Clinical Perspective
By Stephen L. DeFelice, M.D.
Dr. Stephen L. DeFelice, M.D., Medical Tribune, Wednesday, February 11, 1987, Vol 28, N6
IT IS LAMENTABLE that physicians are rapidly losing control over their destiny. The sudden explosion of institutionalized, depersonalized medicine has predictably created an increasingly powerful system of external control, depriving the physician of the traditional freedom regarding patient management. The forces of control will continue to grow, resulting in mass physician employment by bottom-line business administrators. New leaders of medicine will increasingly preach the importance of cost-effective medicine. Patients will be encouraged to choose a “system” rather than a “physician.” And as long as the present perceived value of the physician by the public is an economic one, little can be done to restore the physician to his rightful leadership role.
Can the position of the physician as the primary leader in American medicine be restored? Is there a way in which patients, once again, will clearly view the physician as his or her best friend?
There certainly is! The first step is to reestablish the historically hard-earned image of the physician as the person who is most concerned to cure, or at least lessen, the heavy physical and mental burdens of those diseases that ail us.
This cannot be done by attempts to persuade patients concerning the negatives of cost-effective medicine.
A bold first step is needed to reestablish the beauty and importance of the physician-patient sacrosanct relationship. Once it is established, no governmental or business forces would dare challenge the primacy of the physician as the legitimate force in the practice of medicine.
Let’s switch gears and examine the dynamics of innovation. The basic ingredients of any innovative process are (a) having an idea and (b) testing it. The fewer obstacles between a and b, the greater is the innovative potential. For example, if Einstein or Da Vinci felt the urge to create, he could simply walk to the blackboard or the easel to express such creativity.
The innovative process in medicine usually involves a substance or technique (the idea) and the clinical evaluation of the aforementioned (testing it). Penicillin in a test tube is undiscovered unless it is clinically tested.
One of the great tragedies of our times is that over the past 20 years, a pervasive and aggressive regulating system has evolved that has effectively blocked the caring clinical innovator at nearly every step. To compound the problem, the current ugly face of litigation certainly discourages many physician innovators from testing their ideas in patients. Let there be no doubt that we have quietly, but effectively, eliminated the Louis Pasteurs of our great country.
As a young physician, over 20 years ago, I was convinced that carnitine, a natural substance, had rather exciting potential as a prophylactic or therapeutic agent in the treatment of a variety of diseases, ranging from myocardial ischemia to aging.
Filled with the inspiration and energy of youth, I formulated a strategy to evaluate carnitine’s clinical potential. Then I discovered the brutal truth. Our regulatory and economic system presents enormous additional barriers to demonstrating the clinical value of a natural substance. The combination of regulatory and economic barriers precluded initial clinical trials in this country. I was forced to travel to Yugoslavia and other foreign countries in order to find clinics willing to test carnitine in patients. The present barriers that frustrate and block the creative physician from clinically evaluating a Tibetan herb or a purified tissue extract have virtually placed him in the category of the dinosaur-extinct. And, sad and frustrating as it may be, this situation remains largely unrecognized.
The message was clear. Something had to be done to eliminate the unreasonable barriers that hinder creative physicians from clinically evaluating their hypotheses. I asked myself, “What workable solution would be acceptable to liberals, moderates, and conservatives and, therefore, to Congress, would lead to a modification of our present system, and would open the doors to the clinical evaluation of nature’s vast medical potential?”
I then concluded that physicians should take the initiative and offer themselves- yes, as human guinea pigs-to dramatically accelerate the discovery and delivery of nature’s medical promise by removing the barriers to clinical research.
To test the waters of the acceptability of this proposal, a randomized mail survey of physicians was recently conducted by the Foundation for Innovation in Medicine. A total of 3,100 inquiries were mailed to a cross section of 2,100 male M.D.s, 500 female M.D.s, and 500 D.O.s. Age was also considered. Half of the male physicians surveyed were 50 years old or younger; half of them were 51 years old or older. A total of 10.3% of the physicians responded.
In addition, a telephone survey of seven academic institutions was conducted.
A simple “Yes” or “No” answer was required for the following question:
“Would you as a physician-patient want the privilege to volunteer for clinical research of natural substances under the supervision of a physician-clinical researcher without any FDA, institutional, or other restraints?”
More than 50% of the physician responders answered “Yes” to the proposed question. It was observed that certain physicians who responded “No” had not fully comprehended the question. Further research on physician attitudes, therefore, is indicated.
Though the survey dealt with natural substances, it is important that physicians be willing to volunteer as clinical research subjects in all areas of medicine, ranging from the evaluation of artificial molecules to medical devices, in order to dramatically accelerate the total medical discovery process.
Who would object? Who would be politically opposed? Who will cry “Auschwitz”? Who would shout “foul”? It is difficult to conceive of strong opposition to such a humanistic proposal. Congress has nothing to lose. It is difficult to believe that the American Civil Liberties Union would rush to the protection of the physicians-turned-guinea pigs, questioning whether they had been “properly informed.” William Buckley would probably enthusiastically applaud, while Ralph Nader could conceivably whisper “Bravo” to himself.
In our present age of technology, depersonalization, and distrust, there is a crying need for noble acts, for altruism, the quality that is fading in the shadows of economic medicine. What better way is there for physicians to take risks in order to benefit their patients? In so doing, physicians will assume their rightful and noble role of the primary caretaker of the patient. And, without doubt, the patient will recognize the beauty of such an act and enthusiastically support this objective.
If the aforementioned comes to be, then the power of the physician will once more extend into all areas of medicine. Let’s not forget that, along with the clergy, physicians still maintain the highest positions in opinion polls. Common wisdom continues to tell Americans to trust their doctors over their politicians.
Dr. DeFelice, a Westfield, N.J., endocrinologist, is the author of From Oysters to Insulin: Nature and Medicine at Odds, Citadel Press, 1986 (MT, June 25, 1986).