|
At its July
2003 meeting, the Council discussed with Daniel Callahan
the following chapter from his forthcoming book, "What
Price Better Health? Hazards of the Research Imperative,"
(University of California Press, Berkeley, October 2003). The ideas
contained in this draft chapter are the author's own, and do not
represent the official views of the Council or of the United States
Government.
INTRODUCTION
The Research Imperative
By Daniel Callahan
Recent years have seen an almost unprecedented excitement
about medical research. The dramatic increases in the annual budget
of the National Institutes of Health (NIH), running 10-15% a year,
even as many other federal budgets are being cut, is a good symbol
of that excitement. But it has been fed as well by striking research
progress, by improved health traceable to research, by media interest
and, most importantly, by public enthusiasm. Americans seem to have
a special predilection for scientific progress, technological innovation,
and better health. Hardly a doubt is voiced anywhere about the likely
benefits of an ever greater research commitment.
The human instinct behind research is as fine and basic as the best
of such instincts. It was well caught by Aristotle 2500 years ago
in the opening line of his Metaphysics, when he wrote that “all
men by nature desire to know,” and broadened by Francis Bacon
in the 16th century to encompass the power of science to improve
the human condition. Medical research has been one of the most glorious
of human enterprises and grows stronger every year. I am alive and
entering old age in relatively good health undoubtedly in great
part because of its success in relieving pain and disability and
in forestalling death. Why should the public not be enthusiastic
about research that brings such patently valuable human goods?
Langdon Winner has suggested that it is plausible to think of technology
as a “form of life,” by which he means to describe its
power to reconstruct social roles and relationships.1
We think differently about the world, and live in it differently,
because of technology. Something analogous can be said about medical
research: it gives us a fresh view of the possibilities of living
our lives and managing our miseries, instilling hope and opening
up new options in shaping our body and our mind. Medical research
has become as much a “form of life” as the technology
it creates. It gives us a new means of thinking about life itself.
Yet my intent in this book is to show that within its praiseworthy
activity lie some shadows that require a closer look. My aim is
not to halt research, much less to impugn its great contribution
to our common good, but to enhance the possibility that it will
move forward in the most socially sound way possible. Precisely
because of its value—social, medical, economic—medical
research presents some hazardous temptations: to invest too much
hope in it as a way of relieving the human condition, to excessively
commercialize it, to cut moral corners in pursuit of therapies and
cures, to misuse human research subjects, and to divert attention
from the social and economic sources of sickness.
I call these temptations “shadows” to avoid any implication
that medical research is fundamentally flawed, as if suffering from
some dread disease. On the contrary, it is an essentially healthy,
valid, and a vitally important activity. The shadows I will dwell
on are hardly the whole story, nor are most of the abuses I will
mention dominant and widespread. Most medical research raises no
problems whatever. Nonetheless, for the sake of the continued vitality
and high public status of medical research those shadows should
be explored. They can do great damage if ignored or minimized.
Those shadows are the result, I want to argue, of a cluster of cultural
attitudes and values many if not most of which are part of the larger
American culture and which have had a powerful impact on medical
research. By tracing them to the larger culture I want, at the least,
to put aside two possible responses to my examination. One of them
might see it as an attack on the researchers, as if it is their
values that create the shadows. On occasion that is so, but it usually
turns out that their values have a societal counterpart that has
been brought into play.
The other possible response would be to read my critique as a veiled
way of saying that the very enterprise of medical research is deeply
flawed, beset by cupidity, a scorn for the public, and personal
ambition run wild. “Ethical concerns,” the long-time
commentator on science, Daniel S. Greenberg, has written, “are
a sideshow of science, providing grist for the press and moralizing
politicians, though with little actual effect on the conduct of
the research enterprise….More money for more science is the
commanding passion of the politics of science.”2
I do not share that judgment. The full reality reveals an enterprise
marked by drama, by great human benefits, by unbounded ambition,
by selfless altruism, by flagrant cupidity, by excess in the pursuit
of the good, by moral sensitivity and moral obtuseness—and
by still uncharted possibilities for progress in the relief of pain
and suffering.
I want to try capturing that mixture of the good and the bad, the
light and the shadows, by focusing on the idea of a “research
imperative.” That is not a term that is used by most scientists,
by the media, or by the general public, but it captures the cultural
problem that has caught my eye. One of the few times that term had
been used directly was in an article written by the late Protestant
moral theologian Paul Ramsey in 1976 as part of a debate with a
Jesuit theologian, Richard McCormick. McCormick had argued that
it ought to be morally acceptable to use children for nontherapeutic
research, that is, for research of no direct benefit to the children
themselves and in the absence of informed consent. Ramsey, referring
to claims about the “necessity” of such research, accused
McCormick of falling prey to the “research imperative,”
the view that the importance of research could overcome moral values.3
That was the last I heard of the phrase for many years, but it captures
a variety of important arguments about research that have surfaced
with increasing force of late. It captures, for instance, the meaning
of something once said to me by Joshua Lederberg, a Nobel laureate
for his work in genetics, and President Emeritus of Rockefeller
University. “The blood of those who will die if biomedical
research is not pursued,” he said, “will be upon the
hands of those who don’t do it.” It also captures the
meaning of such commonly heard phrases (which I will be citing as
the book moves along) such as the “necessity” of research,
or the “moral obligation” to pursue certain kinds of
research, or the overpowering “promise” of research
to relieve suffering, a goal not to be denied; or the “need
to relieve suffering” as a justification for the high price
of pharmaceuticals.
The fact that the term “research imperative” itself
has been little used is not important: the cultural reality is,
I believe, that such an imperative is part of our particular medical
culture and our larger social culture, and I hope to make a persuasive
case to support that belief. Some scientists have denied there is
any such imperative at work, and perhaps that is true for many.
But my contention is not that the research community itself is a
hot bed of the research imperative but that it is pervasive in our
culture, finding reflections within science, politics, research
advocacy, and public sentiment. It is a term meant to parallel the
more familiar phrase, that of a “technological imperative.”4
That imperative, as I understand its usage, is meant to point to
another powerful cultural current, particularly in medicine: that
if technologies exist, they ought to be used and usually will be
used. They cease to become psychologically optional, even if in
fact choices can still be made to use or not use available technologies.
I will define the “research imperative” as the felt
drive to use research to gain various forms of knowledge for its
own sake, or as a motive to achieve a worthy practical end. As with
technology, where an attractive innovation generates an interest
in finding an even better version, research has a similar kind of
impetus. Research generates not only new knowledge, but new leads
for even more future knowledge; and that is a major part of its
excitement. Research, that is, generates its own internal imperative,
that of learning still more, and more.
My definition of the research imperative can be made clearer by
imagining it as having a continuum of uses and interpretations,
each of which I have drawn from many years of reading about research,
from watching the way it is talked about by its advocates, and by
the uses to which it is put in the public arena:
--the research imperative as the drive to gain scientific knowledge
for its own sake (e.g., to understand the human genome)
--the research imperative as a felt moral obligation to relieve
pain and suffering (e.g., to find a cure for cancer)
--the research imperative as a rationale for pursuing research goals
that are of doubtful human value or potentially harmful (e.g., some
would argue, research to achieve human cloning)
--the research imperative as a public relations tool to justify
the making of a good living and the pursuit of profit (e.g., the
pharmaceutical industry’s defense of high drug prices)
--the research imperative as the pursuit of worthy goals even at
the risk of compromising important moral and social values (e.g.,
hazardous research on competent human beings without their informed
consent).
Those are five possible meanings of the phrase, and underlying concept,
that is central to my inquiry. They might be thought of as running
along a continuum, moving from most acceptable to not acceptable
(see figure 1). I will on occasion speak of a “benign”
imperative and on other occasions of a “hazardous” imperative
if I think my meaning may be unclear.
FIGURE 1
SPECIFIC MANIFESTATIONS
While I have worked to keep those different senses of the phrase
clear and distinct in the rest of the book, I will no doubt fail
to do that from time to time, or at least seem to fail. The reason
for that will not necessarily be sheer carelessness on my part (though
that can happen), but two other confounding reasons. One of them
is that they will and must on occasion run together, allowing no
sharp separation, and that an admixture of good and bad is a part
of research just as it is a part of the rest of our lives. The other
reason is the pervasiveness of disagreements about the appropriate
goals of research and the morally valid means to pursue them. Some
people think it perfectly fine to carry out research to achieve
human cloning, which might offer insights into the relief of infertility;
hence, they will see nothing more than the research imperative in
its most noble manifestation. Others find the idea repugnant.
Some social scientists believe that it is legitimate on occasion
to deceive research subjects if the reason for doing so is scientifically
valid and there is no other way to carry out the research. Such
reasoning would be rejected out of hand for medical research. In
other words, the category of the research imperative that one person
might judge appropriately applied to a particular line of research
could be heatedly rejected by someone else. So, too, one person
might believe some research is morally imperative while others might
judge it as important and helpful, but not imperative. In any event,
I hope to be reasonably consistent in my use of the term and hope
as well, as the book moves along, that the complexity of the idea
and its power become clear.
Research Ideals
If I have placed a somewhat elusive concept at the heart of this
book, I also bring to medical research a set of animating ideals,
some of them commonplace, others perhaps less so. While I will not
always advert directly to them, those ideals are there just below
the surface. I call them “ideals” not simply because
they are not easily reducible to hard rules, but also because they
represent high aspirations, not always or easily achievable. But
that is no reason not to entertain them and hope to achieve them.
A failure to achieve them is not worthy of condemnation, but a failure
to even try for them could be:
Safe. Research should be carried out in ways that
are physically safe both in its aims and expected results and in
its means. This does not mean that risk cannot be run on occasion,
but the burden of proof when risk is reasonably possible--which
ought to be strong--should lie with those who want to carry out
the research, not with those who will be endangered. There may,
naturally, be reasonable disagreements about what constitutes a
threat to safety and the degree of that threat. Of the various ideals
I will be suggesting, this one is the most accepted, usually defined
as a duty, expressing the principle of non-maleficence, the Hippocratic
rule of “do no harm.”
Socially beneficial. Medical research should aim
to improve and sustain human health, whether at the individual or
population level. Medical research directed solely at meeting individual
desires rather than genuine health problems should be discouraged
as a poor use of research talent and resources.
Resistant to market determinations. For-profit
research, aiming to make a contribution to health while also turning
a profit, is part of American culture, not to be eliminated however
strong the complaints against it. At the same time, the power of
for-profit research should never become strong enough—in trying
to create or meet market demands--to shape overall national research
priorities, much less to discourage research that will bring no
profit or to rob the research community of talented researchers.
Conducive to a sustainable, affordable medicine. Recent
increases in health care costs can be traced in part—and not
an insignificant part—to new technologies and an intensified
use of both old and new technologies. Many if not most of these
technologies are the fruit of research, sometimes NIH-sponsored
basic research, at other times the work of pharmaceutical or biotechnology
research. Research ought to be directed at affordable medical applications
when possible, something that is now threatened by the generation
of technologies that are increasingly unaffordable to many people.
A sustainable medicine--a medicine that is affordable over the long
run, affording equitable access to all--ought to be an ideal of
medical research. It is obvious that not all valid research can
promise affordable medicine, but it should try.
Conducive to equitable access to health care. This
point is closely related to the previous one: a sustainable medicine
ought also to be conducive to equitable access. A research drive
that ends by exacerbating the gap between rich and poor, insured
and uninsured, makes a defective, even hazardous contribution to
health care. This will mainly happen because the technological innovations
(pharmaceutical or otherwise) that come from basic research may
drive health care costs to unaffordable heights. (See a statement
about this possibility by former NIH Director Harold Varmus on this
point on p.____)
Open to meaningful public participation in setting priorities.
Nothing is so important for good science as allowing researchers
to follow their own leads and ideas. Good research cannot be bureaucratically
programmed. Yet it is also true that the public--particularly when
as taxpayers they are paying for the research--should be heard and
its needs and interests taken seriously. Advocacy groups have always
had an important role, but their interests are typically narrow,
oriented toward their own constituencies. The voice of the general
public needs to be heard as well, both about what it sees as its
most promising health needs and also to be part of debates about
controversial research.
Morally acceptable to the public, and sensitive to moral
views held by the public. It is not enough simply to make
certain that a full range of public voices is heard in setting research
policy and priorities. It is no less important that there be a sensitivity
to the various moral perspectives in society and to the possibility
that, at times, the views of a minority may be offended. The research
community, and its lay supporters, ought never assume that its moral
principles are superior to the principles of those who dissent from
various lines of research.
Consistent with the highest human goods and human rights.
There is no necessary correlation between a good life and good health:
some healthy people are unhappy and some happy people are unhealthy.
A long life is desirable, but a short life is not incompatible with
a good life. Good health helps to provide a foundation to enjoy
the fruits of human rights--but a denial of basic rights sometimes
cannot offset even a healthy life.
Converging Issues
If my primary purpose is to assess the research imperative in its
various manifestations, another aim is to relate a variety of issues
within medical research to each other, issues ordinarily treated
separately and commanding their own literature. What were in the
past treated as discrete issues are coming to influence and overlap
each other. The role of the pharmaceutical industry in funding clinical
research bears directly on many problems of human subject research.
The setting of research priorities by Congress can have a potent
effect on the future of health care delivery, influencing what therapies
will be available for distribution and what their costs might be.
The extent of any obligation to carry out research is highly relevant
to determining what moral principles ought to bear on the use of
human subjects to advance research, just as it will bear on research
on embryos or germ line therapy.
There seems, in short, to be a potential unity in the various aspects
of medical research as a scientific and social venture. The term
“research ethics” is now narrowly used to refer either
to human subject research or to scientific integrity in the conduct
of researchers. That term should be expanded to cover the research
enterprise as a whole, to encompass all the ends and means of research
as well as its social and political implications.
This book was written during a period of great public, legislative,
and media attention to medical research, a strong if sometimes overwhelming
stimulus to any author interested in such matters. I began this
book just at the moment of the completion of the Human Genome Project,
mapping the human genome, and wrote much of it during the heat of
the stem cell research debate and the federal crackdown on many
universities for violations of human subject regulations. It was
hard to keep up with it all, and I found myself swinging to and
fro as new developments emerged, drawn to the power of medical research
to change and enrich our lives but at the same time often troubled
by the capacity of some professional and lay enthusiasts to skip
over important moral considerations.
Yet even in those cases it was the mixture of the good and the bad,
tightly bound together, that was most arresting. The capacity of
good people with good motives to do unwitting harm is an old story,
and one on display when the research imperative is pushed too far
or in the wrong way. At the same time it is often the case that
what might be judged wrong or harmful or bad public policy is not
a reflection of bad character or moral carelessness but of a way
of life in a culture, ours, that pushes people one way or the other.
That is why I think of the research imperative as a cultural problem,
not a problem of nefarious researchers, narrow self-absorbed interest
groups, or a benighted public. We are all in this together and,
if fault is to be apportioned, there is enough to convict almost
all of us. Some readers of an earlier draft of the book read it
as a dissenting book. There is surely some dissent in the book,
mainly about a faulty response to, or understanding of, the research
imperative. It is no less meant as an effort to make some better
sense of a social phenomenon of a fascinating, sometimes troubling,
kind: how something as valuable and cherished as research, commanding
a remarkable consensus of public approval, can at the same time
generate a wide range of controversies and disputes, and do some
actual harm. Why is that?
The book moves through three phases, even if they are not always
sharply delineated: the goals or ends of medical research, the means
used to pursue those goals, and the fashioning of public policy
on research. Each chapter has one overriding question, which I will
try to articulate in describing those chapters:
Chapter 1 traces the history of medical research in the United States.
It aims to show the trajectory of research goals and how they gradually
came to embody the research imperative, a note relatively absent
from its earlier history. How and why did a research imperative
arise?
Chapter 2 begins the work of examining the goals of medical research.
This chapter focuses on the most foundational issue, that of the
goals and values of science, of which medical research is simply
one expression of their pursuit. The social obligations of scientists
as well as recent threats within biomedical research to science
integrity are examined as well. What are the animating values
of scientific research and what are the norms of social responsibility
that ought to guide researchers?
Chapter 3 narrows the discussion of goals to that of the goals of
medical research. These goals are related to the goals of medicine,
which should be the point of departure for socially valid research.
The war of medicine against death and aging, two characteristic
notes of contemporary research, are examined as test cases of the
validity of traditionally important research goals. What are
appropriate research goals, and how ought two traditional goals
of research, the forestalling of death and of the burdens of aging,
be best thought of?
Chapter 4 more broadly takes on the goals of medicine, but in this
chapter focusing on the concept of “health,” the cure
of illness and the relief of suffering, and the difference between
a medicine oriented to preserving or restoring health and one aiming
at the enhancement of human traits and the satisfaction of individual
desires. Ought medical research be directed solely at the prevention
of disease and the restoration of health, or should it move on to
the enhancement of human physical and psychological traits?
Chapter 5 looks at the difficult problem of balancing risks and
benefits in medical research. Both risks and benefits encompass
social and cultural values, not simply physical safety. What stance,
and with what values, should the research community and the public
take toward research that has both risks and benefits?
Chapter 6 takes up a principal means of carrying out biomedical
research, the use of human subjects for clinical research. Human
subject research, a long-time troublesome matter, is a principal
and necessary means for pursuing clinical knowledge and thus an
unavoidable topic for this book. Can a balance between subject protection
and research needs be established? Why has human subject research
been such an important issue for medical research, and what are
the history and values that have given it such an important practical,
and symbolic importance?
Chapter 7 looks at the growing and difficult problem of using research
methods that raise serious moral questions or offend some significant
portion of the public. How is controversial research best understood
and dealt with in a pluralistic society? Is it possible to achieve
a consensus, or can that only be done by eliminating valid dissent?
How ought pluralistic societies deal with, and resolve, research
debates that reveal great religious, philosophical, and ideological
differences?
Chapter 8 is the first chapter in the final section of the book,
devoted specifically to some important policy issues of biomedical
research. One of them, in this chapter, is the place of the private
sector, and specifically the pharmaceutical industry, in shaping
the direction and social impact of research: on the costs of health
care, on the pricing of drugs, on its effect upon universities and
researchers, and on health in developing countries. Because
of its importance for health, can the pharmaceutical industry be
held to different, and higher, moral standards than other industries,
and can the need to do research justify high industry profits?
Chapter 9 switches the examination to the public sector, and specifically
the role of the NIH and the federal government in supporting and
directing medical research. The place of Congress, the NIH leadership,
the public, and the research community shaping NIH priorities is
a central consideration. At present there is no well organized
system to set national research priorities: Can such a system be
developed and justified?
Chapter 10 will pull together the varied and numerous strains in
the argument of the book to present a picture of how medical research
might in the future better manifest the ideals of research sketched
in the Introduction. How can a better fit be found between national
research priorities and national health care distribution practices?
_________________
ENDNOTES
- Langdon Winner, The
Whale and the Reactor: A Search for Limits in an Age of High Technology
(Chicago: University of California Press, 1986).
- Daniel S. Greenberg, Science,
Money, and Politics: Political Triumph and Ethical Erosion
(Chicago: University of Chicago Press, 2001), 3.
- Paul Ramsey, “The
Enforcement of Morals: Nontherapeutic Research on Children,”
Hastings Center Report 6, no. 4 (1976): 2
- Eric J. Cassell, “The
Sorcerer’s Broom: Medicine’s Rampant Technology,”
Hastings Center Report 23, no. 6 (1993): 33.
|
