This report identifies, for illustrative purposes only, several alternative treatments. Neither the inclusion of an alternative treatment as an example in this report, nor failure to mention a treatment should be interpreted as an opinion about its effectiveness by the Milbank Memorial Fund or the persons listed in the Acknowledgments.
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Foreword
The Milbank Memorial Fund is an endowed national foundation that supports nonpartisan analysis, study and research on significant issues in health policy. Most of the Fundís work is collaborative, involving decision makers in the public and private sectors. The Fund encourages strategic relationships through which individuals and partner institutions actively contribute their time and other resources. The Fund makes available the results of its work in reports, articles, and books, and publishes the Milbank Quarterly, a peer-reviewed journal of public health and health care policy.
Since its founding in 1905, the Fund has encouraged research and analysis that may lead to enhanced consideration of policy alternatives that a significant number of decision makers regard as achievable. The Fund does not take positions on what policies ought to be implemented, but instead encourages open, reasoned discussion of alternatives.
This report is about the accountability of practitioners of alternative medical therapies to the public. It describes work on behalf of greater accountability by legislators, regulators, professionals in both conventional and alternative medicine, health care purchasers, researchers, and consumer advocates. Members of each of these groups participated in preparing this report by attending meetings, offering information, and reviewing successive drafts.
Many people have strong opinions about the effectiveness of various alternative therapies and about how and by whom practitioners of them should be regulated and reimbursed. The goal of this report is to be neutral on controversial issues about which scientific evidence is inconclusive or does not yet exist.
The report rests on two convictions that are strongly held by the people who participated in writing and reviewing it. The first is that protecting patients from being harmed by alternative treatments should have high priority among public policy makers and regulators, public and private purchasers, health plans, professionals, and consumer advocates. There is a strong public interest in both regulation and vigilance concerning alternative medicine.
The second conviction is that regulation and vigilance should make active use of the findings of medical evaluation research. Scientific evaluation and the communication of evidence from research to the public are essential tools of policy.
The names and affiliations of the people who helped to prepare this report are listed in the Acknowledgments. A number of them planned and guided the project which led to the report. They include: Wayne Jonas, who suggested in 1994, before he joined the staff of the National Institutes of Health, that the Fund convene a meeting on research-based knowledge about alternative medical therapies; Robert Porter, who accorded high priority to the evaluation and regulation of alternative medicine during his service as President of The Federation of State Medical Boards; Ray Bumgarner, a leader of Administrators in Medicine, the national organization of executives of state medical boards, who emphasized the difficulties of regulating alternative medicine; Paula Hollinger, a health professional as well as a legislator, who encouraged and shaped the project from the beginning; Jessie Gruman of the Center for the Advancement of Health, who helped to link the project to the medical research community; and Catherine Mater, who added clarity and focus to the report and its conclusions from her experience as a business executive and public member of a state medical board.
Samuel L. Milbank
Chairman
Daniel M. Fox
President
Acknowledgments
The following persons attended meetings and/or reviewed drafts of this report. They are listed below in the positions they held at the time of their participation.
Brian Berman, Assistant Professor of Family Medicine, University of Maryland, Baltimore, Director of the Division of Complementary Medicine, Co-Director, University of Maryland Pain Center; Rachel Block, Director, Office of Planning and Special Initiatives, Health Care Financing Administration, U.S. Department of Health and Human Services; Ray Q. Bumgarner, Executive Director, Ohio State Medical Board; J. Michael Compton, Executive Director, Maryland Board of Physician Quality Assurance; Devra Davis, Senior Advisor to the Assistant Secretary of Health, Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services; Kay Dickersin, Assistant Professor, Department of Epidemiology and Preventive Medicine, University of Maryland, Baltimore; Robert M. Duggan, President, Traditional Acupuncture Institute, Columbia, Md.; David M. Eisenberg, Associate in Medicine, Department of Medicine, Harvard Medical School, Beth Israel Hospital, Boston; William H. Fleming III, Chair, Special Committee on Health Care Fraud, Federation of State Medical Boards, Member, Texas Board of Medical Examiners; Jonathan M. Fuchs, Vice President, Network Development, Preferred Health Network, Los Angeles, Calif.; Adriane J. Fugh-Berman, Medical Officer, National Institute of Child Health and Human Development, National Institutes of Health; Richard N. Gottfried, Chair, Health Committee, New York State Assembly; Thomas E. Gretter, Member, Ohio State Medical Board; Jessie C. Gruman, Executive Director, Center for the Advancement of Health, Washington, DC; Grant Higginson, Acting State Health Officer, Oregon Department of Health and Human Services; Freddie Ann Hoffman, Deputy Director, Medicine Staff, Office of Health Affairs, Food and Drug Administration; Paula C. Hollinger, Vice Chair, Committee on Economic and Environmental Affairs, Maryland Senate; Wayne B. Jonas, Director, Office of Alternative Medicine, National Institutes of Health; Gary Kaplan, Vice President, American Foundation for Acupuncture Research, Arlington, Va.; Merle Grace Kearns, Chair, Human Services and Aging Committee, Ohio Senate; Fredi Kronenberg, Director, Richard and Hinda Rosenthal Center for Complementary & Alternative Medicine, College of Physicians and Surgeons, Columbia University; Michael Lerner, President, Commonweal, Bolinas, Calif.; Ansel R. Marks, Acting Executive Secretary, New York State Board for Professional Medical Conduct; Catherine M. Mater, Vice Chair, Oregon Board of Medical Examiners; Robert S. McCaleb, President, Herb Research Foundation, Boulder, Colo.; Woodson C. Merrell, Member, New York State Board for Professional Medical Conduct; Joseph M. Millstone, Director, Medical Care Policy Administration, Maryland Department of Health and Mental Hygiene; Robert E. Porter, President, The Federation of State Medical Boards of the United States, Department of Orthopedic Hand and Spine Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, N.H.; Richard Roberts, Professor, Department of Family Practice, University of Wisconsin; Peggy A. Rosenzweig, Ranking Member, Joint Legislative Audit Committee, Wisconsin Senate; William Ryan, Deputy Director, Office of Medicaid, Ohio Department of Human Services; Anne Scheppach, Office of Alternative Medicine, National Institutes of Health; Howard B. Silverman, Director of Chemical Dependency, Government Relations and Public Affairs, Green Spring Health Services, Columbia, Md.; Ann Gill Taylor, Professor, University of Virginia School of Nursing; Alan I. Trachtenberg, Medical Officer, Office of Science Policy, National Institute on Drug Abuse, National Institutes of Health; John J. Ulwelling, Executive Vice President, The Foundation for Medical Excellence, Lake Oswego, Ore.; Jeremy Waletsky, Chair, Fetzer Foundation, Kalamazoo, Mich.; Martin P. Wasserman, Secretary, Maryland Department of Health and Mental Hygiene; Israel H. Weiner, Chair, Maryland Board of Physician Quality Assurance; and Jacqueline M. Yacher, Health Care Specialist, Health Care Financing Administration.
Janice Hopkins Tanne conducted some of the interviews and assisted in the writing of this report. Charlene B. Rydell coordinated the review and revision of the report.
As you read the text of this report, click  for references. |
Introduction
The popularity of alternative medicine has raised issues of accountability for legislators, regulators, health professionals, and consumers. Alternative medicine carries both risks and benefits; it can relieve or increase pain, hasten or postpone death.
Interest in complementary and alternative medicine (often called CAM) among regulators and health professionals is higher than it has ever been. However, its increased use constitutes a challenge to the executive and legislative branches of government, especially at the state level. Examples of the growing interest in alternative medicine include:
- One-third to one-half of the American people use at least one unconventional treatment in addition to their regular medical care, but usually they do not tell their physicians that they are doing so, according to a 1993 study, which estimated that Americans spend $13.7 billion on CAM each year.
- In 1996 Washington State required all health insurers to add coverage of CAM treatments to their coverage of standard medical care. The Seattle City Council then established a clinic, under the aegis of Bastyr University, a naturopathic institution, that provides both natural and conventional medicine.
- In 1996 and 1997 several health plans with millions of members added the services of CAM practitioners to their coverage.
- The budget of the Office of Alternative Medicine of the National Institutes of Health increased from $7.4 million in fiscal year 1996 to $12 million in fiscal year 1997. Included in that amount were funds dedicated to pain research and to establishing a chiropractic research center.
- Books about CAM, for example, titles by physician Andrew Weil, are bestsellers.
- Several academic medical centers have established centers to study CAM, and some prominent teaching hospitals offer therapies like massage and stress reduction. Thirty-four of the nation's 125 medical schools have added alternative medicine elective courses to their curricula.
Patients frequently seek CAM treatments for persistent chronic conditions including low back pain, stress, migraine headaches, and arthritis. Some also seek CAM care for treatment at the end of life, especially after being told that conventional medicine cannot reverse the course of their disease.
Which CAM treatments work? For whom? In what circumstances can a CAM treatment cause harm? Should insurers and governments pay for it? How can they protect the public and also respond to legitimate consumer demand for such services?
Many CAM practitioners seek licensing as a step toward reimbursement, from both publicly-funded programs and private insurers. Decision makers, especially purchasers in the public and private sectors and public regulators, must confront two critical challenges:
- protecting the public from fraud, abuse, and ineffective health care
- spending health care dollars wisely
The Use of CAM
Reliable statistics on the number of people in the United States who use CAM are scarce, but two studies offer a perspective.
The authors of a 1993 study estimated that one-third of the population used some type of CAM. Their estimates were based on a 1990 telephone survey of 1,539 English-speaking adults.
The respondents most often described the use of exercise and prayer, but, even excluding these activities, one in three of them said they had used at least one form of CAM during the year. Many supplemented conventional medicine with relaxation techniques, self-help groups, biofeedback, and hypnosis.
Other popular forms of CAM cited during the survey were chiropractic, massage, imagery, spiritual healing, commercial weight-loss programs, lifestyle diets (e.g., macrobiotics), herbal medicine, megavitamin therapy, energy healing, homeopathy, acupuncture, and folk remedies.
Nearly two-thirds of the people who had turned to CAM did not see a provider, but, instead, treated themselves. The remaining one-third consulted a provider of alternative medicine, making an average of 19 visits each during the 12 months that preceded the study.
The surveyed group used CAM therapy most often for ten troubling, but not life-threatening, conditions, including (in descending order of frequency) back pain, allergies, arthritis, insomnia, sprains or strains, headache, high blood pressure, digestive problems, anxiety, and depression. Thirty-six percent of people who reported back problems relied on CAM, most commonly chiropractic or massage.
Many people using CAM therapy were college educated (44 percent), middle-class (39 percent had incomes over $35,000) adults (aged 25 to 49) living in western states (44 percent).
Almost all individuals surveyed (96 percent) saw a physician as well as a CAM provider, although 72 percent did not tell the physician about their alternative treatment. No individual in the survey saw only a CAM provider for treatment of cancer, diabetes, lung conditions, skin problems, high blood pressure, urinary tract difficulties, or dental problems.
Extrapolating from this survey, the investigators projected that in 1990, 61 million Americans used at least one of 16 CAM therapies and that about 22 million Americans saw a CAM provider. About 425 million visits were made to CAM providers, exceeding by about 47 million the number of visits made to all primary care physicians combined.
The principal investigator of the study, David M. Eisenberg of Harvard University, said during an interview for this report: "In the absence of a second data point, we don't know if the results reported in 1993 represent a steady state or the beginning of a trend." Eisenberg and his colleagues are planning to conduct a second national survey to replicate the earlier one and to examine trends in patient type, kind of treatment, and category of ailments for which relief is sought through alternative methods. They also plan to look at the use of CAM for children.
CAM Is Popular Outside the U.S.
CAM is widely used in other industrialized countries, according to a summary published in the British Medical Journal in 1996. In Britain, one person in ten consults a CAM practitioner each year, and the most popular therapies are acupuncture, chiropractic, osteopathy, homeopathy, herbal medicine, and hypnotherapy. In France, one-third of the population uses CAM, with homeopathy being the most popular treatment. In Norway, homeopathy is also the most popular CAM practice, followed by acupuncture and aromatherapy. Russia legalized alternative medicine in 1993; the officially recognized practices are reflexology, chiropractic, homeopathy, and a breathing method. In Australia, a third of the population regularly visits a natural therapist and two-thirds regularly take vitamins and use other "natural" treatments, the most popular being chiropractic, naturopathy, massage, herbal medicine, and homeopathy. In Japan, scientific Western medicine and CAM co-exist. Two-thirds of the population of Tokyo report using CAM treatments. The most popular CAM therapies are herbal medicine, acupuncture, and acupressure (shiatsu), and more than 600 herbal medicines are available under the national health insurance system. In Germany and the United Kingdom, the national health payment system covers many CAM practices.
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A second study, published in 1997, revealed the popularity of CAM in Portland, Oregon. This study examined the use of CAM in patients of four family practices that were selected to include a variety of patients and practice styles. English-speaking patients were asked whether they relied on CAM and, if so, for what problem, and why; they were also asked whether they saw their family doctor for this problem as well. Patients sought CAM treatment for common medical problems like back pain, anxiety, depression, and chronic pain that are difficult for physicians and osteopaths (MDs-DOs) to cure. Half the patients (57 of 113) reported using some type of CAM.
Users and nonusers of CAM were similar in gender, educational level, age, race, and clinic attendance. Moreover, Eisenberg's study found that patients in western states may use CAM more frequently than residents of other parts of the country.
The most popular CAM therapies used by participants in this study were chiropractic (42 percent), massage (32 percent), herbal medicines (30 percent), megavitamins (24 percent), meditation (21 percent), and homeopathy, naturopathy, and acupuncture (each used by 10 percent of patients).
In the Portland study, a focus group of survey respondents who were asked about their motivations for using CAM listed as the main reasons: "to prevent illness or injuries" (30 percent), for "wellness" (44 percent), and to treat a specific health problem (79 percent). Among their health problems were back pain, headache, anxiety and emotional problems. Other problems, mentioned by 11 percent of the patients, were infections, neck pain, and various musculo-skeletal problems.
More than a third (36 percent) of patients in the Portland study were also seeing a physician for the problem they were treating with CAM. They believed that combined treatment would relieve symptoms faster. Others who solely used CAM believed it to be more effective than traditional medical care (36 percent), but they also felt that their problems were not serious enough to require the care of a physician, or else they did not want to rely on pills and surgery. Slightly more than half (53 percent) of those who used CAM told their family physician that they were doing so.
Cost and Reimbursement Issues
Most CAM treatments (chiropractic is a notable exception) are not reimbursed by health plans or insurance companies; they are usually paid for by the patient. Although the charge for a single visit may be lower than one to an MD-DO, often the treatment requires more visits before it is completed.
Since 1996, however, a number of managed care organizations on the West Coast have begun to offer some type of CAM coverage as an option. Among these are Group Health Cooperative of Puget Sound in Washington State, Blue Cross of Washington and Alaska, PacifiCare and Regents' Blue Cross/Blue Shield of Oregon, and Health Net in California. Most of the largest HMOs in California now offer optional acupuncture and chiropractic care. In 1997, a large managed care company active in the Northeast and in the mid-Atlantic states, Oxford Health Plans, began adding several types of CAM to its coverage of traditional MD-DO care. James Dillard, Oxford's medical director for alternative medicine, is a certified acupuncturist and a doctor of chiropractic as well as a clinical instructor in rehabilitation medicine at Columbia-Presbyterian Medical Center in New York.
Seattle's Natural Medicine Clinic
Late in 1996, an integrated medical clinic offering both natural medicine and MD-DO treatment opened in the Seattle suburb of Kent. The King County Natural Medicine Clinic at the Kent Community Health Center is a collaborative, two-year pilot project by Bastyr University, a college of naturopathic medicine, and Community Health Centers of King County. Funding is provided by the Seattle/King County Department of Public Health.
In its first few months of operation, the clinic was seeing about 100 new patients per month, many of them recent immigrants. Patients can decide whether they want to see a naturopath or a conventional physician, or they can be assigned to one or the other. The clinic provides basic health services, including family-oriented primary care, prenatal and obstetrical services, health education and prevention (e.g., immunizations), referral to specialists, hospitalization, naturopathic medicine, acupuncture, massage therapy, chiropractic care, stress management, and nutrition counseling.
Conditions considered appropriate for initially visiting a naturopathic physician include acne, anxiety, asthma and hay fever, candidiasis, chronic fatigue syndrome, common cold, constipation, Crohn's disease and ulcerative colitis, cystitis, depression, ear infection, eczema, food allergy, headache, heavy menstrual periods, hypertension, insomnia, irritable bowel syndrome, menopause, migraine, osteoarthritis, osteoporosis, premenstrual syndrome, prostate enlargement, rheumatoid arthritis, sinusitis, upper respiratory infection, ulcers, urinary tract infection, and vaginitis.
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In the summer of 1996, Oxford learned from a telephone survey of about 400 members that one-third were already using some CAM therapies. When asked if they would like their health insurer to cover CAM therapies, 75 percent said yes. When Oxford asked the same question of about 100 benefits administrators at major corporations, 89 percent responded positively.
Oxford set up advisory boards of leaders in six CAM disciplines and created an application and review process, including a site visit, for practitioners of these therapies. Today, Oxford offers members acupuncture, chiropractic, yoga, massage therapy, nutritional counseling, and, in Connecticut, naturopathy. Patients can see these CAM practitioners either by referral from their primary care physician or on their own, without referral, in the same way that they see other specialists. In the future, Oxford may also offer members other CAM practices like reflexology, Tai Chi, Alexander technique, Feldenkrais method, aromatherapy, and Reiki.
On July 1, 1997, Matthew Thornton Health Plan in New Hampshire first offered optional direct access to chiropractic, homeopathy, naturopathy, and acupuncture. Some aspects of CAM, like yoga classes, are covered under Matthew Thornton's basic benefit; and members are entitled to discounted rates from a selected list of massage therapists.
Suburban Health Plan in Connecticut and Allina Health System, based in the upper Midwest, also offer access to CAM practitioners. Suburban permits licensed naturopaths to serve as primary care physicians. Other health plans are likely to begin offering some CAM coverage.
Most plans and insurers, however, do not reimburse for CAM therapies, fearing that patients would tend to prefer treatments that are more pleasant than a conventional intervention (compare massage to surgery, for example). Insurers also worry that they might have to pay for CAM treatments in addition to MD-DO treatment, thus incurring higher costs. However, Dillard of Oxford says offering CAM treatments raises employer premiums by only 3 percent.
CAM practitioners charge less, some experts believe, because they are not supporting a professional infrastructure of examining boards, continuing professional education, licensing, certification, and malpractice insurance.
The Problem of Defining CAM
CAM is a broad label for many treatments. These range from the techniques of massage, chiropractic, biofeedback, and yoga, to systems like Ayurvedic medicine, traditional Chinese medicine, and homeopathy that are based on elaborate theories of disease causation, diagnosis, and treatments. Their practitioners claim an imbalance of forces within the body as the cause of disease or of symptoms. CAM treatments may also diverge from conventional medicine in the way they are tailored to individuals so that a patient with identical symptoms and complaints to another may receive entirely different treatments.
Experts offer various definitions of CAM. Wayne B. Jonas, a physician who directs the Office of Alternative Medicine at the National Institutes of Health, describes it this way: "Complementary and alternative medicine comprise those practices used for the prevention and treatment of disease that are not taught widely in medical school, nor generally available in hospitals."
David M. Eisenberg of Harvard used the same definition in his study.
"Integrative medicine" is the term preferred by Andrew Weil, a physician and author who directs the Program in Integrative Medicine at the College of Medicine of the University of Arizona. Weil says, "I want to see a true synthesis of the best ideas and practices of conventional and alternative medicine."
Other terms sometimes used for CAM are "holistic medicine" and "complementary practices."
Like most conventional health professionals, alternative therapists often emphasize the patient's choice of healthy lifestyle as critical to preventing disease. Many CAM systems have traditionally defined themselves as preserving health rather than treating disease.
Many practitioners of CAM present it to the public as invariably gentle, safe, and natural. However, some of the techniques or herbal remedies may be dangerous, or patients may resort to questionable measures instead of seeking effective conventional care.
A senior state official, who had once worked as an emergency medical technician, told of being confronted with a life-threatening emergency that occurred when a couple used a naturopath for home childbirth. Catherine M. Mater, a public member and vice chair of the Oregon Board of Medical Examiners, comments: "CAM practitioners get into trouble when they don't do standard monitoring of the patient's condition."
Popular Types of CAM
The most popular forms of CAM are acupuncture, chiropractic, homeopathy, herbal medicine, massage, and naturopathy.
Acupuncture
Acupuncture is a branch of traditional Chinese medicine. Its underlying philosophy is that health is a state of harmony, or balance, of the opposing forces of nature. Disease represents an imbalance of these forces that leads to excesses or deficiencies of life energy in various organs, resulting in illness if not corrected. The life energy, called qi, is believed to flow through the body in pathways called meridians which connect its surface with the internal organs. Treatment consists of redirecting and balancing energy flow.
Acupuncture has been used in China for more than 2,000 years. Although it has been applied in some Western countries since the late nineteenth century, it became popular in the United States only in 1971, when a New York Times columnist, James Reston, received acupuncture after surgery and wrote about the experience.
Acupuncture practitioners usually insert fine needles through the skin at points along the meridians. Some practitioners may use pressure (acupressure, also called shiatsu), heat, friction, suction, or electromagnetic energy to stimulate these points. Although in China acupuncture is used to treat many conditions, in the United States, it is applied most often to relieve pain.
There are more than 40 schools and colleges of acupuncture in the United States, 20 of which have either been approved, or are currently being reviewed for approval, by the National Accreditation Commission for Schools and Colleges of Acupuncture and Oriental Medicine. An estimated 6,500 acupuncturists practice in the United States; of these, about 3,300 have taken the examination administered by the National Commission for the Certification of Acupuncturists. Thirty-two states regulate the practice of acupuncture, according to The Federation of State Medical Boards of the United States.
Acupuncture may also be performed by naturopathic doctors or chiropractors "in at least 12 states," according to the Traditional Acupuncture Institute. An estimated 3,000 physicians have taken short courses in acupuncture and may use it in their practices.
Several studies find that acupuncture is helpful in treating chronic low back pain, neck pain, arthritic pain of the knee, post-surgical pain, kidney-stone pain, menstrual cramps, and chronic angina. Other studies offer evidence that acupuncture can reduce the nausea and vomiting that accompany pregnancy, sea sickness, chemotherapy, or surgery. Acupuncture has also been documented as helpful to people who are withdrawing from substances they abuse. Studies have reported that acupuncture helps stroke patients, improves exercise performance in young men, and increases uterine contractions in pregnant women who are past their delivery dates. Some experts make a claim for the value of acupuncture in treating bladder instability, sinus problems, and migraine headaches.
A conference convened by the National Institutes of Health in November 1997 reviewed the scientific and medical data on the use, risks, and benefits of acupuncture and issued a Consensus Development Statement. A panel of experts concluded that "there is sufficient evidence of acupuncture's value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value." Moreover, the panel found that in many cases, the "data supporting acupuncture are as strong as those for many accepted Western medical therapies."
Chiropractic
Practitioners assert that health is a state of balance, especially of the nervous and musculo-skeletal systems. They believe that disease is caused by misalignment of the spinal vertebrae, which leads to
dysfunction of nerves, blood vessels, and organs. Manipulation of the spine by the chiropractor restores the body to normal function.
Chiropractic was founded in 1895 by Daniel David Palmer, an American who treated the sick with various therapies, including "magnetic healing." As reported in Consumer Reports in 1994,"...as Palmer told it, he was consulted [in 1895] by a janitor who had gone deaf 17 years earlier while stooping in a mine." Palmer found what he called a "subluxed," or misaligned, vertebra, which he manipulated, thereby, allegedly, restoring the man's hearing.
Palmer opened a school of chiropractic; his son, B.J. Palmer, actively promoted the movement. Rivals established other schools and advocated different techniques of spinal manipulation.
Chiropractors use their hands to diagnose, adjust, and mobilize the various parts of the body, and they rely on two kinds of therapies: joint and soft tissue manipulation. They use those techniques most often to treat back, shoulder, and neck pain.
Chiropractors have been criticized for taking unnecessary X-rays of the spine and for requiring frequent visits. A study at the University of North Carolina at Chapel Hill found that chiropractic treatment of an episode of back pain required anywhere from 10 to 15 visits, compared with three to five visits made to a physician.
The 16 American chiropractic colleges graduate more than 2,800 chiropractors each year. Chiropractic education requires at least 60 undergraduate credit hours, including many in basic science, followed by a four- to five-year chiropractic curriculum. The colleges are accredited by the Council of Chiropractic Education.
As of 1996, more than 71,000 licensed chiropractors practiced in every state, and in Puerto Rico and the Virgin Islands; their license, however, does not permit them to perform surgery or to prescribe drugs. Some chiropractors have additional training and what the American Chiropractic Association describes as advanced certification in a chiropractic specialty. These include chiropractic radiology, orthopedics, neurology, rehabilitation, behavioral health, family practice, nutrition, diagnostic imaging, occupational health, and sports injuries and physical fitness.
A highly regarded randomized, controlled trial in the United Kingdom, published in 1990, was one of several studies that found chiropractic to be useful in treating acute low back pain. Other studies concluded that it is less effective in treating chronic back pain.
Herbal Medicine
Herbal medicine is also called herbology, phytomedicine, or botanical medicine. Because many plants have medicinal properties, about one quarter of pharmaceutical drugs are derived from plants. Drugs developed from plant sources include digitalis for heart problems, vincristine for leukemia, morphine for pain, and aspirin for aches, pains, and fevers.
Herbs have been used for medicinal purposes in most cultures since ancient times, either as single entities or as complex mixtures of several herbs or of herbs and other substances. In industrialized societies, use of herbal medicines has declined since the development of powerful manufactured drugs.
Herbal remedies are more widely used in Europe (particularly in Germany and France) and in Asia than in the United States. Because herbs cannot be patented, pharmaceutical companies are unlikely to invest the millions of dollars required to test them and then submit them to the FDA for approval as drugs. Moreover, unlike pharmaceutical companies, which isolate the active substances in herbs in order to produce standardized drugs, advocates of herbal remedies believe that the number or combination of substances in each herb results in a synergy that is superior to the singular impact of extracted drugs.
A meta-analysis (review of pooled studies) of the herb St. John's wort (Hypericum perforatum) for mild and moderately severe depression, published in 1996 by German and American physicians, concluded that it was more effective than a placebo and was as effective as standard antidepressants but with fewer side effects. The authors raised questions about its methods and cautioned about its efficacy in seriously depressed patients. The active chemical in the herb, they claimed, was not appropriately standardized. Furthermore, the study only compared St. John's wort with anti-depressant drugs that were given at or below their lowest level of efficacy. And, finally, patients were treated for only 6 weeks. An accompanying editorial concluded that: "longer term studies are needed before it can be recommended in major depression."
This report led Wayne Jonas of NIH's Office of Alternative Medicine to call for a trial comparing St. John's wort with the popular antidepressant fluoxetine (ProzacTM). The Office of Alternative Medicine (OAM), the National Institute of Mental Health (NIMH), and the Office of Dietary Supplements (ODS) are collaborating on a study to evaluate the efficacy and safety of a standardized extract of Hypericum in major depression. NIMH, the administering agency, issued a Request for Proposals (RFP) for a randomized controlled trial, and Duke University was awarded a three-year contract in the amount of $4.3 million to conduct the study.
Consumers usually choose and administer herbal medicines themselves, following recommendations by friends, employees in health food stores, and the increasing numbers of books, magazines, and magazine articles devoted to the subject. Health food stores
display publications by manufacturers that contain articles recommending the use of particular herbs.
Traditional Chinese medicine and Ayurvedic practitioners usually blend several herbs into one mixture. These mixtures have been effective in treating, for example, atopic eczema and acute bronchiolitis caused by respiratory syncytial virus in infants. The National Certification Commission for Acupuncture and Oriental Medicine administers an examination in Chinese herbal medicine.
Herbs that have been beneficial, according to researchers, also include: bromelain (reduced post-surgical pain and swelling); topical capsaicin from chili peppers (decreased tenderness and pain in osteoarthritis, fibromyalgia, diabetic neuropathy, and post-herpetic neuralgia); cranberries (decreased urinary tract infections); evening primrose oil (decreased breast pain, both cyclical and constant, reduced itching in atopic eczema, decreased use of painkillers in rheumatoid arthritis); feverfew (prevented severe migraines); garlic (lowered cholesterol, inhibited blood clotting); ginger (reduced nausea and vomiting); ginkgo (improved blood flow in small blood vessels); licorice (acted as an anti-inflammatory agent during treatment of stomach and intestinal ulcers); milk thistle (helped to restore diseased livers); saw palmetto (decreased symptoms of an enlarged prostate); sweet wormwood (decreased malaria parasites in the blood); and valerian (induced sleep). Some herbs, however, are either dangerous or can interact harmfully with prescription drugs.
Homeopathy
The system of homeopathy, founded early in the nineteenth century by
German physician Samuel Hahnemann, is based on two ideas. The first is that like cures like (also called the Law of Similars). Hahnemann claimed that a natural substance that produced a given symptom in a healthy person would cure it in a sick person. Thus, the name for Hahnemann's method: homeo (Greek for "like") and patho ("disease" or "illness").
His second idea was that less is more (also called the Law of Infinitesimals). Hahnemann and his followers took one part of the natural substance that he believed caused the symptoms and thus would cure the disease, diluted it in nine parts of water or alcohol, and shook it vigorously. After further diluting this solution, they shook it, diluted it again, and shook it some more, acting on their conviction that the more dilute the solution, the more effective the remedy. Homeopaths claim that even if no molecules of the active ingredient remain, the solution still retains its "imprint" or "message."
The National Center for Homeopathy, a private organization, estimates that Americans are spending $165 million a year for homeopathic preparations and that sales are rising by 20 percent to 25 percent a year.
Homeopathic remedies are widely available in Western Europe and the United States. These remedies are not regulated by the FDA, which, however, permits marketing of substances listed in the Homeopathic Pharmacopeia as drugs, under the Food, Drug, and Cosmetic Act of 1938. Senator Royal Copeland of New York, a homeopathic practitioner, shepherded the act through Congress.
Homeopaths treat both acute and chronic health problems and use their remedies to prevent disease and promote health in people who are not sick. They prescribe these remedies on the basis of physical, emotional, and mental symptoms. Since homeopathic remedies are highly individualized, people with the same diagnosis may be given different medicines.
Some scientists believe that any benefits produced by homeopathic
medicines are due to a placebo effect, that is, to the act of intervention, rather than to a biological process. However, a meta-analysis of 105 clinical studies of homeopathy published in 1992 found that the majority of studies reported a positive result for homeopathic treatments. A clinical trial conducted in Scotland showed a benefit for hay fever patients.
A meta-analysis of 89 clinical trials published in September 1997 also found that homeopathic remedies have a more positive clinical effect than a placebo. However, there was insufficient evidence to conclude that homeopathy was effective for any single clinical condition.
Training in homeopathy is offered through professional courses at the National Center for Homeopathy in Alexandria, Virginia.
Licensure to practice homeopathy varies among the states. Three states (Arizona, Connecticut, and Nevada) have special boards; in two states (Delaware and New Hampshire), medical boards regulate homeopaths. Other states regulate homeopathy through "scope of practice" guidelines issued by medical boards. As a result of such variable regulations, homeopathic practitioners include physicians, dentists, naturopathic physicians, chiropractors, veterinarians, acupuncturists, nurse practitioners, and physician assistants.
Massage
The goal of massage therapy is to achieve or increase health and well-being and to help the body heal itself through manipulation of soft tissues. Various techniques are used, and there are different schools of treatment.
Massage, an ancient technique, was introduced into the United States in the mid-nineteenth century. The first known American practitioners were two New York physicians who had received training in Sweden. In the 1870's Swedish physicians opened clinics in New York. At first physicians performed massage, but they eventually delegated the technique to nurses and physical therapists. An upsurge of interest in the field began in the 1970's.
Twenty-two states and the District of Columbia require massage therapists to have 500 or more hours of education from a recognized school, and some states also require them to pass a licensing examination. The American Massage Therapy Association Commission on Massage Training Accreditation/Approval (COMTAA) accredits 23 programs in 28 locations around the country. Forty additional programs have received approval for their curricula but will have to become accredited by March 1999 in order to remain affiliated with COMTAA.
The National Certification Board for Therapeutic Massage and Body Work (NCB) administers the most widely used examination. NCB, which is
accredited by the National Commission for Certifying Agencies, administered its first exam in 1992; by September 1997, 27,000 people were certified. Several states have accepted this examination as part of their licensing procedure. Massage therapists are currently licensed in 25 states and the District of Columbia. Some municipalities in states that do not require licensing -- for example, Tucson, Arizona, and Chicago, Illinois -- have passed licensing ordinances.
Some studies indicate that massage helps premature babies gain weight more quickly, reduces swelling of the arm following radical mastectomy, and is effective in relieving pain in patients with soft tissue injuries. Therapeutic touch may be beneficial in wound healing and anxiety.
Naturopathy
Naturopathic medicine blends many approaches, including botanical medicine, clinical nutrition, homeopathy, acupuncture, traditional Oriental medicine, hydrotherapy, and naturopathic manipulative therapy. Naturopathic doctors (NDs) also take courses in basic medical sciences like anatomy, cell biology, and physiology.
When naturopathy began as a formal health care system in the United States at the turn of the century, there were more than 20 naturopathic or "eclectic" schools. Naturopathic practitioners emphasize prevention and treatment of disease through a healthy lifestyle and control of risk factors, treatment of the whole person, and use of the body's natural healing abilities. They stress nutrition and the therapeutic use of foods to promote health, and to identify and treat the causes of chronic and degenerative disease.
The two accredited U.S. naturopathic medical schools (the National College of Naturopathic Medicine in Portland, Oregon, and Bastyr University of Natural Sciences in Seattle, Washington) together graduate about 50 naturopathic doctors a year. Two additional colleges are candidates for accreditation: the Southwest College of Naturopathic Medicine in Scottsdale, Arizona, and the Canadian College of Naturopathic Medicine in Toronto, Ontario. A new program at the University of Bridgeport in Connecticut admitted its first students in September 1997. It has been granted a license to operate by the Connecticut Department of Higher Education, and at the end of one year will be eligible to apply as a candidate for accreditation. The Council on Naturopathic Medical Education, based in Eugene, Oregon, is the accrediting agency for naturopathic programs in the United States and Canada.
More than 1,000 naturopathic doctors are licensed in the United States. Eleven states issue these licenses through special boards (Alaska, Arizona, Connecticut, Hawaii, Maine, Montana, New Hampshire, Oregon, Utah, Vermont, and Washington). In these states, only licensed persons may use the designation "ND" after their name. Several other states allow the practice of naturopathic medicine. In states that do not have licensure laws, graduates of non-accredited schools, like those offering instruction through correspondence courses, may use the designation ND. They may give seminars, and advise people on lifestyle or nutrition, but they are not permitted to diagnose illness or to prescribe remedies. In New Hampshire, graduates of correspondence schools who were already practicing at the time the licensure law was enacted were allowed to continue doing so under a restricted license. In Tennessee and South Carolina, it is illegal to practice naturopathic medicine.
States' Regulation of Health Professionals
The states now regulate more than 1,100 professions and occupations in health and other fields, about 600 of them through licensure. However, half the states regulate fewer than 60 professions and occupations, according to the Council on Licensure, Enforcement and Regulation (CLEAR), an association of state and provincial officials from the United States and Canada.
Of the various CAM practitioners, only chiropractors are required to be licensed in all states. State regulations for other CAM practitioners vary widely. Only chiropractic, acupuncture, and naturopathy have accrediting bodies recognized by the U.S. Department of Education.
"Licensing is more a political process than one based on efficacy or scientific evidence," says Jonathan M. Fuchs, vice president for network development at Preferred Health Network, based in California. "How can we legislate against doing no harm to patients? What is the standard of practice in CAM? We need a standard of practice similar to that for physicians, a minimum standard of efficacy."
Ray Q. Bumgarner, executive director of the Ohio State Medical Board, and former president of Administrators in Medicine, comments:, "It's a question of the effectiveness of lobbying, not the weight of scientific evidence. The problem for legislators is that evidence isn't there [for efficacy in CAM]. Even in mainstream medicine, some standard treatments aren't proven in the strictest sense of that word." "Legislators pay attention to CAM because consumers are paying attention," says Martin Wasserman, Maryland's secretary of health and mental hygiene. "Physicians need to approach CAM with an open mind. They can't ignore it, " he added.
Licensing is the most rigorous level of regulation. "Licensure restricts the scope of practice so that it becomes illegal for unlicensed individuals to provide specific services," according to a 1994 CLEAR publication, which recommends the use of licensure only as the "remedy of last resort." Certification and registration are less restrictive approaches.
In certification, the practitioner who has met standards set by a state agency may use a designated title. The requirements may include education, experience, and/or passing an examination and may be quite similar to licensure requirements. Noncertified individuals may offer similar services to the public but may not use the "certified" title. For example, in Maine, where massage therapists are certified, cosmetologists may use massage techniques while shampooing hair or giving facials, and reflexologists may perform foot massage, but neither may use the title "massage therapist."
In registration, the practitioner merely files his or her name and address with a state agency. Registration is considered appropriate when the profession poses little threat to the consumer and other forms of legal redress are available.
The terms "licensing," "certification," and "registration" are sometimes used in a confusing way. For example, registered nurses take an official examination and must hold a license to practice.
Regulations may vary from state to state; and a profession that is unregulated in one state may be regulated in others. A table at the end of this report compiled by The Federation of State Medical Boards in 1995-96, with additional data supplied by the National Conference of State Legislatures, shows the professions regulated by the states and indicates the type of regulatory board. [Table 1]
Should state regulation of CAM practitioners take the same form as that for other health professionals? Robert M. Duggan, co-founder and president of the Traditional Acupuncture Institute, argues against regulation:
There have never been major issues of public safety with acupuncture. Issues of accreditation and certification stifle creative diversity. This is a personal, highly individualized therapy. Do we need a national standard exam? It just measures the lowest common denominator. It's like trying to standardize art schools. Can we move to a buyer-beware approach in the U.S.?
However, many CAM groups seek regulation. "If they're certified, they have a better shot at getting paid by insurers," says Richard N. Gottfried, a member of the New York State Assembly and chair of its Health Committee. "Three things are important," he continues, "Education, experience, and an examination administered by a national certifying body that's recognized by the state."
States differ in their approaches. Here are the policies of four states -- Maryland, New York, Ohio, and Oregon -- that participated at the invitation of The Federation of State Medical Boards in initial discussions from which this report developed.
Maryland has several boards. The Maryland Board of Physician Quality Assurance licenses physicians, physician assistants, and several kinds of medical technician. Acupuncturists are regulated by the State Acupuncture Board; physicians who practice acupuncture are regulated by the Board of Physician Quality Assurance. Chiropractors are regulated by the State Board of Chiropractic Examiners. Massage therapists were licensed in 1996 and are regulated by the State Board of Chiropractic Examiners. Physicians who practice homeopathy must be licensed as an MD or DO.
New York State has a different organizational structure. The State Education Department licenses all health professionals, including physicians, acupuncturists, chiropractors, and massage therapists. Physicians and physician assistants are disciplined by the State Board for Professional Conduct in the Department of Health; other health professionals are disciplined by the Education Department.
In Ohio, physicians and podiatrists are licensed by the State Medical Board, whose members consist of seven physicians with MD degrees, one osteopathic physician, one podiatrist, and three consumers. To practice acupuncture, the practitioner must be licensed as a physician or a podiatrist. Chiropractors are licensed by the State Chiropractic Examining Board. Massage therapy is licensed by the State Medical Board as a limited branch of medicine.
In Oregon, where there are many practitioners of complementary medicine, the State Board of Medical Examiners licenses physicians and acupuncturists (who may also use Oriental medicines, vitamins, and minerals, and may provide dietary advice). Chiropractors are licensed by the Oregon State Board of Chiropractic Examiners; naturopaths, by the Oregon State Board of Naturopathic Examiners within the Health Division; and massage technicians, by the Oregon State Board of Massage Technicians within the Health Division.
In 1995, Oregon amended its state law governing unprofessional or dishonorable conduct to establish that "the use of an alternative medical treatment shall not by itself constitute unprofessional conduct...."
Oregon defines alternative medical treatment quite broadly:
(i) A treatment that the treating physician, based on the physician's professional experience, has an objective basis to believe has a reasonable probability for effectiveness in its intended use even if the treatment is outside recognized scientific guidelines, is unproven, is no longer used as a generally recognized or standard treatment or lacks the approval of the United States Food and Drug Administration; (ii) A treatment that is supported for specific usages or outcomes by at least one other physician licensed by the Board of Medical Examiners; and (iii) A treatment that poses no greater risk to a patient than the generally recognized or standard treatment.
Other states use different approaches. Several, for example, have decided that the practice of CAM shall not be considered bad medical practice in the absence of negative evidence. In 1993, North Carolina added this section on revocation, suspension, annulment, or denial of license to its Practice of Medicine Act:
The Board shall not revoke the license or deny a license to a person solely because of that person's practice of a therapy that is experimental, nontraditional, or that departs from acceptable and prevailing medical practices unless, by competent evidence, the Board can establish that the treatment has a safety risk greater than the prevailing treatment or that the treatment is generally not effective.
Alaska, Colorado, Kansas, and Washington have similar laws.
Bills introduced in 1997 in Connecticut and Mississippi to broaden the acceptance of CAM practices did not pass. The Connecticut bill would have allowed physicians to practice alternative medicine, provided no harm came to patients. The Mississippi proposal contained language similar to that in the North Carolina law. South Dakota passed a law that applies only to chelation therapy, stating that "the board may not base a finding of unprofessional or dishonorable conduct solely on the basis that a licensee practices chelation therapy." In North Dakota, a similar bill dealing with chelation therapy failed to pass. Minnesota law protects a provider of CAM treatments from malpractice action "so long as his conduct is not inconsistent with ordinary skill and care under the circumstances, even though there were other procedures or types of treatment available."
In 1995 the state of Washington, which has a large complementary medicine community, became the first in the nation to require health insurers to cover CAM. The legislature mandated coverage of CAM by adding a new section to the code regulating insurance stating that every health plan regulated by the insurance commissioner (covering about 65 percent of the population) should be required to:
Permit every category of health care provider to provide health care services or care for conditions included in the basic health plan services to the extent that: (a) The provision of such health services or care is within the health care provider's permitted scope of practice.
Health insurers challenged the law, arguing that the federal Employee Retirement Income Security Act (ERISA) prevents states from regulating self-insured employer benefit plans. The U.S. District Court of Western Washington agreed, declaring the law was preempted by ERISA. The court has ruled that the law was also invalid with respect to insured employer plans because it applied to HMOs, and HMOs are not insurers. When the state asked for clarification on insured plans for individuals, the judge responded that the law was invalid for all plans. Deborah Senn, the Washington insurance commissioner, has appealed to the Ninth U.S. Circuit Court of Appeals. The appeal is pending. The Insurance Department has surveyed carriers and found that, despite litigation, there is considerable compliance with the law in response to consumer demand.
A profession's first step in requesting reimbursement from health insurers is to lobby for licensure. Policy makers in several states say they ask these questions when they evaluate the need for licensing:
- Is the unlicensed practice of an occupation a serious risk?
- Can consumers properly evaluate the qualifications of practitioners offering a service?
- Do the benefits of licensing outweigh the possible disadvantages that would result, for example, from the decreased availability of practitioners or increased costs?
Evaluating CAM: Does It Work?
Many CAM practitioners are skeptical about demands for evaluation. Because most conventional medical practices have not been evaluated in randomized clinical trials, advocates of CAM have some justification for claiming that they are sometimes subject to a double standard.
Moreover, conventional and CAM practitioners often evaluate results differently. Conventional health care professionals emphasize clinical endpoints of treatment that can be measured by physiological change, such as lowering blood pressure or increasing the range of motion in a joint. CAM practitioners, on the other hand, may judge results entirely by the patient's perception of feeling well, improved, or comfortable and better able to live with his or her chronic condition. In addition, although substances like herbs can be put into capsules and evaluated in the same way as prescription drugs, other therapies, especially mind-body therapies, are difficult to test in a rigorous clinical trial.
John J. Ulwelling, executive vice president of The Foundation for Medical Excellence, and former director of the Oregon State Board of Medical Examiners, says:
The most important thing that needs to be done regarding complementary medicine is to separate the useful from the useless. That is expensive, [and] millions of people will continue to seek their own complementary health care with hardly any scientific information [about] whether it is useful or useless. This is the great challenge that faces this country and the great policy issue is how do we get the financial resources to get it done.
Practice Guidelines
Many professional societies, government agencies, and health plans
develop practice guidelines or consensus statements for conventional practices that are based on evidence of efficacy and that specify the appropriate ways to treat a condition or perform a procedure. Several thousand guidelines are available or are now being developed.
However, practice guidelines are not available in CAM and are unlikely to be developed any time soon. A panel convened initially in 1995 by the Office of Alternative Medicine of the National Institutes of Health concluded: "CAM practices currently are unsuitable for the development of evidence-based practice guidelines, in part because of the lack of relevant outcomes data from well-designed clinical trials." Practice guidelines should be based on good studies that show what treatment works best ("evidence based" is the current catch phrase). Individualization of treatment, standard procedure in CAM, contradicts the goal of practice guidelines, which try to reduce variations in practice. In a recently published report, the panel made three recommendations:
- initiate well-designed clinical studies of CAM
- include CAM among the treatment options considered by groups that develop practice guidelines for conventional medicine
- set standards for evaluating the competency of CAM practitioners.
Types of Scientific Trials
When CAM practitioners seek licensure, they may present policy makers with various studies that support the efficacy of a CAM treatment. There are several common types of scientific study:
In a randomized, controlled clinical trial, "controlled" means a treatment is compared with either an existing treatment or a placebo. Medical scientists generally regard this type of study as the most persuasive. To perform one, patients are randomized to groups either for treatment or to receive a placebo, or else they are randomized to one treatment or another. Neither the patient nor the researcher knows to which group the patient has been assigned. These trials should reveal the most effective treatment, and they are supposed to rule out any bias. They are costly to set up and, if the effect is small, large numbers of participants are needed, often for as long as five years. Sometimes participants figure out who is receiving the active treatment. For certain therapies, like biofeedback or acupuncture, it is difficult to design a double-blind trial.
In a large, open trial, both doctors and patients know what treatment is being used. If patients are compared with a control group (for example, people with the same condition in the same community), results will be stronger scientifically than if there is no control group. However, it is difficult to exclude bias; the beliefs of both patients and physicians may affect the results.
Meta-analysis (from the Greek "after," "beyond," or "over") is a technique for analyzing pooled results from a number of studies. When studies are small or conflicting, it may be possible to clarify the results by combining a number of good studies and then analyzing the outcome as a composite.
Anecdotal reports are descriptions by patients or practitioners of successful single cases. Scientists consider it impossible to generalize responsibly from anecdotal reports. Moreover, anecdotal reports cannot distinguish among possible reasons for improvement in addition to effectiveness: placebo response; normal variation (some diseases may wax and wane); the effect of other treatments the patient is receiving; and chance. Because there is no comparison with other treatments or to a placebo, and because many illnesses have a variable course, it is often impossible to decide whether the patient was helped by the therapy or would have felt better anyway.
Regulation of Drugs and Other Products
Before asking the FDA to approve a drug, a pharmaceutical firm tests it in cell cultures and almost always in animals. A drug that shows promise is tested for safety, first in a small group of human volunteers (a Phase I trial), and then in a trial of people who have the targeted disease (Phase II). Next, the drug is studied for efficacy, safety, and proper dosage levels in a larger group of people with the disease (Phase III trials), usually in comparison with a standard treatment or a placebo. Results of these studies are submitted to the FDA as a New Drug Application; if approved, the company can market the drug. Postmarketing surveillance through reports from doctors, and sometimes patients, is conducted in order to detect additional side effects that cannot be seen until the drug is widely used.
Most medications and treatments used by CAM practitioners are not required to undergo the FDA approval process. For example, herbal products may be marketed only as food supplements without any specific claims to improve health. Because they are not regulated as drugs, there may be great variation in potency from batch to batch; one pill may be very powerful while the next is very weak. Vitamins and minerals can also be sold without any specific health claims, although maufacturers are required to declare the amount of each ingredient on the labels.
Using Evidence for Regulation
Most legislation regulating CAM provides very little useful guidance for a state medical board member. How, for example, should members of medical boards interpret the phrases "reasonable probability of effectiveness" or "poses no greater risk to a patient" when considering specific cases where a CAM therapy has been used? "Competent evidence" regarding the efficacy of some CAM treatments may be conflicting, and physician members of state regulatory boards may not be familiar with CAM techniques.
Advocates of CAM therapies often claim efficacy based on anecdotal evidence, the least reliable form. Furthermore, many CAM therapists claim success in the treatment of conditions, like back pain and arthritis, that are characterized by unpredictable and varying symptoms.
"If you can't assess whether any good is being done, is any harm being done?" asks Catherine M. Mater of the Oregon Board of Medical Examiners.
Some CAM leaders disparage the search for evidence of efficacy as the basis for agreement among contending groups in the states. "The main thing is not to provide evidence for or against efficacy. Efficacy in alternative medicine is totally different than in mainstream medicine. Efficacy has got to shift . . .to 'Is there any evidence that it does any harm?'" says Robert Duggan, president of the Traditional Acupuncture Institute.
Some regulators are dubious about such a self-serving claim. Israel H. Wiener, a physician and former chairman of the Maryland State Board of Physician Quality Assurance, for instance, asks whether limited government and private funds should be spent in
paying for unproven CAM therapies that may be no more than placebos.
In 1995, in response to this debate, Robert E. Porter, president of The Federation of State Medical Boards, established a Special Committee on Health Care Fraud. Porter says that he established the committee because practitioners of alternative therapies were proliferating and were lobbying in some states to limit the authority of medical boards to regulate them. The committee's report does not discuss specific CAM practices, but instead limits its review to "those practices, procedures and/or promotions not widely taught in medical schools nor generally available in hospitals that may be offered by allopathic or osteopathic physicians and therefore subject to medical boards' jurisdiction." The committee developed 11 recommendations to assist state medical boards in their oversight of physicians engaging in questionable health care treatments. The Federation accepted these recommendations in April 1997.
They are summarized here:
Recommendations of the Special Committee on Health Care Fraud
The Federation of State Medical Boards of the United States
(Adopted by the Federation, April 1997)
State medical boards should:
- . . . develop mechanisms to identify physicians who may be engaging in questionable health care practices.
- . . . develop criteria for evaluating any health care practice which has been called into question.
- . . . utilize reliable information resources in their evaluation of questionable health care practices.
- [encourage] ancillary staff, including board investigators . . .[to] utilize methods . . .[that] effectively investigate questionable health care practices.
- . . . work in conjunction with state prosecutors in the initiation, development and dispositition of cases involving questionable health care practices.
- . . . carefully evaluate all avenues of potential prosecution and coordinate such with appropriate federal, state and local agencies.
- . . . review their Medical Practice Acts and pursue legislative support for revisions to strengthen the medical board's ability to regulate physicians engaging in questionable health care practices.
- . . . notify The Federation of State Medical Boards of any state legislative initiatives identified that could diminish state medical boards ability to regulate questionable health care practices.
- The Federation of State Medical Boards should monitor federal and state legislative activities regarding health freedom issues and develop strategies to assure that the authority of state medical boards is maintained.
- . . . with the assistance of The Federation of State Medical Boards . . . develop educational opportunities for licensees regarding the prevalence, risks and efficacy of questionable health care practices.
- . . . [The Federation]. . .should collaborate with other agencies and organizations in efforts to identify and eliminate questionable health care practices that are adverse to the public health, safety and welfare.
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The Federation distributed these recommendations, responds to inquiries or requests for technical assistance, and monitors state activity on health care fraud. The special committee continues to advise and educate state boards.
Next Steps in Protecting the Public Interest
Persons accountable to the public participated in preparing this report by attending meetings, giving interviews, and reviewing successive drafts. They were legislators, regulators, professionals in both conventional and alternative medicine, health care purchasers, and consumers. Many disagreed about the details of how best to minimize the harm and maximize the benefit of alternative medicine.
They agreed, however, that many people are accountable to the public for the safety and effectiveness of alternative therapies. Here is a summary of their recommendations about how to achieve greater accountability:
Consumers should be vigilant and informed on behalf of themselves, family members, and friends. They should be persistent in asking their physicians about the potential risks and benefits of alternative treatments.
Conventional physicians should be more curious and better informed about alternative treatments. More physicians should follow the research literature, both domestic and international, on treatments that interest their patients, paying particular attention to the findings of randomized, controlled trials and meta-analyses.
If medical educators accord more attention to scientific evidence about which alternative treatments are effective for whom under what circumstances, more practicing physicians are likely to do so. Medical schools and specialty training programs should accord more attention to evaluating all forms of treatment, including those that originate outside the mainstream.
Some conventional physicians have changed their practices to concentrate primarily on alternative therapies. These physicians should clarify for their patients whether or not they will continue to act as primary care physicians and offer them the full range of conventional preventive and acute care services.
Practitioners of alternative therapies should be more receptive to evaluation of their interventions by the best available methods of medical science. Anecdotal evidence and patient testimonials often evoke interest and sympathy from consumers and legislators, but they are not a plausible substitute for rigorous analysis of safety and effectiveness.
Practitioners of some alternative therapies have historical reasons to be wary of evaluation by the conventional methods of medical research. Evaluation has sometimes been used to prevent them from competing with mainstream physicians. However, persons who contributed to this report say -- off the record -- that alternative practitioners have threatened electoral reprisal and lawsuits as a way to avoid evaluation.
Because health plans are accountable for the health of defined populations, they are responsible for the use and misuse of treatments, including alternative therapies. They should be better prepared to defend decisions about coverage and more forthcoming about evaluating and publicizing evidence about the results (in jargon, the outcomes) of treatment.
A recent court decision in Arizona may foreshadow future rulings. The Arizona court held that the medical director of a health plan is accountable to the state medical board for decisions about patient care. A decision about coverage, the court said, is a decision about care.
State medical boards are accountable for regulating professions that offer health care, including alternative therapies. Many of these boards operate on the basis of laws passed decades ago. Many operate on a financial base that is too small to permit them to oversee fully the safety and effectiveness of the care offered by licensed professionals. Moreover, many boards have inherited a reputation for protecting professions rather than the public.
Evidence mounts that this reputation is no longer deserved. Many state boards define their purpose as protecting consumers; and often have consumers as members. At least six have recently taken steps to enhance consumer awareness by posting on the Internet the names of practitioners who have been disciplined. Only a very small number of physicians has been disciplined by medical boards, and there are not yet data to show how many of this group practice CAM. In Arizona, it was the medical board that brought the suit that clarified the accountability of medical directors of health plans to the public. Ohio's board took the pioneering step of certifying a process (laparoscopic surgery) rather than a profession. Such certification could be extended to alternative therapies.
The advice of the persons who helped to write this report about regulating the accountability of alternative medicine comes down to three points:
- Members of the public, conventional physicians, business and government purchasers of care, health plan leaders, regulators and legislators are often confused about alternative therapies.
- Protecting patients from being harmed by alternative treatments is a high priority for public policy, private purchasers, health plans, individual professionals, and discerning consumers.
- Decisions about which therapists to license and which treatments to reimburse are mainly political decisions to be made state by state. However, scientific evaluation and communication of evidence to the broadest possible public are essential tools of politics and therefore the basis of sound public policy.
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