Intervention and Reflection.pdf

Intervention and Reflection

Basic Issues in Medical Ethics

Intervention and Reflection

Basic Issues in Medical Ethics

Eighth Edition

Ronald Munson

University of Missouri–St. Louis

Australia • Brazil • Canada • Mexico • Singapore • Spain

United Kingdom • United States

Philosophy Editor: Worth Hawes

Assistant Editors: Lee McCracken, Barbara Hillaker Editorial Assistant: Patrick Stockstill

Technology Project Manager: Julie Aguilar Marketing Manager: Christina Shea Marketing Assistant: Mary Anne Payumo Marketing Communications Manager: Stacey

Purviance

Creative Director: Rob Hugel Executive Art Director: Maria Epes Print Buyer: Judy Inouye

Permissions Editor: Roberta Broyer COPYRIGHT © 2008, 2004 Ronald Munson. ALL RIGHTS RESERVED. No part of this work covered by the copyright hereon may be reproduced or used in any form or by any means—graphic, electronic, or mechanical, including photocopying, recording, taping, Web distribution, information storage and retrieval systems, or in any other manner— without the written permission of the publisher.

Printed in the United States of America 1 2 3 4 5 6 7 11 10 09 08 07

For more information about our products, contact us at:

Thomson Learning Academic Resource Center

1-800-423-0563

For permission to use material from this text or product, submit a request online at http://www.thomsonrights.com. Any additional questions about permissions can be submitted by e-mail to [email protected].

Thomson Higher Education 10 Davis Drive

Belmont, CA 94002-3098 USA

Library of Congress Control Number: 2006938500

ISBN-13: 978-0-495-09502-6 ISBN-10: 0-495-09502-8

Production Service: International Typesetting and Composition

Text Designer: Harry Voigt Copy Editor: Margaret C. Tropp

Cover Designer: Yvo Riezebos Design/Matt Calkins Cover Photo Collage: Getty Image/Ryan McVay

Corbis/Burke/Triolo Productions Compositor: International Typesetting

and Composition

Text and Cover Printer: R.R. Donnelley, Crawfordsville

To Miriam

Ronald Munson is Professor of the Philosophy

of Science and Medicine at the University of

Missouri–St. Louis. He received his Ph.D. from

Columbia University and was a Postdoctoral

Fellow in Biology at Harvard University. He

has been a Visiting Professor at University of

California, San Diego, Johns Hopkins School

of Medicine, and Harvard Medical School.

A nationally acclaimed bioethicist, Munson is a

medical ethicist for the National Eye Institute

and a consultant for the National Cancer

Insti-tute. He is also a member of the Washington

University School of Medicine Human Studies

Committee.

His other books include Raising the Dead: Organ

Transplants, Ethics, and Society (named one of

the “Best Science and Medicine Books of 2002”

by the National Library Association), Reasoning

in Medicine (with Daniel Albert and Michael

Resnik), Elements of Reasoning and Basics of

Rea-soning (both with David Conway), and Outcome

Uncertain: Cases and Contexts in Bioethics. He is

also author of the novels Nothing Human, Fan

Brief Contents

PART I: RIGHTS

1

Chapter 1: RESEARCH ETHICS

AND INFORMED CONSENT

2

Chapter 2: PHYSICIANS, PATIENTS,

AND OTHERS: AUTONOMY, TRUTH

TELLING, AND CONFIDENTIALITY

97

Chapter 3: HIV/AIDS

174

Chapter 4: RACE, GENDER,

AND MEDICINE

211

PART II: CONTROLS

269

Chapter 5: GENETIC CONTROL

270

Chapter 6: REPRODUCTIVE CONTROL

364

PART III: RESOURCES

453

Chapter 7: SCARCE MEDICAL

RESOURCES

454

Chapter 8: PAYING FOR HEALTH CARE

509

PART IV: TERMINATIONS

545

Chapter 9: ABORTION

546

Chapter 10: TREATING OR TERMINATING:

THE DILEMMA OF IMPAIRED INFANTS

622

Chapter 11: EUTHANASIA AND

PHYSICIAN-ASSISTED SUICIDE

675

PART V: FOUNDATIONS OF BIOETHICS:

ETHICAL THEORIES, MORAL

PRINCIPLES, AND MEDICAL

DECISIONS

739

PART I: RIGHTS

1

Chapter 1 RESEARCH ETHICS AND

INFORMED CONSENT

2

CASE

PRESENTATION: Face Transplant: “Highly

Risky Experimentation”

3

BRIEFING

SESSION

6

Clinical Trials

8

The “Informed”Part of Informed Consent

9

The “Consent”Part of Informed Consent

10

Vulnerable Populations

10

Medical Research and Medical Therapy

11

Financial Conflict of Interest

12

Placebos and Research

12

Therapeutic and Nontherapeutic Research

14

Research Involving Children

14

Research Involving Prisoners

17

Research Involving the Poor

18

Research Involving the Terminally Ill

19

Research Involving Fetuses

21

Research Involving Animals

22

Women and Medical Research

24

Summary

25

ETHICAL

THEORIES: Medical Research

and Informed Consent

26

Utilitarianism

26

Kant

27

Ross

27

Natural Law

28

Rawls

28

CASE

PRESENTATION: Stopping the Letrozole

Trial: A Case of “Ethical Overkill”?

29

CASE

PRESENTATION: Jesse Gelsinger:

The First Gene-Therapy Death

30

SOCIAL

CONTEXT: The Cold-War Radiation

Experiments

35

CASE

PRESENTATION: The Willowbrook Hepatitis

Experiments

38

CASE

PRESENTATION: Echoes of Willowbrook

or Tuskegee? Experimenting with Children

39

CASE

PRESENTATION: The Use of Morally Tainted

Sources: The Pernkopf Anatomy

40

SOCIAL

CONTEXT: Experimental Medicine

and Phase Zero Trials

41

CASE

PRESENTATION: Baby Fae

43

READINGS

44

Section 1: Consent and Experimentation

44

Stephen Goldby, Saul Krugman,

M. H. Pappworth, and Geoffrey Edsall:

The Willowbrook Letters: Criticism

and Defense

44

Paul Ramsey: Judgment on Willowbrook

47

Principles of the Nuremberg Code

51

National Commission for the Protection of

Human Subjects: Belmont Report

52

Hans Jonas: Philosophical Reflections on

Experimenting with Human Subjects

55

Section 2: The Ethics of Randomized Clinical

Trials

61

Samuel Hellman and Deborah S. Hellman:

Of Mice but Not Men: Problems of the

Randomized Clinical Trial

61

Eugene Passamani: Clinical Trials: Are They

Ethical?

65

Don Marquis: How to Resolve an Ethical Dilemma

Concerning Randomized Clinical Trials

69

xi

Section 3: Relativism and Retrospective

Judgments

72

Allen Buchanan: Judging the Past: The Case

of the Human Radiation Experiments

72

Section 4: Animal Experimentation

79

Peter Singer: Animal Experimentation

79

Carl Cohen: The Case for the Use of Animals in

Biomedical Research

86

D

ECISION

S

CENARIOS 92

Chapter 2 PHYSICIANS, PATIENTS, AND

OTHERS: AUTONOMY, TRUTH TELLING,

AND CONFIDENTIALITY

97

C

ASE

P

RESENTATION

: Donald (Dax) Cowart

Rejects Treatment—and Is Ignored

98

B

RIEFING

S

ESSION 101

Autonomy

102

Paternalism

103

State Paternalism in Medical and Health

Care

103

Personal Paternalism in Medical and Health

Care

105

Informed Consent and Medical Treatment

105

Free and Informed Consent

106

Parents and Children

106

Pregnancy and Autonomy

107

Truth Telling in Medicine

108

Placebos

109

Dignity and Consent

110

Confidentiality (Privacy)

110

Breaching Confidentiality

111

Duty to Warn?

112

Managed Care

112

HIPA Regulations

112

E

THICAL

T

HEORIES

: Autonomy, Truth Telling,

Confidentiality

113

C

ASE

P

RESENTATION

: The Vegan Baby

116

C

ASE

P

RESENTATION

: Big Brother vs. Big Mac

117

S

OCIAL

C

ONTEXT

: Autonomy and Pregnancy

120

C

ASE

P

RESENTATION

: The Death of Robyn

Twitchell and Christian Science

123

R

EADINGS 125

Section 1: Consent to Medical Treatment

125

Gerald Dworkin: Paternalism

125

Dax Cowart and Robert Burt: Confronting Death:

Who Chooses, Who Controls? A Dialogue

134

Douglas S. Diekema: Parental Refunds of

Med-ical Treatment: The Harm Principle as Threshold

for State Intervention

138

Section 2: Autonomy and Pregnancy

143

Alexander Morgan Capron: Punishing

Mothers

143

John A. Robertson and Joseph D. Schulman:

Pregnancy and Prenatal Harm to Offspring

147

Section 3: Truth Telling

152

Mack Lipkin: On Telling Patients the Truth

152

Susan Cullen and Margaret Klein: Respect for

Patients, Physicians, and the Truth

154

Section 4: Confidentiality

161

Mark Siegler: Confidentiality in Medicine—A

Decrepit Concept

161

Supreme Court of California: Decision in the

Tarasoff Case

164

D

ECISION

S

CENARIOS 169

Chapter 3 HIV/AIDS

174

S

OCIAL

C

ONTEXT

: The AIDS Pandemic

175

B

RIEFING

S

ESSION 178

Combination Therapy: AIDS on the Run

179

Decline in Death Rate

179

Infection Rates

179

Protease Inhibitors and Combination Drug

Therapy

180

Limits of the Therapy

180

Best with New Infections

181

Drug Resistance

181

Virus Remains

181

Side-Effects

182

Difficult Regimen

183

Prevention

183

S

OCIAL

C

ONTEXT

: Testing AIDS Drugs in the

Third World

184

S

OCIAL

C

ONTEXT

: Discovering AIDS

188

C

ASE

P

RESENTATION

: The Way It Was: Tod

Thompson, Dallas, 1993–1994

190

S

OCIAL

C

ONTEXT

: Origin of the AIDS Virus

192

S

OCIAL

C

ONTEXT

: Why Isn’t There a Vaccine?

193

R

EADINGS 194

Section 1: AIDS Trials in Africa

194

George J. Annas and Michael A Grodin:

Human Rights and Maternal–Fetal HIV

Transmission Prevention Trials in Africa

194

Danstan Bagenda and Philla Musoke-Mudido:

We’re Trying to Help Our Sickest People, Not

Exploit Them

198

Section 2: Responsibility and Confidentiality

200

Elliot D. Cohen: Lethal Sex: Conditions of

Disclosure in Counseling Sexually Active Clients

with HIV

200

Bernard Rabinowitz: The Great Hijack

206

D

ECISION

S

CENARIOS 207

Chapter 4 RACE, GENDER,

AND MEDICINE

211

C

ASE

P

RESENTATION

: Bad Blood, Bad Faith: The

Tuskegee Syphilis Study

212

B

RIEFING

S

ESSION 215

African Americans and Health Care

215

Disease Differences

216

HIV/AIDS

216

Treatment Differences

216

Why the Gap?

217

The Tuskegee Effect

218

Closing the Gap

219

American Indians and Alaska Natives and

Health Care

219

Indian Health Service

219

Causes of Death

220

Closing the Gap

220

Asian Americans and Pacific Islanders and

Health Care

221

Health Profile

221

Summary

221

Hispanic Americans/Latinos and Health Care

222

Health Profile

222

Recent Changes

222

Undocumented Immigrants

223

Women and Health Care

223

Include Women, Study Women

224

Additional Support

225

Changes in the Right Direction

226

Conclusion

227

S

OCIAL

C

ONTEXT

: Race-Based Medicine?

227

C

ASE

P

RESENTATION

: Lee Lor: Caught

in a Culture Conflict

231

S

OCIAL

C

ONTEXT

: Is Health About Status, Not

Race?

233

S

OCIAL

C

ONTEXT

: Backlash on Women’s

Health?

236

R

EADINGS 238

Section 1: Race and Medicine

238

Patricia A. King: The Dangers of Difference:

The Legacy of the Tuskegee Syphilis Study

238

Jonathan Kahn: “Ethnic” Drugs

241

Armand Marie Leroi: A Family Tree in

Every Gene

242

Section 2: Setting Public Policy

245

James Dwyer: Illegal Immigrants, Health

Care, and Social Responsibility

245

H. Jack Geiger: The Demise of Affirmative

Action and the Future of Health Care

251

Section 3: Perspectives on Gender and Race

253

Susan Sherwin: Gender, Race, and Class in

the Delivery of Health Care

253

Annette Dula: Bioethics: The Need for a

Dialogue with African Americans

258

PART II: CONTROLS

269

Chapter 5 GENETIC CONTROL

270

C

ASE

P

RESENTATION

: Stem Cells: Promises and

Problems

271

B

RIEFING

S

ESSION 276

Genetic Intervention: Screening, Counseling,

and Diagnosis

277

Genetic Disease

277

Genetic Screening

279

Genetic Counseling

282

Prenatal Genetic Diagnosis

283

Ethical Difficulties with Genetic Intervention

286

Eugenics

288

Negative and Positive Eugenics

289

Use of Desirable Germ Cells

290

Ethical Difficulties with Eugenics

290

Genetic Research, Therapy, and Technology

291

Recombinant DNA

292

Gene Therapy

293

Biohazards

294

Ethical Difficulties with Genetic Research,

Therapy, and Technology

295

S

OCIAL

C

ONTEXT

: Genetic Testing and

Screening

296

S

OCIAL

C

ONTEXT

: Genetic Testing: Too Much

Prevention?

300

C

ASE

P

RESENTATION

: Huntington’s Disease:

Genetic Testing and Ethical Dilemmas

303

C

ASE

P

RESENTATION

: G

ENE

T

HERAPY 306

S

OCIAL

C

ONTEXT

: The Human Genome Project:

The Holy Grail of Biology

309

R

EADINGS 312

Section 1: Embryonic Stem Cells: The Debate

312

President’s Council on Bioethics: Cloning and

Stem Cells

312

Pontifical Academy for Life: Declaration on the

Production and the Scientific and Therapeutic

Use of Human Embryonic Stem Cells

316

Michael J. Sandel: The Moral Status of Human

Embryos

318

Section 2: Genetic Selection: A new Eugenics?

320

Julian Savulescu: Procreative Beneficence:

Why We Should Select the Best Children

320

Leon R. Kass: Implications of Prenatal

Diagnosis for the Human Rights to Life

326

Section 3: Dilemmas of Genetic Choice

333

Jeff McMahan: The Morality of Screening for

Disability

333

Dena S. Davis: Genetic Dilemmas and the

Child’s Right to an Open Future

337

Laura M. Purdy: Genetics and Reproductive

Risk: Can Having Children Be Immoral?

346

Section 4: Genetic Testing for Disease

Predisposition

352

Ruth Hubbard and R. C. Lewontin: Pitfalls of

Genetic Testing

352

Robert Wachbroit: Disowning Knowledge:

Issues in Genetic Testing

355

D

ECISION

S

CENARIOS 359

Chapter 6 REPRODUCTIVE CONTROL

364

S

OCIAL

C

ONTEXT

: Shopping for Mr. Goodsperm

365

B

RIEFING

S

ESSION 367

Techniques of Assisted Reproduction

369

IVF

369

GIFT, ZIFT, IVC, ULER, PZD, ICSI, DNA

Transfer, and CD

370

Need and Success Rates

371

Costs

371

Drawbacks

371

Potential Risk to Child

372

Multiple Births

372

Embryos, Eggs, and Transplants

372

Gestational Surrogates and Donor Ova

374

Criticisms of Assisted Reproduction

Practices

375

Benefits of IVF and Other Forms of Assisted

Reproduction

375

Ethical and Social Difficulties

376

Cloning and Twinning

377

The Procedure

378

Reasons for Seeking Artificial Insemination

379

Sperm Donors

380

Issues in Artificial Insemination

380

Ova Donors

381

Surrogate Pregnancy

381

Ethical Theories and Reproductive Control

383

C

ASE

P

RESENTATION

: Hello, Dolly: The Advent of

Reproductive Cloning

384

C

ASE

P

RESENTATION

: Louise Brown: The First

“Test-Tube Baby”

387

C

ASE

P

RESENTATION

: Saviour Sibling

389

C

ASE

P

RESENTATION

: The McCaughey Septuplets:

The Perils of Multiple Pregnancy

390

S

OCIAL

C

ONTEXT

: Postmenopausal Motherhood

392

C

ASE

P

RESENTATION

: Baby M and Mary Beth

Whitehead: Surrogate Pregnancy in Court

394

C

ASE

P

RESENTATION

: The Calvert Case: A

Gestational Surrogate Changes Her Mind

395

R

EADINGS 396

Section 1: Assisted Reproduction

396

Cynthia B. Cohen: “Give Me Children or

I Shall Die!” New Reproductive Technologies and

Harm to Children

396

Gillian Hanscombe: The Right to Lesbian

Parenthood

406

Congregation for the Doctrine of the Faith:

Instruction on Respect for Human Life in Its

Origin and on the Dignity of Procreation

409

Section 2: Saviour Siblings

414

David King: Why We Should Not Permit

Embryos to Be Selected as Tissue Donors

414

S. Sheldon and S. Wilkinson: Should Selecting

Saviour Siblings Be Banned?

416

Section 3: Surrogate Pregnancy

423

Bonnie Steinbock: Surrogate Motherhood as

Prenatal Adoption

423

Elizabeth S. Anderson: Is Women’s Labor a

Commodity?

430

Section 4: Human Cloning

438

Leon R. Kass: The Wisdom of Repugnance

438

Carson Strong: The Ethics of Human

Reproductive Cloning

443

D

ECISION

S

CENARIOS 447

PART III: RESOURCES

453

Chapter 7 SCARCE MEDICAL

RESOURCES

454

C

ASE

P

RESENTATION

: The Prisoner Who Needed

a Heart

455

B

RIEFING

S

ESSION 456

Transplants, Kidneys, and Machines

457

Controlling Rejection

458

Allocation and Scarcity

458

Seattle and Kidney Machines

459

Dialysis Costs and Decisions

459

Microallocation Versus Macroallocation

460

Ethical Theories and the Allocation of Medical

Resources

461

S

OCIAL

C

ONTEXT

: Acquiring and Allocating

Transplant Organs

462

C

ASE

P

RESENTATION

: Selection Committee for

Dialysis

470

C

ASE

P

RESENTATION

: Transplants for

the Mentally Impaired

473

C

ASE

P

RESENTATION

: Drug Lottery: The

Betaseron Shortage

474

R

EADINGS 475

Section 1: Allocating Transplant Organs

475

Jacob M. Appel: Wanted Dead or Alive? Kidney

Transplantation in Inmates Awaiting Execution

475

Robert M. Sade: The Prisoner Dilemma: Should

Convicted Felons Have the Same Access to Heart

Transplantation as Ordinary Citizens?

477

Carl Cohen et al.: Alcoholics and Liver

Transplantation

479

Section 2: Acquiring Transplant Organs

483

Ronald Munson: The Donor’s Right to Take a

Risk

483

Janet Radcliffe-Richards et al.: The Case for

Kishore D. Phadke and Urmila Anandh,

Ethics of Paid Organ Donation

487

Aaron Spital and Charles A. Erin: Conscription

of Cadaveric Organs for Transplantation: Let’s at

Least Talk About It

489

Section 3: Allocation Principles

492

Nicholas Rescher: The Allocation of Exotic

Medical Lifesaving Therapy

492

George J. Annas: The Prostitute, the Playboy,

and the Poet: Rationing Schemes for Organ

Transplantation

500

D

ECISION

S

CENARIOS 505

Chapter 8 PAYING FOR HEALTH CARE

509

C

ASE

P

RESENTATION

: Robert Ingram: Dilemma of

the Working Poor

510

B

RIEFING

S

ESSION 511

Claim-Rights, Legal Rights, and Statutory

Rights

512

Moral Rights

512

Political Rights

513

Health Care as a Right

513

Objections

514

S

OCIAL

C

ONTEXT

: American Dream, American

Nightmare

515

C

ASE

P

RESENTATION

: Massachusetts Takes the

Lead

519

C

ASE

P

RESENTATION

: The Canadian System as a

Model for the United States

521

R

EADINGS 525

Section 1: Justice and Health Care

525

Allen E. Buchanan: Is There a Right to a Decent

Minimum of Health Care?

525

Uwe E. Reinhardt: Wanted: A Clearly Articulated

Social Ethic for American Health Care

530

Section 2: Medicine and the Market

533

Paul Krugman: Health Economics 101

533

William S. Custer et al.: Why We Should Keep the

Employment-Based Health Insurance System

534

Section 3: Alternatives

536

Allan B. Hubbard: The Health of a Nation

536

Ezekiel Emanuel: Health Care Reform: Still

Possible

538

D

ECISION

S

CENARIOS 540

PART IV: TERMINATIONS

545

Chapter 9 ABORTION

546

C

ASE

P

RESENTATION

: The Conflict Begins:

Roe v. Wade

547

B

RIEFING

S

ESSION 548

Human Development and Abortion

549

The Status of the Fetus

550

Pregnancy, Abortion, and the Rights of Women

551

Therapeutic Abortion

552

Abortion and the Law

553

Ethical Theories and Abortion

553

S

OCIAL

C

ONTEXT

: A Statistical Profile of

Abortion in the United States

555

S

OCIAL

C

ONTEXT

: Plan B: Pregnancy Prevention

and Politics

559

S

OCIAL

C

ONTEXT

: RU-486: “The Abortion Pill”

562

S

OCIAL

C

ONTEXT

: The “Partial-Birth Abortion”

Controversy

565

S

OCIAL

C

ONTEXT

: Supreme Court Decisions

After Roe v. Wade

569

C

ASE

P

RESENTATION

: When Abortion Was Illegal:

Mrs. Sherri Finkbine and the Thalidomide

Tragedy

572

R

EADINGS 573

Section 1: The Status of the Fetus

573

John T. Noonan Jr.: An Almost Absolute Value

in History

573

Judith Jarvis Thomson: A Defense of Abortion

576

Mary Anne Warren: On the Moral and Legal

Status of Abortion

586

Don Marquis: Why Abortion Is Immoral

594

Mark T. Brown: The Morality of Abortion and

the Deprivation of Futures

599

Section 2: Feminist Perspectives

602

Susan Sherwin: Abortion Through a Feminist

Sidney Callahan: A Case for Pro-Life Feminism

605

Section 3: Late-Term Abortion

611

Peter Alward: Thomson, the Right to Life, and

Partial-Birth Abortion

611

Paul D. Blumenthal, The Federal Ban on

So-Called “Partial-Birth Abortion”Is a Dangerous

Intrusion into Medical Practice

615

D

ECISION

S

CENARIOS 617

Chapter 10 TREATING OR TERMINATING:

THE DILEMMA OF IMPAIRED INFANTS

622

C

ASE

P

RESENTATION

: The Agony of Bente

Hindriks

623

B

RIEFING

S

ESSION 624

Genetic and Congenital Impairments

624

Specific Impairments

625

Down Syndrome

625

Spina Bifida

625

Hydrocephaly

626

Anencephaly

626

Esophageal Atresia

626

Duodenal Atresia

626

Problems of Extreme Prematurity

626

Testing for Impairments

627

Amniocentesis and CVS

627

Alphafetoprotein

628

New Noninvasive Tests

628

Ethical Theories and the Problem of Birth

Impairments

628

C

ASE

P

RESENTATION

: Baby Owens: Down

Syndrome and Duodenal Atresia

630

S

OCIAL

C

ONTEXT

: The Dilemma of Extreme

Prematurity

631

S

OCIAL

C

ONTEXT

: The Baby Doe Cases

636

C

ASE

P

RESENTATION

: Baby K: An Anencephalic

Infant and a Mother’s Request

638

R

EADINGS 639

Section 1: The Status of Impaired Infants

639

John A. Robertson: Examination of Arguments

in Favor of Withholding Ordinary Medical Care

from Defective Infants

639

H. Tristram Engelhardt Jr.: Ethical Issues in

Aiding the Death of Young Children

646

Robert F. Weir: Life-and-Death Decisions in the

Midst of Uncertainty

651

Section 2: Other Perspectives

657

Michael L. Gross: Avoiding Anomalous

Newborns

657

Section 3: The Groningen Protocol

664

James Lemuel Smith: The Groningen Protocol:

The Why and the What

664

Alan B. Jotkowitz and Shimon Glick: The

Groningen Protocol: Another Perspective

667

D

ECISION

S

CENARIOS 669

Chapter 11 EUTHANASIA AND

PHYSICIAN-ASSISTED SUICIDE

675

C

ASE

P

RESENTATION

: Terri Schiavo

676

B

RIEFING

S

ESSION 682

Active and Passive Euthanasia

682

Voluntary, Involuntary, and Nonvoluntary

Euthanasia

682

Defining “Death”

683

Advance Directives

685

Ethical Theories and Euthanasia

687

C

ASE

P

RESENTATION

: Karen Quinlan: The

Debate Begins

689

C

ASE

P

RESENTATION

: The Cruzan Case: The

Supreme Court Upholds The Right to Die

691

S

OCIAL

C

ONTEXT

: Physician-Assisted Suicide in

Oregon

694

C

ASE

P

RESENTATION

: Dr. Jack Kevorkian, Activist

and Convicted Felon

697

C

ASE

P

RESENTATION

: A Canadian Tragedy

699

C

ASE

P

RESENTATION

: Rip van Winkle, for a Time:

Donald Herbert

700

S

OCIAL

C

ONTEXT

: Physician-Assisted Suicide:

The Dutch Experience

701

R

EADINGS 703

Section 1: The Case Against Allowing

Euthanasia and Physician-Assisted

Suicide

703

J. Gay-Williams: The Wrongfulness of

Euthanasia

703

Daniel Callahan: When Self-Determination

Runs Amok

706

Section 2: The Case for Allowing Euthanasia

and Physician-Assisted Suicide

711

John Lachs: When Abstract Moralizing

Runs Amok

711

Peter Singer: Voluntary Euthanasia: A

Utilitarian Perspective

715

Daniel E. Lee: Physician-Assisted Suicide: A

Conservative Critique of Intervention

722

Section 3: The Killing–Letting Die Distinction

725

James Rachels: Active and Passive Euthanasia

725

Winston Nesbitt: Is Killing No Worse

Than Letting Die?

729

Section 4: Deciding for the Incompetent

Supreme Court of New Jersey: In the Matter of

Karen Quinlan, an Alleged Incompetent

733

D

ECISION

S

CENARIOS 735

PART V: FOUNDATIONS OF BIOETHICS:

ETHICAL THEORIES, MORAL PRINCIPLES,

AND MEDICAL DECISIONS

739

B

ASIC

E

THICAL

T

HEORIES 742

Utilitarianism

743

The Principle of Utility

743

Act and Rule Utilitarianism

744

Preference Utilitarianism

748

Difficulties with Utilitarianism

749

Kant’s Ethics

750

The Categorical Imperative

750

Another Formulation

751

Duty

751

Kant’s Ethics in the Medical Context

752

Difficulties with Kantian Ethics

754

Ross’s Ethics

755

Moral Properties and Rules

755

Actual Duties and Prima Facie Duties

756

Ross’s Ethics in the Medical Context

758

Difficulties with Ross’s Moral Rules

758

Rawls’s Theory of Justice

759

The Original Position and the Principles

of Justice

759

Rawls’s Theory of Justice in the Medical

Context

761

Difficulties with Rawls’s Theory

763

Natural Law Ethics and Moral Theology

764

Purposes, Reasons, and the Moral Law as

Interpreted by Roman Catholicism

764

Applications of Roman Catholic

Moral–Theological Viewpoints in the Medical

Context

766

Difficulties with Natural Law Ethics and

Moral Theology

768

M

AJOR

M

ORAL

P

RINCIPLES 769

The Principle of Nonmaleficence

770

The Principle of Beneficence

771

The Principle of Utility

773

Principles of Distributive Justice

774

The Principle of Equality

775

The Principle of Need

775

The Principle of Contribution

776

The Principle of Effort

776

The Principle of Autonomy

777

Autonomy and Actions

778

Autonomy and Options

778

Autonomy and Decision Making

779

Restrictions on Autonomy

780

T

HEORIES

W

ITHOUT

P

RINCIPLES 782

Virtue Ethics

782

The Virtues

783

Virtue Ethics in the Medical Context

783

Difficulties with Virtue Ethics

784

Care Ethics

784

Values, Not Principles

785

Care Ethics in the Medical Context

786

Difficulties with Care Ethics

787

Feminist Ethics

788

Feminist Ethics in the Medical Context

789

Difficulties with Feminist Ethics

790

In shaping the eighth edition of this book, I have

tried to capture both the intellectual excitement

and the great seriousness that surround

bioethics. I’ve done my best, in particular, to

con-vey these aspects to those new to the field.

By emphasizing cases and presenting

rele-vant medical, scientific, and social information,

I’ve attempted to introduce readers to the basic

issues and make them active participants in the

enterprise of deliberation and problem solving.

I believe that everyone, whatever the level of

knowledge or intellectual sophistication, will find

this a useful and engaging book.

Topics

The topics I’ve selected are all fundamental ones

in bioethics. They reflect the range and variety of

the problems we now confront and involve

ethi-cal and social issues that have excited the most

immediate concern. But more than this, the

problems raised are ones so profoundly serious

that they lead people to turn hopefully to

philo-sophical consideration in search of satisfactory

resolutions.

Readings

The Readings present current thinking about

the topics and show that such consideration

can be worthwhile. All are readable and

nontechnical, and many reveal bioethics at its

best. Although philosophers are strongly

repre-sented, the authors also include jurists,

scien-tists, clinical researchers, social critics, and

practicing physicians. The moral problems of

medicine always have scientific, social, legal,

and economic aspects, and to deal with them

sensibly and thoroughly, we need the

knowl-edge and perceptions of people from a variety

of disciplines.

I have also opted for diversity in another

way, by trying to see to it that opposing

view-points are presented for major topics.

Part of the intellectual excitement of bioethics

is generated by the searing controversies

sur-rounding its issues, and to ignore these conflicts

would be misleading. Even worse, it would deny

readers the opportunity of dealing directly with

proposals and arguments incompatible with their

own views. Hence, I’ve felt an obligation to raise

issues that some would prefer to ignore and to

present proposals to resolve them that others

reject as wrong or even immoral. I hold, along

with most reasonable people, that we must face

our problems and consider seriously all proposed

solutions. Otherwise, rational inquiry evaporates

and power and prejudice take its place.

Chapter Structure

Each chapter for the first four Parts of this book is

like a sandwich with several layers. Each opens

with a Case Presentation or Social Context,

which is followed by the chapter Briefing Session,

then a combination of Social Contexts and Case

Presentations. The variety and number of these

vary by chapter. The Readings appear next, and

after them the Decision Scenarios.

In the Case Presentations, I sketch out the

most important cases in bioethics in narrative

accounts. These are ones that have faced us with

crucial issues and shaped our thinking about

what we believe is morally legitimate in various

areas of clinical practice and medical and

biologi-cal research.

xix

Some of the people at the focus of the cases

are familiar. Nearly everyone has heard of Terry

Schiavo, Jesse Gelsinger, Karen Quinlan, Jack

Kevorkian, and Dax Cowart. Their names have

been in the headlines and on the news many

times—some as recently as last week, others

more than three decades ago.

The Case Presentations focus on events that

have been at the center of discussion. They raise

issues that prompt us to reflect. The image of

Terri Schiavo lying in bed, her limbs sometimes

moving and her mouth occasionally forming a

jerky smile, for example, makes us all think hard

about when or whether life support ought to be

discontinued and whether active euthanasia is

ever morally acceptable. The French woman

who received a partial face transplant makes us

wonder when we are justified in using the powers

of transplant medicine.

Not all Case Presentations center on

indi-viduals. Some focus on defining episodes in the

history of clinical research or social practice.

These include, for example, the Tuskegee Syphilis

Study and the hardly less controversial

Willow-brook Hospital Experiment. The central concern

of such cases is usually with the way groups or

individuals were treated by researchers and by

society. Or it may be the way a particular therapy

has developed and raised issues.

The most important aspect of the Case

Presentations, in my view, is that they remind us

that in dealing with bioethical questions we are

not engaged in some purely intellectual abstract

game. Real lives are often at stake, and real people

may suffer or die.

In the Briefing Session in each chapter, I

discuss some of the specific moral problems that

occur in medical and biological practice, research,

and policy making. I present, in addition,

what-ever factual information is needed to understand

how such problems arise. Finally, I suggest the

ways moral theories or principles might be used

to resolve some problems. Because virtue, care,

and feminist ethics don’t involve principles, I

haven’t tried to invoke these theories. My

sug-gestions, in any event, are offered only as starting

points in the search for satisfactory answers.

The Social Context sections provide

infor-mation relevant to understanding the current

social, political, or biomedical situation in which

issues are being debated. They differ from Case

Presentations in offering a broader and deeper

view of problems such as the funding of health

care, dealing with the AIDS pandemic, and the

social and legal struggles over approving Plan B

for over-the-counter sales.

If we hope to raise the level of public

discus-sion of an issue and genuinely inform the life of

our society and move toward solving important

problems, we must understand and consider the

relevant scientific and medical facts, as well as

the social situation in which the issue arises.

The ongoing debate over embryonic stem

cells provides a good illustration of the

impor-tance of information. No one can make a

rea-soned decision about whether we should allow

(or even encourage) embryonic stem cell

re-search without knowing what embryonic stem

cells are and without a sense of the therapeutic

possibilities they may offer. The debate is not

taking place in a vacuum, however. Policies and

laws have been proposed and criticized, and

any-one wanting to participate in the debate needs

some information about the current situation.

Social Context sections, to be blunt but

accurate, offer a deep background briefing to

help with understanding the issues that are

their focus.

The Readings make up the next layer of a

chapter sandwich. They provide the variety of

basic arguments and viewpoints relevant to the

problems addressed by the chapter. Although

each selection stands alone, I have tried to

repre-sent opposing positions in a fair and evenhanded

fashion. The multiplicity of topics addressed in

the book means, however, that I couldn’t always

represent the varieties and strengths of a general

point of view. The arguments are offered to

prompt inquiry, not to make it unnecessary.

The Decision Scenarios constitute the final

component of each chapter. These are brief,

dra-matic presentations of situations in which moral

questions are crucial or in which ethical or social

policy decisions have to be made. The scenarios

are followed by questions asking the reader to

decide what the problems are and how they

might be dealt with. Thus, the Decision Scenarios

are really exercises in bioethics that can direct

and structure class discussion.

In previous editions, questions in the

Deci-sion Scenarios were sometimes explicitly tied to

particular moral theories or to principles argued

for in the Readings. I took a different approach

this time, because a number of people said that

such questions were too limiting. The questions

following each scenario are intended to prompt

reflection and discussion, so the answers are

likely to draw from the arguments in the

Read-ings, the information in the Briefing Session,

and relevant moral theories and principles. An

instructor can easily follow the old model by

attaching names of authors or ethical theories

to many of the questions.

Foundations of Bioethics

For some readers, the most important feature of

this book may be Part V: Foundations of Bioethics.

In the first section, I sketch the basics of five

major ethical theories and indicate how they

might be used to answer particular moral

ques-tions in medicine and research. In the second

section, I present and illustrate several major

moral principles. The principles are ones

en-dorsed (or at least expressed in practice) by

virtually all ethical theories. Even so, I don’t try

to demonstrate how the principles follow from

or are consistent with particular theories. In the

third section, I present the fundamental ideas

of three ethical theories usually framed as not

involving principles—virtue ethics, care ethics,

and feminist ethics.

The main purpose in these sections is to give

those without a background in ethics the

infor-mation they need to frame and evaluate moral

arguments about the issues in bioethics. The

three parts of the Foundations section are

com-plementary, but they are also self-contained and

may be read separately. The aim of each (and of

all three together) is to help prepare readers for

independent inquiry into bioethics.

Independent Components

What I’ve said about the parts of the

Founda-tions secFounda-tions being independent holds also for

the components of the chapters—the Case

Pre-sentations, Briefing Sessions, Social Contexts,

Readings, and Decision Scenarios. I have written

and arranged everything to stand alone. This

makes it possible for a reader to turn to any

chapter and pick and choose among the

materi-als presented.

Reading the Briefing Session of a chapter

may deepen the understanding of the issues

in-volved in (say) paying for health care, but one

might choose to read only the Case Presentation

discussing the Canadian system. Or, instead, one

might consider only the proposals and arguments

presented in the Readings.

Similarly, one might want to focus only on

gene therapy by reading the appropriate Case

Presentation and Readings and ignore the issues

connected with the various other modes of

genetic control. The components of the book

can be skipped or combined in a variety of ways,

depending on one’s interests.

This is a useful feature for those using the

book as a text. Some instructors, for example,

may want to start with Part V: Foundations of

Bioethics and lay out moral principles or

theo-ries; others may prefer to refer to that section

only in the course of discussing some particular

topic. Still others may choose to ignore it

com-pletely, providing students with whatever

infor-mation they need in lectures or discussions. This

book offers so much flexibility that it is

compati-ble with almost any path an instructor chooses.

Tables of Contents

This is a big book and includes a wide variety of

topics and materials. To make it easier to navigate,

in addition to the main Table of Contents, I have

included a Contents section at the beginning of

each chapter. In addition to listing the Case

Presentations and Social Contexts, the section also

spells out the major subheadings of the Briefing

Session.The Contents pages are designed to

reveal all the topics covered in the chapter at a

glance and prevent readers from getting lost in

the thicket of cases and discussions.

Notes and References

For sources of the materials used in the Case

Presentations, Briefing Sessions, Social Contexts,

and Decision Scenarios, visit the book’s

compan-ion website, www.thomsonedu.com/philosophy/

munson.

Additional Resources

Websites such as the National Library of

Medi-cine, the National Institutes of Health, and the

Centers for Disease Control provide access to

Medline, making it possible to carry out

exten-sive research on almost any bioethical, clinical, or

biomedical topic. Addresses for other medically

related websites are easily located by any search

engine. Medline indexes not only medical

jour-nals, but journals in bioethics.

Those interested in diseases like diabetes

or breast cancer or therapies such as stem cell

rescue or heart transplant can readily acquire a

great deal of up-to-the-minute information by

consulting relevant websites. Everyone knows

by now, of course, that websites often evaporate

like dew in the sun and that the information

supplied by some should not be taken on trust.

Website for This Book

Wadsworth Publishing Company, the publisher

of this book, maintains the Wadsworth

Philoso-phy Shoppe site at http://philosoPhiloso-phy.wadsworth.

com. This book has a web page at that site, with

supplemental materials, and it is there that any

needed corrections will be posted.

Content Changes in the

Eighth Edition

Alterations of importance have been made

throughout the book in response to the impact

that changes in social circumstances, court

deci-sions, scientific understanding, government

regulations, and clinical practice have on moral

issues in medicine. Here is a sample of issues

freshly discussed:

■

Phase 0 clinical trials

■

Backlash on special support for women’s

health

■

The increase in Type II diabetes and its

consequences

■

AIDS becomes a pandemic

■

Progress toward an AIDS vaccine

■

Drugs more effective for one race than

another

■

New developments in the debate over

embryonic stem cells

■

Implementation of the HIPPA privacy

regulations

■

Legislation on late-term abortion

■

Genetic testing leading to too much

prevention

■

The racial health gap

■

Sperm shopping now more accepted and

practiced

■

Saviour siblings through assisted reproduction

■

Groningen protocol for infant euthanasia

■

Massachusetts plan for the uninsured

■

Plan B and over-the-counter sales

■

RU-486 and safety concerns

■

Update on the Canadian health care system

■

Update on assisted suicide in Oregon and

the Netherlands

The Briefing Sessions have been revised in

dozens of ways to take into account changes

in policies, statistics, and relevant scientific or

medical information, or simply to make the text

clearer. (By the way, sometimes even the most

recent statistics may be several years old. A

large-scale study may have been so expensive and

time-consuming it hasn’t been repeated.)

The new Case Presentations and Social

Contexts include the Terri Schiavo case, the

partial face transplant case in France, the

controversy over race-based medicine, social

status versus race as a predictor of health, obesity

and the rise of Type II diabetes, the AIDS

pandemic, heart transplants for prisoners, saviour

siblings, the Donald Herbert case, progress toward

an AIDS vaccine, the baby starved by vegan

parents, and several others.

Each chapter includes from five to eight

Decision Scenarios, and a fair number are new to

this edition. The new ones represent recent cases

or issues that are not presented elsewhere in the

text. The addition of new Decision Scenarios

meant that some others had to be dropped.

The Readings in this edition maintain the

scope of those in the last. Twenty-seven readings

are completely new. Included are selections by

(without attempting to be systematic or

exhaus-tive) Peter Singer, Paul Krugman, Don Marquis,

Julian Savulescu, Ezekiel Emanuel, Winston

Nesbitt, Carson Strong, Janet Radcliffe-Richards,

Robert Sade, David King, and Jeff McMahan.

The new Readings represent the latest and

best thinking on the many complicated issues that

medical practice and research have faced us with.

The arguments presented in the selections are

worth careful consideration by reasonable people.

Envoi

I have tried to be helpful without being too

intrusive. Anyone who teaches bioethics wants

enough flexibility to arrange a course in the way

she or he sees fit. I have attempted to offer that

flexibility, while at the same time supplying readers

with the kind of information and support they

need.

This book, with its Case Presentations,

Brief-ing Sessions, Social Context sections, Decision

Scenarios, and Foundations of Bioethics section,

is more ambitious than any similar work. I’ve

been pleased by responses from my colleagues to

the earlier editions. Even their criticisms were

tempered by a sympathetic understanding of the

difficulty of producing a book of this scope that

attempts to do so many things.

Thanks to the help of many people who

took the trouble to write to me, I was able to

correct errors in this edition that I missed in the

last. I am under no illusion that the book has

achieved perfection, and I would still appreciate

comments or suggestions from those who use

the book and discover ways it needs to be

corrected or can be improved. Communications

may be e-mailed to me or sent to my university

address (Department of Philosophy, University

of Missouri–St. Louis, St. Louis, MO 63121).

I owe so many intellectual debts that I must

declare bankruptcy. This means that those who

invested their help in this project have to settle

for an acknowledgment that is less than they are

rightly owed. My greatest debt is to those authors

who allowed their work to be printed here. I hope

they will find no grounds for objecting to the

way I have dealt with them. I am also grateful to

the following reviewers for their criticisms and

recommendations:

I’m grateful to Jerry Holloway, whose

expertise and industry were crucial to the

pro-duction of this book. Peggy Tropp and Benjamin

Kolstad’s quick eyes and sharp intelligence once

again kept me from making many errors, large

and small.

Miriam Munson’s name deserves to appear

on the title page as an indication of how grateful

I am to her for her hard work and keen judgment.

The book is better because of her. I thank Rebecca

Munson for reminding me that there is more to

life than the making of books, yet I hope most

fondly that she finds success and satisfaction in

her own bookmaking efforts.

I have not always listened to those who have

taken the trouble to warn and advise me, and

this is reason enough for me to claim the errors

here as my own.

Ronald Munson

University of Missouri–St. Louis, 2007

[email protected]

Part

I

Rights

2

Chapter

1

Research Ethics and

Informed Consent

Chapter Contents

CASE PRESENTATION: Face Transplant:

“Highly Risky Experimentation” 3

BRIEFING SESSION 6

Clinical Trials 8

The “Informed” Part of Informed

Consent 9

The “Consent” Part of Informed

Consent 10

Vulnerable Populations 10

Medical Research and Medical Therapy 11

Financial Conflict of Interest 12

Placebos and Research 12

Therapeutic and Nontherapeutic Research 14

Research Involving Children 14

Research Involving Prisoners 17

Research Involving the Poor 18

Research Involving the Terminally Ill 19

Research Involving Fetuses 21

Research Involving Animals 22

Women and Medical Research 24

Summary 25

Ethical Theories: Medical Research and

Informed Consent 26

Utilitarianism 26

Kant 27

Ross 27

Natural Law 28

Rawls 28

CASE PRESENTATION: Stopping the

Letrozole Trial: A Case of

“Ethical Overkill”? 29

CASE PRESENTATION: Jesse Gelsinger: The

First Gene-Therapy Death 30

SOCIAL CONTEXT: The Cold-War Radiation

Experiments 35

CASE PRESENTATION: The Willowbrook

Hepatitis Experiments 38

CASE PRESENTATION: Echoes of

Willowbrook or Tuskegee?

Experimenting with Children 39

CASE PRESENTATION: The Use of

Morally Tainted Sources: The Pernkopf

Anatomy 40

SOCIAL CONTEXT: Experimental Medicine

and Phase 0 Trials 41

CASE PRESENTATION: Baby Fae 43

READINGS 44

Section 1: Consent and Experimentation 44

Stephen Goldby, Saul Krugman, M. H.

Pappworth, and Geoffrey Edsall: The

Willowbrook Letters: Criticism and

Defense 44

Paul Ramsey: Judgment on Willowbrook 47

Principles of the Nuremberg Code 51

National Commission for the Protection of

Human Subjects: Belmont Report 52

Hans Jonas: Philosophical Reflections on

Experimenting with Human Subjects 55

Section 2: The Ethics of Randomized Clinical

Trials 61

Samuel Hellman and Deborah S. Hellman:

Of Mice but Not Men: Problems of the

Randomized Clinical Trial 61

Eugene Passamani: Clinical Trials: Are They

Ethical? 65

Don Marquis: How to Resolve an Ethical

Dilemma Concerning Randomized Clinical

Trials 69

and the dog tried to rouse her by biting and clawing at her face.

No matter which version is correct, the result was the same. The dog ripped off Denoire’s lips and tore the flesh off her nose and chin. How she was discovered has not been made public, but she even-tually was rushed to the local hospital, bleeding and in great pain. The dog, justly or not, was later killed by the authorities.

A short time after Denoire was stabilized med-ically and her injuries treated, she was examined by Dr. Bernard Devauchelle, Chairman of the Depart-ment of Maxillofacial Surgery at Amiens University Hospital. Because of Denoire’s seriously disfiguring wounds but general good health, he decided that she was an excellent candidate for a partial face transplant. It would have to be done without great delay, how-ever, because once scar tissue was fully formed, a transplant would become extremely difficult. Scar tis-sue lacks blood vessels and so would have to be cut away even to start the transplant. Also, the muscles in her face and jaw might become permanently con-tracted and incapable of functioning. Eating and speaking in any normal sense would become impossi-ble. Dr. Devauchelle listed her as an urgent case with Agence Biomedicine, the French organization respon-sible for acquiring and distributing transplant organs. Isabelle Denoire was a thirty-eight-year-old, divorced,

unemployed mother of two living in the town of Va-lenciennes in northern France. On a Sunday evening in May 2005, Denoire had an argument with her sev-enteen-year-old daughter. The daughter, angry, left the house to spend the night with her grandmother. After this point, many facts become hazy and disputed.

In the initial version of events released by one of Denoire’s doctors, Jean-Michel Dubernard, she was upset and wanted to calm herself. To achieve this, she took a couple of pills to help her sleep and went to bed. But this account contradicted an earlier account by Denoire’s daughter, who said her mother tried to commit suicide by taking an overdose of sleeping pills. Denoire eventually confirmed her daughter’s version of what happened, but she said that her reason for try-ing to kill herself was a “secret.” Dr. Dubernard, how-ever, continued to insist that his patient had made no effort to commit suicide.

According to Dr. Dubernard, after Denoire took the sleeping drug, she woke up sometime during the night and got out of bed. Walking through the dark house, she stumbled over the large, aggressive dog she had recently adopted. The dog, startled, then at-tacked her. But once again, Denoire’s daughter told a different story. According to her, after taking the sleeping drug, Denoire fell to the floor unconscious,

Case Presentation

Face Transplant: “Highly Risky Experimentation”

Section 3: Relativism and Retrospective

Judgments 72

Allen Buchanan: Judging the Past: The Case

of the Human Radiation Experiments 72

Section 4: Animal Experimentation 79

Peter Singer: Animal Experimentation 79

Carl Cohen: The Case for the Use of Animals

in Biomedical Research 86

DECISION SCENARIOS 92

Transplant

Isabelle Denoire, some seven months later, would be-come the first person to receive a face transplant of any sort—full or partial.Yet surgeons and bioethicists in France, Britain, the United States, and elsewhere had been discussing the possibility and the issues as-sociated with such a transplant for some time. Some transplant programs were on the verge of finding a suitable candidate for the entirely novel procedure.

France’s national ethics committee had ruled that a face transplant should not be performed as an emer-gency procedure. Under those conditions, the commit-tee decided, the notion of informed consent was an “illusion,” even if the patient asks for the transplant, is provided with the relevant information, and a donor graft is available. In the absence of experience with face transplants, “The surgeon cannot make any promises regarding the results of his restorative ef-forts, which are always doubtful. Authentic consent, therefore will never exist.” The committee did approve partial face transplants, assuming the local hospital ethics committee also approved, but warned that such a transplant would be “high-risk experimentation.”

In July 2005, Dr. Jean-Michel Dubernard, a noted transplant surgeon and a member of parliament, was asked by Dr. Devauchelle to consult on the case. In Au-gust, Dr. Dubernard visited the hospital and examined Isabelle Denoire. “The moment she removed her mask, which she always wore, I had no more hesitation about doing a transplant,” he later said.

Dr. Benoit Lengele, a Belgian plastic and recon-structive surgeon, was also called into the case by Dr. Devauchelle. Dr. Lengele assessed Denoire’s condition and reached the conclusion that at least three or four operations would be needed to reconstruct her face by using bone, cartilage, and skin taken from other parts of her body. The result, he thought, was not likely to be successful either functionally or aesthetically. She was having difficulty eating and talking, because so much of her face was missing, but he was not sure that her problems could be adequately corrected by recon-structive surgery.

Dr. Devauchelle and Dr. Dubernard discussed the possibility of a partial face transplant with Denoire. They told her that the chance that a transplant would be successful was about 33 percent, and the chance that it would be rejected was the same. Most impor-tant, there was also a 33 percent chance that she might die from the surgery, an infection, or as a result of the immunosuppressive drugs she would have to take to control the tissue rejection.

Denoire agreed to the face transplant at once, even though the doctors reminded her that the proce-dure was highly experimental and had never been done before. “We got her permission several times,” Dr. Dubernard later told a reporter, and Denoire un-derstood the risks she would be taking. He also said that he had secured all the permission required for the transplant from the French national ethics committee and the hospital ethics committee. Denoire, he said, had asked only that the name of the hospital, as well as her name, be withheld from the public.

On Sunday, November 27, a surgical team headed by Dr. Devauchelle operated on Denoire at Amiens University Hospital. He grafted onto her damaged and disfigured face a large segment of a donor face that in-cluded the nose, lips, chin, and the lower cheeks.

The face graft was taken from a suicide victim, a woman declared brain dead in Lille, a city some 85 miles north of Amiens. French law permits “pre-sumed consent” in removing organs for transplant, thus making it unnecessary to secure the permission of relatives. Even so, because of the special nature of a facial transplant, the surgeons asked the donor’s fam-ily for consent before removing the tissue. A team of clinical psychologists provided support to the family on the Saturday before the transplant surgery.

On Saturday night, a surgical team headed by Dr. Devauchelle arrived in Lille to remove the face graft. Meanwhile in Amiens, Dr. Dubernard and a sec-ond surgical team were preparing Isabelle Denoire for the transplant. This involved cutting away the scar tis-sue that had already formed in just a few months and identifying the nerves, muscles, and blood vessels that would have to be connected to the donor graft for the transplant to be viable.

Dr. Devauchelle’s team finished its work around five o’clock in the morning on Sunday, then rushed the face graft to Amiens. It was preserved in a saline solu-tion chilled to 39 degrees Fahrenheit. Once tissue has been removed from its blood supply, cells begin to die. Although keeping a graft cold slows the process, the more quickly its blood supply is reestablished, the more likely it is that the transplant will be successful.

Dr. Devauchelle’s team of eight surgeons began using established microsurgical techniques to attach the graft to the remaining portion of Denoire’s face. The techniques are tedious and demanding, requiring, as Dr. Dubernard later said, sewing together the ends of nerves and muscles no larger than “the fibers hang-ing from a strhang-ing bean.” If vessels are not connected properly, blood clots may form and the tissue may die,

and if muscles are not sewn together correctly, the pa-tient will not only lack facial expressions, but may not be able to speak, drink, or chew.

By nine o’clock Sunday morning, four hours after the face graft had been removed from the donor in Lille, its blood supply was reestablished. Surgery could then continue at a slower, more deliberate pace. Even-tually, the top layers of muscle, then the layers of the skin were stitched into place. The surgeons implanted a piece of donor tissue under Denoire’s arm so that it, rather than her face, could be used as a source of biop-sies to assess how well her body was accepting the graft of foreign tissue. The operation took a total of fif-teen hours of meticulous work, with most of the surgery being performed within the narrow field of an operating microscope. When the operation was over, the nurses applauded.

Denoire, after she returned to consciousness Sunday evening, wrote “Merci” on the paper she had been given to help her communicate. By Friday morn-ing, her doctors reported, she was eatmorn-ing, drinkmorn-ing, and speaking clearly, although she still lacked sensa-tion and muscle control in the transplanted segment. The scar running around the edges of the segment was thin, and the skin tones of the donor and recipient were an almost perfect match. From the beginning, Denoire showed signs of accepting her new appear-ance. “This is my face,” she said on Thursday, studying it in a mirror. Because underlying muscles and bone account for much of facial appearance, Denoire’s face looked neither like her donor’s nor like her original face.

In addition to treating her with immunosuppres-sive drugs, Denoire’s doctors also injected her with bone marrow taken from the donor. The idea behind the treatment was that the marrow would turn her into a chimera—that is, her body would acquire a mix-ture of cell types. This, in turn, might lead her immune system to recognize the cells from the face graft as “self,” instead of attacking it as a foreign body. If that happened, the drugs might not be able to prevent the face graft from being rejected.

Reactions

On December 1, Dr. Dubernard held a press confer-ence and announced that surgical teams headed by him and Dr. Devauchelle had performed the world’s first partial face transplant. The procedure, he reported, had been a complete success and the patient was re-covering well.

Dubernard’s announcement was met with an im-mediate barrage of criticisms and questions from the transplant community. The most common criticism was that Dubernard’s group had rushed the trans-plant. They ought to have attempted standard recon-structive surgery first. Now Isabelle Denoire would be exposed to all the hazards of a transplant. She would have to take immunosuppressive drugs for the rest of her life, and this would increase her risk of risk of can-cer and potentially lethal infections. Also, the face graft might still be rejected at any time, maybe even years down the road. These are risks that might be too great for the treatment of a nonfatal condition. Saving someone’s life by giving him a new liver is one thing, but giving someone a new face to improve her ap-pearance . . . can this be worth the risks?

Also, critics charged, Dubernard’s group had se-lected the wrong sort of patient for a transplant. If De-noire had attempted to kill herself, she might very well lack the psychological strength to cope with the stresses and uncertainties associated with an experi-mental surgical procedure. Furthermore, people who are emotionally unstable do not do well in keeping to the rigid drug regimen that a transplant patient must follow to prevent rejection. Finally, the first person to receive a face transplant, even a partial one, could be expected to become the subject of intense public inter-est, and someone like Isabelle Denoire might lack the psychological strength to cope with the demands of the media and the curiosity of the public.

Critics also charged that even the quality of the informed consent Denoire gave to become a face transplant patient might be regarded as questionable. Does someone despairing enough to attempt suicide who has also had her face destroyed possess the ratio-nal capacity to make a free and informed decision about a new procedure that holds the promise of restoring her appearance? Isn’t she more likely to be impulsive and to have unrealistic expectations of the outcome of the surgery?

Transplant professionals directed some of their harshest criticism at the decision by the French sur-geons to inject Denoire with bone marrow stem cells taken from the deceased donor.This is a treatment that is not standard in organ transplantation, and although the technique has been used before, the results have been mixed. “They should not be doing two experi-ments on one patient,” said Dr. Maria Siemionow. “Ethics aside, it will make it difficult to get clean an-swers—if [the transplant] works, why does it work, and if it goes wrong, was it the transplant or the stem