleventh Amendment, which had been added in 1798, States. provided that individuals cannot sue a State (without its consent) in Federal Courts, thus amending (or clarifying) a provi- The Constitution limits only government ac- sion in Article III, Section 2, which extends the Federal judicial power to “cases and controversies between a state and tions, not the actions of private persons. Only citizens of another state. ” The Twelfth Amendment, in 1804, if discriminatory actions by private institu- changed the manner of election of the President by the elec- tions are somehow sanctioned by Federal, toral college; requiring that they cast separate ballots for Presi- dent and Vice President. State or local government (e.g., by licenses, tax gThe Slaughterhouse Cases, 16 Wallace 36 (1873). Twining exemptions or other benefits that give a pri- v. ZVew Jersey, 211 U.S. 78 (1908). vate institution a semi- or quasi-public char- 12

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acter), can they be said to violate the Bill of cation of children rather than their religious Rights. indoctrination.

The other great principle in the Fourteenth Freedom of Speech and Press Amendment, “Equal Protection of the Laws,” is discussed later. Here we will return to a dis- The First Amendment also forbids Congress cussion of the Bill of Rights of 1791. to make laws . . . abridging the freedom of speech, or of the Fundamental Rights press. . . . Freedom of Religion Freedom of speech and press were in 1791 considered the most powerful popular con- The First Amendment embodies four free- straint on government. Because free speech is doms deemed most critical for the preserva- not truly effective without the means of broader tion of republican government: namely, the communication, a free press is included within freedoms of conscience, expression, assembly, this fundamental right–the only technology and petition. It begins: specifically protected in the Bill of Rights. *2 Congress shall make no law respecting an The right of free speech was seldom the sub- establishment of religion, or prohibiting the ject of Supreme Court interpretation until af- free exercise thereof. . . . ter the First World War, when there began a series of cases involving political and social pro- Many of the ratifying generation, or their 13 forebears, had come to this country to be free test or communication. Congress has by law to worship as they chose. Jefferson and Madi- established, and the Court has permitted, a son regarded “freedom of conscience” or “the three-tier system of regulation distinguishing basic inalienable right to religious liberty” as between press, broadcast media, and common a cornerstone of all other rights and liberties, carrier systems. But these distinctions are be- and the prohibition against state interference coming hard to maintain, as discussed in an with it as a basic tenet of republicanism.10 OTA special report, Science, Technology, and the First Amendment (January 1988), as elec- The Establishment Clause applies to State tronic technologies supplement the printed actions, under the Due Process Clause of the press in the dissemination of news, informa- Fourteenth Amendment. Scientific research tion, and opinion. and teaching have stimulated many challenges to the scope of this principle. State laws con- The constitutional status of science, and of cerning the teaching of the principles of evo- scientific communications, is ambiguous. Along lution, which are considered by some churches with artistic expression, scientific communi- to be in conflict with their religious doctrines, cations probably fall somewhere between po- have several times been struck down, most recently in 1987.11 lz’l”he co~ h= established that symbolic expre55iOn as well as speech is protected; for example, wearing an armband (in Technology has figured in other challenges. public school) to protest government actions in Vietnam. Tinker The Court has for example let stand State man- v. Des Moines School District, 393 U.S. 509, 89 S. Ct. 733, 21 L. Ed. 2d 731 (1969). datory vaccination laws in spite of the objec- 13Schenck v. Um”ted States, 249 U.S. 47 (1919), established tions of some religious sects. The Court has a “clear and present danger” test to determine when the gov- also ruled that States may provide transpor- ernment could regulate political expression in the interest of national security. Gitlow v. New York, 268 U.S. 652, 45 S. Ct. tation for children to church schools, in the in- 625, 69 L. Ed. 1139 (1925) modified this doctrine to allow sup- terest of promoting the health, safety, and edu- pression of speech that might lead to “substantive evil” or un- lawful ends. Denzu”s v. Um”ted States, 341 U.S. 494 (1951), allowed conspiracy convictions by distinguishing between IONe~ Riemer, Jmeg Madj”son: (k5V3thg the Americm con- advocacy of illegal acts and advocacy of doctrines. Yates v. stitution (Washington, DC: Congressional Quarterly, Inc., 1986), United States, 354 U.S. 208 (1957), weakened this slightly by pp. 14-15, pp. 136-40. requiring that specific illegal acts be shown; membership in an ll~dwtids v. Aqui]]md et d,, 107 Sup. Ct. 2573 (1987). organization advocating them cannot be made a crime. 13 litical and commercial speech in terms of the trate’s warrant.14 This constraint applies to protection it is afforded. Science, Technology, the States under the Fourteenth Amendment. and the First Amendment also examines the The Supreme Court has in the last 70 years restrictions placed on scientific communica- ruled that wiretapping and more recent elec- tions in the name of both national security and technological export controls, and probes the tronic surveillance devices are “searches,” and more recently, has had to decide whether evi- question of whether the cumulative effects of dence may be seized from bank, medical, and these restrictions are eroding freedoms of 15 insurance records in computerized databases. speech and press. The present report carries So far, the Court has allowed authorities to this discussion further, to examine the restric- “seize” a suspect’s breath (for analysis for al- tions placed on science in the interest of relig- cohol), or one’s urine, semen, blood, or other ion, ethics, and public safety. fluids and tissues for evidence, but these ques- The Rights of Assembly and Petition tions are probably not fully resolved. As another fundamental protection of polit- The Rights of Those Accused and ical freedom, the First Amendment forbids Convicted of Crimes Congress to abridge: The rights of people suspected or accused . . . the right of the people peaceably to assemble of crime are protected in several places in the and to petition the government for a redress body of the Constitution and in the Fifth, of grievances. Sixth, and Eighth Amendments. These civil The Fourteenth Amendment extended this liberties constrain or limit how the State may deprive a person of life, liberty, and property prohibition to the States. State and local gov- l6 ernments can to some extent regulate public in enforcing its laws. The affect of techno- meetings and assemblies to prevent disorder logical changes on interpretation of these Con- and violence; but these necessary police func- stitutional rights is considered in detail in the tions are carefully and suspiciously examined OTA Special Report, Criminal Justice, New by the courts. Technology, and the Constitution, April, 1988. For example, the use of biology-based tech- The Prohibition on Unreasonable niques for identifying offenders, such as DNA Searches and Seizures (genetic) pattern recognition, will probably be challenged constitutionally. The Fourth Amendment, like the First, has repeatedly been brought into question by changing technology. It reads: IiDuring ~ ~rest, a warrantless search is permissible if the authority has “probable cause” to believe a crime has been com- The right of the people to be secure in their mitted. persons, houses, papers, and effects, against 15 Chandler et al., op. cit., footnote 1, p. 168, citing Zurcher unreasonable searches and seizures, shall not v. Stanford Da-ly (436 U.S. 547: 1978). be violated, and no Warrants shall issue, but 16p~o “. Connecticut, 302 U.S. 319, 58 S. Ct. 149? 82 L. Ed. 288 (1937), established “selective incorporation” in determin- upon probable cause, supported by Oath and ing which Bill of Rights provisions related to rights of the ac- affirmation, and particularly describing the cused should be applied to State actions. This was a case in- place to be searched, and the persons or things volving double jeopardy; the guideline or “rationalizing to be seized. principle” enunciated by Justice Cardozo, was whether a particular protection is “of the very essence of a scheme of ordered British authorities in the American colonies liberty, ” such that its bypassing would violate “a principle of justice so rooted in the tradition and conscience of our people issued general “writs of assistance” that al- as to be ranked as fundamental. This case held that the pzwhi- lowed searches at will or on slight suspicion, bition of double jeopardy was not so fundamental, but this was especially for contraband smuggled in viola- overturned later; now only the grand jury provision of the Fifth Amendment and the Excessive Fines and Bails prohibition of tion of Parliamentary duties. The Fourth Amend- the Eighth Amendment have not been “selectively incorporated’ ment prohibited searches without a magis- as limitations on the States. 14

Due Process Retained or Inherent Rights, and Both the Fifth Amendment and the Four- Reserved Powers teenth Amendment provide that a person may The Ninth Amendment says that: not: The enumeration in the Constitution, of cer- . . . be deprived of life, liberty, or property, tain rights, shall not be construed to deny or without due process of law. . . . disparage others retained by the people. The Court has developed two complementary One of the strongest objections raised to a definitions of “due process”: procedural due Bill of Rights during the Constitutional Con- process and substantive due process. Proce- vention and the ratifying process was that the dural due process means that laws, regulations, Federal government was not in general ex- and government procedures must not be arbi- pected to act on individual citizens. The Fed- trary, vague, or inconsistent, and the protec- eral government was to have delegated, limited tions set out in the Bill of Rights should be powers, plus those other inherent governmental carefully applied. “Substantive due process” powers necessary to exercise those authorized suggests that some areas are beyond the reach functions effectively. The philosophy expressed of government authority, and some laws are in the Ninth Amendment is that the “Bill of unconstitutional because of their intent. This Rights did not confer rights but merely protected those already granted by the natural concept has been used to wall off from gov- 19 ernment interference certain private activities, law." primarily marriage, procreation, child rearing, Until 1965 no law had been struck down on and educational choice, held to be beyond the 17 the basis of violation of unenumerated rights. appropriate reach of legislation. In that year, a Connecticut law forbidding the use of birth control was ruled unconstitutional Limitations on Eminent Domain because it violated an unenumerated right of The Fifth Amendment also says that: marital privacy, which is “within the penumbra of specific guarantees of the Bill of Rights” . . . private property may not be taken for public use, without just compensation . . . and one of those fundamental rights assumed to be “retained by the people” because it has This power of “eminent domain” is an in- not been delegated to the nation or a state. 2o herent power of all governments. It means that the rights conferred by private ownership of The Tenth Amendment further provides property must, in some cases, give way to the along the same lines that: good of society as a whole. Thus, when it is The powers not delegated to the United States necessary to build a highway in a given loca- by the Constitution nor prohibited by it to the tion and a landowner refuses to sell land to the States, are reserved to the States respectively, government for that purpose, the land may be or the people. taken for public use, but the owner must be It has been generally understood that this justly compensated. What constitutes “tak- amendment did not alter the distribution of ing” of property has often been challenged, and power between two levels of government, but some of these challenges have been stimulated merely restated the philosophy of government by technology. For example, the Court has held expressed throughout the Constitution, under that airport noise that renders adjacent land which the States retained many sovereign unusable for normal purposes may be a “tak- 18 powers not delegated nor clearly necessary to ing” for which government must compensate. the Federal government. Until the mid-1930s ITCorwin ~d Pelta90n, op. cit., footnote 3, PP. 124-125. the Supreme Court often used the doctrine of 18Grjg@ v. Al]eg~y County, 369 U.S. 841 (1962). Rent-control laws however do not constitute a taking, nor do other legis- ‘gCorwin and Peltason, op. cit., footnote 3, p. 132. lative actions that may diminish the value of property by regu- 20chmdler et ~c, The constj~u~~on~ hiW DjCfhntiry, VO1. 1, lating how it is used. pp. 369-371. 15

“Dual Federalism” to prevent Congress from The right to privacy was finally made explicit using its powers of taxation or interstate and definitive in Griswold v. Connecticut,23 in commerce regulation to accomplish other ends, 1965, as the Court struck down a law forbid- such as making exploitation of child labor un- ding contraception. Since then it has been ex- profitable for interstate businesses. The Tenth panded to include other aspects of marriage, Amendment, in this way, reinforced the effec- reproduction, and health. tiveness of the Fifth Amendment requirement of “substantive due process” as interpreted Equal Protection of the Laws by the Court. No discussion of the Bill of Rights can ignore After 1937, the Court returned to the view the Equal Protection Clause of the Fourteenth of John Marshall that this Amendment is a Amendment, which was intended to buttress truism,21 which does not by itself limit the the rights of former slaves. Yet for nearly national government in exercising powers that ninety years it was not applied as intended. it would otherwise be understood to have. Both The Court held in 1896 that a legal distinction the Ninth and Tenth Amendments, however, between the races did not destroy their equal contributed to the development of the constitu- protection or legal equality, as long as they 24 tional doctrine of “a right to privacy, ” in that were given “separate but equal” treatment. they emphasize the principle that the people, This doctrine was finally modified in 1950, in forming a government, retained some powers and it was definitively struck down in 1954 beyond the reach of government. when public school segregation was ruled unconstitutional.25 In a further series of cases in The Right of Privacy the late 1950s and 1960s, the court established The Bill of Rights as a whole is understood that it will look with great suspicion (“strict to indicate a sphere of personal autonomy scrutiny’ at any different or special treatment where government should not intrude, even of a class of citizens in applying laws for the though this sphere is not exhaustively marked purpose of allocating a benefit or imposing a out or specified by any formal listing of rights. restriction, especially where such classification This sphere of individual autonomy has come is based on race. Later Equal Protection cases to be called the “right of privacy, ” although have extended the scope to classifications other the word “privacy” is not used in the Consti- than those based on race. This transfers the tution. burden of proof to the State and demands more than a showing of reasonableness; the State In one of his classic dissents, in 1928, Judge must demonstrate that it has a compelling in- Brandeis said that the Fourth and Fifth Amend- terest and a critical need to give special treatments together recognized “a right to be let ment to some class of citizens. alone, and defined this as “the most comprehensive of rights and the right most valued In effect, the Court looks at the intent of any by civilized men. ”22 In a 1958 civil liberties classification. If the intent can be shown to be case Justice Harlan spoke of the “vital rela- related to a legitimate legislative objective, and tionship between freedom to associate and not to social discrimination, classifications privacy in one’s associations. ” In a 1969 por- may be allowed to stand. For example, clas- nography case Justice Marshall said that reg- sifications related to age have been allowed, ulation of obscenity cannot extend into “the privacy of one’s own home, ” and that the gov- 23381 U.S. 479. 24p]e~~y “. Fer=son, 163 U.S. 537 (1896). ernment has no business to tell a man “sitting Zssweatt v. Pa”nter, 339 U.S. 629 (1950) struck down one alone in his own house, what books he may read State law requiring separation of races in State law schools; or what films he may watch. ” Brown v. Board of Education, 374 U.S. 483 (1954) definitively ended the doctrine that “separate” could be “equal” in public education and by extension in other public accommodations and “Quoted in Corwin and Peltason, op. cit., footnote 3, p. 132. services. For discussion of related cases and decisions see Chan- zzo]m~tead v. ~njte~ States (277 U.S. 438: 1928). dler et al., op. cit., foonote 1, pp. 308ff. 16 to give special services or protections to those ing to most scholars, the Amendment was pri- under 18 or over 65. Classifications by gender marily intended to prevent Congress from dis- or by indigency are not necessarily suspect, arming the State militia, a touchy subject less but some classifications based on gender have than a decade after the end of a revolutionary recently been disallowed. war and at a time when antifederalists feared the creation of a possibly despotic central gov- Special treatment related to fundamental ernment. 26 If this Amendment was intended, rights, such as the right to vote, the right to as some have assumed, to assure the possibil- cross state lines, or even the right to have cer- ity of revolution against despotism, then the tain medical procedures, are subjected to what modern technology of weaponry has almost the Court calls “strict scrutiny. This is espe- surely negated that protection. cially true when the classification itself is “inherently suspect. ” The Third Amendment provides that No soldier shall, in time of peace, be quar- The Forgotten Amendments tered in any house, without the consent of the Several of the first Ten Amendments have Owner, nor in time of war, but in a manner to been of relatively little importance in our con- be prescribed by law. stitutional history. This provision too was never the subject of ju- A well regulated Militia, being necessary to dicial challenge.27 By the time of the Civil the security of a free State . . . , War, if not before, it had been rendered obso- lete by the advancing technology of warfare The Second Amendment guarantees the and the logistics of modern armies. “right of the people to keep and bear arms. ” Although it is often loosely cited in debate over gun control laws, there have been few if any ‘26corwin and Pe)tason, op. Cit., fOOtnOte a! P. 115. judicial interpretations of this clause. Accord- 271bid.

MOLECULAR BIOLOGY AND NEW TECHNOLOGY Molecular biology is in this decade an ex- From advances in the basic science, or sci- traordinarily productive field of scientific re- ences, of molecular biology are pouring two search and application. The traditional dis- mighty streams of further development. One ciplines of biology, chemistry, and physics here of these is bioengineering, with techniques for converge to support wave after wave of ad- use in manufacturing processing, agriculture, vances in scientific knowledge. New knowledge and environmental management. The second quickly leads to innovative scientific instru- line of development flowing from molecular bi- mentation, which in turn produces further ad- ology is concerned directly with the human vances in knowledge and is also translated rap- body, brain, behavior, and genetic inheritance. idly into practical applications, improved Much is being learned about the materials and testing and measuring techniques, and com- processes of human genetics and about the bio- mercializable technology. In this area, strong chemical basis of body and brain functions. social needs indicate that “market pull” as well Techniques are being developed for their fur- as “knowledge push” will continue to encourage ther analysis, testing, measurement, manipu- innovation and commercialization. These so- lation, correction, or enhancement. cial needs are related to both genetic and infectious diseases (especially the new epidemic Some new or proposed techniques are already of AIDS); mental illness and mental retarda- highly controversial. Such applications are in tion; and the mental and physical problems various stages of study or achievement-some associated with aging. already in limited use, some in laboratory 17 trials, some only promised or even hypotheti- and effective delivery of human services, en- cal. For example, debate has arisen over man- hanced human performance, better health and datory testing for disease exposure and for use prolongation of useful life, even eradication of of drugs, genetic screening for special suscep- tragic physical or mental defects and diseases. tibility to environmental risks, human germ cell or somatic cell gene therapy, interspecies At the same time, many of these biology- gene transfers, brain transplants, fetal surgery, based technological capabilities seem to be par- and several kinds of technologies for assisted ticularly likely to raise political and ethical is- reproduction, including in vitro fertilization, sues, which often ultimately become constitu- the freezing of embryos, etc. tional issues, or are so construed by those Part of the promise of these new biology- seeking their resolution. They may offer alter- based technical capabilities comes from their native explanations of causality in behavior, combination with other especially fruitful areas performance, motivation, or attitude—i.e., bio- of scientific research and technological devel- chemical or genetic determinants or influences opment. Computers and related information rather than choice or will. They provide new technologies have not only made many of the means of influencing, controlling, or modify- breakthroughs in biology possible, but also ing behavior, emotions, or judgment. They make it possible to use this knowledge in ways may challenge religious definitions and prin- commensurate with its enormous complexity ciples. And they may allow individual choices and data richness. More recent rapid develop- to purposefully change the genetic inheritance ments in materials sciences and molecular engi- of future generation. neering may loosen many constraints associated with the differences in nature between These technologies and techniques, in short, organic and inorganic materials. The cognitive, enlarge the capabilities of both individuals and behavioral, and social sciences offer nearly end- the State to make and implement decisions less ways to check, extend, and apply knowl- that increase tension between the general wel- edge gained through biological and chemical fare and individual rights. The State has al- research on human beings. ways claimed an interest in protection of human life, in reproduction, in decisions made for These combined techniques and technologies those who cannot decide for themselves, and are related not only to medicine or public in the welfare of future generations. These are health; they have possible applications in many also the areas in which people most readily as- other fields in which significant issues maybe sert their right to privacy, family integrity, and raised, some of them with obvious constitu- individual autonomy. tional applications. In law enforcement and corrections, the use of biological techniques This conflict is what creates and defines con- such as drug or hormone therapy as alterna- stitutional issues—the testing of the terms of tives to prison could point to a new paradigm the social contract. But until recently, only of criminal justice—treatment for disorders some of the events in these critical areas were rather than punishment for crime. In educa- within the power of either the person or the tion, prediction of performance could affect State to decide or even to influence; and this (perhaps in one of several directions) the de- has minimized the conflict or tended to limit sign of or the equal access to educational op- its effects to the most dependent and power- portunities and resources. In many other areas, less members of society. As technology changes a person may come to be thought of less as this condition and increases the possibility of autonomous and accountable, and more as ma- constitutional clashes, concerned citizens, Con- nipulatable or predictable. gress, and the courts will be called on to re- The opportunities promised by these emerg- examine the nature and scope of constitutional ing technologies are immense: more efficient principles. Chapter 3

The New Biology CONTENTS

Page Molecular Biology: What’s It All About ...... 21 Start With Bacteria ...... 22 Recombining DNA: How and Why? ...... ~ . . . . 24 What Goes On in a Cell? ...... 25 Enzymes and Proteins: Regulating Life ...... 26 Mapping the Human Genome ...... 26 The Evolutionary Record ...... 29 Tools of the Trade: Innovations in Conducting Biological Sciences . . . . . 30 The Changing Environment for Biological R&I) ...... 30 From Science to Technologes: The Uses of New Biology ...... 32 Bioengineering in Industry and Agriculture ...... 32 The Biology of People...... 33

Figures Page 3-1* The Structure of DNA ...... 23 8“2. Replication of DNA ...... 24 3-3. Comparative Scale of Mapping ...... 28 3“4. Preparation of Monocolonal Antibodies ...... 31 Chapter 3 The New Biology

Of all the areas of science and technology risks to human safety or to the environment. where rapid advances are now occurring, prob- It is likely to raise other constitutional ques- ably none will have more direct and profound tions in the future. The second, knowledge of implications for individual rights and respon- human biology, affects assumptions about sibilities than molecular biology. This has come what constitutes human nature, what people to be called “the new biology. ” This field of are capable of, and thus what they can be held research is producing dramatic new knowledge responsible for. New technologies based on this derived from the increasing ability to map and knowledge will also increasingly present peo- manipulate the genetic materials in the cells ple with the necessity for new decisions about of microorganisms, higher plants and animals, life and death, reproduction and inheritance, and people; and from far-ranging explorations culpability and punishment. into biochemical factors in physiological and In order to probe some of these potential mental functions. challenges in later chapters, it is helpful to re- From the new biology flow two major streams view briefly the basic premises and promises of applications. One deals with genetic engi- of the new biology. Those readers who are al- neering in industry, agriculture, and manage- ready well informed about this area may wish ment of the natural environment. The second to skip this chapter, which provides a summary consists of tools and techniques for analysis, in nontechnical language. For those who know prediction, correction, control, and enhance- little about the new biology, it will be worth ment of the human body, brain, and behavior. some effort to read carefully the following section, as a primer for the discussion of poten- The first has already raised several direct tial constitutional issues that follows in later constitutional issues related to the right to pat- chapters on genetics, public health, and medi- ent new “engineered” life forms, and the right cal interventions. of scientists to carry out experiments that some people perceive as imposing significant

MOLECULAR BIOLOGY: WHAT’S IT ALL ABOUT?l In molecular biology the traditional disciplines ecules such as vitamins, hormones, and amino of biology, chemistry, and physics converge and acids. This research had many practical appli- overlap in the study of the detailed structure cations in nutrition, medicine, and agriculture, and functions of biological macromolecules. and was relatively quickly commercialized in These are very large complex molecules made the form of specific products. Macromolecules, up of several subgroups of atoms. Cells, the in contrast, are made in and retained within basic building blocks of all living organisms, living cells and carry out the basic cellular func- are generally made up of such macromolecules. tions. During the first two decades of molecular biology-roughly, the 1950s and ‘60s– Until very recently, biochemistry dealt mostly not with macromolecules, but with small mol- research on macromolecules yielded few practical applications that could give rise to com- mercializable technologies. ‘Much of the material in this chapter, not otherwise attributed, was prepared for the Office of Technology Assessment This changed dramatically in 1974 with the by Dr. Bernard Davis, Professor Emeritus of Bacterial Physi- ology, Harvard University, in the form of a contractor report development of recombinant DNA techniques. “The New Biology,” May 1987. DNA is the basic material in genes. During

21 22 conception the DNA in egg and sperm com- ple viruses that infect bacteria (which are called bine and so transmit traits from one genera- bacteriophages) have even greater advantages tion to the next, from parents to offspring. for many studies. Analysis of their life cycle Along with this continuity, DNA allows for has laid the foundation for understanding the variability, since the traits from two lines of viruses of animals and plants, and gave us the inheritance-two parents-are combined and ability to rapidly identify and characterize the mixed. An ability to analyze, map, and manipu- AIDS virus, as will be described in chapter 5. late DNA opened up both deeper insights into An important consequence of microbial ge- living processes and immense prospects for netics has been the recognition of the remark- practical applications. A review of some key able unity of biology at a molecular level. The steps in the short history of molecular biology, living world is enormously diverse. Millions especially the recombinant methodology, shows of species have adapted to their environment vividly how much unforeseen knowledge we through astoundingly varied structures, func- have gained. It also shows that the advance tions, and behaviors. But at a molecular level of science and technology depends only in part all organisms-man as well as microbe-make on orderly, step-wise research; occasional un- their nucleic acids and proteins from precisely anticipated breakthroughs open up new terri- the same building blocks, and these acids and tories that in turn rapidly spawn new infor- proteins function in essentially the same way. mation and understanding. The inherited differences between organisms— between, for example, a person and an earth- Start With Bacteria . . . worm-appear to be determined by differences The study of bacteria played a key role in in the sequence of the basic building blocks the emergence of molecular genetics. The very comprising the genes. small size of these single-celled organisms— Such basic unity in the midst of diversity about one thousandth the volume of an aver- gives us, with the development of bioengineer- age human cell—had always been a major ob- ing, the ability to make useful products such stacle to dissecting their internal structures. as insulin by inserting human genes into bac- There was no science of bacterial genetics un- teria. The bacterial cellular mechanism can til the 1940s—no one had observed either the then produce insulin, illustrating the fun- transfer of genes between organisms or muta- damental similarity in basic proteins and tions in bacteria. But in 1944 (when pneumo- genetic structures. This close biochemical rela- nia was a leading cause of death), research on tionship between two extremes of biological pneumococcus showed that the material of complexity-the human and the bacteria—is genes is DNA and that it can be transferred evident throughout the living world and pro- between bacterial cells.’ vides strong evidence for its evolutionary con- Bacteria offer several advantages for the tinuity. study of molecular genetics: their relative sim- James Watson and Francis Crick, in 1953, plicity, rapid multiplication (as many as three demonstrated the structure of DNA. Within generations per hour), and the ease of select- DNA the basic building blocks are chemical ing even very rare mutants from populations bases, of which there are only four kinds: ade- of billions of cells. Moreover, the relatively sim- nine, thymine, guanine, and cytosine, known as A, T, G, and C. In order for genes to be passed on from one generation to another, zThe discovery was made by Oswald Avery. Until then ‘t DNA must replenish itself. The fact that DNA was generally assumed that chromosomal proteins carry genetic information and DNA played some secondary role. The import- within the cell is double-stranded, and that ance of the discovery was not widely recognized at the time. complementary bases are paired-A always Avery never received a Nobel Prize. Lubert Stryer, 13iochezm”s- with T, and G with C—gave scientists an im- try, 2nd ed. (San Francisco, CA: W.H. Freeman & Co, 1981), p, 562; or G.J.V. Nossal, Reshaping Life: Key Issues in Genetic mediate clue to how replication occurs. These- Engineering (Cambridge University Press, 1985). quence of each strand-the order in which its 23 building blocks are arranged-serves as a tem- Figure 3-1 .–The Structure of DNA plate for the synthesis of its complementary Phosphate Molecule strand, and hence for the formation of two double-stranded molecules from one. (See figures Deoxyribose 3-1, 3-2). Moreover, mutations could now be Sugar Molecule explained as errors in the pairing of bases during replication. / I Nitrogenous

The research that has grown from the ex- -o”’ planation of DNA by Watson and Crick has provided an enormous amount of detailed information about the chemical and biological properties of DNA. Each gene is a sequence of bases within a chain; within bacteria the length of that chain is about a thousand times o 0 the diameter of a cell. To accommodate this length within the cell, the DNA chain is tightly folded. The genetic information itself is linear, coded much like sequential sentences in a printed book or electronic signals on a magnetic tape.

There are many kinds of errors, or “mis- prints. ” Mutation eventually turned out to be much more complicated than was originally thought. Sometimes chromosomes (or strings of genes) become rearranged, or one base is sub- stituted for another, or bases are duplicated or deleted when they should not be. Some sequences seem to be particularly transposable; they are often transferred to another site in DNA.

Some of these transposable elements also can be incorporated into viruses that can carry them to other cells, to other individuals, or even \ Weak Bonds Between –although rarely-to individuals belonging to Base Pairs other species. This also contributes to the increase of genetic variety. Some scientists even ~ The Sugar-Phosphate J suggest that the role of viruses in causing dis- Backbone ease may be only a byproduct of a more fun- The four nitrogenous bases, adenine (A), guanine (G), cyto- damental evolutionary role in expanding ge- sine (C), and thymine (T), form the four letters in the alphabet of the genetic code. The pairing of the four bases is A with netic variety. As an analogy, there are only a T and G with C. The sequence of the bases along the sugar- few bacteria that cause disease, compared to phosphate backbone encodes the genetic information. those that play essential roles in the cycle of SOURCE: Office of Technology Assessment, 1988. 24

The information contained in genes directs the formation of the other molecules that com- prise the core of the working machinery of cells –RNA and proteins. In this process a DNA sequence, by “un-pairing” its bases, gives rise to a complementary RNA sequence, and this “messenger” RNA is then translated into proteins. Each successive set of three bases in messenger RNA calls forth a specific amino acid. Amino acids are linked together to forma proteins. This translation of RNA to produce proteins occurs with a remarkably low error rate.

Several different regulatory mechanisms that affect the expression of specific genes have been recognized. Such regulatory mechanisms allow even the simple bacterium to adjust the formation of its components to various environmental circumstances. Appropriate human cells “turn on” antibody genes when the body is invaded by a disease organism. The regulatory elements or mechanisms are key factors in the bioengineering synthesis of useful proteins through the use of recombinant bacteria, as described below.

The more complex regulatory processes in the cells of higher organisms, which are of great importance for medicine and pharmacology, Old New New Old are as yet much less well understood. For example, it is not yet understood why certain When DNA replicates, the original strands unwind and serve as templates for the building of new complementary processes (e.g., loss of a limb) are effectively ir- strands. The daughter molecules are exact copies of the reversible in higher animals, but not in plants. parent, with each having one of the parent strands.

SOURCE Off Ice of Technology Assessment Recombining DNA: How and Why? matter between the organic and the inorganic A number of additional discoveries in the world. fields of bacteriology and molecular genetics From another perspective, however, muta- led to the development of recombinant DNA tions are rare exceptions. DNA is transmitted methodology, which is popularly called bio- from generation to generation with extraordi- engineering. Before this development, the nary accuracy. This accuracy depends not only problem of isolating the different genes in a on the inherent chemical stability of DNA, but chromosome seemed unsolvable, because they on repair mechanisms that recognize and cor- are sequences in a giant chain and physical rect most errors in replication and most of the methods for breaking that chain simply yield genetic damage caused by radiation, chemicals, random fragments. The breakthrough came or other environmental factors. with the discovery in cells of “restriction en- 25 zymes, which destroy unwanted DNA by tures. The first branch was described above; cutting or cleaving it at a specific sequence. it aims at determining how genetic informa- Restriction enzymes can be used in the labora- tion is transferred from DNA to RNA and fi- tory to cleave DNA purposefully into a set of nally to production of proteins. The second or fragments with known ends that can be re- structural branch of molecular biology aims linked or recombined with other fragments at determining how these proteins, in turn, that have complementary ends, by using other carry out biological functions through specific enzymes. interactions; for example, how insulin controls the storage and processing of sugar. This By using restriction enzymes and ligation branch too is contributing to both streams of (linkage) enzymes, scientists can now splice a future technological development, that lead- DNA fragment into an appropriate unit and ing to commercial applications for industry and multiply it indefinitely (i.e., “clone” it) by in- agriculture, and that focusing on the human serting it into an appropriate cell that then mul- body and brain. tiplies. After years of effort, a simple procedure has been developed to genetically modify As they study biochemical reactions, scien- the bacterium Escherichia coli or E. coli. Bac- tists are attempting to develop enzymes to af- teria contain a single, very long circular chro- fect not only naturally occurring compounds mosome that contains most of the genetic infor- but also synthesized or novel organic com- mation necessary to function. The chromosome pounds. Genetic variation in the microbial of E. coli, a common bacterium living in the world is so rapid that microbiologists can now human gastrointestinal tract, is some 4 mil- accelerate natural evolution by selecting mu- lion nucleotide base pairs in length. But like tant bacteria with enzymes having the capac- most bacteria, E. Coli contain other “acces- ity to attack a specific organic molecule. sory” genetic elements that carry genes involved in reproduction and resistance to drugs. Researchers are learning that a small num- These small circular units of DNA are called ber of genes can generate large numbers of plasmids and can be transferred from one bac- unique proteins. For example, antibodies are terium to another. specialized proteins that attack and destroy The entire “library” of genes of a mammal, foreign substances, or antigens, thus protect- containing around 3 billion base or building ing the body from disease organisms. This block pairs, can be stored in the bacteria in a process requires very specific physical bind- single test tube. Such a mixture of perhaps 10 ing of the antibody to the antigen. Specificity billion bacteria will contain thousands of differ- results from the unique amino acid sequences ent recombined genes, but the “library” can of antibodies that are encoded by genes. Al- be separated into “books,” or smaller pieces though it is known that the body can gener- of DNA containing several genes, and each ate in excess of a million different types of an- “book” or piece can be inserted indifferent bac- tibodies, there are just a few hundred antibody teria. Ingenious techniques have been devel- genes. Recently it was discovered that this oped for efficiently selecting those cells that enormous number of antibodies can be gener- have incorporated a particular gene. ated by mixing, matching, and splicing a small number of genes together. It is now known that What Goes On in a Cell? natural gene rearrangements of this kind are responsible for the generation of many kinds Molecular biology has two major branches: of proteins. molecular genetics and macromolecular struc- Short synthetic protein chains are already under trial as vaccines. The analysis of the in- 3An enzyme is a complex protein that catalyzes a specific biochemical reaction within the body; that is, causes the reaction teractions of drugs with their receptors in liv- to occur without the catalyst enzyme itself being used, changed, ing cells is also having a revolutionary effect or destroyed. on pharmacology. . .

The proteins in cell membranes, including as valves controlling the flow through a path- the receptors for hormones and drugs, were way from raw material to end-product, each long a mystery to biochemists. They seemed enzyme specific to a particular starting ma- part of an insoluble debris. But new labora- terial. tory techniques, including the use of certain detergents to make them soluable, have made The mechanism by which this occurs involves them accessible to study. Biochemists are now the ability of many proteins to shift between able to make artificial membranes that repro- two stable alternative shapes or conformations; duce some natural biological functions. It is this is called allostery. The same simple prin- not yet clear how far this approach can go ciple has provided a general explanation for toward reconstructing cells from their compo- an enormous variety of biological phenomena, nents, or toward “tissue engineering” formed- from the expression of a gene, to the actions ical purposes. of drugs on the body, to the secret of mechano- chemical coupling resulting in movement in In the future, there maybe nearly unlimited biological systems. It has been useful in ex- possibilities for designing synthetic protein plaining how muscle fibers work, the migra- chains for specific purposes. Enzymes produced tion of cells in embryonic development, and the to order by engineered organisms will be used mechanisms by which some cells, called phago- in the chemical industry, perhaps replacing cytes, engulf and digest foreign bacteria, al- chemical reagents that are more risky to work- lowing the body to resist infection. ers or to the environment. The understanding of this and other regula- Enzymes and Proteins: Regulating Life tory mechanisms is certain to contribute to the understanding and control of disease, to the In the memory of a computer, information development of drugs, and to the manufacture is stored in an intricate pattern of switches, of desired proteins by genetic engineering. each of which may be “off” or “on,” represented by O or 1, so that information is put into a code, like 01001001110. Genetic infor- Mapping the Human Genome mation is stored in a different way, in the linear sequences of four different chemical bases Soon scientists will have mapped the com- within a giant molecule. Thus it uses a 4-letter plete DNA genetic sequence of the common code rather than the 2-letter code of 0/1. bacterium E. coli, with its 3 million base pairs. Some scientists argue that we should now For day-to-day conduct of cellular business, mount a major national effort to do the same cell functions are regulated by still another for the human genome (i.e., complete set of means of transmitting biological information chromosomes), which is about 1,000 times —special proteins that sense the presence or larger. concentration of some molecule and react to it. This key discovery came about through re- There are two alternatives for further work, search that had a more limited aim: to explain ‘‘mapping, and “sequencing” the genome. how bacterial cells stop making a certain amino The difference is important because of current acid when it is supplied to them in the medium policy debates about which way to proceed. At in which they are grown. In this feedback represent, small regions of the genome concerned sponse, the initial enzyme that begins the proc- with specific functions are being sequenced. ess of creating an amino acid is directly in- These regions are identified in two ways: the hibited by the end-product of that process, i.e., sequence of a known protein is used to locate by the presence of amino acid. This spares ma- the corresponding gene, or the abnormal form terial and energy for other purposes when more of a gene associated with a disease is located amino acid is not needed. Enzymes thus act through genetic comparisons and then is used 27

to identify the normal version. To continue The advantages of comprehensively map- along this path would involve studying key ping the human genome are that it would make sites on the human genome; physically, in it much easier and faster to link a newly iden- terms of the succession of restriction enzyme tified gene with a disease or human function. cleavage sites, and genetically, in terms of the Currently, a gene must be located through a genes as they are identified. Detailed sequenc- painstaking search for genetic markers before ing of the various regions, base by base, would it can be isolated and its bases sequenced for be done gradually, with priorities set by inter- further study of its functions. Mapping the full est and importance rather than by location— genome would mean that when biologists want i.e., the work would “skip around” with gaps to study a specific protein within the body, being filled in slowly (See figure 3-3.). analysis of a bit of its amino acid would make it possible to go to the genome database and This program is in fact being carried out now, locate the specific gene that guides the pro- in many laboratories, and the information is duction of that protein. Advocates say this being collected and correlated. It has revealed would dramatically accelerate achievement of unexpected parallels between sequences in the goal of fully understanding human inheri- genes with very different functions. This indi- tance and its limits. Possibly diseases that de- cates that as organisms became more complex and as they therefore increased the number of pend on the interaction of several genes, or that have alternative genetic causes, could be un- their genes, new genes evolved from older ones derstood. There would also be spin-off bene- in branching patterns, much like the branch- fits for many other areas of biological research, ing pattern of the evolution of species through including ecology, immunology, and cancer modification of earlier organs. control. The alternative approach is mapping or complete systematic step-by-step description of the Mapping the entire genome would be a large entire human DNA sequence, containing pos- and ambitious undertaking, probably taking sibly 100,000 genes and over 3 billion bases. 10 to 20 years, and with a cost estimated by Only a few hundred genes have so far been de- some experts to be at least $3 billion. Critics scribed, less than 1 percent of the total. Cur- fear it could divert research funds from other rent techniques can produce rough sequenc- research that they think is more urgent. Some ing of about 20,000 bases a day, and are rapidly sections of the human genome, it is thought, improving. One approach would be to map the will be much more difficult to clone and map structure of DNA in sections some 40,000 than others, and some scientists suspect that bases long. Sections of DNA of that length can the technology is not yet up to the task. be cloned into special vectors called “cosmids,” Some biologists argue that 90 percent of the in such a way that these partial maps would effort of such a project would be wasted be- overlap. Mapping of the complete genome cause it is now believed that only about 10 per- would be the largest single biological project cent of DNA codes for proteins and the rest 4 ever undertaken. A major governmental ini- is “irrelevant” or “junk.” Advocates respond tiative toward this end has been proposed, in- that we do not really know what genetic ma- volving the establishment of a few major re- terial is irrelevant to our needs, and that the search centers to carry out the work with effort to filter out the junk would in any case centralized coordination. It is highly contro- be more time-consuming than systematic versial. mapping. “’Sequencing the Human Genome, ” Issues in Science and Technology, Spring 1987. See “Prologue,” p. 25. This seminar Allowing the U.S. Department of Energy in print includes: Walter Gilbert, 4’Genome Sequencing: Creat- (DOE) to take the lead in mapping the human ing a New Biology for the Twenty-First Century, pp. 26-35: genome has been considered as one possibil- Leroy Hood and Lloyd Smith, “Genome Sequencing: How To Proceed, pp. 36-46; and commentaries by David Baltimore and ity, on the grounds that this would be a natu- Francisco Ayala, pp. 48-56. ral extension of DOE research in molecular bi- 28

Figure 3.3.—Comparative Scale of Mapping

EARTH CELL

UNTRY CHROMOSOM

N GENE

PEOPLE NUCLEOTIDE BASE PAIRS

The number of base pairs of DNA in human cells is roughly comparable to the number of people on Earth. The scale of genetic mapping efforts can be compared to population maps, with chromosomes (50 to 250 million base pairs) analogous to nations, and genes (thousands to millions of base pairs) to towns. 29 ology (focusing on mutations that result from The Evolutionary Record radiation or energy production) and would take advantage of DOE-funded scientific instru- The new field of molecular evolution provides ments and staff at national laboratories. Al- more direct evidence for evolutionary continu- ternatively, the project could be led by a new, ity than even the fossil record. For example, directed effort of the National Institutes of man and chimpanzee, species which separated Health (NIH). An NIH-led effort would build only around 10 million years ago—a short time on a much larger base of biomedical research. in evolutionary history, have about 99 percent These and other strategies for carrying forward of their DNA sequences in common. This sim- genome mapping efforts has been widely de- ilarity indicates that man and chimp have a bated inside and outside of government in the relatively recent common ancestor, compared last 2 years. Most likely is a set of projects to the much smaller genetic overlap between funded through two or more Federal agencies, man and other species. DNA changes over with formal or informal means of coordinated time, due to mutations that are not eliminated, planning. and the more similarity there is in the DNA of two species, the shorter the time in which The situation in mid-1988 is that there is no they have been developing separately and thus single human genome project but instead many diverging. There are decreasing degrees of ho- projects, in NIH, DOE, and other government mology, or genetic similarity, between man and laboratories and in universities and private sec- increasingly distant organisms down to the tor laboratories. They aim at establishing and lowest of the vertebrates. By contrast, bacte- enhancing databases about DNA sequences, ria have been diverging from each other not markers, and gene structure and expression; for thousands of years but for several billion creating chromosomal maps; and developing years, and they show sequence homology only new instruments, analytical techniques, and between very close species; that is, different other scientific resources for biomedical re- bacteria may have very little overlap in DNA search. No agency or organization, and no na- sequences. Some of the gaps in the evolution- tional government, has made a commitment ary record are likely to soon be clarified and to massive sequencing projects, or to a uni- closed by such molecular comparisons, and some tary, single focus program of research like that current misunderstandings and misinterpre- of the Apollo Project, the Manhattan Project, tations may be identified and swept away. or other celebrated government research initiatives. Recent reports by the National Acad- Evolution has implications not only for emy of Sciences5 and the congressional Office describing the origin and development of our of Technology Assessment6 concluded that species but also for increasing our apprecia- any such initiative would be inappropriate. tion of its rich genetic diversity, and for the They suggest, rather, that the Federal Gov- still richer genetic diversity in our environment ernment should, through funding and over- at large. This diversity could be needlessly re- sight, encourage and coordinate the continu- duced by careless or misguided agricultural 7 ing enhancement of databases and resources and environmental management practices. in many cooperating units and centers of re- With respect to humans, a deeper understand- search. ing of the value of the wide variety in nearly all human traits enormously enriches life and literature, and when combined with understanding of the basic unity of life, as revealed by molecular biology, can further complement the ‘National Research Council, Mappin g and Sequencing the

Human Genome (Washington, DC: National Academy Press, already strong moral, political, cultural and re- 1988). ‘U.S. Congress, Office of Technolo~ Assessment, Mapping Our Genes– The Genome Projects: How Big, How Fast? OTA- ‘U.S. Congress, Office of Technology Assessment, Techllof- BA-373 (Washington, DC: U.S. Government Printing Office, ogies To Mainta”n Biological Diversity, OTA-F-330 (Washing- April 1988). ton, DC: U.S. Government Printing Office, March 1987). 30 ligious grounds for treating all races and all the small region on the protein surface that individuals with equal consideration and respect. each is attracted to and binds. The distribution of antibodies elicited by a given antigen Tools of the Trade: Innovations in varies somewhat from person to person, and Conducting Biological Sciences even in the same person at different times. This made it hard for scientists to study the for- Progress in science depends on technical as mation of antibodies. well as conceptual advances. As biochemistry There is a kind of cancer that attacks antibody- expanded its scope it has become increasingly producing cells, called multiple myeloma. The dependent on elaborate (and expensive) instru- 8 cancer makes the “sick” cell reproduce itself ments. Also of major importance has been the use of computers. Automation and com- uncontrollably. The new or daughter cells are puters greatly facilitate the accumulation of clones of (i.e., identical with) the original cell. Scientists learned how to fuse an antibody- data. While the investigator sleeps, his instru- producing cell with a myeloma cell to get a cell ments continue to collect successive samples that is called a hybridoma, which both pro- in a fractionator, to measure radioactivity, to duces one species of antibody and replicates determine or synthesize base sequences in itself over and over. These identical antibod- genes. Indeed the rate of production of data ies are called monoclinal antibodies, and are is overwhelming the ability to publish it; a case a powerful tool for analyzing the process of an- in point is DNA sequence information. tibody formation. (See figure 3-4.) Their speci- The focus of biochemistry on larger mole- ficity allows them to be used, for example, to cules, and the simultaneous focus of cell biol- carry fluorescent markers or poisons to can- ogy on ever finer structures, has had another cer cells. Monoclinal antibodies can be ac- fundamental benefit. It has done away with curate and thorough biochemical scouts, spies, the troublesome range where cell features were and assassins in the service of medicine. They too small to be studied by microscopy but too have nearly unlimited potential for diagnosis, large to be defined chemically. The field of cell therapy, and analysis, and a growing indus- biology increasingly overlaps that of molecu- try has sprung up to produce them. lar biology, and any line between biology and organic chemistry is becoming artificial. The Changing Environment for An even more fundamental breakthrough Biological R&D has been the development of monoclinal anti- The development of recombinant DNA and bodies. An animal produces antibodies in re- monoclinal antibody techniques have had a sponse to the presence within its body of a significant impact on the relationship between disease organism. In the ordinary antibody response, an “antigen” or stimulus (such as a biomedical sciences and industry. Until re- protein on the surface of a virus) stimulates cently most research in biology has not had much potential for commercial applications. the formation of a protein molecule (antibody). But now a substantial number of the leading The antibody is shaped to fit the antigen like researchers have become involved in commer- a lock fits a key. The antibody covers the antigen so that it cannot latch on to another body cial enterprises. cell. This prevents the virus from invading the It is clearly desirable that scientists doing cell and replicating itself. basic research also encourage the development of applications that will benefit society through The difficulty is that a normal antibody re- better health, improved agriculture, or in- sponse leads to the formation of hundreds of creased economic productivity. In the United different antibodies, differing with respect to States, such benefits are perhaps most likely 8For example, high-speed centrifuges, chromatography col- to be realized when the initial discovery is de- umns, flourescence celI sorters, electrophoresis apparatuses. veloped and marketed by an industry. —

31 —

Figure 3-4.—Preparation of Monoclinal Antibodies

Mouse is Mouse myeloma immunized with (tumor) cells a foreign are removed substance and placed In or “antigen. ” tissue culture

Cells divide in liquid medium

The products of this fusion are grown in a selective medium. Only those fusion products which are both “immor- ~ are mixed and tal” and contain genes /l fused with from the antibody producing cells survive. These are called “hybridomas.” Hybridomas are cloned and the resulting cells are screened for antibody production. Those few cells that produce the antibodies being sought are grown in large quantities for production of monoclinal antibodies.

SOURCE Off Ice of Technology Assessment, adapted from Y. Baskin, “In Search of the Magic Bullet, ” Techrro/ogy Rewew, pp. 19-23

But there may also be problems associated too little attention. There may be an adverse with this changing relationship. Scientists who impact on the openness of scientific commu- are also university faculty members may be nication and sharing of knowledge. Concern tempted to spend too much time on commer- about priority in discovery-for either winning cial activities, and too little time on teaching. prizes or patenting-could encourage scientists Students may be attracted to those areas prom- to postpone publication of preliminary or in- ising the most immediate commercial payoff termediate results, as could industrial secrecy. while other lines of basic scientific research get 32

FROM SCIENCE TO TECHNOLOGIES: THE USES OF NEW BIOLOGY Bioengineering in Industry and not ordinarily changed by selective breeding. Agriculture With animals, the extent of possible alterations through genetic engineering may be limited be- People have throughout history domesti- cause the traits one would wish to alter often cated various microbes by empirical selection involve a large number of undefined genes, of genetic variants with improved properties rather than being determined by a single gene. –for example, in making bread, wine, cheese, With plants, somewhat more extensive changes and antibiotics. Now, directed manipulation may be likely. Promising possibilities include of genes through bioengineering can further enhanced resistance to pests, drought, or tem- improve strains. Also new strains of selected perature extremes, and changes in nutritive properties can be designed without waiting to value and flavor. Currently, there is extensive select from variants that nature offers. The use research on the possibility y of incorporating in of enzymes may increasingly replace tradi- various plants the set of genes responsible for tional methods of organic chemistry in manu- nitrogen fixation, thus removing the need for facturing processing, especially if biological expensive nitrogen fertilizer. However, since processing proves to be more environmentally these genes are found naturally only in bacte- benign than older methods. Engineering of mi- ria, it is not yet certain that they will function crobes could also increase both the efficiency or will remain sufficiently stable within a plant. and versatility of the conversion of biomass into energy and other useful products, or solve Technical problems have been encountered the problem of economically producing single- both in achieving strong expression of inserted cell protein for food. genes even in bacteria, and in preventing destruction of the resulting proteins before they A successful early application of the new bi- are harvested. Since genes can also be cloned ology has been the use of recombinant bacte- in cultured mammalian cells and in yeast cells ria to produce mammalian proteins. One of the (which are more similar to mammalian cells first was the human growth hormone, used to than are bacteria), future production of mam- treat children who otherwise would not grow malian proteins may well be shifted to these to normal stature. Another early product was organisms. Moreover, though the knowledge bovine hormone to increase milk production of molecular genetics of higher plants is so far in cows. A third was human insulin for the rela- not well developed, it is conceivable that clon- tively rare diabetic people who are allergic to ing into these organisms will eventually prove insulin derived from other animals. A more re- economical; some optimists suggest that a sin- cent product is tissue plasminogen activator, gle field of corn could meet the world’s need to dissolve the blood clots that may cause coro- for insulin. nary thrombosis or strokes. These products from engineered microorganisms have the added Some scientists hope that eventually it may advantage that they do not risk contamina- be possible to preserve the DNA of rare spe- tion with lethal human viruses as can occur cies that are threatened with extinction. It has with hormones extracted from human tissues been suggested that inserting preserved DNA and glands. The variety of products under de- into the egg of an existing closely related spe- velopment is growing rapidly. cies could allow us to reconstitute an extinct species, or that related DNA might be modi- Manipulation of DNA will supplement, rather fied for that purpose. These applications are than supplant, traditional methods of strain speculative at present, but not beyond the improvement in domesticated plants and ani- realm of possibility. mals. But bioengineering is different from conventional techniques in that it can produce One constitutional issue, that of patenting changes in more stable portions of the genome of engineered organisms, has been addressed 33 by the Supreme Court, which allowed the genetic screening for hereditary diseases asso- patenting of a genetically altered bacterium.9 ciated with known genetic defects, prenatal The Patent Office, citing the Supreme Court diagnosis of disease or defects through test- decision, extended patent protection to other ing of fetal tissue or cells, and human cell ther- bioengineered plants and animals. In April apy. These will be discussed in chapter 4. 1988, Harvard University was granted a patent on a genetically altered mouse, the first Diagnostic Tools and Vaccines patent to be issued for higher life forms. Molecular and cell biology have revolution- Soon thereafter at a meeting sponsored by ized both basic and applied immunology. Mon- several national church groups, a panel of ethi- oclinal antibodies and fluorescent dyes or tags cists and theologians called this “a matter of have provided particularly valuable tools. deep philosophical and spiritual concern” be- Growing knowledge of the complex immune cause it portrays animals ‘as human creations response will surely make it possible to enhance . . . rather than as God’s creation or subject protective responses and to prevent damag- of nature. . . .’” O The patenting of animals, ing allergic responses. Autoimmunity, the ab- and of human cells and tissues, raises issues normal formation of antibodies or immune cells that are now being debated in Congress. Two that attack normal body constituents, is rec- bills before the 100th Congress as it nears ad- ognized as a factor in some chronic diseases journment call for a moratorium on granting and is strongly suspected in others; these in- animal patents. Court cases challenging the clude pernicious anemia, juvenile diabetes, government’s decision to allow experimental multiple sclerosis, arthritis, and ulcerative co- release of engineered organisms for field trials litis. Antibodies and other visible agents are also have some implicit constitutional impli- widely used with microscopy to reveal the dis- cations and will be discussed in chapter 4. tribution of cell components. Their chemical coupling to powerful toxins or drugs promises The Biology of People to provide a means of targeting these agents to specific cells. The new biology is having a profound effect Advances in immunology have also made on the sciences and practice of human genetics, possible simple and sensitive diagnostic tests medicine, and public health. As it does, many for infectious agents, which are also much complex public policy issues are being raised, faster than cultures and other traditional meth- and many of them have constitutional aspects ods. One example is differentiation between and implications that will be explored in later chapters. streptococcal throat infection (which requires antibiotic treatment) and viral infection (for While genetic counseling has been done for which there is no specific treatment). Simple along time, it was practiced mainly on the ba- home tests have been developed for many sis of knowledge of the health and life experi- diseases. ence of parents and grandparents and statis- Vaccines, which stimulate protective anti- tical analysis of health records of the offspring body formation, were formerly prepared by of people with similar heredity. Several radi- modification of either viruses, intact bacterial cally new techniques are now being developed: cells, or toxins. With better understanding of the immune response and improved methods 9D;”amond }-. Chakrabarty, 477 U.S. 303 (1980). for purifying or synthesizing macromolecules, ‘(’United States Patent No. 4,736,866, Apr. 13, 1988. The meeting of ethicists and theologians was sponsored by the Na- it is possible to use specific components of the tional Council of Churches, the Humane Society, the Pres- pathogenic organisms, or synthesized protein byterian Church, t,he New Creation Institute, “and other sequences, to make much more effective and groups, ” as described by David E. Anderson, “Halt Urged on Patents of Engineered Animals, ” The ~rashington Post, Apr. non-toxic vaccines. This should be particularly 30, 1988, p. B8. Quotations are taken from that article. effective against viruses, which offer fewer 34 unique features for selective attack than do Human Body and Brain Enhancement bacteria. Gene therapy is aimed at curing well-defined The methods of molecular biology are also hereditary diseases. But bioengineering might being applied to studies of protozoal parasites. also theoretically be aimed at enhancing de- Some experts believe that prospects are bright sired traits or creating new traits or new phys- for vaccines for parasitic diseases, such as ma- ical or mental capabilities. This possibility has laria or trypanosomiasis, that are major causes often been raised in speculation and in fiction, of death in the Third World. Others are less with some scenarios going as far as the crea- optimistic, although tending to agree that such tion of superior and inferior classes of people. vaccines will ultimately be developed. The In fact, the technical possibilities for signif- problem is that some microbes—including icant enhancement through genetic engineer- some viruses and bacteria as well as protozoa ing appear limited. Genetic manipulation in hu- –have a capability of making reversible ge- mans is likely to be restricted for a long time netic changes that permit them to replace a at least to addition or replacement of a single surface antigen with various alternative anti- gene, and there are only a few known single gens that cannot be neutralized by the same genes with significant effects generally agreed antibodies. to be desirable. If one assumes that the traits society might be tempted to enhance would Targeting Cancer be intelligence (or more precisely, some aspect Animal cells, unlike bacteria, undergo dif- of intelligence), memory, strength, size, ath- ferentiation and organ formation, and these letic ability or some other specialized talent, processes involve intricate interactions with each involves a large and as yet undefined num- neighboring cells. Accordingly, the regulation ber of genes. Anyone attempting to manipu- of cell growth has been much more difficult late such traits would be facing a formidable to study in animals than in bacteria. It is the task. regulation of cell growth that is disrupted in For many years, however, neurobiologists cancer. have been studying conduction of electrical im- Recombinant DNA methodology has already pulses along nerve fibers and the chemical dispelled some of the mystery of cancer, by transmission of impulses from one cell to many tracing the origin of some cancers to altera- others. Specific functions in the brain have tions in the amount or structure of various been identified and localized in specific regions. genes called oncogenes. These gene changes It has been known for some time that some explain why viral infection, radiation, or muta- hormones, distributed throughout the body, genic chemicals as well as spontaneous muta- influence both physiology and behavior.11 tions might all cause cancer. Moreover, re- Now science is identifying a variety of neu- searchers are exploring the effects of these ropeptides, hormones that are released within genes on regulatory mechanisms and on the the brain and modulate functions such as blood cell surface. pressure and digestion. It is increasingly likely Molecular genetics has led to drugs that in- that neuropeptides will prove to be involved terfere with DNA replication and thus in a in controlling mood or emotions, although none limited way with cell growth, and potentially have yet been shown specifically to do so un- with cancer. Growing understanding of the bio- der physiological conditions. It is even possi- chemistry and immunology of cancer offers ble that a biochemical explanation may be promise of greater future advances in prevention or cure and unlike many other advances 1’U.S. Congress, Office of Technology Assessment, Impacts in medicine, they may decrease rather than in- of Neuroscience—Background Paper, OTA-BP-BA-24 (Spring- crease the costs of controlling cancer. field, VA: National Technical Information Service, March 1984). 35 found for violent, aggressive, or antisocial be- gence”14 might be differences among individ- haviors. Such knowledge could be expected to uals in certain proteins of their synapses; lead to medications or treatment for a range whether these proteins can ever be ‘enhanced” of conditions, such as emotional disorders; it is highly controversial at present. could also lead to less beneficial forms of be- Advances in neurobiology will almost cer- havior control or mind control. According to tainly have major impacts on the understand- Dr. James L. McGaw, director of the Center ing and treatment of various mental illnesses. for the Neurobiology of Learning and Mem- A better understanding of the role of biologi- ory at the University of California, Irvine, “The cal factors and the role of social factors could basic science of neuropeptides and neurotrans- eliminate unwarranted blame for mental illness mitters . . . is exploding at the present time. that has been attributed to the family envi- Dr. Herbert Weingartener, Chief of Cognitive ronment or to other aspects of society. Recent Studies at the National Institute of Mental indications that genetic factors may play a Health, added, “We’re sitting on a revolution 12 decisive role in some kinds of manic-depressive that rivals quantum physics in the 1920s." illness have focused attention on biological fac- A second line of research is also leading to tors in other mental illnesses. new theories and new knowledge about the The brain, with its hundred billion or more genetic basis of mental and behavioral traits— cells and a thousandfold greater number of con- the study of identical twins, including pairs nections, seems likely to provide a virtually that were separated at birth by adoption. A endless challenge for molecular scientists. series of studies at the University of Michi- Many people, however, may find that their dis- gan has been widely reported; this research en- coveries, or even their hypotheses and research, tails both biological and social science research are unsettling and disturbing. They bring into and may provide clues for further genetic re- question familiar assumptions about human search. nature, responsibility and freedom, and basic The molecular basis of memory is being equality among people. worked out in simple animals. In higher animals analysis of the paths and mechanisms of The Control of Aging communication between different regions within The branch of biology with the most recal- the brain is providing new insights into the citrant gaps between empirical description and ability of the brain to integrate information, molecular analysis is developmental biology, much like a computer but with complex branch- 13 or the study of how cells and organisms ma- ing rather than more linear connections. ture and age. Scientists still lack adequate There could be ways to enhance the function- knowledge of the mechanisms by which cells ing of these pathways and possibly the stor- in a developing embryo differentiate, move, age of information; already clinical tests of and relate to neighboring cells in an orderly such chemical aids are underway. way to yield a coherent set of organs. They do Individuals appear to differ widely in the understand or are beginning to understand speed of the search-and-find processes in their some of the key features: how genes are selec- brains that produce complex responses to an input of information. The molecular genetics of development suggests that one source of lqThe definition and the use of the term ‘‘intelligence’ is frought with difficulties, both technical/scientific and political. differences in this aspect of “general intelli- It is probably best, from both standpoints, to think of multiple kinds of “intelligences’ or mental capabilities, with people differing in performance across the range both individually, as com- ‘2Both are quoted in Michael Schrage, “Soon Drugs May pared with other individuals, and among and between groups Make Us Smarter, ” Washington Post, Feb. 3, 1985, p. Cl. or populations. Quite distinct from questions of definition or ‘]For a good journalistic account of this line of research, see measurement of intelligence or intelligences, is the mystery of George Johnson, “Memory: Learning How It Works, New York various forms of dyslexia, or defects in specific aspects of han- Times Magazine, Aug. 9, 1987, pp. 16-34ff. dling language. tively turned on or off, how concentration grain life span is a product of improvements in dients of chemicals released by cells influence prevention and treatment of infectious and neighboring cells, and how cells find and ad- other diseases, as well as in nutrition and sani- here to each other. They are still far from un- tation, rather than a product of specific inter- derstanding in detail how nerve fibers extend- ference with the aging process. If life were suffi- ing from specific cells in the brain connect with ciently prolonged, or aging and natural death other specific cells in other brain regions. It sufficiently delayed, then the birth rate might is generally anticipated, however, that ad- need to be lowered to avoid problems of over- vances along these lines will now proceed rap- population. A lowering of the birth rate might idly and the results will be translated into ma- come about either by a general consensus of jor medical advances in the years ahead. individuals, by public policy intervention, or by some natural adaptation. Such interference Despite the progress in cell biology, the basic does not seem to be in sight now, but if it comes mechanism of aging in higher organisms is not about it could radically alter the normal proc- understood—even in terms of whether the key ess of generations with major social conse- changes occur in genes, intracellular struc- quences. tures, membranes, blood vessels, the immune system, or all of these. The general increase —.

Chapter 4 Genetics and the Constitution CONTENTS

Page How Constitutional Issues May Arise...... 39 Genetic Engineering and People: Diagnosis and Therapy ...... 40 Gene Therapy...... + ...... +...... :.. 40 Genetic Control The New Biology and the Old Eugenics ...... 44 Prenatal Diagnosis ...... 45 Genetic Screening in the Workplace ...... 46 Biological Research: Should There Be ’’Forbidden Knowledge?’’ ...... 49 The Right To Do Research ...... 49 The Special Case of Bioengineering Field Releases ...... 52 The Use of Human Tissue or Cells ...... + ...... 54 Federal Guidelines on Funding of Research...... 55 Intersections Between Biology and the Constitution: Overview ...... 56 Chapter 4 Human Genetics and the Constitution

HOW CONSTITUTIONAL ISSUES MAY ARISE The previous chapter described rapid prog- powers of government more effective; or be- ress in biological science, and some of the uses cause they give individuals more power over to which the new knowledge maybe put. Un- their lives, and in so doing bring them into con- derstanding of the nature of living organisms, flict with each other or with values held by the and especially of human bodies and brains and community at large. behavior, directly affects how we act toward each other and toward the physical environ- When people are able to choose non-traditional means of using their environment, of ment. Thus the new biology may have not only reproducing themselves and designing their physical, economic, and social effects but also families, of maintaining the life or easing the political and legal implications. From these po- death of helpless family members, it is inevi- litical and legal implications, constitutional is- table that questions will be raised about sues may arise as governments: whether or not the State has a legitimate in- attempt to regulate new decisions that terest in these decisions and is obligated to act people must make, or new choices that to assure the general welfare or to enforce the people can enjoy; society’s ethical values. collect biological and genetic information Governments may assume an obligation to about people; collect biological or genetic data about people try to use biological knowledge or tech- in order to protect public health, to provide nologies to modify the behavior of indi- compensatory benefits or protections, to as- viduals or groups; sess the effectiveness of government programs act to remove or control risks that are or services, or for other legitimate purposes. newly disclosed by biological knowledge; Governments may step in to mediate the use or of biological data by third parties, such as em- respond to community demands to declare ployers or insurers. Governments may attempt some kinds of scientific knowledge un- to use biology-based techniques to modify in- desirable, for reasons of safety, ethics, or dividual or group behavior in the interest of other values. the individual-as in efforts to prevent drug These propositions assume that govern- use, smoking, alcoholism, or other high risk ments are acting responsibly, legitimately, in behaviors, or in the interest of the commu- the interests of the general welfare, and in ac- nity—for example, drug or hormone therapy cord with the wishes of a majority of the pop- to control violent aggressive behavior.2 As ulation. The constitutional issues are likely to we become potentially more effective in de- arise not because governments assume new tecting exposure to infectious diseases, vul- authoritarian powers as predicated in novels nerability to environmental or occupational such as 1984 or films such as Clockwork diseases, or special susceptibilities to other Orange, but because biology-based technical widespread hazards, in the absence of a tech- capabilities make the exercise of traditional nical “fix” the demands to use strong social

‘Much of the material in this chapter, not otherwise cited, ‘See U.S. Congress, Office of Technology Assessment, Crim”- draws on a report, “Constitutional Implications of the ‘New nal Justice, New Technology, and the Constitution, OTA-CIT- Biology ’,” prepared for OTA by Dr. Sheila Jasanoff of Cornell 366 (Washington, DC: U.S. Government Printing Office, March University’s Program on Science, Technology, and Society, April 1988), for a discussion of the potential use of such therapies 1987. in the criminal justice corrections system,

39 40 controls to reduce such risks will increase. Re- applications of the new biology. There maybe search itself is sometimes seen as imposing so- conflicts over the separation of powers, espe- cietally unacceptable risks, especially when it cially between the courts and the legislature. involves modifying natural life forms or life Attempts to regulate potentially hazardous re- processes. search or the dissemination of knowledge may raise fundamental First Amendment concerns. The collection or use of biological information about people is particularly fraught with This chapter discusses some of the direct ap- potential constitutional issues because of the plications of the “New Biology” that are likely likelihood that it will infringe on individual to raise constitutional problems. These are, autonomy or privacy, or will violate current first, some applications of genetic engineering standards of due process and equal protection to people: diagnosis of hereditary diseases, in- of the laws.3 But issues of constitutional cluding prenatal diagnosis, human gene ther- magnitude may also arise in connection with apy, and genetic screening in the workplace. governmental efforts to control risks presented Other implications of genetic engineering for by industrial, agricultural, or environmental people are discussed in later chapters on medicine and public health. Secondly, some broad questions involving current or proposed limi- Sprivate actions, such a9 those of corporations, wilI ordin~- tations on bioengineering research or techno- ily be insulated from direct constitutional challenge. logical applications are discussed.

GENETIC ENGINEERING AND PEOPLE: DIAGNOSIS AND THERAPY Gene Therapy that could be handed on to the patient’s future offspring. Human gene therapy refers to the deliberate change of genetic material within a human pa- Germ cell therapy, involving inheritable al- tient, with the intent of correcting a specific terations, is unlikely to be undertaken in hu- genetic defect.’ There are two possible kinds mans in the near future because it is techni- of human gene therapy, somatic cell therapy cally too difficult and too risky. The success and germ cell therapy. rate in animals has been low, and the danger of damage to other genes is high. Most medi- Somatic cell therapy will not cause inherited cal investigators probably consider the risk of or inheritable changes. It might be, for exam- this technique in humans too great for the fore- ple, a means of replacing the defective gene seeable future.5 Moreover, some genetic sci- in the bone marrow cells of a child affected by entists argue that germ cell therapy may not genetic immune deficiency. (These bone mar- prove superior to existing technologies. row cells produce blood cells.) If successful, this would “cure” the child, but would have no ef- Somatic cell therapy may become possible fect on his or her own future offspring; genetic in the near future. In June 1988, scientists an- immune deficiency could still be handed down. nounced that they had succeeded in correct- In contrast, germ cell therapy would not help ing, in animals, a serious genetic defect in liver cells, and described this as “an important first already mature people, but would involve in- 6 heritable alterations, that is, characteristics step toward a form of human gene therapy. “ ‘According to Dr. Bernard Davis, Professor Emeritus of Bac- ‘For further detail and elaboration see U.S. Congress, Office terial Physiology, Harvard University. of Technology Assessment, Human Gene Therapy—A Back- cAccording to Harold M. Schmeck, “Gene Technique Used ground Paper, OTA-BP-BA-32 (Washington, DC: U.S. Govern- To Correct Liver Defect, ” New York Times, June 16, 1988. The ment Printing Office, December 1984), from which this section research was to be described in the June Proceedings of the Na- is in part abstracted. tional Academy of Sciences. 41

In mid-July 1988, the NIH Biosafety Commit- with sperm there is still the difficulty that tee was scheduled to begin review of a proposed while only one sperm fertilizes an egg and thus experiment (within NIH) to attempt gene trans- transmits its characteristics, huge numbers of plants in patients enrolled in an experimental sperm are used in the attempt at fertilization, cancer treatment program.7 even with artificial insemination or in vitro fertilization. Gene therapy involving cells that Gene therapy (on either somatic or germ produce ova and sperm would require invasive cells) can take several forms. A new gene may techniques and presumably therapy on many be inserted into a cell; a gene already in a cell cells. Only one, or very few, ova would have may be altered; a defective gene may be re- to be modified. moved from a cell by surgery. Gene modification or gene surgery can now be performed in The practical advantage of somatic cell ther- some viruses, yeasts, and bacteria but not in apy as opposed to germ cell therapy is that humans or in other animals. Gene insertion is it could be performed on individuals at any now possible, although not yet considered stage of development rather than on an early ready to be put into practice in treating people. stage embryo. If necessary, repeated attempts could be made. The reliability of a gene trans- New material that is inserted would code for fer procedure would not have to be as high. (i.e., direct the production of) necessary pro- But somatic cell therapy might not be appli- teins, or would regulate production of particu- cable to disorders that affect multiple tissues lar proteins either to suppressor enhance their or organs, since the cells of each tissue or or- production. There are many possible ways of gan would have to be altered. It would not be inserting DNA or genes into cells: applicable to cells that do not divide, such as ● physically injecting the material into in- brain cells. Finally, it would not prevent the dividual cells, inheritance of the same defects by children of ● treating DNA chemically in such a way the successfully treated patient. that cells are induced to take it up, ● The first attempt to use gene therapy in hu- fusing the cells to membranes that con- mans occurred in 1970 and 1973 in the unsuc- tain the DNA, or ● cessful experiments of an American researcher, designing viruses that will carry the desired Dr. Stanfield Rogers, and a German colleague. DNA material and “infect” targeted cells But because these trials predated the estab- with it. lishment of institutional review boards, they At present, all of these methods are in early did not provoke much ethical debate.8 Re- stages of development. combinant DNA techniques were first used for prenatal detection of disease only in 1982.9 With germ cell therapy, gene insertion would Yet two years earlier, UCLA scientist Dr. Mar- be performed on the cells of an embryo within tin Cline used recombinant DNA techniques a few hours of fertilization. Therefore all cells 10 in treating human subjects. Cline’s patients of the embryo would be affected as they de- were two patients with thalassemia (inherited velop and differentiate into a fetus. It is theo- anemia) in Italy and Israel. retically also possible to insert new genes into sperm or ova, or into the cells that produce Dr. Cline had not gotten approval from them. With good techniques for in vitro fer- appropriate review committees in either the tilization, successful gene therapy on ova and United States or abroad. There was wide agree- sperm has come to seem more feasible. But 80TA, op. cit., footnote 4, pp. 44-45. ‘The gene to be translated is a marker gene, that would en- gThe first success was prenatal detection of sickle cell dis- able scientists to track the migration of special white blood cells ease: see J.C. Chang and Y. W. Kan, “A Sensitive New Prenatal introduced into the patient’s body to attack tumor cells. Mar- Test for Sickle-Cell Anemia, ” New England Journal of Medi- garet Chase, “Human Gene Transplants Closer to Reality as cine, vol. 307, 1982, pp. 30ff. Researchers Pursue Bid for for Experiment, ” Wall Street Jow-- “’Judy Arech et al., Law, Science and Meulcine (Mineola, NY: md, July 13, 1988. Foundation Press, 1984), pp. 168-169. 42 ment in the scientific community that the ex- signed by 56 religious leaders and 8 scientists periments were both premature and unethi- and ethicists was sent to Congress.14 It urged cal.11 The National Institutes of Health that “efforts to engineer specific genetic traits terminated two grants to Cline, who resigned into the germ line of the human species should his division chairmanship. The episode raised not be attempted. ” substantial questions about the enforceability Other objections to or concerns about hu- of existing guidelines governing research with man genetic engineering may apply to either human subjects. According to a 1984 OTA 15 somatic cell or germ cell therapy: study, the Cline experiments “may have cata- lyzed formation of a consensus that the time ● Scientific evidence that the treatments was not ripe” for germ line therapy .12 The will work to the patients’ benefit is not question whether such treatments should ever yet adequate. be attempted, and, if so, under what conditions, ● Precautions against deliberate misappli- awaits resolution through further public debate. cation may be inadequate. ● Gene therapy may be no more effective, There are professional, ethical, and religious economical, safe, or acceptable than alter- objections to human gene therapy, which may native treatments. or may not involve constitutional questions. ● The patients or their surrogate decision- The usual way that such debates are conducted makers may not be adequately informed is in political, ethical, and legal terms, formu- about the risks and benefits of the lated as proposed or alternative public policies. therapy. However, either side may and often does, as ● The effects may not be reversible or an ultimate resort, assert a constitutional right treatable. or a constitutional prohibition on behalf of its position. Increasingly, the Supreme Court has Objections to human gene therapy have fo- put reproductive choices under the umbrella cused particularly on germ cell therapy because of “privacy, that is, within the sphere of per- it affects future generations. By definition, fu- sonal autonomy in which government should ture generations cannot give consent to the not intrude without a compelling public inter- procedure, and there is a risk of propagating est. A brief look at the various positions taken unpredictable and possibly undesirable effects. in this and related controversies may there- These objections can be made to many other fore point to potential or emerging constitu- procedures, of course, that affect the likelihood tional issues. of future descendants and possibly their characteristics (e.g., medical support for diabetics In 1980, the U.S. Catholic Conference, the that now allows them to bear children). More Synagogue Council of America, and the Na- generally, some people point to the possibil- tional Council of Churches jointly sent to the ity of changing the genetic characteristics President of the United States a letter ex- of human populations or of diminishing the pressing concern that “prowess might surpass genetic diversity among human populations. prudence” in the application of genetic engi- These possibilities too are not specific to or neering to human subjects. The President’s limited to genetic engineering as compared to Commission for the Study of Ethical Problems other human activities, both individual and col- in Medicine and Biomedical and Behavioral& lective, that may affect offspring, including search issued a report, Splicing Life, in Novem- ber 1982. ’3 In June of 1983 a resolution Life, No. 83-600500 (Washington, DC: U.S. Government Print- 1’At the time the experiments were performed, Cline’s pro- ing Office, November 1982). tocol was pending app~ova.1 before the-UCLA review commit- l~ConWes9ion~ ~cord, June 10, 1983, S8202-8205; the reso- tee. Cline had prior approval from a review committee in Israel, lution was introduced by Senator Mark Hatfield. but for a protocol that was somewhat different from the one IsThis list, like much of the other material presented in this he actually used. chapter, was developed for and presented in Human Gene “OTA, op. cit., footnote 4, p. 46. Therapy–a Background Paper, already referenced, footnote 4. I:lpresident’s Commission for the Study of Ethical Problems The objections have in some cases been paraphrased or restated in Medicine and Biomedical and Behavioral Research, Sph”cing here. 43 many medical treatments. They are perhaps The third question is whether there is an im- raised more urgently because genetic engineer- plicit constitutional right to refuse treatment, ing represents a systematic, purposeful, and for oneself and for dependents unable to speak unprecedented intervention of a kind that has for themselves. This question is also discussed not been possible before. in chapter 6 on medical interventions, in relation to refusal of life support systems for those Some public apprehension about germ line who can not survive without them. It arises therapy centers on the speculation that such also in discussion of criminal justice, when interventions will gradually erode concepts of treatment becomes (now or potentially) an humanity and personhood, that specialized alternative to or complement to punishment people might be “designed” for certain pur- 18 for violent and aggressive behavior. No defin- poses (such as excelling at athletics, or soldier- itive answer can be given to the question; but ing), or that some faculties or traits such as intelligence or longevity could be enhanced the answer appears to be that there is evolving and still highly qualified recognition of an selectively, creating superior classes of people. explicit right to refuse treatment, within the Some also fear that an all-powerful state may use gene therapy to modify human behavior sphere of personal privacy. Nevertheless, the State also has an enforceable interest in the or engineer new breeds of humans, possibly l6 decision under some conditions. through cross-species transfer of genes. Mandated treatment of specific genetic dis- Constitutional principles are most directly orders as a precondition to receiving a mar- challenged by three general questions that in- 19 riage license has been suggested. This creasingly are raised with regard to potential would be by today’s standards a highly con- scientific and medical interventions. The first troversial policy, raising serious questions of is the question of whether there is a ‘‘right to due process and equal protection. But in this do experiments” or a “right to use scientific area, values and standards have changed over knowledge” embedded in the First Amend- time. Just as compulsory vaccination has been ment; this question is discussed in some de- consistently upheld by the Supreme Court as tail below. a legitimate State policy designed to prevent The second is whether there is a “right to the spread of communicable diseases,zo it treatment, ” where such treatment is life-sav- could be argued that mandatory gene therapy ing and technically available but is economi- would similarly prevent the vertical transmis- cally or otherwise a scarce resource. The exis- sion of disease from one generation to the next. tence of such a right is often advanced by Further legal precedents might be found in sev- ethicists or public interest advocates, but it eral cases in which courts ordered cesarean sec- has not been recognized legally or constitution- tions over the objections of the patient to pro- ally. 17 It is discussed further in chapter 6 on tect the life of the fetus, as discussed in chapter medical interventions, particularly with regard 6. These observations lead directly to consid- to treatments that are either very high cost, eration of eugenic policies in earlier periods of which limits access to them, or which are scarce American constitutional history. because only a few institutions or individuals are equipped to perform them.

l~sW the e~lier report in OTA’S Constitutional Bicentennial ‘%ee, for example, Ted Howard and Jeremy Rifkin, Who series, Crim”nal Justice, New Technologies, and the Constitu- ShouM Play God? (New York, NY: Dell, 1977). tion, op. cit., footnote 2. “Note, however, that Congress chose to make kidney dialy- ‘9Daniel J. Kevles, In the Name of Eugenics (Berkeley, CA: sis available to all for whom it is medically necessary; to many University of California Press, 1985). people this indicated implicit recognition of at least an ethical ao~acobson v. Massachusetts, 197 U.S. 11 (1905). This is dis- right to treatment. cussed in detail in ch. 5. 44

Genetic Control: The New Biology They were also directed at preventing repro- and the Old Eugenics duction by certain types of individuals, especially “mental defective,” and this objective After the writings of Francis Galton in also led to State laws and constitutional chal- 18652’ beliefs concerning the “superiority” of lenges. some racial types and the “unfitness’ of other racial and ethnic groups tragically flourished Two themes were especially prominent in the in both Europe and the United States. These thinking of the pre-World War II eugenicists. First, they claimed scientific support for their beliefs provided the justification for a variety 22 policies of selective propagation, relying in of State-sponsored eugenic policies whose aim was to discourage the multiplication of al- large part on quantitative studies of the “trans- legedly unfit individuals. The mass tragedies mission of traits” through successive genera- of genocide in Europe and legal and social dis- tions. Second, eugenic policies during the period of their greatest success were motivated crimination and persecution in the United to a significant extent by considerations of eco- States are far beyond the scope of this report. To look at only a few of the much narrower nomic efficiency. “Hereditary” criminality, eugenic policies or programs that were adopted pauperism and mental defectiveness, it was al- in the United States is sufficient to provide leged, were imposing heavy burdens on the tax- a framework for asking whether the new biol- payer. In describing the case of the notorious Jukes family of “social misfits, ” the American ogy could lead in its turntoa‘‘new eugenics, Eugenics Society noted that it would have cost raising serious constitutional issues. the State $150 to sterilize the original couple Eugenics doctrines in so far as they labeled and $25,000 to segregate one member for life; entire races and national or ethnic populations by comparison, the total cost to society im- as “inferior’ or ‘unfit implicitly contributed posed by the descendants of the couple was to Federal and State laws and policies that estimated as over $2 million.24 preserved racial segregation and restricted im- 23 Arguments such as these fueled eugenically migration in the late 19th and 20th centuries. inspired legislative and judicial decisions in a number of areas. Many of these laws have re- ZISir Frmcis G~ton, 1822-1911, a cousin of Charles Dmwin! mained in force and are generally, although not was a pioneer in the study of trait inheritance in humans. He did the first systematic studies of twins, and is regarded as the universally, accepted as sound legally and ethi- father of scientific eugenics. Among his books are Human Gen- cally. For example, by 1914, some 30 States ius, 1862, and Natural Inheritance, 1889. had marriage laws that either restricted mar- 22A word that means “pertaining to the production of good riages among the mentally unfit and venereally offspring. Eugenic policies are intended to discourage the multiplication of allegedly “unfit” or inferior individuals, to en- diseased or else declared such unions voida- courage the reproduction of healthy or fit or superior individ- ble.25 But starting in 1907, a number of uals, or to encourage high reproduction in some racial or ethnic groups and discourage or forbid the reproduction of others. They States enacted laws granting authority to the generally have ideological or political purposes but are almost State to sterilize certain classes of people: always defended or justified on some scientific grounds, how- habitual criminals, idiots, or the insane. A chal- ever selective or distorted the presentation of the associated lenge to the Virginia sterilization statute was data and/or theory may be. 23 The stren@ of eugenics doctrines was reflected in ‘r- carried to the U.S. Supreme Court in 1927 as emigration laws beginning with the Exclusion Act of 1882, which Buck v. Bell.26 This case will be discussed at restricted Chinese immigration, and continuing in laws of 1891, 1903, and 1907, which excluded those with certain diseases, greater length in later chapters. Here it is suffi- criminal records, and radical political beliefs. Economic motives cient to note that, swayed by the scientific and were also important, i.e., the opposition of organized labor. The public welfare arguments advanced on behalf driving forces in the laws of 1921 and 1924, excluding orientals and setting quotas by country of origin, were “frankly racial”; the quota system was re-enacted by the McCarran Walter Act of 1952 and only gradually voided after 1965. See Rowland Ber- 24 Daniel J. Kevles, In the Name of Eugenics (Berkeley, CA: thoff, “United States: The People—Population Origins, ” in the University of California Press, 1985), p. 93. Encyclopedia Americana, International Edition, 1986, vol. 27, 251 bid., p. 99. pp. 529-31, 26274 U.S. 200 (1927). 45 of the State, the Court upheld a sterilization The mere fact that such choices are currently order against a 17-year-old retarded woman, left to the discretion of individual couples and with Justice Oliver Wendell Holmes comment- their physicians does not entirely rule out the ing, “Three generations of imbeciles are enough.” possibility of future State intervention, or at least of renewed proposals for State interven- The history of sterilization laws since Buck tion. The discovery of genetic bases for a wide v. Bell has been mixed. In 1942 the U.S. Su- preme Court invalidated a State sterilization variety of illnesses and disorders, both physi- 27 cal and mental, promises to put the study of statute on Equal Protection grounds. How- heredity on a more secure scientific footing ever, in 1976 the Supreme Court of North Caro- than was available to the earlier generation of lina declared a roughly similar statute constitu- eugenicists. The theme of social costs of genetic tional in view of the procedural protections disorders and mental retardation is implicitly afforded to the petitioner. The court noted that the people of North Carolina “have a right to woven into estimates of the frequency of prevent the procreation of children who will genetic illnesses. become a burden on the State. ”28 In the In a much more general sense, research find- 1970s, with much attention focused on the po- ings about genetic and biochemical factors in tential problems of overpopulation and deple- mental performance, ability, aptitudes, or tion of resources, there were some other indi- health often appear to arouse concerns about cations of a revival of earlier eugenic themes. “equality,” “equity,” and “equal opportu- One well-known geneticist29 wrote: nity.” Research on improved methods of measuring such mental attributes also arouse such Thus, in an overpopulated world it can no longer be affirmed that the right of the man concerns, and “intelligence testing” has some- and woman to reproduce as they see fit is in- how come to be taken as a code word for anti- violate. . . . The right that must become para- democratic beliefs. In some cases, this is mount is not the right to procreate but rather merely an exercise in anti-intellectualism, but the right of every child to be born with a sound in other cases it reflects a well-grounded con- physical and mental constitution, based on a cern that scientific information about inher- sound genotype. ent differences among people may easily be dis- Recent emphasis on the constitutional right torted into justification of policies that of individuals to make decisions about repro- establish or preserve different standards of duction without governmental regulation have rights and liberties, and different classes of framed the issue differently; they have focused citizenship. on the right of individuals not to bear children rather than the right to bear children, and thus Prenatal Diagnosis have tended to throw into shadow the older issue of whether government can act to dis- Prenatal diagnosis of genetic or hereditary courage or prevent childbearing. Genetic screen- diseases is already a major application of ing and counseling are seen as mechanisms for molecular genetics. For prenatal diagnosis, fe- enhancing the reproductive options available tal cells are used that are cultured from the to “at risk” couples, particularly in the after- amniotic fluid, or from a biopsy of the placenta math of the liberalization of abortion in Roe even earlier in pregnancy. Such diagnosis is v. Wade. particularly often used with an older mother because of the increased probability that her 2’Skinner v. Oklahoma, 316 U.S. 535 (1942). fetus will have an extra chromosome 21, which 2’in re Moore, 289 N.C. 95 (1976). ‘gBentley Glass, former president of the American Institute causes Down’s syndrome. A procedure called of Biological Science, as quoted by Frederick Ausubel, Jon Beck- chorionic villius sampling is used in fetal with, and Kaaren Janssen, “Stimulus/Response: The Politics assessment to detect chromosomal disorders of Genetic Engineering, “ Psychology Today, June 1975, p. 34. The authors of the Psychology Today article were themselves such as Down’s syndrome as early as 9 weeks then biological scientists on the faculty of Harvard University. into pregnancy. The risks in such procedures 46 to a child subsequently born alive are believed cently disclosed a high rate of success in sex to be small, but are not well known.30 selection through a technique of sperm separation by centrifuge, which depends on differ- When both parents carry a particular single- ences in the DNA content of sperm bearing gene recessive defect, one-fourth of the em- an X chromosome, which produce females, and bryos, on average, will have two copies of that those bearing a Y chromosome, which result defective gene and hence will manifest the dis- 32 in males. ease if they live long enough. More than 2,000 such single-gene diseases are now known, and Attempts to delegalize abortion through con- as many as 2 percent of newborns have a ge- stitutional amendment, or by persuading the netic disease.31 Some genetic diseases do not Supreme Court to reconsider its position that manifest themselves until after child-bearing abortion falls within the protected zone of pri- age. Although most hereditary diseases are vate decisionmaking, will run counter to the rare, some are not. The sickle cell gene is car- societal effects of increasing capability in ried by about 10 percent of American Blacks prenatal diagnosis of hereditary disease. The and the cystic fibrosis gene by about 5 percent desire to exercise a choice is the primary moti- of Caucasians. vation for using the technique; and while use Several hundred of these diseases can now of the technique could in theory be prohibited, it has always proved difficult to enforce probe diagnosed prenatally, some by tests for the hibition of the generation of knowledge that gene product and others by examination of the is strongly desired and readily produced. DNA. It is likely that eventually scientists will be able to diagnose prenatally most single-gene diseases. This knowledge inevitably raises the Genetic Screening in the Workplace question of terminating such pregnancies, forc- Genetic screening may potentially be used ing people to make decisions wherein the past to detect specific hereditable diseases, or a there was no early warning and thus no occa- genetic susceptibility to certain diseases that sion for choice. are not directly inherited, or special vulnera- Some hereditary diseases can be avoided by bilities to environmental risks. sex selection. Because the sex of a fetus can Scientists are now identifying genes that be determined from the amniotic fluid early have no obvious direct effects on health, yet in pregnancy it is technically possible to “se- are statistically associated with future health lect” the sex of a desired child by aborting outcomes or with life expectancy. In some when the fetus is of the other sex; this has led cases these may turn out to be “markers” or some to fear that the natural balance between “indicators’ only vocationally associated with males and females could be upset where there other genes that produce disease, with no dis- are strong cultural preferences for one sex. But ease-causing characteristics themselves. sex selection sometimes has a medical rather than a cultural objective, since some heredi- Other traits may be governed by genes that tary diseases are gender-linked. For example, are not always expressed. For example, a spe- the common form of hemophilia is manifested cific gene appears to indicate a propensity for overwhelmingly in males, compared to females. Alzheimer’s disease, rather than a direct inheritance of it; not all those with the gene show New techniques are likely to provide other the disease. A genetic defect governing lipid means of sex selection. Japanese scientists re-

30Jain Chalmers, director of Britain’s perinatal epidemiologi- s~he d~tors reporting the technique say that in their clinics cal unit at Radcliffe Infirmary, Great Britain, and Thomas C. the technique is used only to produce females for couples with Chalmers, M. D., Boston Veterans Administration Medical Cen- a family history indicating the likelihood of a sex-linked heredi- ter, in a letter to the editor of The iVew York Times published tary disease. The method is now being tried in several U.S. Oct. 8, 1987. clinics, according to newspaper accounts. See Walter Sullivan, 3’V.A. McKusic, Mendelian Inheritance in Man, 6th ed. (Bal- “New Way Devised To Pick Child’s Sex, New York ~“mes, Sept. timore, MD: The Johns Hopkins University Press, 1983). 23, 1987, Sec. A. 4/ metabolism seems to predispose the bearer to health benefits by reducing the incidence of early coronary thrombosis. Understanding of genetic illnesses. It should be emphasized here the complex immune system may in the future that predisposition is a statistical statement reveal much about resistance to various infec- and is not a prediction that any one individual tious diseases, or susceptibility to degenera- will develop a disease. tive diseases ranging from ulcerative colitis to The possibility of screening for environ- diabetes, which are now recognized as having 33 mental susceptibilities at present is very an auto-immune component. Molecular biol- limited, since so far there have been identified ogy may play a large role in advancing the only a few known genetic defects in the abil- understanding of infectious agents, as it did ity to detoxify certain chemicals. Only 2 to 6 in identifying and characterizing the lethal of these have high enough effects to serve as human immunodeficiency virus that causes reliable guides; all are rare.35 However, more AIDS. may be identified in the future. When and if Tests are being developed for genetic pat- such screening becomes more reliable, it could terns that expose one to special risk from an find widespread use in at least some industries environmental factor, or higher-than-usual sen- where mutagens or other toxic substances in sitivity to toxic factors in the environment.34 the workplace remain a problem. For example, some people have a variant form Screening for general disease potential as op- of a single gene that results in a deficiency in posed to specific genetic illness may also re- an enzyme called glucose-6-phosphate dehy- main of limited use for some time. Even when drogenase (G-6-PD). Should these people chance some genes are statistically correlated with in- to take drugs for malaria, or eat fava beans, creased susceptibility to certain diseases, small the lack of the G-6-PD enzyme may cause the differences in susceptibility or resistance to destruction of their red blood cells, resulting environmental factors within the normal range in an acute anemia. Some scientists expect that are not likely to be useful in terms of screen- they may also suffer this response if they are ing for employment or insurance purposes. exposed to chemicals that are similar to the antimalarial drugs. They could meet this ex- Genetic testing in the workplace, for special posure in the workplace; EPA lists more than susceptibility to environmental or occupational 55,000 different chemicals used in production hazards, is still in its infancy; it has been often in this country. Genetic screening or testing discussed but is apparently little used at could, in theory, warn such people and their present.36 employers that they would be at special risk The difficulty is that what may be seen as in certain work assignments or workplaces. a benefit and protection for a worker may also It is these emerging capabilities that raise be seen by some workers as unfairly depriv- the controversial possibility of employers ing them of livelihood or job opportunities, or screening employees or job applicants for ge- as usurping their individual prerogative to netic traits. They might do so either to reduce make decisions about what risks they will as- occupational illness (and liability) by avoiding sume. This point would become even more po- the use of workers with high susceptibility to toxins or other environmental hazards in the ssEdith F. Canter, “Employment Discrimination Implica- workplace, or to reduce the cost of employee tions of Genetic Screening in the Workplace Under Title VIII and the Rehabilitation Act, ” Amen”can Journal of Law and Me& cine, vol. 10, 1983, p. 5, speaks of at least five valid genetic screen- s~That is, abnorm~ production of antibodies, or the Produc- ing procedures. Dr. Bernard Davis, professor emeritus of tion of cells that attack a normal tissue as though it were a for- microbial genetics at Harvard University, vouches for only two. eign material. WA 1982 survey by OTA found that although only 6 out of 34u .s .conge55, office of Technology ASSeSSrnent, ~~e ~O~e 366 companies were then using such techniques, another 55 of Genetic Testing in the Prevention of Occupational Disease, stated that they might do so within the next 5 years (OTA, op. OTA-BA-194 (Washington, DC: U.S. Government Printing Of- cit., footnote 34, p. 5.) Little is known about whether the inci- fice, April 1983). dence of genetic screening has increased in the last 5 years. 48 litically and ethically sensitive if the genetic Although that case involved a Federal em- pattern in question is peculiarly associated ployer, genetic testing would be for the most with an ethnic, racial, or gender group already part an instrument used by private companies. subject to social and occupational discrimi- Accordingly, legal objections to such policies nation. could be made, if at all, only under the two major anti-discriminatory statutes directed The employer has a legal responsibility to protect workers from known occupational haz- against private employers, the Civil Rights Act 37 of 1964 and the Rehabilitation Act of 1973, ards. This would not, at present, require the rather than directly under the Constitution. employer to use genetic screening even if Such civil rights legislation may indicate con- highly reliable tests for a particular suscepti- gressional interpretation of the intent and goal bility were available; but if the employer chose of basic constitutional principles, and the aim to use such tests and then assigned suscepti- of extending to the private sector the restraints ble workers to a high-risk environment, the em- which the Constitution itself imposes on gov- ployer would probably be found negligent. Un- ernment. less the worker had been informed of the risk and refused re-assignment, he or she would Title VII of the Civil Rights Act prohibits probably be covered by workers’ compensation overt discrimination based on racial, ethnic, laws, and the employer could face punitive and gender categories except where the em- damages. These are statutory protections, ployer can show that disparate treatment is rather than constitutional principles, which correlated with a “bona fide occupational qual- would not apply against private sector em- ification. ” Some genetic traits associated with ployers. hypersusceptibility to disease (at a high enough prevalence to be of interest to em- Commonly used genetic screening tests in- ployers) may be associated with particular eth- clude those for detecting glucose-6-phosphate nic or racial groups, but most are not, so that dehydrogenase (G-6-PD) deficiency and sickle overt discrimination against such classes cell trait. Experts differ as to their reliability. 39 would be difficult to demonstrate. The Re- In 1985 the U.S. Air Force Academy decided habilitation Act applies only to employers re- not to admit any candidates who exhibited the 38 ceiving Federal assistance, but it protects all sickle cell trait, because this condition could cause an oxygen deficiency in the blood at high “qualified handicapped individuals, ” which altitudes, which in turn could cause fainting could be argued to apply to workers excluded from jobs as a result of genetic screening. The while piloting a plane. The sickle cell trait af- Act defines a “handicapped individual” as any fects Blacks, and is found in about 10 percent person who “has a physical or mental impair- of Black Americans. The Academy eventually ment which substantially limits one or more abandoned their policy under the threat of of such person’s major life activities”; to bring lawsuits based on the charge that the policy genetic traits within the definition of impair- discriminated against Blacks. The scientific va- ment would require a broader reading, since lidity of the Academy’s presumptions was chal- such traits are harmful only after exposure to lenged, but both the objections to and the with- hazardous workplace conditions. drawal of the decision were based on legal and political considerations rather than on the The recent Supreme Court decision in School question of scientific validation of the pre- Board of Nassau County v. Arline40 illus- sumption about occupational risk based on trates such an expansive reading. The case in- genetic information. volved a claim for job reinstatement by a school teacher suffering from tuberculosis. The

qgc~tir, op. cit., footno~ 35, pp. 328-336; OTA+ oP. cit., foot- sTFor more det~led analysis of the legal and ethical points note 34, pp. 123-126. involved, see ibid., pp. 111-151. doschoo] Bo~d of Nassau County v. Arline, 55 U. S.L.W. op. cit., 278 qSKevle~, footnote 19! p“ ” 4245 (Mar. 3, 1987). 49 decision confirmed that a contagious disease Congress might apply different standards to could be regarded as a handicap within the equal employment opportunities for geneti- meaning of the statute and that a handicap cally limited or susceptible private sector em- may include not merely an actual impairment, ployees, if it has to deal with the issue directly. but also a social perception of the impairment At best, in providing for legal challenges to that substantially limits a person’s major life employment discrimination, both Acts make activities. The decision seemed to indicate that it possible for courts to scrutinize the genetic a potentially strict standard for evaluation screening methods and rationale. They may would be placed on job exclusions based on thus provide some protection against the use genetic traits, and suggested that courts will of frivolous or invalidated scientific tech- look very carefully at job restrictions imposed niques to promote undesirable social ends.41 solely because of a risk of future disability. In summary, neither Congress or the Court has as yet made definitive statements about the The protections afforded by the Rehabilita- constitutional status of genetic testing; but tion Act and Title VII are suggestive but not they will almost surely be challenged to do so conclusive as far as concerns raised by large- at some future time. scale genetic testing in the workplace. Neither of these Acts appears to apply directly to the case at hand. The Courts might apply differ- ‘iSee, for example, Thomas Murray, “The Perils of Prechc- ent standards to government as an employer. tion, ” Genetic Engineering iVews, Januar~’ 1985, pp. 6-7.

BIOLOGICAL RESEARCH: SHOULD THERE BE “FORBIDDEN KNOWLEDGE”? The Right To Do Research that scientific theories may threaten to erode cherished values and undermine traditional in- The new biology has provoked demands that stitutions. some areas of research be made “off limits, ” or at a minimum, heavily regulated. One source These perceptions lead some people, includ- of these demands is the perception that cer- ing some scientists, to argue that those areas tain aspects of bioengineering pose grave risks of research should not be pursued further. A to human safety or to the natural environment. few kinds of knowledge, they say, should be Another source is the perception that in alter- forbidden. Or people may see the methods nec- ing inheritable human characteristics, and in essary to gain scientific knowledge as ethically certain other potential activities such as in- unacceptable. Other people, equally thought- terspecies gene transfer, we are violating nat- ful and concerned, argue that all knowledge ural or divine laws or fundamental ethical prin- is valuable, and that scientific freedom is con- ciples. Neither of these concerns is necessarily stitutionally protected. Both in this century unique to biological science and technology, and in the 19th century, research has been however. conducted—especially experiments on human subjects without their informed consent—that Advanced technology provides great bene- would now be considered unethical and would fits, but often also carries risks to people and not be undertaken or allowed by most Amer- to their environment. Some people, at times, ican research institutions. see technology as out of control, and society as failing to act to prevent possibly disastrous Examples of such controversies occurred in side effects. As modern science pushes ever the 1950s about atomic energy, in 1974 around closer to questions about the origin of the uni- recombinant DNA research; and in the mid- verse, the nature of life, and the determinants 1980s around the experimental release of engi- of human behavior, some people are concerned neered organisms into the environment. A sim- 50 ilar controversy surrounds fetal research. Atomic Energy Act has been generally as- There are demands that some or all experimen- sumed and has not been challenged before the tation on animals be forbidden. These are only Court. Scientific institutions, and the public a few of many recent examples of disputes over in general, appear to have shared the judgment the existence of a right to choose freely among of Congress that the awesome power of nuclear topics for research, to choose methods of car- technology and the risks that it entails justify rying out research, or to communicate the overriding any constitutional protection en- results. 42 joyed by scientific research. This section is not concerned with either pub In July 1974, leading American scientists lic policy issues or ethical issues, per se, but called for a temporary worldwide moratorium only with the question of whether there is a on research on recombinant DNA, because of constitutional challenge inherent in such is- the uncertain risks involved in the possibility sues. Specifically, this section of the chapter of escape from the laboratory. Scientists is concerned with the question of whether there throughout the world voluntarily observed the is a constitutional guarantee of “the right to artificial moratorium. At an international con- conduct research, ” and if so, the scope and ference at Asilomar, California, in February limits of that right. 1975, a consensus was reached among scientists that certain types of research should be The Atomic Energy Act of 1946 placed vast prohibited because of potential hazards, and areas of research off limits to non-govern- other types of research should be subjected to mental researchers and required licensing and stringent, safety precautions. The National regulation of research using radioactive ma- Institutes of Health (the principle source of terials. The great mathematicion, John von funding for recombinant DNA research) later Neumann, told the Congress: promulgated guidelines that incorporated the It is for the first time that science has pro- Asilomar agreement, which would be binding duced results which require an immediate in- on research institutions accepting Federal tervention of the government. . . . A vast area funding. These do not forbid any research or of research impinges on . . . the vital zone of research techniques, but they had almost that society and clearly requires rapid and general effect at an early stage of the research since regulation. most of the laboratories depended on govern- As discussed in an earlier OTA report, Sci- mental funding. ence, Technology, and the First Amendment Again in this decade research on reproduc- (January 1988), when the dictates of national tive techniques and on bioengineering have im- security appear to conflict with individual pinged on sensitive areas and aroused the cry rights of free speech and free press guaranteed of “forbidden knowledge. ” It can be confi- under the First Amendment, the Supreme dently expected that new discoveries, because Court has consistently said that there must of the secrets they promise to reveal, and be a “balancing of interests. ” First Amend- emerging technologies, because of the risks ment rights, although strongly protected, are they appear to entail, will in the future also not absolute. The constitutionality of the re- bring about such debates. straints on research that are included in the The claim of constitutional protection for 42A generation earlier, atomic energy research was protested research rests on the thesis that the First on ethical grounds, and it was later prohibited for non-governmental scientists, although in the interest of national security. Amendment guarantee of freedom of speech Still earlier, research on birth control was protested. Many people necessarily also protects some kinds of action. have grave ethical or religious objections to research on bio- To exercise one’s right to speak, one must also logical and chemical weapons, or on any weapons. Some people object only to some potential applications of basic research, be free to think, formulate concepts and hy- others argue that no effective separation can be kept between potheses, perform calculations, and if one is basic knowledge and undesirable applications. dealing with scientific ideas, to plan and carry 51 out experiments.43 In this respect, the reason- of evolution, relied on the First Amendment ing that research is protected is analogous to prohibition against establishment of religion the rationale for the protection given to the rather than directly on the protection of sci- press in newsgathering. It says that the right ence. In subsequent cases in 1975, 1982, and to gather information (from willing sources) 1987, also dealing with the teaching of evolu- is necessary and integral to the right to pub- tion and “creation science, lower courts have lish or disseminate information. Since the press followed this lead. They struck down state stat- does not however have any greater right to utes that fostered “an excessive entanglement gather information than have any other per- with religion, but did not explicitly base their sons, presumably by the same analogy, scien- decisions on constitutional protection of tists have no right to conduct activities that science. can be forbidden to non-scientists. The Supreme Court has ruled that the First The Court has in some situations distin- Amendment “protects works, which taken as guished between “pure speech, ” and action a whole, have serious literary, artistic, politi- (which might include research), and has said cal, or scientific value” even when, by some that restrictions on the latter are more easily community values, those works might be con- justified. The Court will still take into account sidered obscene. An Indiana obscenity law whether the action, or activity, is essential to when applied to research materials at the Kin- generating and communicating information.44 sey Sex Institute at the University of Indiana The physical activity of research is however was invalidated46 because “the state has un- probably more likely to involve State interests constitutionally intruded itself into . . . pro- that justify regulation, such as public health tected activity . . . the right of scholars to do and safety, than is pure scientific communi- research and advance the state of man’s knowl- cation and publication. edge. ” Most obscenity cases, however, have been concerned with literary rather than sci- Some constitutional scholars make the claim entific works. that science has a specially protected status under the Constitution, and in particular un- In several cases academic social scientists der the First Amendment.45 The prohibition have claimed the privilege of withholding their on governmental establishment of religion, sources of information from juries or courts, according to this argument, was motivated in to protect future research opportunities. The part by the strong intent to prevent religion varying outcomes of these cases suggest, but from interfering with science; the Framers of do not definitely establish, a First Amendment the Constitution were steeped in the Enlight- right to do research.47 In one such case, a enment accounts of religious opposition to Federal court said, Galileo and to Newton. Society has a profound interest in the re- There have been few judicial decisions that search of its scholars, work which has the unique potential to facilitate change through have directly addressed the implications of the 48 First Amendment for the constitutional sta- knowledge. tus of science. A 1961 Supreme Court case, in- None of these decisions appear to establish validating a state prohibition on the teaching definitively that there is a First Amendment right to conduct research, or that there is a “JFor a detailed exegesis of this argument, see John A. constitutional prohibition on government re- Robertson, “The Scientist’s Right To Research: A Constitu- striction or regulation of it. The prevailing con- tional Analysis, ” Southern California Law Review, vol. 51, No. clusion is that scientific activity has general 6, September 1978. “Ibid., citing Saxbe v. Washington Post CO.*, 417 U.S. ato9<58. ‘hHenleuv v. W’ise, 303 F. Supp.62 (N. D.Ind. 1969). “)Steven Goldberg, “The Constitutional Status of American “Robertson, op. cit.. footnote 43, pp. 1240-42. Science, ” Universit~ of I])inois Law Forum, vol. 1979, No.1, ‘“Richards of Rock ford, Inc. v. Pacific Gas & Electric Co., 1979, pp. l-6ff. vol. 71 F.R. D. 388 (N. D. Cal. 1976), at 390. 52

First Amendment protection, but may be lim- The White House Office of Science and Tech- ited or regulated where there is a clear State nology Policy issued, in June 1986, a “Coordi- interest that outweighs individual rights. nated Framework for the Regulation of Biotech- nology, ” specifying the agencies responsible A separate argument is that the right to con- for approving commercial technology products duct research is protected under the Four- and regulating field tests and planned releases teenth Amendment provision that says that of engineered organisms into the open envi- no State shall 50 ronment. . . . deprive any person of life, liberty, or property, without due process of law. Controversy over their controlled release beyond the laboratory raised public policy issues In the early 1920s, the Supreme Court said that involving acceptable levels of risk and regula- this clause tory responsibility.” Some scientists, espe- . . . denotes not merely freedom from bodily re- cially ecologists, believe that there are signifi- straint but also the right . . . to contract, to cant risks of ecological disasters on a local and engage in any of the common occupations of regional basis that argue for a very strict mon- life, to acquire useful knowledge . . . and gen- itoring and regulating of such experiments for erally to enjoy those privileges long recognized a long time to come. Some scientists and pub- at common law as essential to the orderly pur- lic interest advocates have strenuously ob- suit of happiness by free men.49 jected to any release of engineered organ- 52 But the Court has been reluctant to extend this isms. The Foundation on Economic Trends, argument to activities other than intimate per- an interest group led by Jeremy Rifkin, has sonal and family decisionmaking, and has several times challenged in court both plans never applied it to experimentation. for field experiments and the White House Co- ordinated Framework for their regulation.53 The Special Case of Bioengineering The court cases have focused on public pol- Field Releases icy issues of levels of risk, and not on constitutional issues, except in so far as a public inter- Just over 10 years after recombinant DNA est group was found to lack constitutional research began on a major scale, it reached a stage at which field research beyond the laboratory was desirable and practical. This re- ~~These include the Food and Drug Administration, vmious quired the deliberate introduction of engi- components of the Department of Agriculture, and the Envi- neered organisms into the open environment. ronmental Protection Agency. 51 Fed.Reg. 23339. 51u .s .Con=ess, Office of Technology Assessment, New ~e- The first major experiment of this kind in- velopments in Biotechnology-Field-Testing Engineered Organ- volved bacteria that displace other micro- isms: Genetic and Ecolo~”cal Issues, OTA-BA-350 (Washing- organisms which promote frost damage by ton DC: U.S. Government Printing Office, May 1988). 5zAn OTA background paper, public Perceptions of Biotech- nucleating ice on the leaves of crop plants. nology (OTA-BP-BA-45, May 1987) based on a national public Candidates for further tests are engineered opinion survey by Louis Harris & Associates, indicated that bacteria that act as pesticides, fix nitrogen in 52 percent of Americans believe that genetically engineered products are at least somewhat likely to present a serious danger plants, emulsify spilled oil or oil residues, de- to people or the environment, but 66 percent think that overall, stroy toxic wastes, concentrate valuable min- genetic engineering will make life better, and a majority will erals from dilute sources, and recently, organ- accept relatively high levels of risks to gain the potential benefits. Also 55 percent would approve the environmental release isms designed to fight Dutch Elm disease, of an organisms that would significantly increase farm produc- when injected into trees infected with the tion, even if there was a small (one in a thousand) risk of losing fungus that causes the disease. Even at this a local species of plants or fish. But only 1 in 5 of those sur- veyed reported that they had heard about potential dangers early stage, there are a long list of potentially of genetic engineering and only 12 percent could describe a po- beneficial engineered organisms being devel- tential risk or problem. Sqwilliam G. Schiffbaner, oped for testing. “Regulating Genetically Engi- neered Microbial Products Under TSCA, Environmental Law “Meyer v. Nebraska, 262 U.S. 390 (1923). Reporter, News and Analysis, vol. 15 (1985), pp. 10279-10288. 53

standing to sue. 54 However, they reflected a Some ecologists urge that the risks may in- tension between Federal authority based on deed be most likely when a modified organism the Commerce Clause and State police power.55 is returned to its own natural environment, rather than anew one, because it is more likely Opponents of field experimentation have two to persist and because food chains or predator- major concerns: whether genetic transfers be- prey relationships may be subtly disturbed by tween species are inherently hazardous because 57 the modification. they may inadvertently create new or more virulent pathogens, and whether the wide- These factors indicate that risk of signifi- spread introduction of modified or novel organ- cantly detrimental impacts from a planned re- isms could cause major ecological disruptions. lease of bioengineered life forms is small, but A National Academy of Sciences Committee cannot be entirely dismissed. At a minimum, on the Introduction of Genetically Engineered there are the same risks of environmental dis- Organisms into the Environment concluded ruption that are attendant on any introduc- that there is no evidence of unique hazards in tion of a new species or a modified species; the transfer of genes between unrelated organ- these risks depend on the nature of the organisms, and the risks associated with the intro- ism and the nature of the environment, and duction of such life forms are much the same not on the way in which the organism was as those associated with any introduction of changed. unmodified organisms into a new envi- 56 This is both a technical issue and a public ronment. policy issue, and like many public policy issues, The report, read carefully, was stronger than it can also be articulated as a constitutional these conservative conclusions suggest. A issue. In this case, those who protested the re- number of facts should be kept in mind. Modi- search on the grounds that it was inherently fied organisms, whether genetically engineered hazardous were not raising a constitutional is- or changed by traditional breeding practices, sue; soon afterward, however, another scien- are generally not as fit for survival in the wild tist was forced to stop testing the use of engi- as natural progenitors and tend to be at a com- neered organisms because he had not gotten petitive disadvantage for survival and propa- governmental approval. In that case, the gation. Pathogenicity usually depends on a underlying constitutional issue of a “right to large number of traits existing together, and do research” could be raised. the possibility of a narrow genetic change in- Federal preemption in environmental regu- advertently converting a nonpathogen to a lation is well established, although Federal pathogen is remote. An engineered organism statutes reflect some continued deference to will most likely have been modified in only one the traditional police power of the States. There regard and will behave otherwise like the par- are numerous statutory provisions that allow ent strain; other associated and unintentional State governments to assume enforcement changes are likely to be detrimental to the obligations under Federal regulatory schemes organism. The transfer of genetic material to and in many cases to set standards stricter new species rarely leads to its persistence in than those adopted by Federal agencies. Some a population unless strong selection criteria statutes explicitly provide that Federal law are applied. does not preempt State common law provisions relating to compensation and liability.58 ‘)’In December 1986, the Federal Court for the District of Co lumbia dismissed two suits filed by Rifkin. For an account, see Mark Crawford, “Court Rejects Rifkin in Biotech Cases, ” Sci- ence, vol. 235 ( 1987), p. 159. “]fSee, for example, William G. Schiffbaner, op. cit., footnote ‘TBased on extended discussions in sessions on Release of 53, pp. 10279-10288. Engineered Organisms at the annual meeting of the :4 merican “f’The Committee’s report is entitled Introduction of Recom- Association for the Advancement of Science, Boston, N1 4. Feb. binant DNA -Engq”neered Ch-ganisrns Into the Environment: Key 13, 1988. Issues (JVashington, DC: National Academy Press, 1987). ‘hOccupational Safety and Health Act, Sec. 4(b)(4). 54

The issue of “deliberate field release” has role of “lay” courts in such “scientific” con- somewhat overshadowed the 1970s issue of the troversies. risk of accidental release, but this may not last. Some people have in the past strongly ad- In September 1987, virologist at the National vocated the notion of a specialized Science Institutes of Health (NIH) began to introduce Court to evaluate technical arguments. This the genetic code of the AIDS virus into mouse proposal, however, has apparently dropped out embryos, in order to develop an animal model 61 of active discussion in recent years. In the of the latency phase of the disease in humans. carefully designed system of checks and bal- They then became the target of a lawsuit by ances created by the Constitution, groups that the Foundation on Economic Trends, the pub- raise substantial objections to Federal policies lic interest group that had led the fight against related to science and technology are, like other field releases. In this case, no intentional re- interest groups, entitled to a hearing when lease by NIH is contemplated; but the public those objections are based on reasonable con- interest group says that the mice used in the cerns, interests, and values. experiment might escape, and by breeding with wild mice, create an animal reservoir for the disease. The lawsuit asks that NIH be stopped The Use of Human Tissue or Cells from funding or performing “hazardous re- Human tissue and cells can be used for a va- search” and that guidelines for DNA research riety of diagnostic, therapeutic, research, and projects be reviewed. commercial purposes.62 There are three major The “deliberate release” issue can be con- sources of human tissues and cells: patients, strained to an argument about the adequacy volunteer research subjects, and cadavers and of risk assessment and the adequacy of gov- aborted fetuses (including those from both nat- ernment regulation of experiments. The issue ural and induced abortions). The question of of laboratory research is somewhat different ownership of human tissues and cells became in that opponents ask that research be pro- important in 1980 because the Supreme Court hibited because an intolerable risk is alleged ruled that new life forms could be patented, to be inherent in the research and unavoida- and this appeared to mean that biological prod- ble.59 It should be noted that recombinant ucts containing or consisting of altered human DNA experiments are no longer limited to a cells and genes would be patentable. Soon few highly monitored scientific laboratories thereafter Congress amended the patent stat- but are going on in hundreds of commercial, ute to encourage patenting and licensing of in- governmental, and academic laboratories, and ventions resulting from government-sponsored 63 even in some high school biology courses. research. The public interest lawsuits succeeded in de- Physicians outside of the United States have laying by 4 years a University of California just begun to experiment with brain grafts of field test of a genetically altered bacterium ca- human fetal tissue to treat victims of Parkin- pable of increasing the frost resistance of fruit and vegetable crops.60 The fact that resistance by a small but dedicated group stalled a scientific activity deemed harmless by several State ] and Federal agencies, as well as many scien- ‘ For discussion of the pros and cons of the Science Court, see for example Arthur Kanrowitz, “The Science Court Experi- tists, led some citizens to want to reduce the ment: Criticisms and Responses, ” Bulletin of the Atonu”c Sci- entists, April 1977, pp. 44-53. Wu .s .ConWess, Office of Technology Assessment, New ~~ ‘gWilliam Booth, “Of Mice, Oncogenes, and Rifkin, ” Science, velopments in Biotechnology-Ownership of Human Tissues vol. 239, pp. 341-344, Jan. 22, 1988. Also, Amy McDonald, and Cells, OTA-BA-337 (Washington, DC: U.S. Government “AIDS Work With Mice Stirs Debate, ” The Scientist, vol. 2, Printing Office, March 1987), pp. 7-19. No. 1, Jan. 11, 1988, p.1. 63public Law 96.5170 Human cell lines have been patented MFoundation ~n Econom”c Trends v. Heckler, 756 F.2nd 142 and commercialized since that time. See OTA, op. cit., footnote (D.C, Cir. 1985). 62, ch. 2. 55 son’s disease.64 Fetal tissue is far less likely almost certainly encounter strong ethical and to be rejected than adult tissue grafts, and political objections. It is possible that, in the more likely to regenerate itself and grow with future, scientists may find a way of growing the host body. Many experts expect that it will embryonic cells in culture; this may or may become possible to use fetal tissue grafts in not be less disturbing to those who object to repair of other central nervous system dis- the use of fetal tissue.66 In any case, pressure orders, or to treat radiation injuries. Other pos- to allow the use of fetal tissue will almost cer- sibilities are the use of fetal grafts of pancreatic tainly grow if it is successfully used in other islet cells to correct juvenile diabetes, and fe- countries to treat life-threatening disorders. tal heart muscle grafts for repairing or even Some of this conflict could take the form of gradually replacing damaged hearts. These debates over First Amendment rights. In such procedures have not yet been developed. Any cases, the assertion that there should be a zone therapeutic use of fetal tissue in the United of ‘forbidden knowledge’ that is either exces- States is highly controversial; in the spring of sively hazardous or ethically abhorrent could 1988 a moratorium was placed on any feder- be countered by an assertion of a right to do ally funded research that uses fetal tissue for research under the umbrella of the right to free transplant purposes, and NIH researchers speech. This argument would most likely be were instructed by the Assistant Secretary for used in the early, experimental stages of such Health not to treat patients with fetal tissue new medical procedures, since government has implants until legal and ethical issues have a well-established right to regulate the later been further studied. In July 1988, the Admin- practice of medicine. istration announced that it would reconstitute a bioethics board that was first created in 1974 Federal Guidelines on Funding 65 and dissolved in 1981. of Research Fetal tissue comes from fetuses that have The early NIH Guidelines on recombinant undergone spontaneous or induced abortion. DNA research, unlike the atomic energy leg- The use of such tissue is objected to by some islation, did not restrict the right of research- people on the grounds that: ers to carry out experiments. They concerned ● it might be used to encourage, justify, or only the government refusal to fund research lend moral support to the use of abortion in certain areas. The guidelines have since been as a birth control technique; revised so that they do not seriously restrict ● it might create a commercial market for the areas of research, but still impose certain fetal tissue; or safety requirements on how the research is con- ● some women might become pregnant in ducted. The penalty for violation is still only order to produce fetal tissue that is needed loss of Federal funding. by someone they love, or even to produce It is doubtful that a constitutional challenge it for sale. could be made to these guidelines. There are Other people object to the use of fetal tissue few constitutional constraints on the power of as inherently morally reprehensible. the government to spend, but there are even fewer limits on its power not to spend. A gov- In short, any medical, commercial, or re- ernment decision not to fund a specific research search use of fetal tissue in the future will project would clearly be unconstitutional if the G4The first operations, transphmtblg tissue frOm a spontane- decision were found to be based on racial dis- ously aborted fetus to the brains of two Parkinson’s disease crimination, and there are legal requirements patients (with the consent of both parents of the fetus) was performed in Mexico City in late 1987. Larry Rohter, *’Implanted Fetal Tissue Aids Parkinson Patients, ” The New York Times, Jan. 7, 1988. ‘GWilliam Regelson, M. D., Professor of Medicine, Medical “Gina Kolata, “Ethics and Fetal Research: Government Be- College of Virginia Hospitals, in a letter to the editor of The gins to Move, ” New York Times, July 31, 1988, p. E7. New York Times, Oct. 8, 1987. —

56 for competition and fairness; but beyond such Both those who argue that some research incidental constraints, selectivity is proper and should be forbidden and those who advocate necessary. full freedom of research fail at times to distinguish clearly between the objectives of stop- Not every experiment that scientists wish ping research, or stopping the government to conduct can be funded, and the government from funding research, or reducing particular obviously must select those that have the most perceived risks. Both sometimes fail to distin- merit. The judgment as to how beneficial the guish between public policy issues and constitu- resulting knowledge might be is surely an tional issues. Strictly speaking, the question appropriate criterion for selection. The judg- of a constitutional right to do such research ment that the resulting knowledge would not could be raised only when individuals or insti- be beneficial or would not justify its expense tutions were prohibited from engaging in such is also appropriate. research on their own, independent of govern- At this point, however, a possible question ment funding. Federal guidelines and regula- arises. Some demands that research be re- tions about how research is done are less likely stricted, or discouraged by cutting off govern- to be challenged. It has become generally ac- ment funding, are based on the assertion that cepted that the Federal Government may reg- the objective of the research is morally and ulate the way in which research is conducted ethically repugnant or unacceptable. For ex- by recipients of Federal funds (although in such ample, there have been such objections to cases the Courts would undoubtedly still give weapons research, or to certain kinds of weap- strong consideration to any asserted counter- ons research such as biological warfare. There vailing State interest, such as safety). have also been such objections to the concept Nevertheless, restrictions either on an area of human cloning, or to interspecies genetic for research, or the content of research that exchanges in higher animals. If funding deci- may be done with Federal funding, are likely sions were shown to be based on “religious doc- to evoke more controversy in the future, be- trines” they could be challenged under the cause government is likely to be the only source First Amendment’s Establishment Clause. of adequate funding for areas in which indus- However, religious doctrines would have to be try has no interest. clearly distinguishable from general moral ab- horrence, which the Supreme Court has allowed 67 right to engage in homosexual sodomy, ” and defended the as a basis for exercise of State police power. State’s right to outlaw it in part because “Proscriptions against that conduct have ancient roots. ” It specifically denied asser- ‘7 For example, in the recent case dealing with enforcement tions that the belief that sodomy is immoral and unacceptable of laws against sodomy (the case involved an act committed is “an inadequate rationale to support the law, ” saying that with another adult male in the bedroom of the respondent’s “the law. ., is constantly based on notions of morality. ” Bowers home) the Supreme Court said that “there is no fundamental v. Hardwick, 106 S. Ct. 2841,92 L. Ed.2nd 140,54 U.S.L.W. 4919.

INTERSECTIONS BETWEEN BIOLOGY AND THE CONSTITUTION: OVERVIEW The map of possible intersections between In Griswold v. Connecticut,68 in 1965, the biology and the Constitution suggests that cer- Court explicitly articulated the doctrine that tain key concepts of constitutional law may the penumbra created by several fundamen- need to be reexamined in the light of new sci- tal constitutional rights defines a “zone of entific knowledge. Among these are the concepts of “privacy” and “equality.” ‘s381 U.S. 479. 57 privacy. ” Decades earlier, Justice Brandeis ar- significant challenge for the legal system to gued for “a right to be let alone, ” basing this ensure that such knowledge does not erode the right on the Fourth and Fifth Amendments. precious but fragile fabric of social equality The right of privacy, as discussed in chapter that is one of the major constitutional achieve- 2, contains both the concept of autonomy and ments of this century. the concept of confidentiality of personal in- Privacy as a constitutional norm may also formation. Modern challenges to the Fourth be reassessed. Privacy has been recognized as Amendment prohibition on “unreasonable central to notions of liberty and individual au- searches and seizures” have largely focused tonomy as a sphere preserved from arbitrary on search from a distance—i.e., wire tapping government action. Rapidly advancing tech- and later remote sensing—but new challenges niques for reducing the individual to a collec- are arising from government acquisition of in- tion of biological facts and measurements are formation from body tissues and emanations likely to increase the need for explicitly defin- (breath, blood, semen), including genetic infor- ing the scope and nature of this guarantee. mation. Other challenges are arising from the collection and aggregation, in computerized Nevertheless, it is well to remember that not data banks, of personal information, which every social dislocation that might be produced may include genetic information. Both kinds by the new biology must, or should, be a mat- of intrusion on privacy are discussed in some ter of constitutional concern. Many issues will detail in chapter 5, which deals with medical be resolved by Congress, the public, profes- record keeping. sional groups and interest groups without being raised to the level of constitutional chal- The advance of science is almost certain to lenge. Debate on such issues has already been provide new and sophisticated techniques for joined, and its robust character is grounds for distinguishing among individuals in terms of optimism that the political process shaped by biological characteristics or capabilities. Sci- the Constitution will continue to work well in ence may eventually provide an objective ba- the coming century. sis for some classifications that law has pre- ferred to treat as arbitrary. It will be a Chapter 5

Public Health Techniques and Technologies CONTENTS . i Page ~ American Public Health Law, 1787-1887 ...... 62 . : i The Police Power in the Twentieth Century ...... 62 . . : / Due Process and Police Power ...... 62. . #, Privacy and State Police Power ...... 64; / . .: Modern Public Health Techniques and Technologies ...... 66 ‘. ! Prevention: Innoculation and Vaccination ...... 65 Reporting Morbidity Data ...... 67 Screening and Testing Techniques ...... 68 I Contact Tracing...... 76 # Social Controls: Full or Partial Quarantine ...... 77 Treatment ...... ’...... 82 I Blood Banking ...... 83 Public Education and Statistical Forecasting ...... 85

1 Chapter 5 Public Health Techniques and Technologies

The public health is a significant part of “the cannot yet assure anyone that he or she will general Welfare, ” which the Constitution was be cured. intended to better secure. Enormous strides have been made in the medical sciences in the In public health, we are faced with a terrible last two decades, in large part as a result of epidemic at a time when people had become development of the “new biology.” Medical ca- almost complacent about the ability of vac- pabilities increasingly present us, as individ- cines and antibiotics to deal with infectious dis- uals and as a society, with options far beyond ease. The capability to identify risks, predict our traditional understanding of rights and the spread of disease, screen for exposure, and duties, choice and necessity, consent and obli- test for infectiousness is much greater than gation. This chapter deals with the use of med- in historical epidemics; yet in the case of AIDS ical science and associated technologies in we cannot cure the disease, nor prevent it once government programs to protect the health of exposure has occurred. The social frustration Americans. The next chapter discusses some that this incurs may challenge us to define the specific medical interventions as they apply limits of individual rights and the scope of our to individuals. mutual obligations to society. In public health, it is not so much new tech- In dealing with such health provisions as nologies and techniques that promise to raise mandatory vaccination, quarantine, housing future constitutional issues, but rather the use inspections, school health, and mandatory seat of old (and historically accepted) techniques belts, one is nearly always operating under and technologies that appear newly controver- State laws, based on State police power. Po- sial in the context of modern expectations of lice power is the inherent power of govern- privacy and civil liberties and modem attitudes ments to exercise within their jurisdictions rea- about risk and exposure. Another factor is new sonable control over persons and property in scientific capability to identify risks and ex- the interest of the general security, health, posure pertaining to people who are not yet safety, morals, and welfare. ill, or pertaining to licit behaviors such as smoking or overeating. In public health, the Federal Government In some areas public expectations outstrip has only necessary and implied powers derived the ability to solve urgent problems. A high from its powers to tax and spend for the gen- expectation of good health and an unrealistic eral welfare, to regulate interstate commerce, optimism about medical capabilities may con- and to provide for the national defense. The tribute to the growing problem of liability or States retain primary responsibility for pub- malpractice suits against physicians and hos- lic health policies and programs through their pitals. Not all medical interventions are suc- inherent police power. But both State and Fed- cessful. All of the effort thrown into the study eral Government are subject to the Bill of of cancer, with enormously promising results, Rights limitations on governmental power.

61 62

AMERICAN PUBLIC HEALTH LAW, 1787-1887’ In the colonial period, epidemics could dev- States’ public health authority were laid out astate a community. Smallpox and yellow fe- one by one in a Supreme Court decision:2 ver sometimes sickened from 30 to 50 percent ● The police power is very broad, and the of a town’s population within a short time, and State legislature has wide discretion to de- might kill 10 percent. Even measles could be termine when and how it is used. a major disaster; Cotton Mather in 1713 lost ● Public interests must require such inter- his wife, three of his children, and a servant ference by the State; there must be a seri- to measles. The effects of such infection on the ous threat. Indians, who had no resistance from past ex- ● The means used by the State must be “rea- posure, were often even more cataclysmic. sonably necessary” and not “unduly op- Public health programs in the 17th and 18th pressive.” centuries consisted of emergency measures to ● The State must not impose “unusual and meet these crises. When epidemics threatened, unnecessary” or “arbitrary” restrictions towns often declared quarantines, posting on persons or occupations. guards at the docks and on roads leading into ● The courts will examine or supervise the town. Sick people were cared for in their homes legislature’s exercise of police power to en- or the pest house. Town funds were provided sure that these conditions are met. for medical care and to feed and shelter orphans Until well into the twentieth century judi- or the children of sick parents. No one ques- cial decisions about public health law and prac- tioned the right of the authorities to take what- tices seldom emphasized individual rights as ever measures were necessary. such. They turned on questions of how the After the Civil War there was somewhat State exercised its authority, whether or not more disposition to question the scope and the Court perceived that the State was deal- limits of police power. In 1894, the terms of ing with a serious problem, how great an intrusion the State action would be, and how strictly the authorizing statute was read. Courts generally permitted public health authorities great leeway in infringing on the free- IDr John Duffy, Profe9sor Emeritus of Medical Historyt dom of an individual. University of Maryland, assisted in the preparation of this sec- 152 u.S. 133, 136-7 (1893). tion of the chapter. z~~W~O~ “, StW]e,

THE POLICE POWER IN THE TWENTIETH CENTURY Due Process and Police Power ing to be vaccinated when a city board of health had decided vaccination was “necessary for the The tension between the State’s police power public health.” The Cambridge board of health and the constitutional right to due process is did so when a smallpox epidemic threatened central to discussions of modern public health in 1902. Jacobson, refusing to be vaccinated practice. One of the most cited Supreme Court on the grounds that it was dangerous and in- cases on public health and police power is a 3 effective, was tried and fined $5. He appealed 1905 case, Jacobson v. Massachusetts. It in- first to the Massachusetts Supreme Judicial volved the constitutionality of a State statute Court and then to the U.S. Supreme Court, ar- that provided a fine of $5 for any adult refus- guing that the vaccination law violated his Fourteenth Amendment rights to due process 3197 Us. 11. and equal protection of laws (the latter because 63 under the law physicians could declare some And it also said: children “unfit subjects for vaccination”). The safety and health of the people of Mas- The Supreme Court confirmed that the State sachusetts are, in the first instance, for that legislature can enact “reasonable regulations” Commonwealth to guard and protect. They are to protect public health and safety, and may matters that do not ordinarily concern the vest this authority in local bodies like boards Federal government. of health. The Court said that constitutional Jacobson dealt with a real, identifiable, and rights must be preserved, but it found that the familiar public health problem. But in the same Fourteenth Amendment right to “liberty” 1905 term, the Supreme Court dealt with the does not mean absolute freedom, and the State constitutionality of a State statute concerned may restrain personal and property rights in with occupational health and safety, in the case order to secure the “general comfort, health, of Lochner v. New York.4 The statute pro- and prosperity of the State. ” Under the “prin- hibited bakery and confectionery employees ciple of self-defense, of paramount necessity, from working more than 60 hours in 1 week. a community has the right to protect itself The Court framed the issue in this way: against an epidemic of disease. ” Further, the Supreme Court would be “usurping the func- Is this a fair, reasonable, and appropriate tions of another branch of government” if it exercise of the police power of the State, or is it an unreasonable, unnecessary, and arbi- judged the method chosen by the legislature trary interference with the right of the indi- to be unreasonable, arbitrary, or unnecessary. vidual to his personal liberty or to enter into Vaccination was a well recognized, generally those contracts in relation to labor which may accepted means of preventing smallpox; the seem to him appropriate or necessary for the legislature accepted it as such, and the courts support of himself and his family? had no superior knowledge. Judicial review of This decision came less than 2 months after a general welfare enactment, according to the deciding Jacobson. The Court again recognized Court, should be very narrow, and such a stat- that it may not merely substitute its judgment ute would be invalid only when it is “. . . beyond all question, a plain, palpable invasion for that of the legislature and strike down a law. Nevertheless the Court did not view limi- of rights secured by the fundamental law. . . .“ tation of the work day as a health or welfare This case is a starting point for the discus- issue, but as State regulation of economic rela- sion of future cases of constitutional limita- tionships between two competent adults. It de- tions on police power because it confirms that nied that this law was within the police power the legislature need not be “right” in its pub- of the State, because bakers are no less able lic health decisions; its acts need only have “to assert their rights and to care for them- some “real or substantial relation” to the pres- selves than members of other occupations. . . .“ ervation of the public’s health-not the “best” The “welfare, safety, and morals of the gen- way but a “reasonable” way. Courts are not eral public (were) not protected by the law” to be the arbiters of scientific disputes. since there was no evidence that clean and wholesome bread is related to the number of Underlying the Court opinion was the con- 5 cept of a social contract between individual and hours the baker works. This case was con- community and between State and Federal trasted by the Court with an earlier one up- Governments. The Court said: holding a law limiting the working day of underground miners and shelterers, because We are unwilling to hold it to be an element in the liberty secured by the Constitution . . . that one person . . . residing in any community and enjoying the benefits of local govern- 4198 U.S. 45 (1905). ment, should have the power thus to dominate ‘The New York court in upholding the statute had concluded that there was sufficient evidence to demonstrate that the oc- the majority when supported in their action cupation of baker or confectioner was unhealthy and tended to by the authority of the State. result in diseases of the respiratory organs. 64 working underground was “clearly un- A modern court in a police power case still healthy.”6 will not generally evaluate arguments as to the These two cases, within a few months of each scientific soundness of the exercise of police power. For example, the Court ruled in 1955 other, demonstrate the significance of the on the constitutionality of State laws regulat- standards which courts use in evaluating the 9 ing the fitting and sale of eyeglasses. Opti- legislature’s exercise of the police power. Had cians were prohibited from placing an old lens the Court actually applied the Jacobson stand- in a new frame or from reproducing a broken ard of minimal rationality and the presump- lens without a prescription. A trial court struck tion of constitutionality, Lochner would have down this law, holding that the requirements been decided differently. But the vaccination were not ‘reasonably and rationally related to law was indisputably a health law, aimed at the health and welfare of the people. ” But the reducing contagious disease; while in the Loch- Supreme Court reversed, on the grounds that case the law was not perceived as enforc- ner the legislature might have concluded that eye ing a well-recognized medical procedure. Loch- examinations were so important “for the de- ner signaled the beginning of an era in which tection of latent ailments” as to justify their the Court struck down as economic regulations requirement on all possible occasions. Said the many statutes framed around public health Court: goals.’ The day is gone when this Court uses the Ultimately, however, the Jacobson standard Due Process Clause of the Fourteenth Amend- prevailed. In 1934 the Supreme Court returned ment to strike down State laws, regulatory of to the more restrictive standard of judicial re- business and industrial conditions, because view, saying that the Due Process Clause only they may be unwise, improvident, or out of requires that “the law not be unreasonable, harmony with a particular school of thought. arbitrary, or capricious and that the means In summary, the courts will generally be in- selected shall have a real and substantial relation to the object sought to be attained.”8 clined to accept as constitutional public health actions that appear to be reasonably related G~o]den v. ~tidy , 169 U.S. 366 (1898); the COurt found ‘hat to preservation of the health of the population given the dangers of working underground, the deprivation of without attempting to determine independ- fresh air and sunlight, and being frequently subjected to foul air, the law was a proper exercise of police power, designed to ently the scientific validity and efficacy of the protect the health of miners. It also recognized that the State measures taken. Nevertheless, this remains an could reasonably conclude that workers needed protection be- area where the scope of individual rights and cause the owners and workers do not have equal bargaining power. presumed limitations on state power appear TIn Adkjns v. Chi]tien Hospital, 261 U.S. 525 (1923)J ‘he to be constantly subject to challenge. Court struck down a law which established a minimum wage for women and children, the explicit purpose of which was to protect them from “conditions detrimental to their health and Privacy and State Police Power morals, resulting from wages which are inadequate to maintain decent standards of living. ” The Court claimed the law was arbi- The evolution of the concept of privacy as trary, that the “relationship between earning and morals is not a constitutional right was traced in the first capable of standardization, ’ and that the law did not take into account the fact that different people need different amounts chapter. The case of Buck v. Bell, the 1926 case of money to maintain a minimum acceptable standard of living. upholding the right of the State to sterilize in- g~ebbia ~. New York, 291 U.S. 505 (1934). The Court uPheld mates of State mental institutions, was de- a New York statute establishing a board to determine the maximum and minimum prices retailers could charge for milk. Three scribed in chapter 3 and illustrates both the years later the Court upheld a minimum wage law for women. deference to State interests and the lack of ac- The judicial policy of examining the substance of the law under knowledgment for privacy rights that were the the umbrella of the Constitution’s Due Process Clause, and “second guessing” the legislature as to its efficacy, is called “sub- rule until recent decades. Fifteen years after stantive due process. ” It is to be distinguished from “proce- that case, the Court struck down a State stat- dural due process,” in which the Court asks whether a law affects ute providing for compulsory sterilization of people in an arbitrary, discriminatory, or irrational manner. In recent years, the Court has returned to the doctrine of substan- (70., 348 U.S. 483 (1955)” tive due process in emphasizing fundamental individual rights. gwil~.~~on “. L= optjc~ 65

“habitual criminals, ” using the Equal Protec- cation, 12 and obtaining acupuncture treat- tion Clause of the Fourteenth Amendment, but ments.” But the Supreme Court specifically also affirming that marriage and procreation refused to extend this right to cover consen- were fundamental rights.10 sual sodomy .14 It is thus uncertain how this right might be applied in future issues related The right of privacy has repeatedly been to public health techniques and technologies. used by the Courts since 1965 to protect the individual’s right to make decisions about marital, reproductive, and family matters. State supreme courts have extended this right to cover individuals refusing life-sustaining medi- “Rogers v. Okin, 821 F.2d 22 (Neb.,1987). cal care,11 refusal to take anti-psychotic medi- 13An&ews v. ~~]m~, 4$)8 F. SUPP. (s.D. Texas! 1980)” 14~owerS v, ~=~wjc~, 106 s.ct. 2841 (1986). Although the 1[)Skinner v. Oklahoma, 316 U.S. 535 (1942). challenge was brought by a homosexual male, the challenged ‘‘~n re Karen Quin]an, 355 A.2d 647 (N. J., 1976); Superin- statute was written to apply to heterosexual or homosexual be- tendent of 13elchertown v. S~”kewicz, 373 Mass/ 728 (1977). havior, by married or single persons.

MODERN PUBLIC HEALTH TECHNIQUES AND TECHNOLOGIES In the extended discussion that follows, fre- The problems raised by the AIDS epidemic quent reference will be made to the current epi- are not intrinsically new. Larger numbers of demic of acquired immunodeficiency syndrome people die every year from other single causes, (AIDS). Many of the traditional public health including the effects of smoking.15 But the techniques are being used in this epidemic, but problems raised by AIDS are so severe and in a social, political, and legal framework that acute as to revive old and neglected issues of has radically changed in recent decades. New public health and civil liberties, to emphasize scientific knowledge and capabilities are also structural problems in the capability to re- providing new approaches—although not as spond to civil emergencies, and to stress weak many or as rapidly as society had hoped—and points in our social fabric. The problems throw these by definition may raise new constitu- into sharp relief the potential conflict between tional issues. constitutional principles of individual rights and protection of the general welfare. The reso- AIDS is not like most of the severe epidemics lution of AIDS problems, if done humanely and associated with the origins of public health pro- with full attention to both fundamental free- grams in the United States. It appeared sud- doms and the protection of the general welfare, denly, but it is not episodic as were yellow fe- may stand us in good stead in the future in ver, Asiatic cholera, or influenza. It can have other contexts. a very long incubation, it has a very low infec- tivity, and it cannot spread by casual contact. Prevention: Inoculation and There do not appear to be any factors calling for engineering or environmental remedies, Vaccination which have been major factors in control of The major medical innovation during the past epidemics. colonial period was smallpox inoculation, in- Yet AIDS does represent the working of troduced in Boston in 1721, but already an old 16 I th colonies it was denounced some traditional Public Health techniques and practice. n e technologies that need to be examined further ‘%rnoking was officially blamed for 350,000 deaths in 1985, for their constitutional implications; and more 100 times the number of AIDS deaths in the same year, as pertinently, AIDS also demonstrates the pub- pointed out by William Pollin, “Drug Abuse, U. S.A., ” Issues in Science and Technology, Winter 1987, p. 24. lic health applications of some new develop- ‘Gin inoculation, matter from pustules in an active smallpox ments in biology. case was inserted under the skin of a healthy person who thereby, (continued on next page) 66

by some physicians as too dangerous, and by cough reemerged as an epidemic disease when many ministers as an attempt to evade God’s the use of pertussis vaccine diminished dur- punishment for immorality. But because of its ing the 1970s because of public alarm about obvious value, inoculation was an accepted rare side-effects. practice by the time of the Revolution. Nevertheless, vaccination remains a primary The success of inoculation in reducing the tool of public health. Because it was one of the toll from smallpox prepared the way for vac- earliest tools for protecting public health, its cination, introduced by Jenner in 1798.17 Vac- use is well established in law and judicial prece- cination won immediate acceptance, and the dents. At present, there is no vaccine against incidence of smallpox fell sharply during the AIDS, although several are being tested. Should next 30 years. By the 1830s, a generation that a vaccine be developed, there would almost cer- had never known a smallpox epidemic saw lit- tainly not be a mandatory program of vacci- tle reason to be vaccinated, and there was a nation for the general population, since the risk steady rise in smallpox until about the 1870s. of AIDS is concentrated in certain age groups After the Civil War, health officials began urg- and even more narrowly in specific behavior- ing compulsory vaccination of school children defined populations. and mass vaccination of adults during out- Mandatory vaccination laws for more gen- breaks. In spite of a strong anti-vaccination movement, joined by a few doctors alarmed eral infectious diseases would however almost by infections arising from vaccination within- certainly be sustained. The presumption on the fected needles, the movement succeeded in part of the courts would continue to be that most States.18 vaccine programs are a “reasonable” public health strategy. When there is strong public awareness of the Although physicians have generally wel- possibility of epidemics, most people can com- pare the risk of taking the vaccine against the comed vaccines, local medical societies have clear and present risk of the disease, and can often opposed free vaccination for lower income groups by public health departments, unless thus appreciate the value of vaccination. As there is a life-threatening epidemic or the threat immunization programs succeed and the acute 19 disease threat disappears, the benefit to the of one. A possible constitutional issue is the individual is less well perceived. The benefit assertion of the right to a vaccine when one is available for a disease perceived as highly accrues to the community at large. Any risks threatening. But as discussed in the following or undesirable side-effects of a vaccine which chapter, courts have so far consistently main- become known are therefore apt to stimulate resistance. tained that there is no constitutional right to medical treatment and government has no con- Of all infectious human diseases for which stitutional obligation to make it available. a vaccine has been developed, only smallpox has been eradicated; the rest are merely held at bay. In Britain and in Japan, whooping

(continued from previous page) usually, acquired immunity. The immunity came from antibodies 19Degpi~ the ~eat attention to vaccines as a retit of AIDS, produced in response to this small scale invasion of disease organ- the U.S. capability to develop vaccines for new or newly epi- isms, but the response was not understood at the time. demic diseases is in general weak. Almost all vaccines have a ]TVaccination is the use of dead or attenuated viruses from sole manufacturer or a very few possible manufacturers. There cows inoculated with cowpox to produce immunity to small- is no governmental capability for vaccine production. Vaccines pox in humans. are relatively unprofitable and product liability is a strong dis- 18Such waves of popular opposition have been associated incentive to potentiaJ developers. The United States is the only with other public health innovations, such as fluoridation of country in the industrialized world where vaccine manufacture water supplies; they are sometimes attacked as hazardous or is unprotected from litigation regardless of compliance with man- even as plots by internal or external enemies to poison the cit- ufacturing regulations, according to Dr. June Osbom, Dean of zenry. the School of Public Health, University of Michigan. 67

Reporting Morbidity Data tion to make venereal disease reportable on the grounds that it would bring disapprobation on The first necessity in controlling epidemics the association. In 1892 the New York Acad- is to recognize them early. Thus it is manda- emy of Medicine dismissed a similar resolution tory for physicians to report certain infectious on the same grounds. A New Orleans physi- diseases. Historically, there has been little con- cian writing in a medical journal in 1920 called nection between the diseases which cause the proposals to require reporting of venereal dis- greatest morbidity and mortality and those ease “socialist tommy-rot” that would “under- which arouse the greatest public fear or atten- mine the morals of the American people. ” tion. The two diseases that most worried the public in the 19th century were yellow fever Since then, a wide array of mandatory report- and Asiatic cholera—deadly, erratic and un- ing statutes, such as for venereal disease, have familiar. To Americans these epidemics seemed been considered necessary and permissible. to be malignant forces that struck mysteri- Laws requiring mandatory reporting by phy- ously and vanished almost as strangely. Such sicians or health care facilities of the names diseases always awaken more public fear and and other information about people who have stronger public actions than diseases that may been infected receive great impetus from ad- exact a far higher toll but do so consistently vances in the ability to acquire, store, and dis- rather than episodically, and hence become fa- seminate such information using computers.20 miliar conditions of life. The disorders that In this decade, however, mandatory reporting were steadily and consistently responsible for laws have again become highly controversial the most sickness were malaria and respira- in regard to abortion, drug use, and AIDS. tory infections. They were regarded as inevi- The Supreme Court has addressed the issue table, much as we tend to regard high death of mandated release of medical information to rates from automobile accidents. the State by the physician on several recent The chief killer disease of the 19th century occasions. One example concerns New York was tuberculosis. Yet in the early 19th century State’s Controlled Substances Act of 1972, it was regarded as a romantic disease, as pic- which requires reporting by physicians of tured in La Boheme or Camille. Later in the prescriptions for certain drugs.” Public dis- century it was considered a natural disorder closure of the identity of the patients is pro- about which little could be done. Most insur- hibited and punishable by one year imprison- ance policies did not insure against death from ment and a $2000 fine. In spite of this, the tuberculosis; hence the family received no bur- Federal District Court found the law to be un- ial money and the doctor might not get paid. constitutional, as intruding too broadly into Therefore tuberculosis deaths were often re- the doctor-patient relationship, part of the corded under other headings. When health de- “zone of privacy” accorded constitutional pro- partments at the end of the century began tection. But the Supreme Court reversed, find- ordering physicians to report cases of tuber- ing the requirement was a reasonable exercise culosis, the medical profession rose up in arms. of police powers, and that there was no viola- The New York City Health Department, mak- tion of privacy interests.22 ing tuberculosis a reportable disease in 1897, found itself opposed by the New York Acad- emy of Medicine, the County Medical Society, 20 Materi~ in t~s section is drawn largely from “Constitu- tional Implications of Scientific and Technological Advances and most medical journals. The medical socie- in Public Health, ” prepared for OTA by Dr. Leonard H. Glantz, ties went to the State legislature in an attempt Professor of Health Law, Boston University Schools of Medi- cine and Public Health. to limit the powers of the board of health. zlInformation about the physician, the drug and dosage> and Venereal disease has always been under- the name, address, and age of the patient is sent to the computer of the State Department of Public Health. Only 17 de- reported by physicians. In 1882 the American partmental employees have access to the information. Public Health Association rejected a resolu- zzwh~en “. Rw, 429 U.S. 595 (1977). 68

It had been argued without avail that the Ten years later the Supreme Court invali- constitutional right of privacy encompasses dated a Pennsylvania abortion reporting re- two distinct interests; the individual interest quirement which called for very detailed report- in avoiding disclosure of personal information, ing,24 available for public inspection and and the freedom to make certain kinds of im- copying (in a form that would not bear the iden- portant decisions without State interference; tification of the person filing the report). The and that both interests were violated by the Court struck this down on the grounds that: law. Knowing that the State would receive this 1) many of the details were unrelated to health information would make doctors reluctant to interests, 2) the records could be inspected by prescribe, and patients reluctant to use, cer- anyone, which indicated to the Court that the tain medication. legislature had some purpose in mind other than protecting the public’s health; 3) even Justice Brennan, in his concurring opinion, specifically recognized that new technology though the woman’s name was not listed there may require the Court to address this issue were enough data that identification became again: “likely,” and may have been the “obvious purpose of these extreme reporting requirements.” The central storage and easy accessibility The Court said that the law would have a chill- of computerized data vastly increase the po- ing effect on the exercise of a constitutional tential for abuse of that information, and I am right. not prepared to say that future developments will not demonstrate the necessity of some Given the fact that public disclosure about curb on such technology. having AIDS or being an AIDS carrier could have a devastating effect on an individual, it Another case in 1976 involved the report- is reasonable to surmise that the Court may ing requirement of a State abortion law, give as much scrutiny to State AIDS report- . . . the purpose of which shall be the preser- ing requirements, if challenged, as to an abor- vation of maternal health and life by adding tion reporting requirement. The State would to the sum of medical knowledge through the have the burden of proving the public health compilation of relevant maternal health and need and showing adequate privacy safeguards. life data. .. .23 In such circumstances the interests of the The statute stated that the information must State in learning the extent and distribution be confidential, must be used only for statisti- of the disease would have to be balanced against cal purposes, but must be available for inspec- the individual’s concern for privacy. However, tion by local, State, or national health officers. the balance could be struck differently in the The Court also upheld the constitutionality of case of AIDS than in the abortion example, this provision, finding that it is useful in pro- because of the risk to the population at large. tecting the health of female citizens, and may be a resource for future medical decisions. Screening and Testing Techniques25 Given these realistic goals, the guarantee of confidentiality, and the fact that the report- Mandatory testing or screening of large pop- ing has no legally significant impact on the ulations or specific categories of people has abortion decision or on the physician-patient relationship, the Court found no constitutional 24 Thomburgh v. American College of Obstetricians 106 S. (X. 2169 (1986). Reporting requirements included the identification violation, but it did suggest that the law ap- of the referring and primary physicians and the name of the proaches “impermissible limits.” This decision facility or agency; the woman’s political subdivision, age, resi- was especially significant because of the close dence, race, marital status, number of previous pregnancies; the basis for determination that the fetus was not viable; the scrutiny that the Court gives all legislation reg- method of payment; and other information. The report was to ulating abortion. be signed by the attending physician. ~~Materi~ in this section was prepared for O’1’A by: Dr. zsp]an~ p~entho~ of Missouri v. Dan forth, 428 U.S. 52* Sheila Jasanoff, Cornell University Program in Science, Tech- 70 (1976). nology, and Society; Dr. June Osborn, Dean of the School of (continued on next page) 69 been done or has been considered for purposes years for a program of screening, counseling of detecting hereditary disease (primarily in and education.29 the case of newborn infants, where early treat- Following initial support from the Black ment is effective), for control of infectious dis- community, these sickle cell initiatives later ease, and for detecting drug abuse. came under fire. Black leaders questioned the The constitutionality of data collection will propriety of the legislative focus on sickle cell depend on a variety of factors, including the anemia when there are so many other impor- purpose for which information is obtained. tant causes of illness among Blacks.30 Some Thus questions of obtaining information can- critics said that sickle cell screening increased not be wholly separated from questions of use, the potential for stigmatizing a particular mi- which might be, for example, to document the nority group and could reinforce latent feel- spread of the disease. Courts have not been ings of racism. A few saw the overt tie-in be- reluctant to sustain a requirement that public tween screening and marriage-licensing laws school students undergo an annual physical in several States as particularly sinister. In the examination 26 or that couples seeking mar- words of one Black activist, such a connection riage licenses submit to tests for venereal dis- represented “the entering wedge for govern- ease.27 Nevertheless, some features of the test- mental involvement in genetic criteria for ing process, whether for hereditary disease, procreation. ”31 infectious disease, or law enforcement, may Similar concerns are reported to have trou- raise constitutional problems regardless of the bled some leaders of the gay community in the uses to which the State puts the information early days of the AIDS epidemic; fearing that being collected. association of gays with an epidemic disease Screening for Hereditary Disease would intensify discrimination against them, some leaders resisted early efforts at public Mass screening has been undertaken in this education about the ways in which the disease country in the past primarily for the purpose was transmitted.32 Such concerns suggest of identifying individuals at special risk of pro- that whenever mandatory screening programs ducing genetically damaged offspring. Such are limited to identifiable minorities, there may programs were initiated during the 1970s for be perceptions of conflicts between the State’s Tay-Sachs disease and sickle cell anemia. Both interest in public health and the constitutional programs focused on ethnic minorities with goal of equal protection. If testing is limited which those diseases are uniquely associated. to discrete subgroups, then the burden on the The former aroused less concern because it was State to justify it should be especially high. carried out largely without legislative requirements.28 By contrast, laws mandating screen- Mandatory screening for heritable traits or ing for sickle cell disease (associated with peo- biological susceptibilities thus raises issues of ple of African descent) were passed in many due process, unreasonable search and seizure, States in the early 1970s. In 1972 Congress and privacy. The legitimacy of such programs enacted the National Sickle Cell Anemia Con- trol Act, which allocated $115 million over 3 29 Aubrey Milunsky ~d George J. Annas, Genetics and the Law (New York, NY: Plenum Press, 1976), p. 174. (continued from previous page) ‘Lawrence E. Gary, “The Sickle Ceil Controversy, ” in Adela S. Baer (cd.), Heredity and Society, 2nd ed. (New York, NY: Public Health, University of Michigan; and Dr. Leonard Glantz, Macmillan), pp. 363-364. Sickle cell anemia is almost exclusively Professor of Health Law, Boston University Schools of Medi- found in those of Black African ancestry. About 10 to 13 per- cine and Public Health. cent of American Blacks carry the trait (which is recessive); about ~~strejch ~z. Bo=d of Education, 34 S.D. 169 (191 4). 3 percent have the disease, ‘iPeterson v. Wid~de, 157 Wis. 641 (1914). 3] Ibid., p. 366. 28 Madeleine J. Goodman and Lenn E. Goodman, “The Over- ]zRandy Shilts, And the Band Played On: Politics, People, selling of Genetic Anxiety, ” Hastings Center Report, October and the AIDS Epidemic (New York, NY: St. Martin’s Press, 1982, pp. 20-21. 1987), pp. 52-103. 70

will turn to a large extent on the nature of the weight of authority runs counter to this. Courts State’s interest in acquiring information. have held that one does have an interest in avoiding the mandatory testing of urine or Mandatory Drug Testing blood and also in the information contained 34 Drug testing programs have been adopted in bodily fluids, although that individual in- by numerous State and Federal agencies, and terest may be inferior to a State interest. One have given rise to a number of court cases. In court has said, regard to the constitutionality of various forms Drug testing is a form of surveillance, albeit or programs of drug testing, very little is cer- a technological one. Nonetheless, it reports on tain and challenges are likely to continue, at a person’s activities just as surely as if some- least until the Supreme Court decides two one had been present and watching. It is George cases scheduled to come before it in the 1988- Orwell’s “Big Brother” society come to life.35 89 term. One of these cases involves Federal But the Constitution has been found in gen- workers, and one involves railroad employees. eral not to prohibit such bodily intrusions as In the future, the “new biology” is likely to compelled vaccination, blood tests or urinaly- lead to development of many drugs that are sis where the government provides sufficient related to, and closely resemble, naturally justification and evidence of procedural regu- occurring bodily substances such as opiates larity. For example, in Schmerber v. Califor- in the brain. Some of these new drugs maybe nia in 1966,36 the Supreme Court upheld the subject to abuse; that is, may have socially un- performance in a hospital of a blood test for desirable effects. It maybe particularly hard alcohol content performed on an automobile to test for such drugs; and to distinguish them crash victim, without a warrant. It has long from the naturally occurring substances that been established that a State interest in health people may have in widely varying quantities. and safety may justify testing programs that Their detection might require tests that are intrude to some degree on individual liberty even more intrusive than urine analysis, which and privacy. The use of roadblocks and alco- many people find highly objectionable. Thus hol tests to deter drunk driving has been ruled 37 drug testing issues are unlikely to be resolved constitutional. Courts have traditionally completely and for all time. considered that here the gravity of the public interest outweighs the intrusion into personal In considering the constitutional implica- liberty, particularly in view of the effective- tions of drug testing it is necessary to distin- ness of the testing program. guish carefully between what can be done by government with regard to the public or some And in Shoemaker v. Handle (1986)38 breath- categories of the public; what can be done by alyzer and urinalysis tests of race horse jockeys government with regard to its employees; and were deemed constitutional in view of the pro- what can be done by non-government employers cedural safeguards built into the process and with regard to their employees. the fact that testing occurred in the context of a closely regulated industry. In terms of government drug testing in the interest of general law enforcement—testing The ordinary individual as citizen (rather members of the general public to detect viola- than employee) enjoys a significantly higher tions of the laws limiting use of controlled sub- expectation of privacy. Courts are certain to stances-the constitutional question is whether be cautious in assessing the legitimacy of gen- or when drug testing by government officials is “an unreasonable search and seizure, ” un- s~~cfione]~ V. Hunter, 612 F. Supp. 1122 (D. Iowa 1985); der the Fourth Amendment. At least one judge Capua v. City of Phiinfi”eM, 1 IER Cases 625 (U.S. Dist. Ct., N.J. 1986). has argued that one “cannot retain a privacy 35Capua v. City of Pfainfield, at 626. interest in a waste product . . . “33 but the 3’384 U.S. 757 (1966). 37State v. Superior Co’&t in and for County of Pima, 691 P.2d ssJudge Nebeker, concurring, Turner v. Fraterntd Order of 1073 (Ariz. 1984). Police, 500 A.2nd.1000 (D.C. App.1985). W7g5 F,2d 1136 (3 Cir. 1986), 71 eralized screening programs. In order to over- 1988, the Third Circuit U.S. Court of Appeals come these barriers, the government would upheld a program subjecting municipal police have to present an extremely strong showing officers to random urinalysis done in the course of need. of an annual physical examination, yet a month earlier the Sixth Circuit U.S. Court of Appeals When government as employer proposes to struck down a program of compulsory drug test its employees for drug use, it must still testing of firefighters and police officers, say- observe constitutional safeguards. Here one ing the intrusion on their privacy was not must distinguish between drug testing when 42 there is probable cause for suspicion, com- justified. pletely random testing, and mass testing of The courts have banned only “random” drug all employees. testing programs. The courts agree that if a “reasonable cause” or Recent cases have struck down the mass public employer has testing of both Federal and municipal employ- “reasonable suspicion” that a person’s job performance is presently impaired by the use of ees for drug abuse on the ground that the circumstances did not justify dispensing with the drugs, a drug test maybe required. Thus when Fourth Amendment’s requirement that searches public employees were discovered smoking marijuana on the job, it was held that the em- and seizures should be based on individualized 43 ployer could require testing. Certain public suspicion. The most recent Federal precedent is a permanent injunction granted by a U.S. employees such as police have been held to have a lesser expectation of privacy due to their District Court judge in July 1988 to prevent random urine testing of employees of the U.S. “paramilitary nature”; and a search may be Department of Justice. The judge said that be conducted without a warrant, or “probable cause” if there is some objective basis for the cause there was no evidence of a drug prob- 44 search. lem in the Department there was no justification for infringing on the constitutional rights The U.S. Supreme Court has held that “fa- of “trusted and apparently law-abiding em- cilitative searches” such as those conducted ployees. “39 In a case involving municipal by fire marshals and building inspectors can workers, another court noted that the city’s be done without the need for “probable cause” testing program for fire fighters was overly or ‘reasonable suspicion, if they comply with broad in that it would collect information that a reasonable administrative plan and are based bore no relation to the government’s interest on neutral criteria. Thus some experts believe in preventing illegal drug abuse.40 that random drug testing will be upheld if governments use a plan that does not discriminate Courts have also stressed the need for appro- and if there is legislation authorizing such test- priate procedures to protect the employees’ 45 legitimate expectation of privacy against such ing, with appropriate safeguards. administrative searches. One court has even held that a public employee who at the time 42Policeman’s Benevolent Association of New Jersey v. Waslu”ngton Township, CA 3, No. 87-5793, June 21, 1988; Lov- he is hired signs a consent to be tested cannot vorn v. Chattanooga, CA 6, No. 86-6281, May 23, 1988. be held to that consent because “advance con- 43Allen v. City of Marietta, 601 F. Supp. 482 (M =N.D. GA. 1985). sent to future unreasonable searches is not a ‘d~rner, p. 10008. The Fourth Amendment and the Due 41 reasonable condition of employment. ” Process Clause are flexibly applied. The strictness which which both are applied is related to the reasonable expectations of the On the other hand, there is much disagree- person claiming protection and the nature of the interest at stake. ment among courts on these points. In June Thus one court held that jockeys may be subjected to random drug testing because of the long history of testing in that occu- pation and because of the pervasive way the racing industry 39Ruth Marcus, “Drug Tests Blocked for Justice Workers, ” is regulated. (Shoemaker v. Handel, 795 F.2nd 1136 (3rd Cir. Washington Post, July 30, 1988, p. Al. 1986). 40Capua v. City of Pkihfield, ITER Cases 625 (U.S. Dist. Ct., 45See, for example, a letter to the Editor of the New York N. J., 1986). Times, June 18, 1987, from John F. Banzhaf, ;Ird, Professor 41 AZcDonell v. Hunter, 612 F. Supp.1 122, (D. Iowa 1985). of Law and Legal Activism, The George Washi.ngttm University. 72

Another issue was raised in a recent case be- percent.” Because of the potential for stig- fore the U.S. Court of Appeals for the District matization and legal misuse, such error rates of Columbia, involving the testing of school are likely to make judges wary about declar- bus drivers and attendants as part of an an- ing mass testing programs to be lawful. nual required physical examination. The Court Use of drugs is clearly a health hazard. said that such tests were permissible, but also Health professionals treat addicts as sick peo- said that the test must detect current impair- ple, and the Supreme Court has held that drug ment, not merely past use, in order to justify 46 addiction is a disease or “status” for which occupational restriction. people cannot be punished, as opposed to an The use of illicit drugs in the workplace has act or behavior (e.g., possessing or selling prompted private sector employers to begin drugs) for which they could be punished.48 or to consider urine screening programs. They Advocates of mandatory drug testing use pub- may be motivated by concern for safety in the lic health language (“an epidemic of drug workplace, safety in facilities and transporta- abuse”). They also cite the danger to others, tion systems used by the public, the produc- for example, coworkers in factories or passen- tivity of workers, or the general health and wel- gers on trains and airplanes, to justify strong fare of workers. The question is often raised public health measures. However, mandatory as to whether employers have a right to know drug testing is aimed at detecting only illegal or to restrict what is done in the employee’s drugs, although the use of some legal drugs, off-the-job time, so long as it has not been such as tranquilizers, might also result in some shown to affect their performance. impairment of performance. In fact, drug testing does not determine whether one is pres- Debate about drug testing is complicated by ently impaired but detects past use of a drug. the multiplicity of drugs at issue, the compli- Effects of the drug may not have overlapped cation of cross-reacting innocent compounds the workday at all. Because of these factors, that can trigger false-positive test results, the courts have looked closely at random drug practical problem of ascertaining whose urine testing—i.e., testing where there is no prob- is being tested, and questions about the fre- able cause to suspect illegal behavior on the quency of testing. The cost of testing is fairly part of a given person—and for the most part high, especially if confirmatory testing is used, have struck down such provisions. as it should be. How frequently testing should be done is another question that can be decided People not trained in law often forget that only arbitrarily. the Constitution provides limitations on government only; that constitutional provisions Questions about scientific validity play a sig- do not protect them against actions by private nificant part in decisions concerning the per- citizens; and that only when Congress has missibility of mass screening programs. The passed laws embodying those constitutional more accurate and reliable the test, and the principles do they have an effect in the private lower the degree of unavoidable error, the more sector. likely it is to pass judicial scrutiny. The false positive rates associated with some widely Thus it surprises some citizens to learn that used drug screening tests, for example, are un- public employees may, because the govern- acceptably high to many experts. For exam- ment is their employer, have some constitu- ple, the radio-immunoassay screening of blood tional rights in the workplace that private com- may yield a false positive rate of as much as pany employees do not enjoy. Private sector 43 percent for cocaine, while the enzyme mul- employees must depend on State or Federal tiplied immunoassay technique of urinalysis may have a false positive rate as high as 10 47 Morris J. Panner and Nicholas A. Christakis, “The Limits of Science in On-theJob Drug Screening, ” Hastings Center Re- port, December 1986, p. 8. 4GJones v. McKenzie, 85-01624, Nov. 17, 1987. ia~obinson “$ c~”form-a, 380 U.S. 660 (1962). 73 privacy statutes or individual contractual bar- recognition of human antibody responses to gaining agreements with employers; they have HIV. no constitutional rights to their job or to All viruses contain a number of different pro- privacy as a condition of employment. teins or antigens that can stimulate the im- Diagnostic Testing for Infectious Disease mune response. Antibodies to HIV usually appear during the first 4 to 8 weeks after infection Diagnostic testing to determine who has a and nearly always within 3 months, and usu- disease is usually looked on as beneficial for ally persist indefinitely. There are several var- the patient, who can then begin treatment, and iations of the screening test for HIV. for the community, since steps can be taken to reduce the transmission of a disease. The The development of diagnostic AIDS tests exception comes when there is no curative was accomplished within a few months by sev- treatment to be given, when available control eral U.S. firms. Most of the tests are variations measures may infringe on the patient’s free- of what is called an ELISA test. The initials dom, and when the testing creates an infor- stand for enzyme-linked immunosorbent assay. mation file that is viewed as a threat of fur- The virtue of the test lies in its easy readabil- ther infringement or discriminatory actions in ity, using techniques and equipment thoroughly the future. familiar to blood banks and clinical laboratories. Other variations such as indirect immuno- Within less than 3 years of the first reported fluorescence or radioimmuno-precipitation description of the clinical disease AIDS in have been developed, but their principles are 1981, three laboratories had independently iso- similar. All blood and plasma donations to U.S. lated and identified the virus, HIV, that is the blood banks have since 1985 been routinely 49 causative agent of AIDS. This gave imme- screened for AIDS. Testing of individuals can diate hope of developing a test to identify be done by private physicians or in special or infected individuals. Laboratory work then general clinics and laboratories. Protection of established the usefulness of a particular cell the confidentiality and integrity of this data, line to grow the virus to high concentrations most of which is probably computerized, has in tissue culture and allow it to be purified and raised many concerns. concentrated. That in turn facilitated the production of the large quantities of virus needed Media coverage of the race to develop an an- to serve as diagnostic antigen,50 suitable for tibody test was extensive. Nevertheless public confusion over the terms sensitivity and 4gSome critics maintain that this could have been accom- specificity led to a widespread false impression plished as much as 2 years earlier had there been appropriate that the tests were not reliable. This residual funding and attention when the existence of the epidemic was first discovered. For a critical account of the process, see Randy public unease is confounded with very differ- Shilts, And the Band Played On (New York: St. Martin’s Press, ent problems of the uncertainty of clinical diag- 1987). There was competition between research scientists to dis- nosis and prognosis.51 cover the infectious agent, and acrimonious dispute over the allocation of credit for the discovery. Three groups of scientists Any biological phenomenon has “outliers”- used their own terminology in naming the virus. This contributed to serious confusions in discussion even within the scien- i.e., variations extend across a broad range, tific community. The terminologic dispute created problems for with some unusual examples that are far from persons concerned with the critical task of educating the pub- the mean or average. When a disease detec- lic about the new virus and its risks. For that reason an international committee of virologist was assembled and proposed tion test is developed, it can be made highly a uniform nomenclature. The virus was named human im- sensitive, in order to pick up even the outliers munodefi”ciency virus or HIV. As new relatives of that virus are uncovered by further research, they are referred to as HIV- 2, HIV-3, etc. J. Coffin, A. Haase, J,A. Levy, et al., “Human tralize, agglutinate, or precipitate it, rendering it harmless. This Immunodeficiency Viruses, ” Science 232: 697, 1986. is the primary means by which the body protects itself from SOAn ~ti%n i9 a pro~in or c~bohydrati substance-a tofin~ disease. enzyme, or the jacket of a virus-that when introduced into the slDia@osis is identifying a disease from its signs or sYmP- human body stimulates that body to produce antibti”es, or sub- toms. Prognosis is predicting the course of the disease, the likeli- stances whose function is to combine with the antigen and neu- hood of recovery, or the duration of survival in a specific case. 74 or unusual cases, but then it will also pick up detection. 52 This would be of great merit some false signals. If the goal is accuracy, or chiefly because in the interval early in infec- specificity-i.e., no false positives—then the tion, the antibody has not had time to develop, outlier cases or signals must be ignored or al- and a person tested during that time may be lowed to escape. The majority of cases, falling falsely reassured, and may inadvertently in- near the mean, will be clearly recognized, but fect other people as a result. However, the ben- there will be some false negatives. efit of an antigen test maybe counterbalanced by a large number of false negatives, since HIV When the antibody test for HIV was devel- can exist solely as integrated DNA in host oped, it was purposely designed to provide cells, without any antigen expression. Thus maximum protection of the blood bank sup- failure to detect viral antigen would not nec- ply, and therefore was made especially sensi- essarily mean the absence of infection. tive. Here, it was clearly best to err on the side of being too careful, at the cost of a substan- Present AIDS tests are moderately expen- tial number of false positives. Unfortunately, sive and time-consuming, and require trained some press reporters interpreted this as a sign laboratory personnel. Confidential testing is of a poor test, when it fact it was a necessary offered by many physicians and clinics, but accompaniment of appropriate caution. there may be long waits, and there is much variability in the adequacy of the counseling The false positives made it necessary to have that is offered. There have been no “home test a confirmatory test, or supplemental proce- kits,” or tests that give fast results, but a home dure, to be sure that a positive reaction in the test kit is expected to be on the market within ELISA test was in fact an indication of infec- a few months. If fast, inexpensive, and highly tion with HIV. The first supplemental test was accurate tests are developed, some of the purely called the “Western Blot, ” and identified an- technical restraints on mass screening will tibodies to specific proteins of HIV, thus giv- fade. However, medical and public health ex- ing a detailed picture of the immune response perts, persons with AIDS, and care-givers reflected in the patient’s blood serum. This has stress the importance of linking testing to sup- been replaced in some laboratories by other portive counseling. This is important both for supplemental tests, but they operate on the the good of the infected, and to maximize the same general principle. At present, the state likelihood that these people will take care to of the art allows both sensitivity and specific- avoid infecting others. The possibility of “on- ity of greater than 99 percent for the ELISA the-spot” or home testing is likely to further test, which already compares favorably with erode that link to counseling. In the meanwhile, any clinical laboratory test in medical use, and the question is whether large scale mandatory supplemental tests permit very reliable iden- testing programs should be undertaken now. tification of infected individuals when done properly. Recently, questions have been raised In early 1988 researchers at CDC announced about the accuracy of the Western Blot. Many a technique called PCR (for polymerase chain commercial laboratories are apparently un- reaction) or DNA amplification, which identi- familiar with and possibly unskilled in using fies proviral sequences of HIV-I in the DNA it, and there is no standard for its interpre- of blood cells of people who are infected. This tation. method may make it possible to obtain test results within 3 days. CDC currently speaks Some experts hope for a generically differ- cautiously of the “potential utility of the PCR ent supplementary diagnostic test: one that would allow recognition of the antigen rather than the antibody in test material. The hope szIt i9 ~ready possible in specialized laboratories to grow is that it might be possible chemically to iden- HIV itself from white blood cells of persons with HIV antibody, with a success of over 60 percent on a single try, but this is tify virus proteins in blood and tissue samples unwieldy and expensive. Also, antigen is usually not recover- with a greater sensitivity than that of antibody able from Ab-positive persons. 75 technique in complemention or replacing vi- a marriage license application.56 Louisiana rus isolation as a routine means of determin- and Illinois both passed laws requiring AIDS ing the presence of HIV-I. ”53 testing for applicants for a marriage license; Texas passed a similar statute that will go into Debate over the desirability of systemati- effect only when the state incident rate reaches cally screening large populations—e.g., pris- 0.83 (when the law was passed, the rate was oners, Federal employees, marriage license 0.01). But in July 1988, Louisiana repealed the applicants, hospital patients—seems to be premarital test law after only 6 months, and growing. In March, 1988, the U.S. District in Illinois there is also a strong movement for Court for the District of Nebraska refused to repeal. Of 75,000 people tested under the Il- allow a multicounty mental retardation agency linois law, only 10 tested positive (the predic- to require some of its employees to submit to tion had been for 80 to 100 positives) and the testing for HIV infection, on the grounds that cumulative costs for testing were reported to this violated employees’ Fourth Amendment exceed $6 million (paid for by the applicants (search and seizure) rights.” The agency had for a marriage license, at costs of $30 to $200 acted on the grounds that employees might per couple).” transmit AIDS to clients who bit or scratched them. Mandatory testing for health-care professionals themselves has been proposed, but In part the impetus for mandatory testing there has been little public or professional dis- may come from the fact that there is little else cussion of the pros and cons of this measure. to be done, and mandatory screening seems more activist than reliance on voluntary test- Many people, including many public health ing. In some limited populations, mandatory and medical experts, conclude that any bene- testing would provide the opportunity for some fits from mandatory screening programs are control; for example, screening of prisoners al- more than counterbalanced by the separating lows authorities to isolate those who are in- of testing from counseling and the likelihood fected or to take strong measures to prevent of driving persons at risk “underground.” The other prisoners being subjected to risk through National Academy of Sciences/Institute of sexual activity .55 Medicine reached that conclusion, as did a preliminary consultation at the World Health Testing of marriage license applicants could Organization in March 1986. allow an uninfected partner to be warned and possibly reduce the number of infants born in- The issue of how to balance these costs fected with AIDS, but heterosexual couples against the benefits of testing programs has other than IV drug users are not a high risk not yet been fully resolved. The conclusion that group at present. Some States routinely re- mandatory screening is unwarranted is greatly quire testing for syphilis in connection with affected by the lack of treatment, the clear need for counseling in the event of a positive test, Sschin.yih OU et ~., “DNA Application for Direct Detection and the uncertainty that confidentiality can of HIV- I in DNA of Peripheral Blook Mononuclear Cells, ” Sci- ence, Jan. 15, 1988, pp. 295-297. 54 Glover v. Eastern Nebraska Comrnum”ty Office of Retarcia- sGThis is becoming a serious problem in prisons, ~d the tion, DC Neb, No. CV. 87-0-830, Mar. 29, 1988. - rights of prisoners in this regard are a matter of debate and SSAccor&ng ~ ~ofe990r Wayne Welch of The George Wash uncertainty. A Massachusetts trial judge said in September that ington University’s Intergovernmental Health Project staff, a prisoner could not be forced to take an AIDS test merely be- there is already mandatory testing for members of the Armed cause he had scratched and injured a guard. On the same day, Services, the Foreign Service, and the Job Corps, and for Fed- a Federal judge in Minnesota upheld the conviction of an in- eral prison inmates. Prisoners are being screened in seven states. fected prisoner for assault with a dangerous weapon after he Utah has passed a law prohibiting a person diagnosed as hav- bit two judges, noting that the human mouth and teeth do not ing AIDS from marrying. Florida requires pregnant women with ordinarily constitute a deadly or dangerous weapon. Associated “high risk characteristics” to be tested. Press, “AIDS Decisions Diverge in Cases Against Prisoners, ” Nevada, where prostitution is legal, requires that prostitutes The National Law Journal, Sept. 28, 1987, p. 4. be screened for AIDS. Government Executive, July-August 57 CJm&.a G. Bo~m~, “prem~it~ Testing Annoying M~Y 1987, p. 13. in Illinois, ” The Washington Post, July 30, 1988, p. Al. 76 be maintained. Screening at least spares those case of AIDS has become attractive to some who are unknowingly infectious from the ad- Federal officials and State legislatures because ditional grief of finding too late that they have that strategy is perceived to have been useful passed on the infection, perhaps to spouses or in the control of syphilis and gonorrhea. Such offspring. If a cure or effective treatment were action also seems indicated by fairness to peo- possible, past precedents argue that the State ple who have unknowingly been put at direct interest in saving lives and preventing the risk, and may consequently unknowingly put spread of the threat would almost certainly others at risk. override concern about individual privacy To the surprise of many observers, the Amer- rights. ican Medical Association (AMA) in June 1988 Voluntary testing, as compared to manda- recommended that its members warn sexual tory testing, is likely to involve those who are: partners of patients with AIDS and of AIDS 1) already well informed about AIDS, 2) so- carriers. This is an exception to the strong tra- cially responsible about the risks of infecting dition of physician-patient confidentiality, on others, 3) comparatively well off financially, which the AMA has always insisted.58 and 4) relatively sophisticated about medical There are however two problems with man- procedures. Two high risk groups are probably datory contact tracing as a strategy for AIDS least likely to ask for testing: IV drug users control. First, some experts question the as- and prostitutes, who are already at risk both sumption that it was effective in the past. of incurring other life-threatening diseases and Syphilis came under control primarily because of arrest for illegal activities; who are likely of the discovery of penicillin rather than be- to have little access to health services and lit- cause of contact tracing; and gonorrhea is at tle money; and who are hardest to reach with present out of control in spite of contact public education. tracing. The cost of screenings also a significant fac- Second, in those epidemics the impetus for tor. The screening of a unit of blood by the contact tracing was the knowledge that treat- ELISA test costs at least $2 and more comment could be offered to the contact. The pa- monly approaches $5. When a positive ELISA tient had a strong ethical reason for report- test occurs, repeat and supplemental testing ing, and the contact a highly practical reason are required, adding at least another $50 to for welcoming, the news. Both benefits tended the cost. These figures do not include the need to compensate for the sacrifice of privacy. With for skilled counselors and for procedures to as- AIDS there is no therapeutic help to be offered. sure confidentiality of test results. Thus the The only benefit to contacts would be that of economic and social costs of mass screening counseling if their tests prove positive. But 2 for AIDS, both for those who have been exposed or 3 months are usually required for antibod- and for the public at large, are significant. ies to appear, so there may be an interval of uncertainty, distress, and disruption of rela- Contact Tracing tionships even if the tests are ultimately neg- Still another traditional Public Health tech- ative. For public health officials and physi- nique, contact tracing, has also again become cians, sustained infectiousness of the patient controversial because of the AIDS epidemic. over many months makes it difficult to be sure Public health management of sexually trans- of complete contact identification, especially mitted diseases has along history. Mandatory since many sexual partners may be involved. contact tracing-i. e., tracking down and warn- The need for reiterative testing becomes a ma- ing people who have had sexual relations with an infected partner-is a technique that has 581sabel Wilkerson, “A.M.A. Urges Breach of Privacy To usually been closely associated with reporting Warn Potential AIDS Victims,” New York ~“mes, July 1,1988, and testing strategies. Contact tracing in the p. Al. 77 jor difficulty. Techniques for assuring the con- relations with male and female soldiers with- fidentiality of data are available but may be out warning them that he was infected. demanding and expensive, and may still not On June 24,1988, the Presidential Commis- be trusted by those supplying the information. sion on the Human Immunodeficiency Virus These problems must however again be Epidemic recommended that State health offi- weighed against the great benefit of warning cials be required to contact and notify sex part- those who have been exposed, so that in turn ners of persons infected with AIDS. he or she will not unknowingly expose others. Some public health officials are swinging toward Social Controls: Full or Partial support of contact tracing. New York health Quarantine officials for example recently asked physicians to warn sex partners of AIDS patients of the The strategies of final resort for control of risk.59 The City Health Commissioner said, most epidemics are: 1) infrastructure or envi- however, that there is no way to force patients ronmental reform, when there is believed to to disclose the names of contacts, and that un- bean environmental factor such as an animal der current rules governing professional be- vector, and 2) failing all else, social control havior in New York, physicians and hospitals measures including quarantine or isolation. that breach patient confidentiality would be There are no known environmental factors subject to civil penalties, such as lawsuits. Cur- in the AIDS epidemic, in the sense of sanita- rent New York laws do allow health officials tion factors, industrial contaminants, or ani- to notify people who have been in intimate con- mal vectors for the disease agent. One factor tact with patients with venereal disease or in the urban environment proved to be impor- tuberculosis, and some states have already au- tant: the “bathhouses” in some large cities that thorized contact tracing for AIDS cases. Cali- were a primary focus of promiscuous homo- fornia and Texas allow but do not require phy- sexual behavior that facilitated the transmis- sicians or surgeons to disclose positive test sion of the disease. Action by public health results to a patient’s spouse, and provide con- authorities to close these commercial establish- fidentiality safeguards for patients who volun- ments in San Francisco and New York was de- tary consent and list names for contact trac- layed by the protest and political and legal re- ing. Illinois provides immunity from civil sistance of proprietors and clients, on the liability for those willing to provide names for grounds of civil liberties, but once the fact of contact tracing. an infectious disease and a mode of transmis- Some people urge that people who know they sion had been established, there was little are infected should be legally required to warn doubt that the closure fell within the long sex partners. An army sergeant in San Anto- established scope of State police power. nio was recently sentenced to 5 months in Three further social control measures, be- stockade and a dishonorable discharge for ig- yond those already discussed, have been sug- noring orders from officers and having sex gested or proposed in the context of the AIDS without telling his partners he was infected 6O epidemic: full quarantine, excluding children with AIDS, or taking protective measures. with AIDS from public schools, and prohibit- In June 1988, a military trial was beginning ing persons with AIDS (or carrying the infec- of an Army private accused of having sexual tion) from engaging in certain occupations. These potential control measures have very significant constitutional implications. 59 Ron~d Sulhvn, “WWn AIDS Patients’ partners, He~th Official Urges, ” The New York Times, Oct. 15, 1987, p. B1. Quarantine would impose a harsh burden on 60He ~a~ found ~ilty of disobeying officers, of adul~ry, ‘d those infected with AIDS, particularly those of sodomy, but not guilty of aggravated assault and reckless endangerment. “Soldier Guilty of Concealing AIDS Infection who as yet suffer no symptoms of the disease, from Partners, ” The Washington Post, Dec. 3, 1987, p. A20. because the quarantine would be life-long. In 78 spite of this, newspaper polls have shown many 2) the length of time for which a person is in- Americans (one poll said 51 percent) favor fectious and would need to be isolated. Until quarantines, and legislatures in 5 States are recent decades, courts gave great weight to the said to be considering, or to have considered, inherent power of government to protect the such legislation. Florida health authorities general welfare by whatever means were con- have quarantined one prostitute to her home, sidered to be appropriate, by the public and wearing an electronic anklet.61 Social attitudes their legislators even if not by experts. and judicial decisions regarding quarantines For example, a 1909 case involved the quar- may have changed significantly in the last few antine in South Carolina of an elderly woman, decades, but this conclusion is somewhat hypo- who had contracted leprosy many years earlier thetical, as the use of traditional quarantines 62 as a missionary in Brazil. Subsequently she has become relatively rare and unfamiliar. mingled freely in the society of a small town In the early national period, quarantines for years, even teaching Sunday School, until were often imposed. The major infectious dis- the city board of health decided that she should ease problem was yellow fever. The disease be isolated. She had infected no one, medical reappeared in 1793 after a long absence, and authorities testified that she was only slightly a devastating epidemic struck along the en- if at all contagious, and the woman frantically tire coast from Boston to New Orleans. Phila- offered to remain isolated in her own home. delphia, New York, and other cities established Nevertheless, the court permitted her involun- temporary health boards with broad author- tary removal to and confinement in a cottage ity, and began quarantines. They isolated yel- built for her outside the city limits. The court low fever victims and began massive programs held that even though the disease was only to cleanup the foul streets and privies. As the “slightly contagious’ the board of health was epidemic increased in intensity, temporary hos- justified because of the “distressing nature of pitals were established, and funds were pro- the malady.” vided to care for the sick and those left or- By contrast, public health officials in San phaned. Francisco and elsewhere made no move to The disease was spread by water transport quarantine persons with AIDS who continued and generally struck hardest in the low-lying to frequent commercial bathhouses for reasons crowded dock areas occupied by the poor. The of anonymous sexual activity, in spite of the rich fled. Philadelphia and New York City in repeated warnings of their physicians that they 1797 began a policy of evacuating entire sec- were likely to be transmitting the infectious 63 tions of the city. New York, for example, pro- disease. In the intervening half century, atti- vided temporary housing out in the country, tudes toward individual rights had changed in Greenwich Village. The city authorities as- significantly. sumed full responsibility in this way for epi- Even at the turn of the century when quaran- demics of yellow fever for another century, tine was more often applied than now, courts through the final large outbreak in 1905 in New did intervene in quarantine programs where Orleans, when Federal, State, and local offi- the exercise of police power was extreme and cials joined together to cut short the epidemic. arbitrary. In 1900 San Franciso’s board of Courts have since often struggled with the health quarantined a 12 block district inhabited issue of quarantine as an ultimate social con- by 10,000 to 15,000 people, because bubonic trol measure, and have generally dealt with it plague was thought to exist in the area. This according to: 1) the nature of the disease and was challenged on the grounds that it was differentially enforced against Chinese but not GIDebor~ Jones Merritt, “Communicable Disease ~d Con- non-Chinese (most of the residents in the area stitutional Law: Controlling A IDS,” IVew York University Law GZ~ir~ v. Wymm, 65 S.E. 387 (S.C. 1909), Review, vol. 61, No. 5, 1986, p. 775. The Los Angeles Times 49 poll cited by Merritt was published Dec. 19, 1985, p. 1. 63 Shilts, Op. cit., footnote ” 79 were Chinese); there was insufficient evidence voluntarily institutionalized by the commis- of bubonic plague;64 and in many blocks there sioner of health for 2 months’ treatment. In was no evidence of any illness at all. A Fed- refusing a writ of habeas corpus, the State Su- eral judge terminated the quarantine on the preme Court said: grounds that it was “unreasonable, unjust, and 65 There is perhaps no provision of the Federal oppressive. ’ Constitution that is more overworked than the In 1922, the Supreme Court of Illinois up- Fourteenth Amendment . . . It has been so held the isolation of a boarding house opera- many times decided that the Fourteenth Amend- tor who was not ill but was a carrier of typhoid ment does not limit the states in the proper 66 exercise of the police power that the citation bacillus. She could, the court said, be quar- 67 of authority seems needless. antined for as long as she presented a danger to the public, ever though this would likely be A generation later, in 1944, there was a sim- for the rest of her life. The court noted several ilar case in which two women arrested for hav- requirements: the person must be known to ing ‘unlawfully solicited for prostitution” were be ill or infectious (“mere suspicion” was not held without bail until examined for venereal sufficient); State authorities must have reason- disease, pursuant to a State statute. The Su- able ground to believe that public health would preme Court of Illinois upheld their detention be endangered; the action must cease when the on the sole grounds of the charge of prostitu- necessity for it ceases; and the emergency or tion, saying that: necessity must exist, not merely be antici- It has been almost universally held in this pated. However, public authorities need not country that constitutional guarantees must wait until the disease has already been trans- yield to the enforcement of the statutes and mitted to take action. “One of the important ordinances designed to promote the public elements in the administration of health and health. .. .68 quarantine regulations is a full measure of common sense. ” The court also cited with approval another authority, that “whenever a police regulation Some courts were less concerned about the is reasonably demonstrated to be a promoter principles governing exercise of police power. of public health, all constitutionally guaran- The Supreme Court of Ohio, also in 1922, al- teed rights must give way. . . .“ lowed city health commissions to make examinations of all persons suspected of having ve- Even in recent years, courts have upheld statutes that permitted involuntary testing of nereal disease, and “all known prostitutes” 69 were considered to be, per se, reasonably sus- women arrested for prostitution. Public pected. Another regulation allowed the quaran- health measures may be less likely to be limited tine of one who had or was reasonably sus- by courts under constitutional principles when pected of having venereal disease when in the they are aimed at venereal disease, or when opinion of the health commissioner such quar- applied to prostitutes who are by definition en- antine was necessary to protect the public gaged in criminal activity, than in more gen- health. A woman was arrested as a prostitute; eral cases of infectious disease. charges were dismissed but she was then in- But most of these statutes and court decisions occurred during wartime; Dr. Allan M. 70 sqThere had been 11 deaths in which some 5ymptOm5 of bu- Brandt, in his book No Magic Bullet, dis- bonic plague appeared on autopsy, but no case in which a living person was diagnosed as having the disease and no evidence of any transmission of disease by the deceased, ‘5Jew Ho v. Williamson, 103 F. 10 (N.D. Cal 1900). GTEX pate Compwy 139 N.E. 204 (Ohio 1922). G6Peop]e Ex Re]. B~more v. Robertson, 134 N.E. 81 ~ Gspeople ex re]. B~er V. Strautz, 54 N.E. 2nd 41 (1944). (111.1922). The court said that it would not evaluate the wisdom WFor exmple, Peop]e v. SuFrior Court (Hartway) 562 p.2d of the State legislature and board of health, and would not in- 1315 (Cal. 1977). terfere with a particular action so long as it did not appear to ‘OAllan M. Brandt, IVo MaH”c Bullet (Oxford: Oxford Univer- be, on its face, “arbitrary, oppressive, and unreasonable. ” sity Press, 1985). 80 cussed the impact of wartime preparedness ini- transmitted through non-sexual, non-drug re- tiatives on the creation and enforcement of lated contact in even a very few cases would laws aimed at reducing the prevalence of ve- be likely to increase both political demands for nereal disease. In the past, quarantines for ve- and judicial acceptability of quarantine. This nereal disease have been limited in duration occurrence seems highly unlikely. since those who were infected could be rendered The constitutional acceptability of some non-infectious by medical treatment. lesser forms of social control is also still un- The courts have upheld quarantines for clear. For example, continued admission of chil- many other infectious diseases including scar- dren with AIDS to public school has brought let fever71 and tuberculosis;72 and have upheld about conflict in many communities. The Cen- lifelong quarantines for typhoid. But quaran- ters for Disease Control (CDC) in August 1985 tine has come to be used less and less as vac- reassured parents about the “apparent non- cines or cures were developed for many infec- existent risk of transmission” of the virus to tious diseases. other school children and recommended that schools decide how to handle children with On the one hand, the pattern of court deci- AIDS on a case-by-case basis.74 Some school sions about quarantine shows an ever broaden- districts have adopted CDC’s guidelines, some ing tolerance for the exercise of police powers. have refused to admit AIDS children, some This tolerance has expanded from quarantine 75 have segregated them within schools. Both based on demonstrated necessity to quaran- parents and school boards have resorted to the tine based on suspicion of disease, to quaran- courts. State and Federal legislators have in- tine based not on disease symptoms but on ac- troduced bills to ban AIDS sufferers from cusation of sexual activities. On the other hand, schools. These struggles are so far unresolved some constitutional authorities believe that except on a case-by-case local basis. courts would now be very reluctant to uphold the broad use of long quarantines, because con- In the first decades of this century courts cern for individual rights has increased. De- allowed school boards almost unlimited author- borah Jones Merritt, for example, suggests ity to exclude students with communicable dis- that: eases.” Not only children who were ill, but those who had been exposed to infectious dis- Recent developments in constitutional law eases at home or elsewhere could be excluded. suggest that courts would no longer uphold such broad quarantine orders. Although In recent decades, while declining to recognize the courts might still approve the isolation of education as a fundamental right,” the Court individuals who either knowingly engage in ac- has nevertheless scrutinized any law or policy tivities threatening a high-risk of infection to that excludes children from public schools. others or lack the mental competence to avoid those activities, judges would be unlikely to The State was not allowed to exclude un- sustain the quarantine of individuals who are documented alien children, on the grounds that willing to modify their activities to avoid such this would relegate the children to a perma- risks.73 nent ‘subclass, ” that the children were not re- Not all authorities concur in that judgment, 74CDC di~count~ most n-leas of ‘‘casual tr~Smi9SiOn, but on the grounds that courts have in general recognized parents’ fears that body fluids may be exchanged given wide discretion to governments in exer- among children by biting, scratching, uncontrolled urination, cising their police power when the public per- casual injuries, etc. ‘Education and Foster Care of Children In- ceives a serious risk. In particular, some peo- fected with Human T-Lymphotropic Virus Type III/Lymph- adenopathy-Associated Virus, ” 34 Morbidity & Mortafity ple warn, any evidence that AIDS has been Weekly Rept. 517, 519 (1985). 7SMerritt, op. cit., footnote 61, PP. 756 ‘f”

TGIbid. The rem~nder of this section draws heavily on Mer- TIS~O~~ “ Racjowskj, 86 A 606 (1913). ritt, op. cit., unless otherwise referenced. 72Moore ~. Draper, S’7 So.zd 618 ( 1952 ‘la”)” TTpaPa~an “c Al~a”n, 106 S. Ct. 2932, 2943-45 ( 1986); P~Y~er 73 Merritt, op. cit., footnote 61, p. 778. V. Doe, 457 U.S. 202, 223 (1982). -. 81 sponsible for their alien status, and that the fornia court ordered a school district to read- cost of educating these children was insubstan- mit a child with AIDS to kindergarten on the tial in the light of the costs of lack of educa- grounds that AIDS is a handicap under Sec- tion for the children, the State, and the Na- tion 504 of the Rehabilitation Act.82 tion. These reasons could apply to children In a similar case a New York court invali- with AIDS, except that they are unfortunately dated a school board policy excluding children unlikely to live to constitute a permanent sub- with AIDS. Again recognizing that public edu- class. The likelihood of transmission through cation is not a fundamental right, the court schoolroom contact is generally regarded by said that when a State does provide it, it must experts, although perhaps not by all members be available to all on equal terms. The courts of the public, as extremely small or nonexist- will give any denial of schooling close scrutiny ent. A New York trial judge recently followed because of the significant negative impact this this reasoning in ruling that automatic exclu- 83 could have on children. sion of all AIDS patients from public schools would violate the Equal Protection Clause.78 The Public Health Service (PHS) has officially urged that AIDS sufferers or carriers In 1979 the New York City Board of Educa- not be excluded from work, saying that “No tion began to exclude from regular classrooms known risk of transmission . . . exists” for mentally retarded children who were also car- workers in offices, schools, factories, construc- riers of the hepatitis B virus. Hepatitis B is tion sites, food service jobs, health service communicable in a similar fashion to AIDS— delivery, etc.84 The Public Health Service rec- through the use of contaminated needles, ommended only routine disinfection of equip- blood-to-blood contact, and sexual contact ment contaminated by anybody fluids, regard- (usually homosexual contact). While the virus less of known infection. has been isolated in saliva, there is no evidence that it has been transmitted through this Some school districts decide on a case-by- route.” The New York City policy was chal- case basis whether public school teachers and lenged on the grounds that it violated the Re- associated workers with AIDS may continue habilitation Act of 1973, the Education of the to work. Several cities have barred persons Handicapped Act, the New York Education with AIDS or AIDS-Related Complex from Law, and the Due Process and Equal Protec- working as food servers or as teachers. Judi- tion Clauses of the Fourteenth Amendment.80 cial precedents could support these restrictions. Under the rational basis test, as long The Board of Health argued that it was mak- as the courts perceive that there is even remote ing traditional use of the police power to pro- risk of infection,85 they would be obliged to tect the health, safety, and welfare of its cit- uphold such regulations. The Supreme Court izens and that its actions were “rationally held, in 1978, that New York City could con- related” to this purpose. The Court nevertheless struck down the Board’s policy. It cited the Fourteenth Amendment, although it relied children who were carriers, the Board evidently recognized that primarily on antidiscrimination laws.81 A Cali- carriers presented only a “remote possibility” of infecting others. wThomas v. Atascadero Unified School Di.S’trict, No. 886- ‘Hllistrict 27, 130 Misc. 2d 398, 502 N. Y.S.2d 325; cited by 609 AHS(BY) (C. D.) Calif. Nov. 17, 1986. Merritt, op. cit., footnote 61, p. 762. S~District 27 Commum”ty sch~] Bo~d V. Bo~d of Educa- 7gAccording to Dr. Leonard Glantz, Prof. of Health Law, tion, 502 N. Y. S.2nd. 325,337 (Sup.1986). Schools of Medicine and Public Health, Boston University, some ‘recommendations for Preventing Transmission of Infec- authorities think that there is a greater likelihood that hepati- tion with Human T- Lymphotropic Virus Type III/Lymph- tis B could endanger others in a classroom or household than adenopathy-Associated Virus in the Workplace, 34 Morbidity that AIDS could do so. The material on school admission in & Mortd”ty Rept. 681,682 (1985),hereafter cited as PHS Work- this section relies heavily on analysis by Dr. Glantz as well as place Recommendations. Dr. Merritt. 55 The Public Health Service holds that there is some possi- “ONew York State Association for Retarded Children v. bility of such transmission, for example, by direct transfer of Carey, 612 F. 2d. 644 (2nd Cir. 1979). blood through the injury of one person and an open lesion on “The court said that since the policy excluded only mentally another person’s skin, but says that this kind of transmission retarded children and made no effort to find or exclude other is highly unlikely. 82 stitutionally bar all methadone users from care for many Americans. As discussed in the working for its transit authority even though next chapter, there is a growing concern about the bar was “broader than necessary to exclude the availability of adequate medical care for those methadone users who were not actually Americans who may not be able to pay for in- qualified to work. “86 Thus if the courts found creasingly expensive care, or who do not have sufficient grounds to exclude some AIDS vic- access to health insurance: “A(n). . . issue con- tims from health care, personal service, or food fronting society and its political elements is handling occupations, they would be likely to the question of whether health is a universal uphold broad rules barring AIDS victims human right.”87 rather than insist on individualized determi- nations of the threat posed by a particular em- Neither Congress nor the Supreme Court has ployee. But those “sufficient grounds” do not in any way recognized such a “human right” appear to exist, and the Supreme Court has as a constitutional right. But the AIDS epi- said that the protection given to the handi- demic may fuel pressure for new health care delivery mechanisms or programs because of capped by recent legislation extends to peo- the high costs of treatment, because those with ple with infectious disease. AIDS are young and more likely than the aver- None of these judgments are at all conclu- age worker not to have health insurance, because sive; they represent possibilities rather than they may lose their jobs when their illness be- predictions of how courts would decide in fu- comes known, and because health insurance ture situations. Constitutional lawyers and providers try to avoid enrolling those in high- scholars differ strongly on these points. Clearly, risk categories. scientific knowledge about risks and ex- The projected costs of health care for AIDS posures, in this case, has not been sufficient patients in the next few years are enormous. to prevent or resolve challenges to public pol- While AIDS is uniformly lethal, it entails many icy on the basis of constitutional principles; weeks or months of progressive debilitation, it may only have complicated those challenges. including necrologic deterioration. Since this In June 1988, the President’s Commission is a disease of young adults whose health in- on AIDS and the National Academy of Sci- surance is usually dependent on their employ- ences both recommended tough new Federal ment status, early termination of employment laws to prohibit discrimination against the has abroad impact. Home care, day care, long- 28,000 Americans with AIDS and the more term care in skilled nursing facilities, and than 1 million other Americans estimated to hospice care can improve the quality of remain- be infected. The Presidential commission, with ing life for many patients, while reducing costs. a divided vote, recommended that the Federal The range of lifetime health care cost estimates law against discrimination against the handi- per case range from $29,000 to $157,000, re- capped be extended to apply to private sector flecting in part the variation in availability of employees. such options. Health care will become still more costly and Treatment difficult as drug addicts become an increas- Health care in the United States is primar- ingly large proportion of the patients. Many ily provided through the private sector, but of the innovations in patient care so far have the public health system is an important de- relied heavily on the volunteerism character- veloper of new drugs and other health care re- istic of some gay communities, which has no gimes and techniques. In addition, Medicare parallel in some of the other high risk groups. and Medicaid do provide payment for health

87J.C. Snyder, “Public Health in the U. S.A., ” in John Wal- WNew york City Tr~sit Authority v. Bea.zer, 440 U.S. 568 ton, Paul B. Beeson, Ronald Bodley Scott (eds.), The Oxford (1979), as cited by Merritt, op. cit., footnote 61, p. 771. Companion to Medicine, vol. ii, p. 172. 83

The appearance of the first anti-HIV drug, however, appear prohibitive compared to a dis- AZT, raised some thorny issues likely to re- ease that is probably 100 percent fatal. cur with other candidate treatments. The hand- In the meantime, in response to the grow- ful of drugs that have been developed for treating demand from the AIDS community, the ment of virus infections of any sort are usually FDA announced in July 1988 that it would al- very toxic. Antiviral drugs present very differ- low Americans to import unapproved drugs ent problems from those of antibiotics for bac- from abroad in small quantities for personal terial infections. Most bacteria are distinctive, 88 use in treating or preventing AIDS. self-contained organisms, subject to attack through their specialized mechanisms of multiplication. Viruses act as “fifth columns,” tak- Blood Banking ing over the host cell so completely that it is Blood supply and transfusion was a primi- difficult to kill the virus without seriously tive process until World War II. Blood groups damaging the host. were recognized only in the 1930s. Until the AZT, for example, has a serious suppressive need for close matching of blood types was rec- effect on the patient’s bone marrow, usually ognized it was not uncommon for hemorrhage necessitating regular blood transfusions. It has to be dealt with by direct arm-to-arm transfer other toxic properties, often so severe that of untested blood. treatment must be stopped. Its cost is nearly Blood transfer for medical purposes in- $10,000 yearly per patient. This is not a prom- creased dramatically with expansion of surgi- ising solution even in the affluent United cal capabilities and other therapeutic interven- States, where over a quarter of a million cases tions. It prolonged the lives of cancer patients of AIDS are anticipated by 1991; it certainly and many others who needed transfusions for will not work for developing countries. But so maintenance. By 1983, an average of 13 mil- desperate are AIDS patients that even at that lion voluntary blood donations were made per cost, the demand for AZT exceeds the supply. year. Most donations were divided into two The urgent need for some treatment prompted or three components (i.e., red cells, plasma, creation of an unusual mechanism for early platelets). There were over 3 million recipients licensing of AZT and an even more unusual per year, many receiving multiple infusions.89 system to try to get more equitable distribu- The transmission of the disease hepatitis as tion of the drug. The intense pressures that a complication of blood transfusion was rec- prompted these actions will worsen tenfold in ognized in the early 1940s. By misadventure the next 5 years if there are no other effective the newly developed live-virus vaccine for yel- treatments. A large number of unauthorized low fever was stabilized using human serum treatments, ranging from health food diets to that was infected with hepatitis viruses. Over drugs authorized for other medical purposes, 50,000 cases of hepatitis resulted. Blood screen- are being widely used by those with AIDS who ing for the disease agent then began. can afford their often high costs. Many people are highly critical of government agencies ~phdip M+ Boffiey, “F.D.A. Will Allow Patients TO Import for what they view as foot-dragging in testing AIDS Medicines, ” New York Times, July 25, 1988. One exam- these “treatments.” ple of such a drug is dextran sulfate, which the Federal Govern- ment is now beginning to test in human trials, but which is al- Yet other people are concerned that the ra- ready in use in some countries. pidity of licensure of AZT seems to herald more 89J.R. Allen, “Scientific and Public Health Rationales for Screening Donated Blood and Plasma for Antibody to rapid deployment of new drugs in general— LAV/HTLV-III,” Chapter 15 in AIDS: The Safety ofl?kwd and not just for AIDS—and they fear that the slow Blood Products, J.C. Petricciani et al. (eds.), The World Health but cautious approach which has assured drug Organization. New York: John Wiley and Sons Ltd. Also J.C. Petricciani, “Licensed Tests for Antibody to Human T- safety in the past maybe replaced with a faster Lymphotropic Virus Type III, Arm.intern.ilfed. 102: 726-729, but more hazardous approach. Few hazards, 1985. 84

The identification of hepatitis B virus and creased risk of AIDS” (specifically homosex- development of a means of screening had been ual males) be asked to refrain from donating expected to eliminate most of the hepatitis con- blood; that there be expanded medical screen- tamination. But as it turned out, only a small ing of donors to detect early symptoms of proportion of the transfusion-associated hepa- AIDS, and that this screening include exami- titis was eliminated. Clearly at least one other nation for lymph node enlargement and weigh- virus was involved. The remaining blood trans- ing to detect early weight loss. mitted hepatitis was subsequently referred to 90 Critics have since charged that this action as “non-A, non-B hepatitis. ” Later immuno- was delayed by resistance from both blood logic evidence strongly suggests that there are 93 banks and gay organizations. The Centers at least two other hepatitis viruses. for Disease Control officially reported only in The risk of hepatitis is still significant; blood- January 1984 that there were cases of AIDS transfusion hepatitis continues to threaten 7 associated with transfusions, and later in 1984 to 10 percent of those getting transfusions. Ad- some blood banks began using surrogate tests. ditional “surrogate” screening tests have re- Many lots of blood thought to be infected were cently been added in an effort to prevent these withdrawn and destroyed. In April 1984, the infections, and they add several dollars to the AIDS virus was identified, and a specific AIDS cost of each unit of blood. blood screening test became available in mid- 1985. Screening for AIDS now adds about $5 Besides blood donation there is a large “in- per unit to the cost of blood transfusions. dustry” of plasmapheresis growing from extensive demand for gamma globulin and from By the end of 1987, according to the Centers the recent capability to fractionate blood plasma for Disease Control, 1,608 cases of AIDS ac- and prepare concentrated materials (e.g., clot- quired through blood transfusion had been re- ting factors to substitute for genetically lack- ported in the United States. Of all persons with ing proteins in hemophiliacs). The pooling and hemophilia A (12,400 persons), approximately concentrating of donated plasma has allowed 70 percent maybe infected with AIDS; of those the life expectancy of severe hemophilia A pa- with hemophilia B (3,100), about 35 percent tients to rise from about 14 years in the early may be infected.94 The number of cases of 1960s to 42 years in the early 1980s. Unfortu- transfusion-related AIDS will thus increase for nately the same technical feat made them early some time even if the risk of infection through victims of the spread of AIDS.91 blood transfusions has ended. This was the second great disaster to hit Public anxiety about the safety of the blood bloodbanking. By 1982 it was suspected that supply has led to the demand that “directed AIDS was infectious, and that the unknown donations” be allowed, in which one chooses agent might be transmitted through blood ex- one’s own blood donors from personal friends change, and several cases of AIDS in hemo- and relatives. The costs of such a program, i.e., philiacs had been reported.92 In March 1983, subdividing blood units and allowing special the FDA after consultation with the major storage, is potentially very high. It also cre- blood banking organizations, the National In- ates a “two-class” blood system, and so has stitutes of Health, and the National Gay Task been opposed by many professionals in trans- Force, recommended that persons “at infusion medicine. Autologous donation is the process by which W-iepatitis A is caused by still another virus which is phys- one donates one’s own blood for anticipated iochemically similar to polio virus and is rarely a factor in blood transfusions. future use. In planned, elective surgery this 91J. F. Desforges, “AIDS and Preventive Treatment in He- mophilia.,” New Eng. J. Med. 308: 94-95, 1983. 93 Shilts op. cit., footnote 32, parts IV and ‘“ “U.S. Congress, Office of Technology Assessment, Blood 94u !.s ~blic Health service, Centers for Disease COntrOl, Policy & !l’echnology, OTA-H-260 (Washington, DC: U.S. Gov- Morbidity and Mortality Weekly Report, vol. 36, Supplement ernment Printing Office, January 1985), p. 13. No.S-6, Dec. 18, 1987, table 14, p. 40. 85 — can be a wise precaution. It is not generally There are however strong political constraints useful for emergencies. on this strategy because some people perceive Blood supply system professionals generally any information about avoidance strategies insisted that would-be donors must be informed (other than abstinence or heterosexual monog- that tests will be done on the blood and a donor amous marriage) as equivalent to condoning who tests positive will be informed of the re- homosexuality or promiscuity. The Public Health Service and Centers for Disease Con- sults; and most have strongly supported the position of many other health professionals trol had planned to mail an AIDS information that counseling must be offered in conjunction brochure to every U.S. household in October with blood testing for HIV antibodies. An 1987. But because of political resistance from elaborate process has been set up for obtain- those who feared it would offend some religious groups, the President’s Commission on AIDS ing donor consent, notification of results, and 95 follow up counseling. The burden on blood delayed the mailing until late spring 1988. banks is very large. Strong pleas have been There is some evidence that public educa- made for persons whose behavior puts them tion about AIDS has brought about behavior at risk of AIDS not to donate. But in commu- change within the group so far at highest risk, nities without alternative testing sites, access homosexual males. Most observers report, al- to the AIDS test through blood banks means though there is probably no real quantitative that some people will donate in order to find data, that extreme promiscuity has strongly out if they are infected. declined and the use of condoms has risen. The American Red Cross in 1986 instituted Most experts believe however that other high a look-back procedure, in which infected donors risk behavior, i.e., intravenous drug use, is who are identified through a current donation much less likely to change, since its practi- have their prior donations traced. Stored sam- tioners are already accepting very high legal ples are tested; recipients of prior positive do- and health risks. nations are contacted and told of their possi- Public education is also regarded as the best ble contamination. strategy for dealing with some newly identified behavioral or environmental risks, and for Public Education and Statistical some that have been recognized for several dec- Forecasting ades, such as smoking. There will soon be increasing non-genetic predictive power concern- Epidemics are usually attacked through ing the likelihood of a variety of pathologic preventive education, prevention by vaccine, states such as coronary artery disease and drug treatments, and sometimes social control adult-onset diabetes. Medical science is lead- measures such as quarantines. Only the first ing toward a refined definition of desirable has yet shown real promise for the AIDS epi- “health behaviors” to reduce the likelihood of demic in the next decade. Education is now or severity of such outcomes, so much so that the major public health strategy, other than some have been codified in a fully sanctioned research and the screening of blood and organ set of Federal objectives.96 Increasingly, pub- donors. This means a combination of strate- lic health programs emphasize lifestyle change gies to inform the general public about the dis- and preventive health measures. ease in a way that will be effective yet mini- mize diffuse fear, that will alert adolescents The first strongly documented scientific to the lethal hazard implicit in certain be- warnings that smoking was deleterious to haviors, and that will urge people to avoid “William Booth, “The Odyssey of a Brochure on AIDS, ” behaviors that put them at high risk. The Science, vol. 237, Sept. 18, 1987, p. 1410. - NAS/IOM panel proposed that for every dol- 96pub]ic He~th Service, U.S. Department of He~th and Hu man Services, The 1990 Health Objectives for the Nation: A lar invested in research an equal sum should Mid-Course Review (Washington, DC: Public Health Service, be invested in education for prevention. 1986). health came from epidemiologic studies in the and other matters that they regard as highly 1950s, when epidemiologic methods were not personal. Some social observers see the possi- well accepted except when dealing with infec- bility of a backlash against such pressures, tious diseases. The data are now well-estab- such as occurred against “Blue Laws” and ob- lished; smoking contributes directly and ma- scenity and pornography laws, raising new de- terially to over 350,000 deaths a year in the mands for protection of personal privacy and United States, and “passive smoking” (indirect choice. inhalation of tobacco fumes from others’ smoking) has been found to be physiologically real On the other hand, to the extent that fore- and pathologically significant.97 casting carries a useful personal message, issues of cost, access, and equity arise. Affluent This raises a social/ethical, and ultimately people may have full benefit of forewarning and perhaps a constitutional issue, “how much per- preventive care, and others may not, even when sonal liberty can be tolerated in self-damaging much of the predictive capability results from behavior?” Society has debated this issue be- knowledge and technology developed with pub- fore in terms of motorcycle helmets, seat belts, lic funding. It is in fact only recently that and alcohol; and will increasingly face it in government-funded health programs coun- terms of other lifestyle, nutrition, or environ- tenanced reimbursement for any prevention mental factors. Increasingly accurate predic- or health maintenance costs.98 tive power concerning adverse health behavior Public health professionals increasingly ar- brings us closer to the zone in which society gue for a national goal of comprehensive health claims an interest in the individual’s assump- 99 care for all based on the statement in the tion of risk. Complicating this is the question Preamble to the Constitution of the World raised earlier with regard to occupational ge- Health Organization, which the United States netic screening: should some people, who are formally endorsed, that genetically sensitive to some environmental factors, be legally prevented from entering oc- The enjoyment of the highest attainable cupations, jobs, workplaces, or general loca- standard of health is one of the fundamental tions that are accessible to less susceptible rights of every human being without distinc- people? tion of race, religion, political belief, economic, or social condition. .. .100 Public education and social pressure—even without laws and regulations seeking to con- The fundamental public health issue of the next trol behavior-is considered excessively intru- generation may be the question of whether this sive by some people, when it pertains to eating goal can implicitly be found in the constitu- habits, weight control, recreational pursuits tional language of a right to life, liberty, and property. ‘WU s Dep~tment of Health and Human Services, The Flealtk Consequences of Smoking: Cancer, A Report of the Sur- geon General, 1982 (PHS 82-50179); The HeaZth Consequences ‘MC*J, Schramm, “can We Solve the Hospital-Cost Problem of Smoking: Carch”ovmmdar Disease, A Report of the Surgeon in Our Democracy, “ New Eng. J. Med. 311: 729-732, 1984. General, 1983 (PHS 84-50204); The Health Consequences of 99SnYder, op. cit., footnote 87, P. 1170. Smoking: Chronic Obstructive Lung Disease, A Report of the l~premble t. the Constitution, World Health org~”zation Surgeon General, 1984 (PHS 84-50205). Basic Documents (Geneva, Switzerland, 1963), p. 1. Chapter 6

Medical Interventions: The Beginning and End of Life

Chapter 6 Medical Interventions: The Beginning and End of Life1

Rapid progress has been made in medical because their contribution to length of life, technologies in recent decades and seems cer- quality of life, or reduction of suffering is po- tain to continue, with scientific breakthroughs tentially great. Other great achievements in in many fields. Emerging or impending ad- health care occur when there is a sudden dis- vances in medical capability are often foresee- covery such as penicillin, a breakthrough such able, sometimes years. . before they occur. They as organ transplants, or a new vaccine; such can be anticipated when: discoveries often give rise to a long procession of innovations and inventions. ● there are no theoretical or logical barriers to their achievement, Some of the trends and developments noted ● the scientific and technical barriers are in this chapter are already underway. The tim- identifiable and understood, ing and achievability of others are debated by ● there are alternative research strategies experts. Nearly all are, however, considered for attacking the problems, and likely to become available within 5 to 20 years. ● society puts a high priority on achieving This is, indeed, a conservative view. It neglects the goal and therefore provides incentives many other achievements that may be equally for persistent effort. or more likely, or even closer at hand. It is intended only to indicate the fertile, rapidly de- Some medical goals are less definitely achiev- veloping possibilities of medical science and able, yet continue to be strongly pursued technology and their potential power to intervene in matters of life and death. 1 I preparing this chapter, OTA drew on interviews ~d ‘~ n While not all of these developments will im- cus group sessions conducted at the annual meeting of the Amer- pinge on constitutional principles many of ican Association for the Advancement of Science (AAAS), Chi- cago, January 1987; results of a mailed questionnaire to section them involve issues that may face America in officers of the AAAS in December 1986, and an OTA workshop the 21st century. This chapter looks at some on Biology, Medicine, and Public Health, May 1987. In addi- of the most important impending developments, tion, Jonathan Peck, Institute for Alternative Futures, and Irene Jillson, Policy Research Incorporated, as OTA contractors, con- and the possible constitutional implications of tributed to the development of this chapter. their use.

ADVANCES IN MEDICAL TECHNOLOGIES Rapid advancement in information sciences, Computers and Communications materials sciences, and molecular biology mean Knowledge about health care has prolifer- that new technologies will be developed over ated because of better monitoring of bodily sys- the next 5 to 20 years in the areas of medical tems and the environment. Computers have communications and record-keeping, imaging greatly improved the collection, measurement of body structures, surgical techniques, pros- and analysis of statistics on disease occurrence, thetics, organ and tissue implants and trans- outcomes of treatment, and research results. plants, pharmaceuticals and family planning This knowledge has changed the direction of assists. research and development.

89 90

Reporting surgical results was common prac- the computer provides valuable information, tice as far back as the 16th century,2 but un- but in two dimensional form which is easily til recent decades other treatment outcome interpreted by radiologists but less appropri- measures were largely limited to indicators of ate for surgeons. Computer graphics, however, patient satisfaction, postoperative infection can create three dimensional images that are rates and numbers of malpractice suits. Com- more easily usable for appreciating special rela- puters have encouraged expansion of data tionships and rectilinear measurements.6 about results of therapy, and thus assessment 3 Telecommunications technologies may in the of the effectiveness of treatments. New dis- future facilitate the delivery of health care to ease trends now may become evident much rural and remote areas difficult to service with quicker, an important factor in public health health professionals. Information, imaging, programs. and patient monitoring systems can integrate Computers enhance the efficiency of labora- remote areas with regional hospitals.7 tory research by saving labor costs in process- Beyond these new or developing uses of coming, storing and analyzing diagnostic tests puters, there may be new kinds of computers results. Expert systems are used to help in for medical use. Bio-computers made of pro- diagnosis and in designing therapies. Com- teins and other molecules may someday be de- puters analyze and model bodily systems and veloped. These minute, fast machines would processes such as skin blood flow, to determine 4 be invaluable in medical research and medical the best locus for amputations. With com- care. The technical bases for such biocom- puters, scientists simulate the immune system puters already exist or are being developed by and thus search for the basic principles gover- molecular biologists, physicists, and computer ning complex systems. This in turn can lead to 8 scientists. future medical breakthroughs. Outside the laboratory, computers can by Imaging Technologies integrating medical and financial data, allow cost-benefit analysis of various treatment pos- Imaging technologies can analyze bodily tis- sibilities to develop models for more efficient sue and body chemistry, monitor bodily func- allocation of health care resources. Computers tions and diagnose disease. Computerized ax- are also an essential component in nearly all ial tomography (CAT) scanners and position new medical instruments. Older sensors could emission technology (PET) have already pro- aid the physician in perceiving conditions duced more knowledge of normal and patho- within the body, but today’s enhanced medi- logical functions than could have been im- cal sensors can also measure, correlate, ana- agined a few years ago. PET can scan the brain lyze and store information. Computers are also without invasive surgery, reveal biochemical used to design instruments, analyze equipment reactions taking place, show the response of failure, and repair equipment.5 In scanners such as the CAT (computer-aided tomography), 6Michael w. Vmnler ad Jeffrey L. Mush, “3D 1ma@g Aids Skull Surgeons, ” Computer Graphics World, vol. 8, De- cember 1985, pp. 49-50, 52-55. ‘Richard Cales and Donald Trunkey, “Preventable Trauma ‘Chris Higgins, Earl Dunn, and David Conrath, “Telemedi- Deaths,” JAMAU, vol. 254, No. 8, Aug. 23-30,2985, p. 1062. cine: An Historical Perspective, ” Tehxommunicatiom Pohky, 3Clement Bezold, “Health Trends and Scenarios, ” in Jack A. vol. 9, December 1984, pp. 307-313. In the early 1900s heart Meyer and Marion Ein Lewin (eds.), Changing the Future of tracings were successfully sent via telegraph lines by Einthoven, Health Care (Washington, DC: American Enterprise Institute the developer of the electrocardiogram, for analysis at a far-off for Public Policy Research, 1987), p. 84. laboratory site. Various combinations of television and telephone .4 Veterms’ Administration, Rehabih”tation R&D Progress systems have successfully provided service to Indian reserva- Reports (Washington, DC: Veterans Administration Medical tions, jails, and remote areas of Alaska. Their use has generally Center, 1986), p. 11. been constrained because of high costs rather than technical 5Murray Eden, “Smart Instruments, Microprocessors, and inadequacy. Personal Computers, ” International Journal of Technology ‘Michael Conrad, “The Lure of Molecular Computing, ” Assessment in Health Care, vol. 3, 1987, pp. 327-330. IEEE Spectrum, October 1986, pp. 55-60. —

91 a tumor to drug treatment, evaluate changes optics permit looking directly into internal due to stroke, and observe the lesions causing structures of the body; combining lasers and Parkinson’s disease, Alzheimer’s disease, and fiberoptic allows more sophisticated repair perhaps schizophrenia. Magnetic resonance im- and less destructive removal of diseased tis- aging (M RI) reveals not only bodily structures sues, and more sophisticated neurological pro- but even chemical processes within individual cedures. New microsurgery techniques together cells. It can measure blood-flow rates from spe- with immunological advances may eventually cific locations in the brain (to predict possible allow the restitching of severed nerves or spi- strokes), and drugs such as antidepressants nal cords.10 could be labeled with MRI-sensitive com- 9 These procedures and instruments make sur- pounds and traced within the brain. In the gery safer, less traumatic and less fearsome future, this capability will supplement, and to the patient, and more effective. More sur- could even replace in some situations, more gery can now be done on an outpatient basis. subjective modes of diagnosis of mental illness. The added safety may mean that more surgery This could introduce into the constitutional de- will be done in the future, and more radical pro- bate new arguments regarding responsibility cedures will be attempted. This may well ag- for behavior. gravate current debate about when physicians The increased knowledge about health raises should and should not intervene to prolong life, the long range possibility of conflicts over re- and about who has the right to refuse such in- sponse to that knowledge. For example, im- terventions for themselves or for others. The aging equipment shows clearly the arterial development of fetal surgery to correct abnor- plaque build-up often responsible for heart at- malities before birth is, for example, already tacks, much of which, scientists believe, might raising constitutional issues. be avoided by appropriate diet. This has led to development of plaque-dissolving drugs for Some scientists suggest the possibility of limb regeneration and of synthesis of organic cleaning out arteries and ridding kidneys of 11 tissues. In the meantime, models created stones. But not all problems revealed by new from computer scans aid in the design and pro- medical technologies can be resolved by still duction of prosthetics. Research engineers more new technologies. In that case, social con- hope someday to develop cybernetic devices— trols are sometimes proposed. Some people argue, for example, that those who eat irrespon- building on advances in robotics, artificial intelligence and sensing systems—that will per- sibly (thus filling their arteries with plaque) mit paraplegics to walk, blind people to see, are costing society too much in terms of heath and deaf people to hear. This could include elec- care and thus should perhaps be discouraged from doing so, perhaps by higher health insur- tronically assisted and controlled artificial ance premiums. 1°Angioplasty is surgical reconstruction of the blood vessels, in which a balloon catheter is inserted into a blood vessel and inflated to flatten plaque against the wall of the blood vessel. Surgery, Prothesis, and The stereotaxic headpiece is a metal framework surrounding Trauma Repair the patient’s head to allow precise, minimal invasion of the brain for biopsy, removal of tumors, and so on. Laser surgery, using Trends in surgical practice point to con- a cutting and cauterizing ray rather than a blade, minimizes bleeding and swelling, allows spot-welding of detached retinas, tinued development of less invasive and de- and reduces incidental injuries to healthy tissue. Microsurgeons structive surgery. This is illustrated by balloon use high-powered microscopes, extremely thin needles, and angioplasty, the use of stereotaxic headpieces miniaturized instruments to reattach nerves and veins, recon- struct the middle ear, reroute arteries, and perform other ex- in brain surgery, the use of lasers rather than tremely delicate repairs, even in some cases on fetuses in the scalpels in many areas of surgery, and micro- womb. Henry C. Adler et al,, Md”trends (Chicago, IL: The Hos-

pital Research & Educational Trust, 1986), p. 26. - surgery. Surgical instruments made with fiber- I I Replacement skin from human cadavers has been success

& fully transplanted to a burn victim with the aid of the anti- gLawrence G~ton, Med Tech (New york, Ny: ‘~er rejection drug, cyclosporine. See “Harvesting New Skin, ” Sci- ROW, 1985), PP. 286-303. ence 86, vol. 7, April 1986, p. 9.

88-376 0 - 88 - 4 92 limbs or limb supports, arms and hands that Transplants and Implants move in response to neural impulses, hand-held human-like voice synthesizers, and TV cameras The transplantation of hearts and kidneys implanted in eyes. Computerized electromyo- is no longer considered experimental, although graphic (EMG) feedback is being studied for still risky and severely limited by the scarcity the purpose of restoring function in persons of donors. Transplants of livers are still exper- with long-term spinal cord injury .12 imental. The use of artificial organs, such as the artificial heart, is also highly experimental A new class of materials, bio-ceramics, shows and at present beset with serious and seem- great promise in prostheses. Bone will grow ingly intractable problems. Yet a number of into and unite with one class of ceramics for trends are working together to increase the fea- firm fixation of teeth and artificial joints to sibility of organ replacement with either real the surrounding tissues, an innovation that or artificial organs: promises new opportunities for patient reha- ● bilitation. 13 gradual improvement in surgical techniques and in preservation of organs and Further medical technologies being devel- tissues; oped for the care of traumas include: ● developments in pharmacology, and especially in immunosuppressive, anti-rejec- ● Artificial blood for use in treatment of chronic blood disorders and emergency tion therapy; ● treatment for traumas, particularly desir- rapid advances in materials technology, able to prevent transmission of diseases including submolecular and surface engi- such as AIDS and hepatitis, is currently neering; ● at the stage of basic research, although development of sensors that can send feed- many problems are still unsolved. back to control movement of muscles; ● • Dry curing of burns to eliminate serious development of miniature nuclear power infection is undergoing human experimen- packs; and ● tation. computerized registry and matching of po- . Artificial skin and drugs to control rejec- tential organ donors and recipients. tion are being perfected. Implantation of either human organs or arti- • Phototherapy or light treatment for a va- ficial organs may become more practical by the riety of health problems including psori- end of the century. Cryogenic techniques could asis, sleeping disorders and apneas, radia- be developed for preserving organs for later tion-related diseases, etc., is now at the use; or organ incubators with computerized basic research stage. chemical baths and solutions may allow organs ● A diapulse device for promoting healing to be preserved for months.14 pancreatic cells of damaged nerves and spinal injuries is have been frozen, thawed, and grafted onto the at the stage of animal experimentation. kidneys of diabetic rats where they produced . Treatment of damaged spinal cord nerves insulin; scientists will attempt to develop this through bombardment of cells with elec- technique for use in humans.15 trically charged silver ions is being studied by scientists. Transplants of neural-type tissue from a Parkinson’s patient’s adrenal medulla to his brain have been performed in Sweden and Mex- ico, and brain tissue transplants using fetal brain tissue to assist patients with Parkinson’s

‘2Veterans’ Administration, Rehabih”tation R&D Progress IdArthur C. C]mke, July 20, 2019, (New York, NY: MacMil- Reports (Washington, DC: Veterans’ Adrninistration Medical Center, 1986), p. 11, p. 66. lan Publishing Co., 1986), p. 238. 13John W. Boretos, “Bioceramics,” Cfiemtech, vol. 17, ApriI 15 Shawna Vogel, “Cold Storage, ” Discover, February 1988, 1987, p. 224. pp. 52-54. 93 disease have been done in Mexico and else- Entirely new types of therapeutic agents are where.” As discussed in chapter 4, this pro- being developed, some both more potent and cedure has been discouraged in the United more natural to the body than conventional States because of some ethical concerns. Fur- pharmaceuticals. 17 Some possibilities are: ther development of these medical procedures ● Immunomodulators-These maintain pro- and techniques outside of the United States per functioning of the immune system, is likely to stimulatec hallenges to Federal and without the problems associated with cur- State regulation or prohibition. rent cell-killing drugs. New treatments Implants of microchips and biochips may in would involve the use of natural sub- the future allow better monitoring of bodily stances such as interferon, to modif y spe- functions, regulate drug delivery devices, en- cific functions in the body. These immuno- hance defective sight or hearing, and provide modulators will be used, first, as therapy neural control of damaged limbs. Some scien- for immune deficiency diseases and to sup- tists hope that eventually “biological ma- press the immune system for grafting and chines” could be implanted to repair human transplanting organs, then to enhance the tissue and organs. natural killer cells to attack new cancers and other diseases. Advances in biological and non-biological ● Neurotransmitters-Scientists are becom- materials and in microelectronics hold the ing more familiar with the activities of promise of significant advances in related tech- these materials and new and more ef- nologies, such as the following: fective treatments should follow for Par- ● programmable implantable medication kinson’s disease, Alzheimer’s disease, systems including infusion pumps, for use amyotrophic lateral sclerosis (ALS), Hunt- in treatment of such problems as diabetes ington’s disease and mental diseases and cardiovascular disease; some are now caused by neurotransmitter deficiencies. in clinical trials; Some pharmaceuticals to enhance or pro- ● implanted electrodes and brain peptide long memory are already being tested. releasers, for treatment of depression, pro- ● Neurotrophic hormones–It is hoped that pensity to aggression, and other emotional neurotrophic hormones may stimulate disorders; growth in dying nerve cells that produce ● implanted electronic hearing aids; the transmitters. Research to identify neu- ● cerebella pacemakers for control of rotrophic hormones will probably be fol- epilepsy, chronic pain, schizophrenia, and lowed by large-scale synthesis and treat- violent behavior; ment. Drugs capable of penetrating the ● automatic defibrillator for assisting blood-brain barrier could treat loss of func- damaged hearts; and tion in the neocortex due to severe head ● artificial visual implants or assists and im- injury. age enhancers for the visually impaired. ● Mood-altering drugs—These drugs have been found to exist naturally in the body Pharmaceuticals as a class of compounds made up of endor- phins and enkephalins. Many functions Breakthroughs in pharmaceutical products have been attributed to these materials and delivery systems promise radically differ- including acting as a pain-blocking analge- ent medical treatments for many illnesses. sia, tranquilizer, and antidepressant. Opi- Drugs are being developed that act closer to ate blockers can be used to modify such the disease site and are specific to the damag- behaviors as overeating and aberrant sex ing side effects of older untargeted treatments. ITWilliam Check, “New Drugs and Drug Delivery Systems IG’’Brain Graft Revives Sufferer From Parkinson’s Disease, ” in the Year 2000, ” American l%armac~~, ~f)l. NS24, No. 9, Sep- New Scientist, Jan. 14, 1988, p. 28. tember 1984. 94

drives. These substances, being natural Figure 6.1 .—Portable Infusion Pump to the body, may not be addictive and may eliminate the side effects of current “mood elevator” and other drugs. ● Monoclinal antibodies-These products of genetic engineering have opened up a wealth of new therapeutic possibilities, such as cancer chemotherapy in which the cell-killing drugs would attack only the cancer-causing cells in the body. Toxic chemicals attached to the antibodies would then seek out cancerous cells before being activated. Monoclinal antibodies may also be used to kill donor cells that cause lethal conditions in bone marrow transplantations. They can be made to react with infectious bacteria against which antibiotics have not been successful. They can be designed to behave as enzymes, Infusion pump is worn continuously and delivers gonado- tropin releasing hormone intermittently either subcutane- catalyzing chemical reactions and open- ously or intravenously. ing up the possibility of unlimited diversity in specific-acting enzymes. *8 SOURCE” Ferring Laboratories, Inc., Suffern, NY, 1988. ● Prostaglandins-A natural substance in the body, synthesized prostaglandins can can be altered with time and, as equipment be- be used as anticlotting agents useful in comes smaller and simpler, can be used by pa- heart bypass surgery, prevention of heart tients to provide their own chemotherapy at attacks through clot prevention, and home. Another form of delivery system will treatment of asthma, ulcers and inflam- be sprays. mation. ● Vaccines—Synthetic vaccines that confer Reproduction Technologies multiple protection could be used for in- fluenzas. Viruses that cause cold sores, For those wishing to have children, the pos- genital herpes, chicken pox, etc., could be sibilities of technological help have recently attacked with new vaccines. been greatly increased. These new assists are not always successful, and many carry signif- New delivery systems may have nearly as icant risks and high costs. They include fertil- momentous effects on medical care as new ity drugs; artificial insemination using the se- pharmaceuticals themselves do. Especially im- men of the husband, a selected partner, or an portant will be the controlled release of drugs unknown donor; and in-vitro fertilization using at dosages and times that are needed. New ma- either both parents’ germ cells or donated eggs terials used for coating will release drugs at and/or semen, with implantation in the uterus a constant rate through degradation, permea- of either the biological mother or a surrogate ble membranes and electric charges. Magnetic mother. Sperm freezing techniques permit an systems can be used for pulse-released drugs increase in the number of donors and theoreti- such as immunosuppressants for transplant cally make possible the selection of specific patients and implanted pumps will deliver pre- genetic characteristics for the babies. Frozen cise dosages for treatment of cancer and for embryos have increased the ease and success delivery of insulin. (See figure 6-l.) Dosages rate of in-vitro fertilization and implantation, but raised ethical issues regarding the use of l~sW Ch. 3 for a more detailed description. “excess” or left-over embryos. —

For those wishing to curtail production of gin cell reproduction again, and implanting a family, technologies will also provide choices: each new embryo in the womb of a less valu- injectable contraceptives, a contraceptive vac- able brood cow. Chimeras have been developed cine, intrauterine devices for preventing em- by placing foreign genes in animals as com- bryo implantation; and non-surgical sterili- plex as mice. A series of experiments have zation. produced healthy chimeric mice by implant- These “technologies at the beginning of life” ing in the uterus of a mouse, differentiated cells found in tumors. The interesting issue here is promise to raise a number of serious constitutional issues, which are discussed in later sec- that what were thought to be undifferentiated tions of this chapter. cells in a tumor, actually contained a variety of tissues-tooth, bone, gland, etc.—from which Science fiction abounds with stories about could be grown an entire animal.19 chimeras and clones. Chimeras are animals It now appears unlikely that human clones with the genes—and characteristics-of two or chimeras will be developed, although the or more species; in Greek mythology the chi- mera was a beast that had the head of a lion, barriers are in the long-run apt to be ethical the body of a goat and the tail of a serpent. and political rather than technical. The evolu- Clones are animals genetically identical to a tion of this capability could nevertheless re- parent, i.e., reproduced asexually, or to a sib- sult in production of body tissues, or new body parts, and at least in theory could allow uni- ling (when an early stage embryo is divided sex pregnancy and childbearing, even by and reimplanted). These have until recently males. been considered in the class of fairy tales. But large animals such as valuable cattle are now produced in multiple identical copies by remov- 19KW] ]llrnensee and Leroy C. Stevens, ‘‘Teratomas and ing a fertilized egg after two cell divisions, Chimeras, ” Scientific American, vol. 240, April 1979, pp. dividing it and allowing each fragment to be- 120-132.

TRENDS SHAPING THE FUTURE OF MEDICAL TECHNOLOGY Important trends that are emerging in re- 5. a proliferation of techniques to assist, con- gard to new and future medical technologies trol, or avoid reproduction; and are: 6. growing ability to evaluate, diagnose, and 1. an explosive increase in knowledge about give medical or surgical treatment to the fetus in the womb. the biology of disease, the environment, bodily functions and new treatments; Some of these themes, and particularly the last 2. earlier diagnosis and treatment, increas- three listed above, promise to raise complex ingly moving beyond control of symp- ethical, political, legal, and constitutional toms to interventions that will prevent issues. symptoms; 3. an ever larger attention to the costs of Earlier and More Effective Diagnosis, health care in choices of treatment and in Intervention, and Prevention development of new technologies; resulting in an important role for technology Intervention in the disease process can vary assessment; from consumer education on diet and lifestyles, 4. growing capability to maintain basic to genetic engineering and drug therapy. The bodily functions technologically, when shift from controlling symptoms to more posi- neurological control is degraded or almost tive intervention is the result of a circular in- entirely absent; teraction between new scientific knowledge,

88-376 0 - 88 - 5 96 new instruments, and treatment-enabling tech- administering mood-altering or behavior-con- nologies that in turn produce further knowl- trolling medication. edge. Earlier diagnosis and prevention of dis- Public policy problems with the trend toward ease are of particular importance in approaches self care include the cost, which is not currently to chronic illnesses, which constitute the ma- reimbursed by medical insurance providers, jor illness burden in industrialized nations. the question of the reliability of tests and the They will, however, also affect acute illnesses expertise needed for their use, and concern in which genetic, behavioral and environmental about the provision of home care for those who factors can be identified. are unable to care for themselves adequately. Prevention of disease itself carries a poten- These problems do not appear to imply any tial for clashes between the general welfare and constitutional issues. the assertion of individual rights, as illustrated by AIDS containment and crusades against The Growing Importance of Health tobacco use. As knowledge of disease-causing Care Costs behavior, aversion to risk, and the incentive to control health care costs all grow, some peo- The cost of medical care is an important in- ple are arguing that freedom to indulge in un- gredient in a discussion of health care technol- healthy behavior should be curtailed. This is- ogies and their constitutional implications. sue was introduced in chapter 5 as raised by Health care in 1985 accounted for 11.2 percent public health programs. of gross national product, up from 5.9 percent in 1965. Health cost increases far outstrip in- Self-Care flation and although they have lessened, they still outpace price increases of other goods and New technologies, while causing some of this services. This growth is expected to continue, rapid increase in costs, also enable more peo- reaching 15 percent of GNP by the turn of the ple to take care of themselves when ill, thus century.’” In 1985 and 1986 the growth in the potentially reducing health care costs. Home- number of surgical procedures performed, based computers linked with diagnostic-treat- which had flattened since 1981, resumed. ment centers or implanted microchips for sensing body conditions and for release of drugs, The health care system is being reshaped as could for example make possible self-adminis- joint ventures proliferate between hospitals, tered chemotherapy treatment of cancer. In- physicians and other investors; the role of mar- travenous physical and respiratory therapy ket forces becomes more important in technology choices; and consumers and payers of and monitoring of chronic disease could take 21 place in the home. health care demand more say in the process. As costs become a major factor in health care, A strong trend toward self-diagnosis, self- medical decisions are no longer the sole pre- care, and home-care techniques has been evi- rogative of physicians. dent for some time. Pregnancy test kits, kits for testing or measuring urine sugar content, While some technologies such as expert sys- and consumer instruments for monitoring tems and diagnostic testing kits can poten- blood pressure have already become familiar. tially decrease health care costs, others such Further home diagnostic tests are being de- as imaging machines and transplants are likely veloped. Implantable time-released medication to remain very expensive. Technology has been is already in use for some conditions. Some ex- called both the culprit in raising medical costs, perts anticipate the development of “hospitals zOD~iel R. Waldo et al., “National Health Expenditures, on the wrist, ” i.e., wearable devices that mon- 1985, ” Health Care Financing Review, Fall 1986, vol. 8, No. itor certain body functions and make chemo- 1, pp. 1-21. Also see “National Health Expenditures, 1986-2000, ” Health Care Financing Review, vol. 8, No. 4. Figures for 1987 therapeutic and electromagnetic adjustments obtained by telephone from Daniel Waldo, February 1988. as necessary. Potentially, this might include zl~editrends, footnote 10, P. vii. 97 and the benefactor that is improving health yet clear, but this could become an important and life expectancy .22 Even when new, less issue in the future. costly technologies are developed, the rate of While this report cannot explore in depth the use often increases, offsetting potential sav- issue of medical costs, governmental policy ings. And increased knowledge regarding toward medical advances that provides some health hazards in the environment is likely to with great benefits, at high cost to others than increase the demand for health care, including the beneficiaries, is part of the general constitu- research and product development. How the tional discussion on equality of access and of change in hospitals from an altruistically ori- 23 the alleged right to treatment. ented local industry to a for-profit national chain industry affects health care costs is not - 23 F or a discussion of the economies of the distributional is ZZLoui~ p, Gmrison, Jr , and Gail R. Wilansky, “cost Con- c sues and the criterion of social welfare, see John H. Doggeeris, tainment and Incentives for Technology, ” Health Affw”rs, vol. “Medical Insurance, Technological Change, and Welfare, 13co- 5, Summer 1986, pp. 46-58. nomic Inquiry, vol. XXII, January 1984, pp. 56-67.

EXTREME MEDICAL INTERVENTIONS AND THE EXPANDING LIMITS OF PERSONAL CHOICE24 Some of the major “medical miracles” re- A person who is dead ceases to have constitu- cently unveiled or now on the horizon so fun- tional rights. Thus before the redefinition of damentally challenge our assumptions about death, a person on a mechanical ventilator, human limitations that they may change our even if “brain dead, ” was a person and retained view of the proper relationship between the all of the rights of a person under the Consti- State and the individual, or of personal liberty tution; after the redefinition, the person in iden- and responsibility. tical circumstances was a corpse with no rights, and could be used as a source of donor Taking the heart from a person whose cir- organs with or without his or her intent prior culation and respiration could be maintained to death. This redefining of death was brought only with a mechanical ventilator, and transplanting the heart into another person, directly about primarily by three technologies: the elec- troencephalogram, which permitted physicians challenged laws that conventionally deter- to confirm the absence of brain activity or func- mined death as the time when one’s heart tioning; mechanical ventilation, which main- stopped beating. A strict application of this legal definition would make a human heart tained circulation until vital organs could be “harvested”; and immunosuppression drugs, transplant a double homicide, in spite of the which help control rejection and made organ fact that its purpose is to save life. This tech- 25 nological innovation helped to force us to reach transplantation workable. a new definition of death—the death of the The law permitted physicians to develop this brain. new definition of death on their own, because the law has always been that a person is dead when the doctor pronounces him or her dead,

wMuch of the materi~ in this section is based on contractor provided that the doctor make this pronounce- reports: “Constitutional Issues in Extreme Medical Measures ment on the basis of “good and accepted med- at the Beginning and End of Life, ” prepared for OTA by Ge- orge J. Anus, J. D., M. P. H.,Utley Professor of Health Law, Bos- ton University Schools of Medicine and Public Health, and “Con- ‘5 President’s Commission for the Study of Ethical Problems stitutional Implications of Scientific and Technological in Medicine and Biomedical and Behavioral Research, Defin- Advances in Public Health, prepared for OTA by Dr. Leonard ing Death (Washington, DC: U.S. Government Printing Office, H. Glantz, Professor of Health Law, Boston University Schools 1981). G.J. Anus, “Defining Death: There Ought To Be A Law, of Medicine and Public Health, April 1987. Hastings Center Report, vol. 13, No. 1, 1983, pp. 20-21. 98 ical standards. ”26 Some people have objected The concept of constitutional privacy has to having this standard developed by the med- been applied most directly to individual deci- ical profession because they object to giving sions about reproduction. The old deference to physicians the first opportunity at defining the the State interest was indicated in chapter 4 implications of new medical technology for and again in chapter 5 by reference to the case basic rights. of Buck v. Bell, in 1926,30 which upheld the constitutionality of a State’s involuntary steril- The adoption of brain death as an accept- ization statute. Justice Holmes said: “The prin- able criteria for human death raises further ciple that sustains compulsory vaccination is questions: Is brain functioning a necessary or broad enough to sustain cutting the Fallopian appropriate criteria for life, or for personhood, tubes. . . .“ But in a very similar case in 1942, or for rights? Do those who are born without the Court specifically affirmed that marriage functioning brains, e.g., anencephalic neo- 27 28 and procreation were fundamental rights, es- nates, have any rights? What about those sential “to the very existence and survival of who are permanently comatose? If science can the race. ” develop a test that confirms the irreversible loss of all higher brain functions, (neocortical), Griswold v. Connecticut,31 in 1965, was could brain death be expanded to include this however the real landmark case in this area. category as well?29 A State statute made it illegal for “any person” to “use any drug, medicinal article or in- Most medical technologies will not so radi- strument for the purpose of preventing concep- cally alter the rights of individuals in this “all tion. . . .“ The statute also made it a crime to or none” fashion. But many of them have po- “assist, abet, or counsel” any person in com- tentially profound impacts on the definition mitting this illegal act. A Planned Parenthood or application of critical constitutional rights counselor and a physician gave advice on birth because they affect life, death, procreation and control to a married couple and prescribed a privacy. For example, evolving technical ca- contraceptive device for the wife; they were pabilities to assist and support reproduction then arrested and convicted. give rise to questions about the individual rights of the mother and the interest of the The Supreme Court, in overturning the State State in the welfare of the potential or devel- statute, said, “We do not sit as a super-legis- oping fetus. lature to determine the wisdom, need, and propriety of laws. . . .“ But it also said that taken The development of the judicial concept of as a whole, the Bill of Rights creates penum- privacy was described in chapter 2. To recapit- bral rights of “privacy and repose, ” in other ulate, the Supreme Court has concluded that words, a sphere of personal choice in which gov- the rights specifically protected in the Bill of ernment has no business. Rights and buttressed by the Fourteenth Amendment delineate a penumbra of privacy, The Court was recognizing that modern sci- or a sphere of autonomy and confidentiality, ence and technology-in this case, biological on which government should intrude only when science and contraceptive technology-create impelled by an important and pressing inter- new choices for people in their personal lives, est of State. and that government would at times attempt to regulate or negate those choices by control- 2GG.J. Anus, L.H. Glantz, B.K. and Katz, The Rights of Doc- ling (or banning) the use of the technology, tors, Nurses, and Allied Health Professionals (New York, NY: Avon Publishing Co., 1981). especially if this seemed essential for the gen- 27A newborn infant with an incomplete and non-functioning eral welfare. The Court said: brain. 2gA. M. Capron, “Anencephalic Doners: Separate the Dead The present case, then, concerns a relation- From the Dying, Hastings Center Report, vol. 17, No. 1, 1987, ship lying within the zone of privacy created pp. 5-9. 29R. Veatch, Death, Dying and the Biolo~”cai Revolution 30~uc~ v. Bell, Z’j’Zf U.S. 200 (1926). 31381 u-s. 479 (1965). (New Haven, CT: Yale University Press, 1976). 99

by several fundamental Constitutional guar- This was made clear by the abortion deci- antees. . . .Would we allow the police to search sions, Roe v. Wade and Doe v. Bolton34 both the sacred precincts of marital bedrooms for in 1973. The first involved a statute making telltale signs of the use of contraceptives? The it illegal for a physician to perform an abor- very idea is repulsive to the notions of privacy tion even if a woman’s life was endangered by surrounding the marriage relationships. pregnancy. The Court recognized that the right Three Justices concurred that the right of of privacy is “broad enough to encompass a marital privacy is a “fundamental and basic” woman’s decision whether or not to terminate personal right but gave as the source of that her pregnancy.” This right, while not absolute, right the Ninth Amendment.32 Seven years is “fundamental” and may be infringed only later the Court extended the right of “repro- if there is a compelling State interest. ductive privacy” to unmarried persons.33 The The State claimed two such interests: pre- Court said in that case: serving the life of unborn children and protect- If the right of privacy means anything, it ing maternal health. The Court rejected the is the right of the individual, married or sin- latter interest because with new medical tech- gle, to be free from unwanted governmental nology, abortion during at least the first tri- intrusion into matters so fundamentally affect- mester carries less risk to the mother than ing the person as the decision whether to bear childbirth. After the first trimester, the Court or beget a child. said, the State could “regulate the abortion The decision specifically rejected arguments procedure to the extent that the regulation rea- that the State was attempting to regulate po- sonably related to the preservation and pro- tentially harmful articles, because as between tection of maternal health, ” but could not pro- married and unmarried people “the evil, as per- hibit abortion. At the point of fetal viability ceived by the State, would be identical. ” This (when the “fetus could live outside the indicated that the Court will closely scrutinize mother’s womb, albeit with artificial aid”) the State interference into areas of life which are State could prohibit abortion because its in- considered “private.” terest in the potential life becomes compelling. Even then, the State could not prohibit abor- The Court has been strongly influenced in tion when it was necessary to preserve the life cases involving contraception and abortion by or health of the mother. advances in medical technology. Improve- ments in medical technology have allowed in- The second of the two 1973 abortion cases dividuals safer and more effective control over concerned State requirements that all abor- reproduction, and at the same time have tended tions take place in hospitals accredited by the to undercut the State interest so far as that Joint Commission on Accreditation of Hospi- interest was traditionally based on the safety tals. The Court could have chosen to apply a of the mother. “minimum rationality” criteria and accepted the State’s authority to regulate in the interest of public health. Instead it recognized per-

3ZIn Justice white’s concurring opinion it is noted that the suasive data about the technology, indicating State claimed to ban the use of contraceptives in order to dis- that facilities other than hospitals could safely courage all forms of illicit sexual relations, premarital and ex- perform abortions. It found that the State was tramarital. Because he could find no rational relationship between the use of contraceptives by married couples and the attempting to regulate abortions during the legitimate policy of discouraging illicit sexual activity, Justice first trimester of pregnancy contrary to the White found that the law violated the Fourteenth Amendment earlier Roe decision. right to liberty. ‘3Eisenstadt v. 13~”rd, 405 U.S. 438 (1972). The statute at is- Since 1973 the Court has heard a number sue authorized prescription of contraceptives for married persons, made it illegal to prescribe or sell contraceptives to un- of cases involving restrictive abortion statutes, married persons, but permitted both married and unmarried 4 persons to obtain contraceptives if the purpose was to prevent 34RN V:wade, 410 U.S. 113 (1973) and ~Oe v. Bo~ton, 10 disease rather than to prevent pregnancy. Us. 179 (1973). 100 scrutinizing them closely for potential infringe- nition of the interest of the State that is ment on the right of privacy. Some of these grounded on an assessment of technological decisions involved points related to the safety capability will be subject to challenge and rein- of advanced technology .35 A recent case indi- terpretation. cated that the Court will look closely not only The full scope of activities that the Court the legislature’s rationale for legislation but 36 will consider to fall under the rubric of the fun- also at the motive in passing it. damental right to privacy is not yet clear. The These decisions illustrate the relationship be- Court has applied it to the distribution of con- tween new technological capabilities and pres- traceptives, 37 to the possession of obscene sure for reexamination of constitutional pro- materials in one’s own home,38 and to prohi- visions. New abortion methods—safer to the bitions on interracial marriages.39 State Su- mother and less costly than old methods— preme Courts have extended this right further: increased the demand for abortion and at the as a basis for individuals to refuse life sustain- same time undercut one rationale for the ing medical care, or for their families to refuse State’s interest in prohibiting it, i.e., the safety it on their behalf,40 to refuse antipsychotic of the mother, by making early abortion sta- medications, 4] and to obtain acupuncture tistically safer than childbirth. (Continuing po- treatments without State interference.42 litical support for prohibition of abortion in- On the other hand, the Supreme Court has dicates that this rationale was not the only, refused to strike down a law that outlawed con- or perhaps even a primary, reason for the 43 sensual sodomy, saying that where no fun- State’s position.) With medical technology now damental privacy right was implicated (imply- moving back the point of fetal viability, it may ing that the right does not cover all forms of again encourage or at least support reexam- sexual activity per se) the State needs only ination of the Court’s position, for example, show ‘a rational basis for the law. ” The “pre- by eventually challenging the assumption that sumed belief of a majority of the electorate in the second-trimester fetus could not survive. Georgia that homosexual sodomy is immoral Indeed, “artificial wombs” could someday and unacceptable” provided that rational ba- make it possible for all or most of gestation sis. Dissenters on the Court said that the is- to take place outside of a mother’s body. On sue is the right “to conduct intimate relation- the other hand, and probably sooner, progress ships in the intimacy of his or her own in medical technology could make second- and 44 home. ” It appears that the scope of the con- third-trimester abortions as safe or safer for stitutional right to privacy as regards the body the mother as either natural childbirth or and its reproductive functions is still being de- cesareans. In the long run, therefore, any defi- fined by the Court. Ssp]anned p~enth~ of Missouri v. Dan forth, 428 U.S. 52: Another marital privacy issue is suggested A State prohibition of the use of saline amniocentesis for abor- by the recent action of a judge of the Arizona tion after the first semester, based on the argument that alternative methods such as prostaglandin instillation were safer, Superior Court in sentencing a woman to life- was struck down because saline amniocentesis was an acceptable procedure, the alternatives were less readily available, and “7Carey v. Population Services International, 431 U.S. 678 more hazardous techniques such as hysterectomy were allowed. (1976). Thus the prohibition was “an unreasonable or arbitrary regu- 3“Stanley v. Georgia, 394 U.S. 557, 564 (1969). lation designed to inhibit . . .“ abortion. Akron v. Akron Cen- sgLoving v. Virginia, 338 U.S. 1, 12 (1967). 64 terforlieprodzzctive Health, 462 U.S. 416,433 (1983): a statute 401n the case of K~en Quin]~, for example, 355 A. 2d 7 requiring hospitalization for all abortions after the first trimes- (N.J. 1976); also Superintendent of Belchertown v. Saikewicz, ter was struck down as merely an attempt to place “a signifi- 373 Mass. 728 (1977). cant obstacle” in the path of those seeking abortions; the Court dlRoger~ v. Okin, 390 Mass., 489). recognized continuing improvement in safety of second trimes- ~~Andrews v. B~]~d, 498 F. SUpp. S.D. Texas ( 1980). ter abortions. ~SBowers v. ~mdwic~, 106 S. Ct. 2841 (1986). The law was aGThornburgh V. American College of Obstetricians and GY- so written that it applies to married and single persons, and necolo~”sts, 106 S. Ct. 2169 (1986). See L. Glantz, “Abortion to both heterosexual and homosexual behavior. The challenge and the Supreme Court: Why Legislative Motive Matters, ” Am. was brought by a homosexual male. J. Pub. Health, vol. 76, 1986, p. 1452. 44Blackmun, dissenting, 2848, 2853. 101 time probation and ordering her to maintain appealed on the grounds that they violate the birth control throughout her childbearing constitutional right to privacy .45 years. At about the same time a judge in Indi- ana, sentencing a woman for the death of her child, suggested that he would significantly reduce the sentence if she agreed to surgical ‘s’’ Mother Who Deserted Her Infants Is Ordered To Stay On Birth Control, ” New York Times, May 26, 1988. “Is Serializat- sterilization. There were immediate indica- ion the Answer: A Controversial Punishment for Abusive tions that both of these sentences would be Mothers, ” Newsweek, Aug. 8, 1988, p. 59.

MEDICAL INTERVENTIONS AT THE BEGINNING OF LIFE Modifications in the mode of human repro- right, if it exists, extends to homosexual as duction have long been the stuff of science fic- well as heterosexual couples or individuals.49 tion. For example, in George Orwell’s 1984,46 Some experts, drawing analogies from court artificial insemination by donor was mandatory, and in Aldous Huxley’s Brave New challenges associated with sterilization, con- 47 traception, and abortion, suggest that the con- World, reproduction was the exclusive domain of the State, and embryos were produced cept of a “right to privacy” in procreation would be involved if government attempted and monitored in artificial uteruses in govern- to regulate or prohibit such technologies as in ment-run “hatcheries. Much more recently, 48 vitro fertilization (IVF) or the use of frozen em- Margaret Atwood in Handmaid’s Tale pic- 50 bryos for implantation. (See figure 6-2.) tured a nation in which most women are sterile, but a lower caste of “handmaids” bear chil- Constitutional interpretation in this area has dren for the ruling class as surrogate mothers, come to depend heavily on prevailing scientific “two-legged wombs. . . ambulatory chalices. ” views and on up-to-date assessments of technological capability and safety. The steriliza- The Supreme Court has yet to consider whether there are constitutional issues in- tion cases discussed above reflect the values of the eugenics movement of the first t wo dec- volved in human reproduction via the new “noncoital” reproductive technologies that ades of this century; after that period court permit reproduction without sexual inter- decisions reflect new knowledge about genetics and newly available medical alternatives. course. The Supreme Court has protected the right In Vitro Fertilization (IVF) to use birth control outside of marriage. It has and Surrogacy not expressly recognized a right to bear children outside of marriage, and in the Bowers IVF was developed to assist married cou- case, the decision included a dictum to the ef- ples who were unable to have children because fect that State laws against sexual activity out- the wives’ fallopian tubes were blocked or dis- side of marriage were not precluded. Therefore eased. The IVF method bypassed diseased fal- it is uncertain whether there is a constitutional lopian tubes, removing ova from the ovaries right to procreate, by either coital or non-coital through a surgical procedure, combining the means (i.e., through artificial insemination and/or in vitro fertilization), or whether such 49U.S. Congress, Office of Technology Assessment, Infertil- ity: Medical and Social Chojces (Washington, DC: U.S. Gov- ‘[; George Orwell, 1984 (New York, NY: Harcourt, Brace, ernment Printing Office, May 1988), pp. 219-220. 1949). “)More radical or unlikely possibilities such as cross-species “Aldous Huxley, Bravae New WorM (New York, NY: fertilization, extracorporeal gestation (embryos brought to term Harper & Brothers, 1946). in artificial wombs), or cloning might become highly controver- ‘“Margaret Atwood, Handmaid Tale (Boston, MA: sial at the R&D stage, raising the issue of the “right to experi- Houghton-Mifflin, 1986). ment” or ‘‘forbidden knowledge, as discussed in chapter 4. 102

Figure 6-2.-Multicellular Embryo might be challenged as a violation of the separation of church and State. Based on the precedent of Roe v. Wade, the embryo is not considered “viable” until it is implanted in a uterus and thus, at the petri dish stage, it would have no rights that would outweigh the right of the gamete donors to decide whether to use it or not for procreation. If complete extracorporeal gestation outside of the womb becomes a possibility, then it is possible that the Court would be challenged to reconsider this assumption, but to do so would invite a reexamination of some forms of birth control technology, which work by preventing implantation of fertilized ova in the womb. This would, however, imply that rights predate the individual, or that the egg and sperm have rights. Another objection to IVF, however, is that usually more than one embryo is created in the process. Decisions must then be made about the use of “left-over” embryos—i.e., ones created but not needed after transplantation of one of the embryos is successful. Could the State prohibit or regulate secondary use, in which the embryo is frozen and donated to a sterile couple? (See figure 6-3.) If the alterna- Human embryo developing in vitro before transfer to female reproductive tract or cryopreservation. tive to secondary use is destruction or open- ended storage of the embryo, it is difficult to SOURCE: L Reprinted with permission. A A. Acosta and J.E Garcia, “Extracor- poreal Fertilization and Embryo Transfer,” Infertility: Diagnosis and see what interest the State would assert. Could Management, J Alman (cd.) (New York, NY: Springer Verlag, 19S4). the State require the donation of excess embryos to some embryo bank to avoid destruc- ova with the husband’s sperm in a petri dish tion? Gamete donors might claim a property or test tube, and after fertilization and a num- right to choose whether or not the frozen em- ber of cell divisions, transferring the embryo bryo is donated or might object to the State to the wife’s uterus for implantation.51 About allowing their genetic offspring to be raised 3,000 births have resulted from IVF in the by others. Should the State forbid experimen- United States in the past decade. IVF, at least tation on the “spare” embryos? Could the as confined to married couples using their own gamete-producing couple object? In fact, nearly gametes (ova and sperm) appears to raise only always more than one embryo is implanted in one possible constitutional issue: could a gov- the womb of the potential mother, since the ernment prohibit the use of IVF? failure rate is high (as is, very likely, the failure rate for “natural” implantation), and “ex- This would presumably be based on the claim cess” embryos are sacrificed either naturally, of potential harm to the embryo. If such legis- by the body, or deliberately by medical inter- lation were based on an argument that IVF vention. The difficulty is that the more nearly is “unnatural” and therefore “immoral” it scientific artifice approaches “natural” proc- “G.J. Anus and S. Elias, “h Vitro Fertilization and Embryo esses, the more it takes on some of nature’s Transfer: MedicolegaI Aspects of a New Technique To Create own profligacy with potential life. These inter- a Family, ” Family Law Quarterly, vol. 17, 1983, pp. 199-223. twined issues are likely to be brought forward 103

Figure 6-3.—Cryopreservation of Human Embryos Use of a surrogate mother, however, intro- in Liquid Nitrogen Storage Chamber duces a third, unrelated party into the process of procreation. The State has a strong interest in protecting this person from exploitation. “Surrogacy” is in fact an imprecise term; arrangements might involve several different combinations of genetic parents who provide the ova and sperm, a host mother who carries the fetus through gestation, and adoptive parents who may or may not include one or more genetic parents-three, four, or five different persons might be involved. New questions arise as to the terms of the contract between biological parents, host mother, and adoptive parents; the State would be called on to enforce these terms. For example, one question might be the right of the surrogate (host) mother to alienate or give up (by contract) her right to abort; would enforcement of such a contract amount to violation of the Thirteenth Amendment prohibition on involuntary ser- vitude? While a general ban on reproductive surrogacy might be constitutionally challenged as interfering with a right to procreate without State regulation (barring a compelling State interest), a State prohibition on commercial surrogacy, or the buying or selling of embryos, may be permitted as regulation of SOURCE Martin M Qulgley Cleveland Cltnlc, Cleveland OH commerce; the selling of children is for example generally prohibited. in the near future and may or may not be ar- In June 1988, the governors of both Michi- gued as constitutional issues. gan and Florida were reported to have before The capability of preserving the viability of them for signature legislation making it a an embryo through freezing also makes it eas- felony to arrange a surrogate mother contract ier to transfer it to a surrogate mother for for payment. According to news reports bills gestation, rather than to the wife or egg donor. to regulate or prohibit surrogacy have been in- In this case IVF would be used to allow a cou- troduced in at least 18 States.52 ple to avoid pregnancy altogether and yet have State-mandated record-keeping is common, a child with the genes of both. and genetic record-keeping would probably be The line of judicial precedents already de- permissible either to document the safety of scribed supports a married couple, or a woman, procedures such as IVF or to protect the fu- or (probably) a heterosexual couple being pro- ture interests of children in learning about their tected from State interference in the decision genetic heritage. The major limitation on rec- to beget, conceive, or bear a child. In addition ord-keeping in medical practice is assurance fetuses can be protected only after their viability and then only in ways that do not harm ‘zAndrew H. Malcolm, “Steps To Control Surrogate Births the mother. Stir Debate Anew, ” New York Times, June 26, 1988, p. 1. 104 that confidentiality can be maintained.53 The Court used the same reasoning as in the earlier Court has permitted record-keeping and man- case, i.e., the government is not required by datory reporting of abortions and complica- the Constitution to fund any medical care, no tions, but only under very close scrutiny to matter how vital such care may be; funding ascertain that the records are for protection is a matter for Congress or the State legisla- of maternal health and are kept confidential. tures to decide. As discussed elsewhere, some The Court has also approved laws requiring people argue for a different interpretation of pathological examination of fetal tissue. the Constitution, asserting a general “right to Requiring physicians to keep permanent rec- health care,” but unless and until such a right ords of sperm donors, ova donors, surrogate is recognized, the refusal to fund infertility mothers, etc., and the collection of this data treatments while other medical interventions by the State would presumably not raise any are funded would not raise constitutional constitutional issue provided it were released issues. only to those involved, and to the child.54 Finally, there may be issues regarding the Fetal Surgery financing of new reproductive technologies. With the capability of antenatal (before There have been two significant Supreme birth) examination, diagnosis, and treatment Court decisions on the question of State fund- of the fetus has come the possibility of view- ing of abortions under the Medicaid program. 55 ing the fetus as “the doctor’s second patient. In 1977, the Court concluded that laws pro- The ability to intervene to treat the fetus is viding public funding for childbirth, but not at present very limited; in most cases, the only for abortion, were not a denial of equal protec- treatment possible now when a disease or de- tion because poverty is not a “suspect” clas- 56 fect can be diagnosed antenatally is termina- sification, like race or religion and because tion of the pregnancy. But about 50 cases of by failing to fund abortions the State “places hydrocephalis 58 have been treated in the no obstacles in the pregnant woman’s path to womb by surgical decompression, with results an abortion. ” In other words, the State did not that are “not encouraging. ”59 There have cause the poverty that alone prevents the been fewer cases of surgery for urinary tract woman from obtaining an abortion. obstruction, but with somewhat better results. In 1980 the Court examined the constitution- Other potential uses for fetal surgery may in- ality of the “Hyde Amendment, ” which re- clude diaphragmatic hernia, spina bifida, gas- stricted Federal funding of abortions.57 The troschisis, and allogenic bone transplants. These procedures are now experimental, and s~~The Supreme Court has concluded that d prescriptions for cannot be performed without the woman’s in- controlled substances can be entered into a central state com- formed consent, which she is under no obliga- puter, provided there are strict access procedures to limit dis- tion to give. closure to those who need to know, for law enforcement purposes. Whalen v. Roe, 429 U.S. 589 (1977). But in the future it is likely to be possible “J.A. Robertson, “Embryos, Families, and Procreative Lib- erty: The Legal Structure of the New Reproduction, ” So. Cal. to treat the fetus for many conditions. The Law Rev., vol. 59, 1986, pp. 939-1041. procedures are likely to be perfected and to be- bs~~er v. Roe, 432 U.S. 438 (1977). come “standard medical procedures. ” They 5CAs discuss~ in Ch. 2, any laws that distinguish between people on the grounds of race or religion are given particularly will, however, remain highly invasive. They close scrutiny by the Court, and the burden is on the govern- will demand the cooperation of the pregnant ment to show that such classification is necessary and appro- woman, will involve doing things to or through priate and not intended to be discriminatory. sTHWri~ v. McRae, 448 U.S. 297 (1980). The Hyde Amend- ment is named after its congressional sponsor; the regulation under consideration by the Court forbade the use of Federal S8An abnorm~ increase in the volume of fluid within the funds for abortion except where the life of the mother is endan- cranial cavity, resulting in pressure that causes atrophy of the gered, or when the mother was the victim of rape or incest that brain. was properly reported to a law enforcement or public health ‘9S. Elias and G.J. Anus, Reproductive Genetics mm’ the agency. Law (Chicago, IL: Year Book Medical Publishers, 1987). 105 her body, and in some cases may cause her pain complete placenta previa, an abnormal condi- or put her life or health at risk. (See figure 6- tion of the placenta, with a 99 percent certainty 4.) Legislators or the courts will then be asked that her child could not survive vaginal deliv- to deal with the competing rights of the mother ery and a 50 percent chance that she herself and the fetus. would not survive. The court decided that the There have been approximately two dozen unborn child merited legal protection and authorized the administration of “all medical pro- court-ordered “forced cesarean sections” in the past 5 years.60 Only one of these cases, the cedures deemed necessary by the attending first, reached an appellate court level. A woman, physician to preserve the life of the defendant due to deliver her child in about 4 days, had unborn child. ” A public agency petitioned the notified the hospital where she would be at- same court for temporary custody of the al- tended that she would not allow surgery be- legedly deprived child. The court granted this petition on the basis that the State cause it was her religious belief that what happened to the child was the Lord’s will. The has an interest in the life of this unborn, hospital sought a court order authorizing phy- living human being (and) the intrusion involved sicians to perform a cesarean section and give . . . is outweighed by the duty of the state to any necessary blood transfusions. At an emer- protect a living, unborn human being from gency hearing, conducted in the hospital, the meeting his or her death before being given examining physician testified that she had the opportunity to live. The State Supreme Court immediately heard “)V.E. B. Kolfrt, J. Gallagher, and M.T. Parsons, “Court- and denied the petition of the parents to stay Ordered Obstetrical Interventions, ” New England Journal of 61 Medicine, vol. 316, May 7, 1987, pp. 1192-1196. the order, with a two sentence conclusory opinion citing Roe v. Wade.

Figure 6-4.— Laparoscope in Use for Laser Surgery In spite of these legal decisions and orders, however, the woman uneventfully delivered a healthy baby—without surgical intervention. In a second, lower court case, a hospital administration requested that a juvenile court find an unborn baby a “dependent and neglected child” and order a cesarean to safe- guard its life. A cesarean section had been recommended on the grounds of an indication by a fetal heart monitor of possible fetal hypoxia. The patient was an unmarried woman who had previously born twins, and who was described as obese, angry, and uncooperative. She refused a cesarean out of fear of surgery. Her mother and sister and the father of the unborn child had tried unsuccessfully to change her mind. The court ordered the surgery, and it was performed, resulting in a healthy child and no maternal complications in spite of the fact that more than nine hours had elapsed since the tracings of an external fetal heart monitor indicated fetal distress and 6 hours after this

“Jefferson v. Griffen Spal&”ng Co. Hospital, 247 Ga. 86, S,E, SOURCE Martin M Ouigley, Cleveland Cllnlc, Cleveland, OH 2nd 457 (1981). 106 was confirmed with internal tracings. The phy- A somewhat analogous situation occurs sician commented that the case “underscores when a court authorizes a‘ ‘search and seizure’ the limitations of continuous fetal heart mon- of a substance inside the body of a criminal itoring as a means of predicting neonatal suspect. In a famous case65 the Supreme outcome. ’62 Court ruled that blood tests to determine alcohol intake were reasonable, because of the All of the forced cesarean section cases re- strong interest of the community in determin- lied on two earlier cases, Roe v. Wade and Ra- ing guilt or innocence, the inability of deter- leigh Fitkin-Paul Morgan Memorial Hospital 63 mining intoxication by other means, and the in 1964. The latter involved an v. Anderson, very minor bodily invasion involved in draw- 8-month pregnant woman whom physicians be ing blood. In an earlier case, the administer- lieved was likely to hemorrhage severely. If ing of an emetic to induce vomiting in order that happened, she and her unborn child would to extract narcotics capsules that a suspect need blood transfusions, but as a Jehovah’s had swallowed, was held to violate the sub- Witness, she would refuse them. The trial court 66 ject’s interest in human dignity. Much more upheld her refusal and the hospital appealed recently the Supreme Court said it was an “un- to the New Jersey Supreme Court. Although reasonable search and seizure” to order surgery the woman had already left the hospital, against to remove a bullet from an accused robber, be- medical advice, the State Supreme Court de- cause the state would be “taking control of. . . termined that the unborn child was entitled (his) body” and violating his “personal privacy to the law’s protection and that blood trans- 67 and bodily integrity. ” fusions could be forcibly administered to the woman “if necessary to save her life or the life A forced cesarean section is a more intru- of her child, as the physician in charge at the sive and dangerous surgical procedure than time may determine. ” bullet removal, and may be considered more demeaning to the subject’s bodily integrity, This precedent is thought to be of limited personal privacy, and human dignity. On the value. No transfusions were actually done as other hand, the potential State interest in the a result of the decision. It was a one-page opin- life of a child ready to be born is high. Other ion with little analysis or discussion. In any factors that courts may consider are whether case the extent of bodily invasion or risk in- a medical procedure is considered unusual and volved in a blood transfusion is less than that risky, or routine and safe. Many legal experts involved in major abdominal surgery such as believe that surgery involving general anes- a cesarean section. Eight years later, the same thetic or physical invasion of the mother’s body State Supreme Court decided the case of Karen is now unlikely to be permitted. Ann Quinlan, which extended the right to privacy to refusal of medical treatment,64 al- Some ethicists argue that once a woman has lowing Quinlan’s respirator to be removed. implicitly given up the right to an abortion by carrying a fetus to near-term, she has an affirm- Roe v. Wade, as already discussed, said that ative obligation to consent to any medical or the State has a compelling interest in the life surgical intervention that may help the fetus. of viable fetuses, but it also said that it does Opponents argue that this is more a moral con- not have such an interest if the “the life or struct than an enforceable legal obligation. health of the mother” is endangered by carry- First, there is no point in pregnancy in which ing the child to term. These two cases do not a woman formally or publicly waives the right appear to favor the life or health of a fetus over to an abortion, although the State is allowed that of the pregnant woman. to limit the exercise of that right at some point.

62W A. Bowers and B. Salgestad, “Fetal v. Maternal Rights, ” Am. J. Obstet. Gynecol, vol. 58, 1981, p. 209. 65&~mer&r v. Cdjfornja, 384 U.S. 757 (1966). 63210 A. Znd N7 (N.J. 1964). GGRWhjn v. C~jfornja, 342 U.S. 165 (1952). wMatter of Qujn]~n, 355 A. 2nd 647 (N-J. 1976)” G’7~jnston v. Lw, 4’70 Us. (1985). 107

Secondly, the “waiver” argument would mean tention should she begin to hemorrhage. Ac- that a woman has full right to elect abortion, cording to police she ignored this advice, hav- but if she elects childbirth she is required to ing intercourse with her husband and taking surrender basic rights to bodily integrity and amphetamines after she noticed some bleed- privacy. This is, arguably, an unconstitutional ing, and not going to the hospital until many penalty on the exercise of the right to bear a hours later. Her son was born with massive child,68 and would be contrary to the State’s brain damage and died six weeks later. Crimi- presumed interest in encouraging marital pro- nal charges were filed under the State’s child creation. It should be noted that at some time support statute, which includes “unborn in the future the State might not be presumed children. "69 to have an interest in encouraging procreation. The case was dismissed in early 1987 when In the 1970s and even today some people have the trial judge determined that this statute did argued that the State should actively dis- not apply to her conduct. This may not indi- courage population growth. cate how similar cases might be decided. The To some extent, the interpretation of a prosecution, for example, argued that “dis- woman’s constitutional right to refuse medi- obeying instructions” or “failure to follow cal treatment during pregnancy may in the fu- through on medical advice” should be grounds ture be technologically driven: is there a treat- for criminal action. This seems foreign to the ment that is effective in preventing or curing usual meaning of “medical advice” and would a serious illness or defect, is it safe for the surely change the nature of the doctor-patient mother, can it be delivered nonintrusively? relationship. Affirmative answers may encourage courts in The “fetal protection” policy enunciated by the future to give greater weight to the con- the prosecution appears to assume that like stitutional rights of a fetus as compared to mother and child, mother and fetus are two those of the mother. separate individuals with separate rights. But unlike a child, the fetus is absolutely depen- Fetal Abuse dent on the mother’s body and cannot be Less invasive interventions may also require treated without invading the mother. Treat- balancing the interests of a woman with that ing them separately before birth can only be of her unborn child. In some ways, however, done by favoring one over the other where supervision of diet, smoking, or drinkin“ g–that rights conflict; and this appears to many peo- is, of otherwise legal activities-although phys- ple to treat the mother like an inert incubator ically less invasive, could be perceived as re- or culture medium, or like the servant of the quiring more massive infringement on privacy fetus. or liberty than one-time surgery. Could a State Another problem is more technical. Child constitutionally define a new crime, “fetal support laws requiring provision of food, hous- abuse, analogous to “child abuse, ” and use ing, medical attention, etc., do not require par- it to force a pregnant woman to refrain from ents to provide “optimal” or ‘desirable” qual- taking certain actions harmful to a fetus? Or ity of these goods. They do not forbid taking could the State force her to take actions risks with children (e.g., having them ride in thought to be good for the fetus? automobiles, or ski), or even causing pain to Pamela Monson Stewart, because of pla- children (e.g., punishment). Thus fetal abuse centa previa, was advised by her physician to laws would in effect be more stringent than stay off her feet, avoid intercourse, refrain from child abuse laws. taking drugs, and seek immediate medical at- Ggc~. Penal cO&, sec. 270 [West, 1986]: If a parent of a mi- nor child willfully omits, without lawful excuse, to furnish nec- ‘SD.E. Johnsen, “The Creation of Fetal Rights: Conflicts essary clothing, food, shelter, or medical attendance, or other With Women’s Constitutional Rights to Liberty, Privacy and remedial case for his or her child, he or she is guilty of a mis- Equal Protection, ” Yale L. J.. vol. 95, 1986, p. 599. demeanor . . . 108

MEDICAL INTERVENTIONS AT THE END OF LIFE

Various types of life-extending devices such required Medicaid financing of organ trans- as kidney dialysis machines, heart-lung ma- plants. chines, and finally the Jarvis heart, are en- At present, many advanced medical technol- couraging people to think of their organs as ogies are extremely costly. They raise serious potentially replaceable parts, and of death from questions about the equity with which the Fed- aging and deterioration as at least postpon- eral government does make funding allocations able. If life can be extended, should we have to medical care, and whether this raises ques- the liberty to use or to refuse those extenders? tions about due process and equal protection. Could it ever come to be assumed that we have a right to them, or that all have an equal right to them? Use of Artificial Hearts As already noted, there is no constitutional The human trials of artificial hearts in the right to health, or to medical or health care, mid-1980s have constituted the most public in the United States.70 The President’s Com- human experiments in history. The impacts mission for the Study of Ethical Problems in and issues associated with an artificial heart Medicine 71 recognized this, but concluded were debated long before that. The National that: Heart and Lung Institution convened a multi- disciplinary panel to review these issues in the Society has amoral obligation to ensure that early 1970s.73 The Panel noted that many of everyone has access to adequate care without the issues surrounding the artificial heart being subject to excessive burdens. “may lie in the realm of the symbolic and the The Commission based this obligation on the irrational, ” given the role the human heart has criticality of health to the individual’s oppor- always played, in speech, myth, poetry, and tunity to pursue a life plan, the necessity of religion. But 12 years later, when NIH’s most medical care to “relieve pain and suffering and recent panel on the artificial heart reported in restore functioning, and prevent death, ” and May 1985, the artificial heart tends to be seen the fact that most illnesses and injuries are by doctors and by the public as not much differ- beyond the control of the individual. The Com- ent from the other mechanical assist systems mission concluded that the societal obligation with which one has become familiar. The po- does not extend to “everything needed” but tential social issues are viewed primarily in clearly means that everyone should have ac- terms of cost-effectiveness. cess to some level of care. The 1985 panel concluded that were the heart It is therefore argued by many people that fully successful, as much as $4.25 billion an- the courts may, at sometime in the future, con- nually might be necessary to provide one for clude that access to a basic minimum of de- every candidate whose life could be extended cent health care is fundamental to the exer- by the device.74 This is more than is spent on cise of personal liberty. They point out that any other medical procedure, over twice as while the Court has ruled that government much as is spent on kidney dialysis and trans- need not fund any medical procedures, this was plantation, and half the annual budget of the a 5-4 decision.72 A few lower court cases have National Institutes of Medicine. Nevertheless, the argument can certainly be made that the ‘“Of all major industrialized nations, only the United States and the Union of South Africa do not provide some form of health care insurance to all citizens. TSArtifici~ Heut Assessment Panel of the National Heart “President’s Commission for the Study of Ethical Problems and Lung Institute, The Totally Implantable Artificial Heart, in Medicine and Biomedical and Behavioral Research, Secur- DHEW Pub. No. (NIH) 74-191, Washington, DC, 1973. ing Access to Health Care, vol. 1 (Washington, DC: U.S. Gov- “Using a series of assumptions, the panel arrived at a cost ernment Printing Office, 1983), pp. 22. per heart of approximately $150,000, and a range of 17,000 to IYHuris v. McRae, 1980. 35,000 candidates. 109

United States could afford that cost, if high If the government does however decide to enough priority were given to the goal. fund some artificial heart implants, but not all, some rationing or allocation method will be nec- As with other high-cost medical procedures, essary. The Court has in the past been reluc- the question of constitutional importance is tant to interfere with government rationing the following: how should artificial heart im- schemes. For example, a maximum family al- plants (on a post-experimental basis) be allocation under a State Aid to Families with located and funded, or how could access be Dependent Children (AFDC) program was up- rationed or limited to certain groups or indi- held against the challenge that it discriminated viduals? 77 against members of large families. But the There are basically three options: universal Court struck down a food stamp requirement coverage, rationing, and no funding. This ques- that all members of a household be related. tion was presented when kidney dialysis was Even though the Federal Government argued developed in the 1960s.75 At first, patient that this requirement was necessary to prevent selection for dialysis was made by committee; fraud, the Court was unable to find a rational the committee’s deliberations were described relationship between the regulation and the as reflecting “the prejudices and mindless purpose of the food stamp program.78 cliches” of the white middle class.76 To avoid This suggests that a rationing scheme is con- having to make explicit, arbitrary “social stitutional if based on a valid government in- worth” judgments, Congress in 1972 provided terest, if it is for a legitimate government pur- Federal funding for all kidney dialysis and pose, if it is reasonably related to that purpose, transplantation. This approach has not been and if it is not invidiously discriminatory. followed for heart and liver transplantation, When the necessities of life are involved, as perhaps because the kidney program has cost with food stamps, the Court may be more in- much more than originally anticipated. clined to examine critically the relationship be- There are four basic approaches to “ration- tween the statutory purpose and the rationing’ artificial organs (and by extension, other ing scheme. An artificial heart cannot well be extremely costly medical interventions): 1) the considered an optional “luxury” for one who market, 2) committee selection, 3) lottery, and needs it; thus one would expect any rationing (4) the customary approach. scheme the government adopts to be carefully scrutinized. The market approach would let anyone pay for an artificial heart out of their own funds Infant Care Review Committees are a recent or private insurance. This approach seems to example of committee selection procedures; put a dollar value on life; it does not put a high they review decisions to treat or not treat value on fairness and equality. It is also open handicapped newborns. Such committees were to the objection that artificial heart technol- formed to avoid the necessity of explicitly set- ogy was largely developed with public funds, ting out criteria for selection decisions. But and that hospitals and medical schools that in the long run only two results are possi- use and teach implant procedures are heavily ble:79 if a pattern develops in committee subsidized with public funds. It is, neverthe- choices, then it can be articulated and those less, currently constitutionally acceptable decision rules can be codified and used directly; since there is no obligation on the part of gov- if no pattern develops, the committee is vul- ernment to provide any medical care or fund nerable to the charge of arbitrariness. In the any medical program. end, the committee approach may too closely ‘5R.A. Rettig, “The Policy Debate on Patient Care Financ- ing for Victims of End Stage Renal Disease, ” Law and Con- temporary Problems 40:196 (1976). 77Dandrige v. Williams, 397 U.S. 471 (1970). 7fiDavid Sanders and Jesse Dukeminier, “Medical Advance ‘“Department of Agriculture v. Moreno, 413 U.S. 528 (1973). and Legal Lag: Hemodialysis and Kidney Transplantation, ” 79G. Calabresi and P. Bobbitt, Tragic Choices (New York, UCLA Law Rev., vol. 15, 1968, p. 357. NY: Norton, 1978). 110 involve the State in valuing some individuals criminal records, employment, alcoholism, etc. over others. This approach also tends to un- There is little accountability in this approach, dermine the concept of equality and the value but it has not yet been challenged constitu- of human life. tionally. It is not clear whether such procedures might Prolongation of Bodily Functions be successfully challenged by an unselected candidate on the grounds of lack of due proc- As already noted, the mechanical ventilator, ess. If the Court views committee deliberations together with the EEG, required a new defini- as like “adjudicatory hearings at which a de- tion of death—whole brain death. (See figure cision is made based on the “facts’ of the can- 6-5.) This redefinition allowed withdrawal of didate’s medical condition, family support artificial “life support at the time when brain structure, past history, likely compliance with death is already confirmed, since there is “no medical directions, then it might be decided legal duty to administer medical treatment af- that the candidate had certain constitutional ter death."81 But society was presented with rights to be involved in the deliberations (per- anew problem: when is it acceptable to remove haps to have advice of counsel, to call wit- life support systems from one who is not to- nesses, etc.) since his or her life is at stake. If tally brain dead, if removal of the system will the committee is making judicial-like decisions, likely result in death? In other words, if one the Court may also require candidate partici- is “alive” only by virtue of the machine, is that pation. If the Court views the deliberations as life? Or an artificial substitute for life? more like a legislative committee—setting policies and reviewing applications to see if These questions were raised compellingly in they must be excluded on non-discretionary the case of Karen Ann Quinlan. Following an grounds-that may meet the conditions of due episode not completely understood but as- process. sumed to be associated with drug intake, she stopped breathing for at least 15 minutes, af- Another allocation strategy is to put all canter which she was resuscitated in an emergency didates into a pool from which they are selected room. Quinlan retained some brain activity but at random up to the limits of funding for arti- never regained consciousness. Her breathing 80 ficial hearts. This approach takes “equaliz- was done by a mechanical ventilator (figure ing” as the ultimate goal but has little else to 6-6), and she was diagnosed as being in a per- recommend it because it makes no allowance sistent vegetative state, a permanent coma in for the potential for survival, quality of life, which one has sleep-wake cycles but is una- or other relevant characteristics of the candi- ware, so far as can be ascertained, of one’s envi- dates. There are, however, no obvious constitu- ronment or one’s existence. tional problems with this strategy. Convinced that their daughter’s case was The traditional approach of having individ- hopeless, her parents asked that the ventila- ual physicians select patients on the basis of tor be removed and she be allowed to die. Sym- clinical suitability sloughs off public respon- pathetic but fearing criminal prosecution for sibility to private persons and (usually) pre- homicide, physicians insisted that the parents vents decisions from becoming openly contro- obtain a court order. This was refused by a versial or politicized. “Clinical suitability” or lower court after hearing some physicians tes- “medical criteria” often include factors that tify that removal of the ventilator (stopping are not strictly speaking medical, such as de- of treatment) was unethical. The State Su- gree of family support for aftercare; medical preme Court in a unanimous decision82 au- criteria also usually take in mental illness, IQ,

aOGeorge J. Anus, “Allocation of Artificial Hearts in the Year 2002, Minerva v. National Health Agency, ” Am. J. Law 81~n re Spring, 405 N.E.’M 115 (Mass. 1980). and Med., vol. 3, 1977, pp. 59-76. ~ZM~tter of Quin~an, 355 A. 2d 647 (NJ 1976). 111

Figure 6-5.—Examples of Airway Devices Used in Advanced Cardiac Life Support

A nasopharyngeal airway may be inserted through the An endotracheal tube with an inflatable cuff may be in- nose to the back of the throat to keep a path for air open. serted through the nose or mouth (as pictured here) into the trachea. It is the most effective means of securing the airway of an unconscious patient.

An oropharyngeal airway may be inserted through the An esophageal obdurator airway consists of a cuffed mouth to keep a path for air open. tube that is inserted through the mouth into the esophagus. Airholes in the portion that is in the throat allow passage of air into the trachea. A sealed mask prevent: air leakage from the patient’s mouth and nose. When the cuff in the esophagus is inflated, air is prevented from entering the stomach, stomach contents are prevented from entering the trachea and an open airway exists that can be used with a bag-valve device (shown) or a mechanical ventilator. SOURCE’ C K Cassel, M Silverstein, J. LaPuma, et al , “Cardiopulmonary Resuscitation in the Elderly, ” prepared for the Office of Technology Assessment, U S Con gress, Washington, DC, November 1985 ..

112

Figure 6-6.— Positive Pressure Ventilator dians’) choice to refuse medical treatment. The court examined four possible interests:

● the preservation and sanctity of human life, ● prevention of suicide, ● protection of third parties, and ● upholding the ethical integrity of the medical profession. The Court said the ethics of the profession were consistent with removal at the patient’s request. There were no third parties to be protected since Quinlan had no spouse or children and her family requested removal. The ensu- ing death could not be homicide because it would come “from existing natural causes” in the absence of artificial interventions. For the same reason, there could be no charges of assisted suicide. This case has become the touchstone for all post-1976 court cases examining the “right to privacy” in relation to refusing medical interventions. Some courts have based decisions to permit treatment withdrawal on common law battery principles but most also followed the The Bennett 7200a is a microprocessor-controlled volume Quinlan case in enunciating a constitutional ventilator typical of the positive pressure ventilators used in right to refuse treatment. Another State court hospitals today. argued that honoring the right to privacy is itself honoring the sanctity of life: SOURCE: Puritan-Bennett Corp. The constitutional right to privacy, as we thorized the removal, on the basis of Quinlan’s conceive it, is an expression of the sanctity of constitutional right to privacy, saying individual free choice and self-determination as fundamental constituents of life. The value . . . Presumably this right is broad enough to of life as so perceived is lessened not by a de- encompass a patient’s decision to decline med- cision to refuse treatment, but by the failure ical treatment under certain circumstances, in to allow a competent human being the right much the same way as it is broad enough to of choice.84 encompass a woman’s decision to terminate pregnancy under certain conditions. Since these cases courts have ruled that the constitutional right to privacy extends to Only 5 years earlier the same court had ruled refusing any medical intervention, including that there was “no constitutional right to artificial feeding. However, other questions die. ”83 In the Quinlan case, the Court exam- could arise with such devices as the (implanted) ined in detail the question of whether the State artificial heart. If it is seen as an assist ma- had any “compelling interests” in maintain- chine like a mechanical ventilator then the per- ing Quinlan’s life, given her (in fact, her guar- son will have a right to have the machine “un- plugged.” There is little doubt that this would

a3JFK ~emOnCd ~ospit~ V. Heston, 279 A2d 670 (NJ 1971). The young woman in this case was unable to express her wishes 84Suprin~en~ent of &]c~ertOw~ V. S~”kewjCz, S’70 N*E. 2d but was “apparently salvable to long life and vibrant health. ” 417 (1977). 113 be the case with the current version of the arti- stage of life find life unpromising and un- ficial heart, which requires a pneumatically productive and death welcome. In other words, powered device roughly the size of a dish- to accept voluntary euthanasia, some argue, washer. A fully-implantable heart with a ten is to open the door to recognition of a general year power supply could be perceived differ- right to suicide. Further, medical diagnosis ently, perhaps more like the results of a mitral may be incorrect; when medical treatment is valve replacement or a cardiac bypass refused or discontinued, the patient sometimes operation. survives against expectations. Suicide on the other hand is irrevocable. Some people oppose The Right To Die voluntary euthanasia because it would almost surely require direct involvement of the State As described above, the right to refuse or through some sort of prior judicial sanction- terminate the use of life support systems now ing. However, this has also often been the case seems well-established, even when it is virtu- with termination of treatment. Moreover the ally certain that death will rapidly result. State is already directly involved in killing Should a “right to die” also be recognized for through the criminal death penalty. Finally, those who are not machine-dependent? who are physicians might be required to assist or ad- perhaps medicine-dependent? in intractable vise involuntary death, which could erode the pain? or merely tired of dying, or even tired ethical position of the profession or the public of living? trust in it. Some would argue that just as one has a con- These are strong arguments on both sides. stitutional right of privacy in making decisions In the long run, constitutional decisions as to about marriage and reproduction, one should whether the scope of individual privacy and be able to exercise a right of privacy in decid- autonomy extends to an affirmative right to ing against further survival. There is, after all, die will probably depend on both the value no other decision so intensely personal; and it placed on self-determination within the soci- is the only situation when one in fact exercises ety, and the progress made by medical tech- the choice that theoretically underlies all civil nology in preserving not only life, but a high rights and duties—that of consenting or declin- quality of life; that is, physical and mental ing to participate in organized society. Further, health. The greater the degree of control over it can be argued, the State has no compelling life or death that can be offered by science and interest in prolonging life which is already un- technology, the more certain it is that difficult productive and burdensome to the individual choices will be presented, and the more likely and the public, or in delaying a death which it is that constitutional questions will be raised is welcome, inevitable, and already imminent. by those choices. On the other side of the argument, death is always inevitable, and a few people at any

Appendix List of OTA Reviewers, Contractors, Workshop Participants, and External Reviewers

OTA Reviewers June Osborn Dean Clyde Behney School of Public Health Alta Charo The University of Michigan Tim Condon Jonathan Peck Robert Cook-Deegan Associate Director Luther Val Giddings Institute for Alternative Futures Lisa Heinz Roger Herdman Gretchen Kolsrud May 6th and 7th Workshop Participants Claire Macklan Katie Maslow Michael Les Benedict Larry Miike Golieb Visiting Research Fellow Carol Nezzo New York University School of Law Robyn Nishimi J. Pat Browder Kevin O’Connor Clinical Assistant Professor Mark Schaefer School of Medicine, Department of Surgery Gladys White University of North Carolina

Ira Carmen Contractors Professor of Political Science University of Illinois, Urbana George J. Annas Utley Professor of Health Law William Check Boston University Schools of Medicine Medical & Scientific Communications, Inc. and Public Health Tom Christoffel Bernard Davis Associate Professor Professor Emeritus School of Public Health Harvard Medical School University of Illinois at Chicago

John Duffy John Duffy Professor Emeritus Professor University of Maryland, College Park Classics Department University of Maryland, College Park Leonard Glantz Associate Director Daniel Fox School of Public Health Professor of Humanities in Medicine Boston University State University of New York at Stony Brook

Sheila Jasanoff Larry Gostin Associate Professor Executive Director Program on Science, Technology and Society American Society of Law and Medicine Cornell University Howard Kaye Irene Jillson-Boostrom Assistant Professor President Department of Sociology Policy Research Inc. Franklin & Marshall College

117 118

Arthur Kohrman Robert Bock Professor of Pediatrics Dean of the Graduate School La Rabida Children’s Hospital University of Wisconsin, Madison University of Chicago William F. Bridges Gretchen Kolsrud Dean, School of Public Health Program Manager The University of Alabama in Birmingham Biological Applications Program J. Pat Browder Office of Technology Assessment Clinical Assistant Professor Maeva Marcus School of Medicine, Department of Surgery Resident Director University of North Carolina Documentary History Project Jean Chabut Supreme Court of the United States Chief Katie Maslow Center for Health Promotion Analyst Department of Public Health, State of Biological Applications Program Michigan Office of Technology Assessment Tom Christoffel Larry Miike Associate Professor of Health Resources Senior Associate Management Health Program School of Public Health East Office of Technology Assessment University of Illinois, Chicago David Strauss C.S. Chung Assistant Professor Professor of Public Health, University of Chicago Law School Associate Dean, School of Public Health M. Susser University of Hawaii at Manoa Sergievsky Professor of Epidemiology Sergievsky Center Bernard M. Dickens Columbia University Faculty of Law University of Toronto Laurence R. Tancredi Kraft Eidman Professor of Medicine Rebecca Dresser and the Law Assistant Professor Director of the Health Law Program Center for Ethics, Medicine, and Public Issues University of Texas Health Science Center Baylor College of Medicine Robert S. Wachbroit Rochelle C. Dreyfus Research Associate Associate Professor of Law Center for Philosophy and Public Policy School of Law University of Maryland, College Park New York University Daniel Wilder Paul T. Durbin Professor Philosophy Department and Center for University of Wisconsin Medical School, Science and Culture Madison University of Delaware Selwyn Enzer Associate Director External Reviewers Center for Futures Research Graduate School of Business Administration Abdelmonem A. Afifi University of Southern California Dean The University of California, Los Angeles Daniel A. Farber Law School James E. Banta University of Minnesota Dean School of Public Health and Tropical Medicine Peter A. Flynn Tulane University Medical Center Physician 119

Mark Frankel Vincent Novarro American Association for the Advancement of Professor of Health Policy Science The Johns Hopkins University Billy E. F e Gilbert S. Omenn Vice Presid ent for Research and Dean of the Physician Graduate School of Arts and Sciences William C. Richardson Emory University Executive Vice President and Provost Mary E. Guinan The Pennsylvania State University Acting Assistant Director for Science Rebecca W. Rimel Centers for Disease Control Vice President for Programs Public Health Service The Pew Charitable Trusts Bert Hansen Frederick C. Robbins Assistant Professor for History of Medicine University Professor New York University School of Medicine James T. Harrison Case Western Reserve University Deputy Director for Programs Ruth Roemer Department of Public Health President American Health Association and State of Michigan Adjunct Professor of Health Law Peter Barton Hutt School of Public Health Covington & Burling University of California, Los Angeles Sheldon Krimsky David E. Rogers Associate Professor Walsh McDermott Distinguished Professor of Dean of Urban and Environmental Policy Medicine, the New York Hospital Tufts University Cornell Medical Center Jeffrey Levi Barbara Rosencrantz National Gay and Lesbian Task Force Professor of History of Science Harvard University Carol Levine Editor Hastings Center Report Allan Rosenfield Co-Director of Hastings Center Project on Joseph R. Delamar Professor AIDS and the Ethics of Public Health Dean, Columbia University School of Public Health Ernst Mayr The Aggasiz Museum of Comparative Zoology Allan Rosenthal Harvard University Joseph R. DeLama Professor and Dean Columbia University School of Public Health Michael McGinnis Deputy Assistant Secretary for Health Frances Sharples Public Health Service Environmental Sciences Division U.S. Department of Health and Human Oak Ridge National Laboratory Resources M.W. Shaw Deborah Jones Merritt Health Law Program Assistant Professor of Law School of Public Health College of Law University of Texas, Houston University of Illinois, Champaign Roger Shinn J. Robert Nelson Reinhold Niebuhr Professor of Social Ethics Institute of Religion Emeritus Texas Medical Center Union Theological Seminary

Maria I. New Physician 720

Nadya K. Shmavonian Peter V. Tishler Program Officer Associate Chief of Staff–Education, and Pew Charitable Trusts Associate Professor of Medicine Harvard Medical School Paula L. Stamps Associate Professor and Acting Director Winona B. Vernberg Division of Public Health Dean School of Health Services College of Health University of Massachusetts, Amherst University of South Carolina Mervyn Susser David P. Willis Surgievsky Professor of Epidemiology Editor, Milbank Quarterly Columbia University Milbank Memorial Fund 127 —

Other OTA Assessments in Progress as of September 1988

Technological Risks and Opportunities for Future U.S. Energy Supply and Demand Increased Competition in the Electric Power Industry High-Temperature Superconductors: Research, Development, and Applications Oil Production in the Arctic National Wildlife Refuge (ANWR) Technology, Innovation, and U.S. Trade Superfund Implementation Advanced Space Transportation Technologies Maintaining the Defense Technology Base Monitoring and Preventing Accidental Radiation Release at the Nevada Test Site Enhancing the Quality of U.S. Grain in International Trade Grain Quality in International Trade: A Comparison of Major Exporters Agricultural Approaches To Reduce Agrichemical Contamination of Groundwater in the United States Monitoring of Mandated Vietnam Veteran Studies Unorthodox Cancer Treatments Drug Labeling in Developing Countries–Phase I Drug Labeling in Developing Countries–Phase II Federal Response to AIDS: Congressional Issues Preventive Health Services Under Medicare Adolescent Health Rural Health Care New Developments in Biotechnology Methods for Locating and Arranging Health and Long-Term Care Services for Persons With Dementia New Developments in Neuroscience Genetic Testing in the Workplace Communications Systems for an Information Age Copyright and Home Copying Information Technology and Securities Markets New Clean Air Act Issues Municipal Solid Waste Management Managing Low-Level Radioactive Waste Climate Change: Ozone Depletion and the Greenhouse Effect Potential for Mineral Resources Development in Antarctica and the Convention of the Regulation of Antarctic Mineral Resource Activities Infrastructure Technologies: Rebuilding the Foundations

NOTE: For brief descriptions of these studies in progress, see OTA’s booklet on “Assessment Activities”- available from OTA’s Publications Office, 224-8996. 124

Related OTA Publications

Bicentennial Project: –Science, Technology, and the Constitution –Background Paper. BP-CIT-43, September 1987, 32 p. GPO #052-O03-O1086-l; $1.50. –Science, Technology, and the First Amendment –Special Report. CIT-369, January 1988, 80 p. GPO #052-O03-O1090-9; $3.50. –Criminal Justice, New Technologies, and the Constitution–Special Report. CIT-366, May 1988, 64 p. GPO #052-O03-Ol105-l; $2.75. Federal Response to AIDS: –Cost-Effectiveness of Educational Programs to Prevent AIDS–Background Paper. TM-H-24, February 1985. –Do Insects Transmit AIDS?–Staff Paper. September 1987, 48 p. NTIS #PB 88-143 177/AS. –Review of the Public Health Services’ Response to AIDS–Technical Memorandum. TM-H-24, February 1985, 168 p. GPO #052-O03-O0984-6; $5.50. NTIS #PB 85-246 668/AS. Mood Policy & Technology. H-260, January 1985, 64 p. GPO #052-O03-O0977-3; $7.50. NTIS #PB 85-234 8701AS. Impacts of Neuroscience–Background Paper. BP-BA-24, March 1984,36 p. NTIS # 84-196 716/AS. Infertility: Medical and Social Choices. BA-358, May 1988, 412 p. GPO #052-O03-O1091-7; $16.00. New Developments in Biotechnology: –Field-Testing Engineered Organisms: Genetic and Ecological Issues. BA-350, May 1988, 160 p. GPO #052-O03-Ol104-2; $7.50. –Ownership of Human Tissues and Cells-Special Report. BA-337, March 1987, 176 p. GPO #052-O03-O1060-7; $7.50. NTIS #PB 87-207 536/AS. –Public Perception of Biotechnology-Background Paper. BP-BA-45, May 1987, 136 p. NTIS #PB 87-207 544/AS. Life-Sustaining Technologies and the Elderly. BA-306, July 1987, 472 p. GPO #052-O03-O1074-7; $19.00. NTIS #PB 87-222 527/AS. Losing a Million Minds: Confronting the Tragedy of Alzheimer’s Disease and Other Dementias. BA-323, April 1987, 548 p. GPO #052-O03-O1059-3; $24.00. NTIS #PB 87-183 752/AS. The Role of Genetic Testing in the Prevention of Occupational Disease. BA-194, April 1983, 244 p. NTIS #PB 83-233734. Technology Dependent Children: Hospital v. Home Care– Technical Memorandum. TM-H-38, May 1987, 116 p. NTIS #PB 87-194551. Technologies for Detecting Heritable Mutations in Human Beings. H-298, September 1986, 156 p. GPO #052 -O03-O1037-2; $8.00. NTIS #PB 87-140 158/AS.