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15 November 1994 | Volume 121 Issue 10 | Pages 803-804
In the United States, such remedies attract an enormous and growing number of patients. Their use is so extensive that a 1990 survey suggests that there are, in effect, two parallel tracks for those seeking primary care [1]. The first offers "scientific medicine." Focusing on services by internists, family physicians, pediatricians, and obstetrician-gynecologists, it is heavily regulatedsome feel over-regulatedby governmental and other bodies. The second is often called "alternative care" and is provided by massage therapists, acupuncturists, homeopaths, megavitamin therapists, herbalists, and others. It is largely unregulated. People explore each path with equal frequency and often travel on both, spending lots of money as they go [1]. It is difficult to estimate, however, whether expenditures on alternative care save money for the United States. Would we spend more or less if such therapies were not available?
There is ample evidence that physicians practicing scientific medicine can be dangerous for patients. So, too, with alternative offerings, and Woolf and colleagues [2] provide a good example of this in this issue. Until recently, a Chinese herbal product, "Jin Bu Huan Anodyne Tablets," was available not only in health food stores but also in the growing number of pharmacies trumpeting the virtues of "natural" remedies. Unregulated, the tablets sat next to medicines that had survived regulatory oversight. Produced by a "drug manufactory" in China, the package insert in the box asserts that the tablets are "good for anodyne, sedative, spasm and hypnotic." It warns, however, that a transient "sleepy state, little dizziness and felt strengthless or nausea." may occur. But now strong evidence exists that Jin Bu Huan may injure the livers of some adults [2]. Children, too, may be hurt if they ingest these pills accidentally [3]. As a result, long after the tablets became widely available, investigators from the Food and Drug Administration (FDA) have taken steps to remove them from consumer outlets nationwide [4].
Why is there exploding use in the United States and other developed countries of what many term "unscientific medicine?" Do its benefits outweigh its risks? And, given risks, how will they be addressed at a time of antiregulatory, antigovernment sentiment? I suspect that the turn toward unscientific medicine reflects two different but synergistic impulses. The first is deep yearning for cherished and affordable aspects of the good old days, with particular note of their more leisurely pace. The second is growing confusion and disenchantment over expensive scientific medicine, with its mixed messages and unfulfilled promises.
In today's frantic and increasingly impersonal world, replete with fax machines, voice mail, the tortuous information highway, and the bewildering technologies of medicine, people find hope in recreating the past. The "original instrument" movement in music, the renaissance of the portrait painter, the fascination with Wharton's Age of Innocence, and the urban dweller's flight to the country represent point-counterpoints to the suffocation that comes from today's headlong rush. And the countervailing simplicity, clarity, and directness that patients seek may be represented by a tablet or potion derived from an exotic "natural" herb.
At the same time, clinical trials investigate scientific medicine with increasingly sophisticated techniques that proliferate, confuse, and too often disappoint an avid audience. Methodologists who develop and critique their design and findings wield more and more complex tools. How many approaches to multiple regression now exist? Which statistical inference is right for the latest set of data? In 1994, is butter or margarine safer? When do you remove, radiate, or watch prostate cancer? Is lumpectomy for breast cancer really as safe as more mutilating surgery? What's best for back pain? So, even at a time of rich scientific endeavor and discovery, patients turn to plants or homeopathic distillates and announce, "I would rather swallow this! It's pure, it's safe, it's magic, and it will help me face the world"
But now their purity, safety, or magic also comes into question. The contents inside the Jin Bu Huan box, for example, are not Jin Bu Huan; the manufacturers either used the wrong plant or got it wrong on the label. Moreover, the safety is suspect; its effect is not magic alone. The ingredients have a pharmacologic effect that may help or hurt the patient, depending on the total dose and individual susceptibility [2].
How should the benefit that may come from alternative therapies, whether through the placebo effect or beyond, be maximized? And how should the dangers of these therapies be minimized? With respect to the benefits, the multibillion dollar industry that produces and promotes many of the therapies is not shy about extolling their putative virtues. As has been true in the United States since its founding, proponents of alternative therapies find it easy to attract the public's attention [5]. The popularity may grow through future clinical trials that show efficacy, and interest in such trials is increasing. Small-scale experiments are sponsored by the highly visible, albeit modestly funded, Office of Alternative Medicine (OAM), established at the National Institutes of Health (NIH) "to encourage the investigation of alternative medical practices, with the ultimate goal of integrating validated alternative medical practices with current conventional medical procedures" [4]. Larger trials are funded with less fanfare through other branches of the NIH. Private philanthropies, led by the Fetzer Institute in Kalamazoo, Michigan, are investing aggressively in this area. All this activity likely represents a response to public demand and a carefully orchestrated effort to engender interest.
Minimizing hazard is the principal responsibility of the FDA, whose job is "to see that the food we eat is safe and wholesome ... , the medicines and medical devices we use are safe and effective ..." [6]. Until now, the FDA has insisted that before it may be made widely available, a "product is studied scientifically in properly controlled trials, so that we can know whether it works for a specific purpose and so that patients are not exposed to experimental products of no proven value" [4]. The FDA is working with the OAM to initiate trials that test everything from shark's cartilage, touted as a treatment for cancer, to "Dr. Revici's treatment and Bee Pollen products" [4]. But the number of such products already for sale is staggering. What should come off the shelves until efficacy and safety are documented?
The lobby for alternative therapies is powerful. This October, Congress passed "The Dietary Supplement Health and Education Act of 1994." The measure has been cleared for White House approval, and as of this date, President Clinton is expected to sign it. Despite conciliatory rhetoric announcing a compromise, the law, skillfully shepherded by Senator Hatch, represents a defeat for the FDA and a victory for those promoting alternative therapies. It may well become known as the "loophole act"its language is so imprecise that we may soon find even more trucks filled with scientifically suspect substances driving unchallenged to the store or pharmacy. The language shows lawyers hard at work, establishing a rather fine distinction between reducing risk and helping to maintain a healthy body. Claims for risk reduction are now reserved for substances that are reasonably well-established scientifically, such as calcium for osteoporosis. But, as people strive to maintain health, an elixir containing an amino acid can now be advertised as boosting the immune system. The law may make it more difficult for the FDA to proscribe products such as Jin Bu Huan in the future. And, in a step characteristic of politicians who know they are facing matters complex and politically hazardous, Congress dances around the issue of health claims for substances such as herbal products by establishing a Presidential commission to study what to do with them in the future. For now, the laws of the land pose few obstacles for alternative therapies. When they are dangerous, we will learn so primarily from reports of those who were harmed by them.
As alternative therapies proliferate, what role can physicians play in addressing a phenomenon that, at first glance, seems to fly in the face of scientific medicine? First, one should remain humble about physicians' own mixture of art and science. Not so long ago, leeches and frozen stomachs were in their domain, and many of their beliefs today must remain tentative. Second, physicians should learn more about alternative therapies. They need to understand what they are, who uses them, and when. Third, physicians can apply their rich scientific heritage to put alternative therapies to the test. Fourth, they can promote open communication with patients who seek help from both tracks of medicine. In so doing, physicians will gain more insight into the effect of alternative therapies and may help discover and prevent those dangers that exist. And finally, physicians should consider whether the current fascination with such therapies derives, in part, from their growing failure to practice personal medicine. Our citizens cry out for attention. Physicians should work with them, and within medicine, to claim more time for the human interactions that are central to the physician-patient relationship. This may come at the expense of some tests and procedures. It will be well worth the tradeoff.
1. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med. 1993; 328:246-52.
2. Woolf GM, Petrovic LM, Rojter SE, Wainwright S, Villamil FG, Katkov WN, et al. Acute hepatitis associated with the Chinese herbal product Jin Bu Huan. Ann Intern Med. 1994; 121:729-35.
3. Horowitz RS, Dart RC, Gomez H, Moore LL, Fulton B. Jin bu huan toxicity in childrenColorado, 1993. MMWR Morb Mortal Wkly Rep. 1993; 42:633-6.
4. Pendergast MK. (Deputy Commissioner and Senior Advisor to the FDA Commissioner.) Statement before the Committee on Labor and Human Resources. United States Senate. July 22, 1994.
5. Rothstein WG. The botanical movements and orthodox medicine. In: Gevitz N, ed. Other Healers: Unorthodox Medicine in America. Baltimore: The Johns Hopkins University Press; 1988; 29-51.
6. FDA Backgrounder. The Food and Drug Administration: an overview. 1991:BG 91-1,0.EDITORIAL
Bitter Herbs: Mainstream, Magic, and Menace
If nothing else, politicians are often the quintessential pragmatists. I recently asked a German legislator why his country's national health plan pays for homeopathic and other "unscientific" therapies. His reply was simple. "I can't prove they work, but many swear by them. They seem often to replace our doctors' expensive evaluations and tests and, so far as I know, they are safe."
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Beth Israel Hospital, Boston, MA 02215.
Requests for Reprints: Thomas L. Delbanco, MD, Department of Medicine, Beth Israel Hospital, 330 Brookline Avenue, Boston, MA 02215.
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