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 Printing 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 Justice. 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 Technology, and the Constitution (May 1988).

. . Ill
Biology, Medicine, and the Bill of Rights

Project Review Panel

William Carey

Advisor to the Carnegie Foundation of

New York

Washington, DC

James Duggan

Director

New Hampshire Appellate Defender

Program

Concord, NH

Judith Lichtenberg

Center for Philosophy and Public Policy

University of Maryland

College Park, MD

Peter Low

Hardy Cross Dillard Professor of Law and

John V. Ray Research Professor of Law

School of Law

University of Virginia

Charlottesville, VA

The Honorable Pauline Newman

United States Circuit Judge

United States Court of Appeals for the

Federal Circuit

Washington, DC

Monroe Price

Dean

Benjamin Cardozo Law School

New York, NY

Mark Rothstein

Director of Health Law

University of Houston

Houston, TX

Thomas Smith, Esquire

Assistant Director

Criminal Justice Section

American Bar Association

Washington, DC

Paul Stephen

Professor

University of Virginia

School of Law

Charlottesville, VA

Laurence R. Tancredi

Kraft Eidman Professor of Medicine and

the Law

Director of the Health Law Program

University of Texas Health Sciences Center

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

vi
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

with the progress of the human mind.

—Thomas Jefferson

A few decades ago, genes and inheritance

were still mysteries to science. The discovery

of DNA, of how genetic characteristics are

passed on between generations, and how genetic

information is expressed and modified as a person matures, opened the door to understanding and manipulating these fundamental biological processes. Today, in many instances,

we can modify genes and genetic inheritance

to suit our own ends. Some deadly genetic diseases have been traced to their root causes—

making it possible that in the future we will

find a way to cure or avoid them. Genetic engineering holds out the hope for permanent cures

for simple genetic disease, and is already providing better pharmaceuticals, crops, and industrial products. Other new biological technologies amplify the potential of genetic

engineering, and still other biomedical technologies-computerized sensors, artificial prostheses, tissue implants-promise powerful new

capabilities.

The application of new biological advances

is not new. People have throughout history

used all means at their disposal to improve

health, extend their life span, increase the quality and yield of food, have or avoid having children, and enhance their physical and mental

capabilities. For thousands of years we have

bred cattle and beans, used contraception and

fertility enhancers, developed medicines, brewed

drugs, and followed social customs thought to

produce healthy children. These basic human

desires have helped define individual rights

within a society. Social custom, law, and government authority have regulated technologies

in order to help individuals achieve these goals

within the framework of their society. The U.S.

Constitution was designed to guarantee individual rights and to bound the powers of government, while ensuring a place for societal

interests. It guides the application of technologies in those murky areas between individual rights and societal interests, between individual privacy and freedom and the needs

of government to carry out its duties and ensure the social welfare. New biotechnologies,

because of their unprecedented power to extend

human intervention, raise correspondingly

unprecedented challenges to the Constitution

and to the laws built on that constitutional

foundation.

THE CONSTITUTIONAL CONCEPT OF MANKIND

The Constitution of the United States embodies an 18th century view of the nature of

Man: a rational being, possessed of free will

and amoral sense, endowed by his Creator with

inalienable rights and inescapable responsibilities, accountable to the State and to his fellow men through the implicit contract to which

he consents by continuing to live within a

democratic republic.l His biological inheritance, his mental competence, and indeed to

a large extent his present physical and mental health were beyond his own power to control, or that of the State. And though Man had

a natural right to Life, Liberty, and Property,

in the real world all of those—like health, happiness, and the ability to beget children and

raise them to adulthood—could be seen to depend on chance, fate, or the incomprehensible

Will of God. They could be accepted, but seldom 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 philosophy and ethics. We may indeed cling to the

ethical and spiritual truth in the constitutional

assumptions about responsibility. Yet at the

same time we often analyze human behavior

in terms of environment or genes, infantile experiences or biochemical imbalances, socioeco

nomic deficits or neurocortical connections;

and we oscillate between education and coercion, rehabilitation and conditioning, treatment and punishment. In some ways, we have

diminished the scope of accountability embodied in the 18th century political philosophy,

but perhaps we have more than compensated

for this; we have enhanced the 18th century

concept of the fundamental equality of “all

Men” by giving explicit recognition and practical effect to the principle that this includes

women, and men and women of all races and

all economic classes.

WHY THE “NEW BIOLOGY” RAISES CONSTITUTIONAL ISSUES

There are in summary several reasons why

advances in biological knowledge and capability to intervene in human biology have implications for constitutional rights:

1.

2.

3.

The capability for biological interventions,

especially with regard to reproduction,

bodily health, mental functions, and death,

gives people new choices, and forces them

to make decisions about things that were

previously beyond our control. The question arises as to whether the State should

or constitutionally can regulate such decisions in the public interest.

Biology-based technology, alone and in

combination with other kinds of science

and technology, increases the power of the

State to enforce its laws and policies (e.g.,

by screening for drug use, or by using

DNA typing for identification). These uses

may intrude on the constitutionally guaranteed sphere of individual privacy.

The power to identify biological risks (e.g.,

exposure to infectious disease or genetic

vulnerability to chemicals in the environment) often outstrips the capability to remove or reduce those risks. This raises a

demand for social control measures that

sometimes impinge on constitutional freedoms. Some of these are traditional public health techniques falling under States’

“police power” but now often at odds with

increased public expectations of, and judicial affirmation of, the scope of constitutional liberties.

4.

5.

The increasing possibility of effective intervention to prolong life, remove physical and mental handicaps, and enhance

physical and mental performance reinforces

the growing assertion of a “right to health

care. ” Such assertions may be based on

the contribution of Federal funding to the

development of new medical capabilities,

but are also often claimed as a constitutional right although no such right has

been judicially recognized.

Biological knowledge is likely to impinge

on formal or informal religious beliefs or

at least on traditional formulations of religious doctrine. Because the evolution of

English common law, classical political

philosophy, constitutional government,

and the doctrines of several European

Christian churches are historically intertwined, the constitutional separation of

Church and State requires repeated attempts to distinguish between religious

values and common cultural values.

There are strong indications that biological

research will provide increasing evidence for

a genetic and biochemical basis for variations

in human abilities and performance and for

much human behavior, including some behaviors

that we now regard as voluntary, and therefore punishable. New pharmaceuticals, psychosurgery, or other treatments will become available to moderate mental functions and modify

behavior. Genetic engineering of human germ
5

cells or somatic cells could remove inherited

mental traits.

Biology is allowing major human interventions at the boundary between life and death.

By resting the definition of death on brain functions, we have raised the question of how much

quality or competence in brain functioning is

necessary for recognition of constitutional

rights. By making it possible to artificially

maintain bodily functions we have vested in

some people, with or without their willingness,

awesome responsibilities for making decisions

about life and death for other people who can

no longer decide for themselves. At the beginning of life, advancing technological capabilities have changed, and may further change,

the point at which a new life is viable outside

the womb—indeed, gestation from test tube

to “birth” may someday be possible in artificial wombs, reflecting again the question of

when constitutional rights begin.

Advances in biological sciences and technologies are creating choices, in situations where

in the past people had no choice. Or, less positively, they force people to make decisions

about situations that in the past were beyond

human control. Increasingly (though not yet

always) people can choose whether or not to

reproduce, and in the future, they maybe able

routinely to choose the gender of the child they

wish to have, to select some of its genetic characteristics, to choose to use an embryo from

other biological parents, or to donate their own

embryos to others.

New biological knowledge and technologies

give people powers to make critical decisions

about the life and death of themselves, other

people, and future generations. When technology allows people to make such choices or decisions, the question arises as to whether the

State should regulate, or even absolutely control, those decisions. Constitutionally, this

question becomes: would State intervention

impinge on some individual liberty that is

guaranteed by the Bill of Rights? and if so,

is the individual’s interest in exercising that

right far outweighed by the contrary interest

of the State, which is considered to be the public interest?

The balancing of the State interest with individual rights is forever going on, and where

the balance is struck often involves two kinds

of social change. One frequent factor is new

technological capability that gives us new control of natural processes or new power to manipulate our physical and biological environment. The second is the rising expectation of

self-determination and privacy.

Some traditional public health techniques,

well established in law and in constitutional

decisions as permissible under State police

powers, are almost certain to be challenged

anew because of today’s broader interpretation of individual rights of privacy and autonomy. This is occurring, for example, in the context of the AIDS epidemic with regard to

techniques of mandatory reporting, contact

tracing, mandatory testing, and partial or full

quarantine. As the risks of environmental and

workplace contaminants are increasingly revealed, the State could decide to use genetic

screening technology (now at an early and unsatisfactory state of development, but likely

to be made much more effective in the future)

to write regulations forbidding some groups

of people from assuming occupational or environmental risks to which they are especially

vulnerable.

Many kinds of medical and genetic interventions raise complementary questions. First,

when can the State, in the exercise of its police power, legitimately mandate preventive or

therapeutic treatment, as it has long mandated

vaccination, in the public interest? Second,

should the Courts (or Congress) at some point

in the future rule that there is a constitutional

basis for a “right to health” or at least to health

care? If, for example, interventions became

possible (as a result perhaps of research at the

National Institutes of Health) that would significantly control or slow aging and extend normal lifetimes, say by 25 years-would we leave

it to market mechanisms to determine who received this “priceless” boon?
6

Decisions about kidney dialysis and organ

transplants have so far obscured and delayed

rather than answered this question, which is

already being raised by some public interest

groups not only as a public policy issue but

as a constitutional challenge. They argue that

Americans have an “equal protection” right

to the results of medical research supported

by taxpayers.

Recent decisions about the teaching of evolution or of “creation science” in public schools

have not removed the possibility of further efforts to restrict either the teaching or the application of new biological knowledge on religious or quasi-religious grounds. There are

strong indications that a major area of constitutional debate in the future will deal with

conflicts between biological research objectives

and procedures, on the one hand, and religious

or ethical values on the other. The present debates over animal rights, research using fetal

tissue, patenting of human cell lines and derived biological, the safety of bioengineering

laboratories, and release of engineered organisms in the environment, have some common

grounds. Is there a constitutional right to do

research? Should there be areas of “forbidden

knowledge?” What values should be reflected

in Federal research funding allocation and Federal guidelines?

This introduction to the report on “biology

and the Constitution” contains many questions,

and few answers. Indeed, this is true of the rest

of the report. In looking into the future, much

can be anticipated but little can be said with

certainty. When we consider the triple uncertainties of rapidly advancing knowledge, steadily rising expectations of civil liberty and selfdetermination, and conflicting value systems

that are themselves caught in turbulence and

challenge, there are indeed few certain answers

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.

Law, especially constitutional law, is a powerful reinforcer of stability and continuity. The

tension between these two has much to do with

how well a society’s political system can adapt

to economic and social forces that affect the

distribution of power and wealth.

Between 1787 and 1987, the United States

evolved from a small agrarian nation, relatively

poor and powerless in the international system, to a modern industrial world leader. The

Constitution has provided the political and legal framework for technological change, and

it has accommodated both a growth in the role

of government and enhanced expectations of

individual rights.

In the face of technological, social, and economic change, both Congress and the Supreme

Court have repeatedly reexamined the meaning, the intent, and the scope of constitutional

provisions. Both, for example, struggled to decide whether the right of people “to be secure

in their persons, houses, papers, and effects”

does or does not include the right to be secure

in one’s electric communications (from wiretapping), or protection against having the content

of one’s blood, breath, or genetic code ‘seized’

without a warrant.

In constitutional government, the powers of

the State are limited and the rights of individuals are acknowledged and protected. The most

essential individual rights or civil liberties are,

in modern constitutions, nearly always specified in a Bill of Rights.’ The full meaning of

these rights and the strength with which they

will be protected become clear only gradually,

as statutory laws are written and judicial

precedents are set. In the United States, their

scope has been worked out by the courts and

by the political process, often with reference

to English common law. Even the simple and

elegant prose of the United States Constitution has required continuing examination, explanation, and interpretation as social institutions, economic forces, and technological

conditions have changed.

IR~ph c, chandler, Rich~d A. Enslen, and peter G. Renstrom, The Constitutional Law Dictionary (Santa Barbara, CA:

ABC-CLIO, 1985), vol. 1, Individual Rights, pp. 10-11. Great

Britain had no single written “Constitution,” but traditional

rights of individuals based on centuries of common law were

put into statutory form in the Bill of Rights Act of 1689.

TECHNOLOGY AND GOVERNMENT POWER

A constitution empowers a government by

giving legitimate authority to its actions as

the instrument and agent of the people. At the

same time, a constitution, and particularly its

bill of rights, is designed to limit the power

of government. Its effectiveness depends on

the determination of citizens that government

shall abide by these limits.

The role that technology plays in the balance

between individual rights and governmental

power to act in the public interest is seldom

explicitly discussed. But technical capability

at least partly determines the effectiveness of

both government’s actions and the legal restraints on those actions. It also increases the

individual’s power to act in ways that may offend the conscience of the community, or to

create and use technology that may adversely

affect the welfare of others. Can or should civil

liberties, as defined in 1791, restrain governments in regulating such choices?

Opinions on these questions differ dramatically among citizens, among legal experts,

among constitutional scholars, among judges,

and among courts. Hence, the questions addressed in the several reports and papers coming from OTA’s study of “Science, Technology, and the Constitution” are: what new and

9
10

emerging technological capabilities may stimulate constitutional challenges in the foreseeable future? How may Congress and the Court

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

capability are making rapid advances: bioengineering, public health and medicine.2 Before

ZTwo emlier speci~ reports explored similar questions with

regard to new technologies for communication and news reportturning to this analysis, further discussion of

the basic concepts within the Bill of Rights

will be useful.

ing (Science, Technology, and the First Amendment, February

1988) and new technologies for law enforcement (Cn”nu”nal Justice, New Technology, and the Constitution, March 1988). See

also Science, Technology, and the Constitution–Background

Papx, September 1987, for an overview of OTA’S Constitutional

Bicentennial Project.

BY POPULAR DEMAND: THE BILL OF RIGHTS, 1787-91

In 1787, many State constitutions included

a Bill of Rights, but no Bill of Rights was written into the national Constitution. Several

proposals to add one were voted down in the

closing days of the Philadelphia Convention

with relatively little discussion. Most of the

delegates thought that a national Bill of Rights

was unnecessary because the new government

was to have only limited, delegated powers.

An explicit prohibition against the establishment of religion, for example, might imply that

the national government would otherwise have

the power to regulate the practice of religion.

During the critical debate on ratification, a Bill

of Rights might thus increase rather than decrease the already widespread fears of the

power of a new central government.3

The lack of one however, drew more public

criticism than any other aspect of the Constitution. The Constitution was finally adopted

only with the understanding that the first business of the Congress would be to correct this

defect.

Twelve amendments to the Constitution

were therefore proposed by the First Congress

3Jmes MacGregor Burns, The American Experiment.’ ‘he

Vineyard of Liberty (New York, NY: Alfred A. Knopf, 1982),

pp. 53-55. Also Chapter 3, “The Experiment Begins, ” pp. 86-

90. See also, Catherine Drinker Bowan, Miracle at Philadelphia

(Boston, MA: Little, Brown, 1966). Also Edward S. Corwin and

J.W. Peltason, Understandz”ng the Constitution, 4th ed. (New

York, NY: Holt, Rinehart& Winston, 1967), p. 104. The Constitution already included prohibitions of bills of attainder, and

ex post facto laws, and guarantees of the writ of habeas corpus

and of trial by jury in Federal criminal cases.

on September 25, 1789. Ten were ratified by

the States and added to the Constitution on

December 15, 1791.4 Since then, the meaning

and scope of these rights has been asserted or

has been challenged in hundreds of Court cases.

Sometimes the questions raised are directly

related to new technological capabilities. Often

they are indirectly related, because they reflect

profound economic, social, and political changes

associated with technological change.

It is not only the Supreme Court that interprets constitutional protections, although it

does so most formally and definitively. Both

Federal and State courts at all levels repeatedly ponder the rights of citizens, the powers

of governments, and the nature of due process. Congress and 50 State legislatures declare

their understanding of the Constitution in

framing legislation. And Americans are generally willing to assert, either in celebration

or complaint, their own understanding of their

rights. That is one reason we have been called

a litigious society.

Federalism—Dual Citizenship and

Constitutional Rights

Even when Americans can quote from the

Bill of Rights or describe its content, they are

4The two that were proposed but not ratified prescribed the

ratio of Representatives to population and prohibited any increase in Congressmen’s pay during a term. They were probably perceived as not properly included in a list of the rights

of individuals. Corwin and Peltason, op. cit., footnote 3, p. 104.
11

often somewhat vague about just whose actions they are protected from. Americans of

1989, unlike those of 1789, usually do not

clearly distinguish their rights and duties as

citizens of Virginia, New York, or Massachusetts from their rights and duties as American

citizens. The consciousness of dual citizenship

has faded.

The Bill of Rights itself restricted only the

Federal Government, as Chief Justice John

Marshall ruled in 1833.5 In 1868 the addition

of the Fourteenth Amendment changed that:

it said that all persons born in (or naturalized

by) the United States are citizens;6 and it

then continued:

No State shall make or enforce any law which

shall abridge the privileges or immunities of

citizens of the United States. . . .

This was intended to guarantee the rights of

those who had been slaves, and their descendants; it extended the constraints imposed on

the Federal Government to State governments

as well, on behalf of all citizens.7

Yet only in the last three decades has the

Bill of Rights come to be effectively applied

to restrain State governments.8 In 1873, in

the Slaughterhouse Cases,9 the Supreme

‘BarrorI v. Baltimore, 7 Peters 243 (1833).

‘This reversed the conclusion of the Dred Scott Case, before

the Civil War, that Negroes even if free were not “intended to

be included, under the word ‘citizen’ in the Constitution, and

can therefore claim none of the rights and privileges which that

instrument provides for and secures to citizens. . . .” Citizenship was henceforth based on place of birth, not by parentage

or race. By statutory law, Congress has also conferred citizenship on those born outside of the United States to U.S. citizens.

?The States, of course, had their own Bills of Rights, but

Federal courts cannot enforce those protections if the State

courts do not. ~Three ~endments were added immediately after the Civil

War, the Thirteenth, Fourteenth, and Fifteenth Amendments.

The Thirteenth prohibited forever the institution of slavery; the

Fifteenth assured slaves and their descendants of the right to

vote. The Eleventh Amendment, which had been added in 1798,

provided that individuals cannot sue a State (without its consent) in Federal Courts, thus amending (or clarifying) a provision in Article III, Section 2, which extends the Federal judicial power to “cases and controversies between a state and

citizens of another state. ” The Twelfth Amendment, in 1804,

changed the manner of election of the President by the electoral college; requiring that they cast separate ballots for President and Vice President.

gThe Slaughterhouse Cases, 16 Wallace 36 (1873). Twining

v. ZVew Jersey, 211 U.S. 78 (1908).

Court used tortured reasoning to declare that

most key civil and political rights were part

of State citizenship, rather than U.S. citizenship. The “privileges and immunities of citizens

of the United States, ” the Court said, were

limited to a few rights such as travel between

the States and voting for Federal officials. This

declaration has never been explicitly overturned.

But the Fourteenth Amendment went onto

say:

. . . nor shall any State deprive any person of

life, liberty, or property, without due process

of law, nor deny to any person within its jurisdiction the equal protection of the laws. (Emphasis added.)

It was these two provisions that the Supreme

Court eventually used to extend to the States

the limitations placed on the Federal Government by the first Ten Amendments. The Due

Process Clause was used until the late 1930s

to strike down State laws aimed at improving

the lot of workers through economic regulation; the property rights of “corporate persons” were protected through the doctrine of

substantive due process. But in a series of

cases after the Second World War, the Court

has declared that the Fourteenth Amendment

‘‘incorporates’ most of the protections and

rights listed in the Bill of Rights. In effect, it

has said that “due process” includes the fundamental concepts of justice and liberty spelled

out in the first eight Amendments and further

strengthened with the Ninth Amendment

declaration that their enumeration does not

". . . deny or disparage others retained by the

people.” In the discussion that follows, therefore, note is often made that a particular right

has been incorporated by the Supreme Court

into the Due Process Clause of the Fourteenth

Amendment, and therefore is binding on the

States.

The Constitution limits only government actions, not the actions of private persons. Only

if discriminatory actions by private institutions are somehow sanctioned by Federal,

State or local government (e.g., by licenses, tax

exemptions or other benefits that give a private institution a semi- or quasi-public char-
12

acter), can they be said to violate the Bill of

Rights.

The other great principle in the Fourteenth

Amendment, “Equal Protection of the Laws,”

is discussed later. Here we will return to a discussion of the Bill of Rights of 1791.

Fundamental Rights

Freedom of Religion

The First Amendment embodies four freedoms deemed most critical for the preservation of republican government: namely, the

freedoms of conscience, expression, assembly,

and petition. It begins:

Congress shall make no law respecting an

establishment of religion, or prohibiting the

free exercise thereof. . . .

Many of the ratifying generation, or their

forebears, had come to this country to be free

to worship as they chose. Jefferson and Madison regarded “freedom of conscience” or “the

basic inalienable right to religious liberty” as

a cornerstone of all other rights and liberties,

and the prohibition against state interference

with it as a basic tenet of republicanism.10

The Establishment Clause applies to State

actions, under the Due Process Clause of the

Fourteenth Amendment. Scientific research

and teaching have stimulated many challenges

to the scope of this principle. State laws concerning the teaching of the principles of evolution, which are considered by some churches

to be in conflict with their religious doctrines,

have several times been struck down, most recently in 1987.11

Technology has figured in other challenges.

The Court has for example let stand State mandatory vaccination laws in spite of the objections of some religious sects. The Court has

also ruled that States may provide transportation for children to church schools, in the interest of promoting the health, safety, and eduIONe~ Riemer, Jmeg Madj”son: (k5V3thg the Americm constitution (Washington, DC: Congressional Quarterly, Inc., 1986),

pp. 14-15, pp. 136-40.

ll~dwtids v. Aqui]]md et d,, 107 Sup. Ct. 2573 (1987).

●

cation of children rather than their religious

indoctrination.

Freedom of Speech and Press

The First Amendment also forbids Congress

to make laws

. . . abridging the freedom of speech, or of the

press. . . .

Freedom of speech and press were in 1791

considered the most powerful popular constraint on government. Because free speech is

not truly effective without the means of broader

communication, a free press is included within

this fundamental right–the only technology

specifically protected in the Bill of Rights. *2

The right of free speech was seldom the subject of Supreme Court interpretation until after the First World War, when there began a

series of cases involving political and social protest or communication.13 Congress has by law

established, and the Court has permitted, a

three-tier system of regulation distinguishing

between press, broadcast media, and common

carrier systems. But these distinctions are becoming hard to maintain, as discussed in an

OTA special report, Science, Technology, and

the First Amendment (January 1988), as electronic technologies supplement the printed

press in the dissemination of news, information, and opinion.

The constitutional status of science, and of

scientific communications, is ambiguous. Along

with artistic expression, scientific communications probably fall somewhere between polz’l”he co~ h= established that symbolic expre55iOn as well

as speech is protected; for example, wearing an armband (in

public school) to protest government actions in Vietnam. Tinker

v. Des Moines School District, 393 U.S. 509, 89 S. Ct. 733, 21

L. Ed. 2d 731 (1969).

13Schenck v. Um”ted States, 249 U.S. 47 (1919), established

a “clear and present danger” test to determine when the government could regulate political expression in the interest of

national security. Gitlow v. New York, 268 U.S. 652, 45 S. Ct.

625, 69 L. Ed. 1139 (1925) modified this doctrine to allow suppression of speech that might lead to “substantive evil” or unlawful ends. Denzu”s v. Um”ted States, 341 U.S. 494 (1951), allowed conspiracy convictions by distinguishing between

advocacy of illegal acts and advocacy of doctrines. Yates v.

United States, 354 U.S. 208 (1957), weakened this slightly by

requiring that specific illegal acts be shown; membership in an

organization advocating them cannot be made a crime.
13

litical and commercial speech in terms of the

protection it is afforded. Science, Technology,

and the First Amendment also examines the

restrictions placed on scientific communications in the name of both national security and

technological export controls, and probes the

question of whether the cumulative effects of

these restrictions are eroding freedoms of

speech and press. The present report carries

this discussion further, to examine the restrictions placed on science in the interest of religion, ethics, and public safety.

The Rights of Assembly and Petition

As another fundamental protection of political freedom, the First Amendment forbids

Congress to abridge:

. . . the right of the people peaceably to assemble

and to petition the government for a redress

of grievances.

The Fourteenth Amendment extended this

prohibition to the States. State and local governments can to some extent regulate public

meetings and assemblies to prevent disorder

and violence; but these necessary police functions are carefully and suspiciously examined

by the courts.

The Prohibition on Unreasonable

Searches and Seizures

The Fourth Amendment, like the First, has

repeatedly been brought into question by changing technology. It reads:

The right of the people to be secure in their

persons, houses, papers, and effects, against

unreasonable searches and seizures, shall not

be violated, and no Warrants shall issue, but

upon probable cause, supported by Oath and

affirmation, and particularly describing the

place to be searched, and the persons or things

to be seized.

British authorities in the American colonies

issued general “writs of assistance” that allowed searches at will or on slight suspicion,

especially for contraband smuggled in violation of Parliamentary duties. The Fourth Amendment prohibited searches without a magistrate’s warrant.14 This constraint applies to

the States under the Fourteenth Amendment.

The Supreme Court has in the last 70 years

ruled that wiretapping and more recent electronic surveillance devices are “searches,” and

more recently, has had to decide whether evidence may be seized from bank, medical, and

insurance records in computerized databases.15

So far, the Court has allowed authorities to

“seize” a suspect’s breath (for analysis for alcohol), or one’s urine, semen, blood, or other

fluids and tissues for evidence, but these questions are probably not fully resolved.

The Rights of Those Accused and

Convicted of Crimes

The rights of people suspected or accused

of crime are protected in several places in the

body of the Constitution and in the Fifth,

Sixth, and Eighth Amendments. These civil

liberties constrain or limit how the State may

deprive a person of life, liberty, and property

in enforcing its laws.l6 The affect of technological changes on interpretation of these Constitutional rights is considered in detail in the

OTA Special Report, Criminal Justice, New

Technology, and the Constitution, April, 1988.

For example, the use of biology-based techniques for identifying offenders, such as DNA

(genetic) pattern recognition, will probably be

challenged constitutionally.

IiDuring ~ ~rest, a warrantless search is permissible if the

authority has “probable cause” to believe a crime has been committed.

1

5 Chandler et al., op. cit., footnote 1, p. 168, citing Zurcher

v. Stanford Da-ly (436 U.S. 547: 1978).

16p~o “. Connecticut, 302 U.S. 319, 58 S. Ct. 149? 82 L. Ed.

288 (1937), established “selective incorporation” in determining which Bill of Rights provisions related to rights of the accused should be applied to State actions. This was a case involving double jeopardy; the guideline or “rationalizing

principle” enunciated by Justice Cardozo, was whether a particular protection is “of the very essence of a scheme of ordered

liberty, ” such that its bypassing would violate “a principle of

justice so rooted in the tradition and conscience of our people

as to be ranked as fundamental. This case held that the pzwhibition of double jeopardy was not so fundamental, but this was

overturned later; now only the grand jury provision of the Fifth

Amendment and the Excessive Fines and Bails prohibition of

the Eighth Amendment have not been “selectively incorporated’

as limitations on the States.
14

Due Process

Both the Fifth Amendment and the Fourteenth Amendment provide that a person may

not:

. . . be deprived of life, liberty, or property,

without due process of law. . . .

The Court has developed two complementary

definitions of “due process”: procedural due

process and substantive due process. Procedural due process means that laws, regulations,

and government procedures must not be arbitrary, vague, or inconsistent, and the protections set out in the Bill of Rights should be

carefully applied. “Substantive due process”

suggests that some areas are beyond the reach

of government authority, and some laws are

unconstitutional because of their intent. This

concept has been used to wall off from government interference certain private activities,

primarily marriage, procreation, child rearing,

and educational choice, held to be beyond the

appropriate reach of legislation.17

Limitations on Eminent Domain

The Fifth Amendment also says that:

. . . private property may not be taken for public use, without just compensation . . .

This power of “eminent domain” is an inherent power of all governments. It means that

the rights conferred by private ownership of

property must, in some cases, give way to the

good of society as a whole. Thus, when it is

necessary to build a highway in a given location and a landowner refuses to sell land to the

government for that purpose, the land may be

taken for public use, but the owner must be

justly compensated. What constitutes “taking” of property has often been challenged, and

some of these challenges have been stimulated

by technology. For example, the Court has held

that airport noise that renders adjacent land

unusable for normal purposes may be a “taking” for which government must compensate.18

ITCorwin ~d Pelta90n, op. cit., footnote 3, PP. 124-125.

18Grjg@ v. Al]eg~y County, 369 U.S. 841 (1962). Rent-control laws however do not constitute a taking, nor do other legislative actions that may diminish the value of property by regulating how it is used.

Retained or Inherent Rights, and

Reserved Powers

The Ninth Amendment says that:

The enumeration in the Constitution, of certain rights, shall not be construed to deny or

disparage others retained by the people.

One of the strongest objections raised to a

Bill of Rights during the Constitutional Convention and the ratifying process was that the

Federal government was not in general expected to act on individual citizens. The Federal government was to have delegated, limited

powers, plus those other inherent governmental

powers necessary to exercise those authorized

functions effectively. The philosophy expressed

in the Ninth Amendment is that the “Bill of

Rights did not confer rights but merely protected those already granted by the natural

law. "

1 9

Until 1965 no law had been struck down on

the basis of violation of unenumerated rights.

In that year, a Connecticut law forbidding the

use of birth control was ruled unconstitutional

because it violated an unenumerated right of

marital privacy, which is “within the penumbra of specific guarantees of the Bill of Rights”

and one of those fundamental rights assumed

to be “retained by the people” because it has

not been delegated to the nation or a state. 2o

The Tenth Amendment further provides

along the same lines that:

The powers not delegated to the United States

by the Constitution nor prohibited by it to the

States, are reserved to the States respectively,

or the people.

It has been generally understood that this

amendment did not alter the distribution of

power between two levels of government, but

merely restated the philosophy of government

expressed throughout the Constitution, under

which the States retained many sovereign

powers not delegated nor clearly necessary to

the Federal government. Until the mid-1930s

the Supreme Court often used the doctrine of

‘gCorwin and Peltason, op. cit., footnote 3, p. 132.

20chmdler et ~c, The constj~u~~on~ hiW DjCfhntiry, VO1. 1,

pp. 369-371.
15

“Dual Federalism” to prevent Congress from

using its powers of taxation or interstate

commerce regulation to accomplish other ends,

such as making exploitation of child labor unprofitable for interstate businesses. The Tenth

Amendment, in this way, reinforced the effectiveness of the Fifth Amendment requirement

of “substantive due process” as interpreted

by the Court.

After 1937, the Court returned to the view

of John Marshall that this Amendment is a

truism,21 which does not by itself limit the

national government in exercising powers that

it would otherwise be understood to have. Both

the Ninth and Tenth Amendments, however,

contributed to the development of the constitutional doctrine of “a right to privacy, ” in that

they emphasize the principle that the people,

in forming a government, retained some powers

beyond the reach of government.

The Right of Privacy

The Bill of Rights as a whole is understood

to indicate a sphere of personal autonomy

where government should not intrude, even

though this sphere is not exhaustively marked

out or specified by any formal listing of rights.

This sphere of individual autonomy has come

to be called the “right of privacy, ” although

the word “privacy” is not used in the Constitution.

In one of his classic dissents, in 1928, Judge

Brandeis said that the Fourth and Fifth Amendments together recognized “a right to be let

alone, and defined this as “the most comprehensive of rights and the right most valued

by civilized men. ”22 In a 1958 civil liberties

case Justice Harlan spoke of the “vital relationship between freedom to associate and

privacy in one’s associations. ” In a 1969 pornography case Justice Marshall said that regulation of obscenity cannot extend into “the

privacy of one’s own home, ” and that the government has no business to tell a man “sitting

alone in his own house, what books he may read

or what films he may watch. ”

“Quoted in Corwin and Peltason, op. cit., footnote 3, p. 132.

zzo]m~tead v. ~njte~ States (277 U.S. 438: 1928).

The right to privacy was finally made explicit

and definitive in Griswold v. Connecticut,23 in

1965, as the Court struck down a law forbidding contraception. Since then it has been expanded to include other aspects of marriage,

reproduction, and health.

Equal Protection of the Laws

No discussion of the Bill of Rights can ignore

the Equal Protection Clause of the Fourteenth

Amendment, which was intended to buttress

the rights of former slaves. Yet for nearly

ninety years it was not applied as intended.

The Court held in 1896 that a legal distinction

between the races did not destroy their equal

protection or legal equality, as long as they

were given “separate but equal” treatment.24

This doctrine was finally modified in 1950,

and it was definitively struck down in 1954

when public school segregation was ruled unconstitutional.25 In a further series of cases in

the late 1950s and 1960s, the court established

that it will look with great suspicion (“strict

scrutiny’ at any different or special treatment

of a class of citizens in applying laws for the

purpose of allocating a benefit or imposing a

restriction, especially where such classification

is based on race. Later Equal Protection cases

have extended the scope to classifications other

than those based on race. This transfers the

burden of proof to the State and demands more

than a showing of reasonableness; the State

must demonstrate that it has a compelling interest and a critical need to give special treatment to some class of citizens.

In effect, the Court looks at the intent of any

classification. If the intent can be shown to be

related to a legitimate legislative objective, and

not to social discrimination, classifications

may be allowed to stand. For example, classifications related to age have been allowed,

23381 U.S. 479. 24p]e~~y “. Fer=son, 163 U.S. 537 (1896).

Zssweatt v. Pa”nter, 339 U.S. 629 (1950) struck down one

State law requiring separation of races in State law schools;

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

services. For discussion of related cases and decisions see Chandler et al., op. cit., foonote 1, pp. 308ff.
16

to give special services or protections to those

under 18 or over 65. Classifications by gender

or by indigency are not necessarily suspect,

but some classifications based on gender have

recently been disallowed.

Special treatment related to fundamental

rights, such as the right to vote, the right to

cross state lines, or even the right to have certain medical procedures, are subjected to what

the Court calls “strict scrutiny. This is especially true when the classification itself is “inherently suspect. ”

The Forgotten Amendments

Several of the first Ten Amendments have

been of relatively little importance in our constitutional history.

A well regulated Militia, being necessary to

the security of a free State . . . ,

The Second Amendment guarantees the

“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

judicial interpretations of this clause. According to most scholars, the Amendment was primarily intended to prevent Congress from disarming the State militia, a touchy subject less

than a decade after the end of a revolutionary

war and at a time when antifederalists feared

the creation of a possibly despotic central government. 26 If this Amendment was intended,

as some have assumed, to assure the possibility of revolution against despotism, then the

modern technology of weaponry has almost

surely negated that protection.

The Third Amendment provides that

No soldier shall, in time of peace, be quartered in any house, without the consent of the

Owner, nor in time of war, but in a manner to

be prescribed by law.

This provision too was never the subject of judicial challenge.27 By the time of the Civil

War, if not before, it had been rendered obsolete by the advancing technology of warfare

and the logistics of modern armies.

‘26corwin and Pe)tason, op. Cit., fOOtnOte a! P. 115.

271bid.

MOLECULAR BIOLOGY AND NEW TECHNOLOGY

Molecular biology is in this decade an extraordinarily productive field of scientific research and application. The traditional disciplines of biology, chemistry, and physics here

converge to support wave after wave of advances in scientific knowledge. New knowledge

quickly leads to innovative scientific instrumentation, which in turn produces further advances in knowledge and is also translated rapidly into practical applications, improved

testing and measuring techniques, and commercializable technology. In this area, strong

social needs indicate that “market pull” as well

as “knowledge push” will continue to encourage

innovation and commercialization. These social needs are related to both genetic and infectious diseases (especially the new epidemic

of AIDS); mental illness and mental retardation; and the mental and physical problems

associated with aging.

From advances in the basic science, or sciences, of molecular biology are pouring two

mighty streams of further development. One

of these is bioengineering, with techniques for

use in manufacturing processing, agriculture,

and environmental management. The second

line of development flowing from molecular biology is concerned directly with the human

body, brain, behavior, and genetic inheritance.

Much is being learned about the materials and

processes of human genetics and about the biochemical basis of body and brain functions.

Techniques are being developed for their further analysis, testing, measurement, manipulation, correction, or enhancement.

Some new or proposed techniques are already

highly controversial. Such applications are in

various stages of study or achievement-some

already in limited use, some in laboratory
17

trials, some only promised or even hypothetical. For example, debate has arisen over mandatory testing for disease exposure and for use

of drugs, genetic screening for special susceptibility to environmental risks, human germ

cell or somatic cell gene therapy, interspecies

gene transfers, brain transplants, fetal surgery,

and several kinds of technologies for assisted

reproduction, including in vitro fertilization,

the freezing of embryos, etc.

Part of the promise of these new biologybased technical capabilities comes from their

combination with other especially fruitful areas

of scientific research and technological development. Computers and related information

technologies have not only made many of the

breakthroughs in biology possible, but also

make it possible to use this knowledge in ways

commensurate with its enormous complexity

and data richness. More recent rapid developments in materials sciences and molecular engineering may loosen many constraints associated with the differences in nature between

organic and inorganic materials. The cognitive,

behavioral, and social sciences offer nearly endless ways to check, extend, and apply knowledge gained through biological and chemical

research on human beings.

These combined techniques and technologies

are related not only to medicine or public

health; they have possible applications in many

other fields in which significant issues maybe

raised, some of them with obvious constitutional applications. In law enforcement and

corrections, the use of biological techniques

such as drug or hormone therapy as alternatives to prison could point to a new paradigm

of criminal justice—treatment for disorders

rather than punishment for crime. In education, prediction of performance could affect

(perhaps in one of several directions) the design of or the equal access to educational opportunities and resources. In many other areas,

a person may come to be thought of less as

autonomous and accountable, and more as manipulatable or predictable.

The opportunities promised by these emerging technologies are immense: more efficient

and effective delivery of human services, enhanced human performance, better health and

prolongation of useful life, even eradication of

tragic physical or mental defects and diseases.

At the same time, many of these biologybased technological capabilities seem to be particularly likely to raise political and ethical issues, which often ultimately become constitutional issues, or are so construed by those

seeking their resolution. They may offer alternative explanations of causality in behavior,

performance, motivation, or attitude—i.e., biochemical or genetic determinants or influences

rather than choice or will. They provide new

means of influencing, controlling, or modifying behavior, emotions, or judgment. They

may challenge religious definitions and principles. And they may allow individual choices

to purposefully change the genetic inheritance

of future generation.

These technologies and techniques, in short,

enlarge the capabilities of both individuals and

the State to make and implement decisions

that increase tension between the general welfare and individual rights. The State has always claimed an interest in protection of human life, in reproduction, in decisions made for

those who cannot decide for themselves, and

in the welfare of future generations. These are

also the areas in which people most readily assert their right to privacy, family integrity, and

individual autonomy.

This conflict is what creates and defines constitutional issues—the testing of the terms of

the social contract. But until recently, only

some of the events in these critical areas were

within the power of either the person or the

State to decide or even to influence; and this

has minimized the conflict or tended to limit

its effects to the most dependent and powerless members of society. As technology changes

this condition and increases the possibility of

constitutional clashes, concerned citizens, Congress, and the courts will be called on to reexamine the nature and scope of constitutional

principles.
Chapter 3

The New Biology
CONTENTS

Page

Molecular Biology: What’s It All About . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Start With Bacteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Recombining DNA: How and Why? . . . . . . . . . . . . . . . . . . . . . . . . . . ~ . . . .

What Goes On in a Cell? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Enzymes and Proteins: Regulating Life . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Mapping the Human Genome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Evolutionary Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Tools of the Trade: Innovations in Conducting Biological Sciences . . . . .

The Changing Environment for Biological R&I) . . . . . .

From Science to Technologes: The Uses of New

Bioengineering in Industry and Agriculture . .

The Biology of People. . . . . . . . . . . . . . . . . . . . .

Figures

Biology

. . . . . . .

. . . . . . .

3-1*

8“2.

3-3.

3“4.

The Structure

Replication of

of DNA . . . . . . . . . . . . . . . . . .

DNA . . . . . . . . . . . . . . . . . . . . .

Comparative Scale of Mapping . . . . . . . . . . .

Preparation of Monocolonal Antibodies . . . .

. . . . . . .

. . . . . . .

. . . . . . .

. . . . . . .

. . . . . . . . . . . . . . .

. . . . . . . . . . . . . . .

. . . . . . . . . . . . . . .

. . . . . . . . . . . . . . .

21

22

24

25

26

26

29

30

30

32

32

33

Page

. . . . . . . . . . . . . . . 23

. . . . . . . . . . . . . . . 24

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. . . . . . . . . . . . . . . 31
Chapter 3

The New Biology

Of all the areas of science and technology

where rapid advances are now occurring, probably none will have more direct and profound

implications for individual rights and responsibilities than molecular biology. This has come

to be called “the new biology. ” This field of

research is producing dramatic new knowledge

derived from the increasing ability to map and

manipulate the genetic materials in the cells

of microorganisms, higher plants and animals,

and people; and from far-ranging explorations

into biochemical factors in physiological and

mental functions.

From the new biology flow two major streams

of applications. One deals with genetic engineering in industry, agriculture, and management of the natural environment. The second

consists of tools and techniques for analysis,

prediction, correction, control, and enhancement of the human body, brain, and behavior.

The first has already raised several direct

constitutional issues related to the right to patent new “engineered” life forms, and the right

of scientists to carry out experiments that

some people perceive as imposing significant

risks to human safety or to the environment.

It is likely to raise other constitutional questions in the future. The second, knowledge of

human biology, affects assumptions about

what constitutes human nature, what people

are capable of, and thus what they can be held

responsible for. New technologies based on this

knowledge will also increasingly present people with the necessity for new decisions about

life and death, reproduction and inheritance,

culpability and punishment.

In order to probe some of these potential

challenges in later chapters, it is helpful to review briefly the basic premises and promises

of the new biology. Those readers who are already well informed about this area may wish

to skip this chapter, which provides a summary

in nontechnical language. For those who know

little about the new biology, it will be worth

some effort to read carefully the following section, as a primer for the discussion of potential constitutional issues that follows in later

chapters on genetics, public health, and medical interventions.

MOLECULAR BIOLOGY: WHAT’S IT ALL ABOUT?l

In molecular biology the traditional disciplines

of biology, chemistry, and physics converge and

overlap in the study of the detailed structure

and functions of biological macromolecules.

These are very large complex molecules made

up of several subgroups of atoms. Cells, the

basic building blocks of all living organisms,

are generally made up of such macromolecules.

Until very recently, biochemistry dealt mostly

not with macromolecules, but with small mol-

‘Much of the material in this chapter, not otherwise attributed, was prepared for the Office of Technology Assessment

by Dr. Bernard Davis, Professor Emeritus of Bacterial Physiology, Harvard University, in the form of a contractor report

“The New Biology,” May 1987.

ecules such as vitamins, hormones, and amino

acids. This research had many practical applications in nutrition, medicine, and agriculture,

and was relatively quickly commercialized in

the form of specific products. Macromolecules,

in contrast, are made in and retained within

living cells and carry out the basic cellular functions. During the first two decades of molecular biology-roughly, the 1950s and ‘60s–

research on macromolecules yielded few practical applications that could give rise to commercializable technologies.

This changed dramatically in 1974 with the

development of recombinant DNA techniques.

DNA is the basic material in genes. During

21
22

conception the DNA in egg and sperm combine and so transmit traits from one generation to the next, from parents to offspring.

Along with this continuity, DNA allows for

variability, since the traits from two lines of

inheritance-two parents-are combined and

mixed. An ability to analyze, map, and manipulate DNA opened up both deeper insights into

living processes and immense prospects for

practical applications. A review of some key

steps in the short history of molecular biology,

especially the recombinant methodology, shows

vividly how much unforeseen knowledge we

have gained. It also shows that the advance

of science and technology depends only in part

on orderly, step-wise research; occasional unanticipated breakthroughs open up new territories that in turn rapidly spawn new information and understanding.

Start With Bacteria . . .

The study of bacteria played a key role in

the emergence of molecular genetics. The very

small size of these single-celled organisms—

about one thousandth the volume of an average human cell—had always been a major obstacle to dissecting their internal structures.

There was no science of bacterial genetics until the 1940s—no one had observed either the

transfer of genes between organisms or mutations in bacteria. But in 1944 (when pneumonia was a leading cause of death), research on

pneumococcus showed that the material of

genes is DNA and that it can be transferred

between bacterial cells.’

Bacteria offer several advantages for the

study of molecular genetics: their relative simplicity, rapid multiplication (as many as three

generations per hour), and the ease of selecting even very rare mutants from populations

of billions of cells. Moreover, the relatively simzThe discovery was made by Oswald Avery. Until then ‘t

was generally assumed that chromosomal proteins carry genetic

information and DNA played some secondary role. The importance of the discovery was not widely recognized at the time.

Avery never received a Nobel Prize. Lubert Stryer, 13iochezm”stry, 2nd ed. (San Francisco, CA: W.H. Freeman & Co, 1981),

p, 562; or G.J.V. Nossal, Reshaping Life: Key Issues in Genetic

Engineering (Cambridge University Press, 1985).

ple viruses that infect bacteria (which are called

bacteriophages) have even greater advantages

for many studies. Analysis of their life cycle

has laid the foundation for understanding the

viruses of animals and plants, and gave us the

ability to rapidly identify and characterize the

AIDS virus, as will be described in chapter 5.

An important consequence of microbial genetics has been the recognition of the remarkable unity of biology at a molecular level. The

living world is enormously diverse. Millions

of species have adapted to their environment

through astoundingly varied structures, functions, and behaviors. But at a molecular level

all organisms-man as well as microbe-make

their nucleic acids and proteins from precisely

the same building blocks, and these acids and

proteins function in essentially the same way.

The inherited differences between organisms—

between, for example, a person and an earthworm-appear to be determined by differences

in the sequence of the basic building blocks

comprising the genes.

Such basic unity in the midst of diversity

gives us, with the development of bioengineering, the ability to make useful products such

as insulin by inserting human genes into bacteria. The bacterial cellular mechanism can

then produce insulin, illustrating the fundamental similarity in basic proteins and

genetic structures. This close biochemical relationship between two extremes of biological

complexity-the human and the bacteria—is

evident throughout the living world and provides strong evidence for its evolutionary continuity.

James Watson and Francis Crick, in 1953,

demonstrated the structure of DNA. Within

DNA the basic building blocks are chemical

bases, of which there are only four kinds: adenine, thymine, guanine, and cytosine, known

as A, T, G, and C. In order for genes to be

passed on from one generation to another,

DNA must replenish itself. The fact that DNA

within the cell is double-stranded, and that

complementary bases are paired-A always

with T, and G with C—gave scientists an immediate clue to how replication occurs. Thesequence of each strand-the order in which its
23

building blocks are arranged-serves as a template for the synthesis of its complementary

strand, and hence for the formation of two

double-stranded molecules from one. (See figures

3-1, 3-2). Moreover, mutations could now be

explained as errors in the pairing of bases during replication.

The research that has grown from the explanation 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

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 “misprints. ” 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 substituted 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

–although rarely-to individuals belonging to

other species. This also contributes to the increase of genetic variety. Some scientists even

suggest that the role of viruses in causing disease may be only a byproduct of a more fundamental evolutionary role in expanding genetic variety. As an analogy, there are only a

few bacteria that cause disease, compared to

those that play essential roles in the cycle of

Figure 3-1 .–The Structure of DNA

Phosphate Molecule

/

Deoxyribose

Sugar Molecule

I Nitrogenous

-o”’

o 0

\

Weak Bonds Between

Base Pairs

J

guanine (G), cyto-

~ The Sugar-Phosphate

Backbone

The four nitrogenous bases, adenine (A),

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

T and G with C. The sequence of the bases along the sugarphosphate backbone encodes the genetic information.

SOURCE: Office of Technology Assessment, 1988.
24

Old New New Old

When DNA replicates, the original strands unwind and

serve as templates for the building of new complementary

strands. The daughter molecules are exact copies of the

parent, with each having one of the parent strands.

SOURCE Off Ice of Technology Assessment

matter between the organic and the inorganic

world.

From another perspective, however, mutations are rare exceptions. DNA is transmitted

from generation to generation with extraordinary accuracy. This accuracy depends not only

on the inherent chemical stability of DNA, but

on repair mechanisms that recognize and correct most errors in replication and most of the

genetic damage caused by radiation, chemicals,

or other environmental factors.

The information contained in genes directs

the formation of the other molecules that comprise 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,

are as yet much less well understood. For example, it is not yet understood why certain

processes (e.g., loss of a limb) are effectively irreversible in higher animals, but not in plants.

Recombining DNA: How and Why?

A number of additional discoveries in the

fields of bacteriology and molecular genetics

led to the development of recombinant DNA

methodology, which is popularly called bioengineering. Before this development, the

problem of isolating the different genes in a

chromosome seemed unsolvable, because they

are sequences in a giant chain and physical

methods for breaking that chain simply yield

random fragments. The breakthrough came

with the discovery in cells of “restriction en-
25

zymes , which destroy unwanted DNA by

cutting or cleaving it at a specific sequence.

Restriction enzymes can be used in the laboratory to cleave DNA purposefully into a set of

fragments with known ends that can be relinked or recombined with other fragments

that have complementary ends, by using other

enzymes.

By using restriction enzymes and ligation

(linkage) enzymes, scientists can now splice a

DNA fragment into an appropriate unit and

multiply it indefinitely (i.e., “clone” it) by inserting it into an appropriate cell that then multiplies. After years of effort, a simple procedure has been developed to genetically modify

the bacterium Escherichia coli or E. coli. Bacteria contain a single, very long circular chromosome that contains most of the genetic information necessary to function. The chromosome

of E. coli, a common bacterium living in the

human gastrointestinal tract, is some 4 million nucleotide base pairs in length. But like

most bacteria, E. Coli contain other “accessory” genetic elements that carry genes involved in reproduction and resistance to drugs.

These small circular units of DNA are called

plasmids and can be transferred from one bacterium to another.

The entire “library” of genes of a mammal,

containing around 3 billion base or building

block pairs, can be stored in the bacteria in a

single test tube. Such a mixture of perhaps 10

billion bacteria will contain thousands of different recombined genes, but the “library” can

be separated into “books,” or smaller pieces

of DNA containing several genes, and each

“book” or piece can be inserted indifferent bacteria. Ingenious techniques have been developed for efficiently selecting those cells that

have incorporated a particular gene.

What Goes On in a Cell?

Molecular biology has two major branches:

molecular genetics and macromolecular struc3An enzyme is a complex protein that catalyzes a specific

biochemical reaction within the body; that is, causes the reaction

to occur without the catalyst enzyme itself being used, changed,

or destroyed.

tures. The first branch was described above;

it aims at determining how genetic information is transferred from DNA to RNA and finally to production of proteins. The second or

structural branch of molecular biology aims

at determining how these proteins, in turn,

carry out biological functions through specific

interactions; for example, how insulin controls

the storage and processing of sugar. This

branch too is contributing to both streams of

future technological development, that leading to commercial applications for industry and

agriculture, and that focusing on the human

body and brain.

As they study biochemical reactions, scientists are attempting to develop enzymes to affect not only naturally occurring compounds

but also synthesized or novel organic compounds. Genetic variation in the microbial

world is so rapid that microbiologists can now

accelerate natural evolution by selecting mutant bacteria with enzymes having the capacity to attack a specific organic molecule.

Researchers are learning that a small number of genes can generate large numbers of

unique proteins. For example, antibodies are

specialized proteins that attack and destroy

foreign substances, or antigens, thus protecting the body from disease organisms. This

process requires very specific physical binding of the antibody to the antigen. Specificity

results from the unique amino acid sequences

of antibodies that are encoded by genes. Although it is known that the body can generate in excess of a million different types of antibodies, there are just a few hundred antibody

genes. Recently it was discovered that this

enormous number of antibodies can be generated by mixing, matching, and splicing a small

number of genes together. It is now known that

natural gene rearrangements of this kind are

responsible for the generation of many kinds

of proteins.

Short synthetic protein chains are already

under trial as vaccines. The analysis of the interactions of drugs with their receptors in living cells is also having a revolutionary effect

on pharmacology.
26

The proteins in cell membranes, including

the receptors for hormones and drugs, were

long a mystery to biochemists. They seemed

part of an insoluble debris. But new laboratory techniques, including the use of certain

detergents to make them soluable, have made

them accessible to study. Biochemists are now

able to make artificial membranes that reproduce some natural biological functions. It is

not yet clear how far this approach can go

toward reconstructing cells from their components, or toward “tissue engineering” formedical purposes.

In the future, there maybe nearly unlimited

possibilities for designing synthetic protein

chains for specific purposes. Enzymes produced

to order by engineered organisms will be used

in the chemical industry, perhaps replacing

chemical reagents that are more risky to workers or to the environment.

Enzymes and Proteins: Regulating Life

In the memory of a computer, information

is stored in an intricate pattern of switches,

each of which may be “off” or “on,” represented by O or 1, so that information is put

into a code, like 01001001110. Genetic information is stored in a different way, in the linear sequences of four different chemical bases

within a giant molecule. Thus it uses a 4-letter

code rather than the 2-letter code of 0/1.

For day-to-day conduct of cellular business,

cell functions are regulated by still another

means of transmitting biological information

—special proteins that sense the presence or

concentration of some molecule and react to

it. This key discovery came about through research that had a more limited aim: to explain

how bacterial cells stop making a certain amino

acid when it is supplied to them in the medium

in which they are grown. In this feedback response, the initial enzyme that begins the process of creating an amino acid is directly inhibited by the end-product of that process, i.e.,

by the presence of amino acid. This spares material and energy for other purposes when more

amino acid is not needed. Enzymes thus act

as valves controlling the flow through a pathway from raw material to end-product, each

enzyme specific to a particular starting material.

The mechanism by which this occurs involves

the ability of many proteins to shift between

two stable alternative shapes or conformations;

this is called allostery. The same simple principle has provided a general explanation for

an enormous variety of biological phenomena,

from the expression of a gene, to the actions

of drugs on the body, to the secret of mechanochemical coupling resulting in movement in

biological systems. It has been useful in explaining how muscle fibers work, the migration of cells in embryonic development, and the

mechanisms by which some cells, called phagocytes, engulf and digest foreign bacteria, allowing the body to resist infection.

The understanding of this and other regulatory mechanisms is certain to contribute to the

understanding and control of disease, to the

development of drugs, and to the manufacture

of desired proteins by genetic engineering.

Mapping the Human Genome

Soon scientists will have mapped the complete DNA genetic sequence of the common

bacterium E. coli, with its 3 million base pairs.

Some scientists argue that we should now

mount a major national effort to do the same

for the human genome (i.e., complete set of

chromosomes), which is about 1,000 times

larger.

There are two alternatives for further work,

‘‘mapping, and “sequencing” the genome.

The difference is important because of current

policy debates about which way to proceed. At

present, small regions of the genome concerned

with specific functions are being sequenced.

These regions are identified in two ways: the

sequence of a known protein is used to locate

the corresponding gene, or the abnormal form

of a gene associated with a disease is located

through genetic comparisons and then is used
27

to identify the normal version. To continue

along this path would involve studying key

sites on the human genome; physically, in

terms of the succession of restriction enzyme

cleavage sites, and genetically, in terms of the

genes as they are identified. Detailed sequencing of the various regions, base by base, would

be done gradually, with priorities set by interest and importance rather than by location—

i.e., the work would “skip around” with gaps

being filled in slowly (See figure 3-3.).

This program is in fact being carried out now,

in many laboratories, and the information is

being collected and correlated. It has revealed

unexpected parallels between sequences in

genes with very different functions. This indicates that as organisms became more complex

and as they therefore increased the number of

their genes, new genes evolved from older ones

in branching patterns, much like the branching pattern of the evolution of species through

modification of earlier organs.

The alternative approach is mapping or complete systematic step-by-step description of the

entire human DNA sequence, containing possibly 100,000 genes and over 3 billion bases.

Only a few hundred genes have so far been described, less than 1 percent of the total. Current techniques can produce rough sequencing of about 20,000 bases a day, and are rapidly

improving. One approach would be to map the

structure of DNA in sections some 40,000

bases long. Sections of DNA of that length can

be cloned into special vectors called “cosmids,”

in such a way that these partial maps would

overlap. Mapping of the complete genome

would be the largest single biological project

ever undertaken.4 A major governmental initiative toward this end has been proposed, involving the establishment of a few major research centers to carry out the work with

centralized coordination. It is highly controversial.

“’Sequencing the Human Genome, ” Issues in Science and

Technology, Spring 1987. See “Prologue,” p. 25. This seminar

in print includes: Walter Gilbert, 4’Genome Sequencing: Creating a New Biology for the Twenty-First Century, pp. 26-35:

Leroy Hood and Lloyd Smith, “Genome Sequencing: How To

Proceed, pp. 36-46; and commentaries by David Baltimore and

Francisco Ayala, pp. 48-56.

The advantages of comprehensively mapping the human genome are that it would make

it much easier and faster to link a newly identified gene with a disease or human function.

Currently, a gene must be located through a

painstaking search for genetic markers before

it can be isolated and its bases sequenced for

further study of its functions. Mapping the full

genome would mean that when biologists want

to study a specific protein within the body,

analysis of a bit of its amino acid would make

it possible to go to the genome database and

locate the specific gene that guides the production of that protein. Advocates say this

would dramatically accelerate achievement of

the goal of fully understanding human inheritance and its limits. Possibly diseases that depend on the interaction of several genes, or that

have alternative genetic causes, could be understood. There would also be spin-off benefits for many other areas of biological research,

including ecology, immunology, and cancer

control.

Mapping the entire genome would be a large

and ambitious undertaking, probably taking

10 to 20 years, and with a cost estimated by

some experts to be at least $3 billion. Critics

fear it could divert research funds from other

research that they think is more urgent. Some

sections of the human genome, it is thought,

will be much more difficult to clone and map

than others, and some scientists suspect that

the technology is not yet up to the task.

Some biologists argue that 90 percent of the

effort of such a project would be wasted because it is now believed that only about 10 percent of DNA codes for proteins and the rest

is “irrelevant” or “junk.” Advocates respond

that we do not really know what genetic material is irrelevant to our needs, and that the

effort to filter out the junk would in any case

be more time-consuming than systematic

mapping.

Allowing the U.S. Department of Energy

(DOE) to take the lead in mapping the human

genome has been considered as one possibility, on the grounds that this would be a natural extension of DOE research in molecular bi-
28

Figure 3.3.—Comparative Scale of Mapping

EARTH CELL

UNTRY

N

PEOPLE

CHROMOSOM

GENE 

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

radiation or energy production) and would take

advantage of DOE-funded scientific instruments and staff at national laboratories. Alternatively, the project could be led by a new,

directed effort of the National Institutes of

Health (NIH). An NIH-led effort would build

on a much larger base of biomedical research.

These and other strategies for carrying forward

genome mapping efforts has been widely debated inside and outside of government in the

last 2 years. Most likely is a set of projects

funded through two or more Federal agencies,

with formal or informal means of coordinated

planning.

The situation in mid-1988 is that there is no

single human genome project but instead many

projects, in NIH, DOE, and other government

laboratories and in universities and private sector laboratories. They aim at establishing and

enhancing databases about DNA sequences,

markers, and gene structure and expression;

creating chromosomal maps; and developing

new instruments, analytical techniques, and

other scientific resources for biomedical research. No agency or organization, and no national government, has made a commitment

to massive sequencing projects, or to a unitary, single focus program of research like that

of the Apollo Project, the Manhattan Project,

or other celebrated government research initiatives. Recent reports by the National Academy of Sciences5 and the congressional Office

of Technology Assessment6 concluded that

any such initiative would be inappropriate.

They suggest, rather, that the Federal Government should, through funding and oversight, encourage and coordinate the continuing enhancement of databases and resources

in many cooperating units and centers of research.

‘National Research Council, Mapping and Sequencing the

Human Genome (Washington, DC: National Academy Press,

1988).

‘U.S. Congress, Office of Technolo~ Assessment, Mapping

Our Genes– The Genome Projects: How Big, How Fast? OTABA-373 (Washington, DC: U.S. Government Printing Office,

April 1988).

The Evolutionary Record

The new field of molecular evolution provides

more direct evidence for evolutionary continuity than even the fossil record. For example,

man and chimpanzee, species which separated

only around 10 million years ago—a short time

in evolutionary history, have about 99 percent

of their DNA sequences in common. This similarity indicates that man and chimp have a

relatively recent common ancestor, compared

to the much smaller genetic overlap between

man and other species. DNA changes over

time, due to mutations that are not eliminated,

and the more similarity there is in the DNA

of two species, the shorter the time in which

they have been developing separately and thus

diverging. There are decreasing degrees of homology, or genetic similarity, between man and

increasingly distant organisms down to the

lowest of the vertebrates. By contrast, bacteria have been diverging from each other not

for thousands of years but for several billion

years, and they show sequence homology only

between very close species; that is, different

bacteria may have very little overlap in DNA

sequences. Some of the gaps in the evolutionary record are likely to soon be clarified and

closed by such molecular comparisons, and some

current misunderstandings and misinterpretations may be identified and swept away.

Evolution has implications not only for

describing the origin and development of our

species but also for increasing our appreciation of its rich genetic diversity, and for the

still richer genetic diversity in our environment

at large. This diversity could be needlessly reduced by careless or misguided agricultural

and environmental management practices.7 

With respect to humans, a deeper understanding 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

already strong moral, political, cultural and re-

‘U.S. Congress, Office of Technology Assessment, Techllofogies To Mainta”n Biological Diversity, OTA-F-330 (Washington, DC: U.S. Government Printing Office, March 1987).
30

ligious grounds for treating all races and all

individuals with equal consideration and respect.

Tools of the Trade: Innovations in

Conducting Biological Sciences

Progress in science depends on technical as

well as conceptual advances. As biochemistry

expanded its scope it has become increasingly

dependent on elaborate (and expensive) instruments.8 Also of major importance has been

the use of computers. Automation and computers greatly facilitate the accumulation of

data. While the investigator sleeps, his instruments continue to collect successive samples

in a fractionator, to measure radioactivity, to

determine or synthesize base sequences in

genes. Indeed the rate of production of data

is overwhelming the ability to publish it; a case

in point is DNA sequence information.

The focus of biochemistry on larger molecules, and the simultaneous focus of cell biology on ever finer structures, has had another

fundamental benefit. It has done away with

the troublesome range where cell features were

too small to be studied by microscopy but too

large to be defined chemically. The field of cell

biology increasingly overlaps that of molecular biology, and any line between biology and

organic chemistry is becoming artificial.

An even more fundamental breakthrough

has been the development of monoclinal antibodies. An animal produces antibodies in response to the presence within its body of a

disease organism. In the ordinary antibody response, an “antigen” or stimulus (such as a

protein on the surface of a virus) stimulates

the formation of a protein molecule (antibody).

The antibody is shaped to fit the antigen like

a lock fits a key. The antibody covers the antigen so that it cannot latch on to another body

cell. This prevents the virus from invading the

cell and replicating itself.

The difficulty is that a normal antibody response leads to the formation of hundreds of

different antibodies, differing with respect to

8For example, high-speed centrifuges, chromatography columns, flourescence celI sorters, electrophoresis apparatuses.

the small region on the protein surface that

each is attracted to and binds. The distribution of antibodies elicited by a given antigen

varies somewhat from person to person, and

even in the same person at different times. This

made it hard for scientists to study the formation of antibodies.

There is a kind of cancer that attacks antibodyproducing cells, called multiple myeloma. The

cancer makes the “sick” cell reproduce itself

uncontrollably. The new or daughter cells are

clones of (i.e., identical with) the original cell.

Scientists learned how to fuse an antibodyproducing cell with a myeloma cell to get a cell

that is called a hybridoma, which both produces one species of antibody and replicates

itself over and over. These identical antibodies are called monoclinal antibodies, and are

a powerful tool for analyzing the process of antibody formation. (See figure 3-4.) Their specificity allows them to be used, for example, to

carry fluorescent markers or poisons to cancer cells. Monoclinal antibodies can be accurate and thorough biochemical scouts, spies,

and assassins in the service of medicine. They

have nearly unlimited potential for diagnosis,

therapy, and analysis, and a growing industry has sprung up to produce them.

The Changing Environment for

Biological R&D

The development of recombinant DNA and

monoclinal antibody techniques have had a

significant impact on the relationship between

biomedical sciences and industry. Until recently most research in biology has not had

much potential for commercial applications.

But now a substantial number of the leading

researchers have become involved in commercial enterprises.

It is clearly desirable that scientists doing

basic research also encourage the development

of applications that will benefit society through

better health, improved agriculture, or increased economic productivity. In the United

States, such benefits are perhaps most likely

to be realized when the initial discovery is developed and marketed by an industry.
Figure 3-4.—Preparation of Monoclinal Antibodies

Mouse is

immunized with

a foreign

substance

or “antigen. ”

—

Mouse myeloma

(tumor) cells

are removed

and placed In

tissue culture

Cells divide in

liquid medium

~ are mixed and

/l fused with

The products of this

fusion are grown in a

selective medium. Only

those fusion products

which are both “immortal” and contain genes

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.

31

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 commuare 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 inising 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

Agriculture

People have throughout history domesticated various microbes by empirical selection

of genetic variants with improved properties

–for example, in making bread, wine, cheese,

and antibiotics. Now, directed manipulation

of genes through bioengineering can further

improve strains. Also new strains of selected

properties can be designed without waiting to

select from variants that nature offers. The use

of enzymes may increasingly replace traditional methods of organic chemistry in manufacturing processing, especially if biological

processing proves to be more environmentally

benign than older methods. Engineering of microbes could also increase both the efficiency

and versatility of the conversion of biomass

into energy and other useful products, or solve

the problem of economically producing singlecell protein for food.

A successful early application of the new biology has been the use of recombinant bacteria to produce mammalian proteins. One of the

first was the human growth hormone, used to

treat children who otherwise would not grow

to normal stature. Another early product was

bovine hormone to increase milk production

in cows. A third was human insulin for the relatively rare diabetic people who are allergic to

insulin derived from other animals. A more recent product is tissue plasminogen activator,

to dissolve the blood clots that may cause coronary thrombosis or strokes. These products

from engineered microorganisms have the added

advantage that they do not risk contamination with lethal human viruses as can occur

with hormones extracted from human tissues

and glands. The variety of products under development is growing rapidly.

Manipulation of DNA will supplement, rather

than supplant, traditional methods of strain

improvement in domesticated plants and animals. But bioengineering is different from conventional techniques in that it can produce

changes in more stable portions of the genome

not ordinarily changed by selective breeding.

With animals, the extent of possible alterations

through genetic engineering may be limited because the traits one would wish to alter often

involve a large number of undefined genes,

rather than being determined by a single gene.

With plants, somewhat more extensive changes

may be likely. Promising possibilities include

enhanced resistance to pests, drought, or temperature extremes, and changes in nutritive

value and flavor. Currently, there is extensive

research on the possibility y of incorporating in

various plants the set of genes responsible for

nitrogen fixation, thus removing the need for

expensive nitrogen fertilizer. However, since

these genes are found naturally only in bacteria, it is not yet certain that they will function

or will remain sufficiently stable within a plant.

Technical problems have been encountered

both in achieving strong expression of inserted

genes even in bacteria, and in preventing destruction of the resulting proteins before they

are harvested. Since genes can also be cloned

in cultured mammalian cells and in yeast cells

(which are more similar to mammalian cells

than are bacteria), future production of mammalian proteins may well be shifted to these

organisms. Moreover, though the knowledge

of molecular genetics of higher plants is so far

not well developed, it is conceivable that cloning into these organisms will eventually prove

economical; some optimists suggest that a single field of corn could meet the world’s need

for insulin.

Some scientists hope that eventually it may

be possible to preserve the DNA of rare species that are threatened with extinction. It has

been suggested that inserting preserved DNA

into the egg of an existing closely related species could allow us to reconstitute an extinct

species, or that related DNA might be modified for that purpose. These applications are

speculative at present, but not beyond the

realm of possibility.

One constitutional issue, that of patenting

of engineered organisms, has been addressed
33

by the Supreme Court, which allowed the

patenting of a genetically altered bacterium.9

The Patent Office, citing the Supreme Court

decision, extended patent protection to other

bioengineered plants and animals. In April

1988, Harvard University was granted a patent on a genetically altered mouse, the first

patent to be issued for higher life forms.

Soon thereafter at a meeting sponsored by

several national church groups, a panel of ethicists and theologians called this “a matter of

deep philosophical and spiritual concern” because it portrays animals ‘as human creations

. . . rather than as God’s creation or subject

of nature. . . .’” O The patenting of animals,

and of human cells and tissues, raises issues

that are now being debated in Congress. Two

bills before the 100th Congress as it nears adjournment call for a moratorium on granting

animal patents. Court cases challenging the

government’s decision to allow experimental

release of engineered organisms for field trials

also have some implicit constitutional implications and will be discussed in chapter 4.

The Biology of People

The new biology is having a profound effect

on the sciences and practice of human genetics,

medicine, and public health. As it does, many

complex public policy issues are being raised,

and many of them have constitutional aspects

and implications that will be explored in later

chapters.

While genetic counseling has been done for

along time, it was practiced mainly on the basis of knowledge of the health and life experience of parents and grandparents and statistical analysis of health records of the offspring

of people with similar heredity. Several radically new techniques are now being developed:

9D;”amond }-. Chakrabarty, 477 U.S. 303 (1980).

‘(’United States Patent No. 4,736,866, Apr. 13, 1988. The

meeting of ethicists and theologians was sponsored by the National Council of Churches, the Humane Society, the Presbyterian Church, t,he New Creation Institute, “and other

groups, ” as described by David E. Anderson, “Halt Urged on

Patents of Engineered Animals, ” The ~rashington Post, Apr.

30, 1988, p. B8. Quotations are taken from that article.

genetic screening for hereditary diseases associated with known genetic defects, prenatal

diagnosis of disease or defects through testing of fetal tissue or cells, and human cell therapy. These will be discussed in chapter 4.

Diagnostic Tools and Vaccines

Molecular and cell biology have revolutionized both basic and applied immunology. Monoclinal antibodies and fluorescent dyes or tags

have provided particularly valuable tools.

Growing knowledge of the complex immune

response will surely make it possible to enhance

protective responses and to prevent damaging allergic responses. Autoimmunity, the abnormal formation of antibodies or immune cells

that attack normal body constituents, is recognized as a factor in some chronic diseases

and is strongly suspected in others; these include pernicious anemia, juvenile diabetes,

multiple sclerosis, arthritis, and ulcerative colitis. Antibodies and other visible agents are

widely used with microscopy to reveal the distribution of cell components. Their chemical

coupling to powerful toxins or drugs promises

to provide a means of targeting these agents

to specific cells.

Advances in immunology have also made

possible simple and sensitive diagnostic tests

for infectious agents, which are also much

faster than cultures and other traditional methods. One example is differentiation between

streptococcal throat infection (which requires

antibiotic treatment) and viral infection (for

which there is no specific treatment). Simple

home tests have been developed for many

diseases.

Vaccines, which stimulate protective antibody formation, were formerly prepared by

modification of either viruses, intact bacterial

cells, or toxins. With better understanding of

the immune response and improved methods

for purifying or synthesizing macromolecules,

it is possible to use specific components of the

pathogenic organisms, or synthesized protein

sequences, to make much more effective and

non-toxic vaccines. This should be particularly

effective against viruses, which offer fewer
34

unique features for selective attack than do

bacteria.

The methods of molecular biology are also

being applied to studies of protozoal parasites.

Some experts believe that prospects are bright

for vaccines for parasitic diseases, such as malaria or trypanosomiasis, that are major causes

of death in the Third World. Others are less

optimistic, although tending to agree that such

vaccines will ultimately be developed. The

problem is that some microbes—including

some viruses and bacteria as well as protozoa

–have a capability of making reversible genetic changes that permit them to replace a

surface antigen with various alternative antigens that cannot be neutralized by the same

antibodies.

Targeting Cancer

Animal cells, unlike bacteria, undergo differentiation and organ formation, and these

processes involve intricate interactions with

neighboring cells. Accordingly, the regulation

of cell growth has been much more difficult

to study in animals than in bacteria. It is the

regulation of cell growth that is disrupted in

cancer.

Recombinant DNA methodology has already

dispelled some of the mystery of cancer, by

tracing the origin of some cancers to alterations in the amount or structure of various

genes called oncogenes. These gene changes

explain why viral infection, radiation, or mutagenic chemicals as well as spontaneous mutations might all cause cancer. Moreover, researchers are exploring the effects of these

genes on regulatory mechanisms and on the

cell surface.

Molecular genetics has led to drugs that interfere with DNA replication and thus in a

limited way with cell growth, and potentially

with cancer. Growing understanding of the biochemistry and immunology of cancer offers

promise of greater future advances in prevention or cure and unlike many other advances

in medicine, they may decrease rather than increase the costs of controlling cancer.

Human Body and Brain Enhancement

Gene therapy is aimed at curing well-defined

hereditary diseases. But bioengineering might

also theoretically be aimed at enhancing desired traits or creating new traits or new physical or mental capabilities. This possibility has

often been raised in speculation and in fiction,

with some scenarios going as far as the creation of superior and inferior classes of people.

In fact, the technical possibilities for significant enhancement through genetic engineering appear limited. Genetic manipulation in humans is likely to be restricted for a long time

at least to addition or replacement of a single

gene, and there are only a few known single

genes with significant effects generally agreed

to be desirable. If one assumes that the traits

society might be tempted to enhance would

be intelligence (or more precisely, some aspect

of intelligence), memory, strength, size, athletic ability or some other specialized talent,

each involves a large and as yet undefined number of genes. Anyone attempting to manipulate such traits would be facing a formidable

task.

For many years, however, neurobiologists

have been studying conduction of electrical impulses along nerve fibers and the chemical

transmission of impulses from one cell to many

others. Specific functions in the brain have

been identified and localized in specific regions.

It has been known for some time that some

hormones, distributed throughout the body,

influence both physiology and behavior.11

Now science is identifying a variety of neuropeptides, hormones that are released within

the brain and modulate functions such as blood

pressure and digestion. It is increasingly likely

that neuropeptides will prove to be involved

in controlling mood or emotions, although none

have yet been shown specifically to do so under physiological conditions. It is even possible that a biochemical explanation may be

1’U.S. Congress, Office of Technology Assessment, Impacts

of Neuroscience—Background Paper, OTA-BP-BA-24 (Springfield, VA: National Technical Information Service, March 1984).
35

found for violent, aggressive, or antisocial behaviors. Such knowledge could be expected to

lead to medications or treatment for a range

of conditions, such as emotional disorders; it

could also lead to less beneficial forms of behavior control or mind control. According to

Dr. James L. McGaw, director of the Center

for the Neurobiology of Learning and Memory at the University of California, Irvine, “The

basic science of neuropeptides and neurotransmitters . . . is exploding at the present time.

Dr. Herbert Weingartener, Chief of Cognitive

Studies at the National Institute of Mental

Health, added, “We’re sitting on a revolution

that rivals quantum physics in the 1920s."12

A second line of research is also leading to

new theories and new knowledge about the

genetic basis of mental and behavioral traits—

the study of identical twins, including pairs

that were separated at birth by adoption. A

series of studies at the University of Michigan has been widely reported; this research entails both biological and social science research

and may provide clues for further genetic research.

The molecular basis of memory is being

worked out in simple animals. In higher animals analysis of the paths and mechanisms of

communication between different regions within

the brain is providing new insights into the

ability of the brain to integrate information,

much like a computer but with complex branching rather than more linear connections.13

There could be ways to enhance the functioning of these pathways and possibly the storage of information; already clinical tests of

such chemical aids are underway.

Individuals appear to differ widely in the

speed of the search-and-find processes in their

brains that produce complex responses to an

input of information. The molecular genetics

of development suggests that one source of

differences in this aspect of “general intelli-

‘2Both are quoted in Michael Schrage, “Soon Drugs May

Make Us Smarter, ” Washington Post, Feb. 3, 1985, p. Cl.

‘]For a good journalistic account of this line of research, see

George Johnson, “Memory: Learning How It Works, New York

Times Magazine, Aug. 9, 1987, pp. 16-34ff.

gence”14 might be differences among individuals in certain proteins of their synapses;

whether these proteins can ever be ‘enhanced”

is highly controversial at present.

Advances in neurobiology will almost certainly have major impacts on the understanding and treatment of various mental illnesses.

A better understanding of the role of biological factors and the role of social factors could

eliminate unwarranted blame for mental illness

that has been attributed to the family environment or to other aspects of society. Recent

indications that genetic factors may play a

decisive role in some kinds of manic-depressive

illness have focused attention on biological factors in other mental illnesses.

The brain, with its hundred billion or more

cells and a thousandfold greater number of connections, seems likely to provide a virtually

endless challenge for molecular scientists.

Many people, however, may find that their discoveries, or even their hypotheses and research,

are unsettling and disturbing. They bring into

question familiar assumptions about human

nature, responsibility and freedom, and basic

equality among people.

The Control of Aging

The branch of biology with the most recalcitrant gaps between empirical description and

molecular analysis is developmental biology,

or the study of how cells and organisms mature and age. Scientists still lack adequate

knowledge of the mechanisms by which cells

in a developing embryo differentiate, move,

and relate to neighboring cells in an orderly

way to yield a coherent set of organs. They do

understand or are beginning to understand

some of the key features: how genes are seleclqThe definition and the use of the term ‘‘intelligence’ is

frought with difficulties, both technical/scientific and political.

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 compared with other individuals, and among and between groups

or populations. Quite distinct from questions of definition or

measurement of intelligence or intelligences, is the mystery of

various forms of dyslexia, or defects in specific aspects of handling language.
tively turned on or off, how concentration gradients of chemicals released by cells influence

neighboring cells, and how cells find and adhere to each other. They are still far from understanding in detail how nerve fibers extending from specific cells in the brain connect with

other specific cells in other brain regions. It

is generally anticipated, however, that advances along these lines will now proceed rapidly and the results will be translated into major medical advances in the years ahead.

Despite the progress in cell biology, the basic

mechanism of aging in higher organisms is not

understood—even in terms of whether the key

changes occur in genes, intracellular structures, membranes, blood vessels, the immune

system, or all of these. The general increase

in life span is a product of improvements in

prevention and treatment of infectious and

other diseases, as well as in nutrition and sanitation, rather than a product of specific interference with the aging process. If life were sufficiently prolonged, or aging and natural death

sufficiently delayed, then the birth rate might

need to be lowered to avoid problems of overpopulation. A lowering of the birth rate might

come about either by a general consensus of

individuals, by public policy intervention, or

by some natural adaptation. Such interference

does not seem to be in sight now, but if it comes

about it could radically alter the normal process of generations with major social consequences.
Chapter 4

the

Genetics and

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 progress in biological science, and some of the uses

to which the new knowledge maybe put. Understanding of the nature of living organisms,

and especially of human bodies and brains and

behavior, directly affects how we act toward

each other and toward the physical environment. Thus the new biology may have not only

physical, economic, and social effects but also

political and legal implications. From these political and legal implications, constitutional issues may arise as governments:

attempt to regulate new decisions that

people must make, or new choices that

people can enjoy;

collect biological and genetic information

about people;

try to use biological knowledge or technologies to modify the behavior of individuals or groups;

act to remove or control risks that are

newly disclosed by biological knowledge;

or

respond to community demands to declare

some kinds of scientific knowledge undesirable, for reasons of safety, ethics, or

other values.

These propositions assume that governments are acting responsibly, legitimately, in

the interests of the general welfare, and in accord with the wishes of a majority of the population. The constitutional issues are likely to

arise not because governments assume new

authoritarian powers as predicated in novels

such as 1984 or films such as Clockwork

Orange, but because biology-based technical

capabilities make the exercise of traditional

‘Much of the material in this chapter, not otherwise cited,

draws on a report, “Constitutional Implications of the ‘New

Biology ’,” prepared for OTA by Dr. Sheila Jasanoff of Cornell

University’s Program on Science, Technology, and Society, April

1987.

powers of government more effective; or because they give individuals more power over

their lives, and in so doing bring them into conflict with each other or with values held by the

community at large.

When people are able to choose non-traditional means of using their environment, of

reproducing themselves and designing their

families, of maintaining the life or easing the

death of helpless family members, it is inevitable that questions will be raised about

whether or not the State has a legitimate interest in these decisions and is obligated to act

to assure the general welfare or to enforce the

society’s ethical values.

Governments may assume an obligation to

collect biological or genetic data about people

in order to protect public health, to provide

compensatory benefits or protections, to assess the effectiveness of government programs

or services, or for other legitimate purposes.

Governments may step in to mediate the use

of biological data by third parties, such as employers or insurers. Governments may attempt

to use biology-based techniques to modify individual or group behavior in the interest of

the individual-as in efforts to prevent drug

use, smoking, alcoholism, or other high risk

behaviors, or in the interest of the community—for example, drug or hormone therapy

to control violent aggressive behavior.2 As

we become potentially more effective in detecting exposure to infectious diseases, vulnerability to environmental or occupational

diseases, or special susceptibilities to other

widespread hazards, in the absence of a technical “fix” the demands to use strong social

‘See U.S. Congress, Office of Technology Assessment, Crim”-

nal Justice, New Technology, and the Constitution, OTA-CIT366 (Washington, DC: U.S. Government Printing Office, March

1988), for a discussion of the potential use of such therapies

in the criminal justice corrections system,

39
40

controls to reduce such risks will increase. Research itself is sometimes seen as imposing societally unacceptable risks, especially when it

involves modifying natural life forms or life

processes.

The collection or use of biological information about people is particularly fraught with

potential constitutional issues because of the

likelihood that it will infringe on individual

autonomy or privacy, or will violate current

standards of due process and equal protection

of the laws.3 But issues of constitutional

magnitude may also arise in connection with

governmental efforts to control risks presented

by industrial, agricultural, or environmental

Sprivate actions, such a9 those of corporations, wilI ordin~-

ily be insulated from direct constitutional challenge.

applications of the new biology. There maybe

conflicts over the separation of powers, especially between the courts and the legislature.

Attempts to regulate potentially hazardous research or the dissemination of knowledge may

raise fundamental First Amendment concerns.

This chapter discusses some of the direct applications of the “New Biology” that are likely

to raise constitutional problems. These are,

first, some applications of genetic engineering

to people: diagnosis of hereditary diseases, including prenatal diagnosis, human gene therapy, and genetic screening in the workplace.

Other implications of genetic engineering for

people are discussed in later chapters on medicine and public health. Secondly, some broad

questions involving current or proposed limitations on bioengineering research or technological applications are discussed.

GENETIC ENGINEERING AND PEOPLE:

DIAGNOSIS AND THERAPY

Gene Therapy

Human gene therapy refers to the deliberate

change of genetic material within a human patient, with the intent of correcting a specific

genetic defect.’ There are two possible kinds

of human gene therapy, somatic cell therapy

and germ cell therapy.

Somatic cell therapy will not cause inherited

or inheritable changes. It might be, for example, a means of replacing the defective gene

in the bone marrow cells of a child affected by

genetic immune deficiency. (These bone marrow cells produce blood cells.) If successful, this

would “cure” the child, but would have no effect on his or her own future offspring; genetic

immune deficiency could still be handed down.

In contrast, germ cell therapy would not help

already mature people, but would involve inheritable alterations, that is, characteristics

‘For further detail and elaboration see U.S. Congress, Office

of Technology Assessment, Human Gene Therapy—A Background Paper, OTA-BP-BA-32 (Washington, DC: U.S. Government Printing Office, December 1984), from which this section

is in part abstracted.

that could be handed on to the patient’s future offspring.

Germ cell therapy, involving inheritable alterations, is unlikely to be undertaken in humans in the near future because it is technically too difficult and too risky. The success

rate in animals has been low, and the danger

of damage to other genes is high. Most medical investigators probably consider the risk of

this technique in humans too great for the foreseeable future.5 Moreover, some genetic scientists argue that germ cell therapy may not

prove superior to existing technologies.

Somatic cell therapy may become possible

in the near future. In June 1988, scientists announced that they had succeeded in correcting, in animals, a serious genetic defect in liver

cells, and described this as “an important first

step toward a form of human gene therapy. “6

‘According to Dr. Bernard Davis, Professor Emeritus of Bacterial Physiology, Harvard University.

cAccording to Harold M. Schmeck, “Gene Technique Used

To Correct Liver Defect, ” New York Times, June 16, 1988. The

research was to be described in the June Proceedings of the National Academy of Sciences.
41

In mid-July 1988, the NIH Biosafety Committee was scheduled to begin review of a proposed

experiment (within NIH) to attempt gene transplants in patients enrolled in an experimental

cancer treatment program.7

Gene therapy (on either somatic or germ

cells) can take several forms. A new gene may

be inserted into a cell; a gene already in a cell

may be altered; a defective gene may be removed from a cell by surgery. Gene modification or gene surgery can now be performed in

some viruses, yeasts, and bacteria but not in

humans or in other animals. Gene insertion is

now possible, although not yet considered

ready to be put into practice in treating people.

New material that is inserted would code for

(i.e., direct the production of) necessary proteins, or would regulate production of particular proteins either to suppressor enhance their

production. There are many possible ways of

inserting DNA or genes into cells:

●

●

●

●

physically injecting the material into individual cells,

treating DNA chemically in such a way

that cells are induced to take it up,

fusing the cells to membranes that contain the DNA, or

designing viruses that will carry the desired

DNA material and “infect” targeted cells

with it.

At present, all of these methods are in early

stages of development.

With germ cell therapy, gene insertion would

be performed on the cells of an embryo within

a few hours of fertilization. Therefore all cells

of the embryo would be affected as they develop and differentiate into a fetus. It is theoretically also possible to insert new genes into

sperm or ova, or into the cells that produce

them. With good techniques for in vitro fertilization, successful gene therapy on ova and

sperm has come to seem more feasible. But

‘The gene to be translated is a marker gene, that would enable scientists to track the migration of special white blood cells

introduced into the patient’s body to attack tumor cells. Margaret Chase, “Human Gene Transplants Closer to Reality as

Researchers Pursue Bid for for Experiment, ” Wall Street Jow--

md, July 13, 1988.

with sperm there is still the difficulty that

while only one sperm fertilizes an egg and thus

transmits its characteristics, huge numbers of

sperm are used in the attempt at fertilization,

even with artificial insemination or in vitro fertilization. Gene therapy involving cells that

produce ova and sperm would require invasive

techniques and presumably therapy on many

cells. Only one, or very few, ova would have

to be modified.

The practical advantage of somatic cell therapy as opposed to germ cell therapy is that

it could be performed on individuals at any

stage of development rather than on an early

stage embryo. If necessary, repeated attempts

could be made. The reliability of a gene transfer procedure would not have to be as high.

But somatic cell therapy might not be applicable to disorders that affect multiple tissues

or organs, since the cells of each tissue or organ would have to be altered. It would not be

applicable to cells that do not divide, such as

brain cells. Finally, it would not prevent the

inheritance of the same defects by children of

the successfully treated patient.

The first attempt to use gene therapy in humans occurred in 1970 and 1973 in the unsuccessful experiments of an American researcher,

Dr. Stanfield Rogers, and a German colleague.

But because these trials predated the establishment of institutional review boards, they

did not provoke much ethical debate.8 Recombinant DNA techniques were first used for

prenatal detection of disease only in 1982.9

Yet two years earlier, UCLA scientist Dr. Martin Cline used recombinant DNA techniques

in treating human subjects.10 Cline’s patients

were two patients with thalassemia (inherited

anemia) in Italy and Israel.

Dr. Cline had not gotten approval from

appropriate review committees in either the

United States or abroad. There was wide agree80TA, op. cit., footnote 4, pp. 44-45.

gThe first success was prenatal detection of sickle cell disease: see J.C. Chang and Y. W. Kan, “A Sensitive New Prenatal

Test for Sickle-Cell Anemia, ” New England Journal of Medicine, vol. 307, 1982, pp. 30ff.

“’Judy Arech et al., Law, Science and Meulcine (Mineola, NY:

Foundation Press, 1984), pp. 168-169.
42

ment in the scientific community that the experiments were both premature and unethical.11 The National Institutes of Health

terminated two grants to Cline, who resigned

his division chairmanship. The episode raised

substantial questions about the enforceability

of existing guidelines governing research with

human subjects. According to a 1984 OTA

study, the Cline experiments “may have catalyzed formation of a consensus that the time

was not ripe” for germ line therapy .12 The

question whether such treatments should ever

be attempted, and, if so, under what conditions,

awaits resolution through further public debate.

There are professional, ethical, and religious

objections to human gene therapy, which may

or may not involve constitutional questions.

The usual way that such debates are conducted

is in political, ethical, and legal terms, formulated as proposed or alternative public policies.

However, either side may and often does, as

an ultimate resort, assert a constitutional right

or a constitutional prohibition on behalf of its

position. Increasingly, the Supreme Court has

put reproductive choices under the umbrella

of “privacy, that is, within the sphere of personal autonomy in which government should

not intrude without a compelling public interest. A brief look at the various positions taken

in this and related controversies may therefore point to potential or emerging constitutional issues.

In 1980, the U.S. Catholic Conference, the

Synagogue Council of America, and the National Council of Churches jointly sent to the

President of the United States a letter expressing concern that “prowess might surpass

prudence” in the application of genetic engineering to human subjects. The President’s

Commission for the Study of Ethical Problems

in Medicine and Biomedical and Behavioral&

search issued a report, Splicing Life, in November 1982. ’3 In June of 1983 a resolution

1’At the time the experiments were performed, Cline’s protocol was pending app~ova.1 before the-UCLA review committee. Cline had prior approval from a review committee in Israel,

but for a protocol that was somewhat different from the one

he actually used.

“OTA, op. cit., footnote 4, p. 46.

I:lpresident’s Commission for the Study of Ethical Problems

in Medicine and Biomedical and Behavioral Research, Sph”cing

signed by 56 religious leaders and 8 scientists

and ethicists was sent to Congress.14 It urged

that “efforts to engineer specific genetic traits

into the germ line of the human species should

not be attempted. ”

Other objections to or concerns about human genetic engineering may apply to either

somatic cell or germ cell therapy:15

●

●

●

●

●

Scientific evidence that the treatments

will work to the patients’ benefit is not

yet adequate.

Precautions against deliberate misapplication may be inadequate.

Gene therapy may be no more effective,

economical, safe, or acceptable than alternative treatments.

The patients or their surrogate decisionmakers may not be adequately informed

about the risks and benefits of the

therapy.

The effects may not be reversible or

treatable. 

Objections to human gene therapy have focused particularly on germ cell therapy because

it affects future generations. By definition, future generations cannot give consent to the

procedure, and there is a risk of propagating

unpredictable and possibly undesirable effects.

These objections can be made to many other

procedures, of course, that affect the likelihood

of future descendants and possibly their characteristics (e.g., medical support for diabetics

that now allows them to bear children). More

generally, some people point to the possibility of changing the genetic characteristics

of human populations or of diminishing the

genetic diversity among human populations.

These possibilities too are not specific to or

limited to genetic engineering as compared to

other human activities, both individual and collective, that may affect offspring, including

Life, No. 83-600500 (Washington, DC: U.S. Government Printing Office, November 1982).

l~ConWes9ion~ ~cord, June 10, 1983, S8202-8205; the resolution was introduced by Senator Mark Hatfield.

IsThis list, like much of the other material presented in this

chapter, was developed for and presented in Human Gene

Therapy–a Background Paper, already referenced, footnote 4.

The objections have in some cases been paraphrased or restated

here.
43

many medical treatments. They are perhaps

raised more urgently because genetic engineering represents a systematic, purposeful, and

unprecedented intervention of a kind that has

not been possible before.

Some public apprehension about germ line

therapy centers on the speculation that such

interventions will gradually erode concepts of

humanity and personhood, that specialized

people might be “designed” for certain purposes (such as excelling at athletics, or soldiering), or that some faculties or traits such as

intelligence or longevity could be enhanced

selectively, creating superior classes of people.

Some also fear that an all-powerful state may

use gene therapy to modify human behavior

or engineer new breeds of humans, possibly

through cross-species transfer of genes.l6

Constitutional principles are most directly

challenged by three general questions that increasingly are raised with regard to potential

scientific and medical interventions. The first

is the question of whether there is a ‘‘right to

do experiments” or a “right to use scientific

knowledge” embedded in the First Amendment; this question is discussed in some detail below.

The second is whether there is a “right to

treatment, ” where such treatment is life-saving and technically available but is economically or otherwise a scarce resource. The existence of such a right is often advanced by

ethicists or public interest advocates, but it

has not been recognized legally or constitutionally. 17 It is discussed further in chapter 6 on

medical interventions, particularly with regard

to treatments that are either very high cost,

which limits access to them, or which are scarce

because only a few institutions or individuals

are equipped to perform them.

The third question is whether there is an implicit constitutional right to refuse treatment,

for oneself and for dependents unable to speak

for themselves. This question is also discussed

in chapter 6 on medical interventions, in relation to refusal of life support systems for those

who can not survive without them. It arises

also in discussion of criminal justice, when

treatment becomes (now or potentially) an

alternative to or complement to punishment

for violent and aggressive behavior.18 No definitive answer can be given to the question; but

the answer appears to be that there is evolving and still highly qualified recognition of an

explicit right to refuse treatment, within the

sphere of personal privacy. Nevertheless, the

State also has an enforceable interest in the

decision under some conditions.

Mandated treatment of specific genetic disorders as a precondition to receiving a marriage license has been suggested.19 This

would be by today’s standards a highly controversial policy, raising serious questions of

due process and equal protection. But in this

area, values and standards have changed over

time. Just as compulsory vaccination has been

consistently upheld by the Supreme Court as

a legitimate State policy designed to prevent

the spread of communicable diseases,zo it

could be argued that mandatory gene therapy

would similarly prevent the vertical transmission of disease from one generation to the next.

Further legal precedents might be found in several cases in which courts ordered cesarean sections over the objections of the patient to protect the life of the fetus, as discussed in chapter

6. These observations lead directly to consideration of eugenic policies in earlier periods of

American constitutional history.

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 ConstituShouM 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 disright to treatment. cussed in detail in ch. 5.
44

Genetic Control: The New Biology

and the Old Eugenics

After the writings of Francis Galton in

18652

’ beliefs concerning the “superiority” of

some racial types and the “unfitness’ of other

racial and ethnic groups tragically flourished

in both Europe and the United States. These

beliefs provided the justification for a variety

of State-sponsored eugenic policies22 whose

aim was to discourage the multiplication of allegedly unfit individuals. The mass tragedies

of genocide in Europe and legal and social discrimination and persecution in the United

States are far beyond the scope of this report.

To look at only a few of the much narrower

eugenic policies or programs that were adopted

in the United States is sufficient to provide

a framework for asking whether the new biology could lead in its turntoa‘‘new eugenics,

raising serious constitutional issues.

Eugenics doctrines in so far as they labeled

entire races and national or ethnic populations

as “inferior’ or ‘unfit implicitly contributed

to Federal and State laws and policies that

preserved racial segregation and restricted immigration in the late 19th and 20th centuries.23

ZISir Frmcis G~ton, 1822-1911, a cousin of Charles Dmwin!

was a pioneer in the study of trait inheritance in humans. He

did the first systematic studies of twins, and is regarded as the

father of scientific eugenics. Among his books are Human Genius, 1862, and Natural Inheritance, 1889.

22A word that means “pertaining to the production of good

offspring. Eugenic policies are intended to discourage the multiplication of allegedly “unfit” or inferior individuals, to encourage the reproduction of healthy or fit or superior individuals, or to encourage high reproduction in some racial or ethnic

groups and discourage or forbid the reproduction of others. They

generally have ideological or political purposes but are almost

always defended or justified on some scientific grounds, however selective or distorted the presentation of the associated

data and/or theory may be.

23 The stren@ of eugenics doctrines was reflected in ‘remigration laws beginning with the Exclusion Act of 1882, which

restricted Chinese immigration, and continuing in laws of 1891,

1903, and 1907, which excluded those with certain diseases,

criminal records, and radical political beliefs. Economic motives

were also important, i.e., the opposition of organized labor. The

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 Berthoff, “United States: The People—Population Origins, ” in the

Encyclopedia Americana, International Edition, 1986, vol. 27,

pp. 529-31,

They were also directed at preventing reproduction by certain types of individuals, especially “mental defective,” and this objective

also led to State laws and constitutional challenges.

Two themes were especially prominent in the

thinking of the pre-World War II eugenicists.

First, they claimed scientific support for their

policies of selective propagation, relying in

large part on quantitative studies of the “transmission of traits” through successive generations. Second, eugenic policies during the

period of their greatest success were motivated

to a significant extent by considerations of economic efficiency. “Hereditary” criminality,

pauperism and mental defectiveness, it was alleged, were imposing heavy burdens on the taxpayer. In describing the case of the notorious

Jukes family of “social misfits, ” the American

Eugenics Society noted that it would have cost

the State $150 to sterilize the original couple

and $25,000 to segregate one member for life;

by comparison, the total cost to society imposed by the descendants of the couple was

estimated as over $2 million.24

Arguments such as these fueled eugenically

inspired legislative and judicial decisions in a

number of areas. Many of these laws have remained in force and are generally, although not

universally, accepted as sound legally and ethically. For example, by 1914, some 30 States

had marriage laws that either restricted marriages among the mentally unfit and venereally

diseased or else declared such unions voidable. 25 But starting in 1907, a number of

States enacted laws granting authority to the

State to sterilize certain classes of people:

habitual criminals, idiots, or the insane. A challenge to the Virginia sterilization statute was

carried to the U.S. Supreme Court in 1927 as

Buck v. Bell.26 This case will be discussed at

greater length in later chapters. Here it is sufficient to note that, swayed by the scientific and

public welfare arguments advanced on behalf

24 Daniel J. Kevles, In the Name of Eugenics (Berkeley, CA:

University of California Press, 1985), p. 93.

251 bid., p. 99.

26274 U.S. 200 (1927).
45

of the State, the Court upheld a sterilization

order against a 17-year-old retarded woman,

with Justice Oliver Wendell Holmes commenting, “Three generations of imbeciles are enough.”

The history of sterilization laws since Buck

v. Bell has been mixed. In 1942 the U.S. Supreme Court invalidated a State sterilization

statute on Equal Protection grounds.27 However, in 1976 the Supreme Court of North Carolina declared a roughly similar statute constitutional in view of the procedural protections

afforded to the petitioner. The court noted that

the people of North Carolina “have a right to

prevent the procreation of children who will

become a burden on the State. ”28 In the

1970s, with much attention focused on the potential problems of overpopulation and depletion of resources, there were some other indications of a revival of earlier eugenic themes.

One well-known geneticist29 wrote:

Thus, in an overpopulated world it can no

longer be affirmed that the right of the man

and woman to reproduce as they see fit is inviolate. . . . The right that must become paramount is not the right to procreate but rather

the right of every child to be born with a sound

physical and mental constitution, based on a

sound genotype.

Recent emphasis on the constitutional right

of individuals to make decisions about reproduction without governmental regulation have

framed the issue differently; they have focused

on the right of individuals not to bear children

rather than the right to bear children, and thus

have tended to throw into shadow the older

issue of whether government can act to discourage or prevent childbearing. Genetic screening and counseling are seen as mechanisms for

enhancing the reproductive options available

to “at risk” couples, particularly in the aftermath of the liberalization of abortion in Roe

v. Wade.

2’Skinner v. Oklahoma, 316 U.S. 535 (1942).

2

’in re Moore, 289 N.C. 95 (1976).

‘

gBentley Glass, former president of the American Institute

of Biological Science, as quoted by Frederick Ausubel, Jon Beckwith, and Kaaren Janssen, “Stimulus/Response: The Politics

of Genetic Engineering, “ Psychology Today, June 1975, p. 34.

The authors of the Psychology Today article were themselves

then biological scientists on the faculty of Harvard University.

The mere fact that such choices are currently

left to the discretion of individual couples and

their physicians does not entirely rule out the

possibility of future State intervention, or at

least of renewed proposals for State intervention. The discovery of genetic bases for a wide

variety of illnesses and disorders, both physical and mental, promises to put the study of

heredity on a more secure scientific footing

than was available to the earlier generation of

eugenicists. The theme of social costs of genetic

disorders and mental retardation is implicitly

woven into estimates of the frequency of

genetic illnesses.

In a much more general sense, research findings about genetic and biochemical factors in

mental performance, ability, aptitudes, or

health often appear to arouse concerns about

“equality,” “equity,” and “equal opportunity.” Research on improved methods of measuring such mental attributes also arouse such

concerns, and “intelligence testing” has somehow come to be taken as a code word for antidemocratic beliefs. In some cases, this is

merely an exercise in anti-intellectualism, but

in other cases it reflects a well-grounded concern that scientific information about inherent differences among people may easily be distorted into justification of policies that

establish or preserve different standards of

rights and liberties, and different classes of

citizenship.

Prenatal Diagnosis

Prenatal diagnosis of genetic or hereditary

diseases is already a major application of

molecular genetics. For prenatal diagnosis, fetal cells are used that are cultured from the

amniotic fluid, or from a biopsy of the placenta

even earlier in pregnancy. Such diagnosis is

particularly often used with an older mother

because of the increased probability that her

fetus will have an extra chromosome 21, which

causes Down’s syndrome. A procedure called

chorionic villius sampling is used in fetal

assessment to detect chromosomal disorders

such as Down’s syndrome as early as 9 weeks

into pregnancy. The risks in such procedures
46

to a child subsequently born alive are believed

to be small, but are not well known.30

When both parents carry a particular singlegene recessive defect, one-fourth of the embryos, on average, will have two copies of that

defective gene and hence will manifest the disease if they live long enough. More than 2,000

such single-gene diseases are now known, and

as many as 2 percent of newborns have a genetic disease.31 Some genetic diseases do not

manifest themselves until after child-bearing

age. Although most hereditary diseases are

rare, some are not. The sickle cell gene is carried by about 10 percent of American Blacks

and the cystic fibrosis gene by about 5 percent

of Caucasians.

Several hundred of these diseases can now

be diagnosed prenatally, some by tests for the

gene product and others by examination of the

DNA. It is likely that eventually scientists will

be able to diagnose prenatally most single-gene

diseases. This knowledge inevitably raises the

question of terminating such pregnancies, forcing people to make decisions wherein the past

there was no early warning and thus no occasion for choice.

Some hereditary diseases can be avoided by

sex selection. Because the sex of a fetus can

be determined from the amniotic fluid early

in pregnancy it is technically possible to “select” the sex of a desired child by aborting

when the fetus is of the other sex; this has led

some to fear that the natural balance between

males and females could be upset where there

are strong cultural preferences for one sex. But

sex selection sometimes has a medical rather

than a cultural objective, since some hereditary diseases are gender-linked. For example,

the common form of hemophilia is manifested

overwhelmingly in males, compared to females.

New techniques are likely to provide other

means of sex selection. Japanese scientists re30Jain Chalmers, director of Britain’s perinatal epidemiological unit at Radcliffe Infirmary, Great Britain, and Thomas C.

Chalmers, M. D., Boston Veterans Administration Medical Center, in a letter to the editor of The iVew York Times published

Oct. 8, 1987.

3’V.A. McKusic, Mendelian Inheritance in Man, 6th ed. (Baltimore, MD: The Johns Hopkins University Press, 1983).

cently disclosed a high rate of success in sex

selection through a technique of sperm separation by centrifuge, which depends on differences in the DNA content of sperm bearing

an X chromosome, which produce females, and

those bearing a Y chromosome, which result

in males.32

Attempts to delegalize abortion through constitutional amendment, or by persuading the

Supreme Court to reconsider its position that

abortion falls within the protected zone of private decisionmaking, will run counter to the

societal effects of increasing capability in

prenatal diagnosis of hereditary disease. The

desire to exercise a choice is the primary motivation for using the technique; and while use

of the technique could in theory be prohibited,

it has always proved difficult to enforce prohibition of the generation of knowledge that

is strongly desired and readily produced.

Genetic Screening in the Workplace

Genetic screening may potentially be used

to detect specific hereditable diseases, or a

genetic susceptibility to certain diseases that

are not directly inherited, or special vulnerabilities to environmental risks.

Scientists are now identifying genes that

have no obvious direct effects on health, yet

are statistically associated with future health

outcomes or with life expectancy. In some

cases these may turn out to be “markers” or

“indicators’ only vocationally associated with

other genes that produce disease, with no disease-causing characteristics themselves.

Other traits may be governed by genes that

are not always expressed. For example, a specific gene appears to indicate a propensity for

Alzheimer’s disease, rather than a direct inheritance of it; not all those with the gene show

the disease. A genetic defect governing lipid

s~he d~tors reporting the technique say that in their clinics

the technique is used only to produce females for couples with

a family history indicating the likelihood of a sex-linked hereditary disease. The method is now being tried in several U.S.

clinics, according to newspaper accounts. See Walter Sullivan,

“New Way Devised To Pick Child’s Sex, New York ~“mes, Sept.

23, 1987, Sec. A.
4 /

metabolism seems to predispose the bearer to

early coronary thrombosis. Understanding of

the complex immune system may in the future

reveal much about resistance to various infectious diseases, or susceptibility to degenerative diseases ranging from ulcerative colitis to

diabetes, which are now recognized as having

an auto-immune component.33 Molecular biology may play a large role in advancing the

understanding of infectious agents, as it did

in identifying and characterizing the lethal

human immunodeficiency virus that causes

AIDS.

Tests are being developed for genetic patterns that expose one to special risk from an

environmental factor, or higher-than-usual sensitivity to toxic factors in the environment.34

For example, some people have a variant form

of a single gene that results in a deficiency in

an enzyme called glucose-6-phosphate dehydrogenase (G-6-PD). Should these people chance

to take drugs for malaria, or eat fava beans,

the lack of the G-6-PD enzyme may cause the

destruction of their red blood cells, resulting

in an acute anemia. Some scientists expect that

they may also suffer this response if they are

exposed to chemicals that are similar to the

antimalarial drugs. They could meet this exposure in the workplace; EPA lists more than

55,000 different chemicals used in production

in this country. Genetic screening or testing

could, in theory, warn such people and their

employers that they would be at special risk

in certain work assignments or workplaces.

It is these emerging capabilities that raise

the controversial possibility of employers

screening employees or job applicants for genetic traits. They might do so either to reduce

occupational illness (and liability) by avoiding

the use of workers with high susceptibility to

toxins or other environmental hazards in the

workplace, or to reduce the cost of employee

s~That is, abnorm~ production of antibodies, or the Production of cells that attack a normal tissue as though it were a foreign material.

34u s conge55, office of Technology ASSeSSrnent, ~~e ~O~e . .

of Genetic Testing in the Prevention of Occupational Disease,

OTA-BA-194 (Washington, DC: U.S. Government Printing Office, April 1983).

health benefits by reducing the incidence of

genetic illnesses. It should be emphasized here

that predisposition is a statistical statement

and is not a prediction that any one individual

will develop a disease.

The possibility of screening for environmental susceptibilities at present is very

limited, since so far there have been identified

only a few known genetic defects in the ability to detoxify certain chemicals. Only 2 to 6

of these have high enough effects to serve as

reliable guides; all are rare.35 However, more

may be identified in the future. When and if

such screening becomes more reliable, it could

find widespread use in at least some industries

where mutagens or other toxic substances in

the workplace remain a problem.

Screening for general disease potential as opposed to specific genetic illness may also remain of limited use for some time. Even when

some genes are statistically correlated with increased susceptibility to certain diseases, small

differences in susceptibility or resistance to

environmental factors within the normal range

are not likely to be useful in terms of screening for employment or insurance purposes.

Genetic testing in the workplace, for special

susceptibility to environmental or occupational

hazards, is still in its infancy; it has been often

discussed but is apparently little used at

present.36

The difficulty is that what may be seen as

a benefit and protection for a worker may also

be seen by some workers as unfairly depriving them of livelihood or job opportunities, or

as usurping their individual prerogative to

make decisions about what risks they will assume. This point would become even more possEdith F. Canter, “Employment Discrimination Implications 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 screening procedures. Dr. Bernard Davis, professor emeritus of

microbial genetics at Harvard University, vouches for only two.

WA 1982 survey by OTA found that although only 6 out of

366 companies were then using such techniques, another 55

stated that they might do so within the next 5 years (OTA, op.

cit., footnote 34, p. 5.) Little is known about whether the incidence of genetic screening has increased in the last 5 years.
48

litically and ethically sensitive if the genetic

pattern in question is peculiarly associated

with an ethnic, racial, or gender group already

subject to social and occupational discrimination.

The employer has a legal responsibility to

protect workers from known occupational hazards.37 This would not, at present, require the

employer to use genetic screening even if

highly reliable tests for a particular susceptibility were available; but if the employer chose

to use such tests and then assigned susceptible workers to a high-risk environment, the employer would probably be found negligent. Unless the worker had been informed of the risk

and refused re-assignment, he or she would

probably be covered by workers’ compensation

laws, and the employer could face punitive

damages. These are statutory protections,

rather than constitutional principles, which

would not apply against private sector employers.

Commonly used genetic screening tests include those for detecting glucose-6-phosphate

dehydrogenase (G-6-PD) deficiency and sickle

cell trait. Experts differ as to their reliability.

In 1985 the U.S. Air Force Academy decided

not to admit any candidates who exhibited the

sickle cell trait,38 because this condition could

cause an oxygen deficiency in the blood at high

altitudes, which in turn could cause fainting

while piloting a plane. The sickle cell trait affects Blacks, and is found in about 10 percent

of Black Americans. The Academy eventually

abandoned their policy under the threat of

lawsuits based on the charge that the policy

discriminated against Blacks. The scientific validity of the Academy’s presumptions was challenged, but both the objections to and the withdrawal of the decision were based on legal and

political considerations rather than on the

question of scientific validation of the presumption about occupational risk based on

genetic information.

sTFor more det~led analysis of the legal and ethical points

involved, see ibid., pp. 111-151.

qSKevle~, op. cit., footnote 19! p“ 278”

Although that case involved a Federal employer, genetic testing would be for the most

part an instrument used by private companies.

Accordingly, legal objections to such policies

could be made, if at all, only under the two

major anti-discriminatory statutes directed

against private employers, the Civil Rights Act

of 1964 and the Rehabilitation Act of 1973,

rather than directly under the Constitution.

Such civil rights legislation may indicate congressional interpretation of the intent and goal

of basic constitutional principles, and the aim

of extending to the private sector the restraints

which the Constitution itself imposes on government.

Title VII of the Civil Rights Act prohibits

overt discrimination based on racial, ethnic,

and gender categories except where the employer can show that disparate treatment is

correlated with a “bona fide occupational qualification. ” Some genetic traits associated with

hypersusceptibility to disease (at a high

enough prevalence to be of interest to employers) may be associated with particular ethnic or racial groups, but most are not, so that

overt discrimination against such classes

would be difficult to demonstrate.39 The Rehabilitation Act applies only to employers receiving Federal assistance, but it protects all

“qualified handicapped individuals, ” which

could be argued to apply to workers excluded

from jobs as a result of genetic screening. The

Act defines a “handicapped individual” as any

person who “has a physical or mental impairment which substantially limits one or more

of such person’s major life activities”; to bring

genetic traits within the definition of impairment would require a broader reading, since

such traits are harmful only after exposure to

hazardous workplace conditions.

The recent Supreme Court decision in School

Board of Nassau County v. Arline40 illustrates such an expansive reading. The case involved 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., footnote 34, pp. 123-126.

doschoo] Bo~d of Nassau County v. Arline, 55 U. S.L.W.

4245 (Mar. 3, 1987).
49

decision confirmed that a contagious disease

could be regarded as a handicap within the

meaning of the statute and that a handicap

may include not merely an actual impairment,

but also a social perception of the impairment

that substantially limits a person’s major life

activities. The decision seemed to indicate that

a potentially strict standard for evaluation

would be placed on job exclusions based on

genetic traits, and suggested that courts will

look very carefully at job restrictions imposed

solely because of a risk of future disability.

The protections afforded by the Rehabilitation Act and Title VII are suggestive but not

conclusive as far as concerns raised by largescale genetic testing in the workplace. Neither

of these Acts appears to apply directly to the

case at hand. The Courts might apply different standards to government as an employer.

Congress might apply different standards to

equal employment opportunities for genetically limited or susceptible private sector employees, if it has to deal with the issue directly.

At best, in providing for legal challenges to

employment discrimination, both Acts make

it possible for courts to scrutinize the genetic

screening methods and rationale. They may

thus provide some protection against the use

of frivolous or invalidated scientific techniques to promote undesirable social ends.41

In summary, neither Congress or the Court has

as yet made definitive statements about the

constitutional status of genetic testing; but

they will almost surely be challenged to do so

at some future time.

‘iSee, for example, Thomas Murray, “The Perils of Prechction, ” Genetic Engineering iVews, Januar~’ 1985, pp. 6-7.

BIOLOGICAL RESEARCH: SHOULD THERE BE

“FORBIDDEN KNOWLEDGE”?

The Right To Do Research

The new biology has provoked demands that

some areas of research be made “off limits, ”

or at a minimum, heavily regulated. One source

of these demands is the perception that certain aspects of bioengineering pose grave risks

to human safety or to the natural environment.

Another source is the perception that in altering inheritable human characteristics, and in

certain other potential activities such as interspecies gene transfer, we are violating natural or divine laws or fundamental ethical principles. Neither of these concerns is necessarily

unique to biological science and technology,

however.

Advanced technology provides great benefits, but often also carries risks to people and

to their environment. Some people, at times,

see technology as out of control, and society

as failing to act to prevent possibly disastrous

side effects. As modern science pushes ever

closer to questions about the origin of the universe, the nature of life, and the determinants

of human behavior, some people are concerned

that scientific theories may threaten to erode

cherished values and undermine traditional institutions.

These perceptions lead some people, including some scientists, to argue that those areas

of research should not be pursued further. A

few kinds of knowledge, they say, should be

forbidden. Or people may see the methods necessary to gain scientific knowledge as ethically

unacceptable. Other people, equally thoughtful and concerned, argue that all knowledge

is valuable, and that scientific freedom is constitutionally protected. Both in this century

and in the 19th century, research has been

conducted—especially experiments on human

subjects without their informed consent—that

would now be considered unethical and would

not be undertaken or allowed by most American research institutions.

Examples of such controversies occurred in

the 1950s about atomic energy, in 1974 around

recombinant DNA research; and in the mid1980s around the experimental release of engineered organisms into the environment. A sim-
50

ilar controversy surrounds fetal research.

There are demands that some or all experimentation on animals be forbidden. These are only

a few of many recent examples of disputes over

the existence of a right to choose freely among

topics for research, to choose methods of carrying out research, or to communicate the

results. 42

This section is not concerned with either pub

lic policy issues or ethical issues, per se, but

only with the question of whether there is a

constitutional challenge inherent in such issues. Specifically, this section of the chapter

is concerned with the question of whether there

is a constitutional guarantee of “the right to

conduct research, ” and if so, the scope and

limits of that right.

The Atomic Energy Act of 1946 placed vast

areas of research off limits to non-governmental researchers and required licensing and

regulation of research using radioactive materials. The great mathematicion, John von

Neumann, told the Congress:

It is for the first time that science has produced results which require an immediate intervention of the government. . . . A vast area

of research impinges on . . . the vital zone of

society and clearly requires rapid and general

regulation.

As discussed in an earlier OTA report, Science, Technology, and the First Amendment

(January 1988), when the dictates of national

security appear to conflict with individual

rights of free speech and free press guaranteed

under the First Amendment, the Supreme

Court has consistently said that there must

be a “balancing of interests. ” First Amendment rights, although strongly protected, are

not absolute. The constitutionality of the restraints on research that are included in the

42A generation earlier, atomic energy research was protested

on ethical grounds, and it was later prohibited for non-governmental scientists, although in the interest of national security.

Still earlier, research on birth control was protested. Many people

have grave ethical or religious objections to research on biological and chemical weapons, or on any weapons. Some people

object only to some potential applications of basic research,

others argue that no effective separation can be kept between

basic knowledge and undesirable applications.

Atomic Energy Act has been generally assumed and has not been challenged before the

Court. Scientific institutions, and the public

in general, appear to have shared the judgment

of Congress that the awesome power of nuclear

technology and the risks that it entails justify

overriding any constitutional protection enjoyed by scientific research.

In July 1974, leading American scientists

called for a temporary worldwide moratorium

on research on recombinant DNA, because of

the uncertain risks involved in the possibility

of escape from the laboratory. Scientists

throughout the world voluntarily observed the

artificial moratorium. At an international conference at Asilomar, California, in February

1975, a consensus was reached among scientists that certain types of research should be

prohibited because of potential hazards, and

other types of research should be subjected to

stringent, safety precautions. The National

Institutes of Health (the principle source of

funding for recombinant DNA research) later

promulgated guidelines that incorporated the

Asilomar agreement, which would be binding

on research institutions accepting Federal

funding. These do not forbid any research or

research techniques, but they had almost that

effect at an early stage of the research since

most of the laboratories depended on governmental funding.

Again in this decade research on reproductive techniques and on bioengineering have impinged on sensitive areas and aroused the cry

of “forbidden knowledge. ” It can be confidently expected that new discoveries, because

of the secrets they promise to reveal, and

emerging technologies, because of the risks

they appear to entail, will in the future also

bring about such debates.

The claim of constitutional protection for

research rests on the thesis that the First

Amendment guarantee of freedom of speech

necessarily also protects some kinds of action.

To exercise one’s right to speak, one must also

be free to think, formulate concepts and hypotheses, perform calculations, and if one is

dealing with scientific ideas, to plan and carry
51

out experiments.43 In this respect, the reasoning that research is protected is analogous to

the rationale for the protection given to the

press in newsgathering. It says that the right

to gather information (from willing sources)

is necessary and integral to the right to publish or disseminate information. Since the press

does not however have any greater right to

gather information than have any other persons, presumably by the same analogy, scientists have no right to conduct activities that

can be forbidden to non-scientists.

The Court has in some situations distinguished between “pure speech, ” and action

(which might include research), and has said

that restrictions on the latter are more easily

justified. The Court will still take into account

whether the action, or activity, is essential to

generating and communicating information.44

The physical activity of research is however

probably more likely to involve State interests

that justify regulation, such as public health

and safety, than is pure scientific communication and publication.

Some constitutional scholars make the claim

that science has a specially protected status

under the Constitution, and in particular under the First Amendment.45 The prohibition

on governmental establishment of religion,

according to this argument, was motivated in

part by the strong intent to prevent religion

from interfering with science; the Framers of

the Constitution were steeped in the Enlightenment accounts of religious opposition to

Galileo and to Newton.

There have been few judicial decisions that

have directly addressed the implications of the

First Amendment for the constitutional status of science. A 1961 Supreme Court case, invalidating a state prohibition on the teaching

“JFor a detailed exegesis of this argument, see John A.

Robertson, “The Scientist’s Right To Research: A Constitutional Analysis, ” Southern California Law Review, vol. 51, No.

6, September 1978.

“Ibid., citing Saxbe v. Washington Post CO.*, 417 U.S.

ato9<58.

“

)

Steven Goldberg, “The Constitutional Status of American

Science, ” Universit~ of I])inois Law Forum, vol. 1979, No.1,

1979, pp. l-6ff.

of evolution, relied on the First Amendment

prohibition against establishment of religion

rather than directly on the protection of science. In subsequent cases in 1975, 1982, and

1987, also dealing with the teaching of evolution and “creation science, lower courts have

followed this lead. They struck down state statutes that fostered “an excessive entanglement

with religion, but did not explicitly base their

decisions on constitutional protection of

science.

The Supreme Court has ruled that the First

Amendment “protects works, which taken as

a whole, have serious literary, artistic, political, or scientific value” even when, by some

community values, those works might be considered obscene. An Indiana obscenity law

when applied to research materials at the Kinsey Sex Institute at the University of Indiana

was invalidated46 because “the state has unconstitutionally intruded itself into . . . protected activity . . . the right of scholars to do

research and advance the state of man’s knowledge. ” Most obscenity cases, however, have

been concerned with literary rather than scientific works.

In several cases academic social scientists

have claimed the privilege of withholding their

sources of information from juries or courts,

to protect future research opportunities. The

varying outcomes of these cases suggest, but

do not definitely establish, a First Amendment

right to do research.47 In one such case, a

Federal court said,

Society has a profound interest in the research of its scholars, work which has the

unique potential to facilitate change through

knowledge. 48

None of these decisions appear to establish

definitively that there is a First Amendment

right to conduct research, or that there is a

constitutional prohibition on government restriction or regulation of it. The prevailing conclusion is that scientific activity has general

‘hHenleuv v. W’ise, 303 F. Supp.62 (N. D.Ind. 1969).

“Robertson, op. cit.. footnote 43, pp. 1240-42.

‘“Richards of Rock ford, Inc. v. Pacific Gas & Electric Co.,

vol. 71 F.R. D. 388 (N. D. Cal. 1976), at 390.
52

First Amendment protection, but may be limited or regulated where there is a clear State

interest that outweighs individual rights.

A separate argument is that the right to conduct research is protected under the Fourteenth Amendment provision that says that

no State shall

. . . deprive any person of life, liberty, or property, without due process of law.

In the early 1920s, the Supreme Court said that

this clause

. . . denotes not merely freedom from bodily restraint but also the right . . . to contract, to

engage in any of the common occupations of

life, to acquire useful knowledge . . . and generally to enjoy those privileges long recognized

at common law as essential to the orderly pursuit of happiness by free men.49

But the Court has been reluctant to extend this

argument to activities other than intimate personal and family decisionmaking, and has

never applied it to experimentation.

The Special Case of Bioengineering

Field Releases

Just over 10 years after recombinant DNA

research began on a major scale, it reached a

stage at which field research beyond the laboratory was desirable and practical. This required the deliberate introduction of engineered organisms into the open environment.

The first major experiment of this kind involved bacteria that displace other microorganisms which promote frost damage by

nucleating ice on the leaves of crop plants.

Candidates for further tests are engineered

bacteria that act as pesticides, fix nitrogen in

plants, emulsify spilled oil or oil residues, destroy toxic wastes, concentrate valuable minerals from dilute sources, and recently, organisms designed to fight Dutch Elm disease,

when injected into trees infected with the

fungus that causes the disease. Even at this

early stage, there are a long list of potentially

beneficial engineered organisms being developed for testing.

“Meyer v. Nebraska, 262 U.S. 390 (1923).

The White House Office of Science and Technology Policy issued, in June 1986, a “Coordinated Framework for the Regulation of Biotechnology, ” specifying the agencies responsible

for approving commercial technology products

and regulating field tests and planned releases

of engineered organisms into the open environment.50

Controversy over their controlled release beyond the laboratory raised public policy issues

involving acceptable levels of risk and regulatory responsibility.” Some scientists, especially ecologists, believe that there are significant risks of ecological disasters on a local and

regional basis that argue for a very strict monitoring and regulating of such experiments for

a long time to come. Some scientists and public interest advocates have strenuously objected to any release of engineered organisms.52 The Foundation on Economic Trends,

an interest group led by Jeremy Rifkin, has

several times challenged in court both plans

for field experiments and the White House Coordinated Framework for their regulation.53

The court cases have focused on public policy issues of levels of risk, and not on constitutional issues, except in so far as a public interest group was found to lack constitutional

~~These include the Food and Drug Administration, vmious

components of the Department of Agriculture, and the Environmental Protection Agency. 51 Fed.Reg. 23339.

51u s Con=ess, Office of Technology Assessment, New ~e- . .

velopments in Biotechnology-Field-Testing Engineered Organisms: Genetic and Ecolo~”cal Issues, OTA-BA-350 (Washington DC: U.S. Government Printing Office, May 1988).

5zAn OTA background paper, public Perceptions of Biotechnology (OTA-BP-BA-45, May 1987) based on a national public

opinion survey by Louis Harris & Associates, indicated that

52 percent of Americans believe that genetically engineered products are at least somewhat likely to present a serious danger

to people or the environment, but 66 percent think that overall,

genetic engineering will make life better, and a majority will

accept relatively high levels of risks to gain the potential benefits. Also 55 percent would approve the environmental release

of an organisms that would significantly increase farm production, even if there was a small (one in a thousand) risk of losing

a local species of plants or fish. But only 1 in 5 of those surveyed reported that they had heard about potential dangers

of genetic engineering and only 12 percent could describe a potential risk or problem. Sqwilliam G. Schiffbaner, “Regulating Genetically Engineered Microbial Products Under TSCA, Environmental Law

Reporter, News and Analysis, vol. 15 (1985), pp. 10279-10288.
53

standing to sue. 54 However, they reflected a

tension between Federal authority based on

the Commerce Clause and State police power.55

Opponents of field experimentation have two

major concerns: whether genetic transfers between species are inherently hazardous because

they may inadvertently create new or more

virulent pathogens, and whether the widespread introduction of modified or novel organisms could cause major ecological disruptions.

A National Academy of Sciences Committee

on the Introduction of Genetically Engineered

Organisms into the Environment concluded

that there is no evidence of unique hazards in

the transfer of genes between unrelated organisms, and the risks associated with the introduction of such life forms are much the same

as those associated with any introduction of

unmodified organisms into a new environment.56 

The report, read carefully, was stronger than

these conservative conclusions suggest. A

number of facts should be kept in mind. Modified organisms, whether genetically engineered

or changed by traditional breeding practices,

are generally not as fit for survival in the wild

as natural progenitors and tend to be at a competitive disadvantage for survival and propagation. Pathogenicity usually depends on a

large number of traits existing together, and

the possibility of a narrow genetic change inadvertently converting a nonpathogen to a

pathogen is remote. An engineered organism

will most likely have been modified in only one

regard and will behave otherwise like the parent strain; other associated and unintentional

changes are likely to be detrimental to the

organism. The transfer of genetic material to

new species rarely leads to its persistence in

a population unless strong selection criteria

are applied.

‘)’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, ” Science, vol. 235 ( 1987), p. 159.

“]fSee, for example, William G. Schiffbaner, op. cit., footnote

53, pp. 10279-10288.

“

f

’The Committee’s report is entitled Introduction of Recombinant DNA -Engq”neered Ch-ganisrns Into the Environment: Key

Issues (JVashington, DC: National Academy Press, 1987).

Some ecologists urge that the risks may indeed be most likely when a modified organism

is returned to its own natural environment,

rather than anew one, because it is more likely

to persist and because food chains or predatorprey relationships may be subtly disturbed by

the modification.57

These factors indicate that risk of significantly detrimental impacts from a planned release of bioengineered life forms is small, but

cannot be entirely dismissed. At a minimum,

there are the same risks of environmental disruption that are attendant on any introduction of a new species or a modified species;

these risks depend on the nature of the organism and the nature of the environment, and

not on the way in which the organism was

changed.

This is both a technical issue and a public

policy issue, and like many public policy issues,

it can also be articulated as a constitutional

issue. In this case, those who protested the research on the grounds that it was inherently

hazardous were not raising a constitutional issue; soon afterward, however, another scientist was forced to stop testing the use of engineered organisms because he had not gotten

governmental approval. In that case, the

underlying constitutional issue of a “right to

do research” could be raised.

Federal preemption in environmental regulation is well established, although Federal

statutes reflect some continued deference to

the traditional police power of the States. There

are numerous statutory provisions that allow

State governments to assume enforcement

obligations under Federal regulatory schemes

and in many cases to set standards stricter

than those adopted by Federal agencies. Some

statutes explicitly provide that Federal law

does not preempt State common law provisions

relating to compensation and liability.58

‘TBased on extended discussions in sessions on Release of

Engineered Organisms at the annual meeting of the :4 merican

Association for the Advancement of Science, Boston, N1 4. Feb.

13, 1988.

‘

hOccupational Safety and Health Act, Sec. 4(b)(4).
54

The issue of “deliberate field release” has

somewhat overshadowed the 1970s issue of the

risk of accidental release, but this may not last.

In September 1987, virologist at the National

Institutes of Health (NIH) began to introduce

the genetic code of the AIDS virus into mouse

embryos, in order to develop an animal model

of the latency phase of the disease in humans.

They then became the target of a lawsuit by

the Foundation on Economic Trends, the public interest group that had led the fight against

field releases. In this case, no intentional release by NIH is contemplated; but the public

interest group says that the mice used in the

experiment might escape, and by breeding with

wild mice, create an animal reservoir for the

disease. The lawsuit asks that NIH be stopped

from funding or performing “hazardous research” and that guidelines for DNA research

projects be reviewed.

The “deliberate release” issue can be constrained to an argument about the adequacy

of risk assessment and the adequacy of government regulation of experiments. The issue

of laboratory research is somewhat different

in that opponents ask that research be prohibited because an intolerable risk is alleged

to be inherent in the research and unavoidable.59 It should be noted that recombinant

DNA experiments are no longer limited to a

few highly monitored scientific laboratories

but are going on in hundreds of commercial,

governmental, and academic laboratories, and

even in some high school biology courses.

The public interest lawsuits succeeded in delaying by 4 years a University of California

field test of a genetically altered bacterium capable 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 scientists, led some citizens to want to reduce the

‘

gWilliam Booth, “Of Mice, Oncogenes, and Rifkin, ” Science,

vol. 239, pp. 341-344, Jan. 22, 1988. Also, Amy McDonald,

“AIDS Work With Mice Stirs Debate, ” The Scientist, vol. 2,

No. 1, Jan. 11, 1988, p.1.

MFoundation ~n Econom”c Trends v. Heckler, 756 F.2nd 142

(D.C, Cir. 1985).

role of “lay” courts in such “scientific” controversies.

Some people have in the past strongly advocated the notion of a specialized Science

Court to evaluate technical arguments. This

proposal, however, has apparently dropped out

of active discussion in recent years.61 In the

carefully designed system of checks and balances created by the Constitution, groups that

raise substantial objections to Federal policies

related to science and technology are, like other

interest groups, entitled to a hearing when

those objections are based on reasonable concerns, interests, and values.

The Use of Human Tissue or Cells

Human tissue and cells can be used for a variety of diagnostic, therapeutic, research, and

commercial purposes.62 There are three major

sources of human tissues and cells: patients,

volunteer research subjects, and cadavers and

aborted fetuses (including those from both natural and induced abortions). The question of

ownership of human tissues and cells became

important in 1980 because the Supreme Court

ruled that new life forms could be patented,

and this appeared to mean that biological products containing or consisting of altered human

cells and genes would be patentable. Soon

thereafter Congress amended the patent statute to encourage patenting and licensing of inventions resulting from government-sponsored

research.63

Physicians outside of the United States have

just begun to experiment with brain grafts of

human fetal tissue to treat victims of Parkin-

‘

] For discussion of the pros and cons of the Science Court,

see for example Arthur Kanrowitz, “The Science Court Experiment: Criticisms and Responses, ” Bulletin of the Atonu”c Scientists, April 1977, pp. 44-53.

Wu s. .ConWess, Office of Technology Assessment, New ~~

velopments in Biotechnology-Ownership of Human Tissues

and Cells, OTA-BA-337 (Washington, DC: U.S. Government

Printing Office, March 1987), pp. 7-19.

63public Law 96.5170 Human cell lines have been patented

and commercialized since that time. See OTA, op. cit., footnote

62, ch. 2.
55

son’s disease.64 Fetal tissue is far less likely

to be rejected than adult tissue grafts, and

more likely to regenerate itself and grow with

the host body. Many experts expect that it will

become possible to use fetal tissue grafts in

repair of other central nervous system disorders, or to treat radiation injuries. Other possibilities are the use of fetal grafts of pancreatic

islet cells to correct juvenile diabetes, and fetal heart muscle grafts for repairing or even

gradually replacing damaged hearts. These

procedures have not yet been developed. Any

therapeutic use of fetal tissue in the United

States is highly controversial; in the spring of

1988 a moratorium was placed on any federally funded research that uses fetal tissue for

transplant purposes, and NIH researchers

were instructed by the Assistant Secretary for

Health not to treat patients with fetal tissue

implants until legal and ethical issues have

been further studied. In July 1988, the Administration announced that it would reconstitute

a bioethics board that was first created in 1974

and dissolved in 1981.65

Fetal tissue comes from fetuses that have

undergone spontaneous or induced abortion.

The use of such tissue is objected to by some

people on the grounds that:

●

●

●

it might be used to encourage, justify, or

lend moral support to the use of abortion

as a birth control technique;

it might create a commercial market for

fetal tissue; or

some women might become pregnant in

order to produce fetal tissue that is needed

by someone they love, or even to produce

it for sale.

Other people object to the use of fetal tissue

as inherently morally reprehensible.

In short, any medical, commercial, or research use of fetal tissue in the future will

G4The first operations, transphmtblg tissue frOm a spontaneously aborted fetus to the brains of two Parkinson’s disease

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.

“Gina Kolata, “Ethics and Fetal Research: Government Begins to Move, ” New York Times, July 31, 1988, p. E7.

almost certainly encounter strong ethical and

political objections. It is possible that, in the

future, scientists may find a way of growing

embryonic cells in culture; this may or may

not be less disturbing to those who object to

the use of fetal tissue.66 In any case, pressure

to allow the use of fetal tissue will almost certainly grow if it is successfully used in other

countries to treat life-threatening disorders.

Some of this conflict could take the form of

debates over First Amendment rights. In such

cases, the assertion that there should be a zone

of ‘forbidden knowledge’ that is either excessively hazardous or ethically abhorrent could

be countered by an assertion of a right to do

research under the umbrella of the right to free

speech. This argument would most likely be

used in the early, experimental stages of such

new medical procedures, since government has

a well-established right to regulate the later

practice of medicine.

Federal Guidelines on Funding

of Research

The early NIH Guidelines on recombinant

DNA research, unlike the atomic energy legislation, did not restrict the right of researchers to carry out experiments. They concerned

only the government refusal to fund research

in certain areas. The guidelines have since been

revised so that they do not seriously restrict

the areas of research, but still impose certain

safety requirements on how the research is conducted. The penalty for violation is still only

loss of Federal funding.

It is doubtful that a constitutional challenge

could be made to these guidelines. There are

few constitutional constraints on the power of

the government to spend, but there are even

fewer limits on its power not to spend. A government decision not to fund a specific research

project would clearly be unconstitutional if the

decision were found to be based on racial discrimination, and there are legal requirements

‘GWilliam Regelson, M. D., Professor of Medicine, Medical

College of Virginia Hospitals, in a letter to the editor of The

New York Times, Oct. 8, 1987.
56

for competition and fairness; but beyond such

incidental constraints, selectivity is proper and

necessary.

Not every experiment that scientists wish

to conduct can be funded, and the government

obviously must select those that have the most

merit. The judgment as to how beneficial the

resulting knowledge might be is surely an

appropriate criterion for selection. The judgment that the resulting knowledge would not

be beneficial or would not justify its expense

is also appropriate.

At this point, however, a possible question

arises. Some demands that research be restricted, or discouraged by cutting off government funding, are based on the assertion that

the objective of the research is morally and

ethically repugnant or unacceptable. For example, there have been such objections to

weapons research, or to certain kinds of weapons research such as biological warfare. There

have also been such objections to the concept

of human cloning, or to interspecies genetic

exchanges in higher animals. If funding decisions were shown to be based on “religious doctrines” they could be challenged under the

First Amendment’s Establishment Clause.

However, religious doctrines would have to be

clearly distinguishable from general moral abhorrence, which the Supreme Court has allowed

as a basis for exercise of State police power.67

‘

7 For example, in the recent case dealing with enforcement

of laws against sodomy (the case involved an act committed

with another adult male in the bedroom of the respondent’s

home) the Supreme Court said that “there is no fundamental

Both those who argue that some research

should be forbidden and those who advocate

full freedom of research fail at times to distinguish clearly between the objectives of stopping research, or stopping the government

from funding research, or reducing particular

perceived risks. Both sometimes fail to distinguish between public policy issues and constitutional issues. Strictly speaking, the question

of a constitutional right to do such research

could be raised only when individuals or institutions were prohibited from engaging in such

research on their own, independent of government funding. Federal guidelines and regulations about how research is done are less likely

to be challenged. It has become generally accepted that the Federal Government may regulate the way in which research is conducted

by recipients of Federal funds (although in such

cases the Courts would undoubtedly still give

strong consideration to any asserted countervailing State interest, such as safety).

Nevertheless, restrictions either on an area

for research, or the content of research that

may be done with Federal funding, are likely

to evoke more controversy in the future, because government is likely to be the only source

of adequate funding for areas in which industry has no interest.

right to engage in homosexual sodomy, ” and defended the

State’s right to outlaw it in part because “Proscriptions against

that conduct have ancient roots. ” It specifically denied assertions that the belief that sodomy is immoral and unacceptable

is “an inadequate rationale to support the law, ” saying that

“the law. ., is constantly based on notions of morality. ” Bowers

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 fundamenneed 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 argued for “a right to be let alone, ” basing this

right on the Fourth and Fifth Amendments.

The right of privacy, as discussed in chapter

2, contains both the concept of autonomy and

the concept of confidentiality of personal information. Modern challenges to the Fourth

Amendment prohibition on “unreasonable

searches and seizures” have largely focused

on search from a distance—i.e., wire tapping

and later remote sensing—but new challenges

are arising from government acquisition of information from body tissues and emanations

(breath, blood, semen), including genetic information. Other challenges are arising from the

collection and aggregation, in computerized

data banks, of personal information, which

may include genetic information. Both kinds

of intrusion on privacy are discussed in some

detail in chapter 5, which deals with medical

record keeping.

The advance of science is almost certain to

provide new and sophisticated techniques for

distinguishing among individuals in terms of

biological characteristics or capabilities. Science may eventually provide an objective basis for some classifications that law has preferred to treat as arbitrary. It will be a

significant challenge for the legal system to

ensure that such knowledge does not erode the

precious but fragile fabric of social equality

that is one of the major constitutional achievements of this century.

Privacy as a constitutional norm may also

be reassessed. Privacy has been recognized as

central to notions of liberty and individual autonomy as a sphere preserved from arbitrary

government action. Rapidly advancing techniques for reducing the individual to a collection of biological facts and measurements are

likely to increase the need for explicitly defining the scope and nature of this guarantee.

Nevertheless, it is well to remember that not

every social dislocation that might be produced

by the new biology must, or should, be a matter of constitutional concern. Many issues will

be resolved by Congress, the public, professional groups and interest groups without being raised to the level of constitutional challenge. Debate on such issues has already been

joined, and its robust character is grounds for

optimism that the political process shaped by

the Constitution will continue to work well in

the coming century.
Chapter 5

Public Health Techniques and

Technologies
CONTENTS

.

Page i

American Public Health Law, 1787-1887 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62: 

~

The Police Power in the Twentieth Century . . . . . . . . . . . . . . . . . . . . . . . . . . 62 . .

.

i

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

Contact Tracing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 I

Social Controls: Full or Partial Quarantine . . . . . . . . . . . . . . . . . . . . . . . . . 77 #

Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ’. . . . . . . . . . . . . . . . . . . . . . . 82

Blood Banking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 I

Public Education and Statistical Forecasting . . . . . . . . . . . . . . . . . . . . . . . 85

1
Chapter 5

Public Health

Techniques and Technologies

The public health is a significant part of “the

general Welfare, ” which the Constitution was

intended to better secure. Enormous strides

have been made in the medical sciences in the

last two decades, in large part as a result of

development of the “new biology.” Medical capabilities increasingly present us, as individuals and as a society, with options far beyond

our traditional understanding of rights and

duties, choice and necessity, consent and obligation. This chapter deals with the use of medical science and associated technologies in

government programs to protect the health of

Americans. The next chapter discusses some

specific medical interventions as they apply

to individuals.

In public health, it is not so much new technologies and techniques that promise to raise

future constitutional issues, but rather the use

of old (and historically accepted) techniques

and technologies that appear newly controversial in the context of modern expectations of

privacy and civil liberties and modem attitudes

about risk and exposure. Another factor is new

scientific capability to identify risks and exposure pertaining to people who are not yet

ill, or pertaining to licit behaviors such as

smoking or overeating.

In some areas public expectations outstrip

the ability to solve urgent problems. A high

expectation of good health and an unrealistic

optimism about medical capabilities may contribute to the growing problem of liability or

malpractice suits against physicians and hospitals. Not all medical interventions are successful. All of the effort thrown into the study

of cancer, with enormously promising results,

cannot yet assure anyone that he or she will

be cured.

In public health, we are faced with a terrible

epidemic at a time when people had become

almost complacent about the ability of vaccines and antibiotics to deal with infectious disease. The capability to identify risks, predict

the spread of disease, screen for exposure, and

test for infectiousness is much greater than

in historical epidemics; yet in the case of AIDS

we cannot cure the disease, nor prevent it once

exposure has occurred. The social frustration

that this incurs may challenge us to define the

limits of individual rights and the scope of our

mutual obligations to society.

In dealing with such health provisions as

mandatory vaccination, quarantine, housing

inspections, school health, and mandatory seat

belts, one is nearly always operating under

State laws, based on State police power. Police power is the inherent power of governments to exercise within their jurisdictions reasonable control over persons and property in

the interest of the general security, health,

safety, morals, and welfare.

In public health, the Federal Government

has only necessary and implied powers derived

from its powers to tax and spend for the general welfare, to regulate interstate commerce,

and to provide for the national defense. The

States retain primary responsibility for public health policies and programs through their

inherent police power. But both State and Federal Government are subject to the Bill of

Rights limitations on governmental power.

61
62

AMERICAN PUBLIC HEALTH LAW, 1787-1887’

In the colonial period, epidemics could devastate a community. Smallpox and yellow fever sometimes sickened from 30 to 50 percent

of a town’s population within a short time, and

might kill 10 percent. Even measles could be

a major disaster; Cotton Mather in 1713 lost

his wife, three of his children, and a servant

to measles. The effects of such infection on the

Indians, who had no resistance from past exposure, were often even more cataclysmic.

Public health programs in the 17th and 18th

centuries consisted of emergency measures to

meet these crises. When epidemics threatened,

towns often declared quarantines, posting

guards at the docks and on roads leading into

town. Sick people were cared for in their homes

or the pest house. Town funds were provided

for medical care and to feed and shelter orphans

or the children of sick parents. No one questioned the right of the authorities to take whatever measures were necessary.

After the Civil War there was somewhat

more disposition to question the scope and

limits of police power. In 1894, the terms of

IDr John Duffy, Profe9sor Emeritus of Medical Historyt

University of Maryland, assisted in the preparation of this section of the chapter.

States’ public health authority were laid out

one

●

●

●

●

●

by one in a Supreme Court decision:2

The police power is very broad, and the

State legislature has wide discretion to determine when and how it is used.

Public interests must require such interference by the State; there must be a serious threat.

The means used by the State must be “reasonably necessary” and not “unduly oppressive.”

The State must not impose “unusual and

unnecessary” or “arbitrary” restrictions

on persons or occupations.

The courts will examine or supervise the

legislature’s exercise of police power to ensure that these conditions are met.

Until well into the twentieth century judicial decisions about public health law and practices seldom emphasized individual rights as

such. They turned on questions of how the

State exercised its authority, whether or not

the Court perceived that the State was dealing 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 freedom of an individual.

z~~W~O~ “, StW]e, 152 u.S. 133, 136-7 (1893).

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 incases on public health and police power is a

1905 case, Jacobson v. Massachusetts.3 It ineffective, was tried and fined $5. He appealed

first to the Massachusetts Supreme Judicial

volved the constitutionality of a State statute Court and then to the U.S. Supreme Court, arthat provided a fine of $5 for any adult refus- guing that the vaccination law violated his

Fourteenth Amendment rights to due process

3

197 Us. 11. and equal protection of laws (the latter because
63

under the law physicians could declare some

children “unfit subjects for vaccination”).

The Supreme Court confirmed that the State

legislature can enact “reasonable regulations”

to protect public health and safety, and may

vest this authority in local bodies like boards

of health. The Court said that constitutional

rights must be preserved, but it found that the

Fourteenth Amendment right to “liberty”

does not mean absolute freedom, and the State

may restrain personal and property rights in

order to secure the “general comfort, health,

and prosperity of the State. ” Under the “principle of self-defense, of paramount necessity,

a community has the right to protect itself

against an epidemic of disease. ” Further, the

Supreme Court would be “usurping the functions of another branch of government” if it

judged the method chosen by the legislature

to be unreasonable, arbitrary, or unnecessary.

Vaccination was a well recognized, generally

accepted means of preventing smallpox; the

legislature accepted it as such, and the courts

had no superior knowledge. Judicial review of

a general welfare enactment, according to the

Court, should be very narrow, and such a statute would be invalid only when it is “. . . beyond all question, a plain, palpable invasion

of rights secured by the fundamental law. . . .“

This case is a starting point for the discussion of future cases of constitutional limitations on police power because it confirms that

the legislature need not be “right” in its public health decisions; its acts need only have

some “real or substantial relation” to the preservation of the public’s health-not the “best”

way but a “reasonable” way. Courts are not

to be the arbiters of scientific disputes.

Underlying the Court opinion was the concept of a social contract between individual and

community and between State and Federal

Governments. The Court said:

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 government, should have the power thus to dominate

the majority when supported in their action

by the authority of the State.

And it also said:

The safety and health of the people of Massachusetts are, in the first instance, for that

Commonwealth to guard and protect. They are

matters that do not ordinarily concern the

Federal government.

Jacobson dealt with a real, identifiable, and

familiar public health problem. But in the same

1905 term, the Supreme Court dealt with the

constitutionality of a State statute concerned

with occupational health and safety, in the case

of Lochner v. New York.4 The statute prohibited bakery and confectionery employees

from working more than 60 hours in 1 week.

The Court framed the issue in this way:

Is this a fair, reasonable, and appropriate

exercise of the police power of the State, or

is it an unreasonable, unnecessary, and arbitrary interference with the right of the individual to his personal liberty or to enter into

those contracts in relation to labor which may

seem to him appropriate or necessary for the

support of himself and his family?

This decision came less than 2 months after

deciding Jacobson. The Court again recognized

that it may not merely substitute its judgment

for that of the legislature and strike down a

law. Nevertheless the Court did not view limitation of the work day as a health or welfare

issue, but as State regulation of economic relationships between two competent adults. It denied that this law was within the police power

of the State, because bakers are no less able

“to assert their rights and to care for themselves than members of other occupations. . . .“

The “welfare, safety, and morals of the general public (were) not protected by the law”

since there was no evidence that clean and

wholesome bread is related to the number of

hours the baker works.5 This case was contrasted by the Court with an earlier one upholding a law limiting the working day of underground miners and shelterers, because

4

198 U.S. 45 (1905).

‘The New York court in upholding the statute had concluded

that there was sufficient evidence to demonstrate that the occupation of baker or confectioner was unhealthy and tended to

result in diseases of the respiratory organs.
64

working underground was “clearly unhealthy.” 6

These two cases, within a few months of each

other, demonstrate the significance of the

standards which courts use in evaluating the

legislature’s exercise of the police power. Had

the Court actually applied the Jacobson standard of minimal rationality and the presumption of constitutionality, Lochner would have

been decided differently. But the vaccination

law was indisputably a health law, aimed at

reducing contagious disease; while in the Lochner case the law was not perceived as enforcing a well-recognized medical procedure. Lochner signaled the beginning of an era in which

the Court struck down as economic regulations

many statutes framed around public health

goals.’

Ultimately, however, the Jacobson standard

prevailed. In 1934 the Supreme Court returned

to the more restrictive standard of judicial review, saying that the Due Process Clause only

requires that “the law not be unreasonable,

arbitrary, or capricious and that the means

selected shall have a real and substantial relation to the object sought to be attained.”8

G~o]den v. ~tidy , 169 U.S. 366 (1898); the COurt found ‘hat

given the dangers of working underground, the deprivation of

fresh air and sunlight, and being frequently subjected to foul

air, the law was a proper exercise of police power, designed to

protect the health of miners. It also recognized that the State

could reasonably conclude that workers needed protection because the owners and workers do not have equal bargaining

power.

TIn Adkjns v. Chi]tien Hospital, 261 U.S. 525 (1923)J ‘he

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

morals, resulting from wages which are inadequate to maintain

decent standards of living. ” The Court claimed the law was arbitrary, that the “relationship between earning and morals is not

capable of standardization, ’ and that the law did not take into

account the fact that different people need different amounts

of money to maintain a minimum acceptable standard of living.

g~ebbia ~. New York, 291 U.S. 505 (1934). The Court uPheld

a New York statute establishing a board to determine the maximum and minimum prices retailers could charge for milk. Three

years later the Court upheld a minimum wage law for women.

The judicial policy of examining the substance of the law under

the umbrella of the Constitution’s Due Process Clause, and “second guessing” the legislature as to its efficacy, is called “substantive due process. ” It is to be distinguished from “procedural due process,” in which the Court asks whether a law affects

people in an arbitrary, discriminatory, or irrational manner. In

recent years, the Court has returned to the doctrine of substantive due process in emphasizing fundamental individual rights.

A modern court in a police power case still

will not generally evaluate arguments as to the

scientific soundness of the exercise of police

power. For example, the Court ruled in 1955

on the constitutionality of State laws regulating the fitting and sale of eyeglasses.9 Opticians were prohibited from placing an old lens

in a new frame or from reproducing a broken

lens without a prescription. A trial court struck

down this law, holding that the requirements

were not ‘reasonably and rationally related to

the health and welfare of the people. ” But the

Supreme Court reversed, on the grounds that

the legislature might have concluded that eye

examinations were so important “for the detection of latent ailments” as to justify their

requirement on all possible occasions. Said the

Court:

The day is gone when this Court uses the

Due Process Clause of the Fourteenth Amendment to strike down State laws, regulatory of

business and industrial conditions, because

they may be unwise, improvident, or out of

harmony with a particular school of thought.

In summary, the courts will generally be inclined to accept as constitutional public health

actions that appear to be reasonably related

to preservation of the health of the population

without attempting to determine independently the scientific validity and efficacy of the

measures taken. Nevertheless, this remains an

area where the scope of individual rights and

presumed limitations on state power appear

to be constantly subject to challenge.

Privacy and State Police Power

The evolution of the concept of privacy as

a constitutional right was traced in the first

chapter. The case of Buck v. Bell, the 1926 case

upholding the right of the State to sterilize inmates of State mental institutions, was described in chapter 3 and illustrates both the

deference to State interests and the lack of acknowledgment for privacy rights that were the

rule until recent decades. Fifteen years after

that case, the Court struck down a State statute providing for compulsory sterilization of

gwil~.~~on “. L= optjc~ (70., 348 U.S. 483 (1955)”
65

“habitual criminals, ” using the Equal Protection Clause of the Fourteenth Amendment, but

also affirming that marriage and procreation

were fundamental rights.10

The right of privacy has repeatedly been

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 medical care,11 refusal to take anti-psychotic medi1[)Skinner v. Oklahoma, 316 U.S. 535 (1942).

‘‘~n re Karen Quin]an, 355 A.2d 647 (N. J., 1976); Superintendent of 13elchertown v. S~”kewicz, 373 Mass/ 728 (1977).

cation, 12 and obtaining acupuncture treatments.” But the Supreme Court specifically

refused to extend this right to cover consensual sodomy .14 It is thus uncertain how this

right might be applied in future issues related

to public health techniques and technologies.

“Rogers v. Okin, 821 F.2d 22 (Neb.,1987).

13An&ews v. ~~]m~, 4$)8 F. SUPP. (s.D. Texas! 1980)”

14~owerSv, ~=~wjc~, 106 s.ct. 2841 (1986). Although the

challenge was brought by a homosexual male, the challenged

statute was written to apply to heterosexual or homosexual behavior, by married or single persons.

MODERN PUBLIC HEALTH TECHNIQUES AND TECHNOLOGIES

In the extended discussion that follows, frequent reference will be made to the current epidemic of acquired immunodeficiency syndrome

(AIDS). Many of the traditional public health

techniques are being used in this epidemic, but

in a social, political, and legal framework that

has radically changed in recent decades. New

scientific knowledge and capabilities are also

providing new approaches—although not as

many or as rapidly as society had hoped—and

these by definition may raise new constitutional issues.

AIDS is not like most of the severe epidemics

associated with the origins of public health programs in the United States. It appeared suddenly, but it is not episodic as were yellow fever, Asiatic cholera, or influenza. It can have

a very long incubation, it has a very low infectivity, and it cannot spread by casual contact.

There do not appear to be any factors calling

for engineering or environmental remedies,

which have been major factors in control of

past epidemics.

Yet AIDS does represent the working of

some traditional Public Health techniques and

technologies that need to be examined further

for their constitutional implications; and more

pertinently, AIDS also demonstrates the public health applications of some new developments in biology.

The problems raised by the AIDS epidemic

are not intrinsically new. Larger numbers of

people die every year from other single causes,

including the effects of smoking.15 But the

problems raised by AIDS are so severe and

acute as to revive old and neglected issues of

public health and civil liberties, to emphasize

structural problems in the capability to respond to civil emergencies, and to stress weak

points in our social fabric. The problems throw

into sharp relief the potential conflict between

constitutional principles of individual rights

and protection of the general welfare. The resolution of AIDS problems, if done humanely and

with full attention to both fundamental freedoms and the protection of the general welfare,

may stand us in good stead in the future in

other contexts.

Prevention: Inoculation and

Vaccination

The major medical innovation during the

colonial period was smallpox inoculation, introduced in Boston in 1721, but already an old

practice. 16 In the colonies it was denounced

‘%rnoking was officially blamed for 350,000 deaths in 1985,

100 times the number of AIDS deaths in the same year, as

pointed out by William Pollin, “Drug Abuse, U. S.A., ” Issues

in Science and Technology, Winter 1987, p. 24.

‘Gin inoculation, matter from pustules in an active smallpox

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

many ministers as an attempt to evade God’s

punishment for immorality. But because of its

obvious value, inoculation was an accepted

practice by the time of the Revolution.

The success of inoculation in reducing the

toll from smallpox prepared the way for vaccination, introduced by Jenner in 1798.17 Vaccination won immediate acceptance, and the

incidence of smallpox fell sharply during the

next 30 years. By the 1830s, a generation that

had never known a smallpox epidemic saw little reason to be vaccinated, and there was a

steady rise in smallpox until about the 1870s.

After the Civil War, health officials began urging compulsory vaccination of school children

and mass vaccination of adults during outbreaks. In spite of a strong anti-vaccination

movement, joined by a few doctors alarmed

by infections arising from vaccination withinfected needles, the movement succeeded in

most States.18

When there is strong public awareness of the

possibility of epidemics, most people can compare the risk of taking the vaccine against the

clear and present risk of the disease, and can

thus appreciate the value of vaccination. As

immunization programs succeed and the acute

disease threat disappears, the benefit to the

individual is less well perceived. The benefit

accrues to the community at large. Any risks

or undesirable side-effects of a vaccine which

become known are therefore apt to stimulate

resistance.

Of all infectious human diseases for which

a vaccine has been developed, only smallpox

has been eradicated; the rest are merely held

at bay. In Britain and in Japan, whooping

cough reemerged as an epidemic disease when

the use of pertussis vaccine diminished during the 1970s because of public alarm about

rare side-effects.

Nevertheless, vaccination remains a primary

tool of public health. Because it was one of the

earliest tools for protecting public health, its

use is well established in law and judicial precedents. At present, there is no vaccine against

AIDS, although several are being tested. Should

a vaccine be developed, there would almost certainly not be a mandatory program of vaccination for the general population, since the risk

of AIDS is concentrated in certain age groups

and even more narrowly in specific behaviordefined populations.

Mandatory vaccination laws for more general infectious diseases would however almost

certainly be sustained. The presumption on the

part of the courts would continue to be that

vaccine programs are a “reasonable” public

health strategy.

Although physicians have generally welcomed vaccines, local medical societies have

often opposed free vaccination for lower income

groups by public health departments, unless

there is a life-threatening epidemic or the threat

of one.19 A possible constitutional issue is the

assertion of the right to a vaccine when one

is available for a disease perceived as highly

threatening. But as discussed in the following

chapter, courts have so far consistently maintained that there is no constitutional right to

medical treatment and government has no constitutional obligation to make it available.

(continued from previous page)

usually, acquired immunity. The immunity came from antibodies

produced in response to this small scale invasion of disease organisms, but the response was not understood at the time.

]TVaccination is the use of dead or attenuated viruses from

cows inoculated with cowpox to produce immunity to smallpox in humans.

18Such waves of popular opposition have been associated

with other public health innovations, such as fluoridation of

water supplies; they are sometimes attacked as hazardous or

even as plots by internal or external enemies to poison the citzenry.

19Degpi~ the ~eat attention to vaccines as a retit of AIDS,

the U.S. capability to develop vaccines for new or newly epidemic diseases is in general weak. Almost all vaccines have a

sole manufacturer or a very few possible manufacturers. There

is no governmental capability for vaccine production. Vaccines

are relatively unprofitable and product liability is a strong disincentive to potentiaJ developers. The United States is the only

country in the industrialized world where vaccine manufacture

is unprotected from litigation regardless of compliance with manufacturing regulations, according to Dr. June Osbom, Dean of

the School of Public Health, University of Michigan.
67

Reporting Morbidity Data

The first necessity in controlling epidemics

is to recognize them early. Thus it is mandatory for physicians to report certain infectious

diseases. Historically, there has been little connection between the diseases which cause the

greatest morbidity and mortality and those

which arouse the greatest public fear or attention. The two diseases that most worried the

public in the 19th century were yellow fever

and Asiatic cholera—deadly, erratic and unfamiliar. To Americans these epidemics seemed

to be malignant forces that struck mysteriously and vanished almost as strangely. Such

diseases always awaken more public fear and

stronger public actions than diseases that may

exact a far higher toll but do so consistently

rather than episodically, and hence become familiar conditions of life. The disorders that

were steadily and consistently responsible for

the most sickness were malaria and respiratory infections. They were regarded as inevitable, much as we tend to regard high death

rates from automobile accidents.

The chief killer disease of the 19th century

was tuberculosis. Yet in the early 19th century

it was regarded as a romantic disease, as pictured in La Boheme or Camille. Later in the

century it was considered a natural disorder

about which little could be done. Most insurance policies did not insure against death from

tuberculosis; hence the family received no burial money and the doctor might not get paid.

Therefore tuberculosis deaths were often recorded under other headings. When health departments at the end of the century began

ordering physicians to report cases of tuberculosis, the medical profession rose up in arms.

The New York City Health Department, making tuberculosis a reportable disease in 1897,

found itself opposed by the New York Academy of Medicine, the County Medical Society,

and most medical journals. The medical societies went to the State legislature in an attempt

to limit the powers of the board of health.

Venereal disease has always been underreported by physicians. In 1882 the American

Public Health Association rejected a resolution to make venereal disease reportable on the

grounds that it would bring disapprobation on

the association. In 1892 the New York Academy of Medicine dismissed a similar resolution

on the same grounds. A New Orleans physician writing in a medical journal in 1920 called

proposals to require reporting of venereal disease “socialist tommy-rot” that would “undermine the morals of the American people. ”

Since then, a wide array of mandatory reporting statutes, such as for venereal disease, have

been considered necessary and permissible.

Laws requiring mandatory reporting by physicians or health care facilities of the names

and other information about people who have

been infected receive great impetus from advances in the ability to acquire, store, and disseminate such information using computers.20 

In this decade, however, mandatory reporting

laws have again become highly controversial

in regard to abortion, drug use, and AIDS.

The Supreme Court has addressed the issue

of mandated release of medical information to

the State by the physician on several recent

occasions. One example concerns New York

State’s Controlled Substances Act of 1972,

which requires reporting by physicians of

prescriptions for certain drugs.” Public disclosure of the identity of the patients is prohibited and punishable by one year imprisonment and a $2000 fine. In spite of this, the

Federal District Court found the law to be unconstitutional, as intruding too broadly into

the doctor-patient relationship, part of the

“zone of privacy” accorded constitutional protection. But the Supreme Court reversed, finding the requirement was a reasonable exercise

of police powers, and that there was no violation of privacy interests.22

20 Materi~ in t~s section is drawn largely from “Constitutional Implications of Scientific and Technological Advances

in Public Health, ” prepared for OTA by Dr. Leonard H. Glantz,

Professor of Health Law, Boston University Schools of Medicine and Public Health.

zlInformation about the physician, the drug and dosage> and

the name, address, and age of the patient is sent to the computer of the State Department of Public Health. Only 17 departmental employees have access to the information. zzwh~en “. Rw, 429 U.S. 595 (1977).
68

It had been argued without avail that the

constitutional right of privacy encompasses

two distinct interests; the individual interest

in avoiding disclosure of personal information,

and the freedom to make certain kinds of important decisions without State interference;

and that both interests were violated by the

law. Knowing that the State would receive this

information would make doctors reluctant to

prescribe, and patients reluctant to use, certain medication.

Justice Brennan, in his concurring opinion,

specifically recognized that new technology

may require the Court to address this issue

again:

The central storage and easy accessibility

of computerized data vastly increase the potential for abuse of that information, and I am

not prepared to say that future developments

will not demonstrate the necessity of some

curb on such technology.

Another case in 1976 involved the reporting requirement of a State abortion law,

. . . the purpose of which shall be the preservation of maternal health and life by adding

to the sum of medical knowledge through the

compilation of relevant maternal health and

life data. .. .23

The statute stated that the information must

be confidential, must be used only for statistical purposes, but must be available for inspection by local, State, or national health officers.

The Court also upheld the constitutionality of

this provision, finding that it is useful in protecting the health of female citizens, and may

be a resource for future medical decisions.

Given these realistic goals, the guarantee of

confidentiality, and the fact that the reporting has no legally significant impact on the

abortion decision or on the physician-patient

relationship, the Court found no constitutional

violation, but it did suggest that the law approaches “impermissible limits.” This decision

was especially significant because of the close

scrutiny that the Court gives all legislation regulating abortion.

zsp]an~ p~entho~ of Missouri v. Dan forth, 428 U.S. 52*

70 (1976).

Ten years later the Supreme Court invalidated a Pennsylvania abortion reporting requirement which called for very detailed reporting,24 available for public inspection and

copying (in a form that would not bear the identification of the person filing the report). The

Court struck this down on the grounds that:

1) many of the details were unrelated to health

interests, 2) the records could be inspected by

anyone, which indicated to the Court that the

legislature had some purpose in mind other

than protecting the public’s health; 3) even

though the woman’s name was not listed there

were enough data that identification became

“likely,” and may have been the “obvious purpose of these extreme reporting requirements.”

The Court said that the law would have a chilling effect on the exercise of a constitutional

right.

Given the fact that public disclosure about

having AIDS or being an AIDS carrier could

have a devastating effect on an individual, it

is reasonable to surmise that the Court may

give as much scrutiny to State AIDS reporting requirements, if challenged, as to an abortion reporting requirement. The State would

have the burden of proving the public health

need and showing adequate privacy safeguards.

In such circumstances the interests of the

State in learning the extent and distribution

of the disease would have to be balanced against

the individual’s concern for privacy. However,

the balance could be struck differently in the

case of AIDS than in the abortion example,

because of the risk to the population at large.

Screening and Testing Techniques25

Mandatory testing or screening of large populations or specific categories of people has

24 Thomburgh v. American College of Obstetricians 106 S. (X.

2169 (1986). Reporting requirements included the identification

of the referring and primary physicians and the name of the

facility or agency; the woman’s political subdivision, age, residence, race, marital status, number of previous pregnancies;

the basis for determination that the fetus was not viable; the

method of payment; and other information. The report was to

be signed by the attending physician.

~~Materi~ in this section was prepared for O’1’A by: Dr.

Sheila Jasanoff, Cornell University Program in Science, Technology, and Society; Dr. June Osborn, Dean of the School of

(continued on next page)
69

been done or has been considered for purposes

of detecting hereditary disease (primarily in

the case of newborn infants, where early treatment is effective), for control of infectious disease, and for detecting drug abuse.

The constitutionality of data collection will

depend on a variety of factors, including the

purpose for which information is obtained.

Thus questions of obtaining information cannot be wholly separated from questions of use,

which might be, for example, to document the

spread of the disease. Courts have not been

reluctant to sustain a requirement that public

school students undergo an annual physical

examination 26 or that couples seeking marriage licenses submit to tests for venereal disease.27 Nevertheless, some features of the testing process, whether for hereditary disease,

infectious disease, or law enforcement, may

raise constitutional problems regardless of the

uses to which the State puts the information

being collected.

Screening for Hereditary Disease

Mass screening has been undertaken in this

country in the past primarily for the purpose

of identifying individuals at special risk of producing genetically damaged offspring. Such

programs were initiated during the 1970s for

Tay-Sachs disease and sickle cell anemia. Both

programs focused on ethnic minorities with

which those diseases are uniquely associated.

The former aroused less concern because it was

carried out largely without legislative requirements.28 By contrast, laws mandating screening for sickle cell disease (associated with people of African descent) were passed in many

States in the early 1970s. In 1972 Congress

enacted the National Sickle Cell Anemia Control Act, which allocated $115 million over 3

years for a program of screening, counseling

and education.29 

Following initial support from the Black

community, these sickle cell initiatives later

came under fire. Black leaders questioned the

propriety of the legislative focus on sickle cell

anemia when there are so many other important causes of illness among Blacks.30 Some

critics said that sickle cell screening increased

the potential for stigmatizing a particular minority group and could reinforce latent feelings of racism. A few saw the overt tie-in between screening and marriage-licensing laws

in several States as particularly sinister. In the

words of one Black activist, such a connection

represented “the entering wedge for governmental involvement in genetic criteria for

procreation. ”31

Similar concerns are reported to have troubled some leaders of the gay community in the

early days of the AIDS epidemic; fearing that

association of gays with an epidemic disease

would intensify discrimination against them,

some leaders resisted early efforts at public

education about the ways in which the disease

was transmitted.32 Such concerns suggest

that whenever mandatory screening programs

are limited to identifiable minorities, there may

be perceptions of conflicts between the State’s

interest in public health and the constitutional

goal of equal protection. If testing is limited

to discrete subgroups, then the burden on the

State to justify it should be especially high.

Mandatory screening for heritable traits or

biological susceptibilities thus raises issues of

due process, unreasonable search and seizure,

and privacy. The legitimacy of such programs

(continued from previous page)

Public Health, University of Michigan; and Dr. Leonard Glantz,

Professor of Health Law, Boston University Schools of Medicine and Public Health.

~~strejch ~z. Bo=d of Education, 34 S.D. 169 (191 4).

‘iPeterson v. Wid~de, 157 Wis. 641 (1914).

28 Madeleine J. Goodman and Lenn E. Goodman, “The Overselling of Genetic Anxiety, ” Hastings Center Report, October

1982, pp. 20-21.

29 Aubrey Milunsky ~d George J. Annas, Genetics and the

Law (New York, NY: Plenum Press, 1976), p. 174.

‘Lawrence E. Gary, “The Sickle Ceil Controversy, ” in Adela

S. Baer (cd.), Heredity and Society, 2nd ed. (New York, NY:

Macmillan), pp. 363-364. Sickle cell anemia is almost exclusively

found in those of Black African ancestry. About 10 to 13 percent of American Blacks carry the trait (which is recessive); about

3 percent have the disease,

3] Ibid., p. 366.

]zRandy Shilts, And the Band Played On: Politics, People,

and the AIDS Epidemic (New York, NY: St. Martin’s Press,

1987), pp. 52-103.
70

will turn to a large extent on the nature of the

State’s interest in acquiring information.

Mandatory Drug Testing

Drug testing programs have been adopted

by numerous State and Federal agencies, and

have given rise to a number of court cases. In

regard to the constitutionality of various forms

or programs of drug testing, very little is certain and challenges are likely to continue, at

least until the Supreme Court decides two

cases scheduled to come before it in the 1988-

89 term. One of these cases involves Federal

workers, and one involves railroad employees.

In the future, the “new biology” is likely to

lead to development of many drugs that are

related to, and closely resemble, naturally

occurring bodily substances such as opiates

in the brain. Some of these new drugs maybe

subject to abuse; that is, may have socially undesirable effects. It maybe particularly hard

to test for such drugs; and to distinguish them

from the naturally occurring substances that

people may have in widely varying quantities.

Their detection might require tests that are

even more intrusive than urine analysis, which

many people find highly objectionable. Thus

drug testing issues are unlikely to be resolved

completely and for all time.

In considering the constitutional implications of drug testing it is necessary to distinguish carefully between what can be done by

government with regard to the public or some

categories of the public; what can be done by

government with regard to its employees; and

what can be done by non-government employers

with regard to their employees.

In terms of government drug testing in the

interest of general law enforcement—testing

members of the general public to detect violations of the laws limiting use of controlled substances-the constitutional question is whether

or when drug testing by government officials

is “an unreasonable search and seizure, ” under the Fourth Amendment. At least one judge

has argued that one “cannot retain a privacy

interest in a waste product . . . “33 but the

ssJudge Nebeker, concurring, Turner v. Fraterntd Order of

Police, 500 A.2nd.1000 (D.C. App.1985).

weight of authority runs counter to this. Courts

have held that one does have an interest in

avoiding the mandatory testing of urine or

blood and also in the information contained

in bodily fluids,34 although that individual interest may be inferior to a State interest. One

court has said,

Drug testing is a form of surveillance, albeit

a technological one. Nonetheless, it reports on

a person’s activities just as surely as if someone had been present and watching. It is George

Orwell’s “Big Brother” society come to life.35

But the Constitution has been found in general not to prohibit such bodily intrusions as

compelled vaccination, blood tests or urinalysis where the government provides sufficient

justification and evidence of procedural regularity. For example, in Schmerber v. California in 1966,36 the Supreme Court upheld the

performance in a hospital of a blood test for

alcohol content performed on an automobile

crash victim, without a warrant. It has long

been established that a State interest in health

and safety may justify testing programs that

intrude to some degree on individual liberty

and privacy. The use of roadblocks and alcohol tests to deter drunk driving has been ruled

constitutional.37 Courts have traditionally

considered that here the gravity of the public

interest outweighs the intrusion into personal

liberty, particularly in view of the effectiveness of the testing program.

And in Shoemaker v. Handle (1986)38 breathalyzer and urinalysis tests of race horse jockeys

were deemed constitutional in view of the procedural safeguards built into the process and

the fact that testing occurred in the context

of a closely regulated industry.

The ordinary individual as citizen (rather

than employee) enjoys a significantly higher

expectation of privacy. Courts are certain to

be cautious in assessing the legitimacy of gens~~cfione]~ V. Hunter, 612 F. Supp. 1122 (D. Iowa 1985);

Capua v. City of Phiinfi”eM, 1 IER Cases 625 (U.S. Dist. Ct.,

N.J. 1986).

35Capua v. City of Pfainfield, at 626.

3

’384 U.S. 757 (1966).

37State v. Superior Co’&t in and for County of Pima, 691 P.2d

1073 (Ariz. 1984).

W7g5 F,2d 1136 (3 Cir. 1986),
71

eralized screening programs. In order to overcome these barriers, the government would

have to present an extremely strong showing

of need.

When government as employer proposes to

test its employees for drug use, it must still

observe constitutional safeguards. Here one

must distinguish between drug testing when

there is probable cause for suspicion, completely random testing, and mass testing of

all employees.

Recent cases have struck down the mass

testing of both Federal and municipal employees for drug abuse on the ground that the circumstances did not justify dispensing with the

Fourth Amendment’s requirement that searches

and seizures should be based on individualized

suspicion. The most recent Federal precedent

is a permanent injunction granted by a U.S.

District Court judge in July 1988 to prevent

random urine testing of employees of the U.S.

Department of Justice. The judge said that be

cause there was no evidence of a drug problem in the Department there was no justification for infringing on the constitutional rights

of “trusted and apparently law-abiding employees. “39

In a case involving municipal

workers, another court noted that the city’s

testing program for fire fighters was overly

broad in that it would collect information that

bore no relation to the government’s interest

in preventing illegal drug abuse.40

Courts have also stressed the need for appropriate procedures to protect the employees’

legitimate expectation of privacy against such

administrative searches. One court has even

held that a public employee who at the time

he is hired signs a consent to be tested cannot

be held to that consent because “advance consent to future unreasonable searches is not a

reasonable condition of employment. ”41

On the other hand, there is much disagreement among courts on these points. In June

39Ruth Marcus, “Drug Tests Blocked for Justice Workers, ”

Washington Post, July 30, 1988, p. Al.

40Capua v. City of Pkihfield, ITER Cases 625 (U.S. Dist. Ct.,

N. J., 1986).

41 AZcDonell v. Hunter, 612 F. Supp.1 122, (D. Iowa 1985).

1988, the Third Circuit U.S. Court of Appeals

upheld a program subjecting municipal police

officers to random urinalysis done in the course

of an annual physical examination, yet a month

earlier the Sixth Circuit U.S. Court of Appeals

struck down a program of compulsory drug

testing of firefighters and police officers, saying the intrusion on their privacy was not

justified.42

The courts have banned only “random” drug

testing programs. The courts agree that if a

public employer has “reasonable cause” or

“reasonable suspicion” that a person’s job performance is presently impaired by the use of

drugs, a drug test maybe required. Thus when

public employees were discovered smoking

marijuana on the job, it was held that the employer could require testing.43 Certain public

employees such as police have been held to

have a lesser expectation of privacy due to their

“paramilitary nature”; and a search may be

conducted without a warrant, or “probable

cause” if there is some objective basis for the

search.44

The U.S. Supreme Court has held that “facilitative searches” such as those conducted

by fire marshals and building inspectors can

be done without the need for “probable cause”

or ‘reasonable suspicion, if they comply with

a reasonable administrative plan and are based

on neutral criteria. Thus some experts believe

that random drug testing will be upheld if governments use a plan that does not discriminate

and if there is legislation authorizing such testing, with appropriate safeguards.45

42Policeman’s Benevolent Association of New Jersey v.

Waslu”ngton Township, CA 3, No. 87-5793, June 21, 1988; Lovvorn v. Chattanooga, CA 6, No. 86-6281, May 23, 1988.

43Allen v. City of Marietta, 601 F. Supp. 482 (M =N.D. GA.

1985).

‘d~rner, p. 10008. The Fourth Amendment and the Due

Process Clause are flexibly applied. The strictness which which

both are applied is related to the reasonable expectations of the

person claiming protection and the nature of the interest at stake.

Thus one court held that jockeys may be subjected to random

drug testing because of the long history of testing in that occupation and because of the pervasive way the racing industry

is regulated. (Shoemaker v. Handel, 795 F.2nd 1136 (3rd Cir.

1986).

45See, for example, a letter to the Editor of the New York

Times, June 18, 1987, from John F. Banzhaf, ;Ird, Professor

of Law and Legal Activism, The George Washi.ngttm University.
72

Another issue was raised in a recent case before the U.S. Court of Appeals for the District

of Columbia, involving the testing of school

bus drivers and attendants as part of an annual required physical examination. The Court

said that such tests were permissible, but also

said that the test must detect current impairment, not merely past use, in order to justify

occupational restriction.46

The use of illicit drugs in the workplace has

prompted private sector employers to begin

or to consider urine screening programs. They

may be motivated by concern for safety in the

workplace, safety in facilities and transportation systems used by the public, the productivity of workers, or the general health and welfare of workers. The question is often raised

as to whether employers have a right to know

or to restrict what is done in the employee’s

off-the-job time, so long as it has not been

shown to affect their performance.

Debate about drug testing is complicated by

the multiplicity of drugs at issue, the complication of cross-reacting innocent compounds

that can trigger false-positive test results, the

practical problem of ascertaining whose urine

is being tested, and questions about the frequency of testing. The cost of testing is fairly

high, especially if confirmatory testing is used,

as it should be. How frequently testing should

be done is another question that can be decided

only arbitrarily.

Questions about scientific validity play a significant part in decisions concerning the permissibility of mass screening programs. The

more accurate and reliable the test, and the

lower the degree of unavoidable error, the more

likely it is to pass judicial scrutiny. The false

positive rates associated with some widely

used drug screening tests, for example, are unacceptably high to many experts. For example, the radio-immunoassay screening of blood

may yield a false positive rate of as much as

43 percent for cocaine, while the enzyme multiplied immunoassay technique of urinalysis

may have a false positive rate as high as 10

4GJones v. McKenzie, 85-01624, Nov. 17, 1987.

percent.” Because of the potential for stigmatization and legal misuse, such error rates

are likely to make judges wary about declaring mass testing programs to be lawful.

Use of drugs is clearly a health hazard.

Health professionals treat addicts as sick people, and the Supreme Court has held that drug

addiction is a disease or “status” for which

people cannot be punished, as opposed to an

act or behavior (e.g., possessing or selling

drugs) for which they could be punished.48

Advocates of mandatory drug testing use public health language (“an epidemic of drug

abuse”). They also cite the danger to others,

for example, coworkers in factories or passengers on trains and airplanes, to justify strong

public health measures. However, mandatory

drug testing is aimed at detecting only illegal

drugs, although the use of some legal drugs,

such as tranquilizers, might also result in some

impairment of performance. In fact, drug testing does not determine whether one is presently impaired but detects past use of a drug.

Effects of the drug may not have overlapped

the workday at all. Because of these factors,

courts have looked closely at random drug

testing—i.e., testing where there is no probable cause to suspect illegal behavior on the

part of a given person—and for the most part

have struck down such provisions.

People not trained in law often forget that

the Constitution provides limitations on government only; that constitutional provisions

do not protect them against actions by private

citizens; and that only when Congress has

passed laws embodying those constitutional

principles do they have an effect in the private

sector.

Thus it surprises some citizens to learn that

public employees may, because the government is their employer, have some constitutional rights in the workplace that private company employees do not enjoy. Private sector

employees must depend on State or Federal

47 Morris J. Panner and Nicholas A. Christakis, “The Limits

of Science in On-theJob Drug Screening, ” Hastings Center Report, December 1986, p. 8. ia~obinson “$ c~”form-a, 380 U.S. 660 (1962).
73

privacy statutes or individual contractual bargaining agreements with employers; they have

no constitutional rights to their job or to

privacy as a condition of employment.

Diagnostic Testing for Infectious Disease

Diagnostic testing to determine who has a

disease is usually looked on as beneficial for

the patient, who can then begin treatment, and

for the community, since steps can be taken

to reduce the transmission of a disease. The

exception comes when there is no curative

treatment to be given, when available control

measures may infringe on the patient’s freedom, and when the testing creates an information file that is viewed as a threat of further infringement or discriminatory actions in

the future.

Within less than 3 years of the first reported

description of the clinical disease AIDS in

1981, three laboratories had independently isolated and identified the virus, HIV, that is the

causative agent of AIDS.49 This gave immediate hope of developing a test to identify

infected individuals. Laboratory work then

established the usefulness of a particular cell

line to grow the virus to high concentrations

in tissue culture and allow it to be purified and

concentrated. That in turn facilitated the production of the large quantities of virus needed

to serve as diagnostic antigen,50 suitable for

4gSome critics maintain that this could have been accomplished as much as 2 years earlier had there been appropriate

funding and attention when the existence of the epidemic was

first discovered. For a critical account of the process, see Randy

Shilts, And the Band Played On (New York: St. Martin’s Press,

1987). There was competition between research scientists to discover the infectious agent, and acrimonious dispute over the

allocation of credit for the discovery. Three groups of scientists

used their own terminology in naming the virus. This contributed to serious confusions in discussion even within the scientific community. The terminologic dispute created problems for

persons concerned with the critical task of educating the public about the new virus and its risks. For that reason an international committee of virologist was assembled and proposed

a uniform nomenclature. The virus was named human immunodefi”ciency virus or HIV. As new relatives of that virus

are uncovered by further research, they are referred to as HIV2, HIV-3, etc. J. Coffin, A. Haase, J,A. Levy, et al., “Human

Immunodeficiency Viruses, ” Science 232: 697, 1986.

SOAn ~ti%n i9 a pro~in or c~bohydrati substance-a tofin~

enzyme, or the jacket of a virus-that when introduced into the

human body stimulates that body to produce antibti”es, or substances whose function is to combine with the antigen and neurecognition of human antibody responses to

HIV.

All viruses contain a number of different proteins or antigens that can stimulate the immune response. Antibodies to HIV usually appear during the first 4 to 8 weeks after infection

and nearly always within 3 months, and usually persist indefinitely. There are several variations of the screening test for HIV.

The development of diagnostic AIDS tests

was accomplished within a few months by several U.S. firms. Most of the tests are variations

of what is called an ELISA test. The initials

stand for enzyme-linked immunosorbent assay.

The virtue of the test lies in its easy readability, using techniques and equipment thoroughly

familiar to blood banks and clinical laboratories. Other variations such as indirect immunofluorescence or radioimmuno-precipitation

have been developed, but their principles are

similar. All blood and plasma donations to U.S.

blood banks have since 1985 been routinely

screened for AIDS. Testing of individuals can

be done by private physicians or in special or

general clinics and laboratories. Protection of

the confidentiality and integrity of this data,

most of which is probably computerized, has

raised many concerns.

Media coverage of the race to develop an antibody test was extensive. Nevertheless public confusion over the terms sensitivity and

specificity led to a widespread false impression

that the tests were not reliable. This residual

public unease is confounded with very different problems of the uncertainty of clinical diagnosis and prognosis.51

Any biological phenomenon has “outliers”-

i.e., variations extend across a broad range,

with some unusual examples that are far from

the mean or average. When a disease detection test is developed, it can be made highly

sensitive, in order to pick up even the outliers

tralize, agglutinate, or precipitate it, rendering it harmless. This

is the primary means by which the body protects itself from

disease.

slDia@osis is identifying a disease from its signs or sYmPtoms. Prognosis is predicting the course of the disease, the likelihood of recovery, or the duration of survival in a specific case.
74

or unusual cases, but then it will also pick up

some false signals. If the goal is accuracy, or

specificity-i.e., no false positives—then the

outlier cases or signals must be ignored or allowed to escape. The majority of cases, falling

near the mean, will be clearly recognized, but

there will be some false negatives.

When the antibody test for HIV was developed, it was purposely designed to provide

maximum protection of the blood bank supply, and therefore was made especially sensitive. Here, it was clearly best to err on the side

of being too careful, at the cost of a substantial number of false positives. Unfortunately,

some press reporters interpreted this as a sign

of a poor test, when it fact it was a necessary

accompaniment of appropriate caution.

The false positives made it necessary to have

a confirmatory test, or supplemental procedure, to be sure that a positive reaction in the

ELISA test was in fact an indication of infection with HIV. The first supplemental test was

called the “Western Blot, ” and identified antibodies to specific proteins of HIV, thus giving a detailed picture of the immune response

reflected in the patient’s blood serum. This has

been replaced in some laboratories by other

supplemental tests, but they operate on the

same general principle. At present, the state

of the art allows both sensitivity and specificity of greater than 99 percent for the ELISA

test, which already compares favorably with

any clinical laboratory test in medical use, and

supplemental tests permit very reliable identification of infected individuals when done

properly. Recently, questions have been raised

about the accuracy of the Western Blot. Many

commercial laboratories are apparently unfamiliar with and possibly unskilled in using

it, and there is no standard for its interpretation.

Some experts hope for a generically different supplementary diagnostic test: one that

would allow recognition of the antigen rather

than the antibody in test material. The hope

is that it might be possible chemically to identify virus proteins in blood and tissue samples

with a greater sensitivity than that of antibody

detection. 52 This would be of great merit

chiefly because in the interval early in infection, the antibody has not had time to develop,

and a person tested during that time may be

falsely reassured, and may inadvertently infect other people as a result. However, the benefit of an antigen test maybe counterbalanced

by a large number of false negatives, since HIV

can exist solely as integrated DNA in host

cells, without any antigen expression. Thus

failure to detect viral antigen would not necessarily mean the absence of infection.

Present AIDS tests are moderately expensive and time-consuming, and require trained

laboratory personnel. Confidential testing is

offered by many physicians and clinics, but

there may be long waits, and there is much

variability in the adequacy of the counseling

that is offered. There have been no “home test

kits,” or tests that give fast results, but a home

test kit is expected to be on the market within

a few months. If fast, inexpensive, and highly

accurate tests are developed, some of the purely

technical restraints on mass screening will

fade. However, medical and public health experts, persons with AIDS, and care-givers

stress the importance of linking testing to supportive counseling. This is important both for

the good of the infected, and to maximize the

likelihood that these people will take care to

avoid infecting others. The possibility of “onthe-spot” or home testing is likely to further

erode that link to counseling. In the meanwhile,

the question is whether large scale mandatory

testing programs should be undertaken now.

In early 1988 researchers at CDC announced

a technique called PCR (for polymerase chain

reaction) or DNA amplification, which identifies proviral sequences of HIV-I in the DNA

of blood cells of people who are infected. This

method may make it possible to obtain test

results within 3 days. CDC currently speaks

cautiously of the “potential utility of the PCR

szIt i9 ~ready possible in specialized laboratories to grow

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

unwieldy and expensive. Also, antigen is usually not recoverable from Ab-positive persons.
75

technique in complemention or replacing virus isolation as a routine means of determining the presence of HIV-I. ”53

Debate over the desirability of systematically screening large populations—e.g., prisoners, Federal employees, marriage license

applicants, hospital patients—seems to be

growing. In March, 1988, the U.S. District

Court for the District of Nebraska refused to

allow a multicounty mental retardation agency

to require some of its employees to submit to

testing for HIV infection, on the grounds that

this violated employees’ Fourth Amendment

(search and seizure) rights.” The agency had

acted on the grounds that employees might

transmit AIDS to clients who bit or scratched

them.

In part the impetus for mandatory testing

may come from the fact that there is little else

to be done, and mandatory screening seems

more activist than reliance on voluntary testing. In some limited populations, mandatory

testing would provide the opportunity for some

control; for example, screening of prisoners allows authorities to isolate those who are infected or to take strong measures to prevent

other prisoners being subjected to risk through

sexual activity .55

Testing of marriage license applicants could

allow an uninfected partner to be warned and

possibly reduce the number of infants born infected with AIDS, but heterosexual couples

other than IV drug users are not a high risk

group at present. Some States routinely require testing for syphilis in connection with

Sschin.yih OU et ~., “DNA Application for Direct Detection

of HIV- I in DNA of Peripheral Blook Mononuclear Cells, ” Science, Jan. 15, 1988, pp. 295-297.

54 Glover v. Eastern Nebraska Comrnum”ty Office of Retarciation, DC Neb, No. CV. 87-0-830, Mar. 29, 1988.

SSAccor&ng ~ ~ofe990r Wayne Welch of The George Washington University’s Intergovernmental Health Project staff,

there is already mandatory testing for members of the Armed

Services, the Foreign Service, and the Job Corps, and for Federal prison inmates. Prisoners are being screened in seven states.

Utah has passed a law prohibiting a person diagnosed as having AIDS from marrying. Florida requires pregnant women with

“high risk characteristics” to be tested.

Nevada, where prostitution is legal, requires that prostitutes

be screened for AIDS. Government Executive, July-August

1987, p. 13.

a marriage license application.56 Louisiana

and Illinois both passed laws requiring AIDS

testing for applicants for a marriage license;

Texas passed a similar statute that will go into

effect only when the state incident rate reaches

0.83 (when the law was passed, the rate was

0.01). But in July 1988, Louisiana repealed the

premarital test law after only 6 months, and

in Illinois there is also a strong movement for

repeal. Of 75,000 people tested under the Illinois law, only 10 tested positive (the prediction had been for 80 to 100 positives) and the

cumulative costs for testing were reported to

exceed $6 million (paid for by the applicants

for a marriage license, at costs of $30 to $200

per couple).”

Mandatory testing for health-care professionals themselves has been proposed, but

there has been little public or professional discussion of the pros and cons of this measure.

Many people, including many public health

and medical experts, conclude that any benefits from mandatory screening programs are

more than counterbalanced by the separating

of testing from counseling and the likelihood

of driving persons at risk “underground.” The

National Academy of Sciences/Institute of

Medicine reached that conclusion, as did a preliminary consultation at the World Health

Organization in March 1986.

The issue of how to balance these costs

against the benefits of testing programs has

not yet been fully resolved. The conclusion that

mandatory screening is unwarranted is greatly

affected by the lack of treatment, the clear need

for counseling in the event of a positive test,

and the uncertainty that confidentiality can

sGThis is becoming a serious problem in prisons, ~d the

rights of prisoners in this regard are a matter of debate and

uncertainty. A Massachusetts trial judge said in September that

a prisoner could not be forced to take an AIDS test merely because he had scratched and injured a guard. On the same day,

a Federal judge in Minnesota upheld the conviction of an infected prisoner for assault with a dangerous weapon after he

bit two judges, noting that the human mouth and teeth do not

ordinarily constitute a deadly or dangerous weapon. Associated

Press, “AIDS Decisions Diverge in Cases Against Prisoners, ”

The National Law Journal, Sept. 28, 1987, p. 4.

57 CJm&.a G. Bo~m~, “prem~it~ Testing Annoying M~Y

in Illinois, ” The Washington Post, July 30, 1988, p. Al.
76

be maintained. Screening at least spares those

who are unknowingly infectious from the additional grief of finding too late that they have

passed on the infection, perhaps to spouses or

offspring. If a cure or effective treatment were

possible, past precedents argue that the State

interest in saving lives and preventing the

spread of the threat would almost certainly

override concern about individual privacy

rights.

Voluntary testing, as compared to mandatory testing, is likely to involve those who are:

1) already well informed about AIDS, 2) socially responsible about the risks of infecting

others, 3) comparatively well off financially,

and 4) relatively sophisticated about medical

procedures. Two high risk groups are probably

least likely to ask for testing: IV drug users

and prostitutes, who are already at risk both

of incurring other life-threatening diseases and

of arrest for illegal activities; who are likely

to have little access to health services and little money; and who are hardest to reach with

public education.

The cost of screenings also a significant factor. The screening of a unit of blood by the

ELISA test costs at least $2 and more commonly approaches $5. When a positive ELISA

test occurs, repeat and supplemental testing

are required, adding at least another $50 to

the cost. These figures do not include the need

for skilled counselors and for procedures to assure confidentiality of test results. Thus the

economic and social costs of mass screening

for AIDS, both for those who have been exposed

and for the public at large, are significant.

Contact Tracing

Still another traditional Public Health technique, contact tracing, has also again become

controversial because of the AIDS epidemic.

Public health management of sexually transmitted diseases has along history. Mandatory

contact tracing-i. e., tracking down and warning people who have had sexual relations with

an infected partner-is a technique that has

usually been closely associated with reporting

and testing strategies. Contact tracing in the

case of AIDS has become attractive to some

Federal officials and State legislatures because

that strategy is perceived to have been useful

in the control of syphilis and gonorrhea. Such

action also seems indicated by fairness to people who have unknowingly been put at direct

risk, and may consequently unknowingly put

others at risk.

To the surprise of many observers, the American Medical Association (AMA) in June 1988

recommended that its members warn sexual

partners of patients with AIDS and of AIDS

carriers. This is an exception to the strong tradition of physician-patient confidentiality, on

which the AMA has always insisted.58

There are however two problems with mandatory contact tracing as a strategy for AIDS

control. First, some experts question the assumption that it was effective in the past.

Syphilis came under control primarily because

of the discovery of penicillin rather than because of contact tracing; and gonorrhea is at

present out of control in spite of contact

tracing.

Second, in those epidemics the impetus for

contact tracing was the knowledge that treatment could be offered to the contact. The patient had a strong ethical reason for reporting, and the contact a highly practical reason

for welcoming, the news. Both benefits tended

to compensate for the sacrifice of privacy. With

AIDS there is no therapeutic help to be offered.

The only benefit to contacts would be that of

counseling if their tests prove positive. But 2

or 3 months are usually required for antibodies to appear, so there may be an interval of

uncertainty, distress, and disruption of relationships even if the tests are ultimately negative. For public health officials and physicians, sustained infectiousness of the patient

over many months makes it difficult to be sure

of complete contact identification, especially

since many sexual partners may be involved.

The need for reiterative testing becomes a ma581sabel Wilkerson, “A.M.A. Urges Breach of Privacy To

Warn Potential AIDS Victims,” New York ~“mes, July 1,1988,

p. Al.
77

jor difficulty. Techniques for assuring the confidentiality of data are available but may be

demanding and expensive, and may still not

be trusted by those supplying the information.

These problems must however again be

weighed against the great benefit of warning

those who have been exposed, so that in turn

he or she will not unknowingly expose others.

Some public health officials are swinging toward

support of contact tracing. New York health

officials for example recently asked physicians

to warn sex partners of AIDS patients of the

risk.59 The City Health Commissioner said,

however, that there is no way to force patients

to disclose the names of contacts, and that under current rules governing professional behavior in New York, physicians and hospitals

that breach patient confidentiality would be

subject to civil penalties, such as lawsuits. Current New York laws do allow health officials

to notify people who have been in intimate contact with patients with venereal disease or

tuberculosis, and some states have already authorized contact tracing for AIDS cases. California and Texas allow but do not require physicians or surgeons to disclose positive test

results to a patient’s spouse, and provide confidentiality safeguards for patients who voluntary consent and list names for contact tracing. Illinois provides immunity from civil

liability for those willing to provide names for

contact tracing.

Some people urge that people who know they

are infected should be legally required to warn

sex partners. An army sergeant in San Antonio was recently sentenced to 5 months in

stockade and a dishonorable discharge for ignoring orders from officers and having sex

without telling his partners he was infected

with AIDS, or taking protective measures.6O

In June 1988, a military trial was beginning

of an Army private accused of having sexual

59 Ron~d Sulhvn, “WWn AIDS Patients’ partners, He~th

Official Urges, ” The New York Times, Oct. 15, 1987, p. B1.

60He ~a~ found ~ilty of disobeying officers, of adul~ry, ‘d

of sodomy, but not guilty of aggravated assault and reckless

endangerment. “Soldier Guilty of Concealing AIDS Infection

from Partners, ” The Washington Post, Dec. 3, 1987, p. A20.

relations with male and female soldiers without warning them that he was infected.

On June 24,1988, the Presidential Commission on the Human Immunodeficiency Virus

Epidemic recommended that State health officials be required to contact and notify sex partners of persons infected with AIDS.

Social Controls: Full or Partial

Quarantine

The strategies of final resort for control of

most epidemics are: 1) infrastructure or environmental reform, when there is believed to

bean environmental factor such as an animal

vector, and 2) failing all else, social control

measures including quarantine or isolation.

There are no known environmental factors

in the AIDS epidemic, in the sense of sanitation factors, industrial contaminants, or animal vectors for the disease agent. One factor

in the urban environment proved to be important: the “bathhouses” in some large cities that

were a primary focus of promiscuous homosexual behavior that facilitated the transmission of the disease. Action by public health

authorities to close these commercial establishments in San Francisco and New York was delayed by the protest and political and legal resistance of proprietors and clients, on the

grounds of civil liberties, but once the fact of

an infectious disease and a mode of transmission had been established, there was little

doubt that the closure fell within the long

established scope of State police power.

Three further social control measures, beyond those already discussed, have been suggested or proposed in the context of the AIDS

epidemic: full quarantine, excluding children

with AIDS from public schools, and prohibiting persons with AIDS (or carrying the infection) from engaging in certain occupations.

These potential control measures have very

significant constitutional implications.

Quarantine would impose a harsh burden on

those infected with AIDS, particularly those

who as yet suffer no symptoms of the disease,

because the quarantine would be life-long. In
78

spite of this, newspaper polls have shown many

Americans (one poll said 51 percent) favor

quarantines, and legislatures in 5 States are

said to be considering, or to have considered,

such legislation. Florida health authorities

have quarantined one prostitute to her home,

wearing an electronic anklet.61 Social attitudes

and judicial decisions regarding quarantines

may have changed significantly in the last few

decades, but this conclusion is somewhat hypothetical, as the use of traditional quarantines

has become relatively rare and unfamiliar.

In the early national period, quarantines

were often imposed. The major infectious disease problem was yellow fever. The disease

reappeared in 1793 after a long absence, and

a devastating epidemic struck along the entire coast from Boston to New Orleans. Philadelphia, New York, and other cities established

temporary health boards with broad authority, and began quarantines. They isolated yellow fever victims and began massive programs

to cleanup the foul streets and privies. As the

epidemic increased in intensity, temporary hospitals were established, and funds were provided to care for the sick and those left orphaned.

The disease was spread by water transport

and generally struck hardest in the low-lying

crowded dock areas occupied by the poor. The

rich fled. Philadelphia and New York City in

1797 began a policy of evacuating entire sections of the city. New York, for example, provided temporary housing out in the country,

in Greenwich Village. The city authorities assumed full responsibility in this way for epidemics of yellow fever for another century,

through the final large outbreak in 1905 in New

Orleans, when Federal, State, and local officials joined together to cut short the epidemic.

Courts have since often struggled with the

issue of quarantine as an ultimate social control measure, and have generally dealt with it

according to: 1) the nature of the disease and

GIDebor~ Jones Merritt, “Communicable Disease ~d Constitutional Law: Controlling A IDS,” IVew York University Law

Review, vol. 61, No. 5, 1986, p. 775. The Los Angeles Times

poll cited by Merritt was published Dec. 19, 1985, p. 1.

2) the length of time for which a person is infectious and would need to be isolated. Until

recent decades, courts gave great weight to the

inherent power of government to protect the

general welfare by whatever means were considered to be appropriate, by the public and

their legislators even if not by experts.

For example, a 1909 case involved the quarantine in South Carolina of an elderly woman,

who had contracted leprosy many years earlier

as a missionary in Brazil.62 Subsequently she

mingled freely in the society of a small town

for years, even teaching Sunday School, until

the city board of health decided that she should

be isolated. She had infected no one, medical

authorities testified that she was only slightly

if at all contagious, and the woman frantically

offered to remain isolated in her own home.

Nevertheless, the court permitted her involuntary removal to and confinement in a cottage

built for her outside the city limits. The court

held that even though the disease was only

“slightly contagious’ the board of health was

justified because of the “distressing nature of

the malady.”

By contrast, public health officials in San

Francisco and elsewhere made no move to

quarantine persons with AIDS who continued

to frequent commercial bathhouses for reasons

of anonymous sexual activity, in spite of the

repeated warnings of their physicians that they

were likely to be transmitting the infectious

disease.63 In the intervening half century, attitudes toward individual rights had changed

significantly.

Even at the turn of the century when quarantine was more often applied than now, courts

did intervene in quarantine programs where

the exercise of police power was extreme and

arbitrary. In 1900 San Franciso’s board of

health quarantined a 12 block district inhabited

by 10,000 to 15,000 people, because bubonic

plague was thought to exist in the area. This

was challenged on the grounds that it was

differentially enforced against Chinese but not

non-Chinese (most of the residents in the area

GZ~ir~ v. Wymm, 65 S.E. 387 (S.C. 1909),

63 Shilts, Op. cit., footnote 49”
79

were Chinese); there was insufficient evidence

of bubonic plague;64 and in many blocks there

was no evidence of any illness at all. A Federal judge terminated the quarantine on the

grounds that it was “unreasonable, unjust, and

oppressive. ’65

In 1922, the Supreme Court of Illinois upheld the isolation of a boarding house operator who was not ill but was a carrier of typhoid

bacillus. 66 She could, the court said, be quarantined for as long as she presented a danger

to the public, ever though this would likely be

for the rest of her life. The court noted several

requirements: the person must be known to

be ill or infectious (“mere suspicion” was not

sufficient); State authorities must have reasonable ground to believe that public health would

be endangered; the action must cease when the

necessity for it ceases; and the emergency or

necessity must exist, not merely be anticipated. However, public authorities need not

wait until the disease has already been transmitted to take action. “One of the important

elements in the administration of health and

quarantine regulations is a full measure of common sense. ”

Some courts were less concerned about the

principles governing exercise of police power.

The Supreme Court of Ohio, also in 1922, allowed city health commissions to make examinations of all persons suspected of having venereal disease, and “all known prostitutes”

were considered to be, per se, reasonably suspected. Another regulation allowed the quarantine of one who had or was reasonably suspected of having venereal disease when in the

opinion of the health commissioner such quarantine was necessary to protect the public

health. A woman was arrested as a prostitute;

charges were dismissed but she was then insqThere had been 11 deaths in which some 5ymptOm5 of bubonic 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).

G6Peop]e Ex Re]. B~more v. Robertson, 134 N.E. 81 ~

(111.1922). The court said that it would not evaluate the wisdom

of the State legislature and board of health, and would not interfere with a particular action so long as it did not appear to

be, on its face, “arbitrary, oppressive, and unreasonable. ”

voluntarily institutionalized by the commissioner of health for 2 months’ treatment. In

refusing a writ of habeas corpus, the State Supreme Court said:

There is perhaps no provision of the Federal

Constitution that is more overworked than the

Fourteenth Amendment . . . It has been so

many times decided that the Fourteenth Amendment does not limit the states in the proper

exercise of the police power that the citation

of authority seems needless.67

A generation later, in 1944, there was a similar case in which two women arrested for having ‘unlawfully solicited for prostitution” were

held without bail until examined for venereal

disease, pursuant to a State statute. The Supreme Court of Illinois upheld their detention

on the sole grounds of the charge of prostitution, saying that:

It has been almost universally held in this

country that constitutional guarantees must

yield to the enforcement of the statutes and

ordinances designed to promote the public

health. .. .68

The court also cited with approval another

authority, that “whenever a police regulation

is reasonably demonstrated to be a promoter

of public health, all constitutionally guaranteed rights must give way. . . .“

Even in recent years, courts have upheld

statutes that permitted involuntary testing of

women arrested for prostitution.69 Public

health measures may be less likely to be limited

by courts under constitutional principles when

they are aimed at venereal disease, or when

applied to prostitutes who are by definition engaged in criminal activity, than in more general cases of infectious disease.

But most of these statutes and court decisions occurred during wartime; Dr. Allan M.

Brandt, in his book No Magic Bullet,70 disGTEX pate Compwy 139 N.E. 204 (Ohio 1922).

Gspeople ex re]. B~er V. Strautz, 54 N.E. 2nd 41 (1944).

WFor exmple, Peop]e v. SuFrior Court (Hartway) 562 p.2d

1315 (Cal. 1977).

‘OAllan M. Brandt, IVo MaH”c Bullet (Oxford: Oxford University Press, 1985).
80

cussed the impact of wartime preparedness initiatives on the creation and enforcement of

laws aimed at reducing the prevalence of venereal disease. In the past, quarantines for venereal disease have been limited in duration

since those who were infected could be rendered

non-infectious by medical treatment.

The courts have upheld quarantines for

many other infectious diseases including scarlet fever71 and tuberculosis;72 and have upheld

lifelong quarantines for typhoid. But quarantine has come to be used less and less as vaccines or cures were developed for many infectious diseases.

On the one hand, the pattern of court decisions about quarantine shows an ever broadening tolerance for the exercise of police powers.

This tolerance has expanded from quarantine

based on demonstrated necessity to quarantine based on suspicion of disease, to quarantine based not on disease symptoms but on accusation of sexual activities. On the other hand,

some constitutional authorities believe that

courts would now be very reluctant to uphold

the broad use of long quarantines, because concern for individual rights has increased. Deborah Jones Merritt, for example, suggests

that:

Recent developments in constitutional law

suggest that courts would no longer uphold such broad quarantine orders. Although

the courts might still approve the isolation of

individuals who either knowingly engage in activities threatening a high-risk of infection to

others or lack the mental competence to avoid

those activities, judges would be unlikely to

sustain the quarantine of individuals who are

willing to modify their activities to avoid such

risks.73

Not all authorities concur in that judgment,

on the grounds that courts have in general

given wide discretion to governments in exercising their police power when the public perceives a serious risk. In particular, some people warn, any evidence that AIDS has been

TIS~O~~ “ Racjowskj, 86 A 606 (1913).

72Moore ~. Draper, S’7 So.zd 618 ( 1952 ‘la”)”

73 Merritt, op. cit., footnote 61, p. 778.

transmitted through non-sexual, non-drug related contact in even a very few cases would

be likely to increase both political demands for

and judicial acceptability of quarantine. This

occurrence seems highly unlikely.

The constitutional acceptability of some

lesser forms of social control is also still unclear. For example, continued admission of children with AIDS to public school has brought

about conflict in many communities. The Centers for Disease Control (CDC) in August 1985

reassured parents about the “apparent nonexistent risk of transmission” of the virus to

other school children and recommended that

schools decide how to handle children with

AIDS on a case-by-case basis.74 Some school

districts have adopted CDC’s guidelines, some

have refused to admit AIDS children, some

have segregated them within schools.75 Both

parents and school boards have resorted to the

courts. State and Federal legislators have introduced bills to ban AIDS sufferers from

schools. These struggles are so far unresolved

except on a case-by-case local basis.

In the first decades of this century courts

allowed school boards almost unlimited authority to exclude students with communicable diseases.” Not only children who were ill, but

those who had been exposed to infectious diseases at home or elsewhere could be excluded.

In recent decades, while declining to recognize

education as a fundamental right,” the Court

has nevertheless scrutinized any law or policy

that excludes children from public schools.

The State was not allowed to exclude undocumented alien children, on the grounds that

this would relegate the children to a permanent ‘subclass, ” that the children were not re74CDC di~count~ most n-leas of ‘‘casual tr~Smi9SiOn, but

recognized parents’ fears that body fluids may be exchanged

among children by biting, scratching, uncontrolled urination,

casual injuries, etc. ‘Education and Foster Care of Children Infected with Human T-Lymphotropic Virus Type III/Lymphadenopathy-Associated Virus, ” 34 Morbidity & Mortafity

Weekly Rept. 517, 519 (1985).

7SMerritt, op. cit., footnote 61, PP. 756 ‘f”

TGIbid. The rem~nder of this section draws heavily on Merritt, op. cit., unless otherwise referenced.

TTpaPa~an “c Al~a”n, 106 S. Ct. 2932, 2943-45 ( 1986); P~Y~er

V. Doe, 457 U.S. 202, 223 (1982).
-.

8 1

sponsible for their alien status, and that the

cost of educating these children was insubstantial in the light of the costs of lack of education for the children, the State, and the Nation. These reasons could apply to children

with AIDS, except that they are unfortunately

unlikely to live to constitute a permanent subclass. The likelihood of transmission through

schoolroom contact is generally regarded by

experts, although perhaps not by all members

of the public, as extremely small or nonexistent. A New York trial judge recently followed

this reasoning in ruling that automatic exclusion of all AIDS patients from public schools

would violate the Equal Protection Clause.78

In 1979 the New York City Board of Education began to exclude from regular classrooms

mentally retarded children who were also carriers of the hepatitis B virus. Hepatitis B is

communicable in a similar fashion to AIDS—

through the use of contaminated needles,

blood-to-blood contact, and sexual contact

(usually homosexual contact). While the virus

has been isolated in saliva, there is no evidence

that it has been transmitted through this

route.” The New York City policy was challenged on the grounds that it violated the Rehabilitation Act of 1973, the Education of the

Handicapped Act, the New York Education

Law, and the Due Process and Equal Protection Clauses of the Fourteenth Amendment.80

The Board of Health argued that it was making traditional use of the police power to protect the health, safety, and welfare of its citizens and that its actions were “rationally

related” to this purpose. The Court nevertheless struck down the Board’s policy. It cited

the Fourteenth Amendment, although it relied

primarily on antidiscrimination laws.81 A Cali-

‘Hllistrict 27, 130 Misc. 2d 398, 502 N. Y.S.2d 325; cited by

Merritt, op. cit., footnote 61, p. 762.

7gAccording to Dr. Leonard Glantz, Prof. of Health Law,

Schools of Medicine and Public Health, Boston University, some

authorities think that there is a greater likelihood that hepatitis B could endanger others in a classroom or household than

that AIDS could do so. The material on school admission in

this section relies heavily on analysis by Dr. Glantz as well as

Dr. Merritt.

“ONew York State Association for Retarded Children v.

Carey, 612 F. 2d. 644 (2nd Cir. 1979).

“The court said that since the policy excluded only mentally

retarded children and made no effort to find or exclude other

fornia court ordered a school district to readmit a child with AIDS to kindergarten on the

grounds that AIDS is a handicap under Section 504 of the Rehabilitation Act.82

In a similar case a New York court invalidated a school board policy excluding children

with AIDS. Again recognizing that public education is not a fundamental right, the court

said that when a State does provide it, it must

be available to all on equal terms. The courts

will give any denial of schooling close scrutiny

because of the significant negative impact this

could have on children.83

The Public Health Service (PHS) has officially urged that AIDS sufferers or carriers

not be excluded from work, saying that “No

known risk of transmission . . . exists” for

workers in offices, schools, factories, construction sites, food service jobs, health service

delivery, etc.84 The Public Health Service recommended only routine disinfection of equipment contaminated by anybody fluids, regardless of known infection.

Some school districts decide on a case-bycase basis whether public school teachers and

associated workers with AIDS may continue

to work. Several cities have barred persons

with AIDS or AIDS-Related Complex from

working as food servers or as teachers. Judicial precedents could support these restrictions. Under the rational basis test, as long

as the courts perceive that there is even remote

risk of infection,85 they would be obliged to

uphold such regulations. The Supreme Court

held, in 1978, that New York City could conchildren who were carriers, the Board evidently recognized that

carriers presented only a “remote possibility” of infecting others.

wThomas v. Atascadero Unified School Di.S’trict, No. 886-

609 AHS(BY) (C. D.) Calif. Nov. 17, 1986. S~District 27 Commum”ty sch~] Bo~d V. Bo~d of Education, 502 N. Y. S.2nd. 325,337 (Sup.1986).

‘recommendations for Preventing Transmission of Infection with Human T- Lymphotropic Virus Type III/Lymphadenopathy-Associated Virus in the Workplace, 34 Morbidity

& Mortd”ty Rept. 681,682 (1985), hereafter cited as PHS Workplace Recommendations.

55 The Public Health Service holds that there is some possibility of such transmission, for example, by direct transfer of

blood through the injury of one person and an open lesion on

another person’s skin, but says that this kind of transmission

is highly unlikely.
82

stitutionally bar all methadone users from

working for its transit authority even though

the bar was “broader than necessary to exclude

those methadone users who were not actually

qualified to work. “86 Thus if the courts found

sufficient grounds to exclude some AIDS victims from health care, personal service, or food

handling occupations, they would be likely to

uphold broad rules barring AIDS victims

rather than insist on individualized determinations of the threat posed by a particular employee. But those “sufficient grounds” do not

appear to exist, and the Supreme Court has

said that the protection given to the handicapped by recent legislation extends to people with infectious disease.

None of these judgments are at all conclusive; they represent possibilities rather than

predictions of how courts would decide in future situations. Constitutional lawyers and

scholars differ strongly on these points. Clearly,

scientific knowledge about risks and exposures, in this case, has not been sufficient

to prevent or resolve challenges to public policy on the basis of constitutional principles;

it may only have complicated those challenges.

In June 1988, the President’s Commission

on AIDS and the National Academy of Sciences both recommended tough new Federal

laws to prohibit discrimination against the

28,000 Americans with AIDS and the more

than 1 million other Americans estimated to

be infected. The Presidential commission, with

a divided vote, recommended that the Federal

law against discrimination against the handicapped be extended to apply to private sector

employees.

Treatment

Health care in the United States is primarily provided through the private sector, but

the public health system is an important developer of new drugs and other health care regimes and techniques. In addition, Medicare

and Medicaid do provide payment for health

care for many Americans. As discussed in the

next chapter, there is a growing concern about

the availability of adequate medical care for

Americans who may not be able to pay for increasingly expensive care, or who do not have

access to health insurance: “A(n). . . issue confronting society and its political elements is

the question of whether health is a universal

human right.”87

Neither Congress nor the Supreme Court has

in any way recognized such a “human right”

as a constitutional right. But the AIDS epidemic may fuel pressure for new health care

delivery mechanisms or programs because of

the high costs of treatment, because those with

AIDS are young and more likely than the average worker not to have health insurance, because

they may lose their jobs when their illness becomes known, and because health insurance

providers try to avoid enrolling those in highrisk categories.

The projected costs of health care for AIDS

patients in the next few years are enormous.

While AIDS is uniformly lethal, it entails many

weeks or months of progressive debilitation,

including necrologic deterioration. Since this

is a disease of young adults whose health insurance is usually dependent on their employment status, early termination of employment

has abroad impact. Home care, day care, longterm care in skilled nursing facilities, and

hospice care can improve the quality of remaining life for many patients, while reducing costs.

The range of lifetime health care cost estimates

per case range from $29,000 to $157,000, reflecting in part the variation in availability of

such options.

Health care will become still more costly and

difficult as drug addicts become an increasingly large proportion of the patients. Many

of the innovations in patient care so far have

relied heavily on the volunteerism characteristic of some gay communities, which has no

parallel in some of the other high risk groups.

WNew york City Tr~sit Authority v. Bea.zer, 440 U.S. 568

(1979), as cited by Merritt, op. cit., footnote 61, p. 771.

87J.C. Snyder, “Public Health in the U. S.A., ” in John Walton, Paul B. Beeson, Ronald Bodley Scott (eds.), The Oxford

Companion to Medicine, vol. ii, p. 172.
83

The appearance of the first anti-HIV drug,

AZT, raised some thorny issues likely to recur with other candidate treatments. The handful of drugs that have been developed for treatment of virus infections of any sort are usually

very toxic. Antiviral drugs present very different problems from those of antibiotics for bacterial infections. Most bacteria are distinctive,

self-contained organisms, subject to attack

through their specialized mechanisms of multiplication. Viruses act as “fifth columns,” taking over the host cell so completely that it is

difficult to kill the virus without seriously

damaging the host.

AZT, for example, has a serious suppressive

effect on the patient’s bone marrow, usually

necessitating regular blood transfusions. It has

other toxic properties, often so severe that

treatment must be stopped. Its cost is nearly

$10,000 yearly per patient. This is not a promising solution even in the affluent United

States, where over a quarter of a million cases

of AIDS are anticipated by 1991; it certainly

will not work for developing countries. But so

desperate are AIDS patients that even at that

cost, the demand for AZT exceeds the supply.

The urgent need for some treatment prompted

creation of an unusual mechanism for early

licensing of AZT and an even more unusual

system to try to get more equitable distribution of the drug. The intense pressures that

prompted these actions will worsen tenfold in

the next 5 years if there are no other effective

treatments. A large number of unauthorized

treatments, ranging from health food diets to

drugs authorized for other medical purposes,

are being widely used by those with AIDS who

can afford their often high costs. Many people are highly critical of government agencies

for what they view as foot-dragging in testing

these “treatments.”

Yet other people are concerned that the rapidity of licensure of AZT seems to herald more

rapid deployment of new drugs in general—

not just for AIDS—and they fear that the slow

but cautious approach which has assured drug

safety in the past maybe replaced with a faster

but more hazardous approach. Few hazards,

however, appear prohibitive compared to a disease that is probably 100 percent fatal.

In the meantime, in response to the growing demand from the AIDS community, the

FDA announced in July 1988 that it would allow Americans to import unapproved drugs

from abroad in small quantities for personal

use in treating or preventing AIDS.88

Blood Banking

Blood supply and transfusion was a primitive process until World War II. Blood groups

were recognized only in the 1930s. Until the

need for close matching of blood types was recognized it was not uncommon for hemorrhage

to be dealt with by direct arm-to-arm transfer

of untested blood.

Blood transfer for medical purposes increased dramatically with expansion of surgical capabilities and other therapeutic interventions. It prolonged the lives of cancer patients

and many others who needed transfusions for

maintenance. By 1983, an average of 13 million voluntary blood donations were made per

year. Most donations were divided into two

or three components (i.e., red cells, plasma,

platelets). There were over 3 million recipients

per year, many receiving multiple infusions.89

The transmission of the disease hepatitis as

a complication of blood transfusion was recognized in the early 1940s. By misadventure

the newly developed live-virus vaccine for yellow fever was stabilized using human serum

that was infected with hepatitis viruses. Over

50,000 cases of hepatitis resulted. Blood screening for the disease agent then began.

~phdip M+ Boffiey, “F.D.A. Will Allow Patients TO Import

AIDS Medicines, ” New York Times, July 25, 1988. One example of such a drug is dextran sulfate, which the Federal Government is now beginning to test in human trials, but which is already in use in some countries.

89J.R. Allen, “Scientific and Public Health Rationales for

Screening Donated Blood and Plasma for Antibody to

LAV/HTLV-III,” Chapter 15 in AIDS: The Safety ofl?kwd and

Blood Products, J.C. Petricciani et al. (eds.), The World Health

Organization. New York: John Wiley and Sons Ltd. Also J.C.

Petricciani, “Licensed Tests for Antibody to Human TLymphotropic Virus Type III, Arm.intern.ilfed. 102: 726-729,

1985.
84

The identification of hepatitis B virus and

development of a means of screening had been

expected to eliminate most of the hepatitis contamination. But as it turned out, only a small

proportion of the transfusion-associated hepatitis was eliminated. Clearly at least one other

virus was involved. The remaining blood transmitted hepatitis was subsequently referred to

as “non-A, non-B hepatitis. ”90 Later immunologic evidence strongly suggests that there are

at least two other hepatitis viruses.

The risk of hepatitis is still significant; bloodtransfusion hepatitis continues to threaten 7

to 10 percent of those getting transfusions. Additional “surrogate” screening tests have recently been added in an effort to prevent these

infections, and they add several dollars to the

cost of each unit of blood.

Besides blood donation there is a large “industry” of plasmapheresis growing from extensive demand for gamma globulin and from

the recent capability to fractionate blood plasma

and prepare concentrated materials (e.g., clotting factors to substitute for genetically lacking proteins in hemophiliacs). The pooling and

concentrating of donated plasma has allowed

the life expectancy of severe hemophilia A patients to rise from about 14 years in the early

1960s to 42 years in the early 1980s. Unfortunately the same technical feat made them early

victims of the spread of AIDS.91

This was the second great disaster to hit

bloodbanking. By 1982 it was suspected that

AIDS was infectious, and that the unknown

agent might be transmitted through blood exchange, and several cases of AIDS in hemophiliacs had been reported.92 In March 1983,

the FDA after consultation with the major

blood banking organizations, the National Institutes of Health, and the National Gay Task

Force, recommended that persons “at inW-iepatitis A is caused by still another virus which is physiochemically similar to polio virus and is rarely a factor in blood

transfusions.

91J. F. Desforges, “AIDS and Preventive Treatment in Hemophilia.,” New Eng. J. Med. 308: 94-95, 1983.

“U.S. Congress, Office of Technology Assessment, Blood

Policy & !l’echnology, OTA-H-260 (Washington, DC: U.S. Government Printing Office, January 1985), p. 13.

creased risk of AIDS” (specifically homosexual males) be asked to refrain from donating

blood; that there be expanded medical screening of donors to detect early symptoms of

AIDS, and that this screening include examination for lymph node enlargement and weighing to detect early weight loss.

Critics have since charged that this action

was delayed by resistance from both blood

banks and gay organizations.93 The Centers

for Disease Control officially reported only in

January 1984 that there were cases of AIDS

associated with transfusions, and later in 1984

some blood banks began using surrogate tests.

Many lots of blood thought to be infected were

withdrawn and destroyed. In April 1984, the

AIDS virus was identified, and a specific AIDS

blood screening test became available in mid1985. Screening for AIDS now adds about $5

per unit to the cost of blood transfusions.

By the end of 1987, according to the Centers

for Disease Control, 1,608 cases of AIDS acquired through blood transfusion had been reported in the United States. Of all persons with

hemophilia A (12,400 persons), approximately

70 percent maybe infected with AIDS; of those

with hemophilia B (3,100), about 35 percent

may be infected.94 The number of cases of

transfusion-related AIDS will thus increase for

some time even if the risk of infection through

blood transfusions has ended.

Public anxiety about the safety of the blood

supply has led to the demand that “directed

donations” be allowed, in which one chooses

one’s own blood donors from personal friends

and relatives. The costs of such a program, i.e.,

subdividing blood units and allowing special

storage, is potentially very high. It also creates a “two-class” blood system, and so has

been opposed by many professionals in transfusion medicine.

Autologous donation is the process by which

one donates one’s own blood for anticipated

future use. In planned, elective surgery this

93 Shilts op. cit., footnote 32, parts IV and ‘“

94u s ~blic Health service, Centers for Disease COntrOl, !.

Morbidity and Mortality Weekly Report, vol. 36, Supplement

No.S-6, Dec. 18, 1987, table 14, p. 40.
85

—

can be a wise precaution. It is not generally

useful for emergencies.

Blood supply system professionals generally

insisted that would-be donors must be informed

that tests will be done on the blood and a donor

who tests positive will be informed of the results; and most have strongly supported the

position of many other health professionals

that counseling must be offered in conjunction

with blood testing for HIV antibodies. An

elaborate process has been set up for obtaining donor consent, notification of results, and

follow up counseling. The burden on blood

banks is very large. Strong pleas have been

made for persons whose behavior puts them

at risk of AIDS not to donate. But in communities without alternative testing sites, access

to the AIDS test through blood banks means

that some people will donate in order to find

out if they are infected.

The American Red Cross in 1986 instituted

a look-back procedure, in which infected donors

who are identified through a current donation

have their prior donations traced. Stored samples are tested; recipients of prior positive donations are contacted and told of their possible contamination.

Public Education and Statistical

Forecasting

Epidemics are usually attacked through

preventive education, prevention by vaccine,

drug treatments, and sometimes social control

measures such as quarantines. Only the first

has yet shown real promise for the AIDS epidemic in the next decade. Education is now

the major public health strategy, other than

research and the screening of blood and organ

donors. This means a combination of strategies to inform the general public about the disease in a way that will be effective yet minimize diffuse fear, that will alert adolescents

to the lethal hazard implicit in certain behaviors, and that will urge people to avoid

behaviors that put them at high risk. The

NAS/IOM panel proposed that for every dollar invested in research an equal sum should

be invested in education for prevention.

There are however strong political constraints

on this strategy because some people perceive

any information about avoidance strategies

(other than abstinence or heterosexual monogamous marriage) as equivalent to condoning

homosexuality or promiscuity. The Public

Health Service and Centers for Disease Control had planned to mail an AIDS information

brochure to every U.S. household in October

1987. But because of political resistance from

those who feared it would offend some religious

groups, the President’s Commission on AIDS

delayed the mailing until late spring 1988.95

There is some evidence that public education about AIDS has brought about behavior

change within the group so far at highest risk,

homosexual males. Most observers report, although there is probably no real quantitative

data, that extreme promiscuity has strongly

declined and the use of condoms has risen.

Most experts believe however that other high

risk behavior, i.e., intravenous drug use, is

much less likely to change, since its practitioners are already accepting very high legal

and health risks.

Public education is also regarded as the best

strategy for dealing with some newly identified behavioral or environmental risks, and for

some that have been recognized for several decades, such as smoking. There will soon be increasing non-genetic predictive power concerning the likelihood of a variety of pathologic

states such as coronary artery disease and

adult-onset diabetes. Medical science is leading toward a refined definition of desirable

“health behaviors” to reduce the likelihood of

or severity of such outcomes, so much so that

some have been codified in a fully sanctioned

set of Federal objectives.96 Increasingly, public health programs emphasize lifestyle change

and preventive health measures.

The first strongly documented scientific

warnings that smoking was deleterious to

“William Booth, “The Odyssey of a Brochure on AIDS, ”

Science, vol. 237, Sept. 18, 1987, p. 1410.

96pub]ic He~th Service, U.S. Department of He~th and Human Services, The 1990 Health Objectives for the Nation: A

Mid-Course Review (Washington, DC: Public Health Service,

1986).
health came from epidemiologic studies in the

1950s, when epidemiologic methods were not

well accepted except when dealing with infectious diseases. The data are now well-established; smoking contributes directly and materially to over 350,000 deaths a year in the

United States, and “passive smoking” (indirect

inhalation of tobacco fumes from others’ smoking) has been found to be physiologically real

and pathologically significant.97

This raises a social/ethical, and ultimately

perhaps a constitutional issue, “how much personal liberty can be tolerated in self-damaging

behavior?” Society has debated this issue before in terms of motorcycle helmets, seat belts,

and alcohol; and will increasingly face it in

terms of other lifestyle, nutrition, or environmental factors. Increasingly accurate predictive power concerning adverse health behavior

brings us closer to the zone in which society

claims an interest in the individual’s assumption of risk. Complicating this is the question

raised earlier with regard to occupational genetic screening: should some people, who are

genetically sensitive to some environmental

factors, be legally prevented from entering occupations, jobs, workplaces, or general locations that are accessible to less susceptible

people?

Public education and social pressure—even

without laws and regulations seeking to control behavior-is considered excessively intrusive by some people, when it pertains to eating

habits, weight control, recreational pursuits

and other matters that they regard as highly

personal. Some social observers see the possibility of a backlash against such pressures,

such as occurred against “Blue Laws” and obscenity and pornography laws, raising new demands for protection of personal privacy and

choice.

On the other hand, to the extent that forecasting carries a useful personal message, issues of cost, access, and equity arise. Affluent

people may have full benefit of forewarning and

preventive care, and others may not, even when

much of the predictive capability results from

knowledge and technology developed with public funding. It is in fact only recently that

government-funded health programs countenanced reimbursement for any prevention

or health maintenance costs.98

Public health professionals increasingly argue for a national goal of comprehensive health

care for all99 based on the statement in the

Preamble to the Constitution of the World

Health Organization, which the United States

formally endorsed, that

The enjoyment of the highest attainable

standard of health is one of the fundamental

rights of every human being without distinction of race, religion, political belief, economic,

or social condition. .. .100

The fundamental public health issue of the next

generation may be the question of whether this

goal can implicitly be found in the constitutional 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 Surgeon General, 1982 (PHS 82-50179); The HeaZth Consequences

of Smoking: Carch”ovmmdar Disease, A Report of the Surgeon

General, 1983 (PHS 84-50204); The Health Consequences of

Smoking: Chronic Obstructive Lung Disease, A Report of the

Surgeon General, 1984 (PHS 84-50205).

‘MC*J, Schramm, “can We Solve the Hospital-Cost Problem

in Our Democracy,“ New Eng. J. Med. 311: 729-732, 1984.

99SnYder, op. cit., footnote 87, P. 1170.

l~premble t. the Constitution, World Health org~”zation

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

technologies in recent decades and seems certain to continue, with scientific breakthroughs

in many fields. Emerging or impending advances in medical capability are often foreseeable, sometimes years before they occur. They . .

can

●

●

●

●

be anticipated when:

there are no theoretical or logical barriers

to their achievement,

the scientific and technical barriers are

identifiable and understood,

there are alternative research strategies

for attacking the problems, and

society puts a high priority on achieving

the goal and therefore provides incentives

for persistent effort.

Some medical goals are less definitely achievable, yet continue to be strongly pursued

1 In preparing this chapter, OTA drew on interviews ~d ‘~

cus group sessions conducted at the annual meeting of the American Association for the Advancement of Science (AAAS), Chicago, January 1987; results of a mailed questionnaire to section

officers of the AAAS in December 1986, and an OTA workshop

on Biology, Medicine, and Public Health, May 1987. In addition, Jonathan Peck, Institute for Alternative Futures, and Irene

Jillson, Policy Research Incorporated, as OTA contractors, contributed to the development of this chapter.

because their contribution to length of life,

quality of life, or reduction of suffering is potentially great. Other great achievements in

health care occur when there is a sudden discovery such as penicillin, a breakthrough such

as organ transplants, or a new vaccine; such

discoveries often give rise to a long procession

of innovations and inventions.

Some of the trends and developments noted

in this chapter are already underway. The timing and achievability of others are debated by

experts. Nearly all are, however, considered

likely to become available within 5 to 20 years.

This is, indeed, a conservative view. It neglects

many other achievements that may be equally

or more likely, or even closer at hand. It is intended only to indicate the fertile, rapidly developing possibilities of medical science and

technology and their potential power to intervene in matters of life and death.

While not all of these developments will impinge on constitutional principles many of

them involve issues that may face America in

the 21st century. This chapter looks at some

of the most important impending developments,

and the possible constitutional implications of

their use.

ADVANCES IN MEDICAL TECHNOLOGIES

Rapid advancement in information sciences,

materials sciences, and molecular biology mean

that new technologies will be developed over

the next 5 to 20 years in the areas of medical

communications and record-keeping, imaging

of body structures, surgical techniques, prosthetics, organ and tissue implants and transplants, pharmaceuticals and family planning

assists.

Computers and Communications

Knowledge about health care has proliferated because of better monitoring of bodily systems and the environment. Computers have

greatly improved the collection, measurement

and analysis of statistics on disease occurrence,

outcomes of treatment, and research results.

This knowledge has changed the direction of

research and development.

89
90

Reporting surgical results was common practice as far back as the 16th century,2 but until recent decades other treatment outcome

measures were largely limited to indicators of

patient satisfaction, postoperative infection

rates and numbers of malpractice suits. Computers have encouraged expansion of data

about results of therapy, and thus assessment

of the effectiveness of treatments.3 New disease trends now may become evident much

quicker, an important factor in public health

programs.

Computers enhance the efficiency of laboratory research by saving labor costs in processing, storing and analyzing diagnostic tests

results. Expert systems are used to help in

diagnosis and in designing therapies. Computers analyze and model bodily systems and

processes such as skin blood flow, to determine

the best locus for amputations.4 With computers, scientists simulate the immune system

and thus search for the basic principles governing complex systems. This in turn can lead to

future medical breakthroughs.

Outside the laboratory, computers can by

integrating medical and financial data, allow

cost-benefit analysis of various treatment possibilities to develop models for more efficient

allocation of health care resources. Computers

are also an essential component in nearly all

new medical instruments. Older sensors could

aid the physician in perceiving conditions

within the body, but today’s enhanced medical sensors can also measure, correlate, analyze and store information. Computers are also

used to design instruments, analyze equipment

failure, and repair equipment.5 In scanners

such as the CAT (computer-aided tomography),

‘Richard Cales and Donald Trunkey, “Preventable Trauma

Deaths,” JAMAU, vol. 254, No. 8, Aug. 23-30,2985, p. 1062.

3Clement Bezold, “Health Trends and Scenarios, ” in Jack A.

Meyer and Marion Ein Lewin (eds.), Changing the Future of

Health Care (Washington, DC: American Enterprise Institute

for Public Policy Research, 1987), p. 84.

.4 Veterms’ Administration, Rehabih”tation R&D Progress

Reports (Washington, DC: Veterans Administration Medical

Center, 1986), p. 11.

5Murray Eden, “Smart Instruments, Microprocessors, and

Personal Computers, ” International Journal of Technology

Assessment in Health Care, vol. 3, 1987, pp. 327-330.

the computer provides valuable information,

but in two dimensional form which is easily

interpreted by radiologists but less appropriate for surgeons. Computer graphics, however,

can create three dimensional images that are

more easily usable for appreciating special relationships and rectilinear measurements.6

Telecommunications technologies may in the

future facilitate the delivery of health care to

rural and remote areas difficult to service with

health professionals. Information, imaging,

and patient monitoring systems can integrate

remote areas with regional hospitals.7

Beyond these new or developing uses of computers, there may be new kinds of computers

for medical use. Bio-computers made of proteins and other molecules may someday be developed. These minute, fast machines would

be invaluable in medical research and medical

care. The technical bases for such biocomputers already exist or are being developed by

molecular biologists, physicists, and computer

scientists. 8

Imaging Technologies

Imaging technologies can analyze bodily tissue and body chemistry, monitor bodily functions and diagnose disease. Computerized axial tomography (CAT) scanners and position

emission technology (PET) have already produced more knowledge of normal and pathological functions than could have been imagined a few years ago. PET can scan the brain

without invasive surgery, reveal biochemical

reactions taking place, show the response of

6Michael w. Vmnler ad Jeffrey L. Mush, “3D 1ma@g

Aids Skull Surgeons, ” Computer Graphics World, vol. 8, December 1985, pp. 49-50, 52-55.

‘Chris Higgins, Earl Dunn, and David Conrath, “Telemedicine: An Historical Perspective, ” Tehxommunicatiom Pohky,

vol. 9, December 1984, pp. 307-313. In the early 1900s heart

tracings were successfully sent via telegraph lines by Einthoven,

the developer of the electrocardiogram, for analysis at a far-off

laboratory site. Various combinations of television and telephone

systems have successfully provided service to Indian reservations, jails, and remote areas of Alaska. Their use has generally

been constrained because of high costs rather than technical

inadequacy.

‘Michael Conrad, “The Lure of Molecular Computing, ”

IEEE Spectrum, October 1986, pp. 55-60.
91

a tumor to drug treatment, evaluate changes

due to stroke, and observe the lesions causing

Parkinson’s disease, Alzheimer’s disease, and

perhaps schizophrenia. Magnetic resonance imaging (M RI) reveals not only bodily structures

but even chemical processes within individual

cells. It can measure blood-flow rates from specific locations in the brain (to predict possible

strokes), and drugs such as antidepressants

could be labeled with MRI-sensitive compounds and traced within the brain.9 In the

future, this capability will supplement, and

could even replace in some situations, more

subjective modes of diagnosis of mental illness.

This could introduce into the constitutional debate new arguments regarding responsibility

for behavior.

The increased knowledge about health raises

the long range possibility of conflicts over response to that knowledge. For example, imaging equipment shows clearly the arterial

plaque build-up often responsible for heart attacks, much of which, scientists believe, might

be avoided by appropriate diet. This has led

to development of plaque-dissolving drugs for

cleaning out arteries and ridding kidneys of

stones. But not all problems revealed by new

medical technologies can be resolved by still

more new technologies. In that case, social controls are sometimes proposed. Some people argue, for example, that those who eat irresponsibly (thus filling their arteries with plaque)

are costing society too much in terms of heath

care and thus should perhaps be discouraged

from doing so, perhaps by higher health insurance premiums.

Surgery, Prothesis, and

Trauma Repair

Trends in surgical practice point to continued development of less invasive and destructive surgery. This is illustrated by balloon

angioplasty, the use of stereotaxic headpieces

in brain surgery, the use of lasers rather than

scalpels in many areas of surgery, and microsurgery. Surgical instruments made with fibergLawrence G~ton, Med Tech (New york, Ny: ‘~er &

ROW, 1985), PP. 286-303.

optics permit looking directly into internal

structures of the body; combining lasers and

fiberoptic allows more sophisticated repair

and less destructive removal of diseased tissues, and more sophisticated neurological procedures. New microsurgery techniques together

with immunological advances may eventually

allow the restitching of severed nerves or spinal cords.10

These procedures and instruments make surgery safer, less traumatic and less fearsome

to the patient, and more effective. More surgery can now be done on an outpatient basis.

The added safety may mean that more surgery

will be done in the future, and more radical procedures will be attempted. This may well aggravate current debate about when physicians

should and should not intervene to prolong life,

and about who has the right to refuse such interventions for themselves or for others. The

development of fetal surgery to correct abnormalities before birth is, for example, already

raising constitutional issues.

Some scientists suggest the possibility of

limb regeneration and of synthesis of organic

tissues.11 In the meantime, models created

from computer scans aid in the design and production of prosthetics. Research engineers

hope someday to develop cybernetic devices—

building on advances in robotics, artificial intelligence and sensing systems—that will permit paraplegics to walk, blind people to see,

and deaf people to hear. This could include electronically assisted and controlled artificial

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.

The stereotaxic headpiece is a metal framework surrounding

the patient’s head to allow precise, minimal invasion of the brain

for biopsy, removal of tumors, and so on. Laser surgery, using

a cutting and cauterizing ray rather than a blade, minimizes

bleeding and swelling, allows spot-welding of detached retinas,

and reduces incidental injuries to healthy tissue. Microsurgeons

use high-powered microscopes, extremely thin needles, and

miniaturized instruments to reattach nerves and veins, reconstruct the middle ear, reroute arteries, and perform other extremely delicate repairs, even in some cases on fetuses in the

womb. Henry C. Adler et al,, Md”trends (Chicago, IL: The Hospital Research & Educational Trust, 1986), p. 26.

I I Replacement skin from human cadavers has been successfully transplanted to a burn victim with the aid of the antirejection drug, cyclosporine. See “Harvesting New Skin, ” Science 86, vol. 7, April 1986, p. 9.

88-376 0 - 88 - 4
92

limbs or limb supports, arms and hands that

move in response to neural impulses, hand-held

human-like voice synthesizers, and TV cameras

implanted in eyes. Computerized electromyographic (EMG) feedback is being studied for

the purpose of restoring function in persons

with long-term spinal cord injury .12

A new class of materials, bio-ceramics, shows

great promise in prostheses. Bone will grow

into and unite with one class of ceramics for

firm fixation of teeth and artificial joints to

the surrounding tissues, an innovation that

promises new opportunities for patient rehabilitation. 13

Further medical technologies being developed for the care of traumas include:

● Artificial blood for use in treatment of

chronic blood disorders and emergency

treatment for traumas, particularly desirable to prevent transmission of diseases

such as AIDS and hepatitis, is currently

at the stage of basic research, although

many problems are still unsolved.

• Dry curing of burns to eliminate serious

infection is undergoing human experimentation.

. Artificial skin and drugs to control rejection are being perfected.

• Phototherapy or light treatment for a variety of health problems including psoriasis, sleeping disorders and apneas, radiation-related diseases, etc., is now at the

basic research stage.

● A diapulse device for promoting healing

of damaged nerves and spinal injuries is

at the stage of animal experimentation.

. Treatment of damaged spinal cord nerves

through bombardment of cells with electrically charged silver ions is being studied by scientists.

‘2Veterans’ Administration, Rehabih”tation R&D Progress

Reports (Washington, DC: Veterans’ Adrninistration Medical

Center, 1986), p. 11, p. 66.

13John W. Boretos, “Bioceramics,” Cfiemtech, vol. 17, ApriI

1987, p. 224.

Transplants and Implants

The transplantation of hearts and kidneys

is no longer considered experimental, although

still risky and severely limited by the scarcity

of donors. Transplants of livers are still experimental. The use of artificial organs, such as

the artificial heart, is also highly experimental

and at present beset with serious and seemingly intractable problems. Yet a number of

trends are working together to increase the feasibility of organ replacement with either real

or artificial organs:

●

●

●

●

●

●

gradual improvement in surgical techniques and in preservation of organs and

tissues;

developments in pharmacology, and especially in immunosuppressive, anti-rejection therapy;

rapid advances in materials technology,

including submolecular and surface engineering;

development of sensors that can send feedback to control movement of muscles;

development of miniature nuclear power

packs; and

computerized registry and matching of potential organ donors and recipients.

Implantation of either human organs or artificial organs may become more practical by the

end of the century. Cryogenic techniques could

be developed for preserving organs for later

use; or organ incubators with computerized

chemical baths and solutions may allow organs

to be preserved for months.14 pancreatic cells

have been frozen, thawed, and grafted onto the

kidneys of diabetic rats where they produced

insulin; scientists will attempt to develop this

technique for use in humans.15

Transplants of neural-type tissue from a

Parkinson’s patient’s adrenal medulla to his

brain have been performed in Sweden and Mexico, and brain tissue transplants using fetal

brain tissue to assist patients with Parkinson’s

IdArthur C. C]mke, July 20, 2019, (New York, NY: MacMillan Publishing Co., 1986), p. 238.

15 Shawna Vogel, “Cold Storage, ” Discover, February 1988,

pp. 52-54.
93

disease have been done in Mexico and elsewhere.” As discussed in chapter 4, this procedure has been discouraged in the United

States because of some ethical concerns. Further development of these medical procedures

and techniques outside of the United States

is likely to stimulatec hallenges to Federal and

State regulation or prohibition.

Implants of microchips and biochips may in

the future allow better monitoring of bodily

functions, regulate drug delivery devices, enhance defective sight or hearing, and provide

neural control of damaged limbs. Some scientists hope that eventually “biological machines” could be implanted to repair human

tissue and organs.

Advances in biological and non-biological

materials and in microelectronics hold the

promise of significant advances in related technologies, such as the following:

●

●

●

●

●

●

programmable implantable medication

systems including infusion pumps, for use

in treatment of such problems as diabetes

and cardiovascular disease; some are now

in clinical trials;

implanted electrodes and brain peptide

releasers, for treatment of depression, propensity to aggression, and other emotional

disorders;

implanted electronic hearing aids;

cerebella pacemakers for control of

epilepsy, chronic pain, schizophrenia, and

violent behavior;

automatic defibrillator for assisting

damaged hearts; and

artificial visual implants or assists and image enhancers for the visually impaired.

Pharmaceuticals

Breakthroughs in pharmaceutical products

and delivery systems promise radically different medical treatments for many illnesses.

Drugs are being developed that act closer to

the disease site and are specific to the damaging side effects of older untargeted treatments.

IG’’Brain Graft Revives Sufferer From Parkinson’s Disease, ”

New Scientist, Jan. 14, 1988, p. 28.

Entirely new types of therapeutic agents are

being developed, some both more potent and

more natural to the body than conventional

pharmaceuticals. 17 Some possibilities are:

●

●

●

●

Immunomodulators-These maintain proper functioning of the immune system,

without the problems associated with current cell-killing drugs. New treatments

would involve the use of natural substances such as interferon, to modif y specific functions in the body. These immunomodulators will be used, first, as therapy

for immune deficiency diseases and to suppress the immune system for grafting and

transplanting organs, then to enhance the

natural killer cells to attack new cancers

and other diseases.

Neurotransmitters-Scientists are becoming more familiar with the activities of

these materials and new and more effective treatments should follow for Parkinson’s disease, Alzheimer’s disease,

amyotrophic lateral sclerosis (ALS), Huntington’s disease and mental diseases

caused by neurotransmitter deficiencies.

Some pharmaceuticals to enhance or prolong memory are already being tested.

Neurotrophic hormones–It is hoped that

neurotrophic hormones may stimulate

growth in dying nerve cells that produce

the transmitters. Research to identify neurotrophic hormones will probably be followed by large-scale synthesis and treatment. Drugs capable of penetrating the

blood-brain barrier could treat loss of function in the neocortex due to severe head

injury.

Mood-altering drugs—These drugs have

been found to exist naturally in the body

as a class of compounds made up of endorphins and enkephalins. Many functions

have been attributed to these materials

including acting as a pain-blocking analgesia, tranquilizer, and antidepressant. Opiate blockers can be used to modify such

behaviors as overeating and aberrant sex

ITWilliam Check, “New Drugs and Drug Delivery Systems

in the Year 2000, ” American l%armac~~, ~f)l. NS24, No. 9, September 1984.
94

●

●

●

drives. These substances, being natural

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,

catalyzing chemical reactions and opening up the possibility of unlimited diversity in specific-acting enzymes. *8

Prostaglandins-A natural substance in

the body, synthesized prostaglandins can

be used as anticlotting agents useful in

heart bypass surgery, prevention of heart

attacks through clot prevention, and

treatment of asthma, ulcers and inflammation.

Vaccines—Synthetic vaccines that confer

multiple protection could be used for influenzas. Viruses that cause cold sores,

genital herpes, chicken pox, etc., could be

attacked with new vaccines.

New delivery systems may have nearly as

momentous effects on medical care as new

pharmaceuticals themselves do. Especially important will be the controlled release of drugs

at dosages and times that are needed. New materials used for coating will release drugs at

a constant rate through degradation, permeable membranes and electric charges. Magnetic

systems can be used for pulse-released drugs

such as immunosuppressants for transplant

patients and implanted pumps will deliver precise dosages for treatment of cancer and for

delivery of insulin. (See figure 6-l.) Dosages

l~sW Ch. 3 for a more detailed description.

Figure 6.1 .—Portable Infusion Pump

Infusion pump is worn continuously and delivers gonadotropin releasing hormone intermittently either subcutaneously or intravenously.

SOURCE” Ferring Laboratories, Inc., Suffern, NY, 1988.

can be altered with time and, as equipment becomes smaller and simpler, can be used by patients to provide their own chemotherapy at

home. Another form of delivery system will

be sprays.

Reproduction Technologies

For those wishing to have children, the possibilities of technological help have recently

been greatly increased. These new assists are

not always successful, and many carry significant risks and high costs. They include fertility drugs; artificial insemination using the semen of the husband, a selected partner, or an

unknown donor; and in-vitro fertilization using

either both parents’ germ cells or donated eggs

and/or semen, with implantation in the uterus

of either the biological mother or a surrogate

mother. Sperm freezing techniques permit an

increase in the number of donors and theoretically make possible the selection of specific

genetic characteristics for the babies. Frozen

embryos have increased the ease and success

rate of in-vitro fertilization and implantation,

but raised ethical issues regarding the use of

“excess” or left-over embryos.
95

For those wishing to curtail production of

a family, technologies will also provide choices:

injectable contraceptives, a contraceptive vaccine, intrauterine devices for preventing embryo implantation; and non-surgical sterilization.

These “technologies at the beginning of life”

promise to raise a number of serious constitutional issues, which are discussed in later sections of this chapter.

Science fiction abounds with stories about

chimeras and clones. Chimeras are animals

with the genes—and characteristics-of two

or more species; in Greek mythology the chimera was a beast that had the head of a lion,

the body of a goat and the tail of a serpent.

Clones are animals genetically identical to a

parent, i.e., reproduced asexually, or to a sibling (when an early stage embryo is divided

and reimplanted). These have until recently

been considered in the class of fairy tales. But

large animals such as valuable cattle are now

produced in multiple identical copies by removing a fertilized egg after two cell divisions,

dividing it and allowing each fragment to begin cell reproduction again, and implanting

each new embryo in the womb of a less valuable brood cow. Chimeras have been developed

by placing foreign genes in animals as complex as mice. A series of experiments have

produced healthy chimeric mice by implanting in the uterus of a mouse, differentiated cells

found in tumors. The interesting issue here is

that what were thought to be undifferentiated

cells in a tumor, actually contained a variety

of tissues-tooth, bone, gland, etc.—from which

could be grown an entire animal.19

It now appears unlikely that human clones

or chimeras will be developed, although the

barriers are in the long-run apt to be ethical

and political rather than technical. The evolution of this capability could nevertheless result in production of body tissues, or new body

parts, and at least in theory could allow unisex pregnancy and childbearing, even by

males.

19KW] ]llrnensee and Leroy C. Stevens, ‘‘Teratomas and

Chimeras, ” Scientific American, vol. 240, April 1979, pp.

120-132.

TRENDS SHAPING THE FUTURE OF MEDICAL TECHNOLOGY

Important trends that are emerging in regard to new and future medical technologies

are:

1.

2.

3.

4.

an explosive increase in knowledge about

the biology of disease, the environment,

bodily functions and new treatments;

earlier diagnosis and treatment, increasingly moving beyond control of symptoms to interventions that will prevent

symptoms;

an ever larger attention to the costs of

health care in choices of treatment and in

development of new technologies; resulting in an important role for technology

assessment;

growing capability to maintain basic

bodily functions technologically, when

neurological control is degraded or almost

entirely absent;

5.

6.

a proliferation of techniques to assist, control, or avoid reproduction; and

growing ability to evaluate, diagnose, and

give medical or surgical treatment to the

fetus in the womb.

Some of these themes, and particularly the last

three listed above, promise to raise complex

ethical, political, legal, and constitutional

issues.

Earlier and More Effective Diagnosis,

Intervention, and Prevention

Intervention in the disease process can vary

from consumer education on diet and lifestyles,

to genetic engineering and drug therapy. The

shift from controlling symptoms to more positive intervention is the result of a circular interaction between new scientific knowledge,

88-376 0 - 88 - 5
96

new instruments, and treatment-enabling technologies that in turn produce further knowledge. Earlier diagnosis and prevention of disease are of particular importance in approaches

to chronic illnesses, which constitute the major illness burden in industrialized nations.

They will, however, also affect acute illnesses

in which genetic, behavioral and environmental

factors can be identified.

Prevention of disease itself carries a potential for clashes between the general welfare and

the assertion of individual rights, as illustrated

by AIDS containment and crusades against

tobacco use. As knowledge of disease-causing

behavior, aversion to risk, and the incentive

to control health care costs all grow, some people are arguing that freedom to indulge in unhealthy behavior should be curtailed. This issue was introduced in chapter 5 as raised by

public health programs.

Self-Care

New technologies, while causing some of this

rapid increase in costs, also enable more people to take care of themselves when ill, thus

potentially reducing health care costs. Homebased computers linked with diagnostic-treatment centers or implanted microchips for sensing body conditions and for release of drugs,

could for example make possible self-administered chemotherapy treatment of cancer. Intravenous physical and respiratory therapy

and monitoring of chronic disease could take

place in the home.

A strong trend toward self-diagnosis, selfcare, and home-care techniques has been evident for some time. Pregnancy test kits, kits

for testing or measuring urine sugar content,

and consumer instruments for monitoring

blood pressure have already become familiar.

Further home diagnostic tests are being developed. Implantable time-released medication

is already in use for some conditions. Some experts anticipate the development of “hospitals

on the wrist, ” i.e., wearable devices that monitor certain body functions and make chemotherapeutic and electromagnetic adjustments

as necessary. Potentially, this might include

administering mood-altering or behavior-controlling medication.

Public policy problems with the trend toward

self care include the cost, which is not currently

reimbursed by medical insurance providers,

the question of the reliability of tests and the

expertise needed for their use, and concern

about the provision of home care for those who

are unable to care for themselves adequately.

These problems do not appear to imply any

constitutional issues.

The Growing Importance of Health

Care Costs

The cost of medical care is an important ingredient in a discussion of health care technologies and their constitutional implications.

Health care in 1985 accounted for 11.2 percent

of gross national product, up from 5.9 percent

in 1965. Health cost increases far outstrip inflation and although they have lessened, they

still outpace price increases of other goods and

services. This growth is expected to continue,

reaching 15 percent of GNP by the turn of the

century.’” In 1985 and 1986 the growth in the

number of surgical procedures performed,

which had flattened since 1981, resumed.

The health care system is being reshaped as

joint ventures proliferate between hospitals,

physicians and other investors; the role of market forces becomes more important in technology choices; and consumers and payers of

health care demand more say in the process.21

As costs become a major factor in health care,

medical decisions are no longer the sole prerogative of physicians.

While some technologies such as expert systems and diagnostic testing kits can potentially decrease health care costs, others such

as imaging machines and transplants are likely

to remain very expensive. Technology has been

called both the culprit in raising medical costs,

zOD~iel R. Waldo et al., “National Health Expenditures,

1985, ” Health Care Financing Review, Fall 1986, vol. 8, No.

1, pp. 1-21. Also see “National Health Expenditures, 1986-2000, ”

Health Care Financing Review, vol. 8, No. 4. Figures for 1987

obtained by telephone from Daniel Waldo, February 1988. zl~editrends, footnote 10, P. vii.
97

and the benefactor that is improving health

and life expectancy .22 Even when new, less

costly technologies are developed, the rate of

use often increases, offsetting potential savings. And increased knowledge regarding

health hazards in the environment is likely to

increase the demand for health care, including

research and product development. How the

change in hospitals from an altruistically oriented local industry to a for-profit national

chain industry affects health care costs is not

ZZLoui~ p, Gmrison, Jrc, and Gail R. Wilansky, “cost Containment and Incentives for Technology, ” Health Affw”rs, vol.

5, Summer 1986, pp. 46-58.

EXTREME

yet clear, but this could become an important

issue in the future.

While this report cannot explore in depth the

issue of medical costs, governmental policy

toward medical advances that provides some

with great benefits, at high cost to others than

the beneficiaries, is part of the general constitutional discussion on equality of access and of

the alleged right to treatment.23

23 F or a discussion of the economies of the distributional issues and the criterion of social welfare, see John H. Doggeeris,

“Medical Insurance, Technological Change, and Welfare, 13conomic Inquiry, vol. XXII, January 1984, pp. 56-67.

MEDICAL INTERVENTIONS AND THE EXPANDING

LIMITS OF PERSONAL CHOICE24

Some of the major “medical miracles” recently unveiled or now on the horizon so fundamentally challenge our assumptions about

human limitations that they may change our

view of the proper relationship between the

State and the individual, or of personal liberty

and responsibility.

Taking the heart from a person whose circulation and respiration could be maintained

only with a mechanical ventilator, and transplanting the heart into another person, directly

challenged laws that conventionally determined death as the time when one’s heart

stopped beating. A strict application of this

legal definition would make a human heart

transplant a double homicide, in spite of the

fact that its purpose is to save life. This technological innovation helped to force us to reach

a new definition of death—the death of the

brain.

wMuch of the materi~ in this section is based on contractor

reports: “Constitutional Issues in Extreme Medical Measures

at the Beginning and End of Life, ” prepared for OTA by George J. Anus, J. D., M. P. H., Utley Professor of Health Law, Boston University Schools of Medicine and Public Health, and “Constitutional Implications of Scientific and Technological

Advances in Public Health, prepared for OTA by Dr. Leonard

H. Glantz, Professor of Health Law, Boston University Schools

of Medicine and Public Health, April 1987.

A person who is dead ceases to have constitutional rights. Thus before the redefinition of

death, a person on a mechanical ventilator,

even if “brain dead, ” was a person and retained

all of the rights of a person under the Constitution; after the redefinition, the person in identical circumstances was a corpse with no

rights, and could be used as a source of donor

organs with or without his or her intent prior

to death. This redefining of death was brought

about primarily by three technologies: the electroencephalogram, which permitted physicians

to confirm the absence of brain activity or functioning; mechanical ventilation, which maintained circulation until vital organs could be

“harvested”; and immunosuppression drugs,

which help control rejection and made organ

transplantation workable.25

The law permitted physicians to develop this

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,

provided that the doctor make this pronouncement on the basis of “good and accepted med-

‘

5 President’s Commission for the Study of Ethical Problems

in Medicine and Biomedical and Behavioral Research, Defining Death (Washington, DC: U.S. Government Printing Office,

1981). G.J. Anus, “Defining Death: There Ought To Be A Law,

Hastings Center Report, vol. 13, No. 1, 1983, pp. 20-21.
98

ical standards. ”26 Some people have objected

to having this standard developed by the medical profession because they object to giving

physicians the first opportunity at defining the

implications of new medical technology for

basic rights.

The adoption of brain death as an acceptable criteria for human death raises further

questions: Is brain functioning a necessary or

appropriate criteria for life, or for personhood,

or for rights? Do those who are born without

functioning brains, e.g., anencephalic neonates,27 have any rights?28 What about those

who are permanently comatose? If science can

develop a test that confirms the irreversible

loss of all higher brain functions, (neocortical),

could brain death be expanded to include this

category as well?29

Most medical technologies will not so radically alter the rights of individuals in this “all

or none” fashion. But many of them have potentially profound impacts on the definition

or application of critical constitutional rights

because they affect life, death, procreation and

privacy. For example, evolving technical capabilities to assist and support reproduction

give rise to questions about the individual

rights of the mother and the interest of the

State in the welfare of the potential or developing fetus.

The development of the judicial concept of

privacy was described in chapter 2. To recapitulate, the Supreme Court has concluded that

the rights specifically protected in the Bill of

Rights and buttressed by the Fourteenth

Amendment delineate a penumbra of privacy,

or a sphere of autonomy and confidentiality,

on which government should intrude only when

impelled by an important and pressing interest of State.

2GG.J. Anus, L.H. Glantz, B.K. and Katz, The Rights of Doctors, Nurses, and Allied Health Professionals (New York, NY:

Avon Publishing Co., 1981).

27A newborn infant with an incomplete and non-functioning

brain.

2gA. M. Capron, “Anencephalic Doners: Separate the Dead

From the Dying, Hastings Center Report, vol. 17, No. 1, 1987,

pp. 5-9.

29R. Veatch, Death, Dying and the Biolo~”cai Revolution

(New Haven, CT: Yale University Press, 1976).

The concept of constitutional privacy has

been applied most directly to individual decisions about reproduction. The old deference to

the State interest was indicated in chapter 4

and again in chapter 5 by reference to the case

of Buck v. Bell, in 1926,30 which upheld the

constitutionality of a State’s involuntary sterilization statute. Justice Holmes said: “The principle that sustains compulsory vaccination is

broad enough to sustain cutting the Fallopian

tubes. . . .“ But in a very similar case in 1942,

the Court specifically affirmed that marriage

and procreation were fundamental rights, essential “to the very existence and survival of

the race. ”

Griswold v. Connecticut,31 in 1965, was

however the real landmark case in this area.

A State statute made it illegal for “any person” to “use any drug, medicinal article or instrument for the purpose of preventing conception. . . .“ The statute also made it a crime to

“assist, abet, or counsel” any person in committing this illegal act. A Planned Parenthood

counselor and a physician gave advice on birth

control to a married couple and prescribed a

contraceptive device for the wife; they were

then arrested and convicted.

The Supreme Court, in overturning the State

statute, said, “We do not sit as a super-legislature to determine the wisdom, need, and propriety of laws. . . .“ But it also said that taken

as a whole, the Bill of Rights creates penumbral rights of “privacy and repose, ” in other

words, a sphere of personal choice in which government has no business.

The Court was recognizing that modern science and technology-in this case, biological

science and contraceptive technology-create

new choices for people in their personal lives,

and that government would at times attempt

to regulate or negate those choices by controlling (or banning) the use of the technology,

especially if this seemed essential for the general welfare. The Court said:

The present case, then, concerns a relationship lying within the zone of privacy created

30~uc~ v. Bell, Z’j’Zf U.S. 200 (1926).

31381 u-s. 479 (1965).
99

by several fundamental Constitutional guarantees. . . .Would we allow the police to search

the sacred precincts of marital bedrooms for

telltale signs of the use of contraceptives? The

very idea is repulsive to the notions of privacy

surrounding the marriage relationships.

Three Justices concurred that the right of

marital privacy is a “fundamental and basic”

personal right but gave as the source of that

right the Ninth Amendment.32 Seven years

later the Court extended the right of “reproductive privacy” to unmarried persons.33 The

Court said in that case:

If the right of privacy means anything, it

is the right of the individual, married or single, to be free from unwanted governmental

intrusion into matters so fundamentally affecting the person as the decision whether to bear

or beget a child.

The decision specifically rejected arguments

that the State was attempting to regulate potentially harmful articles, because as between

married and unmarried people “the evil, as perceived by the State, would be identical. ” This

indicated that the Court will closely scrutinize

State interference into areas of life which are

considered “private.”

The Court has been strongly influenced in

cases involving contraception and abortion by

advances in medical technology. Improvements in medical technology have allowed individuals safer and more effective control over

reproduction, and at the same time have tended

to undercut the State interest so far as that

interest was traditionally based on the safety

of the mother.

3ZIn Justice white’s concurring opinion it is noted that the

State claimed to ban the use of contraceptives in order to discourage all forms of illicit sexual relations, premarital and extramarital. Because he could find no rational relationship between the use of contraceptives by married couples and the

legitimate policy of discouraging illicit sexual activity, Justice

White found that the law violated the Fourteenth Amendment

right to liberty.

‘3Eisenstadt v. 13~”rd, 405 U.S. 438 (1972). The statute at issue authorized prescription of contraceptives for married persons, made it illegal to prescribe or sell contraceptives to unmarried persons, but permitted both married and unmarried

persons to obtain contraceptives if the purpose was to prevent

disease rather than to prevent pregnancy.

This was made clear by the abortion decisions, Roe v. Wade and Doe v. Bolton34 both

in 1973. The first involved a statute making

it illegal for a physician to perform an abortion even if a woman’s life was endangered by

pregnancy. The Court recognized that the right

of privacy is “broad enough to encompass a

woman’s decision whether or not to terminate

her pregnancy.” This right, while not absolute,

is “fundamental” and may be infringed only

if there is a compelling State interest.

The State claimed two such interests: preserving the life of unborn children and protecting maternal health. The Court rejected the

latter interest because with new medical technology, abortion during at least the first trimester carries less risk to the mother than

childbirth. After the first trimester, the Court

said, the State could “regulate the abortion

procedure to the extent that the regulation reasonably related to the preservation and protection of maternal health, ” but could not prohibit abortion. At the point of fetal viability

(when the “fetus could live outside the

mother’s womb, albeit with artificial aid”) the

State could prohibit abortion because its interest in the potential life becomes compelling.

Even then, the State could not prohibit abortion when it was necessary to preserve the life

or health of the mother.

The second of the two 1973 abortion cases

concerned State requirements that all abortions take place in hospitals accredited by the

Joint Commission on Accreditation of Hospitals. The Court could have chosen to apply a

“minimum rationality” criteria and accepted

the State’s authority to regulate in the interest of public health. Instead it recognized persuasive data about the technology, indicating

that facilities other than hospitals could safely

perform abortions. It found that the State was

attempting to regulate abortions during the

first trimester of pregnancy contrary to the

earlier Roe decision.

Since 1973 the Court has heard a number

of cases involving restrictive abortion statutes,

34RN V:wade, 410 U.S. 113 (1973) and ~Oe v. Bo~ton, 410

Us. 179 (1973).
100

scrutinizing them closely for potential infringement on the right of privacy. Some of these

decisions involved points related to the safety

of advanced technology .35 A recent case indicated that the Court will look closely not only

the legislature’s rationale for legislation but

also at the motive in passing it.36

These decisions illustrate the relationship between new technological capabilities and pressure for reexamination of constitutional provisions. New abortion methods—safer to the

mother and less costly than old methods—

increased the demand for abortion and at the

same time undercut one rationale for the

State’s interest in prohibiting it, i.e., the safety

of the mother, by making early abortion statistically safer than childbirth. (Continuing political support for prohibition of abortion indicates that this rationale was not the only,

or perhaps even a primary, reason for the

State’s position.) With medical technology now

moving back the point of fetal viability, it may

again encourage or at least support reexamination of the Court’s position, for example,

by eventually challenging the assumption that

the second-trimester fetus could not survive.

Indeed, “artificial wombs” could someday

make it possible for all or most of gestation

to take place outside of a mother’s body. On

the other hand, and probably sooner, progress

in medical technology could make second- and

third-trimester abortions as safe or safer for

the mother as either natural childbirth or

cesareans. In the long run, therefore, any defiSsp]anned p~enth~ of Missouri v. Dan forth, 428 U.S. 52:

A State prohibition of the use of saline amniocentesis for abortion after the first semester, based on the argument that alternative methods such as prostaglandin instillation were safer,

was struck down because saline amniocentesis was an acceptable procedure, the alternatives were less readily available, and

more hazardous techniques such as hysterectomy were allowed.

Thus the prohibition was “an unreasonable or arbitrary regulation designed to inhibit . . .“ abortion. Akron v. Akron Centerforlieprodzzctive Health, 462 U.S. 416,433 (1983): a statute

requiring hospitalization for all abortions after the first trimester was struck down as merely an attempt to place “a significant obstacle” in the path of those seeking abortions; the Court

recognized continuing improvement in safety of second trimester abortions.

aGThornburgh V. American College of Obstetricians and GYnecolo~”sts, 106 S. Ct. 2169 (1986). See L. Glantz, “Abortion

and the Supreme Court: Why Legislative Motive Matters, ” Am.

J. Pub. Health, vol. 76, 1986, p. 1452.

nition of the interest of the State that is

grounded on an assessment of technological

capability will be subject to challenge and reinterpretation.

The full scope of activities that the Court

will consider to fall under the rubric of the fundamental right to privacy is not yet clear. The

Court has applied it to the distribution of contraceptives, 37 to the possession of obscene

materials in one’s own home,38 and to prohibitions on interracial marriages.39 State Supreme Courts have extended this right further:

as a basis for individuals to refuse life sustaining medical care, or for their families to refuse

it on their behalf,40 to refuse antipsychotic

medications, 4] and to obtain acupuncture

treatments without State interference.42

On the other hand, the Supreme Court has

refused to strike down a law that outlawed consensual sodomy,43 saying that where no fundamental privacy right was implicated (implying that the right does not cover all forms of

sexual activity per se) the State needs only

show ‘a rational basis for the law. ” The “presumed belief of a majority of the electorate in

Georgia that homosexual sodomy is immoral

and unacceptable” provided that rational basis. Dissenters on the Court said that the issue is the right “to conduct intimate relationships in the intimacy of his or her own

home. ”44 It appears that the scope of the constitutional right to privacy as regards the body

and its reproductive functions is still being defined by the Court.

Another marital privacy issue is suggested

by the recent action of a judge of the Arizona

Superior Court in sentencing a woman to life-

“7Carey v. Population Services International, 431 U.S. 678

(1976).

3“Stanley v. Georgia, 394 U.S. 557, 564 (1969).

sgLoving v. Virginia, 338 U.S. 1, 12 (1967).

401n the case of K~en Quin]~, for example, 355 A. 2d 647

(N.J. 1976); also Superintendent of Belchertown v. Saikewicz,

373 Mass. 728 (1977).

dlRoger~ v. Okin, 390 Mass., 489).

~~Andrews v. B~]~d, 498 F. SUpp. S.D. Texas ( 1980).

~SBowers v. ~mdwic~, 106 S. Ct. 2841 (1986). The law was

so written that it applies to married and single persons, and

to both heterosexual and homosexual behavior. The challenge

was brought by a homosexual male.

44Blackmun, dissenting, 2848, 2853.
101

time probation and ordering her to maintain

birth control throughout her childbearing

years. At about the same time a judge in Indiana, sentencing a woman for the death of her

child, suggested that he would significantly

reduce the sentence if she agreed to surgical

sterilization. There were immediate indications that both of these sentences would be

appealed on the grounds that they violate the

constitutional right to privacy .45

‘

s

’’ Mother Who Deserted Her Infants Is Ordered To Stay On

Birth Control, ” New York Times, May 26, 1988. “Is Serialization the Answer: A Controversial Punishment for Abusive

Mothers, ” Newsweek, Aug. 8, 1988, p. 59.

MEDICAL INTERVENTIONS AT THE BEGINNING OF LIFE

Modifications in the mode of human reproduction have long been the stuff of science fiction. For example, in George Orwell’s 1984,46

artificial insemination by donor was mandatory, and in Aldous Huxley’s Brave New

World,47 reproduction was the exclusive domain of the State, and embryos were produced

and monitored in artificial uteruses in government-run “hatcheries. Much more recently,

Margaret Atwood in Handmaid’s Tale48 pictured a nation in which most women are sterile, but a lower caste of “handmaids” bear children for the ruling class as surrogate mothers,

“two-legged wombs. . . ambulatory chalices. ”

The Supreme Court has yet to consider

whether there are constitutional issues involved in human reproduction via the new

“noncoital” reproductive technologies that

permit reproduction without sexual intercourse.

The Supreme Court has protected the right

to use birth control outside of marriage. It has

not expressly recognized a right to bear children outside of marriage, and in the Bowers

case, the decision included a dictum to the effect that State laws against sexual activity outside of marriage were not precluded. Therefore

it is uncertain whether there is a constitutional

right to procreate, by either coital or non-coital

means (i.e., through artificial insemination

and/or in vitro fertilization), or whether such

‘

[; George Orwell, 1984 (New York, NY: Harcourt, Brace,

1949).

“Aldous Huxley, Bravae New WorM (New York, NY:

Harper & Brothers, 1946).

‘“Margaret Atwood, Handmaid Tale (Boston, MA:

Houghton-Mifflin, 1986).

right, if it exists, extends to homosexual as

well as heterosexual couples or individuals.49

Some experts, drawing analogies from court

challenges associated with sterilization, contraception, and abortion, suggest that the concept of a “right to privacy” in procreation

would be involved if government attempted

to regulate or prohibit such technologies as in

vitro fertilization (IVF) or the use of frozen embryos for implantation.50 (See figure 6-2.)

Constitutional interpretation in this area has

come to depend heavily on prevailing scientific

views and on up-to-date assessments of technological capability and safety. The sterilization cases discussed above reflect the values

of the eugenics movement of the first t wo decades of this century; after that period court

decisions reflect new knowledge about genetics

and newly available medical alternatives.

In Vitro Fertilization (IVF)

and Surrogacy

IVF was developed to assist married couples who were unable to have children because

the wives’ fallopian tubes were blocked or diseased. The IVF method bypassed diseased fallopian tubes, removing ova from the ovaries

through a surgical procedure, combining the

49U.S. Congress, Office of Technology Assessment, Infertility: Medical and Social Chojces (Washington, DC: U.S. Government Printing Office, May 1988), pp. 219-220.

“)More radical or unlikely possibilities such as cross-species

fertilization, extracorporeal gestation (embryos brought to term

in artificial wombs), or cloning might become highly controversial at the R&D stage, raising the issue of the “right to experiment” or ‘‘forbidden knowledge, as discussed in chapter 4.
102

Figure 6-2.-Multicellular Embryo

Human embryo developing in vitro before transfer to female

reproductive tract or cryopreservation.

SOURCE: L Reprinted with permission. A A. Acosta and J.E Garcia, “Extracorporeal Fertilization and Embryo Transfer,” Infertility: Diagnosis and

Management, J Alman (cd.) (New York, NY: Springer Verlag, 19S4).

ova with the husband’s sperm in a petri dish

or test tube, and after fertilization and a number of cell divisions, transferring the embryo

to the wife’s uterus for implantation.51 About

3,000 births have resulted from IVF in the

United States in the past decade. IVF, at least

as confined to married couples using their own

gametes (ova and sperm) appears to raise only

one possible constitutional issue: could a government prohibit the use of IVF?

This would presumably be based on the claim

of potential harm to the embryo. If such legislation were based on an argument that IVF

is “unnatural” and therefore “immoral” it

“G.J. Anus and S. Elias, “h Vitro Fertilization and Embryo

Transfer: MedicolegaI Aspects of a New Technique To Create

a Family, ” Family Law Quarterly, vol. 17, 1983, pp. 199-223.

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 alternative to secondary use is destruction or openended storage of the embryo, it is difficult to

see what interest the State would assert. Could

the State require the donation of excess embryos to some embryo bank to avoid destruction? Gamete donors might claim a property

right to choose whether or not the frozen embryo is donated or might object to the State

allowing their genetic offspring to be raised

by others. Should the State forbid experimentation on the “spare” embryos? Could the

gamete-producing couple object? In fact, nearly

always more than one embryo is implanted in

the womb of the potential mother, since the

failure rate is high (as is, very likely, the failure rate for “natural” implantation), and “excess” embryos are sacrificed either naturally,

by the body, or deliberately by medical intervention. The difficulty is that the more nearly

scientific artifice approaches “natural” processes, the more it takes on some of nature’s

own profligacy with potential life. These intertwined issues are likely to be brought forward
103

Figure 6-3.—Cryopreservation of Human Embryos

in Liquid Nitrogen Storage Chamber

SOURCE Martin M Qulgley Cleveland Cltnlc, Cleveland OH

in the near future and may or may not be argued as constitutional issues.

The capability of preserving the viability of

an embryo through freezing also makes it easier to transfer it to a surrogate mother for

gestation, rather than to the wife or egg donor.

In this case IVF would be used to allow a couple to avoid pregnancy altogether and yet have

a child with the genes of both.

The line of judicial precedents already described supports a married couple, or a woman,

or (probably) a heterosexual couple being protected from State interference in the decision

to beget, conceive, or bear a child. In addition

fetuses can be protected only after their viability and then only in ways that do not harm

the mother.

Use of a surrogate mother, however, introduces 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 servitude?

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

commerce; the selling of children is for example generally prohibited.

In June 1988, the governors of both Michigan and Florida were reported to have before

them for signature legislation making it a

felony to arrange a surrogate mother contract

for payment. According to news reports bills

to regulate or prohibit surrogacy have been introduced in at least 18 States.52

State-mandated record-keeping is common,

and genetic record-keeping would probably be

permissible either to document the safety of

procedures such as IVF or to protect the future interests of children in learning about their

genetic heritage. The major limitation on record-keeping in medical practice is assurance

‘zAndrew H. Malcolm, “Steps To Control Surrogate Births

Stir Debate Anew, ” New York Times, June 26, 1988, p. 1.
104

that confidentiality can be maintained.53 The

Court has permitted record-keeping and mandatory reporting of abortions and complications, but only under very close scrutiny to

ascertain that the records are for protection

of maternal health and are kept confidential.

The Court has also approved laws requiring

pathological examination of fetal tissue.

Requiring physicians to keep permanent records of sperm donors, ova donors, surrogate

mothers, etc., and the collection of this data

by the State would presumably not raise any

constitutional issue provided it were released

only to those involved, and to the child.54

Finally, there may be issues regarding the

financing of new reproductive technologies.

There have been two significant Supreme

Court decisions on the question of State funding of abortions under the Medicaid program.

In 1977, the Court concluded55 that laws providing public funding for childbirth, but not

for abortion, were not a denial of equal protection because poverty is not a “suspect” classification, like race or religion56 and because

by failing to fund abortions the State “places

no obstacles in the pregnant woman’s path to

an abortion. ” In other words, the State did not

cause the poverty that alone prevents the

woman from obtaining an abortion.

In 1980 the Court examined the constitutionality of the “Hyde Amendment, ” which restricted Federal funding of abortions.57 The

s~~The Supreme Court has concluded that d prescriptions for

controlled substances can be entered into a central state computer, provided there are strict access procedures to limit disclosure to those who need to know, for law enforcement purposes. Whalen v. Roe, 429 U.S. 589 (1977).

“J.A. Robertson, “Embryos, Families, and Procreative Liberty: The Legal Structure of the New Reproduction, ” So. Cal.

Law Rev., vol. 59, 1986, pp. 939-1041.

bs~~er v. Roe, 432 U.S. 438 (1977).

5CAs discuss~ in Ch. 2, any laws that distinguish between

people on the grounds of race or religion are given particularly

close scrutiny by the Court, and the burden is on the government to show that such classification is necessary and appropriate and not intended to be discriminatory.

sTHWri~ v. McRae, 448 U.S. 297 (1980). The Hyde Amendment is named after its congressional sponsor; the regulation

under consideration by the Court forbade the use of Federal

funds for abortion except where the life of the mother is endangered, or when the mother was the victim of rape or incest that

was properly reported to a law enforcement or public health

agency.

Court used the same reasoning as in the earlier

case, i.e., the government is not required by

the Constitution to fund any medical care, no

matter how vital such care may be; funding

is a matter for Congress or the State legislatures to decide. As discussed elsewhere, some

people argue for a different interpretation of

the Constitution, asserting a general “right to

health care,” but unless and until such a right

is recognized, the refusal to fund infertility

treatments while other medical interventions

are funded would not raise constitutional

issues.

Fetal Surgery

With the capability of antenatal (before

birth) examination, diagnosis, and treatment

of the fetus has come the possibility of viewing the fetus as “the doctor’s second patient.

The ability to intervene to treat the fetus is

at present very limited; in most cases, the only

treatment possible now when a disease or defect can be diagnosed antenatally is termination of the pregnancy. But about 50 cases of

hydrocephalis 58 have been treated in the

womb by surgical decompression, with results

that are “not encouraging. ”59 There have

been fewer cases of surgery for urinary tract

obstruction, but with somewhat better results.

Other potential uses for fetal surgery may include diaphragmatic hernia, spina bifida, gastroschisis, and allogenic bone transplants.

These procedures are now experimental, and

cannot be performed without the woman’s informed consent, which she is under no obligation to give.

But in the future it is likely to be possible

to treat the fetus for many conditions. The

procedures are likely to be perfected and to become “standard medical procedures. ” They

will, however, remain highly invasive. They

will demand the cooperation of the pregnant

woman, will involve doing things to or through

S8An abnorm~ increase in the volume of fluid within the

cranial cavity, resulting in pressure that causes atrophy of the

brain.

‘9S. Elias and G.J. Anus, Reproductive Genetics mm’ the

Law (Chicago, IL: Year Book Medical Publishers, 1987).
105

her body, and in some cases may cause her pain

or put her life or health at risk. (See figure 6-

4.) Legislators or the courts will then be asked

to deal with the competing rights of the mother

and the fetus.

There have been approximately two dozen

court-ordered “forced cesarean sections” in the

past 5 years.60 Only one of these cases, the

first, reached an appellate court level. A woman,

due to deliver her child in about 4 days, had

notified the hospital where she would be attended that she would not allow surgery because it was her religious belief that what happened to the child was the Lord’s will. The

hospital sought a court order authorizing physicians to perform a cesarean section and give

any necessary blood transfusions. At an emergency hearing, conducted in the hospital, the

examining physician testified that she had

“)V.E. B. Kolfrt, J. Gallagher, and M.T. Parsons, “CourtOrdered Obstetrical Interventions, ” New England Journal of

Medicine, vol. 316, May 7, 1987, pp. 1192-1196.

Figure 6-4.— Laparoscope in Use for Laser Surgery

complete placenta previa, an abnormal condition of the placenta, with a 99 percent certainty

that her child could not survive vaginal delivery and a 50 percent chance that she herself

would not survive. The court decided that the

unborn child merited legal protection and authorized the administration of “all medical procedures deemed necessary by the attending

physician to preserve the life of the defendant

unborn child. ” A public agency petitioned the

same court for temporary custody of the allegedly deprived child. The court granted this

petition on the basis that the State

has an interest in the life of this unborn,

living human being (and) the intrusion involved

. . . is outweighed by the duty of the state to

protect a living, unborn human being from

meeting his or her death before being given

the opportunity to live.

The State Supreme Court immediately heard

and denied the petition of the parents to stay

the order,61 with a two sentence conclusory

opinion citing Roe v. Wade.

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 safeguard 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

SOURCE Martin M Ouigley, Cleveland Cllnlc, Cleveland, OH

“Jefferson v. Griffen Spal&”ng Co. Hospital, 247 Ga. 86, S,E,

2nd 457 (1981).
106

was confirmed with internal tracings. The physician commented that the case “underscores

the limitations of continuous fetal heart monitoring as a means of predicting neonatal

outcome. ’62

All of the forced cesarean section cases relied on two earlier cases, Roe v. Wade and Raleigh Fitkin-Paul Morgan Memorial Hospital

v. Anderson, in 1964.63 The latter involved an

8-month pregnant woman whom physicians be

lieved was likely to hemorrhage severely. If

that happened, she and her unborn child would

need blood transfusions, but as a Jehovah’s

Witness, she would refuse them. The trial court

upheld her refusal and the hospital appealed

to the New Jersey Supreme Court. Although

the woman had already left the hospital, against

medical advice, the State Supreme Court determined that the unborn child was entitled

to the law’s protection and that blood transfusions could be forcibly administered to the

woman “if necessary to save her life or the life

of her child, as the physician in charge at the

time may determine. ”

This precedent is thought to be of limited

value. No transfusions were actually done as

a result of the decision. It was a one-page opinion with little analysis or discussion. In any

case the extent of bodily invasion or risk involved in a blood transfusion is less than that

involved in major abdominal surgery such as

a cesarean section. Eight years later, the same

State Supreme Court decided the case of Karen

Ann Quinlan, which extended the right to

privacy to refusal of medical treatment,64 allowing Quinlan’s respirator to be removed.

Roe v. Wade, as already discussed, said that

the State has a compelling interest in the life

of viable fetuses, but it also said that it does

not have such an interest if the “the life or

health of the mother” is endangered by carrying the child to term. These two cases do not

appear to favor the life or health of a fetus over

that of the pregnant woman.

62W A. Bowers and B. Salgestad, “Fetal v. Maternal

Rights, ” Am. J. Obstet. Gynecol, vol. 58, 1981, p. 209.

63210 A. Znd N7 (N.J. 1964).

wMatter of Qujn]~n, 355 A. 2nd 647 (N-J. 1976)”

A somewhat analogous situation occurs

when a court authorizes a‘ ‘search and seizure’

of a substance inside the body of a criminal

suspect. In a famous case65 the Supreme

Court ruled that blood tests to determine alcohol intake were reasonable, because of the

strong interest of the community in determining guilt or innocence, the inability of determining intoxication by other means, and the

very minor bodily invasion involved in drawing blood. In an earlier case, the administering of an emetic to induce vomiting in order

to extract narcotics capsules that a suspect

had swallowed, was held to violate the subject’s interest in human dignity.66 Much more

recently the Supreme Court said it was an “unreasonable search and seizure” to order surgery

to remove a bullet from an accused robber, because the state would be “taking control of. . .

(his) body” and violating his “personal privacy

and bodily integrity. ”67

A forced cesarean section is a more intrusive and dangerous surgical procedure than

bullet removal, and may be considered more

demeaning to the subject’s bodily integrity,

personal privacy, and human dignity. On the

other hand, the potential State interest in the

life of a child ready to be born is high. Other

factors that courts may consider are whether

a medical procedure is considered unusual and

risky, or routine and safe. Many legal experts

believe that surgery involving general anesthetic or physical invasion of the mother’s body

is now unlikely to be permitted.

Some ethicists argue that once a woman has

implicitly given up the right to an abortion by

carrying a fetus to near-term, she has an affirmative obligation to consent to any medical or

surgical intervention that may help the fetus.

Opponents argue that this is more a moral construct than an enforceable legal obligation.

First, there is no point in pregnancy in which

a woman formally or publicly waives the right

to an abortion, although the State is allowed

to limit the exercise of that right at some point.

65&~mer&r v. Cdjfornja, 384 U.S. 757 (1966).

GGRWhjn v. C~jfornja, 342 U.S. 165 (1952).

G’7~jnston v. Lw, 4’70 Us. (1985).
107

Secondly, the “waiver” argument would mean

that a woman has full right to elect abortion,

but if she elects childbirth she is required to

surrender basic rights to bodily integrity and

privacy. This is, arguably, an unconstitutional

penalty on the exercise of the right to bear a

child,68 and would be contrary to the State’s

presumed interest in encouraging marital procreation. It should be noted that at some time

in the future the State might not be presumed

to have an interest in encouraging procreation.

In the 1970s and even today some people have

argued that the State should actively discourage population growth.

To some extent, the interpretation of a

woman’s constitutional right to refuse medical treatment during pregnancy may in the future be technologically driven: is there a treatment that is effective in preventing or curing

a serious illness or defect, is it safe for the

mother, can it be delivered nonintrusively?

Affirmative answers may encourage courts in

the future to give greater weight to the constitutional rights of a fetus as compared to

those of the mother.

Fetal Abuse

Less invasive interventions may also require

balancing the interests of a woman with that

of her unborn child. In some ways, however,

supervision of diet, smoking, or drinkin“ g–that

is, of otherwise legal activities-although physically less invasive, could be perceived as requiring more massive infringement on privacy

or liberty than one-time surgery. Could a State

constitutionally define a new crime, “fetal

abuse, analogous to “child abuse, ” and use

it to force a pregnant woman to refrain from

taking certain actions harmful to a fetus? Or

could the State force her to take actions

thought to be good for the fetus?

Pamela Monson Stewart, because of placenta previa, was advised by her physician to

stay off her feet, avoid intercourse, refrain from

taking drugs, and seek immediate medical at-

‘SD.E. Johnsen, “The Creation of Fetal Rights: Conflicts

With Women’s Constitutional Rights to Liberty, Privacy and

Equal Protection, ” Yale L. J.. vol. 95, 1986, p. 599.

tention should she begin to hemorrhage. According to police she ignored this advice, having intercourse with her husband and taking

amphetamines after she noticed some bleeding, and not going to the hospital until many

hours later. Her son was born with massive

brain damage and died six weeks later. Criminal charges were filed under the State’s child

support statute, which includes “unborn

children. "69

The case was dismissed in early 1987 when

the trial judge determined that this statute did

not apply to her conduct. This may not indicate how similar cases might be decided. The

prosecution, for example, argued that “disobeying instructions” or “failure to follow

through on medical advice” should be grounds

for criminal action. This seems foreign to the

usual meaning of “medical advice” and would

surely change the nature of the doctor-patient

relationship.

The “fetal protection” policy enunciated by

the prosecution appears to assume that like

mother and child, mother and fetus are two

separate individuals with separate rights. But

unlike a child, the fetus is absolutely dependent on the mother’s body and cannot be

treated without invading the mother. Treating them separately before birth can only be

done by favoring one over the other where

rights conflict; and this appears to many people to treat the mother like an inert incubator

or culture medium, or like the servant of the

fetus.

Another problem is more technical. Child

support laws requiring provision of food, housing, medical attention, etc., do not require parents to provide “optimal” or ‘desirable” quality of these goods. They do not forbid taking

risks with children (e.g., having them ride in

automobiles, or ski), or even causing pain to

children (e.g., punishment). Thus fetal abuse

laws would in effect be more stringent than

child abuse laws.

Ggc~. Penal cO&, sec. 270 [West, 1986]: If a parent of a minor child willfully omits, without lawful excuse, to furnish necessary clothing, food, shelter, or medical attendance, or other

remedial case for his or her child, he or she is guilty of a misdemeanor . . .
108

MEDICAL INTERVENTIONS AT THE END OF LIFE

Various types of life-extending devices such

as kidney dialysis machines, heart-lung machines, and finally the Jarvis heart, are encouraging people to think of their organs as

potentially replaceable parts, and of death from

aging and deterioration as at least postponable. If life can be extended, should we have

the liberty to use or to refuse those extenders?

Could it ever come to be assumed that we have

a right to them, or that all have an equal right

to them?

As already noted, there is no constitutional

right to health, or to medical or health care,

in the United States.70 The President’s Commission for the Study of Ethical Problems in

Medicine 71 recognized this, but concluded

that:

Society has amoral obligation to ensure that

everyone has access to adequate care without

being subject to excessive burdens.

The Commission based this obligation on the

criticality of health to the individual’s opportunity to pursue a life plan, the necessity of

medical care to “relieve pain and suffering and

restore functioning, and prevent death, ” and

the fact that most illnesses and injuries are

beyond the control of the individual. The Commission concluded that the societal obligation

does not extend to “everything needed” but

clearly means that everyone should have access to some level of care.

It is therefore argued by many people that

the courts may, at sometime in the future, conclude that access to a basic minimum of decent health care is fundamental to the exercise of personal liberty. They point out that

while the Court has ruled that government

need not fund any medical procedures, this was

a 5-4 decision.72 A few lower court cases have

‘“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.

“President’s Commission for the Study of Ethical Problems

in Medicine and Biomedical and Behavioral Research, Securing Access to Health Care, vol. 1 (Washington, DC: U.S. Government Printing Office, 1983), pp. 22. IYHuris v. McRae, 1980.

required Medicaid financing of organ transplants.

At present, many advanced medical technologies are extremely costly. They raise serious

questions about the equity with which the Federal government does make funding allocations

to medical care, and whether this raises questions about due process and equal protection.

Use of Artificial Hearts

The human trials of artificial hearts in the

mid-1980s have constituted the most public

human experiments in history. The impacts

and issues associated with an artificial heart

were debated long before that. The National

Heart and Lung Institution convened a multidisciplinary panel to review these issues in the

early 1970s.73 The Panel noted that many of

the issues surrounding the artificial heart

“may lie in the realm of the symbolic and the

irrational, ” given the role the human heart has

always played, in speech, myth, poetry, and

religion. But 12 years later, when NIH’s most

recent panel on the artificial heart reported in

May 1985, the artificial heart tends to be seen

by doctors and by the public as not much different from the other mechanical assist systems

with which one has become familiar. The potential social issues are viewed primarily in

terms of cost-effectiveness.

The 1985 panel concluded that were the heart

fully successful, as much as $4.25 billion annually might be necessary to provide one for

every candidate whose life could be extended

by the device.74 This is more than is spent on

any other medical procedure, over twice as

much as is spent on kidney dialysis and transplantation, and half the annual budget of the

National Institutes of Medicine. Nevertheless,

the argument can certainly be made that the

TSArtifici~ Heut Assessment Panel of the National Heart

and Lung Institute, The Totally Implantable Artificial Heart,

DHEW Pub. No. (NIH) 74-191, Washington, DC, 1973.

“Using a series of assumptions, the panel arrived at a cost

per heart of approximately $150,000, and a range of 17,000 to

35,000 candidates.
109

United States could afford that cost, if high

enough priority were given to the goal.

As with other high-cost medical procedures,

the question of constitutional importance is

the following: how should artificial heart implants (on a post-experimental basis) be allocated and funded, or how could access be

rationed or limited to certain groups or individuals?

There are basically three options: universal

coverage, rationing, and no funding. This question was presented when kidney dialysis was

developed in the 1960s.75 At first, patient

selection for dialysis was made by committee;

the committee’s deliberations were described

as reflecting “the prejudices and mindless

cliches” of the white middle class.76 To avoid

having to make explicit, arbitrary “social

worth” judgments, Congress in 1972 provided

Federal funding for all kidney dialysis and

transplantation. This approach has not been

followed for heart and liver transplantation,

perhaps because the kidney program has cost

much more than originally anticipated.

There are four basic approaches to “rationing’ artificial organs (and by extension, other

extremely costly medical interventions): 1) the

market, 2) committee selection, 3) lottery, and

(4) the customary approach.

The market approach would let anyone pay

for an artificial heart out of their own funds

or private insurance. This approach seems to

put a dollar value on life; it does not put a high

value on fairness and equality. It is also open

to the objection that artificial heart technology was largely developed with public funds,

and that hospitals and medical schools that

use and teach implant procedures are heavily

subsidized with public funds. It is, nevertheless, currently constitutionally acceptable

since there is no obligation on the part of government to provide any medical care or fund

any medical program.

‘5R.A. Rettig, “The Policy Debate on Patient Care Financing for Victims of End Stage Renal Disease, ” Law and Contemporary Problems 40:196 (1976).

7fiDavid Sanders and Jesse Dukeminier, “Medical Advance

and Legal Lag: Hemodialysis and Kidney Transplantation, ”

UCLA Law Rev., vol. 15, 1968, p. 357.

If the government does however decide to

fund some artificial heart implants, but not all,

some rationing or allocation method will be necessary. The Court has in the past been reluctant to interfere with government rationing

schemes. For example, a maximum family allocation under a State Aid to Families with

Dependent Children (AFDC) program was upheld against the challenge that it discriminated

against members of large families.77 But the

Court struck down a food stamp requirement

that all members of a household be related.

Even though the Federal Government argued

that this requirement was necessary to prevent

fraud, the Court was unable to find a rational

relationship between the regulation and the

purpose of the food stamp program.78

This suggests that a rationing scheme is constitutional if based on a valid government interest, if it is for a legitimate government purpose, if it is reasonably related to that purpose,

and if it is not invidiously discriminatory.

When the necessities of life are involved, as

with food stamps, the Court may be more inclined to examine critically the relationship between the statutory purpose and the rationing scheme. An artificial heart cannot well be

considered an optional “luxury” for one who

needs it; thus one would expect any rationing

scheme the government adopts to be carefully

scrutinized.

Infant Care Review Committees are a recent

example of committee selection procedures;

they review decisions to treat or not treat

handicapped newborns. Such committees were

formed to avoid the necessity of explicitly setting out criteria for selection decisions. But

in the long run only two results are possible: 79 if a pattern develops in committee

choices, then it can be articulated and those

decision rules can be codified and used directly;

if no pattern develops, the committee is vulnerable to the charge of arbitrariness. In the

end, the committee approach may too closely

77Dandrige v. Williams, 397 U.S. 471 (1970).

‘“Department of Agriculture v. Moreno, 413 U.S. 528 (1973).

79G. Calabresi and P. Bobbitt, Tragic Choices (New York,

NY: Norton, 1978).
110

involve the State in valuing some individuals

over others. This approach also tends to undermine the concept of equality and the value

of human life.

It is not clear whether such procedures might

be successfully challenged by an unselected

candidate on the grounds of lack of due process. If the Court views committee deliberations

as like “adjudicatory hearings at which a decision is made based on the “facts’ of the candidate’s medical condition, family support

structure, past history, likely compliance with

medical directions, then it might be decided

that the candidate had certain constitutional

rights to be involved in the deliberations (perhaps to have advice of counsel, to call witnesses, etc.) since his or her life is at stake. If

the committee is making judicial-like decisions,

the Court may also require candidate participation. If the Court views the deliberations as

more like a legislative committee—setting

policies and reviewing applications to see if

they must be excluded on non-discretionary

grounds-that may meet the conditions of due

process.

Another allocation strategy is to put all candidates into a pool from which they are selected

at random up to the limits of funding for artificial hearts.80 This approach takes “equalizing” as the ultimate goal but has little else to

recommend it because it makes no allowance

for the potential for survival, quality of life,

or other relevant characteristics of the candidates. There are, however, no obvious constitutional problems with this strategy.

The traditional approach of having individual physicians select patients on the basis of

clinical suitability sloughs off public responsibility to private persons and (usually) prevents decisions from becoming openly controversial or politicized. “Clinical suitability” or

“medical criteria” often include factors that

are not strictly speaking medical, such as degree of family support for aftercare; medical

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

and Med., vol. 3, 1977, pp. 59-76.

criminal records, employment, alcoholism, etc.

There is little accountability in this approach,

but it has not yet been challenged constitutionally.

Prolongation of Bodily Functions

As already noted, the mechanical ventilator,

together with the EEG, required a new definition of death—whole brain death. (See figure

6-5.) This redefinition allowed withdrawal of

artificial “life support at the time when brain

death is already confirmed, since there is “no

legal duty to administer medical treatment after death."81 But society was presented with

anew problem: when is it acceptable to remove

life support systems from one who is not totally brain dead, if removal of the system will

likely result in death? In other words, if one

is “alive” only by virtue of the machine, is that

life? Or an artificial substitute for life?

These questions were raised compellingly in

the case of Karen Ann Quinlan. Following an

episode not completely understood but assumed to be associated with drug intake, she

stopped breathing for at least 15 minutes, after which she was resuscitated in an emergency

room. Quinlan retained some brain activity but

never regained consciousness. Her breathing

was done by a mechanical ventilator (figure

6-6), and she was diagnosed as being in a persistent vegetative state, a permanent coma in

which one has sleep-wake cycles but is unaware, so far as can be ascertained, of one’s environment or one’s existence.

Convinced that their daughter’s case was

hopeless, her parents asked that the ventilator be removed and she be allowed to die. Sympathetic but fearing criminal prosecution for

homicide, physicians insisted that the parents

obtain a court order. This was refused by a

lower court after hearing some physicians testify that removal of the ventilator (stopping

of treatment) was unethical. The State Supreme Court in a unanimous decision82 au81~n re Spring, 405 N.E.’M 115 (Mass. 1980).

~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 innose 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

mouth to keep a path for air open.

An esophageal obdurator airway consists of a cuffed

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

The Bennett 7200a is a microprocessor-controlled volume

ventilator typical of the positive pressure ventilators used in

hospitals today.

SOURCE: Puritan-Bennett Corp.

thorized the removal, on the basis of Quinlan’s

constitutional right to privacy, saying

. . . Presumably this right is broad enough to

encompass a patient’s decision to decline medical treatment under certain circumstances, in

much the same way as it is broad enough to

encompass a woman’s decision to terminate

pregnancy under certain conditions.

Only 5 years earlier the same court had ruled

that there was “no constitutional right to

die. ”83 In the Quinlan case, the Court examined in detail the question of whether the State

had any “compelling interests” in maintaining Quinlan’s life, given her (in fact, her guara3JFK ~emOnCd ~ospit~ V. Heston, 279 A2d 670 (NJ 1971).

The young woman in this case was unable to express her wishes

but was “apparently salvable to long life and vibrant health. ”

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 ensuing 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

Quinlan case in enunciating a constitutional

right to refuse treatment. Another State court

argued that honoring the right to privacy is

itself honoring the sanctity of life:

The constitutional right to privacy, as we

conceive it, is an expression of the sanctity of

individual free choice and self-determination

as fundamental constituents of life. The value

of life as so perceived is lessened not by a decision to refuse treatment, but by the failure

to allow a competent human being the right

of choice.84

Since these cases courts have ruled that the

constitutional right to privacy extends to

refusing any medical intervention, including

artificial feeding. However, other questions

could arise with such devices as the (implanted)

artificial heart. If it is seen as an assist machine like a mechanical ventilator then the person will have a right to have the machine “unplugged.” There is little doubt that this would

84Suprin~en~ent of &]c~ertOw~ V. S~”kewjCz, S’70 N*E. 2 d

417 (1977).
113

be the case with the current version of the artificial heart, which requires a pneumatically

powered device roughly the size of a dishwasher. A fully-implantable heart with a ten

year power supply could be perceived differently, perhaps more like the results of a mitral

valve replacement or a cardiac bypass

operation.

The Right To Die

As described above, the right to refuse or

terminate the use of life support systems now

seems well-established, even when it is virtually certain that death will rapidly result.

Should a “right to die” also be recognized for

those who are not machine-dependent? who are

perhaps medicine-dependent? in intractable

pain? or merely tired of dying, or even tired

of living?

Some would argue that just as one has a constitutional right of privacy in making decisions

about marriage and reproduction, one should

be able to exercise a right of privacy in deciding against further survival. There is, after all,

no other decision so intensely personal; and it

is the only situation when one in fact exercises

the choice that theoretically underlies all civil

rights and duties—that of consenting or declining to participate in organized society. Further,

it can be argued, the State has no compelling

interest in prolonging life which is already unproductive and burdensome to the individual

and the public, or in delaying a death which

is welcome, inevitable, and already imminent.

On the other side of the argument, death is

always inevitable, and a few people at any

stage of life find life unpromising and unproductive and death welcome. In other words,

to accept voluntary euthanasia, some argue,

is to open the door to recognition of a general

right to suicide. Further, medical diagnosis

may be incorrect; when medical treatment is

refused or discontinued, the patient sometimes

survives against expectations. Suicide on the

other hand is irrevocable. Some people oppose

voluntary euthanasia because it would almost

surely require direct involvement of the State

through some sort of prior judicial sanctioning. However, this has also often been the case

with termination of treatment. Moreover the

State is already directly involved in killing

through the criminal death penalty. Finally,

physicians might be required to assist or advise involuntary death, which could erode the

ethical position of the profession or the public

trust in it.

These are strong arguments on both sides.

In the long run, constitutional decisions as to

whether the scope of individual privacy and

autonomy extends to an affirmative right to

die will probably depend on both the value

placed on self-determination within the society, and the progress made by medical technology in preserving not only life, but a high

quality of life; that is, physical and mental

health. The greater the degree of control over

life or death that can be offered by science and

technology, the more certain it is that difficult

choices will be presented, and the more likely

it is that constitutional questions will be raised

by those choices.

Appendix

List of OTA Reviewers, Contractors,

Workshop Participants, and

External Reviewers

OTA Reviewers

Clyde Behney

Alta Charo

Tim Condon

Robert Cook-Deegan

Luther Val Giddings

Lisa Heinz

Roger Herdman

Gretchen Kolsrud

Claire Macklan

Katie Maslow

Larry Miike

Carol Nezzo

Robyn Nishimi

Kevin O’Connor

Mark Schaefer

Gladys White

Contractors

George J. Annas

Utley Professor of Health Law

Boston University Schools of Medicine

and Public Health

Bernard Davi s

Professor Emeritus

Harvard Medical School

John Duffy

Professor Emeritus

University of Maryland, College Park

Leonard Glantz

Associate Director

School of Public Health

Boston University

Sheila Jasanoff

Associate Professor

Program on Science, Technology and Society

Cornell University

Irene Jillson-Boostrom

President

Policy Research Inc.

June Osborn

Dea n

School of Public Health

The University of Michigan

Jonathan Peck

Associate Director

Institute for Alternative Futures

May 6th and 7th Workshop Participants

Michael Les Benedict

Golieb Visiting Research Fellow

New York University School of Law

J. Pat Browder

Clinical Assistant Professor

School of Medicine, Department of Surgery

University of North Carolina

Ira Carmen

Professor of Political Science

University of Illinois, Urbana

William Check

Medical & Scientific Communications, Inc.

Tom Christoffel

Associate Professor

School of Public Health

University of Illinois at Chicago

John Duff y

Professor

Classics Department

University of Maryland, College Park

Daniel Fox

Professor of Humanities in Medicine

State University of New York at Stony Brook

Larry Gostin

Executive Director

American Society of Law and Medicine

Howard Kay e

Assistant Professor

Department of Sociology

Franklin & Marshall College

117
118

Arthur Kohrman

Professor of Pediatrics

La Rabida Children’s Hospital

University of Chicago

Gretchen Kolsrud

Program Manager

Biological Applications Program

Office of Technology Assessment

Maeva Marcus

Resident Director

Documentary History Project

Supreme Court of the United States

Katie Maslow

Analyst

Biological Applications Program

Office of Technology Assessment

Larry Miike

Senior Associate

Health Program

Office of Technology Assessment

David Strauss

Assistant Professor

University of Chicago Law School

M. Susser

Sergievsky Professor of Epidemiology

Sergievsky Center

Columbia University

Laurence R. Tancredi

Kraft Eidman Professor of Medicine

and the Law

Director of the Health Law Program

University of Texas Health Science Center

Robert S. Wachbroit

Research Associate

Center for Philosophy and Public Policy

University of Maryland, College Park

Daniel Wilder

Professor

University of Wisconsin Medical School,

Madison

External Reviewers

Abdelmonem A. Afifi

Dean

The University of California, Los Angeles

James E. Banta

Dean

School of Public Health and Tropical Medicine

Tulane University Medical Center

Robert Bock

Dean of the Graduate School

University of Wisconsin, Madison

William F. Bridges

Dean, School of Public Health

The University of Alabama in Birmingham

J. Pat Browder

Clinical Assistant Professor

School of Medicine, Department of Surgery

University of North Carolina

Jean Chabut

Chief

Center for Health Promotion

Department of Public Health, State of

Michigan

Tom Christoffel

Associate Professor of Health Resources

Management

School of Public Health East

University of Illinois, Chicago

C.S. Chung

Professor of Public Health,

Associate Dean,

School of Public Health

University of Hawaii at Manoa

Bernard M. Dickens

Faculty of Law

University of Toronto

Rebecca Dresser

Assistant Professor

Center for Ethics, Medicine, and Public Issues

Baylor College of Medicine

Rochelle C. Dreyfus

Associate Professor of Law

School of Law

New York University

Paul T. Durbin

Philosophy Department and Center for

Science and Culture

University of Delaware

Selwyn Enzer

Associate Director

Center for Futures Research

Graduate School of Business Administration

University of Southern California

Daniel A. Farber

Law School

University of Minnesota

Peter A. Flynn

Physician
119

Mark Frankel

American Association for the Advancement of

Science

Billy E. F e

Vice Presi ent for Research and Dean of the d

Graduate School of Arts and Sciences

Emory University

Mary E. Guinan

Acting Assistant Director for Science

Centers for Disease Control

Public Health Service

Bert Hansen

Assistant Professor for History of Medicine

New York University

James T. Harrison

Deputy Director for Programs

Department of Public Health

State of Michigan

Peter Barton Hutt

Covington & Burling

Sheldon Krimsky

Associate Professor

Dean of Urban and Environmental Policy

Tufts University

Jeffrey Levi

National Gay and Lesbian Task Force

Carol Levine

Editor Hastings Center Report

Co-Director of Hastings Center Project on

AIDS and the Ethics of Public Health

Ernst Mayr

The Aggasiz Museum of Comparative Zoology

Harvard University

Michael McGinnis

Deputy Assistant Secretary for Health

Public Health Service

U.S. Department of Health and Human

Resources

Deborah Jones Merritt

Assistant Professor of Law

College of Law

University of Illinois, Champaign

J. Robert Nelson

Institute of Religion

Texas Medical Center

Vincent Novarro

Professor of Health

The Johns Hopkins

Gilbert S. Omenn

Physician

Policy

University

William C. Richardson

Executive Vice President and Provost

The Pennsylvania State University

Rebecca W. Rimel

Vice President for Programs

The Pew Charitable Trusts

Frederick C. Robbins

University Professor

School of Medicine

Case Western Reserve University

Ruth Roemer

President American Health Association and

Adjunct Professor of Health Law

School of Public Health

University of California, Los Angeles

David E. Rogers

Walsh McDermott Distinguished Professor of

Medicine, the New York Hospital

Cornell Medical Center

Barbara Rosencrantz

Professor of History of Science

Harvard University

Allan Rosenfield

Joseph R. Delamar Professor

Dean, Columbia University School of

Public Health

Allan Rosenthal

Joseph R. DeLama Professor and Dean

Columbia University School of Public Health

Frances Sharples

Environmental Sciences Division

Oak Ridge National Laboratory

M.W. Shaw

Health Law Program

School of Public Health

University of Texas, Houston

Roger Shinn

Reinhold Niebuhr Professor of Social Ethics

Emeritus

Union Theological Seminary

Maria I. New

Physician
720

Nadya K. Shmavonian

Program Officer

Pew Charitable Trusts

Paula L. Stamps

Associate Professor and Acting Director

Division of Public Health

School of Health Services

University of Massachusetts, Amherst

Mervyn Susser

Surgievsky Professor of Epidemiology

Columbia University

Peter V. Tishler

Associate Chief of Staff–Education, and

Associate Professor of Medicine

Harvard Medical School

Winona B. Vernberg

Dean

College of Health

University of South Carolina

David P. Willis

Editor, Milbank Quarterly

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.