A Half Decade of Progress

 Alan J. Garber, MD, PhD, Editor

In the five years of my tenure as editor of Clinical Diabetes, we have been privileged to witness the explosive appearance of a large number of different classes of pharmacological therapies for the hyperglycemia of patients with diabetes, both type 1 and type 2. The concept of genetic reengineering of insulins to produce insulin analogs with improved pharmacodynamic properties has strikingly enhanced our abilities to effect good glycemic control with fewer adverse reactions in patients with type 1 diabetes. For type 2 patients, the number of orally active antidiabetic agents has increased from one class of agents, namely, the sulfonylureas, to the current total of four classes of agents. The three new classes include agents of potentially even greater glycemic efficacy, such as the biguanide metformin, agents directly improving the underlying insulin resistance of type 2 diabetes, specifically, thiazolidinediones such as troglitazone, and, finally, agents that alter the rate of hydrolysis and absorption of oligosaccharides, such as the alpha-glucosidase inhibitor acarbose.

In sharp contrast, pharmacological therapies assisting in weight loss as management tools for patients with type 2 diabetes have imploded rather than exploded in number. As discussed in detail in this month’s issue (p. 229), agents related to the fenfluramine class of drugs have been withdrawn from the market, and the registration process for orlistat, a pancreatic lipase inhibitor, has been put on hold.

This combination of changes will serve only to accentuate an already pernicious misapplication of medical emphasis upon strategies for successful management of hyperglycemia in type 2 diabetes. With our increased number of oral antidiabetic agents soon to increase even further, practitioners will be sorely tempted to prescribe these agents alone and in combination for even minimal degrees of hyperglycemia without an adequate trial of diet and exercise. This is the easiest and least time-consuming response that can be made by practitioners to the impact of managed care plans whose reimbursement rates seem to spiral ever downward. Since practice overhead is unchanged or even increasing annually, the quantity of service, as well as its quality, will be adversely affected as physicians seek to preserve profitability in what has increasingly become a business takeover of medical care delivery.

Frankly, patients compound this unhappy turn of events. Patients with chronic illnesses have always come to physicians expecting that their physician will prescribe for them a pill that will be totally curative of their condition and that requires no exertion whatsoever on their own behalf. They expect that pill to be free of side effects because, obviously, years of pharmaceutical research should have properly perfected each and every agent currently on the market. This pill should be, at most, a once-a-day pill, because it is unreasonably burdensome to expect patients to remember to take their medicine several times a day or even with each and every meal. Finally, of course, patients expect that these pills will be inexpensive—even cheap, perhaps—because it is clearly unreasonable to expect that one should pay in order to have one’s health restored.

It is with this final point that we have reached the bedrock problem of diabetes management in America. It is a problem not unique to diabetes but instead reflective of our society’s perceptions about itself and about its own health. We have come to expect that good health is the natural order of things, that ill health, when it occurs, is neither our fault nor our obligation to reverse beyond going to the physician. The public is perceptibly unwilling to pay for its own care or to participate actively in that care.

In the past, as a result of the public’s continuing insistence upon medical care second to none anywhere in the world, upon the demand or even the whim of anyone from patient to distant family member, medical costs spiraled upward and out of control. The American medical care system was funded previously either by employer contributions or by governmental contributions. As a result, the system encouraged patient nonparticipation and eliminated any possible incentive for patients to improve their own health.

We have continued to institutionalize such practices, in this case, as managed care. But, as managed care has evolved, it has clearly become a system of rationed care using primary care physicians as "gatekeepers" holding the keys to the kingdom of high-tech medical specialties made available primarily to those who demand such treatments. Contrary to prior expectations, patients have willingly participated in such limitation-of-care schemes, because to do otherwise would necessitate out-of-pocket expense for care otherwise denied or unavailable.

Physician professionalism has largely softened the impact of this system of managed care. Indeed, by their actions, physicians have effectively subsidized the profitability of the managed care organizations that now function largely as bulk resellers of medical services. However, this subsidization is decreasing, thereby exposing patients to the nature and quality of the care provided by their care organizations. Public outcry has, therefore, increased, but changed behavior is not yet evident.

So, after a half decade of progress, we face the new millennium of diabetes care with a bag of shiny new pharmacological tools to treat the same tired, old clinical problem. Stay tuned to future issues of Clinical Diabetes as our new editor, Dr. Irl Hirsch, chronicles the adventures of the forces of pharmacology as they enter into moral combat with patients who epitomize the sedentary, overcomsumptive American lifestyle. In the next half decade, will we see the effects of exercise reproduced by a once- or twice-a-day oral medication? Could it be that patients may learn to rein in their appetites and acquire the self-discipline notably missing from so many other aspects of American society? Could it be that some as yet unimagined treatment for appetite suppression and obesity will become safe enough and effective enough to do for patients with diabetes what they cannot or will not do for themselves, specifically, eat less and lose weight? Or perhaps, will we learn from the final data analysis of the U.K. Prospective Diabetes Study or from the Type 2 Diabetes Prevention Trial that no treatment devised by man can avert the tide of rising hyperglycemia once relative pancreatic failure begins its progressive, irrevocable, unmitigated obliteration of insulin secretory capacity?