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M E DIC A L E X PE R I M E N TAT ION
M E DIC A L E X PE R I M E N TAT ION

Personal Integrity and Social Policy

New Edition

Charles Fried

Edited by Franklin Miller

A ND

Alan Wertheimer

1
 3
Oxford University Press is a department of the University of Oxford. It furthers
the University’s objective of excellence in research, scholarship, and education
by publishing worldwide. Oxford is a registered trade mark of Oxford University
Press in the UK and certain other countries.
Published in the United States of America by Oxford University Press
198 Madison Avenue, New York, NY 10016, United States of America.
© Oxford University Press 2016. No claim to original U.S. government works.
All rights reserved. No part of this publication may be reproduced, stored in
a retrieval system, or transmitted, in any form or by any means, without the
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rights organization. Inquiries concerning reproduction outside the scope of the
above should be sent to the Rights Department, Oxford University Press, at the
address above.
You must not circulate this work in any other form
and you must impose this same condition on any acquirer.
Library of Congress Cataloging-​i n-​P ublication Data
Names: Fried, Charles, 1935–​, author. | Miller, Franklin G., editor. |
Wertheimer, Alan, editor.
Title: Medical experimentation : personal integrity and social policy/​
Charles Fried ; edited by Franklin Miller and Alan Wertheimer.
Description: New edition. | New York, NY : Oxford University Press, [2016] |
Includes index.
Identifiers: LCCN 2015040620 | ISBN 9780190602727 (pbk. : alk. paper)
Subjects: | MESH: Human Experimentation—​ethics—​United States. | Human
Experimentation—​legislation & jurisprudence—​United States. | Human
Rights—​United States. | Public Policy—​United States. | Randomized
Controlled Trials as Topic—​United States.
Classification: LCC R853.H8 | NLM W 20.55.H9 | DDC 174.2/​8—​dc23
LC record available at http://​lccn.loc.gov/​2015040620
1 3 5 7 9 8 6 4 2
Printed by Webcom, Canada
 CON TEN TS

Preface to the New Edition ix

Charles Fried

Introduction to the New Edition 1

Franklin G. Miller and Alan Wertheimer
1. Introduction 9
2. Th
 e Legal Context of Medical Experimentation 17
2.1. General principles  18
2.2. Consent  24
2.2.1. Th
 e Meaning of Consent  24
2.2.2. Qualifications of the Requirement
of Informed Consent  25
2.2.3. Overriding the Patient’s Failure to Consent  28
2.2.4. Withdrawal of Consent and the Continuing
Duty to Disclose  30
2.3. General Legal Principles Applied to Medical
Experimentation  31
 Contents

2.3.1. Non-​therapeutic Experimentation  33

2.3.2. Therapeutic Experimentation  35
2.3.3. M ixed Therapeutic and Non-​therapeutic
Research: The Problem of the Randomized
Clinical Trial  36
2.4. Participation in Experimentation as a Condition
of Medical Treatment  43
2.5. Statutes and Regulations  47
3. The Concept of Personal Care  53
3.1. D
 o Randomized Clinical Trials Really
Pose a Dilemma?  57
3.1.1. Th
 e Burdens on the Experimental Subject  57
3.1.2. Is Personal Care a Coherent Concept?  64
3.1.3. Th
 e Terms of the Conflict: Distributive
Justice and Rights  67
3.2. D
 istributive Justice  69
3.3. Th
 e Good of Personal Care  76
4. P
 ersonal Care: Interests or Rights  90
4.1. E
 conomic Theory and Medical Care  91
4.1.1. Efficiency  91
4.1.2. Distribution  97
4.2. The Concept of Rights  100
4.2.1. R ights and Efficiency  100
4.2.2. Negative and Positive Rights  104
4.3. P
 ersonal Integrity, the Goals of Medicine, and
Rights in Personal Care  105
4.3.1. Personal Integrity  107
4.3.2. S ickness and Death  109
4.3.3. Th
 e Function of Medical Care  110
4.3.4. R ights in Medical Care: Lucidity, Autonomy,
Fidelity, Humanity  113

vi
 Contents

5. Realizing Rights—​Medical Care in General  118

5.1. Preliminary Speculation: The Antinomy
of the Personal and the Social  120
5.1.1. P
 olitical Versus Ethical Theory  121
5.1.2. The Theory of Democracy  124
5.1.3. W
 hat Are We Entitled to Ask of Theory?  126
5.2. T wo Models of the Health Care System  129
5.2.1. Primary Care  131
5.2.2. Th
 e Hospital  142
5.2.3. The Department of Health  146
5.3. Th
 e Antinomy Confronted: Putting the Two
Models Together  148
5.3.1. Th
 e Rightness of Queuing  148
5.3.2. The Obligations of Bureaucrats  155
6. Th
 e Practice of Experimentation  157
6.1. Some Recent Randomized Clinical Trials  159
6.1.1. The Veterans Administration Cooperative
Study Group: Clinical Trial of
Anti-​Hypertensive Therapy  159
6.1.2. The University Group Collaborative
Oral Anti-​Diabetic Agent Randomized
Clinical Trial  160
6.1.3. C oronary Bypass Surgery  161
6.1.4. Th
 e Salk Polio Vaccine Trial  162
6.2. The Concept of Professional Knowledge  164
6.3. R ights in Experimentation  168
6.3.1. L ucidity and the Duty of Candor  168
6.3.2. Autonomy and the Concept of Professional
Accountability  171
6.3.3. F idelity and Humanity  172

vii
 Contents

6.4. R ights in Experimentation: Implementation

and Accommodations  173
6.4.1. A
 lternatives to Randomized
Controlled Trials  174
6.4.2. Accommodation by Differentiation of Role 178
6.4.3. C
 ompensation and Participation 183
From Medical Experimentation to Non-​Medical
Experimentation: What Can and Cannot Be Learned
from Medicine as to the Ethics of Legal and Other
Non-​Medical Experiments? 192
I. Glenn Cohen and D. James Greiner
Concluding Reflections 220
Charles Fried

Index 241

viii
 PR EFACE TO TH E N E W EDITION

Medical Experimentation: Personal Integrity and Social Policy has

been out of print for decades, and for me it had been a case of
out-​of-​sight, out-​of-​mind, as I turned my attention elsewhere.1 So
an invitation—​no doubt spurred by that long-​d istant book—​to
open a conference at Harvard Law School’s Petrie-​Flom Center in
March 2013 on evidence as a public good, gave me the opportunity
to conduct a not very strictly controlled experiment. I accepted the
invitation on condition that I could prepare by not rereading my
1974 text. That way I might learn just how much my thinking has
changed over the intervening four decades—​not only on issues of
medical experimentation but also on the concept of medical care

1. The closest I have come recently to issues relating to medical care has been as a consti-
tutional lawyer defending the constitutionality of the Affordable Care Act—​in print,
as an advocate in the Supreme Court, and in testimony before the Senate Judiciary
Committee. “The June Surprises: Balls, Strikes, and the Fog of War,” Journal of Health
Politics, Policy and Law 38(2), p. 225 (April 2013); and Chapter 4, pp. 51–​68 in The
Health Care Case: The Supreme Court’s Decision and Its Implications, Nathaniel Persily,
Gillian E. Metzger, & Trevor W. Morrison eds. (Oxford Univ. Press, 2013); S. Hrg.
112–​9 04, February 2, 2011: http://​w ww.gpo.gov/​fdsys/​pkg/​CHRG-​112shrg89899/​
html/​CHRG-​112shrg89899.htm.
 Pr efac e to t h e N e w E di t ion

in general and on the distinctly Kantian approach of that book to

issues of social policy. After all, I not only was older (if not wiser)
but also had in those intervening years been a government official,
a judge, and, maybe most important, a recipient of several episodes
of medical care. Present at that occasion were two distinguished
ethicists then working at the National Institutes of Health—​
Frank Miller and Alan Wertheimer. Both had given much thought
to ethical and practical issues relating to randomized trials, and
Wertheimer was to publish his rather radical proposal, so different
from my original conclusions, that we may all have a moral duty—​
though perhaps not an enforceable one—​to participate in clinical
trials.2 Miller and Wertheimer approached me to get my collabo-
ration in a project they had entertained for some time: The 1974
text was distinctive and important enough that it should be repub-
lished. Indeed, they had already discussed the idea with Peter
Ohlin, the distinguished editor at Oxford University Press, which
had previously published the canonical Oxford Textbook of Clinical
Research Ethics. 3 I welcomed that suggestion, asking only that the
original text have an introduction by Miller and Wertheimer and
be followed by an essay by my Harvard colleagues Glenn Cohen
and James Greiner on the burgeoning use of randomized trials in
the social and policy sciences and by my essay reflecting on how
the passage of time, new experiences, and changes in the organiza-
tion of medical practice had affected my perspective and conclu-
sions. This volume is the result, and I am grateful to all those I have
mentioned that the 1974 text is here resurrected in this enlarged
and I hope enriched form.

2. His thoughts were later published as Alan Wertheimer, (Why) Should We Require
Consent to Participate in Research?, 2 (1) J. L. & Biosciences 2, 8–​9 (2015), available at
doi: 10.1093/​jlb/​lsu039.
3. Ezekiel J. Emanuel et al. eds. (Oxford Univ. Press, 2008).

x
 Pr efac e to t h e N e w E di t ion

I must add that since the meeting at Harvard, not only the
field of medical ethics but also the many students and colleagues
he inspired and instructed suffered a great loss when Alan
Wertheimer died on April 10, 2015. Glenn Cohen wrote in his
memoir of this exemplary thinker: “When I was young I wanted
to be Alan Wertheimer.”4
Charles Fried
Cambridge, 2015

4. https:// ​ b logs.law.har vard.edu/ ​ b illof health/ ​ 2 015/​ 0 4/ ​ 2 0/​ r emembering- ​ a lan-​

wertheimer-​not-​only-​a-​philosophers-​philosopher-​but-​a-​lawyers-​philosopher

xi
 Introduction to the New Edition

FR A NK LIN G. M I LLER1 A ND A L A N W ERTH EI M ER 2

Medical Experimentation, by Charles Fried, published in 1974, is

a classic in the ethics of medical care and clinical research. Long
out of print, this book has once again become available for schol-
ars and students in medicine, bioethics, and health policy. It is the
first of a very few systematic philosophical accounts of the ethics
of randomized controlled trials (RCTs)—​the “gold standard” for
evaluating the effectiveness of medical treatments. Fried’s central
concern was with the conduct of RCTs without informed consent
by patients. Twenty years later, this concern might have seemed
to be of mainly historical interest. A formal, detailed, process of

1. Franklin G. Miller, Ph.D., Professor of Medical Ethics in Medicine, Weill Cornell

Medical College; Adjunct Faculty, Department of Bioethics, National Institutes of
Health; Associate Editor, Perspectives in Biology and Medicine.
2. Professor Wertheimer died on April 10, 2015. He was Professor Emeritus at the University
of Vermont and Senior Research Scholar, Department of Clinical Bioethics, National
Institutes of Health. Glenn Cohen, Faculty Director of the Petrie-​F lom Center, wrote a
memoir of Alan Wertheimer on the Petrie-​F lom blog that began as follows: “When I was
young I wanted to be Alan Wertheimer” (https://​blogs.law.harvard.edu/​billofhealth/​
2015/​0 4/​2 0/​r emembering-​a lan-​w ertheimer-​not-​only-​a -​philosophers-​philosopher-​
but-​a-​lawyers-​philosopher).
 M edica l E x per i m en tation

consent for research participation became the norm in the years

following 1966, when U.S. federal regulations required informed
consent (Miller 2014).
In 1999, Robert Truog and colleagues published a “Sounding
Board” article in the New England Journal of Medicine that argued
that informed consent should not be required in some RCTs com-
paring medically indicated treatment (Truog et al. 1999). As an
example, they suggested a trial of two antibiotics to prevent infec-
tion after surgery, which were both known to be effective but had
never been compared in an RCT. They contended that it would
be ethical to waive informed consent for research participation
because “no reasonable person should have a preference for one
treatment over the other.” Their article, however, was a shot in the
dark; it was generally dismissed or ignored because the authors’ the-
sis, which challenged standard research practice and the U.S. regu-
lations governing clinical research, seemed patently unacceptable.
Today, the climate of ethical thinking about RCTs is in a
state of flux. Now, many commentators are extolling the virtues
of the “learning health care system”—​an approach to organizing
and delivering health services that systematically and seamlessly
integrates medical care with clinical research. The main source
of research data to guide learning activities in this system is elec-
tronic medical records, which can be mined for observational
studies regarding medical treatments and institutional practices,
with the aim of promoting continuous improvement in the quality
of medical care. In addition, these records can be tapped efficiently
to gather outcome data for pragmatic, comparative effectiveness
RCTs—​studies that are designed to inform clinicians making
treatment recommendations for patients and mirror the circum-
stances of clinical practice as closely as possible. Various commen-
tators argue that at least some of these RCTs evaluating medically

2
 Introduction to th e New Edition

indicated treatments for patients might be conducted ethically

without first soliciting their informed consent (Faden et al. 2013,
2014). In medical practice today, doctors often have no evidence-​
based reasons for choosing between alternative treatment options
for patients because these treatments have never been compared
head-​to-​head in RCTs; accordingly, some, following the lead of
Truog and colleagues, argue that patients have no interests that
are set back by randomization between medically indicated treat-
ments. Because the selection of treatments recommended to
patients in these situations is essentially random, it is suggested
that there is no need to disclose to patients that they are receiving
a treatment prescription in the context of a randomized trial.
In this context, Fried’s book, oriented around the concept of
personal care as defining the normative ethos of the doctor–​patient
relationship, has become once again a strikingly relevant inquiry
into the ethics of medical care and clinical research. Can pragmatic
RCTs be facilitated without violating personal care? Should we be
prepared to deviate from the legitimate expectations of patients
regarding their medical care in order to promote clinical research
with great promise to improve medical care for the population of
patients and for the benefit of society?
Fried characterized the ethos of personal care as reflecting
both an ideal interpersonal relationship and a set of rights owed
to patients. He analyzed this ethos into four components: lucidity,
autonomy, fidelity, and humanity. Lucidity, which may be better
described as transparency, obliges physicians to inform patients
about relevant facts relating to their medical condition and to dis-
cuss a recommended treatment plan. Autonomy, in this context,
constitutes the patient’s opportunity to decide whether or not
to accept the doctor’s recommended treatment plan. Assuring
that treatment is consistent with the patient’s preferences and

3
 M edica l E x per i m en tation

values emerges out of transparent communication and autonomy.

Fidelity encompasses the doctor’s devotion to promoting the med-
ical best interest of the patient and the patient’s expectation of, and
reliance on, the trustworthiness of the doctor. Fried notes that,
more generally, fidelity involves the idea that “dealings among per-
sons [in specific relationships such as friendship and clinical medi-
cine] create expectations of reliance and trust” (102). Moreover,
“deliberately to disappoint such expectations is a form of deceit”
(102). Finally, Fried explains humanity as follows: “A person has
a right to have his full human particularity taken into account by
those who enter into relations to him” (103). Humanity reflects the
responsibility of clinicians to care for and to care about the par-
ticular patients with whom they enter into a clinical relationship.
Each of these components of personal care can be seen both as an
obligation of clinicians and as a legitimate expectation (indeed, a
right) of patients.
Some commentators on the ethics of clinical research have
argued that RCTs are antithetical to the ethos of personal care by
virtue of selecting treatment randomly rather than by clinical judg-
ment regarding what is best for an individual patient (Hellman &
Hellman 1991). Although Fried was concerned about the poten-
tial of RCTs to compromise personal care, he did not argue that
they are unethical. Instead, he argued that the departure from
personal care involved in treatment selection and delivery under
RCTs must be called to the attention of patients (transparency)
so that they have the opportunity to authorize or refuse research
participation (autonomy). Without this requirement of informed
consent, patients are deceived about their treatment in the context
of RCTs, and fidelity is breached.
Fried criticized the tendency of advocates of RCTs during the
1950s and 1960s to appeal to the concept of equipoise to justify

4
 Introduction to th e New Edition

(or rationalize) the absence of transparency and consent. In a

remark that bears emphasis for the contemporary context, Fried
declared, “An experiment relying on withholding the information
[about random selection of treatment] is deceitful, even if the doc-
tor honestly believes that the choice is so closely balanced as to
make the information irrelevant” (163). In other words, equipoise,
even in the strong sense of clinicians’ indifference between the
treatments being compared in an RCT for patients with a given
condition, does not warrant the absence of informed consent. The
patient’s right to personal care vests the decision to receive treat-
ment in an RCT with the patient. Waiving informed consent to
research participation in RCTs of individual treatment options
violates the legitimate expectations of patients and is thus dis-
respectful. The patient has a legitimate interest in making such
choices “even if we are sure that there is only one rational choice
for him to make” (56).
The randomized trials without informed consent that Fried
criticized in 1974 in some respects differed importantly in their
implications for the interests of patients compared with the type
of quality improvement and pragmatic trials that some now argue
do not require patient consent for research participation (Truog
et al. 1999; Faden et al. 2013, 2014). In particular, Fried focused
on trials of radical versus simple mastectomy for breast cancer
in which it appeared that patients did not consent to being ran-
domized. The clinical context of this type of study epitomizes a
preference-​sensitive treatment choice. Patients likely have strong
preferences between these more or less invasive sorts of treat-
ments, in contrast to the situation posed, for example, by an RCT
comparing two U.S. Food and Drug Administration–​approved
drugs to treat hypertension, with similar side effect profiles
(Faden et al. 2013). Nevertheless, the question remains: Can it

5
 M edica l E x per i m en tation

be ethical to waive informed consent to research participation,

and thus conceal random selection of treatments from patients,
even when an RCT compares two medically indicated treatments
for a medical condition and physicians have no evidence-​based
reasons for preferring one over the other? Fried recognizes that
insisting on the ethics of personal care may mean that “better
remedies would be more slowly developed” while ineffective
treatments would be more slowly withdrawn. He believes that
price “may be worth paying” (168). Maybe, maybe not. In any
case, it is clear that engaging with the arguments in Fried’s classic
book can inform the perspectives of clinicians, investigators, and
policymakers interested in the development of learning health
care systems.
In addition to its normative relevance to the question of
whether informed consent is necessary for RCTs, Fried’s explica-
tion of personal care has informed bioethical thinking about the
challenge of obtaining informed consent to these studies. Today,
“the therapeutic misconception” is a term of art in bioethics that
denotes the difficulty that patient-​subjects have in understanding
or appreciating the important differences between being treated
by doctors in medical care and receiving treatment in an RCT.
Many of those who invoke this term to raise doubts about the qual-
ity of informed consent from patients enrolled in RCTs may not
be aware that the articulation of this theme by Paul Appelbaum
and colleagues relies centrally on Fried’s work. In their first article
exploring the therapeutic misconception, Appelbaum, Roth, and
Lidz (1982) stated that

implicit in Fried’s “personal care” argument is the notion that

unless otherwise informed, research subjects will assume
(especially, but not exclusively in therapeutic research) that

6
 Introduction to th e New Edition

decisions about their care are being made solely with their ben-
efit in mind. . . . This mindset on the part of subjects we shall
refer to as “the therapeutic misconception.” (321)

The extent to which patients enrolled in RCTs genuinely mani-

fest the therapeutic misconception and whether their harboring
therapeutic misconceptions undermine the validity of informed
consent are contested issues today in bioethics. The empirical and
normative salience of personal care is central to this debate.
Finally, the concept of personal care lies at the heart of contro-
versies over what is now sometimes called “rationing at the bed-
side.” Given the allegedly unsustainable cost of medical care, it is
now commonly argued that physicians should sometimes withhold
medical interventions that they believe would have net clinical ben-
efit for their patients. It is not just that the background institutions
should constrain what physicians should do for their patients in the
name of a just health care system, but that the physicians should
themselves sometimes sacrifice the interests of their patients for
the sake of promoting a fairer and less costly health care system. If
we extend Fried’s analysis to this issue, it would seem that bedside
rationing “does violence to the integrity” of the physician–​patient
relationship (74). Whether the advocates of bedside rationing can
meet this challenge is a question that remains to be answered.
Medical ethics is not carved in stone. As medicine and clinical
research undergo transformation, the ethics of the doctor–​patient
relationship warrants re-​evaluation. Is personal care an anach-
ronistic ideal with limited relevance to the contemporary world?
Or does it continue to define a set of obligations of clinicians and
rights of patients that we should continue to cherish and strive to
realize? Anyone seriously interested in the ethics of medicine and

7
 M edica l E x per i m en tation

clinical research will profit from engaging with the analysis and
arguments in Medical Experimentation.

REFERENCES

Appelbaum, Paul S., Loren H. Roth, and Charles W. Lidz. 1982. “The Therapeutic
Misconception: Informed Consent in Psychiatric Research,” International
Journal of Law and Psychiatry 5:319–​29.
Faden, Ruth, Nancy Kass, Danielle Whicher, Walter Stewart, and Sean Tunis.
2013. “Ethics and Informed Consent for Comparative Effectiveness
Research with Prospective Electronic Clinical Data,” Medical Care 51(8,
Suppl 3):S53–​S57.
Faden, Ruth R., Tom L. Beauchamp, and Nancy E. Kass. 2014. “Informed
Consent, Comparative Effectiveness, and Learning Health Care,” New
England Journal 370:766–​68.
Fried, Charles. 2016. Medical Experimentation: Personal Integrity and Social Policy.
New York: Oxford University Press, New Edition.
Hellman, Samuel, and Deborah S. Hellman. 1991. “Of Mice But Not
Men: Problems of the Randomized Clinical Trial,” New England Journal of
Medicine 324:1585–​89.
Miller, Franklin G. 2014. “Clinical Research Before Informed Consent,” Kennedy
Institute of Ethics Journal 24:141–​57.
Truog, Robert D., Walter Robinson, Adrienne Randolph, and Alan Morris.
1999. “Is Informed Consent Always Necessary for Randomized, Controlled
Trials?” New England Journal of Medicine 340:804–​0 6.

8
 C ha pt e r 1

Introduction

This essay, though long and in some respects perhaps exhaustive,

does not seek to be definitive. There never will be a definitive treat-
ment of the law and ethics of medical treatment in general, and so
of medical experimentation in particular. Medicine is concerned
with man’s health, and human health is no more a fixed notion than
is human nature with which it is directly correlated. It is neither
surprising nor particularly unreasonable that in many cultures
medicine is the province of religion. One need only recognize our
own culture’s inability successfully to integrate in or exclude from
scientific medicine psychoanalytic theory and practice to see that
each culture’s definition of and approach to health implicates the
widest range of philosophical presuppositions about man—​both
as an individual and as a social being. Even the view that medicine
is concerned solely with the health of the body implies a view of
the relation of body to person.
Medical experimentation, its proprieties and excesses, have
been treated often and thoroughly in recent years.1 The occasion

1. J. Katz, Experimentation with Human Beings (1972) [hereinafter cited as Katz] is a mas-
sive and comprehensive collection of excerpts from materials bearing on all aspects of
the subject. In addition it contains an extensive index. The work is invaluable for any
serious researcher in the subject and I was greatly assisted by it. Two recent monographs
 M edica l E x per i m en tation

for yet another treatment, where there can be no definitive treat-

ment, arises because these other treatments in pressing towards
concrete conclusions, recognize but do not linger over those deep-
est, most difficult and most insoluble questions within which the
particular subject is embedded. In this essay I shall reverse the
usual, sensible impulse to trade philosophical and theoretical
complexity for a modicum of usefulness. The exploration of philo-
sophical, moral questions will hold center stage here, and concrete
recommendations will be developed as by-​products, hypotheses,
tentative conclusions. There will be concrete conclusions and rec-
ommendations, but in the end it is the speculation and analysis
which lead to them and which they illustrate that I offer as my par-
ticular contributions to this subject, a subject which most broadly
is the relation of man to his body, the terms on which men care for
each other, and the terms on which men and their bodies are at the
disposal of the human groups of which they are a part.
The expanding capability of medicine and the recognition of
an expanding responsibility to offer the best of care to everyone
have forced a recognition of dilemmas that for centuries have been
buried beneath the surface by common consent and professional
reticence. Any thoughtful person now must know that if we do
not engage in continuous and thorough medical experimentation

of special interest are H. Beecher, Research and the Individual—​Human Studies (1970)
and P. Ramsey, The Patient as Person (1970). Finally, two excellent recent symposia are
vol. 98 Daedalus—​Journal of the American Academy of Arts & Sciences, Ethical Aspects
of Experimentation with Human Subjects (1969), also published as Experimentation
with Human Subjects (P. Freund, ed, 1970) [hereinafter cited as Daedalus], and New
Dimensions in Legal and Ethical Concepts for Human Research, 169 Annals N. Y. Acad. Sci.
(1970) [hereinafter cited as Annals].
   The most eloquent recent plea by a distinguished clinician and now a high official in
the British National Health Service for experimentation and particularly for random-
ized clinical trials as part of a rational health policy is A. L. Cochrane, Effectiveness and
Efficiency (1972).

10
 1 Introduction

we risk forgoing the benefits of new remedies, or poisoning our-

selves with insufficiently tested new remedies, or indeed poison-
ing ourselves with accepted but unsound old remedies. Moreover,
where we do not risk harm, we risk waste. And given our social
commitment to make available to all what we offer to some, every
expenditure is potentially multiplied a million fold, and in that
perspective a useless therapy, a wasteful procedure can cost the
price of a year of schooling for the children of a whole region.
As we make this commitment to equality, so too we commit
ourselves to seeing these questions in terms of populations and
generations, and in this perspective the individual, who was tra-
ditionally the unit of the physician’s concern, becomes a fungible
item in the mass, for otherwise it just is not possible to make the
calculations and compute the costs.
It is in this perspective that the claims of experimentation
have become so urgent. If medicine is to be viewed as caring for
populations, then the information on which one acts becomes just
one more factor to be prudently managed in developing an overall
strategy for the best long-​r un discharge of this responsibility. Just
as prudent calculations must be made regarding the comparative
advantages of improved water supplies, better housing, inocula-
tion programs and the like, so the costs of getting or not getting
more information regarding new or old therapies must be weighed
in the equation. And that is all there is to it.
But that is not all there is to it. The inhumanity and the pro-
fessional arrogance of medical experimentation is one of the
popular themes of Western public discourse—​at least since the
Nuremberg trials. Many who have never even heard of the Nazi
doctors see medical experimentation and the claims of the medi-
cal bureaucracy as yet another example of technocratic pretension,
to be treated with suspicion and ultimately to be resisted. Doctors,

11
 M edica l E x per i m en tation

drug companies and medical experimenters are subject to more

searching publicity and to stricter controls than ever before in the
name of the autonomy of the individual. Perhaps all this is a point-
less flurry at the edges as politicians and journalists refuse to admit
the inevitable. Or to the extent that the resistance is effective, per-
haps it represents a harmful irrationality, wasting in the name of
meaningless abstractions real resources that might be used to alle-
viate real misery.
Both tendencies are very powerful, nor do they have a unique
bearing on medical experimentation. Similar conflicts are felt in
the areas of criminal law, procedure and corrections, in the control
of bureaucracies concerned with housing, education, employment,
land use, the environment and technology. And though there are
special interests that profit from the victories of one or the other
side, the conflict is essentially one of ideas. In general those who
favor an overall view in terms of groups and populations appear to
have reason on their side. At any rate they have on their side what
appears to be the apparatus of reason: statistics, calculations, pre-
dictions, cost–​benefit analysis, linear programming, program bud-
geting and so on. On the other side are strong feeling, rhetoric, and
often the conservative, stubborn force of the law. One of my major
reasons for undertaking this study is to see if philosophical analy-
sis, by deflating somewhat the pretensions of the first approach
and rationalizing and clarifying the rhetoric of the second, cannot
come up with something that is clear and coherent and at the same
time true to our moral intuitions. This effort has been made before,
at various levels of abstraction. It is an enterprise that began with
Kant’s attempt to develop a social, political, and personal moral-
ity that avoided what he called “the serpent-​w indings of utilitari-
anism.” The most distinguished recent such work is John Rawls’
A Theory of Justice. By taking medical experimentation as my

12
 1 Introduction

subject, I hope to continue this effort, but focusing on a concrete

application of theory and principles.
The Nazi doctors deliberately inflicted horrible suffering on
helpless, unwilling subjects, just as distinguished doctors for
generations before them deliberately infected unknowing poor,
or ignorant, or retarded subjects with various diseases in order
to study their progress and treatment. That kind of experimen-
tation finds no defenders today. The issues today concern volun-
teers, paid or not, the use of children and incompetents who are
also often “volunteered” by their guardians, and trials of new or
old therapies on ill persons in the course of treating their very ill-
ness. It is the last kind of experimentation that will be the focus
of this essay.
It is in this last category of experiment that the subtlest general
questions are raised and the largest claims are made. These ques-
tions and claims will be used to focus the argumentation through-
out the essay. Problems relating to children and incompetents
I put aside. They are agonizingly difficult, but illuminate more the
special status of infancy or incompetence than the questions of
experimentation.
In the category I am interested in varying modalities of a new
but promising treatment will be tried on an ill person, in part to cure
him and in part to evaluate and perfect the new treatment. Often
traditional alternatives are ineffective or have serious drawbacks.
Thus, it is said, an effort is being made not only to cure the indi-
vidual patient but also to help others similarly afflicted. The most
sophisticated and presently most fashionable version of this form
of therapeutic investigation is the randomized clinical trial (RCT),
in which the allocation of a patient to a particular treatment cat-
egory or its alternative—​sometimes an alternative therapy, some-
times a placebo, that is no therapy at all—​is done at random. In this

13
 M edica l E x per i m en tation

way, if there are enough cases the influence of extraneous factors

on the outcome can be washed out and the effects attributable to
the treatment under investigation isolated. A further refinement is
double-​blind or single-​blind trials in which the results of the ran-
dom assignment are kept from the subject and/​or the investigators
until after the completion of the trial. The RCT has many points of
appeal to medical researchers. Since the factors influencing health
and illness are so numerous, a satisfactory theoretical demonstra-
tion of the full causal efficacy of a therapy is hard to come by. And
for the same reason comparative studies, regression analyses and
the like might fail to notice the significance of some interfering fac-
tor. Finally, in a field fraught with professional rivalries and vested
interests, it is often only the statistically most impregnable demon-
strations that will convince the skeptics.
Complementing the statistical allure of the RCT is its appeal to
what many think is the most rational conception of medical care
for populations as a whole. The RCT invites us to look at diseases
as afflicting populations and at therapies as reducing the incidence
of disease. The RCT by leading not to accounts of a few successful
cures but to comparisons of mortality or morbidity rates in large
groups asks the questions that many think are the relevant ones.
Nor on this view does the individual have anything to complain
about. Ideally randomization will not be resorted to unless and
until there is a real division of opinion regarding the relative mer-
its of the two therapies (including on occasion placebo therapy),
so that no one is being deprived ex ante of the “better” therapy.
Moreover, anyone who is a patient in a system that regularly has
recourse to RCT testing has overall a better chance of being treated
with more effective therapies at less cost. In any case, what else is
to be done if new treatments are to be developed, the sum total of
misery lessened? Somehow the new must be evaluated against the

14
 1 Introduction

old if progress is to be made, and often the RCT is the best way of
accomplishing this.
Because the RCT expresses so neatly a particular way of looking
at the ends of medicine, at social policy in general and at the rights
and obligations of individuals implicated in the implementation
of the policy, I shall make the RCT the particular concern of this
essay. In examining the claims made for the RCT, objections to it,
in considering qualifications and proposing acceptable modalities
and alternatives to the RCT I hope to clarify to some extent the
widening circle of issues related to it: the conflict between care for
individuals and care for groups, the proper ends of medicine, the
significance of consent and the meaning of full disclosure in pre-
serving individual autonomy, the contrast between fairness and
efficiency in social schemes, and the function of compensation to
effect fairness after the fact.
I shall begin in the next chapter with a review of the princi-
pal legal doctrines bearing on the rights and liabilities, permis-
sions and prohibitions relating to those acting and acted upon in
medical research. In this way we can establish some basic con-
ceptual distinctions, identify the issues that have attracted suffi-
cient social attention to be dealt with in legal doctrine, and put a
concrete foundation under our ethical speculations. It is striking
that much of what concerns us has not been dealt with directly in
court decisions or legal codes, although some quasi-​legal sources
like the Nuremberg Code and the Declaration of Helsinki and
some administrative materials like the Department of Health,
Education and Welfare Policy on Protection of Human Subjects2
come closer. In the end, to determine the law regarding RCTs we

2. Federal Register, vol. 38, no. 194, October 9, 1973, page 27882. The proposed rules are
substantially similar to the earlier NIH Guide published in 1971.

15
 M edica l E x per i m en tation

will have to rely to a great extent on extrapolation from existing

precedents and general doctrine. Such extrapolation, however
convincing, is an uncertain guide to what the first actual case will
hold. For in seeing what the implications of a precedent or doc-
trine are a court may decide to abandon or modify it. And this
is just one reason why even the most definitive statement of the
existing law is only a first step: Not only can the law change, but it
is our responsibility to judge if the law is wise, and if it is not wise
to urge that it be changed and to show what the changes should be.
This is what the succeeding chapters seek to do. Chapters 3 and
4 argue that personal care is both an interest and a right, and in
the course of that argument develop a notion of rights at variance
with much economic writing in the health care field. Chapter 5
asks how the theoretical notions in the prior chapters and espe-
cially the rights in personal care come together to form a coherent
whole, given the demands of responsibility for patients not only
on a one-​by-​one basis but as members of social groups and popu-
lations. The method is to confront the theoretical notions of the
previous discussion with the realities of medical economics and
medical practice. The final chapter applies the more general ideas
and arguments to the issues of medical experimentation in order
to test them, deepen them, and bring them down to earth in con-
crete recommendations.

16
Another random document with
no related content on Scribd:
 Second Ballot.
States. No. J. G.
Delegates. Blaine. Arthur. Edmunds. Logan. Sherman Hawley. Lincoln. Sherman
[74]Alabama 20 2 17 1
Arkansas 14 11 3
California 16 16
Colorado 6 6
Connecticut 12 12
Delaware 6 5 1
Florida 8 1 7
Georgia 24 24
Illinois 44 3 1 40
Indiana 30 18 9 1 2
Iowa 26 26
Kansas 18 13 2 2 1
Kentucky 26 5 17 2 1 1 [74

Louisiana 16 4 9 2
Maine 12 12
Maryland 16 12 4
Massachusetts 28 1 3 24
Michigan 26 15 4 5
Minnesota 14 7 1 6
Mississippi 18 1 17
Missouri 32 7 10 5 8 1
Nebraska 10 8 2
Nevada 6 6
New
Hampshire 8 5 3
New Jersey 18 9 6 1 2
New York 72 28 31 12 1
North
Carolina 22 3 18 1
Ohio 46 23 23
Oregon 6 6
Pennsylvania 60 47 11 1 1
Rhode Island 8 8
South
Carolina 18 1 17
Tennessee 24 7 16 1
Texas 26 13 11 2
Vermont 8 8
Virginia 24 2 21 1
West Virginia 12 12
Wisconsin 22 11 6 5
Territories.
Arizona 2 2
Dakota 2 2
Idaho 2 2
Montana 2 1 1
New Mexico 2 2
Utah 2 2
Washington 2 2
Wyoming 2 2
Dist. of
Columbia 2 1 1
Total 820 349 275 85 61 28 13 4
 Third Ballot.
States. No. J. G.
Delegates. Blaine. Arthur. Edmunds. Logan. Sherman Hawley. Lincoln. Sherman
[75]Alabama 20 2 17 1
Arkansas 14 11 3
California 16 16
Colorado 6 6
Connecticut 12 12
Delaware 6 5 1
Florida 8 1 7
Georgia 24 24
Illinois 44 3 1 40
Indiana 30 18 10 2
Iowa 26 26
Kansas 18 15 2 1
Kentucky 26 6 16 2 1 1 [75

Louisiana 16 4 9 2
Maine 12 12
Maryland 16 12 4
Massachusetts 28 1 3 24
Michigan 26 18 3 3 1
Minnesota 14 7 2 5
Mississippi 18 1 16 1
Missouri 32 12 11 4 4 1
Nebraska 10 10
Nevada 6 6
New
Hampshire 8 5 3
New Jersey 18 11 1 6
New York 72 28 32 12
North
Carolina 22 4 18
Ohio 46 25 21
Oregon 6 6
Pennsylvania 60 50 8 1 1 1
Rhode Island 8 8
South
Carolina 18 2 16
Tennessee 24 7 17
Texas 26 14 11 1
Vermont 8 8
Virginia 24 4 20
West Virginia 12 12
Wisconsin 22 11 10
Territories.
Arizona 2 2
Dakota 2 2
Idaho 2 2
Montana 2 1 1
New Mexico 2 2
Utah 2 2
Washington 2 2
Wyoming 2 2
Dist. of
Columbia 2 1 1
Total 820 375 274 69 53 25 13 8
 Fourth Ballot.
States.
No. Delegates. Arthur. Blaine. Edmunds. Logan. Sherman. Hawley. Lincoln.
[76]Alabama 20 12 8
Arkansas 14 3 11
California 16 16
Colorado 6 6
Connecticut 12 12
Delaware 6 1 5
Florida 8 5 3
Georgia 24 24
Illinois 44 3 34 6
Indiana 30 30
Iowa 26 2 24
Kansas 18 18
Kentucky 26 15 9 1 1[77]
Louisiana 16 7 9
Maine 12 12
Maryland 16 1 15
Massachusetts 28 7 3 18
Michigan 26 26
Minnesota 14 14
Mississippi 18 16 2
Missouri 32 32
Nebraska 10 10
Nevada 6 6
New Hampshire 8 2 5 3
New Jersey 18 0 17 1
New York 72 30 26 9 2 1
North Carolina 22 12 8 1
Ohio 46 0 46
Oregon 6 0 6
Pennsylvania 60 8 51 1
Rhode Island 8 1 7
South Carolina 18 15 2 1
Tennessee 24 12 11
Texas 26 8 15
Vermont 8 0 0 8
Virginia 24 20 4
West Virginia 12 0 12
Wisconsin 22 0 22
Territories.
Arizona 2 0 2
Dakota 2 0 2
Idaho 2 0 2
Montana 2 0 2
New Mexico 2 2 0
Utah 2 0 2
Washington 2 0 2
Wyoming 2 2 0
Dist. of Columbia 2 1 1
Total 820 207 541 41 7 15 2
 States. Yeas Nays
Alabama 15 5
Arkansas 14
California 16
Colorado 4 2
Connecticut 2 10
Delaware 6
Florida 2 6
Georgia 12 12
Illinois 22 22
Indiana 30
Iowa 6 20
Kansas 3 15
Kentucky 20 6
Louisiana 16
Maine 2 10
Maryland 16
Massachusetts 21 7
Michigan 12 12
Minnesota 14
Mississippi 18
Missouri 18 24
Nebraska 5 5
Nevada 6
New Hampshire 8
New Jersey 14 4
New York 72
North Carolina 10 12
Ohio 25 21
Oregon 6
Pennsylvania 21 39
Rhode Island 8
South Carolina 3 14
Tennessee 17 7
Texas 12 10
Vermont 8
Virginia 6 18
West Virginia 9 3
Wisconsin 5 17

The Secretary announced the result of the vote as follows: Total number of votes cast, 795; yeas, 332;
nays, 463.

The report of the Committee on Permanent Organization was then made; the name of W. H. Vilas, of
Wisconsin, being presented as President, with a list of vice-presidents (one from each state) and several
secretaries and assistants, and that the secretaries and clerks of the temporary organization be
continued under the permanent organization.
 The Contest over the Platform.

There was a two-days contest in the Committee on Resolutions over the adoption of the revenue
features of the Platform. It advocated the collection of revenue for public uses exclusively, the italicized
word being the subject of the controversy. It was retained by a vote of 20 to 18. To avoid extended debate
in the Convention an agreement was made that Gen. Butler should make a minority report, and that
three speeches should be made, these by Butler, Converse and Watterson. Col. Morrison, of Illinois,
made the majority report, which was adopted with but 97½ negative votes out of a total of 820.
 The Ballots.

Before balloting an effort was made to abolish the two-third rule, but this met with such decided
disfavor that it was withdrawn before the roll of States was completed.
There were two ballots taken on the Presidential candidates, and they were as follows:

First. Second.
Total number of votes 820 820
Necessary to a choice 547 547
Grover Cleveland, of New York 392 684
Thomas F. Bayard, of Delaware 168 81½
Allen G. Thurman, of Ohio 88 4
Samuel J. Randall, of Penn 78 4
Joseph E. McDonald of Indiana 56 1
John G. Carlisle, of Kentucky 27
Roswell P. Flower, of New York 4
George Hoadly, of Ohio 3
Samuel J. Tilden, of New York 1
Thomas A. Hendricks, of Indiana 1 45½

Mr. Hendricks, of Indiana, who was defeated eight years ago on the Tilden ticket, was nominated for
Vice-President by acclamation.
The Kelly and Butler elements of the Convention, at all of the important stages, manifested their
hostility to Cleveland, but there was no open bolt, and the Convention completed its work after sitting
four days.
[In the Book of Platform is given the Democratic Platform in full, and its tariff plank will be found in
comparison with the Republican in the same book.]
 THE CAMPAIGN OF 1884.

In what were regarded as the pivotal States the campaign of 1884, was attended with the utmost
interest and excitement. Blaine, the most brilliant political leader of modern times, was acceptable to all
of the more active and earnest elements of the Republican party, and the ability with which he had
championed the protective system and a more aggressive foreign policy, attracted very many Irishmen
who had formerly been Democrats. The young and more intelligent leaders of this element promptly
espoused the cause of the Republicans, and their action caused a serious division in the Democratic
ranks. Wherever Irish-Americans were sufficiently numerous to form societies of their own, such as the
“Irish-American League,” the “Land League,” the “Clan na Gael,” etc., there supporters of Blaine were
found, and these were by a singular coincidence most numerous in the doubtful States of New York, New
Jersey, Connecticut, Ohio and Indiana. Cleveland’s nomination by the Democrats had angered the
Tammany wing of the party in New York, and not until very close to the election was a reconciliation
effected. Tilden had from the first favored Cleveland, and with Daniel Manning as his manager in New
York, no effort was spared to heal Democratic divisions and to promote them in the Republican ranks.
Thus the Independent or Civil Service wing of the Republican party, which in Boston and New York
cities, and in the cities of Connecticut, confessed attachment to free trade, was easily rallied under the
Democratic banner. In convention in New York city this element denounced Blaine on what it
pronounced a paramount moral issue, and for a time such brilliant orators as Rev. Henry Ward Beecher,
George W. Curtis and Carl Schurz, “rang the changes” upon the moral questions presented by the
canvass. They were halted by scandals about Cleveland, and the Maria Halpin story, almost too indecent
for historical reference, became a prominent feature of the campaign with the acquiescence, if not under
the direction of the Republican managers. Many of our best thinkers deplored the shape thus given to
the canvass, but the responsibility for it is clearly traceable to the plan of campaign instituted by the
Independents, or “Mugwumps,” as they were called—“Mugwump” implying a small leader.
Only Ohio, West Virginia and Iowa remained as October States, and in the height of the canvass all
eyes were turned upon Ohio. In all of the Western States both of the great parties had been distracted by
prohibitory and high license issues, and Ohio,—because of temperance agitations, which still remained
as disturbing elements—had drifted into the Democratic column. If it were again lost to the Republicans,
their national campaign would practically have ended then and there, so far as reasonable hopes could
be entertained for the election of Blaine. This fact led to an extraordinary effort to influence favorable
action there, and both Blaine and Logan made tours of the State, and speeches at the more important
points. Mr. Blaine first went to New York city, thence through New Jersey, speaking at night at all
important points on the Pennsylvania Railroad, and was the following day received by the Union League
of Philadelphia. In the evening he reviewed a procession of 20,000 uniformed men. He then returned to
New York, not yet having uttered a partisan sentence, but in passing westward through its towns, he
occasionally referred to their progress under the system of protection. Reaching Ohio, he spoke more
and more plainly of the issues of the canvass as his journey proceeded, and wherever he went his
speeches commanded national comment and attention. His plain object was, for the time at least, to
smother local issues by the graver national ones, and he did this with an ability which has never been
matched in the history of American oratory. The result was a victory for the Republicans in October;
they carried Ohio by about 15,000, and greatly reduced the Democratic majority in West Virginia.
From this time forward the battle on the part of the Republicans was hopeful; on the part of the
Democrats desperate but not despairing. Senator Barnum, the Chairman of the Democratic National
Committee, was a skilled and trained politician, and he sedulously cultivated Independent and
Prohibition defection in New York, Connecticut, New Jersey, Wisconsin and Indiana. Whether the
scandals growing out of the result be true or false, every political observer could see that the elements
named were under at least the partial direction of the Democratic National Committee, for their support
was inconsiderable in States where they were not needed in crippling the chances of the Republicans.
The Republican National Committee, headed by Mr. B. F. Jones, of Pennsylvania, an earnest and able,
but an untrained leader, did not seek to check these plain efforts at defection. This Committee thought,
and at the time seemed to be justified in the belief that the defection of Irish-Americans in the same
States would more than counterbalance all of the Independent and Prohibitory defection. The
Republicans were likewise aided by General Butler, who ran as the Greenback or “People’s” candidate, as
he called himself. It would have done it easily, but for an accident, possibly a trick, on the Thursday
preceding the November election. Mr. Blaine was at the Fifth Avenue Hotel in New York, and among the
many delegations which visited him was one of three hundred ministers who wished to show their
confidence in his moral and intellectual fitness for the Chief Magistracy. The oldest of the ministers
present was Mr. Burchard, and he was assigned to deliver the address. In closing it he referred to what
he thought ought to be a common opposition to “Rum, Romanism and Rebellion,”—an alliteration which
not only awakened the wrath of the Democracy, but which quickly estranged many of the Irish-American
supporters of Blaine and Logan. Mr. Blaine on the two following days tried to counteract the effects of an
imprudence for which he was in no way responsible, but the alliteration was instantly and everywhere
employed to revive religious issues and hatreds, and to such an extent that circulars were distributed at
the doors of Catholic churches, implying that Blaine himself had used the offensive words. A more
unexpected blow was never known in our political history; it was quite as sudden and more damaging
than the Morey forgery at the close of the Garfield campaign. It determined the result, and was the most
prominent of half a dozen mishaps, which if they had not happened, must have inevitably led to the
election of Blaine.
As it was, the result was so close in New York, Connecticut, New Jersey, Indiana and West Virginia,
that it required several days to determine it, and it was not known as to New York until the 19th of
November.
The popular vote for Presidential electors was cast on the 4th of November last, and the results are
tabulated below. Where differences were found to exist in the vote for Electors in any State the vote for
the highest on each ticket is given in all cases where the complete statement of the vote of the State has
been received. The results show a total vote of 10,046,073, of which the Cleveland ticket received
4,913,901, the Blaine ticket 4,847,659, the Butler ticket 133,880, and the St. John ticket 150,633,
showing a plurality of 66,242 for Cleveland. The total vote in 1880 was 9,218,251, and Garfield’s
plurality 9464. It should be noted, in considering the tabulated statement of this year’s vote, that the
Blaine Electoral tickets were supported by the Republicans and the People’s Party in Missouri and West
Virginia, and that Cleveland Electoral tickets were supported by the Democrats and the People’s Party in
Iowa, Michigan and Nebraska. The People’s Party claims to have cast about 41,300 votes for the fusion
ticket in Michigan and about 33,000 votes in Iowa. The vote of California is official from all but two
counties; the unofficial reports from these are included in the totals given in the table. South Carolina
returns 1237 “scattering” votes.
 1884.
STATES. Electoral Vote.
Blaine, Rep. Cleveland, Dem. Butler, People’s St. John, Pro. Blaine. Cleveland.
Alabama 59,444 92,973 762 610 10
Arkansas 50,895 72,927 1,847 7
California 102,397 89,264 2,017 2,920 8
Colorado 36,277 27,627 1,957 759 3
Connecticut 65,898 67,182 1,685 2,494 6
Delaware 12,778 17,054 6 55 3
Florida 28,031 31,769 74 4
Georgia 47,603 94,567 125 184 12
Illinois 340,497 312,314 10,910 12,074 22
Indiana 238,480 244,992 8,293 3,013 15
Iowa 197,082 177,286 1,472 13
Kansas 154,406 90,132 16,346 4,495 9
Kentucky 118,674 152,757 1,655 3,106 13
Louisiana 46,347 62,546 120 338 8
Maine 72,209 52,140 3,953 2,160 6
Maryland 85,699 96,932 531 2,794 8
Massachusetts 146,724 122,481 24,433 10,026 14
Michigan 192,669 189,361 763 18,403 13
Minnesota 111,685 70,065 3,583 4,684 7
Mississippi 42,774 78,547 9
Missouri 202,029 235,988 2,153 16
Nebraska 76,877 54,354 2,858 5
Nevada 7,193 5,577 3
New Hampshire 43,249 39,192 552 1,575 4
New Jersey 123,436 127,798 3,496 6,159 9
New York 562,005 563,154 17,064 25,003 36
North Carolina 125,068 142,905 448 11
Ohio 400,082 368,280 5,179 11,069 23
Oregon 26,852 24,593 723 488 3
Pennsylvania 474,268 393,747 16,992 15,306 30
Rhode Island 19,030 12,394 422 928 4
South Carolina 21,733 69,890 9
Tennessee 124,078 133,258 957 1,131 12
Texas 88,353 223,208 3,321 3,511 13
Vermont 38,411 17,342 785 1,612 4
Virginia 139,356 145,497 143 12
West Virginia 63,913 67,331 805 927 6
Wisconsin 161,157 146,477 4,598 7,656 11
Total 4,847,659 4,913,901 133,880 150,663 182 219
Plurality 66,242
There was no hitch in the count of the vote in any of the Electoral Colleges, held at the capitols of the
various States. On the 9th of February, 1885, the two Houses of Congress assembled to witness the
counting of the vote. Mr. Edmunds, President of the Senate, upon its completion, announced that “it
appears” from the count that Mr. Cleveland has been elected President, etc. This form was used upon his
judgment as the only one which he could lawfully use, the Electoral law not having as yet determined the
power or prescribed the form for declaring the result of Presidential elections.
 Cleveland’s Administration.

President Cleveland was inaugurated on the 4th of March, 1885,

amid much military and civic pomp and ceremony. Jubilant
Democrats from all parts of the country visited the National Capital
to celebrate their return to National power after a series of
Republican successes extending through twenty-four years. The
inaugural address was chiefly noted for its promises in behalf of civil
service reform. It showed a determination on the part of the
President to adhere to the pledges given to what are still termed the
“Mugwumps” prior to the election. The sentiments expressed
secured the warm approval of Geo. W. Curtis, Carl Schurz, Henry
Ward Beecher and other civil service reformers, but were
disappointing to the straight Democrats, who naturally wished to
enjoy all of the fruits of the power won after so great a struggle. Vice-
President Hendricks voiced this radical Democratic sentiment, and
was rapidly creating a schism in the ranks of the party, but his
sudden death checked the movement and deprived it of organization,
though there still remains the seed of dissatisfaction, much of which
displayed itself in the contests of 1885.
President Cleveland appointed the following Cabinet:
Secretary of State: Thomas F. Bayard of Delaware.
Secretary of the Treasury: Daniel Manning of New York.
Secretary of War: W. C. Endicott of Massachusetts.
Postmaster-General: Wm. F. Vilas of Wisconsin.
Secretary of the Interior: L. Q. C. Lamar of Mississippi.
Attorney-General: Augustus H. Garland of Arkansas.
Up to this writing, May, 1886, the Administration of President
Cleveland has not been marked by any great event or crisis—its
greatest political efforts being directed toward appeasing the civil
and holding in close political alliance with the civil service reformers,
without disrupting the Democratic party by totally refusing to
distribute the spoils of office. It had long been predicted by practical
politicians that a serious attempt to defeat the doctrine “to the victor
belongs the spoils,” would destroy the administration attempting it.
The elections of 1885 point to a realization of this prophecy, though
it is yet too soon to accurately judge the result with nearly three years
of administration yet to be devoted to its pursuit.
Ohio witnessed in her last October election the first great struggle
under the Democratic State and National Administrations. Gov.
Hoadley was renominated by the Democrats, and Judge Foraker was
renominated by the Republicans. The latter were aided by the strong
canvass of John Sherman for his return to the U. S. Senate. The
contest was throughout exciting, some of the best speakers of the
country taking the stump. The result was as follows:

Foraker, R. 359,538
Hoadley, D. 341,380
Leonard, Pro. 28,054
Northrop, G. 2,760

The Irish-Americans who had left the Democratic party to vote for
Blaine, adhered to the Republican standard, and really increased
their numbers—more than a third more voting for Foraker than for
Blaine, while the Mugwump element practically disappeared. The
Prohibition vote had almost doubled, but as all third or fourth
parties as a rule attract their vote from the parties in which the most
discontent prevails, the excess came not from the Republican but the
Democratic ranks.
Pennsylvania’s result, following in November, was similar in all
material points to that of Ohio. Col. M. S. Quay, an acknowledged
political leader and a man of national reputation, thought it wise that
his party should oppose in the most radical and direct way, the
Democratic State and National Administration, and with this
purpose became a candidate for State Treasurer. The Democrats
nominated Conrad B. Day of Philadelphia. The result was as follows:

Quay, R. 324,694
Day, D. 281,178
Spangler, Pro. 15,047
Whitney, G. 2,783
 Col. Quay’s majority greatly exceeded all expectation, and was
universally accepted as a condemnation of the two Democratic
administrations.
New York, of all the November States, very properly excited the
most attention. The Democrats renominated Gov. Hill upon a
platform tantamount to a condemnation of civil service reform—a
platform dictated by Tammany Hall, which was already quarrelling
with the National administration. The Mugwump leaders and
journals immediately condemned both the Democratic ticket and
platform, and joined with the Republicans in support of Davenport.
The result was:

Governor.
Hill, D. 501,418
Davenport, R. 489,727
Bascom, Pro 30,866
Jones, G. 2,127

Lieutenant-Governor.
Jones, D. 495,450
Carr, R. 492,288
Demorest, Pro. 31,298
Gage, G. 2,087

In New York the Irish-Americans, angered by the return of the

Mugwumps, whose aristocratic and free trade tendencies they were
especially hostile to, under the lead of the Irish World left the
Republicans and returned to the support of the Democracy. They
decided the contest and their attitude in the future will be of
immediate concern in all political calculations. The net results in
three great States gave satisfaction to both parties—probably the
most to the Republicans, but it is certain that they left politics in a
very interesting and very uncertain shape.
 THE CAMPAIGN OF 1886.

The campaign of 1886 showed that the Republican party was

capable of making gains in the South, especially in Congressional
districts and upon protective and educational issues. Indeed, so plain
was this in the State of Virginia that Randolph Tucker, for whom the
Legislature had apportioned a district composed of eleven white
counties, refused to run again, and Mr. Yost, editor of the Staunton
Virginian, who had canvassed the entire district on tariff issues and
in favor of the Blair educational bill, was returned over a popular
Democrat, by 1900 majority. Of the ten Congressmen from Virginia
the Republicans elected six. Morrison, the tariff reform leader of
Illinois, was defeated, as was Burd of Ohio, while Speaker Carlisle’s
seat was contested by Mr. Thoche, a protectionist candidate of the
Knights of Labor. These and other gains reduced the Democratic
majority in the House to about fifteen, and this could not be counted
upon for any tariff reduction or financial measures. The Republicans
lost one in the U. S. Senate.
Local divisions in the Republican ranks were seriously manifested
in but one State, that of California, which chose a Democratic
Governor and a Republican Lieutenant-Governor, so close was the
contest. The Governor has since died, the Lieutenant-Governor has
taken his place, but the Legislature re-elected Senator Hearst,
Democrat, who had previously been appointed before the retirement
of Governor Stoneman.
New York city witnessed, not a revolution, but such a marked
change in politics that it excited comment throughout the entire
country. The Labor party ran Henry George, the author of Progress
and Poverty, and other works somewhat socialistic and certainly
agrarian in their tendencies, for Mayor of the city. Hewitt, the well-
known Congressman, was the candidate of the Democracy, while the
Republicans presented Roosevelt, known chiefly for his municipal-
reform tendencies. Hewitt was elected, but George received over
60,000 votes, and this unlooked-for poll changed the direction of
political calculations for a year. George was aided by nearly all the
Labor organizations, and he drew from the Democrats about two to
the one drawn from the Republicans—a fact which greatly raised the
hopes of the latter and at the same time made the Democrats more
cautious.
In 1886 the Republicans and Democrats, with the qualifications
noted above, held their party strength, with the future prospects so
promising to both that at this early date preparations began for the
Presidential campaign, General Beaver, defeated for Governor of
Pennsylvania in 1882 by a plurality of 40,000, was now elected by a
plurality of 43,000, though the Prohibitionists polled 32,000 votes,
two-thirds of which came from the Republican party. The general
result of the campaign indicated that the Republicans were gaining
in unity and numbers.
 THE CAMPAIGN OF 1887.

Interest in the forthcoming Presidential campaign was everywhere

manifested in the struggles of 1887. The first skirmish was lost by the
Republicans, and while it encouraged Mr. Cleveland’s
administration, it gave warning to the Republicans throughout the
country that they must heal all differences and do better work. So
quickly was this determination reached that Rhode Island came back
to the Republican column in November, by the election of a
Congressman.
The elections of the year, as a whole, were largely in favor of the
Republicans, and three pivotal States were captured—Connecticut,
New Jersey, and Indiana, with Virginia claimed by both parties. True
the issues and candidates in Indiana and Connecticut were purely
local, a fact which contributed largely to the continued hopefulness
of the Democracy, who had again carried New York by an average
majority of 14,000, notwithstanding Henry George now ran for
Secretary of State in the hope of more greatly dividing the
Democratic than the Republican vote. He did this, in somewhat less
proportion than when he ran for Mayor of the city, but the agitation
of High License for the cities alone, and the Prohibitory agitation led
to the union of all the saloon interests with the Democracy. These
interests, headed by the organization of brewers, established
Personal Liberty Leagues in all of the larger cities, which Leagues
held a State Convention at Albany said to represent 75,000 voters, or
500 to each delegate. The figures were grossly exaggerated, but
nevertheless an alliance was formed with the Democratic party in the
State by the substantial adoption of the anti-sumptuary plank in its
platform. Sufficient Republicans were in this way won to balance the
Henry George defections from the Democracy, and the result was
practically the same as in 1886. The Mugwumps supported the
Republicans in 1886, but they cut little if any figure in 1887. It was
very plain to the hind-sight of the Republican leaders of New York,
that if they had resisted and resented the formation of the Personal
Liberty Leagues, and made a direct and open issue against the
control of the saloon in politics, they would have easily won a victory
like that achieved in Pennsylvania. Two acts contributed to the
swelling of the Prohibitory vote, which in 1887 came more equally
from both parties. Governor Hill had vetoed the High License act,
and thus angered the Temperance Democrats, while the Republicans
had failed to submit to a vote of the people the prohibitory
amendment, thus angering an additional number of Republicans, so
that the Prohibitory vote was swelled to 42,000.
New York’s complete vote for Secretary of State was:

Grant, Republican 452,822

Cook, Democrat 469,802
Huntington, Prohibitionist 41,850
George, United Labor 69,836
Beecher, Greenback 988
Preston, Union Labor 988
Hall, Progressive Labor 7,768
Scattering 1,351

Total vote 1,045,405

The Republicans of Pennsylvania met the growing temperance

agitation in such a way as to keep within and recall to its lines nearly
all who naturally affiliated with that party. The State Convention of
1886 promised to submit the prohibitory amendment to a vote of the
people, and the Republican Legislature of 1887 passed the
amendment for a first time, and also passed a High License law,
which placed the heaviest licenses upon the cities, but increased all,
and gave four-fifths and three-fifths of the amount to the city and
country treasuries.
During the closing week of the campaign of 1885 in Pennsylvania,
a combination was made by the brewers of Allegheny County with
the Democracy for a combined raid against the Republican State
ticket headed by General Beaver. A large sum of money was raised,
and the sinking societies, or such of them as could be induced to
enter the movement, were marshalled as a new and potent element.
The result was a surprise to the Republicans and a reduction of about
4,000 in their majority. Thus began the movement which this year
culminated in the organization of Personal Liberty Leagues
throughout the cities of New York and Pennsylvania. Encouraged by
this local success in Pennsylvania and angered by the passage of a
High License law, an immense fund was raised in Philadelphia and
Pittsburg, and the Democratic workers in all singing and social clubs
and societies were employed to create from these, as their nucleus,
the Personal Liberty Leagues. In Philadelphia alone the Central
Convention represented over 300 societies, and this fact led to
extravagant claims as to the number of voters whose views were thus
reflected. The organization was secret, but the brewers, maltsters,
and wholesale dealers who created it, opened State headquarters and
likewise established a State headquarters for the Leagues. Much the
same plan was adopted in Pittsburg and great boasts were made that
it would be extended to all the towns and cities of the State. From the
first combinations were made by the Democratic city committees, the
State Committee giving them a friendly wink.
This work was allowed to go on for a full month, the Republican
State Committee, and the Republican city committees as well, giving
such careful investigation to the facts that every charge could be
proven. Then it was that the State Address was issued, wherein all
the leading facts were given and each and every challenge accepted.
The Republican party thus publicly renewed its pledge to cast the
second and final legislative vote for submission to the people the
prohibitory amendment for the maintenance of high license, and just
as unequivocally pledged the maintenance of the Sunday laws
assailed by the Personal Liberty Leagues.
The effect was to group in a solid and an aggressive mass of good
citizens all who believed that the people should not be denied the
right to make their own laws upon liquor as upon other questions; all
who valued a high license which, while general, placed the higher
charges upon the cities, and which gave three and four-fifths of all
the revenues to the city and county treasuries, and as well all who
believed in maintaining an American Sabbath.
The grouping of these three positions proved more powerful than
the quarter of a million dollars supplied the combination by the
brewing and wholesale liquor interests; more powerful than the
hundreds of social and singing societies supposed to be grouped with
the Democratic liquor combination; more powerful than all of the
combined elements of disorder planted by the side of the Democracy.
 It was a royal battle, fought out in the open day! Indeed, the
Republican address compelled publicity and made a secret battle
thereafter impossible. Every effort at continued secrecy was
immediately exposed by the Republican State Committee and the
leading daily Republican journals, and every country paper bristled
with these exposures. In very desperation the combination became
more and more public as the canvass advanced. It was shown that
the Personal Liberty Leagues were under the direction of the
Socialists, and this arrayed against them all of the Israelites in the
State besides thousands of other law-abiding citizens; the demand
for the repeal of the Sunday laws compelled the opposition of all
branches of religious Germans—Catholics, Lutherans, Mennonites,
Dunkards, etc.—and called forth the protests of nearly all of the
pulpits. The fact that in Philadelphia and Allegheny the brewers and
wholesale dealers, just as they do in the great cities of New York, own
nearly all of the saloons—drinking places without accommodations
for strangers and travellers—and that their battle was for the saloon
in competition with the hotel, inn or tavern, divided the liquor
interests and induced all who favored the High License bill, partially
framed to protect this class, to support the Republican party. So true
was this that a resolution before the Convention of the State Liquor
League indorsing high license save a few vexatious features, came so
near passing that the saloon keepers subsequently established a
separate organization.
The battle at no time and in no place took shape for prohibition
beyond that sense of fair play which suggests submission to a vote of
the people any question which a law-abiding and respectable number
desire to vote upon. The battle was almost distinctly for and against
the Sunday laws and for and against high license, and the
Republicans everywhere gave unequivocal support to these
measures. In Allegheny, shocked the year before by the sudden raid
of the brewers, some of the leading politicians for a time feared to
face the issues as presented by the Republican State Committee, and
really forced upon them by the Democratic liquor combination, but
an eloquent Presbyterian divine sounded from his pulpit the slogan,
a great Catholic priest followed, the Catholic Temperance Union and
the T. A. B.’s, not committed to prohibition, but publicly committed
to high license, passed resolutions denouncing the combination.
Some of the assemblies of the Knights of Labor followed, and in open
battle the Republicans of Allegheny accepted the issue and the
challenge and were rewarded for their courage by a gain of 1,200 just
where brewing and distillery interests are strongest. The Democratic
liquor combination did not show a gain over their Gubernatorial
majorities in a single German county except Northampton, where a
citizens’ local movement by its sharp antagonism drew out the full
Democratic vote for their State ticket. The combination, with all of
the power of money, with the entire saloon interests, with the
Personal Liberty Leagues, called from the Republican ranks in the
entire State not over 12,000 votes, of which 6,000 were in
Philadelphia and 4,000 in Allegheny. These were more than made up
by 15,000 out of 32,000 Prohibitionists who returned to the
Republican party, and by 5,000 Democrats who joined the
Republican column. Given more time, and with the issues as
universally acknowledged by all parties as they have been since the
election, far more Prohibitionists would have returned and more
Democrats would have voted the Republican ticket. As it was, the
Prohibition vote cast was about equally divided between the
Democrats and Republicans; there was probably more Democrats
than Republicans. In 1886 the 32,000 Prohibitionists comprised
24,000 Republicans and 8000 Democrats. All of the latter remained
and were reinforced in nearly every quarter. There had always been
from 5,000 to 6,000 third party Prohibitionists.
If the Republicans had not bravely faced the issues thus forced
upon them they would have lost the State, for the Democratic liquor
combination polled 15,000 votes more than the Republican
candidate—Colonel Quay, an exceptionally strong man—had received
in 1885; but the bravery of the Republicans and the fact that their
attitude was right called out 60,000 more votes than the party cast in
’85, and in this way increased its majority despite all combinations.
These are the leading facts in the most novel of all the campaigns
known to Pennsylvania’s history. The situation was much the same
in New York.
The total vote for State Treasurer was: