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December 2000 (Volume 78)
Bradford H. Gray
Milbank Memorial Fund
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This issue of the Quarterly reflects much of the breadth of the field of health and health policy. The issue begins with an empirical study of the operation of an important mechanism for making health insurance available. Subsequent articles consider a problem in the ethics of the development of new biomedical knowledge, explore the border between health and social policy in a study of the outcomes of drug treatment in the welfare population, and examine the problem of trust in the managed care era.
By the time this issue is published, a new president of the United States will have been elected. Health care will have received more public debate than in any year since the collapse of the Clinton health reform proposal in 1994. The first article in this issue presents an empirical study of an idea that was identified with the Clinton proposal, but that bears no necessary connection to it—the health insurance purchasing cooperative. Such cooperatives might help to enable small employers to offer employees an affordable choice of health plans. In some ways, this is an idea whose time never came. Yet it had much appeal because it addressed some very practical problems, and examples exist from which we can learn.
Elliot Wicks and Mark Hall have studied those pioneering examples. In their article “Purchasing Cooperatives for Small Employers: Performance and Prospects,” they describe how these organizations worked, what purposes they served, and the extent to which they achieved their purposes. Most important, they draw lessons about what can and cannot be expected of this health insurance mechanism that could attract more interest among policymakers because of its attractive features. Wicks and Hall suggest governmental policies that might facilitate the formation of such cooperatives. Everything for Sale was the arresting title of Robert Kuttner’s 1997 book about the circumstances in which markets do and do not work well (Kuttner 1997). He did not write about commercial institutional review boards but he could have. The need for independent ethical review of research involving human subjects before it is carried out is one of the most agreed-upon matters in bioethics. The institutional review board (IRB) was invented out of recognition that protection of the rights and interests of human research subjects could not be ensured if left solely to researchers. Not only were researchers sometimes seemingly unaware of those rights and interests but they also had a legitimate interest—the pursuit of their research questions—that could sometimes conflict with the interests of subjects. The IRB was invented so that ethical issues would be given due attention and weight by a party that did not have a stake in the research. IRBs became the vehicle for carrying out federal regulations regarding ethical research.
Although some commentators worried that locating the ethical review function at the research institutions itself created a conflict of interest (Annas 1980; Veatch 1975), an early empirical study suggested that the mechanism was being implemented seriously by such institutions (Gray, Cooke, and Tannenbaum 1978). Two different national commissions blessed the IRB mechanism (with recommendations for improvement) two decades ago (National Commission … 1978; President’s Commission … 1981, 1983). But the seeds of problems have always been built in—in the extreme decentralization of the system, in the volume of work assigned to many IRBs, in uneven and frequently inadequate institutional support, and in the fact that similar but different regulatory structures applied to federally supported research and to the research that is done in fulfillment of the regulatory requirements of the Food and Drug Administration.
Many aspects of the system have come under scrutiny in recent years. Several academic institutions have faced suspension of their authorization to carry out federally supported research because of serious shortcomings in their IRBs’ oversight activities (D’Auria 1999). Earlier this year, the secretary of the Department of Health and Human Services even moved the office that oversees the IRBs and the regulatory system under which they operate from the National Institutes of Health into the secretary’s office. The reason, once again, was concern about conflict of interest or its appearance. Could the NIH, with its research mission, give proper priority to a function that might sometimes delay or inhibit research (Office of Inspector General 1998)?
In “Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards,” Trudo Lemmens and Benjamin Freedman critically analyze the solution that has developed regarding the need for the ethical review function for research that is not based in academic institutions and that is done for commercial purposes. The creation of commercial institutional review boards is a solution that Kuttner would recognize. But is it a good one? Lemmens and Freedman’s analysis focuses once again on the problem of conflict of interest. They call for reform, with conclusions that also have implications for review boards in academic settings.
Two aspects of the article “Employment Outcomes among AFDC Recipients Treated for Substance Abuse in Washington State” by Thomas Wickizer and his colleagues are worthy of comment. First, as the authors note, this appears to be the first paper to provide evidence that treatment for substance abuse in the AFDC population enhances the likelihood of movement from welfare to work. This finding must be qualified by several limitations of the study, which of necessity relied on administrative data in which there were no true control groups, but it merits the attention of researchers and policymakers. The second point, which hardly needs to be emphasized for readers of this journal, is that health policy and social policy should not be thought of as distinct fields. In this case, a health intervention—substance abuse treatment—plays an important role in achieving a social policy goal—moving people from public assistance to employment.
The final article in this issue is concerned with a topic that has been examined previously in the pages of the Quarterly (Mechanic 1996; Mechanic and Rosenthal 1999)—the implications of managed care for trust in the doctor-patient relationship. Social scientists have long been interested in trust, including its role in facilitating economic relationships (Barber 1983). But in health care, trust long had a taken-for-granted quality, as an element that was a natural part of the idealized doctor-patient relationship. Although methods of physician payment have always created potentially perverse incentives and although a considerable body of health services research shows that economic incentives affect patterns of patient care decisions, it was only with the rise of managed care that serious attention began to be given to whether the relationship between payers and physicians might have—or should have—implications for patient trust. A body of excellent research is developing on this topic and is cited in the article by Huw Davies and Thomas Rundall, “Managing Patient Trust in Managed Care.”
Davies and Rundall make a simple point that has challenging implications—that something less than full trust (or faith, as they term it) is often in the patient’s best interest. Optimal trust, not full trust, should be the goal to which we aspire. They argue that the degree of trust that might be considered optimal will vary according to the circumstances of interdependence in the patient-physician relationship. They suggest several avenues for future research based on these ideas.
This issue is the combined product of the editorships of my predecessor, Paul Cleary, and myself. Reviewers for all of these papers were assigned by Paul Cleary, who accepted the papers by Lemmens and Freedman (“Ethics Review for Sale?”) and by Davies and Rundall (“Managing Patient Trust in Managed Care”) before his term as editor ended on June 30. The final reviews and revisions of the other two papers were received after I became editor, and I made the editorial decisions on those papers.
Bradford H. Gray Editor, The Milbank Quarterly
Annas, G.J. 1980. Report on the National Commission: Good as Gold. Bioethics Quarterly 2(2):84–93.
Barber, B. 1983. The Logic and Limits of Trust. New Brunswick, N.J.: Rutgers University Press.
D’Auria, J. 1999. Far Beyond Informed Consent: US Research Institutions Keep Close Watch on OPRR’s Suspensions. Journal of Investigational Medicine 47:259–66.
Gray, B.H., R.A. Cooke, and A.S. Tannenbaum. 1978. Research Involving Human Subjects: An Empirical Report on Human Subjects Review Committees. Science 201(4361):1094–1101.
Kuttner, R. 1997. Everything for Sale: The Virtues and Limits of Markets. New York: Knopf.
Mechanic, D. 1996. Changing Medical Organization and the Erosion of Trust. Milbank Quarterly 74:171–89.
Mechanic, D., and M. Rosenthal. 1999. Responses of HMO Medical Directors to Trust Building in Managed Care. Milbank Quarterly77(3):283–303.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1978. Institutional Review Boards: Report and Recommendations. Bethesda, Md.
Office of Inspector General, Department of Health and Human Services. 1998. Institutional Review Boards: A Time for Reform. Washington, D.C.: U.S. Government Printing Office.
President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 1981. Protecting Human Subjects: The Adequacy and Uniformity of Federal Rules and Their Implementation. Washington, D.C.
President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 1983. Implementing Human Research Regulations. Washington, D.C.
Veatch, R.M. 1975. Human Experimentation Committees: Professional or Representative? Hastings Center Report 5(5):31–40.
Author(s): Bradford H. Gray
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Volume 78, Issue 4 (pages 505–508) DOI: 10.1111/1468-0009.00183 Published in 2000
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