Book Review

Economics and Ethics in Health Care

Managing the Medical Arms Race: Innovation and Public Policy in the Medical Device Industry

N Engl J Med 1993; 328:1360-1361May 6, 1993

Article

Managing the Medical Arms Race: Innovation and Public Policy in the Medical Device Industry
By Susan Bartlett Foote. 285 pp., illustrated. Berkeley, Calif., University of California Press, 1992. $35. ISBN: 0-520-07591-9

A major contributor to escalating health care costs is the proliferation and use of expensive forms of medical technology. Without control of these “medical arms,” it is unlikely that the steady increase in health care expenditures will be attenuated. What is most bothersome about this problem is that medical techniques are frequently developed for use in treating the later stages of uncommon, often fatal diseases. Such forms of technology benefit a relatively small population, mostly in the later stages of life and often in situations requiring the use of heroic measures. Hence, increased spending on medical technology may divert funds from more pressing health priorities. Should we be perfecting an artificial heart when 37 million Americans lack basic health care? On the other side of the coin, how can we remain on the cutting edge of innovation in medicine without the research and development of new techniques? Can we do this and at the same time address our population's immediate health care needs? Such are the challenges posed by the medical arms race.

Susan Foote starts us thinking clearly about this problem. Her concise, readable, and interesting book covers the historical background and the policy dilemmas impinging on the federal government and the medical-device industry. To organize this problem, she uses a policy matrix or two-by-two table that compares the factors that promote or inhibit the discovery and distribution of medical devices, then deals with each of these elements in turn. She describes the role of the National Institutes of Health and governmental space and defense programs in stimulating and supporting basic research underlying the discovery of new forms of technology. Governmental health care policy has also played a major part in the promotion and distribution of new medical devices, first through Hill-Burton funds for hospital construction, and later through Medicare and Medicaid. Government and society have also seen the need to inhibit the development and distribution of new forms of technology, both to protect the public from unsafe devices and to contain costs. The development and enforcement of regulations by the Food and Drug Administration, along with product-liability court decisions, have inhibited research on new devices. Certificate-of-need legislation and governmental efforts at cost containment may also delay and decrease the distribution of medical devices.

Foote describes the development of these forces in a dynamic fashion, using clear, easy-to-follow analyses of the effect of policy decisions. She cites specific examples, such as the Dalkon Shield and the artificial heart, to describe the background and the policy context within which new forms of technology have been developed, promoted, and sometimes inhibited. Her book thus accomplishes two goals. First, it informs those dealing with these issues today that the historical background must be understood for the current challenges to be appreciated. Second, it describes vividly how public policy affects the medical marketplace, even in our relatively free market society. These are lessons not to be overlooked. By careful observation and analysis, Foote has at least partly accomplished the goal she set for herself -- namely, to do for medical devices what Paul Starr (The Social Transformation of American Medicine. New York: Basic Books, 1982) accomplished for the medical profession, what Charles Rosenberg (The Care of Strangers: The Rise of America's Hospital System. New York: Basic Books, 1987) and Rosemary Stevens (In Sickness and in Wealth, American Hospitals in the Twenty-First Century. New York: Basic Books, 1989) did for hospitals, and what Henry Grabowski and J.M. Vernon (The Regulation of Pharmaceuticals: Balancing the Benefits and Risks. Washington, D.C.: American Enterprise Institute for Public Policy Research, 1983) did for the pharmaceutical industry. All are important pieces of our current health care puzzle.

The Medical Arms Race stops short of its goal in some important ways, however. The best hope for managing this race without throwing out the baby with the bath water may be to develop and promote scientific assessments of technology. New research and policy paradigms are being developed to meet the need for such information. These evaluations are coming from the fields of clinical epidemiology, medical decision and cost-effectiveness analysis, and outcomes research. Examples include the evaluation of various devices to treat back pain, gallbladder disease, and cataracts by the medical-effectiveness and outcomes-research initiative supported by the Agency for Health Care Policy and Research, and cost-effectiveness analysis of new medical techniques, such as bone densitometry for the early diagnosis of osteoporosis.

Governmental and voluntary organizations will need to learn to use this information if our society is truly going to control health care expenditures. These new methods of formulating policy may at long last provide a rational basis for deciding whether and when to use expensive forms of technology, especially when there is a tendency to overexploit beneficial techniques by extending the indications for their uses. Although Foote recognizes them as important developments, she does not describe or analyze them in any detail in her book. As a result, the book takes only the first step toward giving a better understanding of how our society will deal with new and expensive forms of medical technology. Perhaps it is too early to anticipate how these newer forces will play themselves out; therefore, how we will manage the medical arms race must remain a question.

Alvin I. Mushlin, M.D., Sc.M.
University of Rochester Medical Center, Rochester, NY 14642