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The past quarter century has seen a transformation of the pharmaceutical industry from blind empiricism to the design of drugs to act as agonists or antagonists at specific receptor sites. As truly effective technology, many have led to marked savings in cost. Savings have been achieved when therapeutic drugs, often highly specific, can be substituted for surgery and other invasive procedures and when therapeutic drugs can be used to prevent illness and the need for treatment. Further savings are achieved with the reduced prescription of ineffective drugs. It is estimated that therapeutic drugs and vaccines contribute about half of medicine's contribution to increased life expectancy and improved quality of life in this century at about 7% of national expenditures for medical care in the United States.

Fifty years ago, when medicine had relatively few effective treatments to offer, its value was unquestioned. Twenty-five years ago clinicians had become concerned that treatment could sometimes do harm and McKeown published epidemiological evidence claiming that medicine did little good. This state of affairs was used by Illich to bolster his crusade against technology in general. Today it is clear that medicine now makes a large contribution to health. But doubts still exist and alternative pathways to health are continually exhorted. Large-scale efforts at behavioural modification, encouraging the adoption of healthier lifestyles, have been largely unsuccessful. Social activists now argue that funds should be diverted from medical care to social programmes that, they claim, might contribute more to health. While it is true that health is strongly associated with socio-economic status (income, education and occupation), there is little sense of how best to reallocate scarce resources so as to improve the health impact of social and economic programmes. Social reform is not a substitute for medical care. Rather, our social environment is a second, important but quite separate, determinant of health and well-being.

Freedom and responsibility, how much of each and how they are balanced, have profound implications for our personal lives and for our work. The health of a population and its achievement in the workplace are enhanced when individuals have some freedom and some responsibility, but not too much of either, and when civil associations of individuals rather than individuals acting alone are the essential social units. The consistent association of social contacts with health and productivity provides strong support for the premise that intimate relationships are the focus around which people's lives revolve. Membership of a "social network" may be merely conforming to a reigning social norm, and this could mean having to pay an important price in the loss of creativity associated with individualism. But social conformity should not prevent individuals from going their own way, and it should be possible to combine the luxury of individuality with an active life in civic affairs. Less than complete freedom may fall short of existential utopia, but it may be best for our health and wellbeing.

The extraordinary increase in life-expectancy that occurred early in this century has been attributed largely to non-medical factors. Life-expectancy has continued to rise, and medical care can now be shown to make substantial contributions. Three of the seven years' increase in life expectancy since 1950 can be attributed to medical care. Medical care is also estimated to provide, on average, five years of partial or complete relief from the poor quality of life associated with chronic disease. The association of social factors with health is well-known, but except for occupation, it is not known how they might act or whether they are proxies for some other yet to be identified factor.

The impact of medical care on the quality and length of life of the population has been poorly documented. The rapid growth of evidence of efficacy of therapy for individual medical conditions now offers the opportunity to create an inventory of benefits. A method for creating such an inventory is described, as is its application to a selection of condition-treatment pairs, chosen for their high incidence of prevalence, their serious outcomes, and the demonstrated efficacy of their treatment. An aggregate effect of medical care on life expectancy is found to be roughly five years during this century, with a further potential of two years. Although there is no overall index of quality of life analogous to life expectancy, our inventory demonstrates the enormous burden of pain, suffering, and dysfunction that afflicts the population for which medical care can provide a large measure of relief.

"Efficacy"-medical care that is achievable under optimal conditions-is generally considered to be the appropriate standard for quality assurance. In this paper I argue that what is needed is a broadened definition of efficacy that includes the appropriateness of an intervention as well as the level of technical skill used in its provision. To establish efficacy, so defined, I suggest that well-designed nonexperimental, as well as experimental, studies be undertaken that employ registries and data banks, as well as formal clinical trials, and that decision analysis be used to synthesize the results. This will require a significant effort and investment in outcome studies of medical and surgical technologies. With growing recognition by the public that quality can be highly variable-aided by the Health Care Financing Administration's publication of hospital mortality and morbidity data-the medical care system will ignore outcome studies and quality assurance at its own peril.

The authors suggest that new surgical procedures be carried out initially in selected institutions and that complex procedures for which it has been or can be demonstrated that mortality is inversely related to the volume of experience also be regionalized. Regionalization in the latter instance can have a small overall impact on surgical practice but a large impact on the adverse consequences of high risk operations that are performed only occasionally.

This study examines mortality rates for 12 surgical procedures of varying complexity in 1498 hospitals to determine whether there is a relation between a hospital's surgical volume and its surgical mortality. The mortality of open-heart surgery, vascular surgery, transurethral resection of the prostate, and coronary bypass decreased with increasing number of operations. Hospitals in which 200 or more of these operations were done annually had death rates, adjusted for case mix, 25 to 41 per cent lower than hospitals with lower volumes. For other procedures, the mortality curve flattened at lower volumes. For example, hospitals doing 50 to 100 total hip replacements attained a mortality rate for this procedure almost as low as that of hospitals doing 200 or more. Some procedures, such as cholecystectomy, showed no relation between volume and mortality. The results may reflect the effect of volume or experience on mortality, or referrals to institutions with better outcomes, as well as a number of other factors, such as patient selection. Regardless of the explanation, these data support the value of regionalization for certain operations.

Early clinical trials, observational or randomized, hasten the prompt evaluation of new operations. Early clinical surveillance facilitates the design and implementation of randomized clinical trials when they are necessary. Of equal or greater importance, long-term surveillance of operations allows continuing evaluation when their use becomes widespread. Standards, coordination, review, and funding of the evaluation of new operations we believe should be centralized in a single national agency, for which an Institute of Health Care Assessment might be created. Implementation and regulation of the evaluation we believe should remain at the local or regional level with existing mechanisms and agencies being used, such as institutional human research committees and local health systems agencies.