WHITE HOUSE COMMISSION
COMPLEMENTARY and ALTERNATIVE MEDICINE POLICY
+ + +
Meeting on Training, Education, Credentialing
and Licensing of CAM Practice
+ + +
+ + +
Thursday, February 22, 2001
Hubert H. Humphrey Building, Room 800
200 Independence Avenue, S.W.
ChairpersonJames S. Gordon, M.D., Director
Commission Members Not Present
William R. Fair, M.D.
Attending Surgeon, Urology (Emeritus)
Memorial Sloan-Kettering Cancer Center
Chairman, Clinical Advisory Board of Health, LLC
Stephen C. Groft, Pharm.D.
Michele M. Chang, C.M.F., M.P.H.
Joseph M. Kaczmarczyk, D.O., M.P.H.
Senior Medical Advisor
Doris A. Kingsbury
Geraldine B. Pollen, M.A.
Senior Program Analyst
P R O C E E D I N G S
DR. GROFT: Good morning, everyone. If you take your seats, we will get started. We're a little bit late. With the threat of the snowstorm coming this afternoon, we want to maintain some degree of sanity here in the Washington area, because if you have been here in the midst of the snowstorm, you know what it's like.
The Commission members are here and they will be sequestered for the next two days, regardless of the outcome of the weather. So we're happy they are here, and it will be a very, very busy meeting.
I am Steve Groft, and I am serving as the Executive Director of the Commission. I will turn it over to Jim Gordon here in just a minute. I would like to thank everyone for coming and listening. For those of you who we have asked to send information, I think our response to your response has been overwhelming. We have been extremely pleased at the thought that has gone into many of the responses that we have heard from the public.
I think you will see later on in the breakout sessions, and we will talk about that a little bit later as well, that it has been tremendous. There has been a lot of thought, and you can see that people have been thinking about some issues for a number of years. I think the Commission now, with us being in operation and getting ready to prepare the report, you are going to see tremendous changes coming within the next two to three years, with more and more emphasis coming on CAM therapies and products. It is a very exciting time.
Just a couple of notes. This will have a little bit of a different format. Until today, the Commission was pretty much in a listening, and in an information-gathering mode. We will continue to do those two functions, but we also want to start to develop recommendations.
I guess I have been hearing that the Commission has already taken a position on certain issues and we're looking at this, we're thinking this. I can assure you, we have really not taken any position and developed any recommendations. This will start today, and at future meetings, you will start to hear more and more things. We really won't come up with definitive recommendations even today or at the March meeting. You will see them as we get ready for the interim report in July.
So please stay with us. We do welcome your input and advice. We read everything that comes in, and so it's quite a bit.
I just wanted to let you know, also, there will be a Town Hall meeting in the Minneapolis-St. Paul area on March 16th. It is going to be at the University of Minnesota. There have been a number of new initiatives there that we want to go out and hear about.
We had a Planning Committee; we had a very successful meeting in Seattle, Washington, that there was a Planning Committee, and it worked out extremely well. I think those of you who traveled with us to New York for the CAM marathon, 12 hours to listen to about 136 speakers, we knew we were in New York, but we didn't know it was that big. So it was a tremendous effort, especially with Jim chairing the entire session; a tremendous turnout and tremendous responses that we heard from people.
If you have not visited our website, please do so. We've made a lot of efforts to get the agendas, the Federal Register announcements, and now the transcripts up from the meeting. By next week, we will have all the transcripts on the Internet and our website from all the meetings, except this one.
It is changing, and the registrations are going through the website. It is more interactive, and it will become even more so in the future as we go along. So please do visit it, and we can cut down some of the costs to the offices, because as soon as have the meeting schedules, they are up there. Please look at it and follow our activities.
One last thing. This afternoon and tomorrow morning, many of you had wanted to provide some comments at the Open Public Session. Because of the time factor, we are only able to devote about an hour and a half tomorrow afternoon, and that only permitted approximately 20 people to make presentations to the Commission. So Dr. Gordon has agreed this afternoon, during the first breakout session, and then again tomorrow morning at the second breakout, Breakout Session No. 2, starting at about 8:15, we will have a small conference room that we will meet with whomever would like to come in and talk with Dr. Gordon, myself and Michele Chang, the executive secretary.
So we want to hear from you, and if you feel that we haven't given at the Open Public Session, we will be available to talk with you at that point in time. I think it is the best we could do in the situation that we are looking at. It is going to be 634-F, and there will be some schedules. There are some schedules in the back of the room.
Also, in the breakout session, I know some of you have certain groups that you would like to hear what they said in their responses to the Commission on the issue that we are discussing today. We have them in the back of the room, so feel free to go to that conference room and area to listen to what is going on.
We are restricting public participation at that point because they are small group discussions, but they need to go through a lot of material and come up with some type of draft recommendations at that point in time, so we ask your cooperation. There will be breaks for you to talk with the Commission members and with the Chair at various points during the next two days.
DR. GORDON: Thank you, Steve.
Good morning, everybody. We are going to sit for a moment in silence and collect ourselves, and be present together in the room. So let's do that.
[Moment of silence observed.]
DR. GORDON: I want to begin now by welcoming our new commissioner. This is his first commission meeting, and that is Dr. Joe Pizzorno, who was president of Bastyr College in Seattle. Although he is retired from that, he has not retired from being the leader in complementary and alternative medicine, and hoping all of us nationally move things ahead.
So, Joe, welcome. Do you want to say a couple of words to everyone?
DR. PIZZORNO: Well actually, I have been following what the Commission has been doing very carefully for the last almost a year, and I want to congratulate you all for the work that you are doing.
I can't tell how delighted I am to be a part of this, and hopefully will work collaboratively with you over the next year to get a report that will change health care. Thank you.
DR. GORDON: Great.
DR. GORDON: Thanks so much, Joe.
Joe Fins should be here later. Bill Fair is not going to be coming today. We also have a new member of the Commission, and I think it is important that he be introduced.
So, Dean, if you would introduce the new member who is here with us.
DR. ORNISH: This is our new member. His name is Lucas Ornish. He is three months and one week old.
DR. ORNISH: Thank you. If I fall asleep during the meeting, it's nothing personal, you understand. I have been up since 3:00 this morning.
DR. GORDON: Thank you. It's great to have Lucas here with us, as well as you.
It's great to be back with all of the Commissioners. One of the things that has been happening that I have been able to observe, and that we have been able to observe here in the office, very clearly, is the evolution of the Commission and the evolution of everyone's engagement of the process.
So I have been struck, both at the last full commission meeting, and also at the meeting in New York, about how well we have been working together and how committed commission members have been in a variety of ways, everything from being extremely disciplined about questions and extremely focused in questioning, to a willingness to participate and participate in helping to plan meetings.
This meeting, as the Commissioners know but perhaps people in the audience don't know, is a different format. It is a format that is specifically designed for this topic of education, professional education, and credentialing. It is one that has engaged every commission member in small group discussion and planning.
As Steve mentioned, there will be small groups, starting this afternoon, which will address all of the issues on the agenda from different professional perspectives. We are very excited about this format, and in order to make it happen, the Commissioners have had to do a great deal of work. You may see on some of the desks, there are two large books of information that people have been pouring over.
Also, the staff has done an extraordinary job in reaching out to about 150 organizations which have submitted. We have gotten an overwhelmingly positive response in terms of a variety of different organizations.
You will see and hear about some of them in the small group meetings, as well in the large group, that have sent us their thoughts, their responses to, I think, very well-crafted questions about what their thoughts are about CAM education from their various perspectives, from perspectives of professionals, conventional professionals, CAM professionals, consumers' groups, licensing boards, et cetera, et cetera, et cetera. So this has been an extraordinary effort, and I am very much looking forward to the day.
As Steve mentioned, there will be a time this afternoon and tomorrow morning for any of you who would like to talk with me, or with Steve, or Michele in Room 634-F. We will be there. We will be very happy to hear from you. We encourage you to go to the small groups. I think I said once before, the operation of the Commission is not only transparent, it's translucent, and we welcome you to see us working together, beginning to craft some of the recommendations.
One of the things I want to echo that Steve said that I think is important, and emphasize, is, there will be many recommendations. This is for Commissioners as well. We want you to make many recommendations from your small group meetings, and we are going to put them all up. We are not going to decide today, and I will probably say this this afternoon, which ones, or the wording. What we want to do is get the best thoughts of the small groups, and then we will put them together.
So without further ado, let's begin with the first panel.
MS. CHANG: Would the following speakers please come up to the tables: Dr. Louis Orzack; Jennifer Engstrom; Deborah Danoff; Peter Scoles.
If you have your name plates in your packages, if you could put them up in front of you so the Commissioners know who is speaking. Thank you.
Plenary Session I: CAM Education and Training
DR. GORDON: Good morning, and thank you all for coming. We will begin with Dr. Louis Orzack.
DR. ORZACK: My name is Louis Orzack. I am a professor at Rutgers University. The last 25 or 30 years, I have been doing academic research on the development of professions, both in the United States and in Europe.
Thank you very much for your invitation. The challenge you face and I face is enormous. I want to make several points concerning elements of profession, what they are. I then plan to summarize how changes in and of these professions and their services occur and do not occur. Then, to make this clear, I will discuss how complementary and alternative medicine can influence medical practice and medical education.
I will use a couple of examples of significant change in two non-CAM fields. One was far outside the mainstream of health care, the second has recently a dramatic change in educational standards for entry to practice.
Finally, I will offer some suggestions for the Commissioners to consider in order that they can meet their responsibilities. These will focus on the process of educational change for CAMs.
In my written document I present a roster of elements that characterize professions. This is not just an academic exercise. It is what we all mean when we refer to the term "profession." I cannot define them or elaborate them in the limited time I have, but I want to point out some truisms. The first, is that professions are complex. The second, is that change in any one or more of the elements is likely to touch off changes elsewhere in the system. Whether we want to discuss established professions or emerging professions, all of these elements must be affected.
All professions comprise a complex of those features. The infusions of resources that sustain, allow expansion, or curtail the experience of professions come from exchanges with the larger society. Professions flourish or disappear, depending on the stability, the increases or the decreases of those infusions. Compare health care in the modernized world with that in regions where doctors without frontiers choose to work.
I use that scheme in research about professions and professional services in order to take a look at them in a large framework. Let me briefly enumerate what they are without defining them. I just don't have time to do that.
First, cultural and ideological mandates; second, the services and the responsibilities they offer that are accepted in different ways in society, the scopes of practice, the scopes of service, the scopes of responsibilities. There are differences. Third, public expectations in consumer issues; (4) practice standards; (5) educational systems; (6) legitimacy and legal standing; (7) regulatory systems, including licensing; (8) qualification mechanisms; (9) associations and peer interactions which provide benefits, and also impose controls; (10) association and government exchanges; (11) ethics, discipline and sanctions; (12) scientific research and technological applications; (13) boundary interactions among specialties; (14) practice patterns, such as whether people function in an independent way or in organizational settings, or both; (15) income sources, whether fees, salaries, or third party; (16) socialization and recruitment; and finally, (17) the careers, the trajectories of careers.
All of us must continue to be aware of the complexities of professions. Emerging now or previously emerged. This provides a basis for understanding professions, a reference guide. None of the entire series of elements exists by itself. They are interrelated. Professions comprise all of these, and these elements are intertwined and interconnected.
How do they change? Well, let me give you some examples. I will provide some examples, certainly not an exhaustive list, of external sources of change. Certainly, if public confidence of health services, or in the services of particular kinds of practitioners, deteriorates, a profound crisis may occur. Internal sources of change may induce dramatic shifts in the stability of elements of professions. Changes in public perceptions of provision of health care, the quality of health care, provided by medical practitioners, may, over time, take several forms.
Medical education's adaptation to these changes may be hastened through several avenues, among which I identify a few: (1) when entering medical students introduce messages calling for a change; (2) patient's and consumer's orientations to CAM practitioners and reliance on CAM-initiated or CAM-informed sources of information; (3) insurance carriers, state workmen's compensation systems, Medicare and Medicaid programs, and regulatory and licensing boards develop more accepting approaches to CAM services.
Changes in compensation levels, restrictions on practitioners choices, pushing our medications upon physicians by pharmaceutical reps are illustrations, possibly, of counter trends.
Ethical shortfalls or provision of services sought by patients may in fact open up opportunities for change in practitioner-patient relations. When we hear of examples of abuse, mistakes, exploitation, boundary-crossing, or neglect, the reaction to that may allow for opportunities for alteration of practices.
Determination of the validity of CAM contributions and interventions is an essential key, it seems to me, of their acceptance within health services by medicine, their incorporation within medical practice, and their inclusion within education, both in medical disciplines and in continuing education programs for those already in practice.
Practitioners in complementary and alternative medicine can increasingly become primary providers within health care services, provided that medical practitioners gain an improved knowledge of the competencies of CAM providers and reciprocally refer patients.
To illustrate some of the drastic-change opportunities that have occurred, changes that have occurred, in two health-service providing professions, I want to use as examples, as I mentioned, two non-CAM fields. They are optometry and audiology.
About 1900, optometry boasted that it was a drugless profession. In all states, optometrists are now legally able to use topical anesthetics and therapeutic agents, employ complex instrumentation in examining eyes, and provide a significant range of vision-care services. The formal education base of schools and colleges provide the O.D. degree, the Doctor of Optometry degree. Accreditation of the schools and colleges requires adherence to develop standards. A national examination tests graduates, while licensing boards in every state relies on its use. Further clinical residency slots in health care settings have been established for optometrists. Reciprocal referral exchanges with public health practitioners, internists, pediatricians, and other primary care providers are increasingly common. Although, I understand not so with ophthalmologists. This is still not common with that field.
As a leader in that field put it recently, "The scope-of-practice responsibility advanced when leaders in education and in associations in the field chose to move ahead." "The result claimed," he stated, "is that the practicing O.D. has become part of the mainstream of health care activities."
Audiology is the second field I am using as an example. It's on the verge of major change. Last year, an out-of-court settlement in a U.S. Federal Court provided for a landmark shift in educational practice.
DR. GORDON: Dr. Orzack, I'm sorry. We are going to have to ask you to conclude in a few seconds.
DR. ORZACK: Let me do so by making some suggestions. Change can occur, and it must be pursued as a vital objective.
CAMs can move in educational change processes based on these kinds of occurrences. They can and should place greater emphasis on educational standards located in diverse regions and states. They should strive to advance common educational standards. They should strengthen efforts to encourage consumers of its services to seek opportunities to support inclusion in health services.
They should move toward still greater public support by encouraging and generating greater public attention at CAM interventions in media and community events. They should seek greater participation in health service programs and facilities jointly with medical practitioners, and they should participate and support validation projects in collaboration with health care researchers on a multi-professional basis.
These are initial suggestions for change. Other avenues for change undoubtedly will occur to you and should be actively pursued on a broad-based, multi-faceted approach. Thank you very much.
DR. GORDON: Thank you. What we have done here is we have given 10 minutes to the speakers, and it is really important that we conclude on time because we have a very tight schedule.
On the other hand, we have an ample amount of time, or a reasonable amount of time if not ample, a reasonable amount of time for questions. So we will be coming back to all of you for questions.
The next speaker will be Jennifer Engstrom.
MS. ENGSTROM: Good morning, everyone. I am a third year medical student at Case Western Reserve University School of Medicine. I have been involved in efforts to facilitate the integration of CAM education into traditional education, both at my own school and through the American Medical Student Association.
I want to thank you very much for your invitation. I am here to convey to you the medical students' perspective on CAM education.
As we all know, medicine today is experiencing a paradigm shift in what is perceived as fundamental to the nature and delivery of health care. Specifically, this involves a blending of two philosophies: biomedicine and holistic medicine.
An increasingly knowledgeable patient population is now seeking alternatives to conventional medical therapies. Patients choose to use CAM because they find it provides relief from symptoms, promotes healing, and empowers them to take an active role in their own health care.
Recent trends indicate that over 42 percent of the general population use some form of CAM. Consequently, there is an overwhelming trend toward reforming health care education, research and delivery to better serve the needs of society. Furthermore, the AMA regards competency in CAM as relevant to and representative of cultural competence in health care delivery.
Medical students have expressed tremendous support for the inclusion of CAM within traditional core curricula. According to the 1999 AAMC Medical School Graduation Questionnaire, 63 percent of medical students rated their education in alternative medicine to be inadequate. Interestingly, this number has only improved by 3 percent since '98, despite the doubling of CAM elective courses offered at medical schools over the past two years, from 34 schools in '96 to 75 in '98. Evidently, CAM elective courses alone are not adequately preparing future physicians to meet the needs of their patients.
A recent report by the AAMC on the Medical School Objectives Project calls for physicians to be sufficiently knowledgeable about both conventional and non-conventional forms of care. In order to accomplish this goal, medical education must begin to reflect a more integrative type of medical practice. Presenting information within the core curriculum does not constitute blind advocacy, but instead, prepares future physicians to critically evaluate the research literature and advise their patients accordingly.
Currently, less than 30 percent of patients who use CAM disclose this information to their physicians. It is important to note that patients properly counseled by a physician knowledgeable about CAM are more likely to reject modalities found to be unsafe or ineffective than patients who do not receive such counsel due to lack of physician education.
Education about CAM serves four major purposes: (1) to increase the cultural competency with respect to patient belief systems and cultural values; (2) to prevent contraindicated or deleterious care; (3) to potentially improve the results of medical care beyond what might be achieved using either conventional or alternative medicine alone; and (4) to explore the potential cost effective alternatives to expensive medical technology, particularly when 70 percent of the health care budget is spent on chronic, debilitating illnesses, such as cardiovascular disease and chronic pain, both of which are particularly amenable to complementary therapies.
Incorporation of CAM within traditional medical education should involve cohesive integration across all subject areas. Limitations in time and resources are a reality at all medical institutions, and necessitate that integration by without tremendous increase in the volume of information to be presented so as not to detract from other core subject matter. Instead, medical students should be introduced to CAM as representing a wealth of potentially valuable health care models needing further investigation.
The following list outlines the main objectives which would be considered representative of a comprehensive CAM curriculum. These general guidelines represent the interests of U.S. medical students, the NIH First National Conference on Medical and Nursing Education in CAM Therapies, the Society for Teachers of Family Medicine, the AAMC, and the Uniformed Services University of Health Sciences: (1) to define CAM and the modalities encompassed by this definition; (2) to facilitate and encourage medical students to reflect upon the issue raised by the growth and practice of CAM in scientific, clinical, and social contexts; (3) to introduce medical students to the historical development, philosophy and cultural origins of CAM modalities; (4) to provide students the opportunity to observe CAM practice so that they may formulate their own opinions about CAM; (5) to give students the opportunity to look at specific CAM therapies in more depth; (6) to consider the evidence base for CAM regarding safety, efficacy, and cost effectiveness; (7) to discuss the relevance of CAM in specific clinical situations, and this would include on indications, contraindications, frequency and duration of treatment, and costs; (8) to provide students with guidelines for appropriate referral to CAM providers; (9) to prepare medical students for practicing medicine within the context of the multidisciplinary, integrative health care team; (10) to give students the training regarding medical, legal and ethical aspects, including licensing, referral and liability issues; (11) to provide students with opportunities to learn how to talk to patients regarding their health care believe system, which may include the use of CAM; and (12) to allow students to personally experience the underlying concepts of mind-body medicine from which many CAM modalities derive.
Medical students not only want access to CAM, they want to see CAM cohesively integrated into the classroom and clinical training. It is important to note that this does not imply that an exhaustive CAM curriculum be implemented overnight. Ideally, CAM education would be best integrated in two major ways: during the first year of medical school, it would be most appropriate to offer a general survey course to introduce students to the various modalities and provide an overview of the seven major CAM categories defined by the NIH.
Second, relevant CAM topics should be integrated into traditional medical courses. Pharmacology should include evidence-based information on herbals and nutritional supplements, including potential benefits, side effects and contraindications. Ideas on energy-based medicine, including acupuncture and qigong, should be discussed within the context of neurology.
Case Western Reserve School of Medicine is one of a handful of medical schools which represents a potential model for comprehensive CAM education. Over 15 CAM electives are offered to first- and second-year students, including mind-body medicine, manual healing, and spirituality and healing. Lectures on acupuncture and psychoneuroimmunology are directly integrated into the core curriculum.
During their fourth year, students can also complete a clinical CAM elective in which they spend a month with various CAM providers. CWRU provides an area of concentration credit in CAM for students who complete a minimum of the aforementioned credits. Furthermore, 10 hours of CAM education is included in the Family Medicine Residency Program at university hospitals of Cleveland.
Future physicians need to become conversant in complementary and alternative medicine so that they are more adequately prepared to meet the needs of their patients. Comprehensive CAM curriculum will not only serve to prevent deleterious care, but more importantly, it will facilitate the advancement of a new integrated paradigm for health care delivery, one which represents the best that both conventional and alternative medicine has to offer. After all, science is interested in increasing the accuracy of knowledge, not in the finality of opinion.
DR. GORDON: Thank you.
The next speaker will be Dr. Deborah Danoff.
DR. DANOFF: Good morning. Thank you very much for inviting me to be here. I am Deborah Danoff. I am a physician and assistant vice president in the Division of Medical Education at the Association of American Medical Colleges, and I appreciate the opportunity to speak to you on behalf of the Association of the American Medical Colleges.
The AAMC is a nonprofit association founded in 1876 to work for reform in medical education. The association comprises the 125 accredited U.S. medical schools, the 16 accredited Canadian medical schools, over 400 major teaching hospitals and health systems, 90 academic and professional societies, representing nearly 100,000 faculty members, and the nation's medical students and residents.
The AAMC has as its purpose the improvement of the nation's health through the advancement of medical schools and teaching hospitals. As an association of medical schools, teaching hospitals, and academic societies, the AAMC works with its members to set a national agenda for medical education, biomedical research, and health care, and assists its members by providing services at the national level that facilitate the accomplishment of their missions.
In pursuing its purpose, the Association works to strengthen the quality of medical education and training, to enhance for biomedical knowledge, to advance research in health sciences, and to integrate education into the provision of effective health care. Today, the Association carries out a broad range of programs and studies to represent its constituents.
The AAMC recognizes the importance of an evolving curriculum in medical education to meet the needs of our patient population. The AAMC strategic plan, "Taking Charge of the Future," stated: "The AAMC should stimulate change in medical education to create a better alignment of educational content and goals with evolving societal needs, practice patterns and scientific developments."
We know that complementary and alternative medicine, hereafter referred to as CAM, has a significant presence in the United States. The AAMC has undertaken a number of major initiatives to assist our institutions in their review and revision of curriculum for medical students and residents. Some of this information has already been very ably presented by the previous speaker.
The Medical School Objectives Project, called M.S.O.P. or MSOP, was established in 1996 and has issued three major reports with an additional three reports due this year. Expert panels in consultation with major stakeholders developed these reports that focus on the education of medical students. In 1999, we also established a committee to develop a Graduate Medical Education Core Curriculum. We have also focused specifically on CAM with the establishment in 1998 of a special interest group on CAM.
The following information provides some of the highlights of the reports I have just mentioned: The MSOP addresses directly the expectations for graduating medical students and makes concrete recommendations for educational objectives to assure that our graduates will be able to meet the needs and expectations of the 21st century. MSOP I, entitled "Learning Objectives for Medical Student Education: Guidelines for Medical School" sets forth 30 program-level learning objectives that represented a consensus within the medical education community on the knowledge, skills and attitudes that students should possess prior to graduation from medical school. It focuses on the attributes of physicians who are defined as being altruistic, knowledgeable, skillful, and dutiful.
Particularly relevant to your commission are the following specific recommendations that medical schools must ensure that before graduating, a student will have demonstrated the following: knowledge of the important non-biological determinants of poor health, and of the economic, psychological, social and cultural factors that contribute to the development and/or continuation of maladies; knowledge of the epidemiology of common maladies within a defined population and the systemic approaches useful in reducing the incidence and prevalence of those maladies; an understanding of the power of the scientific method in establishing the causation of disease, and the efficacy of traditional and non-traditional therapies; knowledge about relieving pain and ameliorating the suffering of patients; the ability to communicate effectively with patients, patients' families, colleagues and others with whom physicians must exchange information in carrying out their responsibilities.
MSOP II, "Contemporary Issues in Medicine: Medical Informatics in Population Health" identifies specific educational elements for educating medical students to have a population health perspective. This perspective encompasses the ability to assess the medical needs of a specific population, implement and evaluate interventions to improve the health of that population and provide care for individual patients in the context of the culture, health status, and health needs of the population.
MSOP III, "Communication in Medicine" focuses on the critically important issue of patient-physician communication. The report reviews general recommendations for teaching and evaluating communication skills. In addition, because cross-cultural sensitivity and awareness is so critical to developing an effective doctor-patient relationship, this report specifically addresses this area, as well as that of spirituality in medicine and end-of-life care.
The Graduate Medical Education Core Curriculum Report identifies five domains of knowledge and provides examples of measurable educational objectives. This work closely parallels and complements the work of the Accreditation Council for Graduate Medical Education. The five domains defined in GME are biomedical ethics, scholarly medical practice, communication in medicine, medical professionalism, and the health care system.
Again, the following elements are of particular interest to the Commission: knowledge of differing ethno-cultural viewpoints and religious beliefs; the ability to provide their patients clear information about treatment programs and options, health maintenance and illness prevention; the ability to serve as the patient's advocate; knowledge of the health care needs of the community; knowledge of community health care organizations and resources; knowledge of the principles of population-based medicine; the ability to work with social service and public health agencies, religious institutions, police and other community as appropriate in assisting their patients.
Following on the publication of these reports, the AAMC and its member institutions will be developing educational and evaluation programs to support these objectives. I hope that this very brief overview of some of the educational initiatives of the AAMC will be helpful to you. I have provided you with some information about the MSOP III Report, and will be glad to provide additional details if that would be helpful.
The increased attention paid to CAM in our medical schools mirrors the trend amongst American health care providers and consumers. All of our medical schools provide education about mind-body interaction through our focus on the bio-psychosocial model of disease. We also provide specific instruction on the pathophysiology of disease, as well as attention to disease prevention and health promotion.
In addition to these general educational experiences, a significant number of schools provide teaching about CAM. Data from the 1998-99 Liaison Committee on Medical Education, LCME, school report indicates that more than 75 of the 125 schools provide this education. Seventy-four schools provide this as part of a required curriculum. Sixty-three schools provide it as part of an elective program.
A sampling of offerings in 2001 include: Overview of CAM; Human Values in Medicine; Prevention of Injury from Herbal Medications; A Scientific Look at Alternative Medicine, Patient-Centered Care. Schools are developing both required and elective programs that focus on a wide range of topics.
Information on teaching in the more than 7,000 graduate medical education programs is not as well defined. We know that particularly those programs in primary care are incorporating this teaching into their residency education programs. It should be noted that the ACGME recently established core curriculum requirements that emphasize the need to deal with diverse patient populations.
The AAMC recognizes the importance of exposing medical students and residents to education about CAM. Physicians need to be well informed about the conceptual basis, efficacy and safety of alternative therapies. They must be aware of the potential value, as well as the complications of CAM therapies, and of the potential drug interactions that can occur between herbal preparations and standard pharmaceuticals.
They need to be able to obtain accurate information from patients about their use of these therapies. In addition, physicians must be able to assist their patients to make informed choices in health care, and thus to be able to discuss CAM in this context.
The foundation of this education should occur in medical school, with further development as appropriate in residency training. We also support the need for scientifically rigorous, high-quality research on alternative modalities to provide a basis for evaluating their safety and appropriate use.
The AAMC and its member institutions are committed to improving the health of the public. We belief that the focus should be on evidence-based medicine, regardless of origin, conventionality or approach.
I hope the information that I have provided today will be of assistance in your deliberation, and I look forward to responding to your questions.
DR. GORDON: Thank you very much, Dr. Danoff.
There are additional questions that Dr. Danoff and Dr. Jordan Cohen, President of the AAMC, responded to. I refer commission members to those answers, which I think are very helpful.
Dr. Peter Scoles.
DR. SCOLES: Thank you. I am Pete Scoles. I direct examination programs at the National Board of Medical Examiners.
Jennifer, let me apologize for causing you so many sleepless nights this spring.
DR. SCOLES: Now, I am an orthopedic surgeon. I am happy to be addressing alternative medicine today, and not alternative surgery. Let me start with a few words of background about the National Board and the U.S. Medical Licensing Examination.
The National Board of Medical Examiners, located in Philadelphia, is a nonprofit organization founded in 1915. Our mission is the production and delivery of valid and highly reliable examinations for the health care professions.
In addition to the USMLE, the National Board provides examinations for professional organizations and specialty boards that certify physician specialists, physicians' assistants, physical therapists, and in fact veterinary physicians.
The USMLE is the largest examination program operated by the National Board. The USMLE is jointly owned by the Federation of State Medical Boards and the National Board of Medical Examiners. I belief that Dr. James Winn, Executive Vice President for the Federation, will be speaking with us this afternoon.
The purpose of the USMLE is to assess the physician's ability to integrate basic science and clinical medicine to provide safe and effective patient care. The USMLE is the only pathway to licensure for physicians who are graduates of accredited medical schools in the United States and Canada. All graduates of international medical schools seeking licensure in the United States must also pass the USMLE. Finally, a growing number of osteopathic medicine also take the USMLE.
The NBME provides content outlines for each step of the USMLE, but it does not provide detailed information on content distribution. Further information on the examination is available on the CDs that I have provided to the ladies at the front desk. There are sample examinations for Step 1, 2, and 3 there for you. We will not score those.
USMLE has a very powerful effect on undergraduate and graduate medical curriculum design. Although it's not the purpose of the examination to drive course content, medical school faculties predictably pay very close attention to content areas covered by the examination. Student study materials they belief will be included in the USMLE. Many students enrolled in the review courses offered by test preparation companies, not surprisingly, those companies base their courses on their best guess of USMLE content.
The examination certainly has a secondary effect on the practice of medicine. Doctors practice what they have been taught. It is essential that the National Board avoid the perception of unproven, ineffective, or unethical methods of treatment.
State medical boards rely on USMLE to certify that a physician will provide scientifically based and ethical care. They must be assured that the materials contained in the examination are based on sound principles and scientific reasoning. If items regarding alternative therapies are included on USMLE, they must be held to the same standard of evidence as traditional therapies.
Let me turn now to the current status of CAM on the USMLE. As you have heard, the AAMC Report on Medical School Objectives emphasizes that physicians should be sufficiently about traditional and non-traditional modes of care to provide intelligent guidance to the patients.
Staff at the National Board and members of the governing committees for the examination concur with AAMC conclusions and recommendations. The governing committees of USMLE reviewed covered of CAM last summer with the assistant of Dr. Wayne Jonas, a member of this panel. I must tell you that the depth of CAM item pools in USMLE is not great.
Based on this review, USMLE governance has made initial recommendations for further development of content areas. Pathophysiologic processes, principles of pharmacology, evaluation of the effects of therapy, and patient communication skills, all fall within current content and task outlines at the USMLE.
General areas in which CAM could be included in the examination include: (1) evaluation of communication skills; (2) the side effects and adverse drug interactions associated with herbal and alternative medications; and (3) critical evaluation of medical literature related to CAM.
Our Step Committees have made specific recommendations to NBME staff. The Step 1 examination is concerned with, basic science is fundamental to the practice of medicine. CAM coverage in Step 1 currently includes a very small number of items related to pharmacology.
The Step 1 exam pool could be expanded to include questions on alternative therapies for which mechanisms of actions have been established. In addition, the exam could include questions about adverse drug side effects and the interactions of medications with other pharmaceutical agents. On the other hand, areas in which evidence for efficacy was based on less than rigorous research should be avoided until further studies are complete.
The Step 2 examination assesses the ability of a physician in training to practice in a supervised environment. There are currently a limited number of CAM-related items in the Step 2 exam pool. The Step 2 content outline could incorporate additional CAM items.
Since students who take the Step 2 examination encounter patients in out-patient clinics, hospital settings, and emergency departments, communication skills are essential. Questions which probe side effects from self-prescription, drug interactions, interpretation of medical literature, and the reaction of physicians to patients who use CAM are all relevant.
The Step 3 examination assesses competency to provide unsupervised general medical care. The Step 3 Committee believes that it is essential to emphasize the scientific basis for practice and to avoid the perception of endorsement of unproven methods. The Step 3 Committee recognized the need to respond to new content areas to patient-driven concerns. They identified five areas where CAM therapies could be included. These were: history-taking; communication skills; medical effectiveness of alternative therapies; side effects; and drug interactions.
In conclusion, it appears that given the frequency of the use of CAM and the potential for severe drug interactions and side effects, it appears reasonable to include items related to CAM on USMLE. We could take two approaches to this. We could employ our current protocols to appoint basic scientists and academic physicians with interests and expertise in CAM to our test material development groups. This vacancy is open over the course of the next four years. This is how we usually incorporate new areas.
They would be allowed approximately four years before items that were developed appeared as live test questions on USMLE. Alternatively, we could assemble a special task force to rapidly develop CAM materials for all three steps of the examination. A CAM task force that met for three years could be expected to add 600 to 900 items to our examination pools, with the first live items becoming available in a year and a half to two years.
The three-year cost estimate for this would be approximately $200,000. The cost of such an effort must be weighed against competing pressures to broaden coverage in areas such as end-of-life care, pain management, and domestic violence. Foundation funding can assist in deepening item pools quickly, but I must point out that it never influences examination blueprints.
Thank you for the opportunity to review this with you. I would be happy to answer further questions about USMLE in the question-and-answer session.
DR. GORDON: Thank you very much.
We now have a chance for questions. Wayne, do you want to begin?
DR. JONAS: So many wonderful presentations. I want to thank Dr. Scoles. I was at that meeting, and I was very impressed by the interest of all the groups and their active involvement and depth of knowledge in these areas, actually. The proactive steps that you are taking, I think, will have a major impact on what goes into the curriculum and what goes on the tests, and I will never curse a question again that I see on some of those -- well, maybe never.
DR. JONAS: Maybe never. I guess, the key issues that kind of cut across a lot of these areas in my mind have to do with skills training. I think it is pretty clear that information, communication skills, cultural competency, and a number of items that are already part of what we would like to see physicians, and any health care practitioner, be part of or have skills of, need to also address areas of CAM.
But then when we get to the area of provision of care: Should I prescribe an herb; should I deliver acupuncture; et cetera, et cetera, it becomes a little bit more problematic. For example, P-6 acupuncture for nausea and vomiting has been shown to be safe and effective.
How can we make these available? That is a skill-based type of thing. How does that come into medical education, would be my question. I think that is the most difficult area that we would need to examine.
That would be my first question. Then I had one specific question for Dr. Orzack. I am wondering if anyone would like to comment on how that comes about, or if there are ways in which your organizations and activities can incorporate a skills-based training provision of care, rather than simply knowledge.
DR. DANOFF: I will make a stab at answering that. I think that one must recognize that medical education occurs over a continuum, and that in becoming a skilled practitioner, we are talking about an extended process.
In undergraduate medical education, the focus is clearly on teaching people about things, as opposed to the specific skills of doing things, other than very core diagnostic and therapeutic activities. We constantly wrestle with the fact that therapeutic activities are very appealing, and in many cases we try to point out to students at the undergraduate level that the focus needs to be on understanding what the underlying principles are and some of the other aspects of medical education.
I would therefore say that the specific example which you have given would be something that I would anticipate would be appropriate at the post-graduate level, the residency or fellowship level, directly related to the modalities where it would be used.
So, for example, if you are talking about a modality that would influence pain management, then I would anticipate that that would be taught in residency programs where that skill was taught along with other skills, like brachial block or any other techniques that might be used for pain control.
DR. JONAS: I think it would be very useful to see some of that spelled out in a little bit more detail in some of these areas. To elaborate on the skills development, I think, would be very useful to clarify those things. I continually think that evidence-based approaches and clarifying what we mean by that, and making that the lead area, as you have done with GME, and a number of people have mentioned today, is the key approach to really covering many of these areas. So I just want to emphasize that.
Ms. Engstrom, would you like to see some kind of specialty training, post-graduate training, residency training, for example, in some of these areas? Would that be something that you think that would be of value?
I know there are some programs that are trying to be developed along those lines.
MS. ENGSTROM: Right. There is a fellowship for integrative medicine. I think that is a appropriate and useful for physicians who come out of primary care residency programs who want to gather some more experience in practicing integrative medicine, whether they practice each individual therapy that they learn in that fellowship or not, or whether they just learn the appropriateness of a referral to different CAM providers.
I think that at this point it would be beneficial to include CAM skills and further training in residency programs. I think that in the future there will be a residency program geared more toward integrative medicine, and not as a separate fellowship. I don't see that happening in the near future, but I do think that things will go that way.
As far as right now, I believe that the most appropriate way to deal with this is to provide more education and skills training at the residency level, and make it part of the core curriculum in the residency programs, and also have elective time for residents who want to learn about particular modalities, so that they can spend a month, two months, learning about acupuncture or herbal therapies, and also learning about the programs that are available, such as the Helms course, that they can take to get further education on specific modalities.
DR. GORDON: Dr. Orzack?
DR. ORZACK: I don't know if this is working, but I will speak rather loudly. The approach that I would urge on you is to view this not only in terms of skills, but also in terms of responsibilities. The responsibilities, aside from medical students, medical residents and so on, they also have to do with medical practitioners who are out there.
I will throw a question at you. What can be done for continuing medical education for the, I don't know, what is it, a couple of hundred-thousand medical doctors who have already been educated, most of whom, I guess, have gone through residencies already? They are beyond that point.
What would be the role of the licensing boards, the regulatory agencies? Will they be expected to require CE work, continuing education work, in CAM by medical practitioners who are already out there?
I don't know the answer to that. I suggest that you might want to deal with that.
DR. GORDON: Thank you.
DR. JONAS: I just wanted to ask Dr. Orzack one question.
Actually, you have partly addressed it already. The vast amount of knowledge and information that is behind what you presented, I am almost embarrassed to even ask a question in these areas, but my summary of this, as you have implicated right now, is that the process by which professions emerge and become established is largely, number one, getting their act together about accountability and responsibility, as you have mentioned, and then a maneuvering around to establish themselves in that area, and then a gradual process, a very complex process, of public acceptance.
Is that a reasonable, simplistic summary of what you were saying?
DR. ORZACK: It is a reasonable, simplistic summary, of course. One of the matters that you must add to that, or must keep in mind, is the matter of time frame and method. While it hasn't been mentioned here, and I don't know whether I had an opportunity in my remarks to deal with it, but it is in my written text, I am not holding this out as a prototype, the desirable way to go, but in that field of audiology that I mentioned, they went to court, and now there is a legitimation been given to a doctor of audiology degree, which will complement the master's level accreditation.
That court settlement occurred last year, and a number of universities are lickety-split setting up AUD programs. Sooner or later, very shortly, I think, you will see, probably, pressure on the state legislatures and the licensing boards and so on to change their licensing procedures and the administrative procedures to allow doctors of audiology with that degree to practice. There are a lot of ways of doing this. Time frame is one of them.
If I may take one more second, I think it is a matter of responsibility. What will be the responsibilities of the health care providers, medical doctors and others, 10 years from now? I think that could well be a starting point for your work.
DR. GORDON: Thank you. I am going to ask one question, and then Tieraona and Dean.
The question I have is for Dr. Danoff and Dr. Scoles, in particular. The way the reference to mind-body medicine, for example, is presented is as an academic subject that one could learn regarding the research evidence and the physiologic connections.
One of the things that I found in teaching in medical schools for many years is that students very much appreciate the experience of the mind-body connection through relaxation techniques or biofeedback or imagery.
I am wondering if either of you has given thought to seeing that as an area to encourage for medical students' self-care and self-knowledge, as well as for teaching to patients.
DR. DANOFF: I think the issue of the bio-psychosocial model of disease and the issue of mind-body interaction is one that is being increasingly addressed in the medical curriculum.
One of the other elements is the issue of self-care and wellness for practitioners. I think that in that realm there is already a fair amount of discussion about the need to teach behavioral modification activities that may be of benefit to individuals.
DR. GORDON: Great. Thank you.
DR. SCOLES: I think there is something paradoxical about speaking about relaxation techniques and examinations in the same breath.
DR. GORDON: I always thought they went together.
DR. SCOLES: For the successful students, I am certain they do.
The National Board is studying incorporation of a standardized patient examination, a test of clinical skills, in the USMLE: should we integrate and deploy that examination as part of the USMLE sequence. That 10-case interview examination should give us the opportunity to explore lots of these kinds of areas.
It is not live yet. It will be several years before it goes live if it proves to be practical, but that is a vehicle to do this.
DR. GORDON: Great. Thank you.
DR. LOW DOG: I think this is for Dr. Scoles or Dr. Danoff, either one. I am just curious, when we talk about evidence-based, there actually is more evidence then I think we are willing to contend, and actually some of it quite good; a lot of it, not.
My question is, for instance, saw palmetto. We had meta-analysis in JAMA. The USP came out with a favorable monograph on saw palmetto once. We reviewed the evidence, including a panel of experts of urologists. Glucosamine, we have had a meta-analysis. "Lancet" just now came out with a, really, pretty well done study, looking at, this actually may be a disease-modifying agent in osteoarthritis.
So when we have the evidence, it does appear that if it is not from a pharmaceutical company or it is not being driven through the channels that we normally go through, that on some level there is a considerable log time to introducing that into curriculums or testing.
I am curious how we are going to get past that. When there is evidence available, it seems if it has less side effects, it is less costly, why we are not introducing those to formularies, why medical students aren't learning about it in medical school when we learn about all the rest of the drugs that we are learning about. It seems almost as if there is a two-tiered system, and I just wondered if anybody could comment on that.
DR. SCOLES: Well, I think in terms of licensing examinations, there is a built in lag time, an unavoidable delay, between concept and implementation of an item that is scored on an examination. The psychometric characteristics of examination-building almost mandates a four-year delay period before an examination item can actually be counted against the score of an examination. It is the nature of the beast.
There are growing bodies of evidence, reliable evidence in some of these areas, and those increase, they will be incorporated in examinations, but I think we will have an unavoidable delay in inclusion of examination items.
DR. LOW DOG: Will those be treated as CAM? I guess I am always confused. Is a rheumatologist who prescribes glucosamine a CAM provider? Or is he just somebody that is a good doctor, who has read the evidence in peer-reviewed medical journals who is using the best medical care for that individual patient? Do you have to have a CAM group come together that are specialists in these fields to be able to integrate some of these things into the testing?
DR. SCOLES: No, I don't think so. Many of these areas are currently covered in our content blueprints and our examination outlines. The model that we build the examination around, the fundamental architecture, is the 100 or so most common reasons that individuals come to physicians for in the United States, modified by expert judgement for high-impact but low-frequency occurrences, and adjusted for basic science in preclinical curriculum. Most of the therapies that you speak of fall under that umbrella and can be included in that umbrella.
DR. GORDON: Dean, and then Charlotte, and then Joe.
DR. ORNISH: Well, I also want to thank the people who made presentations, and [say] how much I enjoyed hearing them. I have just two brief questions. The first, for Dr. Orzack.
Part of the function of professions is to create standards and accountability, as Dr. Jonas mentioned also, but also part of it is to create exclusion, either by legislation or by jargon and so on. You gave two examples of the audiologist versus the NT, the optometrist versus ophthalmologist, and the growing tendency of legislation that allows them to function more or less autonomously.
One of the recurrent themes that we hear in the various testimony before us is, should CAM be done through a primary care physician that then brings in other acupuncturists and massage therapists, et cetera, or should people be able to get reimbursed autonomously of a physician.
I am wondering, can we learn anything from the experience that you described with the audiologist and the optometrist, by analogy?
DR. ORZACK: Do I have to answer that question?
DR. ORZACK: I really would have to think about it and take another look at a lot of material I have, because I have written in both those areas. I am not really sure how to deal with that. I think you may have to, again, think in terms of a long time frame with incremental changes.
I don't know if that is totally unsatisfactory. I mean, I ought to be able to whip out an answer, but I am not sure I can.
DR. ORNISH: Well, we can talk later.
DR. ORZACK: I would like to.
DR. ORNISH: For Dr. Scoles, a quick question. You outlined two methods here, two approaches, one of a four-year lag time of basically using the conventional methods that you do now but, just, including broadening the scope of it, and the other would be calling a special commission together.
The first question is, why does it take four years? Is that something unique to CAM, or does it always take four years for any board question? And if so, why such a long time?
Second, is, of the two approaches that you outlined, which do you prefer and why?
DR. SCOLES: Well, it takes four years for an item to become live because there is an initial cycle of identifying an item assignment, then writing the assignment by a test author, then review of that item by a group of peers, then pretest of that item in an examination pool until a sufficient number of reference candidates have taken the item, then calibration of its statistics, re-review of the item, and then inclusion of that item in a test bank, and then its random selection for an examination that a student might take. That cycle is a three- to four-year cycle.
We can cut a year off that cycle. We can move it from four years to three years, to a live pool, if we shorten the item assignment/item writing period, and bring people, actually, together in Philadelphia to write the items instead of having them do it on their home territory and send them in.
I would probably prefer that we follow our standard protocols in this area and begin to integrate individuals with knowledge in CAM into routine test committees, so we have a broad distribution, and therefore higher acceptance of the items in the examination.
DR. ORNISH: Thank you.
DR. GORDON: We are already at our time limit, so if we can have one quick question from each of Charlotte, Joe, and George. The we definitely have to close.
SISTER KERR: Thank you. Thank you for your presentation. When I often hear people speaking about including CAM in educational settings, particularly medicine, I often hear the emphasis being on how to introduce modalities.
Some people who have been in this field -- we heard some of them in New York -- those who have been in this for quite a while said they really had come to the conclusion that the emphasis should be on foundational work at the conceptual level, paradigm change.
Jennifer, you spoke to this.
Even at the level of speaking about new epistemology. So for me, the question becomes, what do you think about that? And my concern is that I don't hear that emphasis when people present. My own bias is, we need to be talking about it at the level of history of medicine, the philosophy of healing.
Jennifer, you mentioned acupuncture, for example, being under the Department of Neurology. I would put it under the Department of Energetic Medicine, along with homeopathy, and maybe some other things.
We need your help. How will we do this? I didn't hear this emphasis at all this morning, although I heard incredibly beautiful, clear presentations. Please give me some advice on this. Thank you.
DR. DANOFF: Perhaps my presentation was clear but not complete. Certainly, the underpinning, both of the Medical School Objectives Project and the GME Core Curriculum are indeed is issues related to foundational aspects. Tat is, an understanding of belief systems, of values, and of how those belief systems and values influence how we perceive health and illness and how we approach both disease treatment and disease prevention.
So if the impression is that we would focus specifically on modalities of therapy, I think that that was a mispresentation on my part. I think that the principles are clearly very important ones, and indeed the principles allow you to make subsequent modifications more easily than if you are just teaching about a specific modality, rather than understanding the context in which that modality might be considered. So I do think that the basic belief systems are very important.
If I may take one moment to comment on curriculum development, because that question was raised before. The medical schools and residency programs constantly revise curriculum. So every year, if you look at a specific lecture or a specific series of lectures, changes have occurred.
The problem is that, depending upon how you look for change, you may not be able to see it over a prolonged period of time. If you change a curriculum, the student in the first-year curriculum, that will not be apparent for four years, until that student graduates from medical school.
If a single lecturer changes a particular element within their course, for example, a rheumatology lecturer introducing new modalities of therapy, your students may learn that but that may not be apparent if you do an overview. If you said to people, well, what have you changed in your curriculum, they might not even think of that as an issue that they should be bringing forward.
So I think it is a little bit like the diagnostic procedure of biopsy versus excision, if I may use that example. Part of the issue, when we think about medical education and changes in medical education, is, what is the granularity of our inspection of those changes, but I can assure you that change goes on constantly.
On a macroscopic level, we can see that over the last four to five years, the number of schools that are including issues related to complementary and alternative medicine, or issues related to end-of-life care have changed significantly. So there is change occurring, and it does occur constantly.
DR. ORZACK: If I may complement that, there is a great deal of change in the knowledge incorporated in practice in all professions. There is also a great deal of resistance. There are rivalries among professions and providers.
Certainly, as a university professor, I would like to candidly admit there is a lot of rivalry among academics. How much time will be spent in my program compared to how much time you want. You are going to take something away from me.
So I think there are a lot of issues in this. Again, there is no simple answer to that intriguing question, and broad-based question, that you asked: How does change occur and how may it occur.
DR. GORDON: Joe?
DR. PIZZORNO: Actually, my question was answered.
DR. GORDON: Okay. George.
MS. ENGSTROM: I would like to make just one final important point on this topic. I think that is an important task of the Commission, to try and convey to the medical community and medical schools, and to acknowledge the evidence base of CAM, and also the relevance, both philosophically and conceptually, to facilitate the efforts of educators at medical schools who are currently trying to implement these changes, because there is a lot of resistance. I think it is a task of the Commission to try to convey this, to facilitate the forward movement of this.
DR. GORDON: Do you have a specific suggestion for doing that?
MS. ENGSTROM: Just making sure that the policy recommendations are disseminated properly throughout the medical community, to support the efforts of educators at each institution.
DR. GORDON: Thank you. George.
DR. BERNIER: I would like to follow up on that, Jennifer. Very clearly, there has been a very strong national push on the part of the medical students to see change occur in this area.
Do you feel you could identify a major driving force that has pushed students to try to adopt CAM-related curricula?
MS. ENGSTROM: I think the main driving force is that medical students come to medical school wanting to help people, and they see in their communities people that they know using these modalities. They use them personally. They see the potential of them. And so, I think that is where it comes from. When you come to medical school, you have a very open mind.
One interesting thing that I noted when I started the Integrated Medicine Interest Group at Case Western, each year the enrollment became larger and larger and larger. What was interesting was that students who had already completed one or two years of medical school were much more resistant to CAM.
I can't make that point enough, that we need to expose medical students and future health care providers to CAM early with the philosophy behind them and the concepts, going back to the history of medicine, all of that, early, so that we come into this with an open mind, and with that open mind, we can then look at the research literature, and then proceed from there.
DR. BERNIER: Thank you.
DR. GORDON: Thank you all very much. We really appreciate it.
The next panel.
MS. CHANG: The next panel is Dr. Alfred Fishman, Dr. Geraldine Bednash, Neil Sampson, and Sara Collina, please.
DR. GORDON: While the panel is getting seated, I am going to ask the Commissioners to, please, just ask one question to begin with. Okay? That way, we will make sure that everybody has a chance, and if there is time left over, you can ask additional questions.
MS. CHANG: We would ask that, speakers, if you could look in your folders and take out your name tags, and go ahead and put them up on the tables.
The speakers who have left, if you could leave the little insert, the plastic piece, so that the next person can put their speaker thing up. Thank you.
DR. GORDON: Dr. Alfred Fishman. Nice to see you again.
DR. FISHMAN: Thank you very much for inviting me back. There was a lot of discussion at home about whether this was a chance to redeem myself for the last performance.
DR. FISHMAN: But I am very pleased, and thank you. I enjoyed the previous communications. They have a personal touch. For example, I am on the Board of Visitors of Case Western Reserve, and we are going out there, I think, next week. I am going to ask to review what they are doing on CAM. So it has already been a productive session for me.
DR. GORDON: Incidentally, Dr. Fishman's submission can be found behind Tab 30, for those of you who are looking at it, under Discussion Group 1.
DR. FISHMAN: Now, I have been asked to deal with two questions. One was to provide some sort of a summary of a Josiah Macy meeting, which I will come to in a minute, and the second is, including CAM in the medical education programs, who should fund it.
To put my presentation into perspective, let me make one comment at the beginning. As I listen to the individual people advocating one aspect of education over another, I realize how different the approaches are from institution to institution. I sympathize with a commission that has to generalize from particulars. For example, Case Western is different from the Harvard program, which is different from the Penn program. I can go right on through.
So homogenization is not an easy task without losing the flavor of what you are trying to do. So what I intend to do is tell you, as a continuum, of what we have been trying to do at one institution. I think that the credit, if there is any credit, belongs to the previous dean who said, if we are going to look at CAM and where it fits into the academic health center, we are going to do it as though we were creating a new department or an institute, and therefore we are going to do it through a working group, through reviews. It has to go up through the provost, to the president, and it has to involve the faculty.
So this is now the end of three years of this kind of an effort, and this relates to the Macy Conference because Dr. Osborne was called in halfway through our proceedings to review what we had done up to that point. Dr. Osborne, who was raised as a microbiologist, infectious disease expert, et cetera, and who came in very much as a doubting Thomas, was convinced that this was something that had to be taken into account, and that led to this Macy Conference.
I should also point out that in the process, we had a cosponsored conference with the NIH on the ethics of complementary and alternative medicine. So that, we have taken each step separately.
Now, I won't go through this. We have established how you introduce academic practices into the system, what are the legal issues. We have a process for accepting or not, just as though you were doing brain surgery: Do you accept acupuncture, or don't you; what are your credentials; how were you evaluated. We have been fortunate in being able to do it without disrupting the system.
Now, about the Macy Conference, several people who are on this commission were present. Let me just give you a very quick, bird's eye view. It was a meeting, as a Macy meeting always is, with about 30 people or so, consisting of consumers, practitioners, deans, physicians, other health care professionals.
What was the purpose? Well, it marked the end of our three years of our research on how we do clinical, education and research. But the key question is, how do you integrate CAM; what are the challenges to medical education.
To cover these topics, incompletely, we dealt with the history and the ancient roots, research on safety and efficacy, quality control, but the big emphasis in the meeting turned on what it was that you could have of added benefit to the existing faculty, and one of the biggest advantages could be in appreciating multiculturalism. That was a topic that was discussed again and again. In fact, we were accused of oversight in the medical curriculum. And so, this has been turned to great advantage.
What were the common themes in there? One that impressed me, that you may see in the write-up, was the concept of humiliation. I had never given this very much thought before. The concept of humiliation by a psychiatry professor, as you can tell, was that both the physicians and the patients are humiliated by the encounters.
The physician has been beaten over the head by HMOs, by hurry-up-and-do-this-quickly. The physician feels degraded. The patient feels as though the patient has a secret that he or she is withholding from the physician. So the bottom line is that there has to be steps taken to overcome barriers to communication.
And then, we went through a whole series of how inadequate scientific medicine in dealing with the whole person, the problem of caring. One of the things that came out, and really is passed over lightly here, too, is the problem dealing with herbs. It is almost impossible to do good research until somebody standardizes what an herb is. Therefore, you can have somebody spending a lifetime studying ginkgo, and find that that preparation is not like any other ginkgo preparation in the world, and therefore the results are not particularly generalized.
Anyway, we will go on. So the conference moved ahead to conclude that science-based medicine and CAM have a lot to teach each other. Another point that was made repeatedly is, medical practitioners, in the way they approach patients, don't really have a good understanding of the placebo effect and how to use it well, because most of the emphasis in the literature is what goes wrong when you take this or you take that, et cetera, what interferes.
Well, what are the practical aspects? Everybody agreed that we need more research and greater accountability.
With respect to recommendations, I will just skip very lightly. One, formal courses were held to be unrewarding. You sit there in a big amphitheater and lecture at students. It is like ships passing in the night. So that, again, comes back to the point is different schools teach in different ways.
The other thing is, don't teach the physicians to be practitioners of the different modalities. That should be later. Let them understand what is going on rather than how to do it. That doesn't mean they shouldn't observe. They can attend, they can witness, they can do everything you want, but they really should catch the meaning behind it, the concept behind it. The other thing is, you must use CAM to promote the art of communication and listening. That was a theme again and again, and there were some recommendations which are detailed over here.
For shortage of time, and I haven't done justice at all to the meeting, I would like to address the question of whom and how to teach. When we went through it, we said this is a very big problem because you can't talk about funding until you know whom you are teaching. Well, the first group we wanted to teach was the public. I have some brochures here. At the College of Physicians of Philadelphia, we set up as part of this distinguished library and building, a room, almost this size, which is a walk-in library.
Anybody can come into it. There is a librarian, a computer for storage and data retrieval, et cetera. So if you came in and you said, "I would like to learn something about an herb," the librarian would help you, et cetera. The CDC came to review it, has endorsed it.
At the moment, what we are doing is we are communicating with the public library system of Philadelphia to introduce into the libraries replicas of this particular station so that anybody can walk in and get health information which includes complementary and alternative therapies. If any of you all are interested in that, the building is magnificent. It is worth a visit.
So that is the public. The college students, we had a great time in introducing what we think is CAM in sociology, anthropology, folklore and history. The students love it. They have some of the people who were trained in complementary/alternative therapies come down and talk to them about what they are giving in folklore. Suddenly, they say, "Oh, my god, that goes right on to the present time, doesn't it."
So, at any rate, we have invaded the universities and we have been well received. Honest, they have given us banquets.
DR. FISHMAN: But the big thing that you are asking about is physicians, and there are, again, different categories. There are four that we identify: The medical student is easy; the residents, not difficult; academic physicians, tough; practicing physicians, near impossible.
DR. FISHMAN: That calibration is unofficial, but I tell you, the medical students we have had, as I said before, an attempt to devise a curriculum at Penn, which is unusual, for the last three years. As a result, we have got working groups that are trying to say what goes into the curriculum. Therefore, it has not been difficult to say, where does CAM fit.
Well, in the first year, you fit CAM; new students; new faces; what is professionalism; what are the cultural backgrounds of what we are doing; what is the Hippocratic tradition; are we living up to it; what is the impact of having HMOs, et cetera, driving you wild so you have too little contact time.
Quit? All right, I'll quit. Then, I won't go anymore.
I just wanted to tell you, by strategic bombing you can incorporate at each specialty. For example, orthopedics, orthopedics give lectures on it. Acupuncture, the people who are acupuncturists do it. Mind-body and psychiatry, there are sessions. In pharmacology, there are discussions of herbs where they are relevant. So this is all built in because of the system.
The only point I would make in concluding is that, when one talks about education and generalizes from single models, it is very difficult. I wish that this Commission could do site visits and actually take a look and see some of the things that are going on, because it is impossible to portray them in a brief presentation like this.
Thank you very much.
DR. GORDON: Thank you very much.
Dr. Geraldine Bednash.
DR. BEDNASH: Good morning. Thank you. I am Geraldine Polly Bednash, more commonly known as Polly Bednash. I am the executive director of the American Association of Colleges of Nursing. Our organization represents over 550 senior colleges and universities that offer baccalaureate and graduate degrees in nursing.
I am pleased to be here today to provide you with some comments related to nursing education, the nature of the education for professional nursing practice, and the types of issues that face nursing educators when they are addressing the subject of complementary and alternative medicine and therapies.
As part of my remarks this morning, I was asked to provide you with a brief overview of professional nursing education. As many of you may know, there are a variety of ways that an individual can be prepared for entry-level professional nursing practice. This morning, however, I will address the baccalaureate and master's degree program characteristics as part of my remarks. Over 550 senior-level colleges and universities in the U.S. have baccalaureate nursing programs that prepare for entry-level practice. In addition, a master's degree in nursing is offered in almost 400 institutions.
The typical baccalaureate nursing education consists of four years of study with the first two years focused on the general studies, the core of physical and social sciences course work, and the liberal arts. Nursing course work begins, typically, in the second year of the baccalaureate program, while a small percentage of the students are given course work in the first year.
Nurses prepared for entry-level practice in baccalaureate programs are typically awarded a bachelor of science in nursing. These graduates are prepared for practice in complex environments that demand systems competencies, critical thinking and analysis skills, and the ability to function in teams and in ambiguous environments.
The master's degree-educated nurse is prepared for advanced practice with the greatest portion of these receiving preparation to serve as a nurse practitioner. I, myself, am a nurse practitioner. Over two-thirds of all master's graduates are prepared in this role. Other roles at the advanced level include preparation as nurse midwives, nurse anesthetists and clinical nurse specialists. That curriculum is typically one-and-a-half to two years in length and, after graduation, these nurses typically sit for certification in their area of specialization.
Nurses prepared at the baccalaureate-entry level and at the advanced-practice level each must have both an awareness of the potential for complementary or alternative therapies to be a part of the patient's armamentaria of self-care interventions and must have an ability to assess how these therapies are either complementary or potentially harmful to the patient.
Our organization has developed standards for both baccalaureate and master's level education in nursing. In each of our standard documents, we explicitly note the requirement that thorough assessment of the cultural, lifestyle and multiple therapies are a basis for any interventions by the nurse clinician. In addition, we have an explicit standard that the student must develop an awareness of complementary modalities and their usefulness in promoting health.
Unfortunately, however, there are great gaps in the available science for nurses and other health professionals who attempt to assess the utility of these therapies or provide advice and counsel to the patients for whom they care. Nurses, like other health care professionals, are acutely aware of the growing practice of consumers to self-select a range of complementary therapies or to seek consultation from non-traditional health care providers.
This is a recent issue, for instance, of "Nursing Spectrum." "Nursing Spectrum" is a Gannett Corporation publication that is circulated free to over 1 million registered nurses. It focused on the issue of complementary therapies and provided for the practicing nurse a range of resources to be used in assessing these therapies.
The American Holistic Nurses Association has published guidelines related to the curricula for CAM. In addition, a number of nurse educators have designed tools for the education of nursing students to assist them in making evidence-based decisions about interventions related to CAM therapies.
At a minimum, nurses must be prepared to advise patients and their families who use self-selected CAM therapies and practices. They must have a core of evidence-based content for their practice and must be able to evaluate critically the best evidence available on any new therapies.
At the University of Virginia, Dr. Ann Taylor, a professor in the School of Nursing, directs the Center for Study of Complementary and Alternative Medicine at that university. She notes that a major deficit faced by nursing and other health professional educators is the lack of a significant base of data on these therapies, and comments that even existing resources are quickly outpaced by the emergence of new alternative practices or therapies. In addition, much of the content given to nurses and other health professionals is limited in its focus and often exposure to this content depends upon the availability of an interested or concerned faculty member.
Our organization would not support the establishment of a requirement that a specific and separate course in CAM therapies would be required for all nursing students. However, we do support the need to have clear and consistent information provided to nursing students about these therapies in the full range of course work that the student experiences.
I agree with you, Dr. Fishman, on this issue.
This Commission could make a significant contribution to the education of all health professionals through a recommendation that an easily accessible and evidence-based resource of data on these therapies be made available to educators and clinicians. The use of the Internet can assist not only the consumer of CAM therapies but also can assist the provider who is attempting to intervene or consult successfully.
The major barrier to successful education on this important topic is more likely to be overcome through a widespread education program for faculty and clinicians and through the development of sophisticated resources for effective interventions.
The work of The National Center for Complementary and Alternative Medicine at NIH is central to this. Several websites, including those sponsored by NIH and one interesting one, Quackwatch.com, are also beginning to offer resources for both providers and consumers.
Using state board exams as a carrot or stick to force attention to specific issues is often seen as an attractive option. This discussion is also accompanied often by a call to require accrediting bodies to assess this content in a given curriculum; however, it is unlikely that more than a cursory assessment of the knowledge base of the test taker is possible on any given specialized topic when a lengthy and comprehensive test is administered. Moreover, accreditation today is likely to focus more on outcomes than the process of the education.
One last thought should be part of any conversation about the use of complementary and alternative therapies. The growing interest in these by consumers of health care is symptomatic of a concern that also should be addressed. Consumers turn to these therapies primarily because they do not believe in or trust in the ability of traditional forms of health care to resolve their health care needs. These consumers, already distrustful of the health care system, are highly unlikely to readily volunteer information about their use. Consequently, it is vitally important that health care providers have the ability to develop strong therapeutic relationships and have an ability to elicit truthful histories in their assessment of the consumer's health care practices and beliefs.
I would suspect that a whole bunch of us in this room already use alternative therapies or complementary therapies, and I wonder if we asked everyone who does that to raise their hand whether we would get an honest answer here.
This requires both good interpersonal skills, relationship building and a sensitivity to cultural diversity and beliefs. Without these, the provider is unable to elicit the information that will assist both individuals in the therapeutic relationship to reach their health care goals.
In closing, we would therefore like to offer the following recommendations:
First, the establishment of an expanded database or databases on the range of complementary and alternative therapies and providers that are in use, the evidence that has emerged on these therapies and their efficacy, and a resource base for information and consultation;
The development of a generic curriculum for all health professionals on complementary and alternative therapies and the skills necessary to assess their use by patients and their families with a strong emphasis on the therapeutic relationship and interpersonal skill development;
Continued federal support for research to assess CAM therapies to develop the evidence base for practice;
A communication vehicle for health professionals to provide a consistent stream of information on these therapies;
A train-the-trainer initiative to provide faculty and nursing or other health professions' education programs with the skill to teach the future clinician about these therapies;
A widespread continuing education intervention for the practicing nurse or other health professional;
And, a communication tool for the consumer of health care to provide accurate and timely information about the evidence available on complementary and alternative therapies.
Thank you for the opportunity to be here today, and I look forward to the conversation.
DR. GORDON: Thank you very much, and thank you also for being so precise and ending so beautifully, and for the recommendations.
DR. BEDNASH: Later on, I will tell you about my own complementary experiences.
DR. GORDON: Okay.
MR. SAMPSON: Good morning, happy to be here. I wanted to have this opportunity to speak before this distinguished Commission on the role of the Health Resources and Services Administration, U.S. Department of Health and Human Services and the Bureau of Health Profession in preparing tomorrow's health providers.
As you are all aware, demographics of this country are changing. In fact, within the next two years, the Hispanic population in America is expected to surpass the African-American population to become the most populous minority group. By 2050, less than 50 years from now, the total number of all minority groups combined is expected to make up approximately half of the U.S. population. In other words, we are fast becoming a majority of minorities.
With these changes in demographics, there comes a changing reliance in involvement and understanding and acceptance of conventional health care practice as we know it. More and more Americans of all cultures are taking an active role in meeting their own health care needs. As a result, more and more are turning to and relying on complementary and alternative therapies.
The increase among consumers is spurring a change in health education curriculum as schools strive to prepare their students. In fact, we have been told already that approximately half of the medical schools in the country have courses or other educational activities in CAM. We have heard some of that discussion already.
However, we believe the inclusion or expansion of CAM should not be limited to the education for physicians alone. Rather, CAM therapies should be incorporated into the curriculum for all health professions disciplines. The current involvement of the Bureau in training and education programs on CAM is very limited. The Bureau's Division of Nursing currently funds three graduate programs that include content on complementary and alternative therapies, and the Bureau funds a Chiropractic Demonstration Project Grants Program which supports research projects where chiropractors and physicians collaborate to identify and provide effective treatment for spinal and lower back conditions.
Currently, research is the only activity legislatively authorized under this program. Unfortunately, that is the extent of the Bureau's involvement in CAM. I wish I could share good news on the financial assistance available to CAM students. The reason for this is simple, most of the Bureau's programs for health professions' development come through what is referred to as Title 7 and 8 of the Public Service Act. Training and education programs are established through the specific legislation in the Public Health Service Act, and these programs are directed toward specific health disciplines.
As a result, we have very little leeway in how we allocate funds. In Fiscal 2000, the Bureau awarded 1,741 new and continuation grants. This year, we will invest some $350 million in training and education programs directed towards physicians, nurses, dentists, public health professionals and allied health professionals.
Where do we go? Should the Bureau be involved in training and education programs for CAM practitioners? We believe we should and for a number of reasons. First and foremost, to keep pace with the changes in the nation's health care system. It is imperative that providers are prepared to meet the challenges of the future. The federal government, through the Bureau, can play a leadership role by convening medical education leadership conferences, encouraging the development of standards of education, and positioning Titles 7 and 8 as vehicles for faculty development and curriculum development initiatives.
Secondly, as awareness of the effectiveness of these therapies becomes known, educational content about these therapies is already being integrated into the curriculum and clinical practice of providers. Graduates of these programs are increasingly using CAM therapies to promote health and the well being of their patients.
While the knowledge about CAM is still developing and evolving, the Bureau believes that there should be a minimum level of post graduate education required for all non-allopathic and non-osteopathic physicians, which leads to state certification or licensure. This would allow for some level of standardization. For other health professions disciplines, we believe that all educational and training programs should address a set of core requirements which are aligned with program accreditation, other recognition and licensing requirements.
The licensure of all practitioners, whether they provide complementary and alternative therapy or conventional health care, is absolutely necessary as a safeguard the public. To illustrate, there was just an article in Sunday's "San Francisco Chronicle," just this past week, that discussed a physician who was working for the past 20 years at community clinics treating poor patients, flew volunteer medical missionary missions to Mexico, and worked as the head physician at an L.A. clinic. The problem was is that he wasn't a physician. Over the years, he falsified his credentials and basically was practicing as a provider, and the result is you end up with requirements where we need stricter controls for credentialing and licensing activities.
Certainly, this isn't a CAM issue. The problem is that it does show the need for strong state licensing/certification requirements for public protection.
Finally, the structure of the work force, namely scopes of practice, credentialing, roles, numbers and mix has been and continues to be a matter of debate. Emerging therapies and professions are part of this debate. Such changes can be influenced but probably not imposed from the federal level.
However, it is important and relevant to periodically monitor the workforce to determine shifts and trends which could impact access to practitioners, health care delivery, cost and quality. Such efforts help identify problems and allow for policy makers, state and national leaders, health professionals, state providers and payers and consumers to determine issues, discuss strategies and consider appropriate actions.
The Bureau, through our National Center for Health Workforce Information, has held court in future meetings on health workforce issues. Through such research meetings, we can better assess the impact of health care workforce on health care delivery and determine where we go from here.
Unfortunately, we know that, once we get beyond physicians, nurses, dentists, pharmacists, our data are very limited. This is where professional associations, schools, licensing bodies can help. These groups can help collect the data we need to assess emerging CAM workforce issues. The Bureau's role in health professions' training and education is assuring that the right providers with the right skills are available to provide health care in the right places. We recognize the growing interest in complementary and alternative therapies. We believe that tomorrow's health care providers must be prepared to meet the needs of their patients, and we are ready to meet those challenges.
Thank you very much.
DR. GORDON: Thank you very much.
MS. COLLINA: Good morning. I am Sara Collina. I am a senior policy analyst at the National Breast Cancer Coalition. On behalf of the Coalition, I want to thank you for this opportunity. We strongly support the goals of the Commission, and we appreciate this opportunity to contribute.
The National Breast Cancer Coalition is a grass roots organization made up of over 500 organizations and 60,000 individual members. Our goals are to increase federal funding for breast cancer research and collaborate with the scientific community to implement new models of research, to improve access to high quality health care and breast cancer clinical trials for all women, and to expand the influence of breast cancer advocates in all aspects of the breast cancer decision-making process.
I will be addressing this issue in the context of quality health care because, ultimately, we think that that is what CAM and all other health care policies should be about, finding ways to describe, measure and provide quality health care for everyone.
So, what is quality care? Some focus on morbidity and mortality. Others describe it by what it isn't, too much, too little or the wrong care. These approaches lack a patient perspective. We need the right care at the right time, but the right care can be a very personal choice. Two reasonable patients with the same diagnosis may chose very different treatments.
On the other hand, quality care is not simply personal taste or a popularity contest among doctors. Of course, we want to avoid rude doctors and long waits, but we can get free parking, sparkling water in the waiting room, a long relaxed visit with our provider and leave with the wrong diagnosis.
The National Breast Cancer Coalition has a different approach. We think of quality breast cancer care as six core values: access, information, choice, respect, accountability and improvement. We are publishing a guide to quality care based on these values, and we will be happy to share it with you. Briefly, the goal of the guide is to give breast cancer patients a different and better way of thinking about quality care. We want to move away from a "doctor knows best" mentality and equally damaging "more care is better care" approach. Instead, we ask patients to take some time to learn about breast cancer care and become their own advocates.
The guide is our best advice. It is what we tell our family and friends about breast cancer care. We explain the value of medical evidence, how doctors do and do not use it, and how it should be used. We describe what clinical guidelines are and how to find them. We explain the difference between absolute and relative risk. We discuss why a second opinion should be from a doctor outside the institution of the first doctor. We describe the laws regarding medical confidentiality and laws requiring coverage of certain procedures. We advise bringing a tape recorder to doctor appointments. We describe what coordinated care is and what should be covered in a comprehensive treatment plan.
These are just a few examples to give you a sense of our values and how we approach the issue of education and training of CAM practitioners.
The National Breast Cancer Coalition believes that both the medical community and patients should approach CAM with an open but critical mind, exactly as they should approach conventional care. The same questions apply: What are the risks? What are the benefits? How strong is the evidence that answers these questions?
The two categories of CAM versus conventional medicine are really not helpful to patients. The categories themselves encourage the misperceptions; that conventional medicine is all based on evidence, it is not; and that CAM therapies are natural and therefore harmless, obviously untrue.
Many conventional providers are justifiably angry and worried that patients are being tricked into wasting precious resources on dangerous and ineffective CAM treatments, but many have yet to learn about effective CAM treatments. For example, an oncologist may have no idea that acupuncture can alleviate nausea associated with certain cancer treatments. This "Us-Them" mentality about CAM has serious consequences because many conventional health care providers know so little about CAM therapies they fail to discuss it with their patients. Patients respond by lying or withholding information and then end up weighing the potential risks and benefits of CAM therapies on their own.
The medical community needs to stop thinking in two categories and, instead, focus on developing better systems for creating and weighing evidence that can tell us what we really need to know, what does and does not work. Allow me to use the Quality Care Values to describe in more detail our vision of CAM education.
Information. Patients need accurate and complete information in order to make good decisions. They need a clear and complete presentation of all conventional medical options, along with what is and is not known about how well they work and what harm they can do. The patients need the exact same evidence-based information for CAM, and they need it at the same time and place that they receive information about conventional treatment options.
Choice. Guided by accurate information, patients should be able to chose among therapies that offer some benefit. Patients should also be told about all clinical trials that are relevant to them. CAM that has some evidence of efficacy must be part of the range of choices presented to patients. Relevant CAM clinical trials need to be presented to all patients as a reasonable health care option.
Respect. Providers need to treat the patient as a whole person rather than a disease or a body part. For example, discomfort and anxiety need to be taken seriously. They are a real and powerful part of breast cancer and many other health care experiences. They can also often be alleviated. All care providers should have a basic knowledge of CAM and provide an overview to patients. They should also respectfully encourage patients to be honest about their interest in or use of CAM.
Accountability. Patients need competent providers with credentials that mean something to patients. The system should be easy to understand and transparent so that everyone can easily learn what a credential or license means, but credentials by themselves do not create accountability.
It is a clear and accessible appeals process that protects patients. Any licensing or credentialing process must include a convenient and effective way for patients to appeal or complain, and there must be meaningful consequences. This is true for both CAM and conventional practitioners.
Access. Breast cancer patients should have access to interventions that have been shown to help. All providers should either provide or refer patients to CAM therapies that have been shown to have some efficacy. Health insurers and plans should have an evidence-based approach to coverage and educate patients about CAM.
Improvement. We want a health care system that is continually learning from patient care. We need more and better evidence about both conventional breast cancer care and CAM. NBCC belibelieves that CAM research has been extremely underfunded. A large investment in this kind of research can not only bring great health benefits to patients, but in the long run could provide savings in health care costs. Right now, breast cancer trials consist mostly of drug companies exploring slightly different ways of using their patented drugs or slightly different combinations of existing drugs. We need a different focus, and CAM research is fertile ground for innovative questions about breast cancer.
We also need to expand our notion of health services research. We need to be measuring what matters, not just morbidity or mortality and not just a handful of quality of life measures. CAM research often requires innovative design which may help expand what we measure and how.
The federal government needs to fund not only CAM research, but also CAM education for all the players: patients, health care providers, employees and third- party players. There is so much misinformation and mistrust around this issue a major educational effort by the federal government could go a long way in dispelling myths and getting effective treatments to patients. NBCC strongly supports increased funding for more and better research to find out what CAM therapies are effective. We also strongly support a federal educational initiative on CAM and evidence-based medicine.
CAM practitioners certainly need consistent and educational standards and accountability within the licensing and credentialing process, but this by itself would do little to help women get the care they need. We believe that patients will be better able to chose the right provider, CAM or otherwise, when there are national standards for health care, standards that are comprehensive, evidence-based, updated regularly and accessible to everyone.
These guidelines should not be broken into conventional versus CAM, but rather include the entire range of care options. Guidelines can't tell anyone what their treatment should be, but they can provide an invaluable overview of what we have learned from medical research so far. Patients will and should continue to make very different choices about health care, but one national trustworthy source for evidence-based health care information would provide a powerful tool for patients and their loved ones who are trying to get quality care. It would also highlight what research questions remain.
From patient perspective, it is not either conventional or CAM but what actually helps that matters. Health care policy needs to reflect this view. CAM should be completely incorporated into all aspects of health care policy.
Thank you for this opportunity. We believe that breast cancer advocates and patient advocates have an important role to play in the development of CAM policy, and we look forward to working with you in the future.
DR. GORDON: Thank you very much and thank you for the recommendations, as well.
DR. PIZZORNO: This is directed to Mr. Sampson. As Dr. Orzack stated I think so eloquently earlier this morning, for a profession to become distinct it needs to establish educational and practice standards, and those educational and practice standards must evolve over time.
At what point does the profession come under the purview of your organization and, once it does come under your purview, what impact can you have on those emerging professions?
MR. SAMPSON: Generally, the way they are recognized is, first, almost all of them have to be accredited. That means the Department of Education is the first area that gets approached for accreditation, the accrediting body which has to be separate from the professional body. They have to then show that they have a series of information, science, et cetera, in order to get accredited.
So that then sets up the base. The next piece is then specific legislation which allows that emerging profession to be included in the coverage of the Acts, so they then have to get specifically mentioned. That is really the only way that they are done.
The second part of the question is the degree of involvement. Most of the involvement we have would not be so much in the emerging profession, it is to assist them. It depends on how the law is structured, what Congress says that we are willing to use monies for to do this. Most typically, they are the kinds of things that were developed or mentioned here. Once these are accredited and licensed and standardized, then the issue would be curriculum development, faculty development and to some degree student support. Those would be the kinds of issues.
DR. GORDON: Effie.
DR. CHOW: Thank you very much for your presentations. I am glad to see a nurse on board here because being that there are so many nurses that have been underrepresented. So I am very happy to see that.
Many of you mentioned about evidence based. In fact, for the last panel, very strongly so, and this panel. Then, you also talked about culturally sensitive and looking at cultures. Then, the next comment is that it should be evidence based before practiced. What does that mean in terms of looking at practices that has been successful within the culture, but because there has been no money and it is new to this Western civilization that it isn't "evidence-based" from the way we research biomedical?
Are you talking about absolute controlled studies and squeezing it into a box, et cetera? Could you make comments on that. And should there be practice if it has been proven that it is used in the cultures successfully?
DR. FISHMAN: Can I take a crack at that?
DR. GORDON: Sure.
DR. FISHMAN: One of the big problems I think that we face is that, when we talk about CAM, we are talking about such a span of activities that some are potentially threatening. For example, acupuncture and asthma, I have had some experience with that. You have to take it into account. You have to be very good at what you are doing.
On the other hand, there is music therapy and there are other therapies where if you listen to a radio while studying that is music therapy in a way.
So, therefore, we have not been circumspect in breaking it down modality by modality. There is a big difference, also, in what I as a practitioner in my office can do and what I as a professor of medicine put in the book to teach medical students. For example, I can have you come in, make believe you are a patient, and you say, "I have been taking this medication. It is good." I say, fine, that is great. Evidence is there.
On the other hand, if you come in to me and you say, "Should I take this?" I will say, well, you better be careful now because you are taking phytoestrogens, you are taking this, you are taking that. Or, I can go further and say, uh-uh, you really can't do that.
So one of the big problems that we have faced in dealing with your question is do we break down CAM into modality-by-modality and treat it that way? And the second is, what do you want the money for? Do you want the money to investigate whether a cultural activity such as acupuncture -- the way we do it is not in the context of the framework that everybody does who really knows acupuncture in China. For example, I visited China, it is a whole scheme of things. Over here, it is like one thing. Or, we will do tai chi, and it becomes a part of physical therapy.
So the question is, how do we sort out CAM? A very critical point. What do we want? What warrants research? What warrants money?
On the other hand, why don't we just take the evidence that, look, this thing works, it is harmless. We will keep looking, but if we can prove it, yes, use it.
MS. COLLINA: If I could add that this issue of squeezing it in a box is interesting to me because we have struggled with this.
Obviously, as a breast cancer organization, there is a lot of unanswered questions. It seems to me that we need answers and we want answers and we want some way, a design of some sort of trials and some way of systematically exploring what works and what doesn't.
To the extent that the box is a problem, we need to change the shape. We need to look at that. We need to rethink what we mean by a clinical trial, what we mean by evidence. It doesn't mean that we give up the basic core aspects of evidence-based medicine, but I think there are more creative ways of looking at it.
I don't know if I am following up here or not, but I would say that that is exactly where the funding should be focused until we answer that question. Too often in conventional medicine, things have come into the system because we don't really know but people are interested in having it, and then we learn later that it doesn't work.
So I think that is a perfect example that that is where the focus should be, and the focus should be in looking for new and creative ways of measuring.
DR. BEDNASH: Just another piece of this, I think there is a difference between developing a bond and a partnership with the person in that therapeutic relationship, so that you have a sensitivity to their own cultural beliefs and views about what is helpful and what gets them through the experience that they are having.
I can tell you that when my father had his bypass surgery and ended up developing shingles afterwards and said he would rather have another bypass and have his chest split open again than to have to go through the shingles experience, it was so terrible. None of the traditional therapies and medications he was given helped.
His brother-in-law, who is from Mexico, drove in and picked him up, and took him to a provider in Mexico who gave him an injection. I think, as far as I can tell, it was a vitamin B injection. My father came home and was cured.
Now, I think we don't understand the placebo effect, you are absolutely correct, but we also don't understand the power of the cultural beliefs. We are Latinos. What my father believed was going to be helpful to him was helpful to him.
So there is this partnership. It may not be that I, as a more traditionally oriented provider, would suggest that he go and get this, but I need to understand how it does relate to him or someone else in their seeking some kind of relief or some kind of ability to control this health care experience.
So it is a partnership. Above all, I think we need to be concerned about not creating harm or intervening when there is the potential for harm. Sometimes, the only way we can do that is through some base of knowledge that comes from the more traditional evidence-based protocols to give us that comfort level.
MS. CHOW: Thank you very much. I do want to know, how many are practicing alternative medicine? [Laughter.]
DR. GORDON: Wayne, and then Charlotte.
DR. JONAS: I can't decide between communication and evidence, so I am going to defer to Charlotte for her question.
SISTER KERR: Assuming we can define food, would you say that real food for real people is a complementary alternative medicine? Specifically, I was thinking to start with Sara.
MS. COLLINA: I think that is a perfect example of what is wrong with the category. I mean, that category means nothing to me. I couldn't even tell you right now as a patient which things that I am doing you would consider to be complementary or alternative. Because there is very little profit in food research and nutrition research, it has been underresearched. And so, in that way, it is like many complementary interventions. At the same time, there is clear biological -- I mean, there is very little controversy in the medical community that it impacts health. So I think that is the perfect example of what is wrong with the category.
SISTER KERR: And when you answer, if anyone else does, is there something we need to say about that in policy?
MS. COLLINA: Well, I guess I will just jump in here and say this is why I think that, to the extent that we can give up the label -- and I realize that that perhaps feels like a big task, but from where I sit that doesn't feel like a big task. People don't look for complementary and alternative medicines. They look for things that will help them. That is the only question people are asking.
So, like I said, I think the categories themselves are very limiting, and not only does it create stigmas and confusion about CAM, but it creates a lot of dangerous myths about what conventional medicine is and is not.
DR. BEDNASH: I would like to also come in here, too, because I think I agree with you in what you are saying, Sara.
I am very concerned about the power of language and what language conveys and more concerned -- not to be offensive to my colleagues in other fields but to be concerned about the use of the term "medicine" as the baseline here. Because medicine is medical practice and medical practice does not represent the full range of health care and health care professionals today.
I worry about medicine and a focus on that as a baseline against which all others are measured, rather than the notion, as all of us are aware, that health care is provided by a variety of individuals, a variety of professionals, who have a scientific base for their practice, and some of what are considered complementary providers have a scientific base and they are not alternatives to medicine they are in fact team members and partners in the process.
I would strongly encourage us to think about complementary and alternative health care practices, although sometimes it is hard to figure out what is alternative and what is not depending on where you sit in your life, in your culture, in your beliefs. So I think language is very important and it is very harmful in its process. Anything that can be done to change that would be very useful.
SISTER KERR: I noticed when you presented you said "complementary and alternative medicine and therapies." It really hit me right between the eyes there. Thank you.
DR. BEDNASH: I thought about dropping "medicine," but you are the Commission on Complementary and Alternative Medicine, and I think it is complementary and alternative health care practices and policies for those. It is not medicine only.
I am very concerned that there is a strong emphasis in today's conversations about medicine and medical practice and medical education and medical certification and examination. There is a National Council of State Boards of Nursing. I am sure there are councils for the licensure of a whole range of professionals that ought to be in this dialogue because you want to influence them as much as they want to influence you.
DR. GORDON: I would like to make one point. We agree that there has been more of a focus on medicine. In the solicitation of recommendations and considerations, we consulted all the professions, including a number of different nursing organizations. Your point is well taken. We used medicine as one example, just as a little bit later on we are going to use acupuncture and Chinese medicine as an example of a so-called CAM approach.
I had a question for Mr. Sampson. I really appreciated your remarks and I am wondering what you would have us do, what you would like us to do to support you in helping to encourage training both in this more holistic approach and in specific CAM modalities, and also for CAM practitioners? You indicated an interest in encouraging this to happen.
What can we do as a Commission? What kind of recommendations would you like to see from us?
MR. SAMPSON: You have broken down -- I mean, in terms of health professions, there are two parts. One part is conventional, the conventional practitioners and their need for information on complementary and alternative therapy and how they can be used and which ones are effective, just some information on what is occurring in various cultures and populations. That is essential because you can't treat an individual without knowing basically the whole person, and you need to know what can help and also what they are doing so that you can work as a part of that.
So that has to do with faculty development for all of the professions. It has to do with, again, curriculum reform and the integration of research findings when we do find information out into practice. We do have some programs that do that. Their primary job is to take the findings from such places as ARC or NIH or FDA or others and try to put them into practice as to how they would. Because, remember, any individual that comes out of a health professions program today has what a 30-, 40-year career ahead of them. So you want to influence the next three or four decades, that is where most of the practitioners are.
So that is one set of issues, make sure that we can provide information to current practitioners, to get faculty development and faculty mentors going and that kind of activity for the existing health professions.
The other side is for those practitioners, we can refer to CAM practitioners, there is a different problem. That one is, as we sort of describe the issue: One, there has to be an acceptance by the public. I mean, that is really where all these are going to start occurring and where they are going to grow. Then, the profession itself has to come together, has to get a core set of knowledge, has to start standardizing its approach to treatment, has to deal with the 50 state -- or 56 depending on how many you want to call -- the state licensing procedures, the accrediting requirements, and the universities and colleges and the whole educational and academic infrastructure that is going to support them, et cetera. So that all has to occur.
Then, there has to be an issue where there is specific legislation that says these kinds of practitioners -- and names them -- will be available for these range of things, which for the profession itself would include curriculum, faculty support, perhaps the support for students and a whole host of issues that are similar for the kinds of programs that support medicine, nursing, dentistry, et cetera, et cetera.
DR. GORDON: I am wondering if also one of the issues that we have heard about many times is many practitioners, both conventional and CAM -- or CAT, I suppose might be a better term, I kind of like that -- CAT pratitioners, want continuing education. I am wondering if the Bureau, as a possibility, might be interested in supporting some of the efforts at continuing education for this whole spectrum of practitioners.
MR. SAMPSON: When I started out, I said primarily taking information and putting it into practitioners, you know, those community-based programs working with the local professional groups at perhaps the nursing associations, state medical societies, local medical societies, the CE.
Yes, we do a number of those activities. What is occurring today in practice for a lot of us is that we still have individual practitioners, but more and more people are coming together in teams and working in groups. They are finding that that is really the best way to deal with the patient population. That is one of the critical bases for understanding not only the therapies but who the practitioners are. If you don't work with them, you don't understand what they can offer, how they can provide.
If one doesn't work with a social worker as a case manager for a very complex geriatric case, then the nurse or the physician or others don't understand how valuable that social worker is in making sure that the treatment plan, the therapeutic plan, can actually occur. You know, if you just send a very complex elderly patient home without knowing what is going to occur and what the home setting is, the likelihood of that individual really being able to benefit is limited.
That is where these kinds of activities -- we have found that in a number of different ways. So, an appreciation of the other practitioners is important, a kind of inter-disciplinary training. Continuing education is also where it can work, but sometimes that is difficult to do. The kind of continuing education we have today we are not quite sure, frankly, it is very effective.
So, while it is a wonderful idea, we haven't really found the necessarily best mechanism to assure that lifelong learning, which is really what CE is supposed to be, is actually occurring as opposed to, you know, a nice cruise where we go and do a little course work in the morning and then we can spend the rest of the day playing golf or something.
DR. GORDON: Would you be interested in some recommendations about effective continuing education from us?
MR. SAMPSON: That is exactly what we would be interested in. That, and as I said what we need also is then the authority to act. We are somewhat restricted. Certainly, one way to start is in the interdisciplinary part. That is not easily done in most of the academic institutions. Academic institutions, if they are training particular health professionals, they stick to their own. Pharmacy school, it is tough for them to break out.
We are trying to look at ways that -- you know, we think anatomy is the same for a physician or really a nurse or a pharmacist or another practitioner. You know, the body doesn't change that much. But that doesn't occur. And, yet, if people work together, there is an opportunity to do that.
So we would suggest that one of the things that you might want to consider is how interdisciplinary education would be very valuable.
DR. GORDON: Great. Thank you.
Do you have a quick question, Wayne? We are just about out of time.
DR. JONAS: Very briefly, I just wanted to know, Ms. Collina, has the National Breast Cancer Coalition kind of taken the next step, it seems to me the next obvious step, and that is how to really integrate patient perspective into the development of this better system of evidence-based medicine that you have described which I think is a broader system than what we currently have in terms of better research?
Because these are value issues, and it is not simple just to have a panel of lay people or patients who then sit on a few advisory boards. Have you thought about actual mechanisms as to how patient values can be injected into the research system and into the evidence-based decisions that are made?
MS. COLLINA: That is a good question. Well, I will tell one story. We have been integral in founding a very innovative research program as part of the Department of Defense. We were looking to dramatically increase breast cancer research funding, and we were told that there was a firewall, that there was absolutely nothing we could do about the fact that this money was on this side and this money was civilian.
So we just jumped over the wall and said, all right, then let's have a war against breast cancer. We would like to have this amount of money spent on innovative ways of thinking about breast cancer. And we have, through that -- I wish I had the numbers here because it would be very interesting. We, the taxpayers, all of us, have funded a dramatically impressive new --many, many new different kinds of ways of thinking about breast cancer research and some of them have included some CAM.
Although, what I would be interested in hearing from you all is ways that we could even expand that. For example, though, there are a number of ways in which breast cancer advocate involvement is integral to that. Every single panel, including the scientific peer review process, includes a trained advocate. So I think that is a model.
DR. JONAS: Do you have a training program then?
MS. COLLINA: Yes, we do. We have a science course for breast cancer activists.
DR. JONAS: So that they know how to communicate and interact in those various groups?
MS. COLLINA: We have. I know all about this. Yes. We now have over 1,000 breast cancer activists who have graduated from Project Lead, our science course for breast cancer activists. It is a very intense course. It starts about 7:00 in the morning, ends about 10:00 at night. It is five days.
Anybody who is interested, any breast cancer survivors out there who would like to have the tools of science to be able to dialogue effectively with the scientific and medical community and also just become a better advocate, has gone through this process. It is a free program. We do it four times a year across the country. We will be doing it in Europe next year. It has provided us an opportunity to become educated.
DR. JONAS: Can we get information about it?
MS. COLLINA: Absolutely.
Are we done? Because I want to try to answer a question that came up before which is this issue of -- it seemed like it was laid out as a very difficult question, the issue of should practitioners incorporate CAM into their practice or should they refer others. Was that the question or was there some question about whether that was a sort of a tricky thing, whether people should be doing the acupuncture or referring the acupuncture.
If I heard that question right, that doesn't seem, from where I sit at least, to be a very complicated question. I mean, from a patient's perspective, the issue is that the care is coordinated and that it is convenient and that it is respectful. So I don't care if I go to my -- I mean, certainly with breast cancer we are used to having a team. I don't need my surgeon to be able to do acupuncture. I just need my surgeon to understand that they are a part of a team, and this issue of interdisciplinary rises right to the surface here.
What I need is for a team of people to understand how they all relate to each other, to communicate. And I need one person, not me, to be able to coordinate all aspects of my care. I guess it doesn't matter to me, from where I sit, whether one person -- I don't need one person to do it all.
DR. GORDON: Great. Thank you. Thank you all.
We are going to take a 15 minute break, then we will resume.
MS. CHANG: If the following speakers would please come up to desk: Dr. Joseph Helms, Dr. Lixing Lao, Mark Blumenthal, please.
Plenary Session II: Continuing CAM Education
DR. GORDON: We are going to begin the next panel now, and the first speaker will be Dr. Joseph Helms.
DR. HELMS: Mr. Chairman, members of the Commission, I have been involved in physician acupuncture education since 1977. During this quarter century, the discipline of medical acupuncture has emerged and defined itself, creating its training guidelines, establishing its practice standards and regulating its credentialing requirements. I am pleased to review its history and its current status for the Commissioners and for the public.
It is necessary to clarify that I address only the discipline of medical acupuncture. That is, acupuncture as taught to and practiced by physicians who are licensed in conventional, allopathic and osteopathic medicine. I do not address other disciplines of acupuncture that are taught or practiced by credentialed non-physicians in this country.
M.D. and D.O. physicians come to acupuncture already fully qualified in Western biomedical science and practice. Having spent over 4,000 hours in their formal training programs, they are experienced as health care providers and are embracing it as an additional discipline to integrate into their practices. Most physicians limit their acupuncture practice to 25 percent or less of their professional activity.
In 1980, the first comprehensive medical acupuncture training program in the United States was sponsored by the American Holistic Medical Association, as one of its core training modules. It was accredited for 200 hours of continuing medical education and was the forerunner of the Medical Acupuncture For Physicians Program which has been sponsored since 1983 by the Office of Continuing Medical Education of the UCLA School of Medicine.
From its beginning, the Medical Acupuncture Program has been enthusiastically received by physicians and spread quickly by word of mouth and favorable coverage in conventional medical newspapers and meetings. Because medical acupuncture is an unusual discipline in medicine, one that requires the student to think and perceive in non-conventional ways, the teaching of the discipline must be clear and rigorous.
The content and organization of the curriculum and the standards of the knowledge base and clinical skills required of the didactic and clinical teachers in the UCLA program have surpassed all criteria expected for compliance with the Association of Teachers of Family Medicine and the Accreditation Council for Continuing Medical Education.
The early professional challenges faced by graduates of Medical Acupuncture Programs involved recognition by conventional medical bodies such as third-party payers, liability insurance providers, hospital staff privileges, academic status and state medical boards.
To address these and other challenges, in 1987, graduates of the AHMA and UCLA programs created the American Academy of Medical Acupuncture to represent the professional interests of well-trained physician acupuncturists. Entry membership requirements were established as 200 hours of formal training. Full membership requires an additional 20 hours of training.
The formal training of 220 hours was adopted in 1987 by the World Federation of Acupuncture and Moxibustion Societies which is a World Health Organization-sponsored entity, as a requirement for physicians training in its member societies, consistent with the full membership requirements in the American Academy of Medical Acupuncture.
In this country, as individual states created training guidelines for physicians, 200 hours was the amount of formal training uniformly adopted as necessary to develop safe and effective practice skills. The UCLA program and that of the New York University College of Medicine and Dentistry, which are the two major resources for physicians acupuncture education in the United States, maintained their training programs to conform with these standards.
The 200-hour criteria is considered to be the minimum formal didactic and clinical training to prepare a physician to safely and effectively practice medical acupuncture. It is the equivalent of completing training through the first year of medical residency. Like practicing all medical specialties, practicing medical acupuncture is a lifelong open book examination. Physicians are encouraged to work with study groups, regional chapters of the AAMA, and the national symposia of the AAMA, to broaden and deepen their knowledge base and clinical skills.
The AAMA requires an additional 20 hours of CME in acupuncture for full membership and 50 hours every three years for membership renewal. The American Board of Medical Acupuncture requires 300 hours of formal training for qualification.
Since 1984, there have been numerous meetings of physicians from Western countries to discuss the standards of physician training and practice of acupuncture. These have been sponsored by national medical acupuncture societies in the United States, Canada, Australia, Sweden, Germany, Belgium and France, and have served as the forum for cross-fertilization and standardization.
Several enduring international societies, the Pan Pacific Forum on Medical Acupuncture for the Pacific Rim Countries and the International Council of Medical Acupuncture and Related Therapies for European countries, have developed from these meetings and continue to serve educational needs and international exchange of the member countries. The common denominator in the national and international societies is integrating Western biomedical training with traditional theory and practice of acupuncture.
In 1996, the World Health Organization's Division of Traditional Medicine convened an international assembly that voted on training guidelines for different levels of acupuncture practitioners. This document was approved by the World Health Assembly and has been distributed to member nations.
Qualified physician graduates from schools of Western biomedicine who wish to include acupuncture as a technique in their clinical work are recommended to have not less than 200 hours of formal training. This training should include the history and cultural context of acupuncture, the basic theory of acupuncture and Chinese medicine, knowledge of the acupuncture points, traditional methods of diagnosis and the principles and techniques of acupuncture treatment.
The document acknowledges that qualified Western physicians already know medical theory, diagnosis, safe practice techniques and practice management, and that their use of acupuncture will address problems they commonly treat in their medical specialties. The WHO training guidelines embodied that which has been recommended and practiced in Western countries for 10 to 15 years. The regulations have been well established in all European and Pacific Rim countries and are time tested in the United States. They provide a matrix in which each training program can provide its physician students with an education in acupuncture that results in substantial theoretical understanding of the discipline and a responsible and effective technique for its execution in clinical practice.
Public safety is well protected by the current standards of training and regulation. In the United States, the American Academy of Medical Acupuncture recommends that individual state medical boards require the 200-hour minimum formal training for physicians to register as medical acupuncturists. Currently, all states except three that require physician registration follow the 200-hour standard. Most state medical boards, however, are disinclined to regulate or certify physicians in medical acupuncture. They argue that the discipline is included in the scope of practice of medicine and does not need additional registration.
In the practice of medicine, it is the hospital staff privilege and liability insurance guidelines that document quality of training. AAMA membership eligibility is the gold standard in every state for practice privileges and insurance coverage. The AAMA serves the profession and the public by establishing minimum training and practice standards for membership, offering continuing education in medical acupuncture, recommending practice privileges and liability insurance qualifications, encouraging regulation by state medical boards and by disseminating reliable information about the discipline to the public.
The American Board of Medical Acupuncture, a sister society to the AAMA, offers a certification process in medical acupuncture that requires documentation of acupuncture practice and results and passing an examination. Because the majority of physicians practicing acupuncture in the United States are graduates of the UCLA Medical Acupuncture for Physicians program, the majority of physicians in the AAMA are UCLA graduates. Membership is not limited to UCLA graduates, rather members come from all schools and disciplines of acupuncture taught in the country.
Given the wide public acceptance of acupuncture and the broad appeal of the discipline to physicians, it seems reasonable to organize exposure programs for physicians in training as well as physicians in practice. There is certainly a strong interest among medical students, residents and fellows in acupuncture and other CAM disciplines. Exposure programs are being tested in medical schools around the country and some specialty programs such as anesthesiology, pain medicine and osteopathic manipulative medicine require exposure to acupuncture.
Programs for medical students of as little as one or two hours provide useful information and orientation to the phenomenon of medical acupuncture. Half-day or full-day programs for residents and fellows can give an experience of the technique and an understanding of its role when integrated into practice.
In conclusion, with respect to the training and education, credentialing and licensing of physicians practicing medical acupuncture, I contend that the discipline has defined and regulated itself and a standard in a fashion that is acceptable by national and international standards.
Furthermore, the medical acupuncture training and credentialing infrastructure has shown, through 25 years, to be reliable for these physicians, and safe for their patients. I consider medical acupuncture to be a mature and effective discipline with a responsible training, credentialing and accountability system, and recommend that it be endorsed by the Commission in its current form.
I strongly recommend that exposure programs for medical students, residents, fellows and practicing physicians be encouraged in all specialties of medicine. Such an education exposure will inform them of the value of medical acupuncture, how to refer appropriate patients for treatment and the recommended format and content-responsible training. Thorough basic training and follow-through programs also should be made more readily accessible through conventional CME vehicles.
Thank you very much for inviting me to offer this presentation to the Commission.
DR. GORDON: Thank you.
DR. LAO: Good morning, and thank you for the opportunity to speak here today. My name is Dr. Lixing Lao. I studied traditional Chinese medicine, known as TCM, and acupuncture at the Shanghai University of Traditional Chinese Medicine, and have practiced acupuncture and TCM for more than 18 years.
Many of you may know me as a researcher because of my work at the University of Maryland where I conduct clinical trials on the efficacy of acupuncture. I was the principle investigator on acupuncture research for postoperative pain after dental surgery which was one of two uses of acupuncture which received the full endorsement by NIH at their 1997 consensus conference.
I come to you today, however, to talk about education, training, licensure and certification of acupuncturists in this country. Ten years ago, along with some very dedicated and esteemed colleagues, I founded the Maryland Institute of Traditional Chinese Medicine, a school that is accredited by Accreditation Commission for Acupuncture and Oriental Medicine, known as ACAOM, and is a representative of acupuncture schools that prepare students to become certified by the National Certification Commission for Acupuncture and Oriental Medicine.
I currently teach and serve a board member and clinical director of the school, and the comments I am about to make reflect my experience in this capacity, as well as from my experience as a former board member of the Maryland State Board of Acupuncture which regulates acupuncture licensing for the State of Maryland, and as a site visitor for ACAOM which is the nationally recognized accrediting agency in the United States for the quality of education and training in the field.
First, I would like to talk about the training of professional acupuncturists. Accredited schools provide a minimum of three years of acupuncture training program, more than 2,000 hours, with at least 500 hours of clinical training and 360 hours of training in Western medicine, and a full year of acupuncture and oriental medicine training program. The Western medical component focuses mostly on training acupuncturists to recognize signs and symptoms indicating that the patient should be referred to another practitioner, such as a physician, and also trains students on how to effectively communicate and interact with the conventional medical system.
This is similar to other health care professional, such as chiropractors, psychologists, and even physicians who are trained to work with the medical system and refer patients when necessary to another type of provider. This is emphasized throughout acupuncture training, even though it is more common for a patient to come to us after they have already pursued treatment by a conventional health care provider.
This typical three- to four-year training program is comparable with the number of training hours that are required by other health professions, and is considered to be a minimal amount of time required for understanding the richness and complexity of a medical system that has been under development for at least three thousand years.
Acupuncture and TCM is a medical system not just a collection of points on the body and, like modern Western medicine, it takes years of study and practice to achieve competency and lifetime of learning to achieve mastery. Acupuncture schools provide extensive training meridian theory, diagnostic methods, tongue diagnosis, pulse diagnosis, differentiation of Chinese medicine, accurate acupuncture point locations, various acupuncture needling techniques, principle about treatment, dynamics of acupuncture formulas for point combinations and dynamics of Chinese herbal formulas which is not unlike the combination of different drugs that, when taken together, have an effect far different from the individual components.
Perhaps the most important part of the training, however, is extensive clinical training that the students receive. Like a doctor fresh out of medical school, it is not until one gets some clinical experience that all the information and theory starts to come together in a practical way. In our school, following ACAOM's high standards, the student begins by spending 150 hours doing clinical observation, and then 500 hours where they must provide at least 250 treatments to at least 30 patients before they can graduate. Each case is discussed with a clinical supervisor, most of whom have been trained in China and have many years of practical experience.
Traditional Chinese medicine is a completely different way of looking at health and illness, as compared to Western medicine. While the bodily organs such as liver, spleen, heart, lung and kidney are the same, their function in the Chinese medicine is very different than their function in Western medicine. Therefore, someone presenting with asthma may be diagnosed with a kidney yin deficiency, and someone with irregular menstrual cycles may have liver qi stagnation. Obviously, training in Western medicine diagnosis has very little overlap with Chinese medicine. Traditional Chinese medicine in acupuncture often provide fundamental health care for the patient rather than just symptom relief.
Why I make these points to illustrate the contrast between the 2000 hours high standard acupuncture training as compared to fewer hours of training in some other health professions? I believe that it is a very positive phenomenon that more and more physicians are learning about acupuncture and chose to use it as part of the treatment options they have in their profession. When they incorporate this modality into their practice, it can significantly benefit and improve patient care, especially for temporary relief of some symptoms and simple illnesses.
However, just like a family physician would recognize the limitations by referring patients with a cardiovascular disorder to a cardiologist, a health care professional with minimum training should recognize limits when treating patients with a complicated, chronic condition that requires comprehensive treatment by a professional acupuncturist.
I must take issue that in some states even a fully trained professional acupuncturists is required to practice under the supervision of some other types of health care providers. It is incomprehensible to me how a physician, for example, with little or no training in acupuncture can be legally authorized to supervise a licensed acupuncturist. This is like requiring an electrician to supervisor a plumber. Knowledge of one field does not automatically confer knowledge of the other field, and it does nothing to assure the competency of the practitioner.
This is a public safety issue. I urge the Commission to consider this issue and be fully aware of the different levels of training and scope of practice among health professionals. People seeking acupuncture are unlikely to understand the difference in training among different types of practitioners.
In addition to accreditation standards, national certification is one of the few ways that the public can determine the level of training of a practitioner. Just like every medical doctor is required to take a board examination, most states require acupuncture practitioner to pass the national examination offered by the National Certification Commission for Acupuncture and Oriental Medicine in order to be eligible for an acupuncture license. The passage of a national examination ensures that the practitioner has the basic knowledge of acupuncture and TCM required for an entry level acupuncture practitioner.
Another reason that is very important for the Commission to look at the education, training, licensure and certification is for reimbursement. More and more insurance companies are beginning to cover acupuncture, although with many limitations and restrictions. I sincerely hope that in the near future all government health care programs, such as Medicare, Medicaid and the military, include acupuncture in their health care program. Some of these programs do not even offer acupuncture or only offer it if performed by a physician.
To assure high quality of practitioners, I hope that the Commission will recommend that licensed acupuncturists be part of the health care team to help to facilitate that to happen.
As acupuncture and TCM become more and more incorporated into mainstream medical systems, it is important that acupuncture practitioners and medical doctors work together rather than competing with each other to deliver the best health care for the patients. In the University of Maryland medical system where I work, physicians, medical acupuncturists, professional acupuncturists work together as a team referring patients to each other as appropriate. Our patients are very satisfied with the health care we have been delivering in this system. I truly believe that this should be an ideal model for the health care system in this country.
In summary, I would like to ask this Commission to recognize that acupuncture is a comprehensive medical system that requires extensive training to be fully and correctly practiced. The national standards for accreditation of acupuncture schools assure high quality and comprehensive training program and a national exam, such as NCCAOM examination, for certification of acupuncturists assures that the practitioners have a basic level of knowledge necessary for high quality care. These are gold standards for all health professionals and are important tools to protect the public from untrained and unqualified providers.
Other health professionals should have a basic understanding of acupuncture as a different approach to healing that can complement conventional treatment and be encouraged to include acupuncture as part of health care options for their patients.
Health care reimbursement should be made available to patients receiving treatment of acupuncture and Oriental medicine.
Finally, I would like to mention that the American Association of Oriental Medicine and the National Acupuncture and Oriental Medicine Alliance have read these remarks and fully concur with these recommendations.
Thank you very much, and I will be happy to answer any questions. Thank you.
DR. GORDON: Thank you, Dr. Lao. One of the things that I want to mention, just for you as well as for other speakers, is we very much appreciate efforts of organizations to come together to make recommendations together. In a sense, one part of our effort is to encourage that in the fields. So, thank you for that.
MR. BLUMENTHAL: Thank you.
I am from Austin Texas. Thank you for inviting me back to speak. I am grateful for the invitation. I hope it doesn't reflect poorly on the collective wisdom of the Commissioners that I am back here again.
I am going to be speaking about herbs only, not CAM in general, because our specialty is herbal medicine at the American Botanical Council. Basically, I have been teaching, for the last four years now, a course in the pharmacy school at the University of Texas on herbs and phytomedicines in today's pharmacy, and I have had a little bit of experience in dealing with at least those students who are in their fifth year tract for the Pharm.D. degree on how much they know or don't know about botanical medicine and alternative medicine and nutrition in general.
It is surprising and disappointing and, of course, even a one semester course in herbal medicine for these pharmacists, in my opinion, is inadequate to adequately train them for what they are going to have to deal with when they get out there in the open market either as retail pharmacists and/or as health system pharmacists.
I will stray a little bit from the printed remarks that I have given you for the record. Because you have them, there is no reason to be verbatim about it. I would like to share just a few things about our organization.
We are a non-profit organization that is committed to disseminating accurate, responsible science-based information on herbs and medicinal plants, at the same time honoring the various traditions and indigenous cultures from which those information come.
We were probably the first organization in the country to develop a home-study course for CE for pharmacists on herbal medicines, introduced with the help of the Texas Pharmacy Foundation back in 1994. Also with the Texas Pharmacy Foundation, we started a series of ethnobotany on-site herbal tours to the Amazon Rain Forest, which have now been extended to Belize, Costa Rica, and Africa twice, for pharmacists and physicians for CME credit.
So we actually take pharmacists and other health care professionals on-site into the Amazon and other places where they can see plants that modern pharmaceutical drugs are derived from, as well as how local cultures, indigenous cultures, utilize these plants in a very different but in some cases very sophisticated ways, within the context of their culture, as medicines, as well as as foods in some cases.
I would like to point out that as far as CME courses are concerned for physicians, right now, for botanical medicine, the only one I know of that is really adequate -- and even then, it is only five days which is inadequate -- is the Columbia University course developed by Dr. Freddie Kronenberg, of which several people here are on the faculty.
I usually lead that off with a course in botanical history. That is the history of herbs in medicine and pharmacy which I think is an important aspect of any CME. People need to understand the relationship that plants and plant drugs have had in the entire evolution of medicine and pharmacy. I think that was alluded to earlier.
This is a five-day course. It was originally designed for physicians. It has also opened up to other health care professionals, and it is taught by, primarily, M.D.s like Dr. Low Dog, who is here, but also Ph.D. pharmacognosists and ethnobotanists. Some herbalists and acupuncturists also participate in the teaching here.
I would like to tell you a little bit about a project we are doing at ABC in the area of CE for health care professionals. We are developing a book of monographs of 30 of the most popular herbs in the U.S. market, focusing on their therapeutics, and this book will also serve as a reference book as well as a CME and CE course accredited now by the Texas Medical Association.
To our knowledge, it is the first time a medical organization has actually accredited CME monographs on herbal medicines; also, simultaneously accredited by the Texas Nursing Association, the University of Texas College of Pharmacy at Austin, and the American Dietetic Association. So these monographs, which are extensively peer-reviewed, focusing on therapeutics, will be marketed for all the four major conventional health care professions.
It will be about 400 pages and will include not only the focus on individual herbs and the information available on them, extensively referenced, but also inclusion of fairly classic herbal combinations from Ayuveda, Chinese Medicine, some from Western Europe that have been evaluated in published clinical trials.
So we are basically showing that physicians and pharmacists should not just focus on herbals as individual monopreparations, but as well they should be aware of the fact that in many traditional cultures, in fact, the rule is that herbs are used in combinations and the exception is that they are used individually. We will focus on some of those leading combinations that have been the subject of published clinical trials in the West.
Basically, we are also going to be focusing on the branded names of those products used in published clinical studies, at least acknowledging those brands in tabular form in summary forms of tables, as well as various charts, because one of the biggest questions we get in CME and CE courses from physicians and pharmacists are, "We know about ginko, we know about saw palmetto, we saw all the wealth from that analysis of JAMA, but we want to know which brand should we recommend, which brand should we trust. We don't understand these products. We don't understand this industry. We don't necessarily trust it. What brands?"
Well, obviously, those that are subject of published clinical trials are at least the first ones that one should look at for possible evidence of their safety and efficacy, and we will be outlining and highlighting those; not to promote or support those products, per se, but at least to acknowledge the fact that they have been clinically studied, at least in one or more clinical studies. And I believe, in reference to my previous testimony back in October, this also helps provide an incentive for private investment in botanical research because people should get their name mentioned when they do clinical research.
I would also like to point out that Dr. Victor Sierpina, at the University of Texas Medical Branch in Galveston, is a recipient of a CAM Curriculum Development Award from NCAM. I am sure you are all aware of that. I am involved with that program, and there will be, I think, a great deal of herbal medicine material produced in that recommendation for how to develop curriculum in medical schools for CAM.
Ms. Axelrod asked me to deal with a couple of recommendations and questions in my testimony, so I will try to do this, briefly.
Who should be receiving continuing education? I believe, frankly, all health care professionals should get some form of herbal CE. Of course, it should be tailored to the extent that herbs show up in their particular practice, but particularly physicians of most types, pharmacists, dieticians, clearly, who are constantly helping people evaluate their dietary intake, they should know about dietary supplements and their risks and their benefits. Unfortunately, there always seems to be too much emphasis on the risk and very little acknowledgement or support for the benefits.
Nurses, as well, in various levels, depending on their exposure to patients with respect to the use of dietary supplements.
So, I think that very few medical or health care modalities are basically immune from the proposal that they should get some CE accreditation in alternative medicine, especially botanical medicine. There may be some exclusions, neurosurgeons or possibly orthopedists, but even then more dietary supplements are being shown to be useful in some kinds of classic orthopedic conditions, neurosurgery as well. So I am not sure that anybody is really immune from the need for being aware of the latest scientific and clinical research on these products.
Who should be teaching these materials? Well, this is a problem. I think there is a paucity of adequately trained people to actually address the issue of how to understand, from a scientific and clinical perspective, the risks and benefits of herbal medicines. I think that there are number of people that are fairly well qualified. Many of them are herbalists and naturopaths who may or may not have an extensive knowledge of conventional biomedicine and, therefore, might be marginalized or might not be well received by some medical practitioners or conventionally-trained practitioners. I hope that is not the case anymore. I think, historically, that may have been the case.
But the fact is that there are a number of people out there who have an extensive knowledge of herbs who are not trained in the conventional medical modality or domain and, yet, that should not preclude them from being able to offer expert instruction in this area.
What should be taught? And how and by whom should the content be determined? Well, clearly, I have already said history. I think it is important for people to know the history of their own profession, especially as it relates to botanical medicines, and I teach this at the Columbia course. I emphasize it in my pharmacy class, as well. One of our elective texts in the pharmacy class is a book called "Green Medicine," by Barbara Griggs, a British author who chronicles the development of herbal medicine in the West and how it intertwines and has been marginalized and/or oppressed at various times in the Western world over the last 2,000 years.
I also think some degree of information about regulation of herbal medicines needs to be included. I think there is too much misinformation or lack of knowledge by conventional health care practitioners about the regulations and/or underregulation, as the case might be, or lack of enforcement by the agencies, as different people might characterize it, on herbal medicines and the distinction between the regulations on herbal medicines and dietary supplements compared to conventional drugs.
Of course, therapeutics, and it is in here as well, but I think the therapeutics should focus not only on the risks, but also support the benefits.
The rest of my comments are in here, and I would like to point out that I have also included some recommended reference materials and texts, some basic outline of my class in the pharmacy school, and the basic outline of the monographs that we are publishing at ABC for health care practitioners.
In conclusion, I would like to say that one of the primary recommendations that I would recommend is that any kind of CME or CE courses be adequately and appropriately peer reviewed by people knowledgeable in this area. It is very discouraging to see information published in medical and/or pharmacy texts and journals regarding herbal medicine that are often misleading or grossly inadequate. I have cited a point here in the written portion here.
There is a lack of adequate reviewers in this area, possibly, or the lack of proper review. I think this merits your attention because some of the material being published from conventional publications is lacking in accuracy on these herbal medicines, and this is something that needs to be addressed if this is going to be included in any kind of course.
I thank you for inviting me.
DR. GORDON: Thank you very much.
DR. BRESLER: This is for Dr. Helms. First, I want to congratulate you on your pioneering work in developing your training program for physicians and how you stood up to the early criticism that you must have had in doing so.
If we look at your program as a model for other training programs that will bring physicians up to speed in CAM procedures, we also have some concerns about scope of practice issues. We have heard a lot of testimony from people who have concerns that patients will go seek alternative practitioners and, therefore, not have access to conventional care which has proven efficacy.
The question that I have is: When you compare the scope of practice for people that have had 200 hours of training versus those who have had 2,000 hours of training, I have no doubt that physicians could treat musculo-skeletal pain problems with that level of training, but if you are dealing with complex issues like endocrine disorder and so forth, looking at it from a TCM point of view, do you feel that your practitioners have adequate training to be able to handle that as well as the non-medical practitioners? And, two, if you feel that they don't, do they ever refer these complex cases to the non-physician acupuncturists?
DR. HELMS: This is an important question that always comes up in the discussions of comparing the training expectations of physicians who are embracing acupuncture as an additional discipline and those health care providers who have traditional Chinese medicine as their primary or exclusive health management offering.
The physicians who come through the program are all licensed, fully qualified by American and Canadian standards which as we know are the highest qualifications in the world for practicing responsible medicine, and they bring that entire discipline to bear on every decision they make, whether they are using chemotherapy or acupuncture as their chosen treatment modality.
Clearly, 200 hours does not cover the full spectrum of traditional Chinese medicine and it is not designed to do so. It addresses acupuncture from a neuro-anatomical, neuro-physiological basis, as well as from the tradition of acupuncture, divorced from the rigors of the herbal diagnostic system under the rubric of traditional Chinese medicine.
So the acupuncture quality that a physician trained in medical acupuncture walks out with from a program is, I claim, equal or superior to the acupuncture training that non-medical practitioners are given. The difference has to do with embracing traditional Chinese medicine as a separate discipline. That is where physicians are not engaged.
The complexities, the application of traditional Chinese medicine to complex chronic medical problems, particularly internal medicine problems, are often far more responsive to Chinese herbal input than they are to acupuncture alone. That is made clear to the physicians who are participating in the program. And, when herbal evaluation and treatment is indicated, physicians are instructed to have adequate training himself to address that or to refer the complex patients to work collaboratively with the licensed TCM practitioners.
So we are not comparing acupuncture and acupuncture with your question. Your question implies the comparison of medical acupuncture which is embraced by physicians for incorporation and integration into their specialties versus the discipline of traditional Chinese medicine as imported from Communist China.
They are different disciplines. They overlap in some of the acupuncture perspectives, but the versatility and flexibility of the acupuncture that is taught to the physicians in a 200-hour program is adequate to responsibly apply it not just to muscular-skeletal problems, but to general medical as well as specialty medical problems as well, as either a sole intervention or as a complement the conventional medical intervention.
When it is serving as a complement to other CAM disciplines, then obviously the physician, as he would with other specialties in medicine, would work collaboratively with other CAM practitioners.
DR. BRESLER: Do your graduates, in fact, do that? Do they work in collaboration?
DR. HELMS: Yes. Yes.
DR. GORDON: Effie.
DR. CHOW: I think there is value in both aspects, but I wonder if Mr. Lixing Lao would expand on -- because, Dr. Helm, you are saying that the traditional acupuncturists have the same training. Could you elaborate on, without the herbal training, how many hours of training does the acupuncture version have.
The other thing is, are the organizations in communication? Because there is lots of discussion that we should all work together. Perhaps the medical doctors who are trained in acupuncture have not had the exposure to the extensiveness which acupuncture can work with the individual in complex cases and that the exposure is important. Because if you haven't had exposure, you can't expect them to know.
Could you or both of you make comments on that.
DR. LAO: As I mentioned in my speech, I already mentioned that there are two programs. One is acupuncture purely program is about 2,000 hours, and the other program acupuncture practitioner program, usually about 3,000 hours, approximately.
DR. CHOW: So the acupuncture is 2,000 hours?
DR. LAO: Yes. Yes, approximately. I want to emphasize that usually acupuncture treatment is not just points and meridians. They are also based on the TCM diagnosis. This part takes lots of hours, if I answer the question.
The second question is mainly how to collaboratively work with other physicians. I think this is also, recent years, I think since the awareness of usefulness of acupuncture brings up, more and more physicians get more and more open minded and accept acupuncture treatment. So, from my own experience, I can tell I get lots of referrals from physicians. Also, the medical acupuncturists, we work together very nicely. The acupuncturists also refer patients to physicians when they feel there is a need for the diagnosis for medication from physician, they work together. I think this is the direction.
DR. HELMS: I would like to address your question of the comparison of the training. The 2,000 hours that are involved in training a student wishing to embrace the health care discipline of traditional Chinese medicine or the acupuncture division of traditional Chinese medicine starts with basic exposure to medical sciences, to the basic sciences, to physical examination and necessary in that process is training a student how to be a responsible and safe primary health care provider.
2,000 hours are not spent exclusively training that person in acupuncture. Physicians come to acupuncture training as added specialties. They are already fully trained as primary care providers, fully licensed as practicing physicians, and they come to acupuncture with the ability to embrace this additional discipline to incorporate into their practices.
So the difference in hours is not the valid comparison. The valid comparison is the content of the program and the evaluations of the skills and knowledge base that are accomplished in each of the programs. I would contend that I would place my best student in equal status with the best student coming from a TCM program and my worst student with the worst student coming from a TCM program, and I think that we have practice parity.
DR. CHOW: The part is that, do you see a collaboration on a larger level? You are saying you are collaborating. Is there a collaboration on a larger level with the NCCAOM?
DR. HELMS: To my knowledge, there is not a direct collaboration between the physician and the non-physician professional societies. There is exchange of the material of the disciplines in that physicians who have gone through full TCM training are teaching in the physician environment and are bringing the quality of the full herbal model and the herbal diagnostics and the application of TCM to complex medical problems either as exposure or as in-depth courses for physician acupuncturists.
DR. GORDON: Tom, and then Charlotte.
MR. CHAPPELL: Mr. Blumenthal, in your presentation we get down to the what should be taught question. This group is hearing a lot of different recommendations about how we handle standards and safety and efficacy issues concerning herbs. We have had recommendations of creating standardization.
As I understand herbs and our knowledge of herbs to date, we don't know what active elements in certain herbs are doing the actual work. There is more research needed before we could boast standardization. At the moment, we are standardizing markers instead of active ingredients.
Given still the lack of ability to land on a single active ingredient the way we do in FDA sort of orientation to drugs and to build a claim around a single drug, how do you think we should approach the consumer's concern, the physician's concern, for employing more herbs in their well being and health care? What can we do to improve the confusion or the quality?
You do address this in some respects, but the language you use is that it bears clarification.
MR. BLUMENTHAL: Well, thank you, Tom. That is a $64 question you are asking there.
The issue of standardization deals with the fact that herbs are, by nature, chemically complex, which is part of the natural situation, and that different herbs, even the same herb will have different chemical profiles depending on where it is grown, how it is grown, chemotypes, processing procedures, et cetera. This is anathema to a chemist, pharmacologist, pharmacist who is trying to focus on one single ingredient based on the reductionist biomedical model. At the same time, we have evidence that different kinds of non-standardizable preparations can be clinically effective, as documented in published clinical studies, as published by Dr. Francis Brinker [ph] in "HerbalGram 46."
There are a number of studies on "non-standardized preparations." The issue of standardization goes well beyond chemistry, as well. There are standardization issues that go from agricultural production of these herbs as well, which is from the ground up. I mean, that is another issue as well, but it is part of quality control. The standardization is often a chemical conversation in the popular domain, but it really goes beyond that into quality control issues; determining what seed you are going to use, how you are going to process. Those are all part of standardization.
The issue I think that you were speaking about is how do consumers and health care professionals identify products that are reliable, safe, effective and repeatedly reliable, and that is not always easy to deal with. There is no published GMPs at this time that deal directly with botanical products. FDA was rumored to have published GMPs, the four dietary supplements that were supposed to be --
DR. CHAPPELL: You mean, Good Manufacturing Practices?
MR. BLUMENTHAL: Yes, Good Manufacturing Practices. Thank you. That deal with quality control, quality assurance, standard operating procedures, et cetera. FDA did release those in the last year. They got slowed down at OMB, Office of Management and Budget. Now, with a new administration, everything is up for review, so we don't know. I think they were withdrawn, I guess, or pulled back. We don't know where the GMPs are at this time, as far as the process, if they will be published in the original form that was recommended by FDA last year, at the end of last year.
We don't have operative GMPs dealing with herbal medicine, so the industry and various members of the industry have had to ascribe to GMPs on their own on a voluntary organizational level. The baseline being the GMPs that are required for all conventional foods because legally herbs are foods not drugs, except for the few that are approved as over-the-counter drug ingredients like cineole, aloe, cascara, et cetera, and psyllium.
DR. CHAPPELL: But there are GMPs for food, drugs, beverages, everything else that we consume, and herbs are the only ones that have no GMPs.
MR. BLUMENTHAL: Well, herbs do have GMPs, but the GMPs are the default GMPs required for conventional foods. There are no specific GMPs for herbs or dietary supplements. Those are pending, but the GMPs that do govern herbs are the same GMPs that govern tomato juice, apple juice, fruit cocktail, salsa or anything else that is a conventional food, until such time as these new GMPs are released.
Even then, by the way, when those GMPs are released by FDA, at whatever level they are going to come out, based on what tinkering that may or may not happen with the new administration, there is an exclusion for small businesses that exempts various companies. I think the small business exclusion under the federal government definition is something like somebody with less than 300 employees which, as you know, is probably going to exempt most of the people making herbal products except for a very few.
So the real challenge here, I think the bottom line is that there are a number of voluntary initiatives by different individual manufacturers and organizations to meet or exceed levels of GMP that are not yet required by the government. It is voluntary.
DR. CHAPPELL: But the industry would not resist --
DR. GORDON: Excuse me. I think we really need to focus here on education and training. Afterwards, Mark has already said that he would be available to us for consultation on some of these other very important issues.
DR. HELMS: Mr. Chairman?
DR. GORDON: I would like to go with Charlotte.
Joe, you would like to ask an herbal question?
DR. HELMS: No. I am wondering if I might be given a moment to offer some recommendations from my perspective as an educator in medical acupuncture that ties into some of the discussions that were already brought up this morning, at the conclusion or before the discussion continues.
DR. GORDON: Sure, if it is brief, because I want to give the Commissioners a chance.
DR. HELMS: I can be brief.
I think it is, first, important to identify that, for physicians learning acupuncture, the environment in which they are learning sophisticated acupuncture is as a continuing medical education event. We have spent a fair amount of time interviewing and working with our clinical preceptors who are involved in academic training programs, and the uniform conclusion is that, in the case of exposure to medical acupuncture to medical students, less is more. A brief exposure showing the clinical value rather than trying to give a full program would make sense. However, when one goes to the resident level or to particularly the fellow level then fuller programs can be done.
In the ideal of worlds, if we are going to open up the spirit of integrating CAM disciplines and CAM consciousness into medical training, I would love to have access to all first-year medical students during the first two weeks of their education so that I could expose them to the philosophy of diagnosis and treatment models contained in acupuncture so that they could have that in mind as early steps of what they can do to better understand their patients as they are seeing them and, even if it were a fully integrated program, give them gradually more complex therapeutic work as they go through their training.
Obviously, this needs supervision to make it work, which is my second point. The area that needs most attention in terms of growing, simple exposure or more complex training, is trainers. Training trainers, I think is a very important area for considering funding and assistance. It is one of the areas that is underdeveloped in the private sector involved in acupuncture training. It is to be emphasized here that academic centers, university academic centers are not necessarily the best environments for creating responsible exposure to CAM training, even for physicians; hence, the value of the post-graduate CME vehicles.
The other area that could be enhanced for propagation and quality in physicians practicing acupuncture are resident centers where clinics that are supervised by trained trainers are available to graduates of the CME programs for an extra week or a month or six months of exposure to acupuncture practice. That is not currently available because most of this work is done in private environment. Again, I am not convinced that academic centers are the most flexible to accommodate this notion; hence, breaking some barriers in terms of funding, training the trainers, funding resident programs might need to be considered for most effective integration.
DR. GORDON: Thank you. Charlotte, and then Tieraona.
SISTER KERR: Thank you. This is specifically to acupuncture. Thank you, first, to both of you, your pioneering work. You are part of a long history in America.
I want to follow up on what Effie said. Your presentations, to me, were two of the clearest I have heard on two particular visions on acupuncture education and practice in America. The discussion about how many hours with the physician and your opinion, we have heard from other presenters in terms of the non-physician acupuncturists.
It was not clear to me, Dr. Lao, when you responded to Effie's question -- I was clear you say you thought the physicians and the non-physician acupuncturists worked together, the medical acupuncturists, and that was working very well. It was not clear to me what your opinion was as to whether or not you thought that was enough hours.
I understood, Dr. Helms, that you felt that, for example, the 2,000 hours, much of what is taught would have been included in your preparations as a primary care level as a physician.
So, I would like you to clarify further what your opinion is on that.
The second, Dr. Helms, is for example, in the 2,000 hours, some people though it would be -- I suspect you might say it is not within your realm to comment on nursing, particularly, for example, nurse-practitioners have a lot of background and preparation. Do you feel, perhaps, something like a 200-hour course could be appropriate for other health care practitioners and have you done any collaborative work in that area?
The other thing, Dr. Helms, is what would happen if the recommendation came out that the 200 hours for physicians was not felt to be broad enough for the practice of acupuncture in America.
DR. LAO: Let me clarify my opinion. Actually, I addressed it in the speech, but maybe too fast.
SISTER KERR: I got it. Your speech was superb, but I still wasn't clear.
DR. LAO: As I mentioned, actually, I would encourage it. I think it is very good, phenomenal, that lots of physicians get interested in acupuncture training. I think it is a very good thing because they can significantly benefit the patients on a daily basis, because lots of patients come with just with a headache, toothache, and they can use acupuncture to relieve the symptoms.
As I mentioned also in the speech, I will give you an example, like family medicine practitioners, they always refer patient with cardiovascular disorder to the cardiologists. So everybody has specialists.
I think, in my opinion, that professional acupuncture, that is like a specialty. In certain cases, we can refer to each other, with physicians and medical acupuncturists working together. This is my opinion.
I will give an example. At University of Maryland, a complementary medicine program where I work, we work together very nicely, and patients are very happy about the collaboration that we have.
Is that clear enough?
SISTER KERR: So that, if there was collaboration and understanding scope of practice, you feel fine about it?
DR. LAO: Yes.
SISTER KERR: Okay.
DR. LAO: That is right.
DR. HELMS: To address my part of your question, I think it is less important to compare hours of training than it is to compare content of the material covered and the evaluation of the mastery of the knowledge base and the clinical skills through observed evaluation and written examination.
The training that is expected for membership eligibility. Ultimately, board certification by the American Board of Medical Acupuncture is consistent with World Health Organization guidelines for all acupuncture, all core acupuncture training, not just physician acupuncture training. This is consistent in the teaching programs, as well as in the examination process. So, if we compare content and performance, we are certainly working on an equivalent product in terms of acupuncture ability.
With respect to other medical disciplines that have parallel training in the biomedical sciences, certainly dentists, podiatrists, dental surgeons are accepted into the programs because they fall under the rubric of physician practitioners in the United States and have parallel basic training and clinical training to be able to integrate the material intelligently.
Nurse practitioners and physician assistants because they have additional training beyond regular nursing training probably would qualify for a modified training program, modified from a TCM-based to a 3,000 hour program, if the goal of their practice is to work in collaboration with a physician environment where the physician is practicing acupuncture.
So, certainly, that would be a reasonable avenue to explore. In fact, a couple of trial admissions were made into the UCLA program of nurse-practitioners and physician assistants. Certainly, those who came through were qualified to handle the material. They didn't have the clinical judgment that is assumed in a physician that goes through it, so additional modification would be necessary to make a program worthwhile, probably an expansion of that.
Your third question of what would my response be if the Commission recommended that 200 hours is not adequate training for physicians in the United States; to that, I would appeal; to that, I would ask you to appeal to the weight of international accord. This issue has been discussed, identified by national societies, international meetings, international societies and international medical organizations such as the World Federation of Acupuncture Societies and the World Health Organization. For the last 14 years, all formal documentation addressing physician training for an appropriate level of safe, responsible and effective practice has come to the number of 200 hours of formal acupuncture training.
DR. GORDON: Thank you. We have one very quick question, one very quick answer. We are already behind time and we need our full lunch hour, not just to eat in peace but also we have some training that needs to be done.
DR. LOW DOG: Mark, thank you again for coming and for all the great work that the American Botanical Council has done. You spoke about education for health care practitioners which is very important, but I am a little bit interested in your thoughts about education and educational standards for herbalists because that has been raised several times here about variation in training, et cetera. I am not talking about an intact cultural education; if you are a Navajo person training on the reservation, you are going to get the education. I am talking about everything else.
MR. BLUMENTHAL: Well, I wrote an article a few years ago, I got a lot of heat and hate mail on it, called "What is an Herbalist." Because that term is not well-defined under any laws of licensure or practice that I know of and it is basically used quite liberally by a number of different people, including people who are manufacturing or making products at home, people growing herbs in their garden, people who have a clinical herbalist or medical herbalist type of shingle out that are unlicensedly doing some kind of health care guidance counseling of some sort, some people who have gone to become acupuncturists so they can have some legitimate cache to deliver medicine but within the context of an appropriately licensed modality.
For starting off with, it is unclear what an "herbalist" is in legal terms. In practical terms, I think you and I know that it is somebody who is trying to use herbs for health care purposes. The herbalists themselves, to my knowledge, the ones that get together under the guise of the American Herbalist Guild, I don't think can even agree on this issue is the problem. They spend a lot of their time just discussing should there even be licensure or not. That is one issue. And, to what extent should there be some sort of training.
There is a group called the Botanical Medicine Academy, which is comprised of herbalists and naturopaths, and they have gotten together with the American Herbalist Guild to try to put together some core curriculum criteria for developing ways to communicate outside the herbal community to health care practitioners. I referenced that in my written remarks. But I think the question you ask is global, and I think it is very difficult to come down with succinct answers to how one sets up criteria for evaluating and training an herbalist because it is such a widespread area and it covers many different modalities and cultural issues as well.
DR. GORDON: We are going to have to stop. I know we could go on for a long time, but we would like to be able, with all three of you, if we have further questions, to be able to ask you about some of these issue. I think you really presented a very good groundwork for us to begin with, so thank you very much.
MS. CHANG: If the last panel would come up to the table before we break for lunch: Denise Murray Edwards, Sue South and Dr. Murray Kopelow.
DR. GORDON: Dr. Kopelow, is the information correct that you have to leave at 12:30? I would like to ask you to present first, and we will have a few minutes for questions for you specifically. Then, we will ask the other two presenters.
I appreciate your indulgence on this.