Senator Frist, members of the Subcommittee, I am honored to participate in this hearing and to provide background on the topic of Alternative Medicine Research.
My remarks are intended to address the following themes: (1) definitions and terminology; (2) prevalence, cost and patterns of use; (3) education; (4) research challenges, and (5) priorities and mechanisms of support. Detailed references for many of my comments can be found in written materials prepared for the American Board of Internal Medicine and submitted to Senator Frist's staff.
I. Definitions and Terminology
In a survey published by the New England Journal of Medicine in 19931, my colleagues and I [BIH1] defined alternative therapies as "those interventions not taught widely in U.S. medical schools nor generally available in U.S. hospitals." Examples include: chiropractic, acupuncture, homeopathy, herbal remedies, dietary supplements, massage, meditation, etc. This is a pragmatic and imperfect definition at best, and, there is currently no consensus in defining the full spectrum of "alternative medical therapies." Moreover, the terms "alternative," "complementary," "traditional" and "integrative" medicine are all in common use.
A few months ago I appeared on a panel which included a woman, my age, who had lived for the past twenty years with chronic non-Hodgkins lymphoma. She stated that she owed her survival to a combination of both conventional and alternative therapies but added that she respectfully disagreed with the pragmatic definition described earlier. "With all due respect, Dr. Eisenberg," she said, "I would define alternative therapies differently. In my mind, these are therapies which, by and large, I have had to pay for out of pocket and which I did not feel comfortable discussing with any of my doctors." Her definition speaks to the enormity of our shared challenge.
II. Prevalence, Cost and Patterns of Use
Findings from our National Survey of Alternative Medicine Use published in 1993 in the New England Journal of Medicine include the following:(1)
An estimated one in three respondents reported using at least one alternative therapy to treat a serious or bothersome medical problem during the past year.
Seventy-two percent of alternative medicine consumers did not inform their medical doctors of their alternative therapy use.
A majority of respondents used alternative therapies for chronic as opposed to life-threatening medical conditions. (Alternative therapies for cancer and HIV illnesses accounted for only 3% of all alternative medicine use.)
Extrapolating from survey data, Americans made an estimated 425 million visits to providers of alternative medical therapy in 1990, exceeding the 338 million visits made to all U.S. primary care physicians during the same period.
Out-of-pocket expenditures associated with alternative therapy use in the United States in 1990 amounted to $10.3 billion, nearly equal to the $12.8 billion out-of-pocket expenses incurred that same year for all U.S. hospitalizations.
An estimated one third of alternative medicine use is attributed to health promotion and disease prevention.
The highest use of alternative therapies is found in the so-called "baby boom" generation now age 30-55. An estimated one in every two of these individuals currently use alternative therapies. In the decades to come, this large segment of our population is apt to use and demand more alternative medicine services and benefits.
Apart from survey research, if one picks up a newspaper one cannot help but read about the explosive pace by which insurance carriers and managed care organizations are now offering alternative medicine services. The Oxford Health Plan, Blue Shield of California, Kaiser Permanente of California and Health Net are notable examples. Some have established "Alternative Medicine Provider Networks." Some provide discounted fee-for-service to chiropractors, acupuncturists and naturopaths, while other "products" include paid benefits for visits to alternative medical providers. In the case of Oxford, approval by one's primary care physician is not necessary. We will surely see more of these managed care options in the coming months.
At least 40 U.S. medical schools currently offer courses devoted to the topic of alternative medicine. Information from an ongoing survey of U.S. and Canadian medical school courses devoted to this area suggests that: 1) enrollment in theses courses remains small; 2) the format and the content of existing curricula vary considerably; and 3) there is a need to define a core content for curricula involving alternative medical therapies. The American Association of Medical Colleges has recently established a Special Interest Group devoted to alternative medicine. In my opinion, we must, with the assistance of Deans for medical education throughout the United States, identify a core body of knowledge for physicians in this area. This is essential if we are to educate the next generation of physicians, nurses, physician assistants, and pharmacists to responsibly advise patients who use, seek or demand alternative medical services. Historically, this has not been an area of high priority within the Office of Alternative Medicine at the National Institutes of Health. Nonetheless, education in this domain will require additional attention and support.
As a member of the NIH Alternative Medicine Program Advisory Council, I have suggested that new NIH training grants be developed to train clinician researchers in this area. Imagine how different the experience of medical care would be for a cancer patient who knew that at his or her institution there was at least one medical oncologist who, in addition to possessing expertise in oncology, chemotherapy, radiation therapy, etc., also was knowledgeable about the most commonly used, "unproven" cancer therapies and could therefore responsibly advise them once conventional options were exhausted. We all have family members and friends who would seek out such an oncologist. Moreover, other clinicians and physicians-in-training would view this individual as an invaluable professional resource.
By envisioning a series of federally funded training programs, we can educate and train oncologists, orthopedists, rheumatologists, primary care doctors, nurses, pharmacists and others to be sufficiently knowledgeable about alternative therapies so as to responsibly advise patients who rightfully ask, "So, Doc, what else should I try? What should I avoid? Will it interact with my conventional therapy? Will you or my primary physician think less of me for asking?" The government can and should support advance fellowship training for clinicians who wish to serve as local experts to advise patients and perform research in this complicated area.
IV. Research Issues
Despite findings which confirm extensive use of alternative therapy in the United States and internationally, relatively little is known about the safety, efficacy, cost-effectiveness and mechanism of action of individual alternative therapies. In short, there is a paucity of satisfactory research involving alternative medical interventions.
One might ask why this is so. In part, this can be explained by the fact that historically practitioners of alternative therapies have not been highly trained in research methodology; and, experts in research methodology have had little exposure to or interest in pursuing alternative medicine research. As a result, sound research methodologies have not been applied to produce authoritative findings in the majority of instances.
The current environment can therefore be described as follows:
- There is an enormous popular demand.
- There is a paucity of satisfactory research.
Alternative medicine treatments lack standardization and include both relatively safe and toxic interventions.
The training, licensing, and credentialing of alternative medicine providers, with the possible exception of chiropractors, is highly inconsistent.
- Malpractice liability issues remain unclear.
Toxicity issues pertaining to herbs, vitamins and supplements remain poorly studied and are not readily available.
Professional guidelines whereby medical doctors refer to providers of alternative care are absent.
An atmosphere of mistrust, misperception and extremism is common to both the medical and the alternative medical communities.
The following tools will be necessary to improve research in this area. These include:
Lastly, there are a variety of unaddressed policy issues. These include:
A full text database of peer reviewed studies, systematic reviews, meta-analyses and selected texts involving alternative medical therapies.
A comprehensive toxicology index pertaining to herbs, vitamins and supplements commonly used by the public. This needs to be accessible to the practicing MD, RN, pharmacist, etc.
The equivalent of a MedWatch initiative to provide surveillance of adverse effects pertaining to alternative medical therapies and/or their interaction with conventional treatments (e.g., prescription medications). [Ideal for collaboration involving NIH and CDC.]
A national listing of licensed alternative medical providers (e.g., chiropractors, acupuncturists, massage therapists, naturopaths, and homeopaths) in each of the 50 states as well as a uniform credentialing process.
Clearly defined scope of practice guidelines pertaining to each of the alternative medical licensed professionals based on a review of existing guidelines in all fifty states.
- Malpractice liability concerning referrals by medical doctors or institutions to alternative medical providers.
- Specific referral guidelines unique to each of the alternative medical professions.
- A review of educational requirements of licensed alternative medical providers.
- Suggested educational requirements for allopathic physicians with regards to alternative medical practices.
Heterogeneous reimbursement patterns which now include paid benefits and/or a range of reduced fee-for-service products and alternative medicine "carve-outs."
The need for coordination with the Federation of State Medical Boards and other licensing organizations.
V. Priorities and Mechanisms of Federal Support
Nearly four years ago I participated in a hearing devoted to alternative medicine research funding, overseen by Senator Harkin and members of the Appropriations Subcommittee. We debated the pros and cons of establishing ten federally funded Centers of Excellence devoted to the investigation of alternative medical therapies. These Centers now exist at institutions such as Stanford, Harvard, Columbia, the Universities of Maryland, Texas and California. The majority of these Centers will soon celebrate their second birthday.
These Centers are young and just beginning to demonstrate their potential. There are more than one hundred studies currently underway. Some involve a systematic review of the existing medical literature; some involve surveys, others outcomes research, several randomized controlled trials and a variety of basic science, laboratory investigations. These varied frames of reference are essential and will enable us, over time, to prioritize our national research agenda. Let me re-emphasize that these Centers are barely two years old. Let me also thank Senator Harkin and his colleagues for their leadership which has resulted in this growing body of investigation.
The Office of Alternative Medicine currently has an annual budget of $12 million. Each OAM funded Center currently receives $300,000 to $400,000 per year in direct federal support. Arguably, this has been referred to as a "homeopathic level of funding." Definitive clinical and basic science experiments frequently require several times this amount for a single investigation. In addition, experienced academic personnel are costly as are the sophisticated research teams, laboratory and computer equipment necessary to distinguish useful from useless alternative medical therapies.
The principal criticism leveled at this fledgling field is that there is not enough responsible science to make sense of it. Implicit in this criticism is the fact that there are not enough responsible scientists devoted to this challenge. I fully agree with this criticism. I strongly disagree, however, with the notion that the solution is to shut this research off. On the contrary, it must be expanded, encouraged and receive an even more substantive federal commitment. An enhanced federal commitment involving the NIH and, I suggest, the CDC, AHCPR, FDA, HCFA, and HRSA is necessary to improve and stabilize the science so as to navigate based on evidence, not fadism, anecdote or market appeal.
The harshest critics of the Office of Alternative Medicine hail from the basic science community, especially the physical sciences. These critics remain principally focused on issues of quackery, charlatanism and the myriad unproven theories and clinical claims which are part and parcel of this diverse area. I do not argue one iota with their desire to clean up the quackery, disprove the nonsense, identify those physicians and alternative medical providers who are willfully and callously pedaling worthless nostrums. We must correct these problems, and again, this must be accomplished using our standard rules of scientific evidence. This is quite feasible. Not long ago, Laetrile was the posterchild of the unproven cancer therapy world. State legislatures demanded that Laetrile be made available and paid for. Two randomized controlled trials disproved Laetrile's purported efficacy and today this therapy is rarely used or discussed by our patients.
But this dogged focus on the insatiable desire to debunk useless treatments misses the larger point of this entire line of inquiry. Many of us who dedicate our professional academic careers to a rigorous and fair assessment of alternative medical therapies are not inspired solely by the mechanisms whereby magnets do or do not work nor are we motivated primarily to put charlatans in prison. Our motivation comes from one source, namely, our patients. Their questions are more demanding, more challenging and often more complicated. Debunking the false claims represents the tip of the iceberg.
It is one thing to prove or disprove the worth (or worthlessness) of shark cartilage as a treatment for middle age women with advanced ovarian or breast cancer. It is an altogether different proposition to answer the question: Should a woman with breast or ovarian cancer pursue a particular dietary regimen, exercise program, use of selected vitamins or supplements and/or participate in group psychotherapy in order to sustain a remission and/or improve the quality of her remaining life? Which options, if any, should be recommended in preparation for a bone marrow transplant? And when she or her friend with advanced cancer suffer from pain, nausea or unimaginable fatigue, might she benefit from acupuncture or massage therapy if only to palliate her suffering? What credentials should she seek in choosing the appropriate acupuncturist or licensed massage therapist? Who will or should pay for these services? These are also relevant, testable, scientific research questions but they are more apt to be asked by a clinician or epidemiologist than a physicist. To answer these questions we need more federal resolve not less.
We must also consider how to involve the Agency for Health Care Policy Research (AHCPR) in issues pertaining to cost-effectiveness (or lack thereof), patterns of referral to licensed alternative providers and models of so-called "integrative care." Can improved models of integrative (i.e., conventional and alternative) medical management produce: (a) superior clinical outcomes, (b) improved patient satisfaction, (c) improved quality of life and (d) a reduction in overall resource utilization - i.e., cost? Will employees with back pain return to work any faster if both conventional and alternative therapies are deployed in an integrative fashion? These questions can and should be put to a series of experimental tests in partnership with major HMOs and the Health Care Financing Administration.
We should also do more to engage the Centers for Disease Control and FDA in major efforts to review the safety and efficacy of commonly used dietary supplements, herbs, botanicals and the like. Think for a moment about the millions of Americans who have cancer and who simultaneously take chemotherapy as well as herbs and supplements. It is conceivable that in some instances chemotherapy will interact in an adverse fashion with some herbs, supplements or radical diets. By extension, everyone taking a prescription medication should be able to rely on a medical doctor or pharmacist or nurse specialist to review their risk of experiencing some unintended adverse interaction if they take both a prescription medication and herbs or supplements. There is currently little research in this area. Acquiring this information will require a massive effort which, in my view, is essential to public safety.
Perhaps the single largest impediment to progress in this area is the continued marginalization of our scientific efforts. What do I mean by this? The NIH Alternative Medicine Program Advisory Council has gone through considerable growing pains. It has taken nearly four years to accept that there is no substitute for excellent science and excellent science takes time, money and talent. In order to attract and maintain the kind of world class scientists who must — I repeat must — be the principal investigators or coinvestigators of this research, we must commit sufficient resources from within our most prestigious federal health agencies. Grants must ultimately involve our most trusted and respected research institutions.
What if the current level of federal support for alternative medicine research was raised from $12.5 million per year to $125 million or $200 million per year and included participation from the NIH, the CDC, the Health Care Financing Administration, and AHCPR? What if there were an NIH Center for Alternative Medicine Research instead of an Office of Alternative Medicine? What if this Center had the authority to administer its own grants in addition to a mandate requiring it to develop sustainable partnerships with all existing Centers and NIH Institutes? Two weeks ago the Principal Investigators of all ten federally funded NIH Centers of Alternative Medicine Research, myself included, signed a letter in support of this concept — if only to cut down on the bureaucracy and get the work done.
If this kind of federal support were to materialize and I will defer to you, the administrative organization and mechanism whereby it could evolve — then you would see many more senior academic faculty come forward to be part of this scientific inquiry. Some will be motivated by a desire to discredit aspects of alternative therapy and to demonstrate that certain alternative medical theories or practices are useless or dangerous. Others will be motivated to test and demonstrate the utility of individual therapies and their judicious integration with conventional medical care, especially as applied to patients with common, chronic or life threatening illnesses such as back pain, heart disease, cancer and AIDS. Still others will be interested in the economics and others by mechanisms of action of individual therapies.
My suggestion is that we engage more of the leaders of the scientific community. Let the body of scientific information emerge as it has been known to do once resources have been committed. Moreover, with an increased federal commitment and mandate, junior faculty and those now preparing for a career devoted to clinical and basic science research will come forward and publicly acknowledge this is where they wish to spend their professional energies. Until very recently, this field was associated with a kind of unavoidable "anti-tenure titre." That is to say that academic researchers interested in this line of inquiry have all too often been labeled as blind advocates who are throwing away the promise of a successful career. This kind of marginalization is also an impediment which must be eliminated. It can only be diminished by applying more resources and by engaging our most respected research colleagues, federal agencies and academic institutions.
In short, if the biggest problem we face is a lack of good science then we must, "Get it the old fashioned way. . . we have to pay for it." In the process, I am confident that the next generation of clinician researchers will receive important training, experience and legitimacy, thereby improving on the scientific contributions which will be made during the coming decade.
David Grimes, MD, writing in the Journal of the American Medical Association about the "uncritical acceptance of medical innovation" said, "Doing everything for everyone is neither tenable nor desirable. What is done should, ideally, be inspired by compassion and guided by science, and not merely reflect what the market will bear." As more and more managed care organizations provide alternative medicine benefits, we must have leadership from our federal health agencies to ensure that these services are indeed guided by science and do not merely reflect market opportunities. The NIH, AHCPR, CDC, HCFA, and other federal agencies have the tools to safeguard the public in this area. We in the academic medical community stand ready, willing and able to do more. An enlarged federal commitment for alternative medicine research, implemented through administrative mechanisms which I defer to this Committee, is essential if we are to deliver the information on safety, efficacy, cost effectiveness or lack thereof which the public deserves and demands.
This Committee is to be applauded for its willingness to consider this controversial topic. My thanks, once again, for involving me in your deliberations.
Eisenberg DM, Kessler RC, Foster C, Morlock FE, Calkins DR, Delbanco TL.
Unconventional Medicine in the United States: Prevalence, Costs, and Patterns of Use
New England Journal of Medicine 1993 (Jan 28); 328 (4): 246–252
Copyright © 1997, Beth Israel Deaconess Medical Center
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