Government Reform and Oversight Committee
February 12, 1998
James S.Gordon, MD
My name is James S. Gordon, M.D. I'm a Clinical Professor in the Departments of Psychiatry and Family Medicine at the Georgetown University School of Medicine and Director of the Center for Mind-Body Medicine. I was the first Chairman of the Program Advisory Council of the National Institutes of Health's Office of Alternative Medicine, and after my initial two-year term, I was reappointed by NIH to an additional year as Chairman. I've published well over 100 articles in the scientific and popular press and written or edited ten books, including most recently "Manifesto for a New Medicine: Your Guide to Healing Partnerships and the Wise Use of Alternative Therapies." For more than twenty-five years, I've been integrating a variety of complementary and alternative approaches into my practice and teaching of medicine and psychiatry.
We are in the midst of a revolution in the practice of medicine and a transformation in the kind of health care Americans want and receive. We are in the processing of shifting the center of gravity of our system from high-tech diagnosis and treatment to self-care and mutual help; from a Western biomedicine preoccupied exclusively with finding the ultimate cause of and instituting aggressive treatment for discrete disease states to a "world medicine" which is equally concerned with balance and harmony within the individual and between the individual and his or her natural and social world; from a relentlessly secular system of treatment to a profoundly spiritual approach to care. For tens of millions of Americans, it is no longer a question of either modern science or ancient wisdom, but of combining both in a new, richer, more effective and more humane synthesis.
Thirty years ago, Americans and their physicians believed that blood pressure and heart rate, the pain of cancer and the level of responsiveness of the immune system were utterly beyond the control of the individual. Acupuncture and Chinese medicine were anthropological curiosities whose practices were limited to the Asian community in the United States. Physicians could lose their membership in state medical societies for referring patients to chiropractors. And massage was a subject for dirty jokes.
Today we know that ordinary human beings are capable of mobilizing their minds--through biofeedback, relaxation, imagery and hypnosis--to improve and alter virtually every physiological function. Between twelve and fourteen thousand acupuncturists practice openly in the United States, and some 3,000 are physicians. Chiropractors have won anti-trust suits against the AMA, are licensed in every state and serve approximately 10% of the population. Massage therapy is a growing profession whose practitioners are providing relief from stress, enhancing the mood of depressed patients, and giving help to those with cancer and post-operative pain.
In their 1990 national survey, Dr. David Eisenberg and his colleagues found that some 34% of Americans were already using these and other "alternative" therapies. The word "alternative" designated practices other than those taught in medical school or in post-graduate training. Seven years later, it is likely that over 40% of Americans use these therapies and that the vast majority use them as a "complement" to conventional therapies, as part of a self-created program of health care. Physicians in increasing numbers (close to 90% of family physicians in one study) are looking for information about these approaches, and studying and incorporating them into their practices. More than one-half of all American medical schools presently have electives which offer an overview of these alternative and complementary therapies.
When attacks are launched against "alternative medicine," the attackers tend to turn their sights on practices they believe to be inherently foolish. "Imagine actually giving research money to studying massage therapy," they say. Or ,"Why bother with herbs when we already have drugs?" or, "Do you really expect us," as one major figure in American medicine recently said to me at Grand Rounds at one of our most respected teaching hospitals, "to take prayer seriously?" Some laugh at homeopathy--the use of infinitely small doses of substances to relieve symptoms that larger doses of those substances could produce. And many simply state that all of the therapies for which there is good evidence (for example, biofeedback) are already included within the medical canon, while there is obviously no "good" evidence for the others.
The complaints about insufficient data are rarely grounded in thorough study. There is, in fact, a sizable body of research information on a variety of different alternative and complementary therapies. I cite several hundred epidemiologic and randomized controlled studies from peer-reviewed journals in Manifesto for a New Medicine. "Alternative Medicine: Expanding Medical Horizons," a report prepared by over 200 researchers and clinicians for the Office of Alternative Medicine contains many hundreds more citations. And, those who deny the possible utility of therapies for which there is no clear mechanism or resist funding studies of them, I think, are both obtuse and forgetful. Aspirin was happily used by conventional physicians long before we had any notion of why it worked.
We know, to cite just a few examples, that meditation, relaxation therapies, imagery and hypnosis can contribute in a major way to decreasing stress, relieving pain and insomnia, as well as altering blood pressure, enhancing immune functioning, and helping to reduce the frequency and intensity of epileptic seizures. There are hundreds of carefully controlled studies in peer-reviewed journals, mostly from Europe and Asia, on the utility of herbal preparations, for example, astragalus and echinacea for enhancing immunity and St. John's wort for alleviating depression. Massage appears to make a major difference in the growth, development and well being of premature babies. And homeopathy--improbable as it may seem--does in a careful meta-analysis seem to have very real effects on a variety of conditions. In some cases, the evidence is far more impressive than that brought forward to justify a host of surgical procedures and other expensive, side-effect laden, commonly used, high-tech interventions such as electronic fetal monitoring of normal births or the insertion of tubes in the ears of babies with chronic infections.
There are, of course, a number of alternative and complementary therapies that have not been adequately studied. This is precisely why Congress established the Office of Alternative Medicine at the National Institutes of Health. These include therapies that hundreds of thousands or, indeed, millions of Americans are looking to for answers to their health problems, therapies about which patients would hope to query their doctors, just as they might about the latest antibiotic or the newest surgical technique. Half a million people have used intravenous EDTA chelation to treat heart and peripheral vascular disease. Many of these people claim that chelation has been a life-saver. Most conventional physicians regard the success as an illusion, if not a hoax. People with HIV look to herbal therapies to enhance immune functioning. And cancer patients--as many as 70-80% of them in some studies--scour the bookstores and search the Internet for help with tumors that are poorly treated by conventional physicians or for side effects of even successful treatment.
The Office of Alternative Medicine (OAM) was created to make information about what is and is not known about alternative and complementary therapies available to patients, clinicians and researchers. It was mandated by Congress to "investigate and validate" promising new therapies. Funded at $2 million, in 1992, it was a small but bold initiative. It was seen as a "beacon of hope" by many who were desperate for reliable answers about the efficacy of unconventional therapies, as well as by those who practiced or studied these therapies. For the first time, the government would pull together information scattered in thousands of journals across all the continents and sort through it, culling what was valuable and discarding what was not, and making the results as widely available as possible. For the first time, there would be a body within the world's premier research organization, the National Institutes of Health, committed to a fair study of these therapies and rapid dissemination of the results of these studies.
In the six years of its existence, the OAM has funded forty small studies on specific alternative therapies and has established ten academic centers, some of them at the nation's most respected medical institutions, devoted specifically to studying these therapies. It has brought together unconventional practitioners and conventional researchers so that they might work together to develop methodologies appropriate to the therapies and the therapeutic systems under study and rigorous enough to satisfy the most exacting scientist. It has published Alternative Medicine: Expanding Medical Horizons and begun to make available the results from the studies it has funded. It has begun to build bridges with other NIH Institutes and the researchers in them and with other federal agencies, including the Food and Drug Administration and the Center for Disease Control. It has provided technical assistance to dozen of investigators who are committed to the scientific study of their treatments. The OAM has developed a Consensus Conference on the use of relaxation therapies and acupuncture. It has helped open the way to the approval and use of herbal therapies and has just recently funded a major prospective study on the treatment of depression which will compare in head-to-head clinical trials St. John's wort with one of the Prozac-like, selective serotonin re-uptake inhibitors in the treatment of depression.
The OAM has moved too slowly for some, particularly with regard to life-threatening illness for which there is no conventional medical answer, and has not always been responsible to the needs of its constituents. For others, its progress has been too rapid. Still, in spite of its still minuscule budget (its first director, Joseph Jacobs, M.D., called it "homeopathic") and opposition within and outside of it, the OAM provides an opportunity for authoritative data collection, evaluation and dissemination; a focus for scientific exploration of the efficacy of alternative and complementary therapies; a forum for debate about research priorities and methodologies; and the possibility of the systematic study of the usefulness of these therapies and of the ways they may enlarge and enrich medicine in America.
In order for the OAM to move ahead more effectively, significant increases in its funding and changes in its structure are necessary. I'll address these later. They hold great promise for the authoritative evaluation of complementary and alternative therapies and for the creation of a means by which people can most quickly obtain the most promising new treatments. Now, however, I want to turn my attention to another matter: the Access to Medical Treatment Bill
Scientific evaluation takes a considerable amount of time. Randomized, controlled studies that satisfy the criterion of the FDA require a great deal of money as well as time. The Access Bill makes it possible for people to safely obtain treatments that have not been approved by the FDA while the engines of scientific progress move slowly ahead. The bill, which has been introduced in both the House and Senate, permits any individual to be treated by a licensed health care practitioner with any method of treatment that that person requests; whether or not it has been approved by the Food and Drug Administration. The bill, whose co-sponsors range from conservative Republicans like Orrin Hatch (Utah) to liberal Democrats like Tom Daschle (S.D.), would not only expand health care options, it would also bring alternative therapies safely within the embrace of our health care system.
At present, fears of punitive action have some clinicians and researchers reluctant to share information - positive or negative - on the alternative therapies they use. Some practitioners have been arrested for practices that the FDA deems illegal. Others, including a number who treat cancer or HIV, have moved their clinics to Mexico, the Bahamas and Latin America. Some of these people appear unethical as well as unscientific but others are offering treatments that seem to hold genuine promise. The net result of forcing them off-shore is that patients who cannot get the care they want in the United States must go where it is unregulated, and physicians and other health practitioners in this country are unable to practice or study the medicine they believe will help.
The threat of overzealous regulation has made impossible exactly the kind of scientific investigation that the FDA and other regulatory agencies say they want. By requiring that practitioners who wish to offer alternative therapies be licensed, the legislation will help keep these practices within the compass of state regulatory boards. It will require that all practitioners report both positive and negative effects to the Department of Health and Human Services. And by insisting that practitioners who use these treatments not derive any financial benefit from them (other than fee-for-service) the bill removes the legitimate concern that unscrupulous practitioners can make huge profits from the drugs or devices they use.
The Access to Medical Treatment Act will make it possible for all of us to explore, with some reassurance of safety, all of the complementary and alternative therapies that are available. It will, as well, provide some feedback about therapies that have been, at least in individual cases, helpful or damaging. But it will not do the job of providing us with the rigorous scientific data that we need to fully evaluate these therapies. That job rests, as it should, with the Department of Health and Human Services and most particularly with the NIH and the Office of Alternative Medicine.
The Office of Alternative Medicine, as first established, was an office within the Office of the Director of NIH. A year ago, it was transferred to the Office of Disease Prevention. Congress increased its budget from $2 to $12 million and most recently to $20 million. This increase is, however, a pale reflection of the interest in the office. The OAM receives some 1200 calls a month, as many or more than institutes with 50 or 100 times its budget, from people desperate for information (up to 80% of them have cancer).
With its current budget, the OAM cannot afford to establish the database that Congress mandated and evaluate the existing literature on alternative and complementary therapies. It can not adequately fund academic centers for the investigation of promising therapies for particular physical and mental disorders. And it certainly can't investigate and validate promising and/or controversial therapies. An adequate study on St. John's wort for depression - a single herb for a discrete condition - to be funded by the Office but through and under the auspices of the National Institute of Mental Health, will cost $1.5 million a year for three years, or approximately one-twelfth of the OAM's entire budget. An appropriate clinical trial of chelation therapy, the kind that is needed to help Americans determine whether or not this procedure actually works and, if so, for what conditions, would cost significantly more. The size of the Office's staff is also completely inadequate to investigate the hundreds of therapies that tens of millions of Americans are using. A budget of $100-150 million with staff large enough to manage it would enable the Office to begin to address the scientific and human questions that are continually being addressed to it.
However, more than money is needed. The current position of the OAM as an Office restricts its capacity to do the research it is mandated to perform. All of its grants have to be funded in collaboration with and through the administrative mechanism of other Institutes. This means, quite simply, that other Institutes with other priorities and other means of calibrating scientific importance and public accountability may frustrate the research agenda set by sectors of the scientific community and the representatives of public organizations who advise the OAM. When the National Institute of Mental Health agrees that a study comparing St. John's wort, which has been used regularly by over 20 million Germans, is a worthy subject of study, the granting mechanism proceeds apace. If, however, the National Heart, Lung and Blood Institute, based on its evaluation, decides it is not important to study chelation therapy, or the National Cancer Institute disagrees about the value of investigating a new, widely-used and apparently promising but controversial, unconventional cancer treatment, careful, scientific investigations of these widely-used approaches simply cannot proceed. The OAM needs to become the National Center for Complementary and Alternative Medicine, an independent NIH body with its own granting capacity and an advisory council with the authority to approve these grants.
The OAM is also limited in a second, and equally important, way. It is not able to create its own standing review committees, committees which would include members with expertise in complementary and alternative approaches as well as in scientific methodology. At present, there are approximately 26 standing review committees at NIH, with 125 people. At last count, none of the members of these review committees had degrees or licensure in any of the commonly used complementary or alternative therapies. There were, for example, no chiropractors, acupuncturists nor, so far as we were able tell some months ago, did any committee member with M.D.'s and Ph.D.'s have adequate expertise on complementary and alternative therapies. Transforming the OAM into a Center would enable it to appoint distinguished researchers and clinicians with significant expertise in these areas to its review panels. It would put the scientific study of complementary and alternative practices on equal footing with the scientific investigation of conventional medical and surgical therapies.
We also need a well-funded, independent Center to explore the utility of comprehensive approaches to the diseases which kill and disable large numbers of Americans, approaches which include a variety of alternative and complementary, as well as conventional, medical treatments. We need to see if shifting the emphasis from high-tech treatment controlled by physicians to teaching self-care and helping people to help one another can alter health status as it does mood, self-esteem and sense of control. We need to move beyond our single minded focus on modern biomedicine to explore the richness and relevance of the world's many healing traditions. We need to determine if some plants in the world's pharmacopeia may have greater benefits and fewer side-effects than manufactured pharmaceuticals. We need to be open-minded enough to see if the "vital energy"--the Chinese call it "chi," the Indians "prana"--which is regarded as an integral part of every healing system in the world can be measured scientifically and used therapeutically.
We need a Center committed to finding out not only whether these therapies work and if so, how, but how they can be implemented in real life, in hospitals and clinics across the country, for the poor who cannot pay out of pocket as well as for the wealthy who can. And we need to see if these approaches are indeed capable, as a number of them have already been shown to, to save us significant amounts of money.
We need a Center where we can create models for the health care of the future and for the education of those who will practice it on themselves and others. This Center could help create a larger, more humane, more intellectually and humanly responsible professional education that will enrich and humanize the lives and practices of medical and nursing students and their future patients.
Finally, a Center with wide-ranging authority is necessary because complementary and alternative therapies are not simply specific approaches to specific disease states. When used appropriately, they embody a new way of approaching health and illness with implications not only for research and treatment but for every aspect of health care and education: for the financing of health care; for the education of future health professionals; and, indeed, for our conceptualization of health and illness.