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many practitioners argue that scientific studies aren't needed because some nonconventional practices have proven their worth through hundreds of years of use. The intensity of this debate and the flak OAM will continue to take are likely to go unabated for a while. But the parameters of the debate are changing, and the two sides are coming closer together. Mainstream medicine is becoming more accepting of alternative medicine, and practitioners of nonconventional therapies are being taught the value of randomized, controlled clinical studies. Lois R. Ember As William R. Harlan, associate NIH it has remained controversial ever since. It was not set up to do its own research, but director for disease prevention, who C&EN Washington that fact is often lost in the din of criticism oversees OAM, explains, "We are seeing n 1991, Sen. Tom Harkin (D-Iowa) lodged against it. It isn't so much the mon- the beginning of a merger of compleadded a small provision—an earmark, ey—now at $50 million for fiscal 1999— mentary and alternative therapies with in political jargon—to the National In- that makes the office such an irritant to its conventional therapies, and it is becomstitutes of Health's spending bill that es- critics. It's the questioned validity of some ing increasingly difficult to define them tablished the Office of Alternative Medi- alternative therapies that OAM's existence as beyond the boundaries of conventional medicine." Maybe, he speculates, "in cine (OAM) within the nation's premier appears to legitimize. medical research complex. OAM's first NIH has long studied aspects of alterna- 25 years, the dividing line between the two will only mean we don't budget, which was for fiscal have a proof of efficacy of alter1992, was $2 million. Now $2 milnative therapies." lion is not much money, especially when compared with This convergence is important NIH's multi-billion-dollar budget, because OAM has recently rebut it was all Harkin could conceived a hefty boost in budget vince his colleagues to support and has been elevated to a cenfor this controversial office. ter—the National Center for Complementary & Alternative Harkin's reason for creating Medicine (NCCAM)—that plans the office was simple: He beto emphasize clinical trials. The lieved that established medicine center will be able to execute had ignored for too long the pogrants that will be reviewed by tential of alternative medicine. scientists or practitioners of its So he set up OAM to evaluate own choosing—things it couldn't and coordinate, through other do as an office. NIH institutes, research on complementary and alternative theraAlternative medicine is a mepies, and to spread information lange of mostly untested and unwidely on these nonstandard regulated treatments, practices, treatments. and products, and Americans are freely offering themselves as Complementary, or adjuncguinea pigs in a wide-ranging tive, medicine is defined as pracand ill-defined experiment. tices such as relaxation therapy or massage that a mainstream physiThe use of unorthodox, noncian might prescribe along with standard therapies is rising conventional treatments. Alternasteeply, and consumers are, for tive medicine is commonly de- Tibetan 17th-century painting of medicinal plants. the most part, paying for them fined as those therapies that are out-of-pocket. Also, the multi-bilnot widely taught in medical schools or tive medicine, but OAM serves as the pub- lion-dollar industry is swiftly moving into generally available in hospitals. lic focal point for these nonconventional the mainstream and changing the landThis definition of alternative medicine practices. As such, the office is a lightning scape of the health care system and the may have been true at one time, but it is rod for the uncertainty and controversy mind-set of influential politicians. rapidly becoming outmoded. More U.S. enveloping alternative medicine today. Just how mainstream alternative medmedical schools are discussing—if not acMany mainstream researchers believe icine has become was made evident on tually teaching—alternative therapies, and that most of what falls under the rubric Nov. 11 when the American Medical Asmore traditional physicians are blending of alternative medicine is patently non- sociation devoted an entire issue of its orthodox and unorthodox practices. sensical, and these practices should be premier journal to the subject of nonOAM sparked the fury of mainstream discarded if they can't scientifically be standard medicine. When this bastion of science when it was created in 1991, and shown to have merit. On the other side, orthodoxy sees fit to recognize a topic it
ALTERNATIVE MEDICINE GOES MAINSTREAM
NIH's Office of Alternative Medicine, now a center with $50 million, plans to stress randomized clinical trials
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14 DECEMBER 7, 1998 C&EN
had previously dismissed as folklore, "this tells you that in this country this type of medicine is beginning to have an impact," a high-ranking official of the National Institutes of Health tells C&EN. However, not all of the traditional medical community is buying into alternative medicine. Only a few months earlier, the editors of the New England Journal of Medicine wrote: "There cannot be two kinds of medicine. . . . There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work." But they grudgingly noted with chagrin and concern the rapid rate of growth of nonstandard practices. The reasons for the skyrocketing statistics are complex. The triumph of scientific medicine—lengthening life expectancy—may be a key reason Americans are clamoring for alternative medicine. Disenchanted with high-tech medicine and the punch-clock mentality of managed care, they are turning to nonconventional thera-
pies and practices to treat the chronic, debilitating disorders of old age. But Americans are hedging their bets. They are not using alternative medicine alone but in conjunction with conventional medicine because these nonstandard health care practices are more in tune "with their own values, beliefs, and philosophical orientations toward health and life," concludes Stanford University School of Medicine's John A. Astin in his survey published in May \J. Am. Med. Assoc, 279, 1548 (1998)]. By taking these alternative paths, Americans are wresting decision-making control from traditionally paternalistic physicians. And when they turn to nontraditional therapists, Americans usually find a willing listener and the spiritualism they seem to be seeking as the millennium approaches. Users and advocates of alternative medicine care not that popular practices like homeopathy and touch therapy defy scientific explanation and maybe even
A wealth of alternatives: Defining the terms Acupuncture: An ancient Chinese healing technique that usesfineneedles to pierce the skin, supposedly to tap into a grid of flowing energy called qi that controls organs. Aromatherapy: A practice in which essential botanical oils and essences are used to treat physical and psychological problems. Ayurveda: A 3,000-year-old Indian medical practice that uses diet, exercise, yoga, meditation, herbs, and massage to treat imbalances in physical, emotional, and spiritual harmony thought to bring on illnesses. Chelation: A standard medical procedure for treating heavy-metal poisoning now being touted by nonmedical advocates as a cardiovascular treatment Chiropractic: The therapy with which practitioners treat disorders of the spine, joints, and muscles with manipulation that is said to restore or maintain health of the body. Herbal supplements: Plants that are made into pills or liquid extracts to cure disorders. Harkens back to ancient times when healers combed nature's pharmacy. Homeopathy: The centuries-old theory—meaning like cures like—that holds that very small doses of substances that would at high doses cause adverse
symptoms can be used to cure those symptoms. Some preparations are so dilute that the "active" ingredient no longer remains. Hypnosis: Method of inducing a trancelike state to foster healing; now widely used in standard medicine. Naturopathy: A 100-year-old practice that relies on diet, fasting, massage, herbs, homeopathy, and other "ratiind" treatments to treat many disorders, including cancers. Osteopathy: The system of medical practice in which practitioners manipulate muscles and the spine to expedite recovery from disease or injury. Practitioners receive medical training and can prescribe medications. Oxygen therapies: Use injected oxygen, ozone, or hydrogen peroxide to treat serious disorders, including cancer and AIDS; one therapy, hyperbaric oxygen, subjects patients to a high oxygen atmosphere while they are reclining in a pressurized tank. Reflexology: A practice in which spots on the foot are massaged to stimulate specific organs. Therapeutic touch: The caregiver, usually a nurse, moves hands inches above the patient's body to realign disturbed "energyfields;"also called energy healing.
Sources: Cassileth, Barrie. "The Alternative Medicine Handbook: The Complete Reference Guide to Alternative and Complementary Therapies," New York: W. W. Norton, 1998; Gordon, James S. "Manifesto for a New Medicine," Reading, Mass.: Addison-Wesley, 1997.
Budget of NIH's alternative medicine office rises steeply $ Millions 501
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the laws of nature. But the lack of logical underpinnings sends critics of unorthodox therapies up the wall. These critics with their scientific arguments have made little headway in halting the growth of the alternative medicine industry. And undeterred, the booming industry has been able to pump huge sums of money into institutions and professions with political clout. Nowhere has this clout been more evident than in two key congressional actions: the 1992 formation of OAM, and passage of the 1994 Dietary Supplement Health & Education Act. That act undercuts the Food & Drug Administration's power to regulate vitamins, minerals, and herbs and gives supplement manufacturers wide latitude in marketing their products without having to prove them safe or effective. But in their advertising, supplement makers must now, under new Federal Trade Commission guidelines, substantiate their claims with "competent and reliable scientific evidence." Although 1992 and 1994 may have been banner years for the industry, Harkin—who believes that bee pollen pills alleviate his allergies—has year after year tended assiduously to the welfare of his creation. He has made certain that this pygmy office is not swallowed up by its behemoth parent. And because of him, OAM's budget has increased steadily and steeply over its eight-year life span, sometimes against daunting odds. In short, Harkin has been relentless in seeing that alternative medicine has a fairly prominent profile within the federal health research establishment. His legislative legerdemain was clearly on display in late October. DECEMBER 7, 1998 C&EN 15
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Buried deep in the massive 1999 spending bill is a provision elevating OAM to NCCAM. Accompanying this upgrade is a hefty increase in budget, from $20 million in fiscal 1998 to $50 million in fiscal 1999. Congress stipulated that $20 million had to be allocated to peerreviewed research grants and contracts. This was Harkin's second attempt to elevate OAM to a center. His first effort failed in early 1997, but he gained a powerful ally for his quest: Republican colleague Sen. Arlen Specter of Pennsylvania, who chairs the committee that drafts NIH's budget. Both senators have a deep, personal interest in alternative medicine. And together they succeeded in getting OAM upgraded, boosting its budget, and making sure that half of NCCAM's 18member advisory council consists of people who practice alternative medicine plus at least three people who represent consumers of alternative medicine. They also saw to the creation of a Presidential Commission on Complementary & Alternative Medicine to study and make recommendations to Congress about research, training, insurance coverage, and licensing of practitioners. The director of NCCAM will be appointed by Donna E. Shalala, secretary of the Department of Health & Human Services, and will report to NIH Director Harold E. Varmus. Varmus says NCCAM's formation "will ultimately result in the expansion of clinical research in this field." NIH is now searching for a new director of NCCAM, someone who has expertise in planning and conducting clinical research, especially clinical trials. At press time, the front-runner was rumored to be a cancer specialist. Unlike OAM, the center is mandated by law "to conduct basic and applied research." The center must also train scientists to conduct research on complementary and alternative practices and therapies. But in most other respects, NCCAM will continue programs initiated by OAM. Critics, some of whom in 1997 fought the office's elevation to a center, are now taking a wait-and-see attitude. "I'm not pessimistic, I'm guarded at the moment," says Stephen Barrett, a retired psychiatrist and respected skeptic who runs the web site Quackwatch. "If the new director has a solid scientific approach and is free to pursue that approach, that will be great." Another critic, Ursula Goodenough, a biologist at Washington University in St. Louis, says she's "pleased that there has 16 DECEMBER 7, 1998 C&EN
St. John's wort studied as treatment for depression Hypericum perforatum, better known as St John's wort, has been used in folk medicine for hundreds of years. Extracts of the herb are licensed in Germany to treat anxiety and sleep and depressive disorders. In fact, some German physicians prescribe St John's wort in lieu of Prozac to treat depression. Clinical trials in Germany have found that the extracts work better than placebos in treating patients with mild to moderate depression, but the studies have been too small and of too short a duration to determine the risk of relapse and the possibility of later side effects. Despite the lack of solid data on the herb's effectiveness and safety, Americans in droves are emptying the shelves of their local health stores of St John's wort to self-medicate their depression. More than 17 million Americans suffer from clinical depression, a brain disorder. Treatment and lost productivity cost the U.S. as much as $44 billion a year. Traditionally prescribed antidepressants are relatively expensive and have side effects that make some patients reluctant to take them. If St John's wort can be shown to offer little risk with credible benefits, its moderate cost would be a boon to those patients suffering clinical depression. Enter the National Institutes of Health's National Center for Complementary & Alternative Medicine. In collaboration with the National Institute of Mental Health (NIMH) and NIH's Office of Dietary Supplements, the center is funding the first rigorous clinical trial of St John's wort that will be large enough and long enough to determine whether the herb produces a therapeutic effect The three-year, $4.3 million study is being coordinated by Jonathan Davidson,
been additional funding and an elevation of the office to a center if the increase in funding and status are accompanied by a rigorous program wherein alternative therapies are evaluated in double-blind clinical trials to determine whether they work or don't work beyond a placebo effect." Goodenough is reinforcing points raised by Varmus in his commencement address last year in which he called for breaking down the boundary between alternative and conventional medicine. "Let's adopt another mind-set: There are methods that work and methods that don't. [There are] methods that have been properly tested so we know whether they work, and those that have not [been tested]," Varmus said. "Let's re-
a psychiatrist at Duke University Medical School. The randomized, placebo-controlled, double-blind trial is elegantly designed. Some 336 patients diagnosed with moderate depression from 12 participating sites across the U.S. will be divided into three groups. One group will receive St. John's wort; another will be given sertraline, which is a selective serotonin reuptake inhibitor and a commonly used antidepressant; and the third group will receive a placebo. Sertraline, the comparator arm of the study, will validate the trial Norman E. Rosenthal, a psychiatrist at NIMH, points out that this trial is also "thefirststudy to compare St John's wort with a selective serotonin reuptake inhibitor." Patients receiving St John's wort will take a standardized extract—between 900 and 1,800 mg per day—of the herb made by Lichtwer Pharma (Berlin). Extracts of St. John's wort contain at least 10 constituents that may contribute to its pharmacological effects. The extracts for this trial, however, are standardized against only one constituent, hypericin or naphthodianthron. All patients will take eight tablets a day containing Hypericum, sertraline, or placebo for eight weeks. This is considered the acute phase of the trial At the end of this phase, those patients responding positively will be studied for an additional 16 weeks. During this second phase, they will continue to take the treatment originally assigned to them. Given the lengthy enrollment period, the duration of the trial itself, and then the time needed to analyze the data, a spokesman at the coordinating center at Duke expects a published paper no sooner thanfiveyears.
place the uncertainty of anecdote with the power of clinical trials." Yet another critic, Stanford University chemist Paul Berg, a 1980 Nobel Laureate, agrees that the center "needs someone who can develop an effective scientific program for alternative therapies." And that, he continues, "means properly conducted clinical trials whose results are evaluated by an unbiased group of investigators." Barrie R. Cassileth, who is the author of "The Alternative Medicine Handbook: The Complete Reference Guide to Alternative and Complementary Therapies" recently published by W. W. Norton, and is also affiliated with Duke and Harvard Universities and the University of North Carolina,
observed the workings of OAM closely as and NIH doesn't deal in the area of pri- the ways of scientific medicine. "The proa member of the office's advisory council mary care. NIH takes a basic and clinical ponents saw OAM as an affirmative action until 1996. She expects "the next director scientific approach," he explains. But program, not a scientific endeavor, and will be even more mainstream than [the with the same breath, he argues that al- that was the root of my problems," Jacobs current director] Wayne B. Jonas, and I ternative therapies have "to stand on tells C&EN. "Not-so-veiled threats on NIH's suspect those involved in initiating the their own merits" and gain legitimacy budget" and the constant pressure from congressional staffers trying "to maniputhrough clinical testing. center will be outraged." Even Robert L. Park, a physicist at the The 1991 law set up OAM within the late the research agenda" made Jacobs say University of Maryland, College Park, and office of the director of NIH and stipulated "enough is enough" after two years. Alan an ardent critic of OAM, says he is en- that a director was to head OAM and an Trachtenberg filled in as acting director couraged by the possibility of a advisory council until Varmus appointed Jonas, the current, scientist steeped in clinical rewas to guide its but soon-to-depart, director in 1995. Varmus never wanted a separate and search being named director of work. The council discrete NIH entity responsible for NCCAM. "This may well backfire alternative medicine, and when he on Harkin," he chortles. Most of appointed Jonas, he seized the opOAM's money has gone to fundportunity to revamp OAM. To ing "true believers," and most of maintain tighter control, Varmus the practices studied range from placed the office directly under "the totally preposterous to the Harlan's supervision. merely implausible," he asserts. Joseph J. Jacobs, OAM's first The office is an awkward NIH director who is now medical dichild, tugged in many directions. rector for Vermont's Medicaid It must operate within the conprograms, has a more nuanced fines of the traditional scientific opinion that appears, in part, to conventions revered by NIH. Harmirror Varmus' thinking. Jacobs Harlan (above): beginning lan, a representative spokesman would never have established of a merger; Jonas: best of for the NIH culture, holds that OAM, believing its creation "just healing and best of science new health care practices have to added bureaucratic redundancy" be based on evidence obtained to NIH programs that could "have used met for the first time in 1993, chaired by from randomized clinical trials—the hallthe money to fund studies at existing in- former NIH researcher James S. Gordon, mark of NIH research. Yet, OAM must stitutes." Furthermore, he believes that who now directs the Center for Mind/ also respond to and placate advocates of OAM's creation and now its elevation to Body Medicine, a holistic medical practice alternative medicine who argue that a center has "ghettoized and marginal- in Washington, DC. practices validated through centuries of ized alternative medicine." According to Jacobs—a self-described use need no scientific proof. On further reflection, Jacobs tells yuppie, Native American, and Ivy LeagueBy trying to serve as a bridge between C&EN that maybe alternative medicine trained physician—the council he had to these two clashing cultures, OAM has should not be at NIH at all. "Alternative deal with was stacked with advocates who had to sail some rough seas. Choosing medicine is an extension of primary care, had no conception of and no interest in Jonas, a physician who practices home-
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news focus opathy, for director was a deliberate move to placate both camps. Homeopathy uses verv dilute solutions of substances that cause disease at higher concentrations in the belief that like cures like. Sometimes preparations are so dilute that not a single molecule of the "active" ingredient remains. Although this seems to contradict the laws of chemistry, physics, and medicine, a meta-analysis of 186 studies published over the past 30 years concluded that homeopathic remedies were more effective than placebos, but could not show its effectiveness for any single clinical condition. Jonas was an author of this analysis, published in the British medical journal The Lancet [350, 834 (1997)]. As OAM director, Jonas has aimed "to bring together the best of healing and the best of science." But even though Jonas has been able to better structure and organize the office, he has not until recent years been able to sponsor or conduct clinical trials. OAM's budgets have been much too small to do more than surveys and pilot studies. In 1993, under Jacobs' directorship, OAM began to issue exploratory grants of $30,000 to fund pilot projects that would identify promising areas for future research. By September 1994, 42 projects had been funded, and many of the recipients were not researchers but practitioners. According to Jonas, most of these 42 grants "have been completed. Some have been published; some have not. Some of them have shown promising things," and others have identified areas not worth pursuing. As "an example of what these little pilot grants were designed to do," Jonas points to one that explored the effects of acupuncture as a treatment for arthritis of the knee. The results—though not definitive—looked promising. So OAM, in conjunction with the National Institute of Arthritis & Musculoskeletal & Skin Diseases, has decided to fund a larger study. In 1994, OAM began to set up cooperative research centers—mainly at universities—to study alternative and complementary therapies for the treatment of certain conditions. Some of these centers—which now number 13—have also been cofunded by other NIH institutes. Most of the centers focus on the efficacy and safety of alternative practices for treating cancer, heart or neurological disorders, allergies, aging, and pain and for promoting women's health. But at the Consortial Center for Chiropractic Research in Davenport, Iowa, the fo18
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NCCAM sponsors 13 research centers Research centers have generally been funded at $1 million over three years, but this year the Minneapolis Medical Research Foundation, the University of Michigan, and the University of Arizona have each received grants for $5 million over five years. All centers conduct research on the efficacy and safety of promising alternative therapies for the treatment of specific disorders or conditions. Institution
Focus of research
University of Texas, Houston Cofunding: National Cancer Institute Columbia University Cofunding: NIH's Office of Research on Women's Health Kessler Institute for Rehabilitation, West Orange, N.J. Cofunding: National Institute of Child Health & Human Development
Cancer
Bastyr University, Seattle Consortial Center for Chiropractic Research, Davenport, Iowa University of Maryland, Baltimore Cofunding: National Institute of Arthritis & Musculoskeletal & Skin Diseases Stanford University School of Medicine, Palo Alto, Calif. Beth Israel Hospital, Boston University of California, Davis Minneapolis Medical Research Foundation University of Virginia, Charlottesville Cofunding: National Institute of Dental Research University of Michigan, Ann Arbor University of Arizona, Tucson
cus—as its name indicates—is on a category of treatment for many conditions. These centers have been "funded at a low level"—around $1 million over three years—"primarily to stimulate the development of infrastructure [and capability] and to do pilot work," Jonas explains. "They were not funded at a level to do large projects." But that is changing as of this year. The original program is now being "superseded by [one] that offers grants that are larger in terms of money and more demanding in the type of research to be done," Harlan explains. Research groups competing for these grants will "have to put forward at least three research studies that meet meritorious peer review to be considered for funding," he adds. Three of the 13 centers—the Minneapolis Medical Research Foundation, the University of Michigan, and the University of Arizona, Tucson—have competed again for funding under the new program. Each has been awarded $1 million a year for five years to focus on alternative treatments for addictions, cardiovascular diseases, and pediatrics, respectively. They are now more like typical NIH
Women's health
Stroke, neurological diseases
HIV/AIDS Chiropractic Pain
Aging General medical conditions Asthma, allergies, immunology Addictions Pain Cardiovascular diseases Pediatrics
research centers—more independent of NIH than the original OAM-funded centers. But they are being held to higher scientific standards, and they are expected to produce solid results. Much of the exploratory research funded under OAM's original program will fade out as the newer centers focus more sharply on "categorical disease areas such as AIDS," Harlan says. For this reason, the center on research on women's health at Columbia University will not be funded by NCCAM after August of next year. "The expectation is that the center studying aging might look at menopause with unconventional therapies," Harlan explains. Over the nextfiveyears, three-quarters of NCCAM's budget will be diverted to support these research centers, pilot studies that precede clinical trials, large clinical trials that NCCAM will cofund with other NIH institutes, and research training. The remainder of the budget will support dissemination of information to the public and administrative costs. Future NCCAM research initiatives will include, for example, the treatment of dementia with gingko, the efficacy of
herbal supplements for treating enlarged acupuncture to be no more than a comprostate glands, and the effectiveness of plex placebo." Whether acupuncture acts merely as a garlic in treating aspects of cardiovascuplacebo in treating the pain of osteoarthrilar disease, Jonas says. NCCAM will also be joining other tis may soon be known. Jonas says that NIH institutes in funding pilot studies NCCAM, in conjunction with the National that use acupuncture for a variety of Institute of Arthritis & Musculoskeletal & clinical conditions. These studies are Skin Diseases, is now funding a large, mulexpected to evolve into full-blown clin- ticenter, randomized clinical trial. The coordinating center is the University of Maryical trials. land, Baltimore. The pilot studies come on the (Another study heels of a consensus conference will soon be fundon acupuncture that OAM sponsored last year. The conference found that acupuncture was effective in treating postoperative dental pain and the nausea and vomiting accompanying surgery and chemotherapy. It found less compelling evidence for acupuncture's usefulness in treating headaches, menstrual cramps, asthma, and osteoarthritis but suggested further study. Critics of alternative medicine and of the office found the acu- Cassileth (above): next puncture consensus conference a director will be more sham. There was no consensus, mainstream; Jacobs: would not have established OAM contends Wallace Sampson, a retired professor of medicine at Stanford ed to study the effectiveness of gluUniversity and now editor of the new cosamine and chondroitin sulfate for treatjournal Scientific Review of Alternative ing the pain of osteoarthritis.) Medicine, published by Prometheus Acupuncture is an excellent example Books. "Not a single authority or re- of a practice that skates the boundaries searcher who reported negative results between alternative and complementary was invited to participate—either as a medicine. As Harlan explains, "Acupuncpresenter or [as a member of] the pan- ture is now an adjunctive modality more el," Sampson points out. He says that commonly in use for pain and maybe "the scientific literature decisively shows even for nausea and vomiting. But for the
treatment of alcoholism, it would be considered alternative because there are no supportive data." More collaborative research, a goal of Jonas' when he became OAM director, will continue to be a major thrust for NCCAM. With small budgets and a minuscule professional staff, OAM has always had to piggyback research projects onto the scaffolding of other NIH institutes. "That is where the expertise is, that is where the proper peer review is, that is where the infrastructure to execute the research is, and that is the way you make sure you get good science done," insists Jonas. That leverage will be put to good effect in a large, multicenter trial of St. John's wort—or Hypericum perforatum—for the treatment of depression that NCCAM is cofunding with the National Institute for Mental Health and the NIH Office of Dietary Supplements. Widely prescribed in Germany, St. John's wort has never undergone a large enough trial of sufficient length to indicate its safety and effectiveness over the long term. Duke University is coordinating this NIH study. The complexion of NCCAM's 18member advisory board has changed in concert with the center's more sciencebased orientation. Highly politicized when Jacobs was director, the board "is now a science-based council," says former council member Cassileth. A current board member, Harry G.
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Surveys that chart Americans' increasing use of alternative therapies questioned In 1993, the New England Journal of some form of alternative medicine, up Medicine published the results of a ran- from 61 million (three out of 10) in domized telephone survey that queried 1990. And these 83 million Americans more than 1,500 Americans on their use were conservatively estimated to be of 16 alternative medical therapies. The spending $27 billion for all alternative results were unexpected and eye pop- therapies, mostly out-of-pocket. Visits to ping. Fully a third of the U.S. popula- practitioners of alternative therapies— tion was estimated to be using at least 50% of which were to chiropractors or one of these alternative therapies, and massage therapists—exceeded total vismost people were paying for them en- its to all primary care physicians in the U.S. tirely out of their own § Most Americans are pockets. using alternative therThe survey also apies along with stanshattered some stereodard medicine, but typic myths: Those they are not telling most likely to use untheir conventional conventional medihealth caregivers that cine were not poor they are using these and uneducated but other modalities, middle aged, middle which troubles Eisenclass, and college eduberg. He is also bothcated. Females were ered by another of his the predominant ussurvey's finding. "An ers, employing the estimated 15 million therapies to treat adults are using prechronic conditions scription drugs along such as back pain, arwith herbs or vitamins, thritis, and headaches. and we don't know Though published whether there are inin 1993, the survey Eisenberg: dramatic increase in teractions between was actually conduct- use of alternative therapies these," he explains. ed in 1990 by David Eisenberg and his colleagues define M. Eisenberg, an assistant professor of medicine at Harvard Medical School, alternative medicine functionally—as and colleagues. Eisenberg is also direc- interventions that are neither taught tor of the Center for Alternative Medi- widely in medical schools nor generalcine Research & Education at the Beth ly available in U.S. hospitals. Many disIsrael Deaconess Medical Center in pute the use of this definition, believing that it greatly overestimates usage Boston. Seven years after his first survey, of alternative therapies. Eisenberg decided to revisit the issue. For example, according to Barrie R. This time, 2,000 Americans were ques- Cassileth, author of "The Alternative tioned about their use of the same 16 al- Medicine Handbook: The Complete ternative therapies considered in the Reference Guide to Alternative and earlier survey. Included among the ther- Complementary Therapies," who is apies considered alternative were chiro- also affiliated in medicine with Duke practic, acupuncture, massage, biofeed- and Harvard Universities and the Uniback, megavitamins, homeopathy, re- versity of North Carolina, "Eisenberg laxation techniques, spiritual healing, didn't define alternative and compleself-help, herbal remedies, both com- mentary medicine in a rational way. He mercial diets and diet-based lifestyles 'medicalized' many lifestyle activities like vegetarianism, and various forms of and self-help regimes and included "energy" healing such as touch and them as alternative medicine." If these magnets. activities are removed, "a very small The results of this second survey were percent of people are involved in activipublished in the Nov. 11 issue of the ties you could call alternative medicine," Journal of the American Medical Asso- she contends. ciation, an issue devoted entirely to alAnd Stephen Barrett, a retired psychiternative medicine. As Eisenberg tells atrist, author of prize-winning medical C&EN,. "There has been a dramatic in- books, guiding spirit behind the web crease in the prevalence of use and in site Quackwatch (http://www.quackthe amount of dollars spent on alterna- watch.com), and peer reviewer of severtive therapies." al articles published in JAMA's issue on In 1997, an estimated 83 million alternative medicine, says: "He set up Americans (four out of 10) were using some categories that don't fit into his 20 DECEMBER 7, 1998 C&EN
definition of alternative therapies, and as a result, his total numbers are exaggerated." As examples, Barrett argues that hypnosis, massage, and relaxation therapies are now part of mainstream medicine and that Weight Watchers— Eisenberg's example of a commercial diet—is not complementary and alternative medicine. As a result of his "too wide definition," Eisenberg's first survey exaggerated the number of users of alternative medicine by 100%, Barrett contends. Eisenberg's 1993 article claiming that one out of three Americans used alternative therapies and the establishment of the Office of Alternative Medicine (OAM) at the National Institutes of Health in 1992 "lit a spark that started a forest fire, and now we have the age of quackery," exclaims Barrett. Barrett sees an improvement in Eisenberg's second article. "He points out some of his categories that are challengeable" as alternative therapies. Although Cassileth and Barrett contend that Eisenberg overestimated the use of alternative medicine, Joseph J. Jacobs, OAM's first director, argues that Eisenberg's methodology may actually be underestimating the number of users. In both surveys, telephones were used to collect the data, and respondents had to be English-speaking. These constraints probably eliminated a great number of poor, non-Englishspeaking users of alternative medicine who do not own telephones, Jacobs explains. William R. Harlan, associate NIH director for disease prevention, says Eisenberg's definition, though commonly used, may be outdated. "More medical schools now have curriculums on complementary and alternative medicine, and more traditional physicians are practicing alternative therapies" in conjunction with standard treatments. It is, he says, becoming increasingly difficult to define alternative therapies as beyond the boundaries of conventional medicine. All would agree with Eisenberg on the need for more rigorous study of alternative therapies. Eisenberg recommends "more support for scientific evaluation to distinguish useful from useless, safe from unsafe." He tells C&EN that it is important for federal agencies and the private sector— especially those makers of herbs, vitamins, and other supplements—"to come to the table and jointly design research to distinguish useful from useless therapy."
Preuss, professor of medicine at Georgetown University, Washington, D.C., agrees. "The council meetings are run professionally. There is an agenda, and we advisers are asked for our advice." He's "impressed by some of the people on the board, by the depth of their knowledge." Speaking of the office as a whole, Barrie says the transformation "is the expected natural evolution of an office at NIH. It moved from a freewheeling, politically directed group to a much more science-based organization." But is the senator who established OAM pleased with his creation? Harkin's legislative director, Peter Reinecke, says the senator has mixed feelings. "He's frustrated that the office hasn't been able to accomplish more; it has reviewed only a limited number of therapies." However, Reinecke says Harkin is pleased "that the creation of the office has spurred a great deal of interest and increased involvement of the research community." It is certainly true that practices and products that were once considered alternative are now receiving a great deal more use by.mainstream physicians who want to use the full armamentarium against diseases and disorders. That is what Gordon, OAM's first advisory board chairman, says his medical practice is all about. "I'm not interested in alternative medicine but in what the best medicine is for people." Gordon faults OAM for not having "supplied enough information to the public." But Barrett claims that "OAM has given out a lot of misleading information and certainly no useful information. None of the research funded by OAM has clarified anything," he insists. Gordon also says OAM has failed to tackle the basic science issue: How do the therapies work? He acknowledges that OAM could not study underlying mechanisms with its budget. But he says NCCAM, with more money, "needs to do more clinical and outcomes research." There is a need, he claims, to study disorders in which treatment with "a comprehensive intervention program [alternative and traditional medicine] works better than just traditional medicine alone." Sampson, who has followed OAM closely with a skeptical and jaundiced eye, says, "OAM has given out millions of dollars in grants and hasn't come up with serious findings." And fellow critic Barrett agrees. "As far as I can tell, not a single treatment has been judged worthwhile or useful—or has been debunked—as a result of any of
the research done by OAM." Barrett, who credits Jonas with having done "a decent job of setting up the framework—processes and mechanisms—for gathering information in a legitimate way," asks: "Is there any form of alternative medicine that OAM has considered quackery?" Jonas answers carefully. "I would say 80 to 90% of the [proposals] that come into the office, we don't consider pursuing because they are [from] people making claims for which there are no data." He adds, "A number of the pilot trials did not show promising results, and so they weren't pushed through. Now you can say that those [trials] demonstrated that they were not effective, and they are, therefore, not going to be pursued. There are quite a number of those." Jonas also points out that OAMsponsored consensus conferences have found "a number of therapies... not to be effective." The acupuncture consensus conference, for example, found the therapy "not more effective than placebo for smoking cessation or obesity treatment." Barrett claims the existence of OAM "has done incalculable harm for decades
to come, and no amount of benefits will counter that harm." He believes the same pernicious forces behind OAM's creation are also evidenced in other ways. These include the billions of dollars that have flowed into the dietary supplement industry, which he terms corrupt; the weakening of federal regulatory power that once monitored the dietary supplement industry; the infiltration of medical education by alternative medicine in "a malignant way"; and the publication of low-quality papers on alternative medicine in "throwaway, not big, medical journals." Maybe Barrett is wrong. Maybe the center can make a difference. Americans turn to alternative medicine when they believe that mainstream medicine has failed them. It may well turn out that most alternative therapies are effective because of the placebo effect: Patients using them believe they will work, so they work. But NCCAM, as the focal point for alternative medicine within NIH, can foster the research that will determine whether these treatments are inherently effective—or mere placebos.^
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