The President's Council on Bioethics click here to skip navigation

 

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

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

  1. Langdon Winner, The Whale and the Reactor: A Search for Limits in an Age of High Technology (Chicago: University of California Press, 1986).
  2. Daniel S. Greenberg, Science, Money, and Politics: Political Triumph and Ethical Erosion (Chicago: University of Chicago Press, 2001), 3.
  3. Paul Ramsey, “The Enforcement of Morals: Nontherapeutic Research on Children,” Hastings Center Report 6, no. 4 (1976): 2
  4. Eric J. Cassell, “The Sorcerer’s Broom: Medicine’s Rampant Technology,” Hastings Center Report 23, no. 6 (1993): 33.




  - The President's Council on Bioethics -  
 
Home Site Map Disclaimers Privacy Notice Accessibility NBAC HHS