Lesser Harms: The Morality of Risk in Medical Research available in Hardcover, Paperback
Lesser Harms: The Morality of Risk in Medical Research
- ISBN-10:
- 0226314529
- ISBN-13:
- 9780226314525
- Pub. Date:
- 11/01/2006
- Publisher:
- University of Chicago Press
- ISBN-10:
- 0226314529
- ISBN-13:
- 9780226314525
- Pub. Date:
- 11/01/2006
- Publisher:
- University of Chicago Press
Lesser Harms: The Morality of Risk in Medical Research
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Product Details
| ISBN-13: | 9780226314525 |
|---|---|
| Publisher: | University of Chicago Press |
| Publication date: | 11/01/2006 |
| Series: | Morality and Society Series |
| Edition description: | 1 |
| Pages: | 246 |
| Product dimensions: | 6.00(w) x 9.00(h) x 0.50(d) |
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LESSER HARMS
The Morality of Risk in Medical Research
By SYDNEY A. HALPERN
The University of Chicago Press
Copyright © 2004 The University of Chicago
All right reserved.
ISBN: 978-0-226-31451-8
Chapter One
The Origins of a Moral Logic of Risk
Medical-research communities have longstanding traditions for handling the risks that human experiments entail. A cornerstone of these traditions is the logic of lesser harms, whereby hazardous interventions are moral if they generate net benefit and the risks are lower than those of the natural disease. Four other expectations have accompanied lesser-harm reasoning: researchers require that animal tests precede human experiments; they delay or suspend human use if the hazards of a procedure appear too grave; they insist that only scientifically sound experiments are moral, because bad research cannot contribute to the common good; and many have begun human testing by first experimenting on themselves. Evidence for these traditions can be found in the work of historians and ethnographers who study medical researchers and in the statements and actions of clinical investigators, present and past.
Modern communities of medical researchers-investigators devoted to developing and testing new medical interventions-did not coalesce until the second half of the nineteenth century. Before then, a variety of professional groups were instrumental in inaugurating new medical procedures, including natural scientists and empirically minded physicians. These early medical innovators also observed a moral logic of risk.
In this chapter, I examine historical episodes in which those initiating and studying medical innovations articulated or displayed their moral logic with clarity. Members of social groups often find it difficult to put words to their informal norms and customs. The professionals introducing new medical procedures were no exception in this regard. Their rules for conducting human experiments often remained tacit or only partly articulated. But periodically, medical innovators made cohesive statements of their moral reasoning. Members of a fledgling scientific community articulated lesser-harm logic in early-eighteenth-century debates over smallpox inoculation. Empirically minded physicians and public health advocates invoked lesser-harm reasoning in nineteenth-century disputes over smallpox vaccination. Supporters and leaders of the new laboratory medicine asserted the importance of animal experimentation-and by extension, clinical moratoria-in the 1880s, during controversy surrounding the use of Pasteur's rabies vaccine. Early in the twentieth century, spokesmen for the emerging medical-research community in America gave voice to a full range of moral traditions when responding to the allegations of antivivisection activists.
My analysis of these episodes sheds light on the character of experimenters' informal morality and the purposes their moral logic has served. I argue that traditions for conducting human experiments are, in large measure, an outgrowth of the cognitive norms of science. But when medical innovators give voice to their traditions, it has often been to serve social ends. Experimenters' moral traditions have been a set of standards for decisions about proceeding with human experiments. They have also provided rhetorical tools for justifying both clinical use of hazardous medical interventions and the pursuit of medical science itself.
Before I proceed, several caveats are in order. I am not attempting here to provide a comprehensive history of traditions for handling experimental or otherwise risky medical interventions. There are undoubtedly many occasions, unexamined in the pages below, in which scientists give voice to their moral traditions. Nor is it my intention, in noting similarities across episodes, to obscure important differences in the groups undertaking vaccine innovation. The communities that inaugurated use of different immunizing agents were by no means the same. Furthermore, while physicians were among the early medical innovators, those introducing new procedures were often at odds with the practicing branch of the medical profession. There were fundamental tensions between the research and practicing segments of medicine and, to a considerable degree, these persist today.
Finally, in pointing to historical antecedents of twentieth-century investigatory morality, I am not suggesting that expressions of normative traditions have the same meaning for early innovators and later generations of researchers. Periodic changes occur in the institutions of science and in the dominant paradigms and methods that help shape its content. Moral traditions are bound to have different meanings for investigators who work in disparate professional contexts. Such differences notwithstanding, a clear pattern emerges from the historical record: later medical researchers borrowed freely from the conceptual and linguistic formulations of experimenters who preceded them. The discourse of early medical innovators was a cultural resource for subsequent generations of scientists.
The Logic of Lesser Harms
Eighteenth- and nineteenth-century professional communities articulated lesser-harm logic in a series of controversies over the use of immunizing agents. During the 1720s, members and supporters of the earliest scientific associations-societies founded in Europe during the second half of the seventeenth century-invoked lesser-harm logic when promoting smallpox inoculation. They sought to address public fears about the hazards of inoculation and to demonstrate the social utility of the new empirical science. In the nineteenth century, public health advocates borrowed from the same moral tradition when constructing arguments supporting compulsory vaccination.
Marshaling Evidence for Smallpox Inoculation
In the early decades of the eighteenth century, the newly established scientific societies of Europe took up the matter of smallpox inoculation. In Britain, physicians and surgeons who supported the scientific movement introduced inoculation in the early 1720s. Members of the Royal Society of London (constituted in the early 1660s) oversaw early inoculations and undertook the collection of evidence on the procedure's effectiveness and safety. Proponents of the new science among the educated classes encouraged these activities. In France, opposition from the conservative medical establishment delayed the use of inoculation until the 1750s. There mid-century advocates for the procedure included royalty, court physicians, scientists in the Académie Royale des Sciences, and many among les philosophes-intellectuals who championed Enlightenment thought.
The association of smallpox inoculation with modern science is not without irony. Inoculation was by no means a product of Western scientific discovery. The procedure had arrived in Europe and America from the East-China, India, Persia, Turkey-where it had long flourished as a medical practice. But to champions of the natural philosophy sweeping contemporary European thought, inoculation exemplified the social benefits of empirical inquiry. Scientists and their supporters declared that judgments about the procedure should be based upon systematic observation. They defended their position in debates that became highly visible through a series of pamphlet wars.
Inoculation generated opposition on both religious and medical grounds. Conservative theologians argued that the procedure usurped Providence, promoting vice and immorality. Medical practitioners raised several objections. Some questioned whether it was moral to deliberately inflict a disease even if the result was protection from a more serious affliction. (Successful inoculation resulted in a mild case of smallpox. While most inoculated cases were less serious than natural smallpox, deaths from smallpox did occur among the inoculated.) Other physicians doubted that inoculated smallpox would consistently protect against the natural disease. Still others speculated that the procedure might induce serious diseases other than smallpox-contemporary medical theory held that the state of the blood at the time of infection determined what type of illness a person contracted. Pamphlets distributed by the opposition fanned widespread fears about the dangers of the new procedure.
Proponents of inoculation avoided debating religion or medical theory. They insisted that decisions about the procedure's use be grounded not on public fears, religious doctrine, or medical theory, but rather upon observation and reason. For the scientific community, inoculation was an occasion for applying empirical methods of natural philosophy to a matter of social importance and for demonstrating that these methods had practical utility.
British empiricists pursued two approaches when applying methods of the new science. First, they conducted experimental demonstrations of inoculation, witnessed by the broader community of scientists. Then they collected and reported numerical evidence on the relative probabilities of death from natural and inoculated smallpox. The second approach would involve the calculation of lesser harms.
The most highly visible experiment took place at London's Newgate Prison in August 1721. With the permission of the king, surgeon Charles Maitland inoculated six prisoners who had been condemned to die. Two court physicians oversaw Maitland's prison inoculations. One was Sir Hans Sloane, a fellow of the Royal Society and a leading promoter of the new science. Twenty-five witnesses attended the demonstration, including prominent members of the Royal Society and Royal College of Physicians. Announcements issued prior to the experiment invited interested parties not only to attend the procedures but also to visit the prisoners in the weeks following their inoculations. The results of the experiment were auspicious. Of the six inmates, five contracted mild cases of smallpox and quickly recovered. One, previously afflicted with natural smallpox, had no reaction to the procedure.
Shortly after the Newgate demonstration, scientists began collecting data on the relative harms of inoculated and natural smallpox. James Jurin was the chief chronicler of numerical evidence. Jurin was a physician, mathematician, and secretary to the Royal Society between 1722 and 1727, under Isaac Newton's presidency. During his tenure as secretary, Jurin compiled yearly reports on the mortality rates of natural and inoculated smallpox. These accounts addressed two questions: Did inoculation provide genuine security against natural smallpox? And were the hazards of the procedure lower than the risks of the naturally contracted disease? Jurin's results appeared in the Royal Society's publication Philosophical Transactions and as separately bound, and widely distributed, offprints.
Historian Andrea Rusnock details the methods Jurin used to compile evidence. For information on inoculated smallpox, he drew on a wide-ranging network of correspondents. By letter, Jurin solicited and received data on the numbers and results of inoculation. He took great care in assessing the reliability of his informants' testimony. He investigated ambiguous cases and refuted what he judged to be false accounts of negative outcomes. Jurin based his early calculations of mortality from natural smallpox on the London bills of mortality, which had been instituted in the 1660s to track outbreaks of epidemic diseases. He also received reports from his correspondents on natural-smallpox mortality within communities experiencing epidemics. Jurin thus functioned as an informal clearinghouse for national and international communications on the status of inoculation, not only soliciting information, but also making his accumulated knowledge available in response to outside inquiries. He exchanged information with scientific societies on the Continent and received reports on inoculation from as far away as Boston.
The outcome of Jurin's inquiries was favorable for the subsequent adoption of inoculation. He found no instances where successful inoculation-indicated by a distinctive lesion at the point of incision and a mild case of smallpox-failed to provide protection against the natural disease. Regarding relative hazards, Jurin reported that inoculated smallpox carried a substantially lower risk of mortality than naturally contracted smallpox. In 1728, a colleague of Jurin's updated the Royal Society's reports of inoculations performed in the British Isles, Germany, and America. The accumulated record included 845 cases of inoculated smallpox with 17 fatalities. This yielded a death rate of 1 in 50 cases. In contrast, the death rate for natural smallpox was approximately 1 in 6 cases. The implication was clear: inoculation yielded undoubted benefit and its risks were discernibly lower than the hazards of the natural disease.
The inoculation controversy in early-eighteenth-century Britain sheds light on both the conditions giving rise to lesser-harm reasoning and the purposes to which the logic was put. Several historical developments made the calculation of lesser harms possible. For one thing, growing use of inoculation allowed its clinical outcomes to be studied. Following the Newgate demonstrations and several other experiments, upper-class parents in Britain began to inoculate their children in small but growing numbers. Lesserharm formulations, when based on human-use data, are inevitably post hoc arguments. Another factor making calculations like Jurin's feasible was the availability of numerical evidence on fatalities from natural smallpox. As already mentioned, in the London bills of mortality, scientists had access to data that allowed them to estimate the risk of death from the naturally occurring disease. Still another factor was the development of the field of mathematics then called probability. While Jurin used simple arithmetic in calculating the relative risks of dying from natural and inoculated smallpox, the availability of probability theory undoubtedly fostered his adoption of a mathematical approach to the problem.
Most important for the present argument, Jurin and his colleagues drew upon prevailing notions about the conduct of scientific inquiry. Both experimental demonstrations and the calculation of lesser harms had roots in contemporary beliefs about how to ascertain matters of fact. Seventeenth-century empiricists adopted the view that, because knowledge of the physical world can be derived only through experience, truths concerning natural sciences are unavoidably provisional and revisable. From this perspective, arriving at shared understandings about experimental truths was inherently problematic. Steven Shapin and Simon Schaffer argue that scientists developed a number of strategies for authenticating knowledge and generating agreements about what constitutes a scientific fact. These strategies included conducting experiments in public space (including the laboratory), securing multiple witnesses to publicly announced experimental demonstrations, and invoking the testimony of observers deemed reliable and trustworthy. Collective witnessing served to correct for individual bias and differences in observational ability.
Like experimental demonstrations, mathematical calculation of lesser harms was compatible with prevailing strategies for discerning empirical truths. Contemporary natural philosophy viewed knowledge in the sciences as inherently probabilistic. Basing determinations of fact upon observation and experience left findings vulnerable to human fallibility. The best one could hope for when apprehending the natural world was a high degree of probability. British scientists applied mathematical-and probabilistic-analysis to a wide range of phenomena.
If the calculation of relative harms was a means for determining matters of fact, it was also a vehicle for programmatic argument. Jurin and his colleagues invoked lesser-harm reasoning in response to critics and detractors of inoculation. The Royal Society's numerical evidence on benefits and hazards of inoculation was crucial to the growing acceptance of the procedure in eighteenth-century Europe. Contemporary tributes to Jurin's work acknowledged the practical ends of lesser-harm calculations. John Woodhouse, a physician from Nottingham, wrote to Jurin in 1726:
Hearty thanks for your good Intentions to the Publick by continuing This Annuall Account which will I doubt not soon Convince all Enemys to this Practice and Establish it for the Great Benefit of Mankind.
(Continues...)
Excerpted from LESSER HARMS by SYDNEY A. HALPERN Copyright © 2004 by The University of Chicago. Excerpted by permission.
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Table of Contents
AcknowledgmentsList of Abbreviations
Introduction
1. The Origins of a Moral Logic of Risk
2. Negotiating Moral Boundaries: The Polio Vaccines of 1934-1935
3. Research Sponsors and the Culture of Risk
4. Formalizing Responses to Research Hazards
5. The Social Nature of Moral Action
6. Moral Traditions in an Era of Government Oversight
Notes
Selected Bibliography
Index