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CLINICAL DIABETES
VOL. 14 NO. 4 JULY/AUGUST 1996

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EDITORIAL

Competition and Confusion in the Direction of Medical Care
Alan J. Garber, MD, PhD, Editor

As medicine transforms itself from a 19th century cottage industry into a 21st century collection of corporate caregivers, guidelines have proliferated for the treatment of virtually every chronic disease.

These guidelines may be based upon comprehensive multicenter clinical trial data, small-scale clinical research center investigations, extrapolations of animal data and other research, expert opinion, or a combination of all of the above. Guidelines may be the result of an impartial expert review of the literature, or they may be issued by the medical directors of health-care plans.

Guideline issuance may derive from august, dispassionate, outside bodies, such as the National Institutes of Health, or they may be the product of the financial or insurance organizations that now provide a large proportion of medical care in America.

Regardless, guidelines exist to standardize medical care for a given condition and to assure the quality of care delivered. However, more recent guidelines, particularly those with a financial origin, seem designed to limit care to subpopulations of patients, thereby reducing physician discretion and limiting clinical decision making.

Such a phenomenon clearly followed the 1993 publication of the results of the Diabetes Control and Complications Trial. Initially, the American Diabetes Association (ADA) and other expert groups recommended the widespread applicability of intensive diabetes management to virtually all pubertal and post-pubertal patients with insulin-dependent diabetes mellitus (IDDM). Increasingly, however, guidelines have appeared seeking to narrow the population thought to benefit from intensive diabetes management.

The ADA continues to recommend that an HbA_1c of less than 7% should be produced in patients with IDDM and that values greater than 8% are unacceptable and worthy of remedial action. How-ever, we find increasing disagreement with such recommendations. Indeed, the major point of dissension is that the goals of the ADA are difficult to achieve. Therefore, they should be abandoned in favor of looser guidelines, which are presumably easier to attain. There is little scientific or clinical support for such a devaluation of goals.

Efforts have also been made to exclude the entire population of patients with non-insulin-dependent diabetes mellitus (NIDDM) from intensive management, although it is the essential position of the ADA that such management is likely beneficial to patients with NIDDM as much as it is to patients having IDDM. Despite recent clinical evidence indicating that intensive control in NIDDM yields benefits similar to those observed in IDDM, revisionist thinking continues. Results of the recent Kumamoto Study (Diabetes Res Clin Pract 28:103-17, 1995), demonstrating clear benefit from intensive management in Japanese patients with NIDDM, are often dismissed as irrelevant to American patients with NIDDM. The principal difference cited is the relatively greater degrees of obesity in American as compared to Japanese patients with NIDDM.

This seems an unreasonable position to take, in view of the identical nature of diabetic complications in Japanese and American patients with diabetes and the similar efficacy of similar glycemic control in NIDDM patients in Japan as compared to IDDM patients in America. Any objective analysis of such a disagreement would therefore conclude that concerns other than improved patient care must predominate in the formulation of a view seeking to exclude patients with NIDDM from aggressive management consideration.

This may reflect the sloth of the practitioners involved; the failure of health-care insurance or provider organizations to reimburse for the materials, personnel, and efforts necessary to produce intensive management; or an honest desire to produce cost-effective care for patients with diabetes. Nonetheless, the diabetes community is ill served by the creation of guidelines and practice standards sharply at variance to those of the ADA.

A similar concern has arisen regarding the treatment of hyperlipidemias in various populations, especially in the young and in the elderly. Although the National Cholesterol Education Program (NCEP) of the National Heart, Lung, and Blood Institute clearly regards all individuals at risk from cholesterol-associated heart disease and has issued guidelines to that effect, other organizations have disagreed.

Whereas the American Heart Association has clearly endorsed the guidelines of the NCEP, the American College of Physicians has not. The latter group considers cholesterol screening and treatment in the elderly not to be cost effective, primarily because of an analysis dependent upon declining relative risk of heart disease as the result of increasing cholesterol.

Nonetheless, the NCEP regards treatment of the elderly as being of major concern. This population is at highest absolute and attributable risk and, therefore, is most meritorious of cholesterol management since this would produce the greatest reduction in coronary artery disease in America. The creation of markedly dissimilar guidelines by different, and yet relatively equally prestigious, organizations serves only to confuse practitioners and to undermine organized strategies for long-term health care in America.

Furthermore, the concept of patient care guidelines based upon cost effectiveness may be an ethical conundrum for physicians. Doctors treat one patient at a time. Their forsworn obligation is to that patient. Physicians may not prescribe noxious or harmful treatments and are enjoined to improve the lot of their patients. As such, ethical practice standards require that physicians prescribe treatments that are safe and effective.

On the other hand, it is the patients' role to implement such treatments if they agree with the recommendations of their physician. Patients may reflect upon the cost of the recommendations being made, but they must under all circumstances be persuaded of the quality of the recommendations and the care provided.

American medical care has introduced recently a distortion into this decision making process. Since the bearers of the cost of care, namely governmental or employer organizations, are not the recipients of care, a fundamental disconnect results. Patients will always desire the most expensive and usually least participatory treatments recommended to them. Payers of such care, seeking to limit their cash outflow, are now attempting to limit care and services.

At first, this was by the mechanism of usual and prevailing costs' paid by various insurers. When the usual and prevailing charges reimbursed by insurance companies never equaled the existing charges of anyone in a given community, that system was abandoned for other techniques of limiting cash outflow. We now come to an era in which there is not only downward pressure upon amounts reimbursed, but outright limitations of reimbursement for services and materials required.

Some organizations wish to pay incentives to physicians to limit care. The acceptance of such incentives for participation in efforts to limit care represents a basic change in the role of physicians. Their participation in such plans is fundamentally unprofessional and unethical and represents a violation of physician obligations to patients.

On the other hand, patients do not help themselves by anticipating that managed care organizations, health insurers, or the government will pay the cost of all of their medical care, medical devices, medications, treatments, or self-care education. In this era of cost containment, patients still maintain the primary obligation to see to their own health. Guidelines should exist not only for physicians, but also for patient awareness, so that they know what their future holds in terms of adverse medical outcomes.

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