Heterodoxy, Peer Review, and the Medical Boards
Jane M. Orient, MD
The following correspondence from Dr. Orient to Dr. John Sullivan at the University of Arizona College of Medicine conveys important information pertaining to the role medical boards play in "free market" medical care. It is printed here excerpted for the benefit of the readers of the Medical Sentinel.
Dear Dr. Sullivan,
I am dictating a few thoughts with reference to the first meeting of the Alternative Medicine Committee as well as the meeting with the representative from the Board of Medical Examiners. I unfortunately will not be able to attend either meeting because of a schedule conflict.
The subject of alternative medicine raises a number of issues with regard to evaluating treatment. There is a lot of pressure to restrict physicians' treatments to practice guidelines and to methods that have been shown to be both safe and effective in double-blind controlled trials. If we were to insist on this across the board, a huge number of medical treatments that physicians rely on would be ruled out. Additionally, any new treatment that cannot meet the $500 million hurdle required for FDA approval would be permanently ruled out. The trend to rely on expert committees suggests to me that we are moving toward the Prussianization of American medicine, adopting a system rather like the Geheim Rath (secret council) system that prevailed in Prussia at the close of the 19th century. The Geheim Rath set the standard of care, and none of his younger colleagues wanted to disagree with him because they may have cherished the hope of one day becoming Geheim Rath. Of course, today we have committees rather than individuals, but the result would be no different.
Even expert committees have an inherent bias, as does FDA-approved peer review. The elite groups tend to become inbred. As a personal example, I remember that when I was an intern and resident at Parkland Memorial Hospital in Dallas it was forbidden even to discuss the technique of treating diabetic ketoacidosis (DKA) with continuous infusions of low-dose insulin. When I came to the University of Arizona to finish my residency, I treated a case of DKA using the standard Parkland flow sheet and giving boluses of 100 units of insulin all night long, hoping not to shock the patient into hypoglycemia. At morning report, my fellow residents were horrified. The chairman of the Department of Medicine came to my rescue (Dr. Rubin Bressler) and asked what was (and still is) the most important question: How is the patient doing? Fortunately, the Silver Fox of Parkland was not in charge of dictating nationwide protocols for the treatment of DKA.
We know that physicians who undertake unusual methods of treating patients may be sanctioned by the Board of Medical Examiners. Impossible stipulations may be placed upon them, such that the treatment has to be discontinued. Certainly no other physician would want to risk similar sanctions by undertaking to treat these patients by a similar method. These patients often tend to be very complicated patients with chronic illnesses that have been unresponsive to standard medical treatment and are seldom welcomed in physicians' offices. Each one of them is an experiment with an n of one. (This might be true of more patients than we realize: we are increasingly beginning to recognize the tremendous biochemical individuality.)
It really is rather paradoxical. We will accept the use of expensive poisons, such as chemotherapeutic agents, to treat patients when the demonstrable benefit may be only a mean increase of life expectancy of several months. Statistically significant perhaps, but clinically significant, who knows? On the other hand, relatively benign treatments that have not been subjected to the double-blind controlled studies may be inaccessible. There is not only the $500-million cost hurdle for FDA approval, but the possibility that statistical significance would never be reached because there is only a (small) subset of the population that could hope to benefit from the treatment due to biochemical individuality or rarity of the disease.
At the same time, we realize there is such a thing as a charlatan, interested only in extracting peoples' money with promised cures that he has no reason to believe will be of benefit.
I think we seriously need an answer to the dilemma of protecting patients, while at the same time promoting medical advances and not closing off access to treatments that may be beneficial. We also need to protect patient confidentiality. I believe that the key to such a method is open access to pertinent information.
In the fall of 1999, the Medical Sentinel, the official journal of AAPS, instituted a policy that we hope will be followed widely: researchers must make redacted raw data available for independent scrutiny. Our open data, public review policy goes beyond the inbred type of peer review that journals generally have. Additionally, by imitating the blind peer review process the Medical Sentinel uses in evaluating all articles, in which reviewers do not know the name of the authors, we can also possibly avoid some of the prejudice that may attend review by one or a few chosen members of the Board of Medical Examiners. We also need a method that recognizes that physicians are professionals. Throughout history they have been enjoined to practice according to the Oath of Hippocrates, which is to prescribe that regimen that is best for the patient according to their own knowledge and judgment. If each and every individual physician is not presumed to be competent to make careful observations and to prescribe prudently, then medicine is really not a profession. If everything can be done with treatment protocols, then perhaps we should do without physicians altogether. Of course, we recognize that there are varying abilities, but I think it is a mistake to say that one small group, politically appointed, can sit in infallible judgment on just who the real physicians might be....
We have to recognize that science and medicine overlap, but are not one and the same. We need ways to enhance progress in both the art and science of medicine. Of course, we are aware of the placebo effect and the effect of regression toward the mean. These apply with all modes of treatment...
Jane M. Orient, MD
Dr. Orient is the Executive Director of the Association of American Physicians and Surgeons (AAPS), 1601 N. Tucson Blvd., Suite 9, Tucson, AZ 85716. Website: http://www.aapsonline.org.
Originally published in the Medical Sentinel 2000;5(3):104-105. Copyright
©2000 Association of American Physicians and Surgeons.