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 Volume I

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 Monday, December 4, 2000
 (Afternoon Session)

 Hubert H. Humphrey Building, Room 800
 200 Independence Avenue, SW
 Washington, D.C.

 A F T E R N O O N  S E S S I O N [1:35 p.m.]

 Public Comment


DR. GORDON: This is the section for Public Comment. We are going to have three panels of four persons on each panel. I would like the first panel to come forward. It is Francine Butler, Nancy Dolores Kolenda, Diana Chambers, and Rustrum Roy. Oh, we are going to get two panels together. This is our logistician here. We would like the second panel to come up. It will make life easier. David Murray Blalwas, Kathleen Golden, Natalia Egorov, and David Edgar Molony, please. What we will do is we will have the first four speakers and then we will have a time for questions from the commissioners, and then the next four speakers. Each speaker in public comment time has three minutes, and we are going to be ruthless. So, we invite you to make full use of your three minutes. First is Francine Butler.

MS. BUTLER: Thank you. Good afternoon, everyone. On behalf of the members of the Association for Applied Psychophysiology and Biofeedback, I want to express thanks to the Commission for inviting us to share some thinking on access, delivery, training, and credentialing of CAM providers. I serve as executive director of the Association representing an organization that is 32 years old, has 1,800 members in several disciplines. We are primarily psychologists, I would say about 65 percent, physicians, and nurses each represent 8 percent, social workers, physical therapists, occupational therapists, dentists, chiropractics represent another 12 percent, and the balance are students. Biofeedback is one of the most well-established of the CAM therapies. The efficacy of biofeedback for the treatment of specific disorders compares favorably to traditional medicine. There is a large body of scientific work demonstrating treatment efficacy and absence of adverse side effects. Only a month ago, HCFA agreed to recognize biofeedback for the treatment of incontinence. Nevertheless, biofeedback is not a household word, nor is it an accepted word in traditional medical treatment. The largest problem with access and delivery that patients confront is denial by third-party payers because biofeedback is still branded as experimental. Individuals should not have to be forced to turn to other procedures with high-risk factors when biofeedback has virtually no associated risk factors for treatment, nor should patients who are unable to afford services be encouraged by physicians or insurance companies to use medication or therapies that in some cases may be less effective or simply treat the sympto

MS. We recognize that more research is needed. Like other CAM treatments, biofeedback has not been provided adequate clinical research funding to conduct necessary large-scale clinical outcome studies, so that treatment can be evaluated as to efficacy and risk, but biofeedback and other CAM applications should not have to be held to higher standards than other medical protocols, of bearing the proof of burden of efficacy either. Access is more than just finding a practitioner. It means responsible delivery of, and public access to, quality information about the conditions for which the treatment has efficacy. It implies developing guidelines for good practice management and delivery of service. It implies developing a knowledge base and ensuring that practitioners have met at least minimal criteria to deliver treatment. I am proud to say that biofeedback has met all of those criteria. APB, the membership association, has developed practice guidelines and standards. We have prepared white papers on efficacy, and we have developed consumer information brochures. Most importantly, we recognize the need for identifying providers, and through the Biofeedback Certification Institute of America, we developed a procedure for credentialing practitioners. Our goal is to see that this credential be the recognized standard of practice in this field. Hopefully, we can be a resource to the Commission and to other colleagues as they develop these areas in their practice. Despite these efforts, our work is not done, and we are far from it. With the good officers of the Commission and the NCCAM, we will have support to complete the needed clinical research and remove the barriers to acceptance in the third-party arena. In turn, cost effective and efficacious biofeedback will contribute to benefit our citizens' health and welfare. Thank you.

DR. GORDON: Thank you very much. Nancy Dolores Kolenda.

MS. KOLENDA: Good afternoon, everyone, and I thank you for allowing me to be here and express some of my ideas concerning advancing clinical research. I am the director of the Center for Frontier Sciences at Temple University, and in my 13 years there I have seen a real revolution come about and acceptance of new complementary and alternative medicine therapies. The question that I raise today is what can be done to expand the current research environment, so that practices and interventions that lie outside conventional science are adequately and appropriately addressed. Well, my response to this question is the fact that it is important that the major medical schools and research centers throughout the United States have access to funding to set up models to study various CAM therapies, such as herbal medicine and homeopathy and acupuncture. I believe it is important for the NCCAM and the firms that are related to these various therapies to make this funding available to these schools and institutions. The idea that I really see fourth in this is that when you review the latest figures as to what is being spent on CAM therapies, you can see that there are firms benefiting from these investments, and they, in turn, must be willing to invest in furthering the research on such therapies. I have really seen the importance in it right now because our major medical schools I may say, speaking from our own and Temple, are going through critical financial crises right now in health centers, and I am sure they would be more open now than ever to incentives to advance the research in complementary and alternative medicine therapies, and encourage that we help to find that for them and make it accessible for them, and stimulate them to do so. I thank you.

DR. GORDON: Thank you. Diana Chambers.

MS. CHAMBERS: Good afternoon. It is good to be with you again. Before addressing the issues of access and delivery, I just want to pick up on the conversation that we started in October on language and philosophy of healing, because I have been thinking about it some more, and we have been discussing it at length with different leaders in the field what the options might be. We have thought about matrix medicine or multidimensional medicine, and all sorts of things, but at this point, Friends of Health is recommending using the phrase "whole person healing" as the phrase to best describe the practices for which we are advocates. "Whole person" moves us beyond the distinction of mind and body, and allows for inclusion of the spirit dimension, and "healing" is preferred over "medicine," the latter being so associated in many people's minds with drugs or a pill. We are concerned to recognize that the practices for which we advocate have their own long-standing foundations, and they should not be defined over against conventional allopathic medicine. As far as philosophy is concerned, we want to recognize that in integrative medicine we have the meeting of two vastly different philosophies, with Western high-tech medicine focused on fixing, fighting, and curing disease, while whole person healing practices focus on prevention, wellness, and health. Probably the greatest distinguishing factor between these two philosophies can be found at the point of death. While Western allopathic medicine treats death as an event always to be opposed and avoided at all costs, whole person healing recognizes that death is part of the human experience, and it is possible, and indeed a part of healing, to die well. So, Friends of Health wants to ask the Commission to include within its work a very careful review of these issues of language and philosophy, knowing that the ways in which we name practices define them and affect their very nature. The language of CAM is clearly limited. Many of the people testifying in front of this commission have evidenced their frustration with the language, and these limitations need to be addressed before the practices that we care about lose their essential nature because of the language that we apply to them. I also want to say a couple words about access and delivery. Friends of Health has a particular commitment to the poor and underserved population, so I am delighted to have an opportunity to say a couple of things for them. The first question you raised was do patients and health care providers have ready access to CAM practices and interventions, and clearly from the perspective of the poor, the answer is no. The constituency with which we are concerned is the poor, both urban and rural, and other than a few notable exceptions, such as the wellness center at N Street Village here in D.C., that offers whole person healing practices to women who are in transition from drug and alcohol abuse and were formerly homeless, there are almost no targeted provision of such whole person healing services. For those without insurance and who cannot afford to pay out of pocket, there is no access at all to these practices, and this must be addressed both for issues of equity and also that this constituency places a significant burden on the public purse, which could be alleviated through preventive whole person healing practices. I have some ideas as to what we might do about that.

DR. GORDON: Thank you. Rustrum Roy.

DR. ROY: Thank you,

MR. Chairman. I bring a slightly different perspective from most of our colleagues here, that of a working scientist, a physical scientist, 50 years on the faculty at Penn State, 25 years directing its major physical science lab, and deeply in the state about science today from nano stuff to diamonds. I am involved in the whole integrative medicine, friends of whole person healing group through my mentor, Linus Pauling, to my friendship with Norman Cousins and Yvonne [Illich] and Chopra, and that is how I have gotten into it for 25 years. From that perspective, I am going to respond to your questions about access. Access for whom? There are three communities I want to identify, which have not been touched on much. The first community is the half million physicians in harness -- I am not talking about new medical students -- in-harness physicians. Are they being given the appropriate knowledge about whole person healing? The second population is academic scientists or the world of science, research scientists, and the third is the general attentive public, which, in theory, we call the attentives. The first one, how the present approaches are much too small. You need real emergency education program for the in-harness physicians. The consumer public is going to them, and how are you going to attack him? I work with Andrew Weil at the University of Arizona. We take four fellows a year, and now we are doing CME stuff. Maybe we will get 100, but that is piddling compared to the problem. So, you have got to think of an emergency, not making them into alternative providers, but making them into knowledgeable about and how to guide people. The second population is the world of science. In science, we have moved beyond all this pettiness. We are in a globalized world where we take information from China, from India, from anywhere. Here, we are stuck in a Western model. You have to get out of that. This is not the only source of truth. So, if the Ayatollah is running around telling people what science is, and they have had the press up until now, we really have to change that attitude among the scientists with information. We have collected a group of the highest powered world scientists, and these people will be working now for the next several years on presenting to show that science in the best sense is not opposed to alternative medicine at all. In fact, it may very well be the basis. To the public I give you an example of a newspaper, the Pittsburgh Post Gazette, as compared to the Times or the Post or the Los Angeles Times, does a wonderful job on educating its citizens in Pittsburgh about the kind of stuff that alternatives do, a modest, balanced presentation, so that we don't hear it occasionally as some funny stuff over here, so we need that. Now, I have got a recommendation. I worked with the President. In Reagan's administration, we had zeroing out of science education. What you need, I think what our country needs is whole person healing education, a crash program. The Congress took it from zero to 700 million now, and we can have a modestly ramped-up science education program, CAM education program.

DR. GORDON: Thank you. Panel Discussion

MS. SCOTT: Thank you all for your presentations. I was wondering if,

MS. Chambers, you could elaborate on some of your thinking about access to those communities of people who typically don't have access, and include some of your recommendations for how you would make sure that this population is included.

MS. CHAMBERS: Yes. Thank you. The question that the Commission had asked was how can access to safe and effective CAM practices and interventions be improved. Well, for the poor, the real question is how such practices can even be introduced, let alone improved. So, I believe that the first step is to identify the most prevalent conditions that threaten the health of the poor, such as obesity, heart disease, diabetes, drug and alcohol abuse, and determine which whole person healing practices might be most efficacious, such as acupuncture for the treatment of recidivism in alcoholics. Then, given the culture of poverty, which is the environment of the poor, I believe there must be a tremendous commitment of quality resources to affect even marginal change. One basic step in this direction would be the expansion of Medicare and Medicaid to cover whole person healing practices and products with the associated financial commitment to support this expansion, and then if provision of whole person healing practices and products for the poor were taken seriously, not only is the potential for significant cost savings, and hence broader provision through the release of resource, but -- I feel very strongly about this -- is the knowledge that the poor have been treated and welcomed as whole persons, a dignity that in the field of health provision, the more privileged have been able to claim for themselves. So, for actual delivery to the poor, speaking from my personal 10-year experience of working with inner city programs that are concerned with the poor, I can testify to the obvious, that religious institutions offer by far the most effective systems for delivery to the poor of information, encouragement, and group support practices. These systems have been shown many times over to be substantially more cost effective than federal and local government initiatives, so I feel that a coherent strategy for involving religious institutions in the provision of whole person healing practices and products should be introduced. Thank you.

DR. GORDON: Effie.


DR. Rustrum Roy, your concepts for the first two was very interesting. What is your third, the general --

DR. ROY: The general public?

DR. CHOW: Yes.

DR. ROY: In the National Science Foundation where we now have $700 million for science education, remember, it was zero, it is $700 million per year, we do science literacy. That is at the level of the general public, and we do also science education for making scientists. Now, let's address the population of the general public. We need CAM literacy among the general public. It is the kind of thing which the League of Women Voters did a wonderful job in the seventies on educating about the nuclear threat. It was very balanced, they got the best advice from DOE, it was earlier in those days, and we can do the same thing. We can give balanced education for the general public. We have an excellent model, and I propose that we have a joint -- maybe the Public Health Service and NSF jointly. NSF has a lot of experience in doing this kind of getting science knowledge out to general public, which they never use, by the way, and we spent $700 million on that, and we now need CAM knowledge, so they can use it. A lot of us know that wellness is going to be the most cost effective. So, I would think that the model that we have is existing, it is funded, I don't know, a few hundred million bucks, in the NSF and the federal agency to do exactly what I am talking about in the area of CAM.

DR. CHOW: If you have the model, is that possible for you to send it in to us?

DR. ROY: Of course, of course, sure.

DR. CHOW: We would appreciate that.

DR. ROY: I will. Thank you.

DR. GORDON: Charlotte.


DR. Roy, thank you for your presentation, and all of you. I would like you to speak -- you can just go off from here because I know you can say a bunch of things -- about the new science, the world science, and the implications for research in alternative medicine.

DR. ROY: Well, it is not really new in a way. When quantum mechanics was introduced, most of the people missed the significance of it. You remember that Einstein opposed it for 27 years. I have quoted him at least 20 times when he opposed quantum mechanics. But the real implications of quantum mechanics opened the door for many of the phenomena which we see. I have come back on the red eye from Honolulu to get here in time for this, and we had a whole groups of presenters in Honolulu on this kind of topic about saying what is the model of science which permits the interaction of humans with so-called dead matter, and what are the models in which we can see many of the phenomena manifest in Qigong practice, that we used to say, well, this is all nonsense from China. Well, you know, acupuncture was also labeled that way. Within science, there is nothing to say then. Science from Aristotle to all the great, we have said, science is based on fact, not on explanations. The facts are the first principles of science. I am quoting [Nicho] Mccann Ethics from Aristotle. So, in a very real sense, science permits us to go where man has never been before, women had never been before. We can go to some of these new, well-established scientifically validated and empirical data in China and India, and so on. We should look at them. We don't stamp them and say this is okay, but we should look at them.

DR. GORDON: Thank you. Yes, Conchita.

DR. PAZ: This is for Francine Butler. I was wondering if there is other areas besides the incontinence issue that biofeedback would be real helpful for.

MS. BUTLER: Yes, indeed, there is a whole panoply of applications for which biofeedback has been demonstrated effectively. Just for fun I brought our notebook on white papers with us, and this is a summary of probably 16 different applications, quick summaries with the kinds of applications and the data used to support these demonstrations.

DR. GORDON: Buford.

MR. ROLIN: This is for

MS. Chambers. You gave an example of acupuncture and how it could be used. Are there models or do you have any data for other models that you may submit to us?

MS. CHAMBERS: With regard to acupuncture specifically?

MR. ROLIN: Right, acupuncture or any of the other areas that you mentioned.

MS. CHAMBERS: I can certainly get that acupuncture materials for you. The traditional Acupuncture Institute has been doing a study at -- I think it is called Penn North -- Penn North in Baltimore, that has shown a lot of advantages of the use of acupuncture and a lot of cost savings, working with the disadvantaged population, so, yes, we can get that to you.

DR. GORDON: Buford, there are two also at Hennepin County where Pat Culliton works. They have done work with alcoholics, and we can ask her for that, and in New York, Michael Smith will be presenting on work with addicts, that he really organized. There are a couple hundred programs now around the United States based on his original work with addicts, that I think will be interesting. We can get those, as well.

MR. ROLIN: Thank you.

DR. GORDON: Any other questions?

DR. JONAS: I have an issue with the suggested approach, Diana, that you had for approaching the whole person healing. You took really what was a reductionistic approach to a holistic phenomena by suggesting that we look at the most common diseases and then see which treatments would effectively alleviate them. A whole person approach, in my perspective, would, in fact, look at chronic disease in general, and look at ways in which health can be promoted and thus a variety of conditions alleviated including improvement in function and this type of thing.


DR. JONAS: It is a little bit difficult to then conceptualize how to deliver that in a disease-oriented, trained, reimbursed health care system, so I am just wondering if you had any thoughts about how that might be addressed.

MS. CHAMBERS: I agree with you, Wayne. I think I went that route because it is such an enormous field and issue and concern, and to try to break it down and to pick out a piece that might be doable was why I had gone that route. I mean I feel like nutrition is a terribly important area for the poor and disadvantaged, and if we could work on nutritional health -- and we were talking a little bit about that this morning -- that that would have a massive impact on all these other diseases that we are seeing. And yet I have been then thinking, okay, so how do we do that. We have got to change the entire culture because the poor eat at McDonald's, you know, and you are not going to persuade them to go to Safeway and buy vegetables, take them home and steam them. It is not going to work. So, that is why I had focused on a few things, but I would love to see the nutritional emphasis be a primary one, because I think it would have such a broad effect on the whole person healing.

DR. JONAS: So, in that case, not focused on a particular illness, but as general for health.

MS. CHAMBERS: Well, another way to look at it would be that those other illnesses would have been affected by the nutrition.

DR. JONAS: I had one brief question for Nancy Kolenda. That is, a number of groups are now getting into this field from the orthodox community, because there has been some money available. How can we go about sorting through which ones are truly going to capture the spirit of whole person health or how many are looking really at the bottom line, which is getting redder and redder by the year? Is there a way to approach those?

MS. KOLENDA: I think that there is a way to approach them. I know one thing, at our medical school now I am getting more questions asked about is there funding for different therapies. I have two doctors up at our medical school now that want to set up studies on acupuncture, and I said, well, you can apply to NCCAM, and they will give you guidelines on how to file for a grant. Our medical students particularly, they are hungry for knowledge. They are upset that we don't have enough elective courses, and nutrition like is one thing we had a very big discussion on last month at our school that it is so important, that they get so little training in this, so I said that if they would do research on these different issues and the importance nutrition plays in overall wellness, I think we will be able to, you know, address these and get their interest in it. I know one thing, in fact, even I have talked to two major representatives from pharmaceutical firms who are also showing an interest to see what is out there, and the definition they ask for is what are CAM therapies, and I tell them what I know from my experience and what I have read and researched to investigate, but they are interested there, so I am hoping that funding will come about and see the importance it will play in overall health and reduce the cost of health care as a whole.

DR. GORDON: Thank you. We will move on to the next panel. David Murray Blalwas.

DR. BLALWAS: Thank you. Good afternoon. My name is David Blalwas. I am a nationally board-certified licensed acupuncturist practicing in Maryland. I would like to thank the Commission for this opportunity to testify. I am here today representing State Associations of Licensed Acupuncturists from all across the country. My testimony concerns two important points. One. To present the Commission with data concerning delivery of services and patient satisfaction from a written survey of acupuncture patients conducted in the State of Maryland. I have copies of the surveys for the Commission's full consideration. Two. In light of this evidence, to convince the Commission to recommend nationwide outcomes-based research studies on acupuncture and Oriental medicine as performed by fully trained licensed acupuncturists, and to have this research be the foundation for the formal governmental recognition of acupuncture and Oriental medicine as a medically effective, separate and distinct system of medicine in America today. The survey was created and conducted by professional medical researchers. The written questionnaire was designed to provide journal quality outcomes-based research data on the care provided by fully trained licensed acupuncturists. The researchers received 1,004 completed patient surveys. To our knowledge, this is the most extensive acupuncture survey of patient satisfaction conducted in the nation to date. Here is a sample of the results from the survey. When asked to rate the effectiveness of their acupuncture care, 55 percent reported it very effective for back pain, 49 percent reported it very effective for arthritis, 54 percent reported it very effective for allergies, 68 reported it very effective for stress and tension. When asked, "With acupuncture, do you think you have been able to reduce your health care costs," 82 percent of patients responding said it reduced their visits to medical doctors, 73 percent said it reduced their use of prescription drugs, 56 percent said they avoided surgery, 69 percent said it reduced coverage demands from insurance companies. When asked about a variety of lifestyle outcomes associated with acupuncture, 56 percent strongly agreed that it helped them work better, 56 percent strongly agreed they have less pain, 49 percent strong agreed they were less susceptible to illness. When asked, "Who do you consider to be your primary health care provider," 44 percent of patients said medical doctor, 39 percent of patients said acupuncturist. This outcomes-based format we used in this study makes it possible to capture the full range of health benefits received by patients of acupuncture. While single variable double-blind studies can provide data on a single effect, acupuncture care has long been known to provide simultaneous multiple physical and emotional healing benefits. We therefore strongly urge the Commission to recommend that futures studies into the effectiveness of acupuncture should take this outcome-based form. This allows for the expression and evaluation of the full range of health benefits patients receive from acupuncture treatment. Lastly, let me stress that acupuncture and Oriental medicine is a separate medical system. It is a form of medicine whose history, philosophical approach, and treatment techniques are wholly different from allopathic care. It should not be viewed as simply a pain management technique that can be incorporated into the Western medicine system. It is a separate medicine that offers a much needed complement to the allopathic model. Simply put, the preventive, restorative, and health maintenance medicine people receive from acupuncture care is precisely what is missing from American's health care system today.

DR. GORDON: Thank you very much. Kathleen Golden.

MS. GOLDEN: Good afternoon and thank you for having me here today. I am a licensed health care provider of acupuncture and Oriental medicine in New York State. I represent the Acupuncture Society of New York, which is a professional organization representing the interests of the practitioners and patients of New York. As our focus today is access and delivery, I would like to talk about an issue that I think affects access and delivery for patients. Acupuncture and Oriental medicine is a rich complex form of health care. I feel strongly that Americans are obligated to preserve the integrity and wholeness of the medicine. It has been an unfortunate pattern in our country to dilute the traditions of culture to suit an impatient nation. I do not wish to see acupuncture and Oriental medicine diluted to serve existing hierarchies of health care in subsuming this medicine to augment the diminishing financial returns currently experienced or to boost professional all-controlling egos. In this country, the acupuncture and Oriental medicine profession has established national education standards. These standards generally require graduation from an accredited three-year Master's degree program, passing a national board exam in acupuncture and/or Chinese herbs, which is administered by an impartial third party, and clean needle technique. Completion of these standards enables a provider to be licensed in their state. In many states, allied health care providers are able to practice acupuncture with a minimal amount of training. For example, in New York, doctors, dentists, and osteopaths can take a 300-hour training program in acupuncture and then become certified to practice acupuncture. In many other states, this is also the case. An unfortunate consequence of this disparity in education is that the public consumer is generally unaware of the differences in education and quality of care that are possible. It is also true in many states, including New York, that insurance companies will only cover acupuncture administered by a certified acupuncturist. That is to say, the Western doctor with 300 hours of training is eligible to bill an insurance company for acupuncture services while the licensed acupuncturist is ineligible. This is where the issue of insurance parity comes in. It is absolutely impossible to begin to comprehend the depth of the scope of acupuncture and Oriental medicine in a 300-hour course. Yet, in many instances, the patient with limited financial resources has no option but to accept treatment from the less educated provider. This is due to archaic insurance company reimbursement policies. Parity is not mandate. Mandate forces an insurance company to cover acupuncture services. Parity insures that if an insurance company chooses to provide reimbursement coverage for acupuncture and Oriental medicine, that all providers legally eligible to provide that service under the laws of an individual state be included in the reimbursement of that service. It is also imperative that all providers be given fair and equitable financial remuneration for their services. There are many patients in America who can benefit from acupuncture and Oriental medicine. It is important that this medicine be available to all who seek its benefits and that the patient seeking care under insurance coverage be in a position to choose who will provide that care. A patient should not be locked into settling for a provider with 300 hours of training or less, when a provider with three years of training is a possibility. It is unacceptable that due to limited resources and/or limits in provider entre that Americans be denied choice in deciding access and delivery as concerns acupuncture and Oriental medicine. I have recommendations and all, so pass this around to the Commission for supporting materials. Thank you.

DR. GORDON: Thank you. Natalia Egorov.

DR. EGOROV: Thank you. Members of the Commission, good afternoon. My name is Natalia Egorov. I am a Pharm D., a CAM patient, a CAM provider, student of Oriental medicine, clinical and consultant pharmacist as a Pharm D., and chair of the Education and Research Committee and Executive Board Member of CSOMA which is California State Oriental Medical Association. My interest is in facilitating infrastructure development for the appropriate and ethical integration of CAM and conventional medicine. As such, I am in a unique position in California with CSOMA to witness and speculate on the multiple layers of challenges and opportunities in providing greater access and delivery of safe and effective CAM in general, and Oriental medicine specifically, to our patient populations. Many of these layers are as rich in their need for further integrated scientific inquiry as inquiry into their anthropologic humanistic and cultural aspects. The primary concern of everyone that I have spoken with, interviewing them in preparation for this testimony is that these two different paradigms of healing in medicine, by their very nature, if one is attempted to be integrated into another, the paradigm is lost, and that is the greatest concern of all CAM providers that I have spoken with, and this is the greatest caveat of integrated medicine. Indeed, I believe one would be courting abject failure of optimized access and delivery of CAM without also embracing soft, qualitative, evaluations of real-world CAM systems of access and delivery, as these tools are also evidence-based, as basic scientists have expounded on. An example of this failure to meet the demands and needs of the People of America for CAM is the current inadvertent loss of the holistic paradigm through fragmentation during validation studies and during attempted integration as with managed care. It is also clear to me that true, sustained gains in integrative infrastructure development necessitate a change in management paradigm similar to TQM and CQI principles. I would be happy to go into that a bit more. Being customer-focused, the consumer, and empowering "front-line process owners," for example, Oriental medicine practitioners, in a non-threatening, multidisciplinary learning system nurtures a health care system where true meeting of the minds, teamwork, and innovation is powerful enough to overcome the current unhealthy health system riddled with its ego-based destructive inertia of turfing and distrust. It follows, then, that the greatest incentive to increasing the probability of successful access and delivery of Oriental medicine, for example, is to include and empower full-scoped, independently licensed Oriental medicine practitioners in key processes. Another is to support a Professional Doctorate in Oriental medicine, which includes acupuncture. I have details on how that can be done and what our profession has done to increase access and delivery in California. Thank you.

DR. GORDON: David Edgar Molony.

DR. MOLONY: Good afternoon. My name is David Molony. I am a professional acupuncturist and the Executive Director of the American Association of Oriental Medicine. The AAOM was founded in 1981 and is the oldest and largest national organization of acupuncture and Oriental medicine professionals. We were instrumental in creating the national certification and accreditation commissions for acupuncture and Oriental medicine in the early eighties, and for passing licensing statutes in many of the 39-plus states where acupuncture is licensed. Over one billion people in China have ready access to surgical and pharmaceutical medicine of European origin, as well as to acupuncture, herbal, and manual medicine of Chinese origins. The providers of these primary care services include nearly three-quarters of a million doctors of conventional medicine and over a half million doctors of traditional Chinese medicine. These two different systems of medicine co-exist harmoniously because Chinese citizens have equal access to, and a basic understanding of, both syste

MS. Their medical doctors were raised in a country familiar with its own traditions, and their doctors of traditional Chinese medicine have training that is an evolving system of medicine that is balanced with a year or more of conventional diagnostic and therapeutic principles and procedures. Both professions are thus reasonably well prepared to help patients make informed decisions about their health care options. We highly recommend looking at the Chinese model for the harmonious co-existence of traditional and modern, CAM and non-CAM therapies and professions. The AAOM supports similar direct access to Oriental medicine professionals in this country who are well trained and licensed as primary health care providers, as professional acupuncturists are in a growing number of states. We also support direct access to Oriental bodywork therapists, whose standards of practice leave little potential for confusion of their services as a substitute for comprehensive medical diagnosis and treatment. This could also expand into other aspects, as well. We suggest the Commission can reduce the cost of health care on a national level by recommending direct access to qualified Oriental medicine professionals through federal programs and by suggesting to State Governors and Secretaries of State on its use in public benefit programs, such as Worker's Compensation and Medicare, as well as private clinics, hospitals, and through state regulated health plans. Oriental medicine has historically had a strong tradition of preventative wellness and self-care, and we are taught to serve as "guides" or "navigators." We communicate from a functional and energetic perspective, as well as from the conventional mechanical and biochemical perspective. We have found that open and direct communication increases patients' confidence in our care, improves patient compliance, empowers patients to take more responsibility for their own health, speeds recovery, and often reduces the need for access to costly and possibly more dangerous interventions. If prevention is to be recognized for its cost savings, and its more obvious health benefits, then Oriental medicine has a lot to offer. Unfortunately, our profession faces constant interference with patient access to our services from the existing medical establishment, and we are asking for your help to alleviate the situation. I would like to thank the Commission for your efforts to improve health care in America and to integrate old traditions and modern innovations to create a new medicine for the new millennium.

DR. GORDON: Thank you. So, we have some time for questions from the commissioners. Tieraona, Ming, George, David. We will just come around like this. Panel Discussion

DR. LOW DOG: I like the whole concept in China where traditional Chinese practitioner and also medical doctors, they spend time actually learning from each other, so that there is an understanding and there is less animosity then, but would you agree that in some ways it is more difficult here because there, they are not studying homeopathy, anthroposophical medicine, Reiki, polarity, and massage therapy, Western herbal medicine, Ayurvedic medicine, biofeedback -- do you see what I am saying? Here, because this country has so many modalities, not to even discuss the [quidendesmo] or the traditional healing practices of all the indigenous populations of this country. It is just this vast, vast pool of healing modalities that makes, I think, it more difficult in some ways in this country, because it wasn't just one tradition that we are asking people to look at, it is many, as has been represented by so many people. I guess my question is how do you think we can best help fix this problem between Western physicians and CAM therapists when it is so vast and it is so big, and the paradigms are so at odds with one another often?

DR. MOLONY: I imagine you are asking me. I think it has a lot to do with patient education more than anything else and patient choice, because I do think that if the patients are educated as to their choices, the people who are familiar with the [Kodenderos] will choose the [Kodenderos], and as long as those particular people have an awareness of their limitations, which I think is an important aspect of any CAM therapy, and should be in the education of any CAM therapy, that that would be able to expand in that way, but it all starts with people education and making it so that they are aware of their choices in the matter. I mean you ask almost any patient before they are exposed to acupuncture, which luckily for us is one of the first alternative things people choose because of the pain aspect of it, and they are totally unfamiliar with any aspect of CAM, and also they believe they worship at the altar of God of Science. We have to recognize that science is not a god, and science, although we need to look at fact, doesn't have truth with a capital T.

DR. LOW DOG: So, basically, not to focus on education of physicians, which is what I thought at the beginning was about trying to cross, almost cross-training, but your recommendation is primarily to education of consumers, so that consumers can make educated choices, which then comes to access, that any practitioner should be available to provide any type of therapy?

DR. MOLONY: It is difficult for practitioners to recognize their limitations especially in the Western medical conundrum that they are stuck in, and I think that it is important that we all recognize our limitations, and that there is just so much information out there that we have to really work at grasping where we stand with what we are working with. I worship conventional medicine, like I was a month premature, and I am really happy I am alive, but I think that the understanding has to work on understanding limitations, as well as patient education I guess would it would be.

DR. GORDON: One thing I want to remind everybody is we only have a very few minutes for questions, so if we are going to get the most questions from the most people, we have to move it along, questions should be brief, and answers as brief as possible.

DR. BLALWAS: I just wanted to add one thing to David's statement, and I think it has to do with education of consumers, but also education of medical professionals in the sense of establishing a certain degree of equality for people from CAM modalities who are licensed and fully trained to be able to perform those services and to really complement each other in terms of taking the strength of one particular medicine and applying that to another medicine which may not have that particular strength. In the case of acupuncture and Western medicine, the sort of preventive/restorative maintenance benefits that acupuncture has been shown to have for 3,000 years, combining that with the acute care and trauma specialties that Western medicine does so well, really provides an environment that serves the patients equally well, but I think the lack of sort of the barriers and the turf battles that have existed in this country so far are keeping that education exchange from happening.

DR. GORDON: Ming, I think you are next in line.

DR. TIAN: The question is, what is Oriental medicine, the definition, and if you can make a definition because they are talking about acupuncture, which as I understand we need a national standard for, non-physician acupuncture plus the training requirements, and also it is what is Oriental medical doctors, what is qualification for that, what is training program, because the issue I brought up this morning is we have so many herbal remedies or herbal medicine we are using for medical professionals, do patients need to ask Oriental medical doctors or medical professionals who have the knowledge to instruct patients to use that, because they have no idea which works and how much, what is dosage. Thank you.

DR. BLALWAS: Well, it is funny that you ask this question. This is a question that is a very hot topic among the acupuncture and Asian medicine community right now. Several weeks ago, there was a task force convened by the National Commission for the Certification of Acupuncturists in Oriental medicine, and they brought a group of us together from the world of acupuncture, from the world of herbs, from the world of Qigong, Tai Chi, Asian bodywork, and a number of other disciplines to actually try to began to tackle this issue of what is Oriental medicine. We weren't able to do that, not in that one setting, but because of the wide range and diversity of what is being called Oriental medicine now, this particular organization felt it was necessary in order to address this question now to serve the American public in terms of them knowing which practitioners are qualified and who they are going to.

DR. MOLONY: Simply put, Oriental medicine is a way of looking at health and healing in the human body, and it needs definition, a succinct definition within our community, but at the same time, as opposed to conventional medicine, it is a different field of medicine.

DR. GORDON: George.

DR. BERNIER: A question for

DR. Molony. It is really great to hear that the Western and Oriental medicines and disciplines have lived in such great harmony. Has it been a coexistence status totally or has there been intermingling of modalities with time?

DR. MOLONY: Well, as with any group of people, there is always ego battles, but in traditional Chinese medicine hospitals, one has access to conventional medicine, testing processes. There is referral out to the conventional medicine if indicated. Conventional medicine hospitals also refer to in- patient Chinese medicine hospitals and also usually have outpatient acupuncture and herbal medicine programs in their hospitals.

DR. BERNIER: So, you wouldn't be seeing people who were sort of certified in both areas.

DR. MOLONY: Well, there always are people certified in both areas either due to interest or to an illness or to other reasons. I think

DR. Xiao Ming Tian is certified in both.

DR. GORDON: David.

DR. BRESLER: This is for Kathleen Golden. Over the years, traditional Chinese medical practitioners have an abhorrence for what they call cookbook acupuncture. Yet, we are here to talk about access and delivery. For about 30 years I have been teaching anesthesia residents at UCLA how to suppress the gag reflex just by putting pressure on the large intestine 4 point. It works better than 30 milligrams of diazepam. It is strictly a cookbook approach, but I would much rather have them, if they are having trouble intubating a patient, use a little acupuncture than push more medications. Do the acupuncturists see the possibility of there being a level of acupuncture that is not TCM, that can increase access and delivery, that we could train American physicians to do?

MS. GOLDEN: Well, I do see that that is very relevant and very helpful. I think my suggestion was that in that setting, you wouldn't bring in a licensed acupuncturist just to do large intestine 4, but what my fear is that there will be this subsuming of our profession and that that will become the only way that, for example, the low income patients that we are talking about receive acupuncture is with cookbook acupuncture. I see that happening a lot and, you know, for me in New York recently, the issue of podiatrists wanting to be certified, so that they could, quote, unquote, "treat bunions," a similar type of a situation, and I do have a problem with that, because I do believe that the patient population that they were talking mostly about, for example, were the elderly, saying they could bring them in and just treat those bunions, and our way of looking at it is if we are going to have access to the elderly population and treat them for their bunions, bunions is not just bunions in Oriental medicine, which I use that term very broadly, we are struggling with it in our profession, but it is an umbrella term to discuss what we do. We could work on the deeper issues that brought about the bunions in the first place, and I think that that is more relevant to access and delivery, to treat the whole patient rather than just the bunion. So, to get back to your idea of large intestine 4 in the operating room, I think that we would be willing to work with the operating room staff and to work something like that out. I mean, for example, you said that Mike Smith is going to testify in New York, and in New York, what we have is people that just do the 5 needle protocol. That has worked out very well for us, I believe, in my state, because if you go to school for three years, you don't necessarily want to just be doing those 5 needles all the time, but in terms of access and delivery to that patient population which needs it, which I have done a lot of that supervision, it has been very, very helpful so I could see that model working in the operating room in terms of large intestine 4. So, I think if we had communication and we agreed, okay, this is the setting where --

DR. GORDON: Excuse me, I am going to interrupt because we really need to move along.

MS. GOLDEN: Sure, okay. I hope I answered your question to a certain extent.

DR. MOLONY: I just wanted to mention that as long as there is ethics involved, and the development of ethical standards when people go outside of their scope, that's all.

MR. CHAPPELL: Kathleen Golden, please. Is the vision for acupuncture in Oriental medicine to be kept away from integrated systems, a stand-alone, or would you see this still as a healing --

MS. GOLDEN: I do think that the idea of integration is very relevant. I do think that, as David pointed out, you know, we each have something very special to offer to the health of the American public, and what I am concerned with is what I have seen happening is sort of this subsuming of our medicine, and it just becoming large intestine 4, liver 3, when there is this rich complex philosophy behind it. I do think that the way that our country can most benefit is to keep the paradigm special and for us to be able to do our work and for Western medicine to be able, as both Davids said, acute medicine, Western medicine excels at that, and certainly for all of my patients, I feel that they need to have their yearly checkups and if I can't see into the body that diagnostic tests -- if we work together, see, my issue is we are not quite working together right now, and I would like to see us have more dialogue and more flow for the benefit of our patients.

DR. GORDON: Effie. Again, time is of the essence. We are already about 10 or 15 minutes behind.

DR. CHOW: Thank you very much, my associates. I really appreciate it. There is sort of a gradation of the large intestine 4, and then the whole cultural identification, everything is valuable. Are any of your organizations in particular, David, is there any outstanding models that you know of now in China -- I mean there is better ones and there is not so good ones -- and also here in the United States, are you aware of or can you get models to us that you can deliver to us for using it as a model?

DR. MOLONY: Models for?

DR. CHOW: For integration.

DR. EGOROV: In California, I have come across numerous groups of multidisciplinary CAM providers. A lot of them are licensed health care professionals who also do CAM mixed with straight CAM, we may call it, and I have been very curious myself as to where is their portal of entry for these patients, how do they do differential diagnosis as a group, and do a care plan, and how does it work exactly. So, I could provide you with some examples that I have come across and within the structure that I work myself as a CAM provider.

DR. CHOW: Those are the individual ones. What about institutional?

DR. MOLONY: I will work with Natalie and get something.

DR. CHOW: Great. That is terrific. I think that is really important.

MS. GOLDEN: Can I say something? I do work in an AIDS day treatment program, and we have a wonderful integrative model where we have Western medical staff, as well as "holistic" medicine staff, and the way that we work is that we communicate with each other all the time about what is happening with the patients, and so that model, I think, is very effective. I could get that model to you, as well.

DR. GORDON: That would be very helpful.

DR. CHOW: That would be great.

DR. JONAS: I have a question really for the panel as a whole. In terms of the basis upon which access should be delivered, I think, Kathleen Golden, you mentioned insurance parity, and I think eventually it does come down to who is going to pay in order to get access. My question for the panel is what would you recommend to be the basis for that insurance parity? For example, should it be state licensing in which case then the competition for the various types of professional practitioners with each of the state legislatures becomes the main focus, should it be outcomes research, such as what was described in terms of patient satisfaction, in which case probably the majority of CAM practitioners could demonstrate that the majority of patients are satisfied with their care, or should it be other types of approaches, any suggestions or comments?

DR. MOLONY: I know in Australia, they did a study and they found that as far as safety and efficacy, the more training somebody received, the better the patient, the more safe the patient was and the more effective their treatment, and that is essentially a given. I imagine there is a certain plateau at which you reach, that continued training doesn't really -- it starts to get more incremental, but --

DR. JONAS: So, should the basis be on the ability to be trained or to demonstrate that the training is effective, and if so, which way?

DR. MOLONY: I would imagine the development of certification programs developed through psychometrics.

DR. JONAS: So, you would offer training then, training and licensing should be the basis?

DR. MOLONY: Some CAM things don't require quite the intensive training as maybe Oriental medicine does.

DR. JONAS: We have heard in the research panel, for example, a number of suggestions along the lines of what

DR. Blalwas suggested, that we should do more outcomes-based research, look at what practitioners' patients are, what kind of benefit they are getting and how satisfied they are. Is this the appropriate basis you think for reimbursement or for insurance parity?

MS. BUTLER: Within biofeedback, we have taken the route that certification is the pathway to go on, and that came about for a number of reasons over a number of years. Because it is a multidisciplinary organization and people who use this methodology come from medicine, occupational therapy, PT, et cetera, they have their own licensing requirements, and to ask a physician to go get another license in biofeedback or a psychologist to be licensed in biofeedback, it just made no sense. But certification is even across the board, and it asks the candidate to demonstrate knowledge in that field over a course of education and training and supervised practice and examination. That evens the playing field. There are probably other models.

DR. MOLONY: It also depends on if you are talking sickness or wellness.

DR. BLALWAS: I actually think it is both. I think the two points you make need to be complementary, to coin a phrase, in gaining this access, because the first thing is to quantify through this kind of research that the medicine works for a variety of different health care issues, and then make sure that the people who will be delivering those services are fully trained enough to be able to provide those services to patients.

DR. JONAS: Actually, I am suggesting that that type of research is not going to advance us in terms of being able to demonstrate, because all of the professions will be able to demonstrate that they are effective and that patients are satisfied. However, you have helped, I think, a lot in terms of what this commission needs in terms of training. We can certainly address issues of training and this type of thing whereas, we cannot address issues necessarily about a licensing, which is a state-based thing, but as a federal commission we could suggest some types of national standard of training that then the states could use if they wished to make decisions about licensing.

MS. GOLDEN: For our particular profession, those are in place.

DR. JONAS: I understand.

MS. GOLDEN: So, that is sort of what I was talking about, to base it on those standards.

DR. GORDON: We are going to have to end this panel. Obviously, we are all very engaged. That's the good news. Thank you very much. We really appreciate your input. We may well be coming back to you to talk with you about education and licensing, and those other issues that you raise. Thank you very much. Public Comment [Continued]

DR. GORDON: The next panel is Elaine Marie Wallzer, Bhavna P. Bhut, Bruce Dooley, and Salvatore D'Onofrio. Are the other panelists here? [No response.]

DR. GORDON: Let's begin with Bruce Dooley.

DR. DOOLEY: Hi. I am Bruce Dooley. I am an M.D. from a warm state south of here, whose name I was told not to mention in Washington. I am here to discuss a little bit something on a different note. I have been involved with some issues that have been involved with some CAM physicians being brought before their medical boards across the United States and somewhat brutalized in a disciplinary fashion. I went to search for this because, of course, this involves our livelihood, every M.D. and DO practicing has over their head of their license being pulled by the Medical Board. I am here to tell you today that my investigations revealed that there is an organization called the Federation of State Medical Boards, which I think you need to be aware of. This is a federation, it is a private corporation, private organization, formed in 1912, an interesting time. That is when Rockefeller got into the pharmaceutical industry. It is when the Flexner Report came out, and that is when the AMA's Quackery Committee went underground. The Federation, as they call it, develops policy at their annual meetings, which is then handed down to the state medical boards to be enacted in their own states. An example of this is the Special Committee's report, which you have been given, or summary of them, on Questionable and Deceptive Health Care Practices. This is a blueprint for state medical boards to basically identify and then crack down on complementary and alternative physicians in their state. This is definitely a disincentive for other physicians to enter this field, and therefore limiting access to patients of these people. They delineated in their definition we can't decide whether it is complementary alternative medicine, so we are going to decide to call it questionable medicine. They also told the states to coordinate and collaborate with the FTC, the FDA, HCFA, U.S. Postal, AMA, and many other federal and state agencies to get their physicians. They changed the definition of "harm" in 1996, interesting. The mandate of the state medical boards is to protect the public from harm. They added on, not just "physical harm," but "economic harm" and "indirect harm," economic harm if the patients lost money on the procedure, and indirect harm if they failed to go seek appropriate therapy. They also controlled the testing of the national medical boards and the FLEX exams and the PLAS. They instruct the state medical boards -- and I was there and heard this -- to resist state and national legislative efforts to pass freedom of medical access bills. They are actively lobbying against freedom of access medical bills both on a national and on the state level. They also maintain a physician data bank, which is the disciplinary marks are never expunged once a physician is given a disciplinary mark. In summary, the Federation of the State Medical Boards, one, develops strategies to curtail the expansion of CAM, two, it lobbies federal agencies, state medical boards, and legislatures on the implementation of these strategies, and, three, indirectly and powerfully influences the course the content of all new physician training via the medical testing. These anti-CAM activities and bias of the Federation of State Medical Boards, only a fraction of which are represented here, I believe warrant further investigation by this commission. Clearly, it is troublesome that a private corporation should wield such influence on the members of state medical boards and the physicians' means of livelihood. Thank you.

DR. GORDON: Thank you. Salvatore D'Onofrio.

DR. D'ONOFRIO: Good afternoon and may God continue to shed the grace of his light upon these proceedings. My name is

DR. Salvatore Anthony D'Onofrio. I am not a medical doctor, I am a nutrapathic doctor and a Doctor of Divinity. I am in service to humanity through natural health principles in the name of God Almighty for the last 22 years. I do not practice disease symptom supplementology. Please do not include natural health practitioners in alternative or complementary medicine. Commissioners, there is nothing alternative or complementary to allopathic medicine about natural health principles. God has created and given us a maintenance responsive unit. Natural health principles are the primary methods of maintenance through spiritual, mental, emotional, and physical modalities since time immemorial. Individually determined amounts of clean air, water, and food have been the basis of natural health principles since creation. The truth is the alternative or complement to natural health practices is allopathic medicine. I believe that natural health principles is a God- given right, protected by the Constitution. It is not a crime. I believe that the best way for medical doctors to truly study natural health principles is to legally allow doctors to practice natural health principles without attack from misinformed medical boards. Because people get well from what we do, medical boards assume we practice medicine. We do not practice medicine. There is a type of bill from Minnesota that would, if we drafted it to include medical doctors, would allow medical doctors to practice and learn and experientially report from clinics on natural health principles in outcome studies that medical science could accept. I believe that doctors should do an internship under a qualified naturopath from one of the state accredited four-year colleges like Bastyr before practicing, as I had to do. You know, we each all have our own values, and we should honor them through intelligent understanding. This medical bill from Minnesota would be a real good model to allow doctors to practice and experientially learn what we do. You see, natural health practices is not alternative medicine, and it is not a crime, yet we are attacked all the time. We need to have God bless us with understanding and cooperation through education. We have natural health principles. You take a couple of things like vitamin therapy out of it, and apply it to a disease, that is alternative medicine, or you use a drug, and that is allopathic medicine. So, we have three different modalities. Keep them separate, educate ourselves about them, and then integrate them. Thank you.

DR. GORDON: Are there questions from the commissioners? Panel Discussion

DR. JONAS: So, you would suggest no licensing then?

DR. D'ONOFRIO: Well, I would suggest accreditations first, and then licensing maybe by words that know about what we do, definitely not licensing from a medical board, because we don't practice medicine.


DR. LOW DOG: What I am understanding you to say is -- and I think that many of us sort of are talking around it -- is that the fundamentals of health, I am not sure have to be given by a licensed practitioner, they should start when our children are very small, about how do you eat properly, how do you handle your anger and your stress, how do you move in ways that make you feel good, and those are the things that would probably keep all of our patients out of all of our offices, that those are the fundamentals of health and that everything else besides that is actually practicing medicine, however health oriented it is.

DR. D'ONOFRIO: Yes. And we need medicine. I mean I am the first person to -- I refer people to medical doctors every day. They refer people to me. I tell people if you get your finger cut off, you don't want to see a chiropractor or be popping pills, you want a surgeon. If you have raging septicemia, you go get some antibiotics, but as you were saying, as we teach our children, a doctor means teacher, I teach natural health principles to build health, not to fight disease. It is like putting, in my mind, putting a fire out with gasoline. I try not to focus on that. We teach them to focus on health.

DR. GORDON: Any other questions? [No response.]

DR. GORDON: I have one for

DR. Dooley.

DR. James Winn appeared before the commission the last time we had hearings, and he said very clearly to us that he was interested in not only working with CAM research, but in helping CAM researchers to develop IRBs, and I believe that one of the areas he mentioned they had a particular interest in working collaboratively with was the area of chelation. So, I am wondering whether your information is up to date. Have you talked with him recently?

DR. DOOLEY: I went to the April meeting, their last annual meeting, and I can tell you just an example. Larry Dixon, who is on Winn's advisory board, was a past board member of the FSMB. The Senator from Alabama is Executive Director of the Board of Medical Examiners, and he was one of the speakers. Here is what he said. "About the chelationists, is there a Board present that has successfully prosecuted a chelationist, revoked a license and made it stick? We find that very difficult. We got the major chelationist in our state but only when he branched out into other forms of quackery." So, everywhere I was going --

DR. GORDON: But I wonder if perhaps you might contact -- I am just curious about this -- you might contact

DR. Winn and perhaps indicate that you appeared here and talked with us, and that we said to you that he had appeared and that he was quite interested in working collaboratively. I wonder if you would consider pursuing that as a way of working.

DR. DOOLEY: Sure, I would, but as I mentioned, I was on the board of ACAM when our president, then Terry Chappell, sent 23 letters to Winn, requesting ACAM, a 25- year-old organization, you can't get older than that, and he rejected every one.

DR. GORDON: We will be happy to supply you with

DR. Winn's testimony, and we will be interested to hear how things develop.

DR. DOOLEY: I would love to work with him if he seriously means that.

DR. D'ONOFRIO: A point on chelation. I was just at the California Medical Association's study on alternative health, and they refused to study chelation therapy because it is considered by them to be quackery because of one anecdotal incident, a friend of the chairman of the board was harmed by an improper application of chelation therapy. So, what he is talking about is rampant. We need to avoid these people.

DR. GORDON: My comments don't reflect on the truth of what he is saying. I believe what he is saying. Also, our hope is that things are changing and perhaps changing significantly, and what we heard from

DR. Winn was pretty clear, I think, about beginning to reach out and to say we are going to do things differently. We will be happy to give you both copies of his testimony, and we hope that things can move ahead.

DR. DOOLEY: Great.

DR. D'ONOFRIO: Thank you.

DR. DOOLEY: I do have one thing to say, though, that, you know, in a disease care industry, which is a trillion dollar, quote, unquote, disease care industry, with the major players being the hospitals and the pharmaceutical cartel, if you will, all of that money comes through disease, and it seems like if there is going to be any kind of sense of fighting a single spot, laser focus would be the M.D.'s and the DO's who actually write the prescriptions and therefore are the source of their funding.

DR. GORDON: Thank you very much. Please keep us posted. We are going to keep a five-minute break and the next panel will then come up. Session III: Use of CAM for Selected Health Conditions

DR. GORDON: Some of the people on this panel are very good friends of mine, so I am very happy to welcome them, as well as to welcome those I am just meeting. This is a panel on the Use of CAM for Selected Health Conditions. We have people who are offering services and people who are receiving them, and people who are both offering and receiving. We will begin with Addiction and HIV with Howard Josepher. Addiction and HIV/AIDS

MR. JOSEPHER: Good afternoon. Thank you for inviting us here. My name is Howard Josepher. I am the Executive Director of Exponents, Incorporated, a not-for- profit organization that functions in New York City. The people that come to our programs are overwhelmingly inner city individuals from minority communities. They are also the people that make up the majority of AIDS and new HIV infections both in New York and in this country. They are people who have just come out of prison or involved with the criminal justice system. The needs that we are confronted with by our clients are all-encompassing, and we have come to understand that you cannot treat drug addiction, HIV infection, or AIDS specifically without addressing other needs that stabilize the individual and make health and healing possible. Examples are for the people, our clients, our patients, there is a need for primary care, there is a need for food. There is a need for housing. There is a need for health education, and, of course, stress reduction, and we also feel that in looking at the individual, we also have to take that holistic view of the economic and cultural environment that our clients come from. Conventional treatment for substance abuse or drug addiction, excluding methadone maintenance, in this country, are generally behavior modification or psychotherapeutically-oriented models that focus on abstinence. Because of AIDS, we created an alternative approach to engaging and working with drug addicts. This approach did not require abstinence as a requirement for participation. This is important when you understand that one in seven addicts in this country ever get treated and that the treatment field has come to rely upon coercion and mandates to get people into treatment progra

MS. So, the need to create models that people who have problems with drugs and AIDS, the models that they want to attend. We created our program ARRIVE in 1988. Today, we have over 5,300 graduates, many employed in the AIDS and substance abuse field. The program runs for eight weeks, three times a week, which means 24 classes. Each class is two and a half hours. While attending ARRIVE and some of the postgraduate ARRIVE classes, topics cover both traditional and alternative approaches to health and recovery. Topics include or experiences include risk reduction for sex and drug use, tuberculosis, the immune system, nutrition, and vitamin supplements, aromatherapy, and environmentally soothing music. We also cover hepatitis, especially hepatitis C, diabetes, stress management, and meditation, sound healing for immune boosting utilizing crystal bowls, cognitive psycho-education, relapse prevention. We teach about infection control, cost mainstream HIV and AIDS medications, and also complementary and alternative treatments. We talk about and teach about syringe cleaning and harm reduction. We do make referrals to other progra

MS. A brief meditation is practiced before, in the beginning, and the end of every one of our ARRIVE classes. Our work demonstrates the need for complementary and alternative approaches to addiction treatment. If the health of an individual is enhanced, and if community safety for the larger community is assured and maintained, then, health models like ARRIVE, not focusing primarily and solely on abstinence, would be a valuable expansion of the continuum of treatment for drug and alcohol addiction. Did I get in under that? That was the first time I have ever done that.

DR. GORDON: Good job. Denise Drayton.

MS. DRAYTON: My name is Denise Drayton. I am a graduate of the ARRIVE training program, and I am currently a staff member at Exponents, Assistant Director of Education at the ARRIVE program, and I was asked to briefly describe why I chose unconventional approaches to treat my health condition and what health results I have experienced. I am also HIV-positive, so alternative therapy has been especially beneficial to me in dealing with the dual disease. I was first introduced to holistic medicine when I was admitted into a detoxification center for heroin addiction. The method that was used for inpatient treatment was conventional, but included acupuncture for stress and pain. I continued with my acupuncture treatment in an outpatient program. My next encounter with alternative therapy was as a student in the ARRIVE program. We were taught visualization and deep breathing meditation. I incorporate several methods in maintaining my sobriety. I have been clean for 10 years as a result of holistic treatment, faith- based therapy, and self-help progra

MS. I choose to use the holistic approach to dealing with HIV in the form of massage, meditation, visualization, acupuncture, and deep breathing. I also attend workshops for stress management and burnout, because as an HIV- positive person in the work force, it can be stressful at times. I surround myself at work and home with a stress- less environment. I have a crystal fountain at work, a sound fountain at home, and a sound aromatherapy diffuser in my office. So, when people step into my office, they are all like they are in la-la land. I also attend meditation workshops that help me deal with the stress burnout pertaining to, like I said, being positive in the work force, and I believe this has had a positive effect on my health. HIV sometimes affects my memory, and I feel by playing meditative music in combination with aromatherapy, I have experienced a more centered feeling in focusing on my work on the job. After testing positive, I wanted to quit smoking to clear up my lungs, and I knew that pneumonia was a possible opportunistic infection for people with HIV, so I quit smoking with acupuncture. I actually joined a contest and I figured I would cheat by taking acupuncture. I did not win the contest, but I got back my lungs, so I was very happy for that. I had sessions, I took on sessions, and I have been smoke-free now for eight years. Although I take Western medicine for my HIV, I feel that therapies are complementary. Sometimes the side effects of HIV medication causes body aches, and massage is essential in relaxing the body, and meditation helps me focus on something other than the pain. They asked me what barriers and obstacles I face, and still face, in trying to obtain care. I am fortunate to have a workplace that incorporates and promotes healing through alternative methods, employee activities, stress- reducing devices, and conducting free alternative medicine workshops and encouraging wellness care. However, in my community, this type of therapy is not readily available. The clinics don't offer other methods, and if they do, it is not well promoted. It is really not obvious to people that come into the clinic that this is going on. There is a natural distrust of anything that is not tradition in my community. It is looked upon like voodoo or something because of the lack of education that is surrounding it. If it is perceived as not in accord with religion, it is not well accepted. Many people have never experienced some of the alternative treatments that are available. So, my recommendation that I would like to see happen to make it easier for me to receive care is I would like to see expanded health care insurance to provide for alternative therapies. I would recommend outreach to communities of color that provide information and education on alternative therapies and how they can work with HIV medications. I would like to see doctors do some inner healing when it comes to HIV, maybe get into CAM, some meditative approaches that help them deal with their own issues, so that they can attend to whatever affect before they can then get involved with the healing process. Thanks.

DR. GORDON: Thank you very much, Denise. Jeanne Andrews. Cancer

MS. ANDREWS: Hi. My name is Jeanne Andrews. I am a wife, mother of four, former teacher, and presently a student for the past 21 months. Twenty-one months ago I was diagnosed with Stage IV colon cancer. I had resection of my colon and underwent six months of chemotherapy. When I was first diagnosed, a friend of mine suggested massage therapy, and she said, Jeanne, it is not a luxury, it is really beneficial for you. I did start massage therapy, and then another friend recommended seeing a nutritionist. I went to a nutritionist and got a lot of guidance there. But it was two months into my chemotherapy when I was first working under the guidance of

DR. Fred Smith, oncologist, that I said, you know, I don't feel in control here, what else can I be doing. Besides, I was experiencing the effects of the toxins in my body, and I just felt that I had to be more in control. It was then that he recommended that I contact

DR. Gordon, and was given a book, Comprehensive Health Care. I read that book within two days, and I was just amazed at all of the information there that I had no knowledge of prior to my illness. As a result, I contacted Jim's office, we met, and I investigated some of their programs including their group support system. I attended that, and as a result, I learned deep meditation, visualization, and a number of other forms of relaxation. I believe that my cancer, well, I believe that the disease can be treated by Western medicine, but it is treating the disease, and not the source, so I really felt that I needed to treat the whole body. Anyway, as I got into the various modalities, various things worked for me, others did not, so I adjusted along the way. Well, in April of this year, 2000, they discovered another large tumor. It was too large to operate, so they put me through a series of, well, just six weeks of an experimental drug. It ravaged my body and I was just beside myself, so I again readjusted various nutrients and supplements, and then I discovered Qigong. I traveled up to New Jersey three weeks during the course of the summer, and went through intensive medical Qigong. In the meantime, I was also doing massage therapy, Reiki, various other things, but the Qigong I believe really helped me. You see, during this point of time, I had completed the chemotherapy, the six weeks, and although the tumor had shrunk, I then went into the Qigong, and the cancer markers went from 31 to 15 under the Qigong. Well, when I came back after the three weeks, they did discover several weeks later a blockage occurred. To make a long story short, they wanted to operate, perform this radical surgery that would have been eight hours long, kept me in the hospital three to five weeks. I refused to go through that, and I went back once more for Qigong. When I came back, I went in for the operation because I had to have this obstruction cleared. As it turned out, I was in the operating room two and half hours later, when I woke up, I asked if I had the ostomy, and the doctor said, "Jeanne, this is incredible." He said, "What should have been the worst case scenario has turned out to be the best case scenario." He said, "We didn't have to touch your colon." Well, they also took my blood, did some bloodwork on me, and today, my markers are down to 0.6. I continue to do medical Qigong, as well as acupuncture, working with my supplements, massage therapy, and Reiki, and I truly believe that all of this, the CAM treatments have been a tremendous help to my whole system. But again I also believe that there were obstacles that I encountered, and that was, first of all, my medical doctor not truly believing in CAMs, but yet he was willing to give me this information. In searching out the various treatments, I did have to do a lot of footwork until I came across

DR. Gordon, and I continued to travel, though, different places, so there was no central location for me to grasp all of these modalities. My trip up to New Jersey three and a half hours over three different times -- actually, four different times -- you know, I wish my medical Qigong master was here in the D.C. area. It would make my life easier. With the exception of acupuncture, I discovered that this was getting to be an expensive proposition. Acupuncture was only covered by my insurance company if it is done through a licensed medical doctor. So, I thank you very much for inviting me here and being able to share my story of hope.

DR. GORDON: Thank you very much, Jeanne. We also have some written testimony from Barry [Cassilot], who is Chief of the Integrative Medicine Service at Memorial Sloan- Kettering, and we will be coming back to the issue of integrative care for cancer probably when we deal with reimbursement issues, which we will come back to later. The next speaker is Richard Collins,

DR. Richard Collins. Heart Disease

DR. COLLINS: Thank you, Jim. Good afternoon. You have my bio in front of you. I don't think the audience has that, so let me just give you a little background. I am a cardiologist and Director of the Heart Disease Reversal and Prevention Program in Omaha, Nebraska, and nationally, maybe some of you don't know this, but I am also known as the "Cooking Cardiologist" on Live with Regis. Let me give you some sound bytes because you have all of the information in front of you. Heart disease remains the number one killer in America and while the death rate from cardiovascular disease has dropped due to technology, the absolute number continues to rise because of new onset of disease. The number is increasing in alarming fashion for the African-American, Native American, Hispanic, and in younger age women. It is American's most costly illness. In this country, the approach to cardiovascular disease management has been a

MR. Fix-it-up approach to acute disease therapy. Little is spent on preventative measures until after the fact, and even after the fact, conventional therapy has not been shown to be cost effective with 30 to 50 percent re-stenosis after angioplasty or stent placement, revascularization after bypass after seven years, and costly recurrent admissions for heart failure. The

DR. Dean Ornish program for heart disease reversal and prevention strikes at the very root cause of the disease process, stabilizing plaques, reducing angina by greater than 60 percent, reducing costly readmissions to the hospital, and improving quality of life and well-being. We, as cardiologists, can talk about new angioplasty, widgets, balloons, but if we do not begin to manage behavior and lifestyle in America, we will never reduce the onset of newly diagnosed heart disease in this country. Unfortunately, we, as cardiologists, are being trained as firefighters rather than forest rangers. The Lifestyle Residential Study, published in 1983, documented that heart disease can be managed by intensive lifestyle control, again confirmed by the Lifestyle Heart Trial in 1990 with a five-year follow-up. The demonstration project with Mutual of Omaha in mass controls was completed in 1998. The cost savings -- hang onto your placards, Commissioners -- it was $29,000 per patient. The findings also have recently been noted in High Mark, Blue Cross/Blue Shield of Pennsylvania with their embracement of the Ornish program. For the insurees in Pittsburgh, a cost savings has been noted of more than $17,000 per person, improvement in SF well-being scores, outcomes, and reduction of angina. Lifestyle behavior should be listed as a prudent, first-choice medicine. The barriers to established heart disease prevention programs are the same barriers that actually continue to perpetuate coronary heart disease in America - denial, time constraints, diet controversies, risky lifestyle behavior, unwillingness to change, and financial concerns. Our health care system in America is crisis control and fix-up medicine. In fact, most preventive and wellness programs across the United States have been cut due to cost constraints. We are shooting our own feet. We can't afford to treat heart disease on a crisis basis, let alone afford to consider managing it on a chronic basis. A new model of disease management needs to be created. I believe we are on the edge of seeing that model with the introduction by High Mark, the first insurance company to totally embrace heart disease management through lifestyle intervention. In regard to recommended policies, carefully structured programs will need to be certified and policies created to ensure compliance before reimbursement. The Ornish program has already met those requirements with over 20 years of experience in outcome on research data. Embracing the Ornish program by accessing this to all populations should be your next top priority. Thank you.

DR. GORDON: Thank you very much. Walter Czapliewicz.

MR. CZAPLIEWICZ: Good afternoon and thank you for inviting me here today. My name is Walt Czapliewicz. I am 45 years old and a resident of Pittsburgh, Pennsylvania. About 11 months ago, I became a participant in the

DR. Dean Ornish program for reversing heart disease offered to me by High Mark, Blue Cross/Blue Shield. I came to the program with a medical history of hypertension and coronary heart disease. In fact, before I joined the Ornish program I had three heart attacks, the first one in December of '96, and the following year I had two more heart attacks, and in October of 1997, I had bypass surgery. I seemed to be doing well for about two years. Then, in the fall of 1999, I started experiencing chest pain again. The bypass was clogging up again. The pain became more and more frequent, so I was taking nitroglycerin pills several times a week. I would get pain after walking, after meals, or during times of stress. I could tell by how I felt that I was probably going to have a fourth heart attack pretty soon or need heart surgery. As the new year approached, I saw a story in the newspaper about

DR. Ornish's program. I asked my cardiologist for his thoughts, and he recommended it. I started the program 11 months ago, and right from the start I followed it 100 percent. Within the first 10 days, my chest pain diminished greatly and was completely gone after six weeks. In fact, I haven't had any chest pain since then. I have lost 64 pounds in the past 11 months. Even though I am eating more food and more frequently than before, so I don't feel deprived or hungry, because the food is low in fat, it is also low in calories. When I started the program, my stress test was abnormal. After only six weeks, it came back negative, and after just nine weeks of the program, my resting blood pressure went from 160/80 to 128/72. My cholesterol is much lower now, overall down from 196 to 114, and my triglycerides down from 311 to 116. All four of the program's components, diet, exercise, stress management, and group support have really been a true blessing for me. The results I have experienced in the first weeks alone made me even more committed to the program. I am fortunate to live in an area where my health insurance company had the vision to make this program a reality. In 1997, High Mark became the first health insurer in the country to both provide and pay for the Ornish program for their customers. My experience with the program and the High Mark staff has been nothing but positive. Many of the participants are over age 65. In fact, I was the youngest one in my group, but as we all know, heart disease can strike any of us, young and old alike. The older participants in the program are doing as well as the younger ones. We share group meals, exercise sessions, and perhaps most importantly, our life experiences, all of which created a close-knit group working toward a common goal, good health. I also manage stress so much better than before. The nutrition portion of the program also has contributed to my improved health status and a more positive attitude. The diet consists primarily of fruits, vegetables, grains, beans, non-fat dairy and egg whites, no added oils, which makes the diet about 10 percent fat. I also was advised to take some vitamins and fish oil supplements. I manage a catering company, so this was a big change in my diet at first, but I have adjusted well to it. The recipes in the program from appetizers to desserts are delicious, nutritious, and easy to prepare, and I feel so much better. The program supervision is also very comforting. We are guided through the program sessions by some very skilled professionals including a medical director, registered dietitians, exercise physiologists, stress management instructors, behavior or health clinicians, and nurse case managers. All participants remain under the care and control of their own physicians, who receive regular progress reports and copies of all tests. In closing, I would like to reiterate my dramatic improvements in the

DR. Dean Ornish program. This program reflects the commitment to offering innovative solutions that truly improve one's health. The program treats the underlying causes of heart disease, not just the symptoms, and may spare some patients surgery, and most importantly, improve the quality of life. I think that just about everyone would benefit from a program like this whether or not they had heart disease. I hope this commission can find ways to make programs like this more widely available. Thanks to this program, I feel like I am 35 again. I feel better, look better, and I am healthier than I have been in years. Coming into the program, I knew I was going to have another heart attack and need bypass surgery soon, but now I don't, and now I don't have to endure that pain and fear. I truly believe this program saved my life. Thank you.

DR. GORDON: Thank you very much. J. Donald Schumacher. Hospice Care

DR. SCHUMACHER: Now you want me to talk about hospice care. You have never heard the expression "not following the fan dancer?" I want to talk with you a little bit about the picture of hospice in the United States today and how it does relate very much to the topic of complementary and alternative medicine. Dying in America has become a very difficult grace. Fully 53 percent of all patients in the United States die in the hospital, 24 percent of all Americans die within nursing homes although most individuals would prefer to be at home receiving the comfort, love, support, and dignity of a competent support agency, as well as their own family members. While I see hospice care becoming more and more necessary in our culture, unfortunately, I find us dealing with more and more complicated and late referring issues than I ever thought possible. I think hospice care in many ways is the epitome of what really good complementary alternative medicine is. I am not talking about hospice according to the hospice Medicare benefit, which has a very difficult six-month prognosis to take a look at, but some of the basic core issues of hospice care revolving around the fact that patients and families have to have the benefit of good quality support and choice while they are going through the process of dying, whereas, most patients who are in hospital settings and nursing homes, as you will, by interview find out don't feel as though they have much choice at all. What is the true picture of hospice right now in our country? Well, unfortunately, one-third of the patients that we take care of die within seven days. Most individuals come to us essentially as train wrecks. They have been living and dying in very difficult circumstances, many of them in unrelenting pain with very complicated symptoms that are not being able to manage by traditional medicine, and they come into our program and unfortunately, very late within our care. We, in hospice care now, refer to what we are doing in our jobs, as opposed to end-of-life care, we are doing, in fact, brink-of-death care where patients come in and die so soon that they don't get the entire benefit of what hospice can actually provide. We are running, in fact, hospice emergency roo

MS. Many are living in pain for a long period of time upon admission, and they have been in high-tech settings that do not allow for patient participation in their own choice of health care. Self-determined life closure, one of the hallmarks of hospice care and hospice support, one of the four presented by the National Hospice organization often comes at the very end of the patient's life. Patients now are very used to having things done to them as opposed to being able to choose things for their own health and their own well-being. How can complementary and alternative medicines help? Well, many of the hospice programs that you will talk with around the country right now really are searching for new ways to support the traditional medicine that they are providing to patients and families, because the traditional medicine, largely around medications, do not work for many individuals. Our program, I can tell you as a clinical psychologist, that in addition to the alleviation of symptoms, patients who are participating in their own process of choice around death, grief, and loss, generally have a better sense of well-being, are able to face what is happening to them, around them, with much more courage and much more comfort and support, and they end up feeling stronger mentally and physically to battle whatever the outcome of the disease might bring. What do we actually use? Our program -- I was very happy to hear several of the participants up here talk about massage -- we use massage quite often for patients in our programs, therapeutic touch for patients in our progra

MS. Many of our nurses are trained in therapeutic touch, and oftentimes engage, in addition to the traditional therapy that they are providing to patients and families, with some really, really good quality stress reduction through those two methods. We also use homeopathy quite often, good chiropractic care and acupuncture. I was so happy to hear the acupuncture discussion earlier. I think acupuncture is a huge opportunity for all of you to really significantly benefit patients and their families without having patients engaging in longer term use of narcotics and very debilitating medication. Let me tell you right now we have a patient in our program. She is 24 years old. She has metastatic disease. She has many, many tumors that are on her spine. She has two young children, age 2 and 4. For a long period of time -- she was admitted into our program -- for a long period of time she had been living in excruciating pain, and the narcotics that she was being given to help reduce the pain, helped to reduce the pain, but she was so out of it because of the level that was necessary, that she was not able to actively engage in the care of her children. Through acupuncture, guided meditation and visualization, we have been able to cut her prescription medications and narcotics by half, and she is now much more engaged in the care of her children than she ever had been in a long period of time. Remember for all of you that while we are sitting here talking about how these things can help other people, everybody in this room will die. We do not know if it will be from HIV or AIDS, cancer, or heart disease, but at some point in time, hopefully in a ripe old age, all of us around these tables are going to be needing to have the benefit of all kinds of choice in alternative therapies, and if many of you are like myself, the very pushy baby-boomer, who is going to demand a lot of things, death cappachino, death latte, and a personal death trainer, we are on the right track as health care providers trying to tailor a different model of care for individuals who are going to be very demanding as they age and die.

DR. GORDON: Thank you very much. [Applause.]

DR. GORDON: Thank you all, to use Jeanne's words, for these stories of hope. We are very glad that you came to share these with us. Questions from the commissioners? Panel Discussion

MS. LARSON: I worked in hospice for five years, and my question to you is I saw the numbers actually decreasing and decreasing in the last eight years, referrals, you know, two days before death. Now, we have a program that we know works. We have access to the program, so we are interested here in access and delivery. What changed?

DR. SCHUMACHER: The competing streams of revenue for health care right now have become much more demanding. As an example, in our community, we have two large health care systems, both of whom own home health agencies, and pretty much own, heart, body and soul, the physicians that are supporting that hospital system. Because of that, not to the benefit of the patient, but to the benefit of the individual health care system, more and more patients are being kept away from external agencies, such as hospice care. You would see an increase in some hospice programs for or with those hospital systems that do have hospice as one of their core programs, but those are few and far between around the country. I would hope that the Commission would recommend some form of streamlined and untangling of these competitive streams of revenue. Physicians are fighting with hospitals, hospitals are fighting with physicians, there is such a dearth of understanding of what patients need as they are dying, it is absolutely unconscionable, but we have run into that very situation. Our median length of stay has gone from about 29 days down to 14 days, and that is absolutely wrong for patients who need this care.

MS. LARSON: Let me say that briefly it is an issue of capturing the money by certain parties.


DR. GORDON: Before we go on to David and then Effie and Bill, could you give us some documentation of what you are talking about?

DR. SCHUMACHER: Sure, absolutely.

DR. GORDON: And give us a sense of where things are going wrong and the kinds of recommendations you would like us to make?

DR. SCHUMACHER: Be happy to, absolutely. I will get that to Michele.

DR. GORDON: Thank you very much. David.

DR. BRESLER: Despite the hospice movement, far too many patients are still dying alone on respirators in hospitals.


DR. BRESLER: What is the movement doing or how is it going to help get access, greater access for these patients to more humane situations in the hospital?

DR. SCHUMACHER: This morning I was at the Center to Advance Palliative Care, a project that is being funded by the Robert Wood Johnson Foundation. It is a very exciting prospect because one of the topic areas that we talked about this morning was the fact that many individuals in hospitals are not able to make appropriate decisions about getting off of ventilators and out of ICUs and cardiac care units. I think that through a lot of national hospice and Robert Wood Johnson-sponsored organizations, it is our attempt to work within each one of the hospital settings now, to begin to work with the inpatient staff themselves to recognize when a patient and family can make another choice. I am not saying that this is easy. I know that when it is going to my turn to die, I am going to be kicking and screaming all the way and demanding all of those things, but I do think that people, given a choice to recognize that prior to it becoming absolutely totally unbearable, having a choice about when you decide to stop the aggressive therapy because it is no longer working, I think people, given another day of peace, are more willing to do it. It is just that right now they are not given the choice, and some of that is because of the dollars that we talked about. It is our hope that we can remove people from those very difficult situations by working within the hospital settings.

DR. GORDON: Effie.

DR. CHOW: Thank you for the touching stories and report. In regards to hospice, if the expense is growing and there is diminishing funds, is there any way of working with home care and expanding the hospice concept to home care type, that it would be less expensive?

DR. SCHUMACHER: Eighty percent of our care is provided at home. You are talking about home health care?

DR. CHOW: Home health care.

DR. SCHUMACHER: Home health care is also one of the competitors for the federal Medicare dollar, and they have done a really nice job pitting us against each other. I think that there are some opportunities for us to work collaboratively together, but I learned just this morning of a couple of programs around the country who don't quite see the benefit of being cooperative with other hospice programs, and they are trying to manage, as I said earlier, all of that end-of-life patient care within their home health license, and it really is not the same kind of care. One very important issue, and that is if you are a home health patient being cared for at home, you pay your own medications, you pay your own prescription drugs. If you are hospice patient, those drugs are paid for by the hospice program. Most people don't recognize that until you are in hospice care despite the marketing that we do. So, that is a very large issue, home health-hospice dialogue is a very large issue.

DR. FAIR: My question deals with the two presentations on the Ornish program, and I think,

MR. Czapliewicz, what you mentioned, that this program is probably good for everybody, and I think you are probably right, we would get very little argument from that statement from physicians about that. My question to you and also

DR. Collins, is what recommendations, if any, do you have, how do we get this to influence the lifestyles of people before they get heart attacks? I mean here is a cardiologist that sort of had this epiphany after he got his heart attack, yet, I am sure you knew all of this intellectually before you had your heart attack. It seems to me that that is the problem, and that is really the big payoff, because it would be much more of cost benefit than the figures

DR. Collins gave. So, through your experience, both of you, do you have any recommendations to the Commission about how we could get this before the actual event occurs?

MR. CZAPLIEWICZ: Well, for myself, I think, you know, this is kind of funny, but you have got to start advertising pork as the other white meat. It all goes back to educating people about what they are doing to their bodies. That is what I went through in this program. They taught me what I was doing wrong, and boom, and I think that just has to be expanded somehow.

DR. FAIR: We have been doing this for a long time. We have an epidemic of obesity, an epidemic of diabetes in people in their 30s, I mean we are doing something not right.

DR. COLLINS: We have in America, which I call -- you have heard about the French paradox -- we do have an American paradox. We are the only country that drive to exercise facilities, we are the only country that it takes one calorie to roll down a car window to get a 700-calorie breakfast, and we are the only country where we are obsessed with diets, and yet we are gaining weight at lightning speed. I call this the American paradox. Our society is gearing it up to guarantee that you get heart disease when you put your shoes on. We have taken cultures that were here in this country well before us and are giving them heart disease at lightning speed. It is very difficult in America to get someone's attention because heart disease happens to the other guy, not you. I think there is some technology around the corner to draw people's attention. The electron beam CT scanner, as controversial as that is, with one breath hold you can lay down and see if you are laying down plaque. That has been shown to really get your attention, when your plaque load is excessively high. I picked up a number of patients in their 30s and 40s who thought they were immune to heart disease, they had so much calcium in their arteries they looked like the plumbing in an old house. So, as a cardiologist, this is the hardest thing that I have, is to get someone's attention. We need to because heart disease is occurring at a much younger age. If I were to give a cholesterol screening test today, the people that would show up would be those that were 60 and 70. We need to get the 20-year-olds and the 30-year-olds.

DR. FAIR: I guess that is the gist of my question, and maybe there is no answer, but I will share one thing with you. When I lived in Manhattan and belonged to a health club, I was amazed at the way people would stand in line to wait to take the elevator for one floor to go up and use the Stairmaster. It astonished me.

DR. COLLINS: That is the American paradox.


DR. FINS: This is for

DR. Schumacher. Thanks so much for so eloquently telling us that hospice care really is the ultimate in integrative medicine and really blends the best of both worlds. I want to ask you two questions about funding. One is the Medicare hospice benefit and to follow up on my fellow commissioner's comments about decreasing access. Could you comment on what the hospice benefit and the regulations surrounding that has done, in your opinion, to access the hospice and referral rates? The second question is the stability of the research funding. You mentioned the Robert Wood Johnson Foundation. What percentage of funding for this integrative practice comes from philanthropic sources versus from government sources, and is there a role for increased government funding?

DR. SCHUMACHER: Oh, no, not at all.

DR. FINS: I am sort of leading the witness here.

DR. SCHUMACHER: We have seen a lot of that recently, but what kind of role do you think the Federal Government should have in funding this kind of research and outcome studies and delivery system to optimize this integrative practice?

DR. SCHUMACHER: I think about this and talk about this quite a bit. I think the largest difficulty with hospice in this country is the six-month criteria, and no matter how healthy or unhealthy we are as individuals, just to face that as looming in your future, many individuals resist it. One of the largest examples of where that is most easily seen and understood is with children. We have 31 children in our program today. We have a program called Essential Care, and we largely provide care to them through a largely extended home health license as opposed to a hospice license. Kids and families will never accept hospice care until the last day or two because everybody hopes for a longitudinal life for their own child. So, I think that is the largest issue, and as treatments have become more sophisticated, and people are more aware that more and more things can be done, there is always this true or unrealistic hope that, gee, maybe if I keep on trying this chemotherapy or this radiation, I will be able to kick this and go forward and live my life. So, I think that is the largest issue. The Federal Government needs to develop 20 demonstration projects around the country that will do a variety of different things. One, they will allow hospice programs to provide care without a reimbursement cap. They will allow hospice programs to provide care without a criteria or prognostic cap. They will give people opportunities to develop different kinds of services, so that without a patient having to walk in and say, yes, that I am dying, you can be put in a care path or in a trajectory where you get the kind of support that hospice provides, and you can receive the chemotherapy and the radiation and the surgery without hospice being a horrible choice for you, because that has what we have been, I think, winnowed down to in our care model. We are a horrible choice for people. Gosh, what a great feeling, it's awful, and people make that horrible choice very much at the end because as I probably, and so will you, you don't want to do it until you absolutely have to. So, I think the Federal Government ought to do 20 demonstration projects and really take a new look at developing a seamless model of care from diagnosis, through the bereavement of your family, so that you can go through that trajectory without having to make terrible choices throughout the process of your disease.

DR. GORDON: Wayne.

DR. JONAS: Thank you. I think that is excellent.

DR. SCHUMACHER: So, sign you up, right, you will participate.

DR. JONAS: Sign me up now, absolutely, how do I get in this, and where do I get reimbursed, right. What percent of individuals enrolled in hospice get identified CAM modalities? You have mentioned a number in your program, but in my experience in taking care of patients in hospice, a lot of times it is primarily kind of pain control and this type of thing, and there isn't a lot of acupuncture, aromatherapy. If individuals happen to know something about music, they will bring that in, that type of thing.

DR. SCHUMACHER: It helps if the CEO has used all of these therapies because then you tend to promote it within your organization. I think probably 15 percent at a max I would say in hospice care would do that. The thing that needs to be educated -- and this is one of the things that the commission can do -- is hospice CEOs and hospice managers need to recognize that they can contract with these providers of service in their community to provide this care under the hospice Medicare benefit. Whatever the patient or family needs to reduce painful symptoms, you can contract for those and provide them, which is how we operate in our program, but it is a low utilized piece of information right now.

DR. JONAS: One question to

DR. Collins. Is there any data on the number of individuals that are eligible and enter the Ornish program, that then do not do 100 percent compliance, as you described, and either drop out or only do 20 percent compliance, and this type of thing, and what percent that is, first of all, and any kind of effects on that?

DR. COLLINS: We have a careful screening procedure. We really know what criteria guarantees your success. That is number one. And once you go through that hoop, and the anatomy is proper, we have an adherence rate of 90 percent-plus.

DR. JONAS: I will reverse the question then. How many individuals are screened and because of non-medical or other reasons, because there is a better therapy around or something, are not then entered into the program?

DR. COLLINS: It depends upon a chronic disease basis. We have exclusion criteria, and that roughly is about 1 in 10, that they might be excluded because they continue to smoke or haven't really taken care of some lifestyle problems, that really a lifestyle program of this nature would not be ideal. The anatomy, we are learning a lot more about the anatomy. There is an element of the catheter-ocular reflex in America, that if you see it, you want to balloon it or stent it. We have realized that once an artery is touched, lifestyle cannot control it. What you need to do is leave an artery untouched and let lifestyle then take over and reverse the process.

DR. JONAS: So, complementary with conventional therapy may be problematic in this case.

DR. COLLINS: Well, what happens is not necessarily so, because those arteries that need to be taken care of, are taken care of, but the fact is that in the next event, the next event that will happen to you will not be on the one that was stented or angioplastied, but it was that 30 or 40 percent lesion that is just sitting there ready to happen again.

DR. JONAS: And that will not be then susceptible or remediable?

DR. COLLINS: It is if it is untouched, yes, it cuts down second events.

DR. JONAS: So, it is about 1 in 10 that get into the program that are --

DR. COLLINS: No, no, no.

DR. JONAS: One in 10 are excluded.

DR. COLLINS: One in 10 are excluded.

DR. JONAS: Okay.

DR. GORDON: A couple of things that I think that the program ARRIVE could shed some light on, that might be really useful. One is in the area of prevention, and the other is in the area of creating a healing community. I wonder if you could talk a little bit about your efforts to reach out into the jails and prisons, and how you feel that works, and how that may help prevent recidivism, as well as prevent increasing illness from HIV.

MR. JOSEPHER: We do a substantial amount of outreach in the institutions in New York, primarily that you want to engage them actually even before they come out into the street, so a whole new area that is being developed in addiction work with the criminal justice population is transitional planning, where the idea is to engage people in the institution and inform them of the various kinds of services that are available out in the communities, so that you can provide some kind of a safety net upon release, and they don't just fall in the cracks, and then the whole cycle of recidivism happens. But it must be said that most of the innovation and inroads that are happening in addiction treatment now are happening because of HIV and AIDS, and that AIDS in the drug-using community has required us to engage these individuals sooner rather than later, to present alternative models to work with them to stop the spread of AIDS and help care for people who are already living, and that whole school is something we call "harm reduction," but we have so many barriers to any kind of innovation in the drug field because it is completely surrounded with political messages, and any other complementary or alternative approach is looked at as radical and sends out the wrong message that drugs are being tolerated. But we are seeing again, because of HIV, that we can get people, we can engage them while they are still active, even though they are not even ready to get off of drugs, we can bring them along at a different pace, at a pace maybe that they are ready to work with, and I think this widens our net substantially.

DR. GORDON: As a White House Commission, do you see also recommendations that we could make that would make it easier to create this kind of integrative treatment for people who are positive or people who are coming out of prison who are addicted?

MS. DRAYTON: What I wanted to say about alternative treatments or alternative methods, I was noticing that women are the highest population now being incarcerated, and because the holistic approach deals with mind, body, spirit, emotional health, mental health, as well as physical help, I would like to see some inroads for women incarcerated to have maybe alternative therapies, meditation, positive affirmation, something that tells them that they are not boxed into this life for the rest of their life, that there is a way out or some sort of change happens, some sort of relaxation, some sort of efforts made, outreach to women, so that when they do get on the outside, they have a little more positive attitude and can maybe deal with life stress situations in a better way instead of going back to some of the same stressors, and then reacting in the same way using drugs or working the streets, or whatever it was that made them feel those things.

MR. JOSEPHER: Just to quickly answer that question, Jim, is that as Denise spoke about them, her personal experience, that the utilization of auricular acupuncture helped her substantially, not only in reducing stress, so that she could deal with her HIV, but also with dealing with her withdrawal from nicotine and cocaine. But this is not a reimbursable function, auricular acupuncture, in the substance abuse field. You know, it all does come down to money, and if there is money, there is going to be programs, and in that way more people are going to be helped. In drug treatment, it used to be you went into a treatment center for 28 days to get your treatment. Because the HMOs have squeezed that to such an extent now, you can only get seven days if you are lucky that will be reimbursed. So, basically, the treatment now for most of these places is to teach people about 12-step programs, which are certainly extremely valuable, but there is very little treatment going on in these places for the people who do not have private funds or even insurance for the people that we work with.

DR. GORDON: Thank you. George.

DR. BERNIER: I wanted to ask a related question, and that is, are there good studies that indicate there is a real positive value of including the CAM medications in individuals that are withdrawing or individuals who then withdraw for a while? I ask that not to question what happened in your situation, but just has anyone tried to put that together in an organized way?

MR. JOSEPHER: I heard in the previous session here of Mike Smith,

DR. Mike Smith from New York City, who developed auricular acupuncture. He has a substantial documentation to the effectiveness of it. Again, effectiveness of treatment doesn't mean very much in the substance abuse field. We have had studies galore showing the effectiveness, the reduction of crime, reduction of recidivism, and we still do not invest, so I don't know what will move that, but I do believe the documentation is there both for complementary and alternative methods and for traditional methods, but it is a field that still prefers to treat drug use primarily through incarceration.

DR. BERNIER: I would guess incarceration is a very, very expensive way of trying to deal with a habit.

MR. JOSEPHER: Yes, but the expense is, that really determines it, is where are we spending those expensive programs, and they are, in New York State, it is an industry to build institutions in rural areas which generate employment in Upstate economies, when seven out of eight people come from the inner city themselves, but these institutions are upstate. Many years ago, I think it was Eisenhower who warned about the military industrial complex, well, we have now a substance abuse institutional complex, and the documentation is out there, the political will is not there.

DR. GORDON: Charlotte. SISTER KERR: Denise, you really did some hard things, in my opinion, to heal. I wanted to ask you, if you had to say, if it is possible to say, what one thing most helped you to heal yourself, what would you say, of all the things?

MS. DRAYTON: Immediately, I can point to acupuncture. Actually, one thing led to another. Spiritually, I was bankrupt, so when I came in to go into detoxification, the first thing somebody said to me was you are an African queen, you are a child of God, you are a beautiful woman, you don't deserve this life. So, right then I was swept in, you know, I bought right into it because I hadn't heard that. So, there was that spirit thing, and then right after they swung me right into this fantastic acupuncture where my back was in tremendous screaming pain from the detoxification, because they take you gradually through methadone and then they ease off the methadone, and then what - acupuncture. So, it was like one blended into the other, and the total experience was what helped me. SISTER KERR: Did you have your acupuncture in a group or did you meet in a group with other people having treatment?

MS. DRAYTON: Yes, it was in a group setting, in a very comfortable chair with a very wonderful person, and when the acupuncture needed assistance, it was with Tiger balm and heated peat moss, massage therapy. It was wonderful. SISTER KERR: What I understand from that data and particularly acupuncture is that when the community embraces the whole process, that is when it is most effective. What I had thought you might say was that someone touched you at the level of the spirit, which is what you said, and I don't hear us saying too much about that, you know, and I would invite you to speak about that if you speak again, because you spoke it even though you didn't name it to me. I thank you for bringing that up because it is something we have to be looking at as a commission, I think, and I would appreciate any other input on that. That you.

MS. DRAYTON: Thank you.

DR. FINS: This is also for

MS. Drayton. I was struck by something that you said at the very end of your testimony, that the people in the African-American community have a distrust I think of things that are not traditional. I would like you to say more about that, and what does that really mean? Is there a perception that if it is not traditional, it is somehow second rate, and yet what this did for you was extraordinary.


DR. FINS: It saved your life whereas traditional therapies may not have been as successful.


DR. FINS: So, how do we get the message out, through public education, the Public Health Service, and the like, what kind of concrete recommendations can be do at a national level that that individual practitioner did for you when he or she was so complimentary and said you were a child of God? What can we do at a national level to bring others in?

MS. DRAYTON: I think what is influential to people in my community is peer education. If it is coming from someone who has experienced it and has a working knowledge of it through first-hand experience, they tend to believe it. Usually, if there is any kind of holistic healing going on, it is in the little bodegas or the little tearooms or whatever, and it is immediately kind of associated with cult, voodoo, or something not quite in line with traditional religious beliefs, Baptists, whatever, and so it is looked upon not with -- it is distrusted. So, I think if it was brought more out into the light, not in the little backrooms, and more in the clinic settings, if you had peer educators, while you are waiting to see the doctors in the clinic, do a little talk on holistic medicine and some of the benefits of it, that would be helpful.

MR. JOSEPHER: May I add to that, that while I think race is sometimes a barrier, if teachers had information and have conviction, they transcend those barriers. We have had the good fortune for the last 10 years to have an alternative expert come to our ARRIVE program, teach five times a year. The guy lives in Washington, D.C., and pays his own way up five times a year. He is the chairman of this commission. He has brought alternative medicine to the minority communities in New York City. We are thankful for him.

DR. GORDON: Thank you. I wanted to ask Jeanne one question before we closed. Thank you very much, Howard. The other thing I want to say to all of you is I love going there. It is a spiritual uplift for me to go there. I feel so well used and so happy to be there. So, I think part of what we need to do from my perspective is encourage all the young people who are in health care to go out and serve, and to really serve where they are being heard and they are being most useful. So, thank you, too. Jeanne, you began to say something, and I just want you to say a little bit about it, about the whole question of finances, and you said a little bit earlier at lunchtime, too, that in your situation you had the resources, but you started to point out, and I would like you to underscore it a little bit, the things that were not paid for and the things that you would like, even though you had extremely good experience, all the things that were not paid for and your effort to try to create integrative cancer care.

MS. ANDREWS: Well, I have done Reiki, massage therapy, support groups, Chinese herbs, various vitamin supplements, acupuncture, art therapy, and I believe that all of those, the only thing -- well, I know -- the only thing that has been covered has been acupuncture only when done under a medical doctor, done by a medical doctor. My Chinese herbs alone cost me, on a monthly basis, $110 a month, and I take on an average of six to eight supplements, two to three times a day, and many of them are very expensive. So, it is a costly treatment, but for me it has been working. If I can just address that lady down, one very important aspect that I forgot to mention is that prayer has been a very important part of my healing, my own prayer, as well as prayer from many individuals throughout the country. In talking to Denise over lunch, again, if you don't have hope or a faith, I think it is so hard to beat something like this, and encouraging other people to consider the prayer, the spirit is so much a part of the whole healing process.

DR. GORDON: Thank you very much. Thank you all very much. We are going to have a break for about 10 minutes. [Recess.] Session IV: Issues in Integrating CAM in Service Delivery

DR. GORDON: This panel is going to be beginning in Tab O, and this is Session IV, Issues in Integrating CAM in Service Delivery. We will begin with Richard Miles.

MR. MILES: I will start out by saying I am not a practitioner. I dropped out of the business world about 30 years ago and met several of the people in the room when I was the organizer and manager of major conferences in the early seventies including the first national symposium on acupuncture at Stanford in June of '72. We designed that event for 250 docs. We were going to hold it in the Student Union, Nixon went to China, James Reston wrote an editorial in the New York Times, and 1,400 doctors came to this conference, and away we went with what has now become holistic health complementary medicine, whatever we want to call it. My interest in the whole arena, living in the Bay area, the San Francisco Bay area, at that time in the late sixties, early seventies, the San Francisco area was the fountain of social change, shall we call it, and I was interested in what was driving that and came to the conclusion that what was happening was a major shift in belief about how the world operated. The management expert, Peter Drucker, wrote a book in '67, called "Managing in the Age of Discontinuity," in which he pointed out that all of the institutions of Western culture were reexamining the assumptions upon which they were based. I think that is happening throughout the culture, and I think medicine and health care are a major part of that, and this shift of how we view the world is a major driver of the development and interest in CAM. When I talk to physician groups I say, or to other health care professionals, I say that the focus that you have talked about mostly is about what you do. The new trend in what is happening is who you are while you are doing it. The attitude of the past has been that we are separate observers of the world, not participants in it. My friend, Brendan O'Regan, who used to be the Director of Research at the Institute of Noetic Science, referred to that as the infinitely extrapolated mistaken notion. We cannot be objective and separate observers of the world, we are participants in a living system. So, my particular interest in health and in this whole arena, has been looking at it from the point of view of living syste

MS. In your handout materials, toward the back of the report that I wrote for the Institute for Noetic Sciences, you will see a list of 12 factors in a person's life that can affect their capacity for self-regulation and self-healing. The kind of general attitude of our medical system has been that when you present disease, you are essentially ill and need to be made well. The interventions will cure you. The emerging perspective is that you are essentially well and need to be made ill, and if you can get the illness out of the way, if you can get the factors that are contributing to this illness out of the way, the system will heal itself. The living system that we live in, including the whole planet and the life system that we are part of, is a self-regulating, self-healing system. That is my view of it. What I do now as a business consultant is work with organizations and programs that are trying to develop this particular kind of concept. The one that I probably spent the most time with, that some of you may be familiar was, was the work of Arthur Kaslow in Santa Barbara, in the late seventies and early eighties, wrote a book about his practice called "Freedom from Chronic Disease." Arthur said all of these chronic disorders that are presented to me are the same problem, it is just the weakest link in the system that is going down. So, his whole practice was based on reestablishing the function of the system, not on treating the disease, and he would work with nutrition. He had a staff of five people. He had an acupuncturist, he had a yoga teacher, he had a nutrition counselor, and he had a psychotherapist, and himself, and he was essentially a nutritionally-based physician. His whole point was that what we need to do is turn this person's life around, not fix their disease, and he had a very successful clinical practice in Santa Barbara and in Denton Beach in San Diego. I was on a panel about two months ago at a conference in the Bay area on industrial ecology, which in itself is kind of an oxymoron, but this conference, the panel that we were asked to participate in was called "Managing Living Systems," and the four of us who were on the panel got in touch with the conference people and said you cannot manage a living system. So, the point that I would make here is that we should listen rather than do to, we should be with, we should care for people, and reestablish connections with other people, with nature, and with the living systems, and allow the diseases of this culture to heal themselves rather than try to fix them. Thank you.

DR. GORDON: Thank you, Dick. Berkley Bedell.

MR. BEDELL: Michele, I requested that my testimony together with copies of information on my foundation be passed out. My time has started, so I don't want to wait here while she does that. First of all, though, I want to thank you folks for taking the time to be on this panel. This isn't in my testimony, but I just appreciate this tremendously because I think you have got a real opportunity. I don't know how much the government is going to listen to what you are going to have to say, but I have a feeling the press will, and the people will, and it is my belief that the change is going to come from the people rather from the press. Some of you served with me on the advisory committee to the Office of Alternative Medicine. The report language establishing that office declared that it was to "investigate and validate" alternative treatments for disease. Time after time our advisory committee passed resolutions calling upon the Office to conduct what we called "field trials," where we asked them to go out and conduct scientific trials to "investigate and validate" the treatments being administered at alternative medical facilities around the world. I believe the Director of the Office of Alternative Medicine was supportive of those efforts. Unfortunately, the Director and top bureaucracy at NIH would not permit us to "investigate and validate" any alternative treatments. Three years ago my wife and I decided since the government would not investigate these treatments we would try to do it ourselves. We formed the National Foundation for Alternative Medicine to "investigate and validate" alternative medical treatments. We are starting with cancer. We are sending teams with a medical doctor on the team to visit alternative cancer clinics and go over their patient records. We are finding clinics in Europe administering low-cost, non-toxic cancer treatments with success that would not be expected at major cancer clinics here in the United States. These treatments are based upon a completely different concept of how to treat cancer. They treat the whole body, rather than concentrate all efforts on destruction of the tumor. The tragedy is that some of the non-toxic medications used in these treatments cannot be administered here in this country. In most areas of our society if one develops a better product, the product grows in popularity, and the inventor benefits. This is simply not true in medicine in our country. It is no secret that employees of the FDA leave their posts to take high-paying jobs with the pharmaceutical industry and conventional medical community. The Director of NIH, that was a party to preventing the Office of Alternative Medicine from "investigating and validating" alternative treatments, is now President and CEO of Memorial Sloan-Kettering Cancer Center. The former Commissioner of FDA is now Dean of the Yale Medical School. His deputy director took a job with a pharmaceutical company. I have a friend who was selling Deprenyl as a supplement. He made the mistake of claiming that it could help Parkinson's disease, which it does. He has a wife and young son. He just been sentenced to 13 years in prison. The government asked that he be sentenced to life. He has hurt no one, only helped people. As you know, I served 12 years in the Congress. Most of the members of Congress are dedicated to doing what they think is in the best interest of the people. Some of them are fearless in that regard. However, they cannot be completely informed on all matters. Like most of our society, they are not aware of the restrictions imposed by our government on anyone who would develop a medication or treatment that might challenge conventional medicine and the pharmaceutical industry. One of your duties is to make recommendations in regard to health policy. You have a unique opportunity. You can take advantage of it or shrink from it. The public is turning more and more to alternative medicine. I plead with you to have the courage to recommend passage of The Access to Medical Treatment Act. This would make it possible for these non-toxic treatments to be tried under strictly controlled circumstances. You should also recommend that any medical treatment that has been in use in a foreign country where there is no evidence of it posing a danger to the patient be permitted to be administered here in the United States. It is a crime that our people do not have access to the non- toxic treatments we are finding in Europe. People all across the land are turning in increasing numbers to alternative medicine. You are in a unique position. You can have the courage to make a statement that will be heard, or you can shrink from this opportunity and come forth with a meaningless statement that ruffles no feathers. In the meantime, people in our country will continue to die because we are unwilling to open up the system to treatments that are being administered in other countries. [Applause.]

DR. GORDON: Thank you, Berkley. Thank you as always for your leadership and inspiration and for reminding us of which way our noses are pointed. I appreciate it. Paul Kurtz.

DR. KURTZ: Delighted to be here. I was intrigued by the sessions all day. I suppose I am the token skeptic, having been invited about a week ago. In any case I represent perhaps the leading critic of alternative medicine, The Committee for the Scientific Investigation of Claims of the Paranormal, publisher of the Skeptical Inquirer, and the Scientific Review of Alternative Medicine, a new journal published by the Council for Scientific Medicine. Perhaps we represent the so-called "Establishment" in medicine today. I have just returned from Australia where we had a World Skeptics Congress on Alternative Medicine, and we brought people from China, India, and other parts of Asia. They were critical of Qigong. I didn't hear any of that today. They prefer Western medicine, but pursued Qigong because of the cost, and similar for the kind of healings in India. In any case, we are committed to scientific medicine because we submit, in deference to

MR. Bedell, that this has been the most effective way of curing disease and leading to human health. What we want is coherent theories that are falsifiable, randomized, double-blind clinical tests, and tests of effectiveness. What I have heard today largely were testimonials from patient and practitioners. Now, I think much of what I heard or some of what I heard I would agree with, but I would not call it alternative medicine. I think that term is a misnomer. You have packed everything into it. For example, lifestyle management in cardiology, I had a bypass, I do that. I don't know that that is alternative medicine, nutritional therapy, and many other things. There are plural methods of therapy. The main thing is are they effective, and the only way to judge that -- and you, as commissioners on this Presidential Commission, have an obligation to see that these methods are carefully judged by double-blind tests, that they are coherent theories, that you can find mechanisms if they work and why they work. Now, I applaud the call for evidence-based clinical tests that I have heard during the day. Let me tell you why the skeptics are skeptical about alternative medicine. First, if you are going to have double-blind tests, they cannot be done simply by proponents. Now, we have heard about the tests of acupuncture or homeopathy. You need neutral observers, you need skeptics involved in this, not people trying to get funding and trying to sell a cause, and also there are a good deal of negative tests. I haven't heard any testimony about the negative tests. There is a good deal of literature where people are unable to replicate these clai

MS. One problem that we find is the failure of replication, and a further problem is experimental bias. Experimental bias enters into many fields, and particularly into protofields where people are trying to establish a new profession, and naturally, they want the results. So, the tests must be done by neutral observers who are objective and impartial, neither strong negative skeptics, nor strong proponents, but people who are committed to scientific research. One problem that we found continually in the field of pseudoscience, and we have examined so many from astrology to parapsychology, so many fields that claim to be sciences, and one problem that we find is the protocol. The protocol has to be very rigorous and very tight, and there cannot be any sensory leakage. Now, this commission is going to make recommendations to the new administration, whoever it is. Do we know who it is at this moment? I haven't heard. Okay. It is vital that there be objective and impartial tests, not special pleadings for funds for the government for research or for insurance coverage. I mean what is at stake really is the health and the welfare of the American public, and you have an obligation to see that that is safeguarded. Now, it may be that many of these pluralistic alternatives that you have work. Okay. Let's have an open and fair, impartial hearing. Let's not be biased pro or con, and let scientific testing do the work. It has been very effective in the last century in extending the life of people and getting rid of infectious diseases, many of the wonders of surgery. These powerful methods ought to be extended, and not limited or reduced. I submit that this commission should open its panel to your critics, and that there be fairness, and that you should invite those who disagree and can bring the negative results and the contrary criticisms, so you can hear that. You need a balanced position. I didn't find it today. But, in any case, thanks for inviting me.

DR. GORDON: Thank you very much for coming. I just want to say before we move into questions, we would invite you to help us put together balanced panels of researchers who would question in a honest, fair, and open way some of the modalities that we are discussing.

DR. KURTZ: I think that is the best service you can do to the public in investigating what is effective and what is not.

DR. GORDON: We look forward to working with you, and Steve Groft, our executive secretary, is very happy to collaborate with you in putting together those panels. So, thank you very much. David, Tom, and Effie, to begin with. Panel Discussion

DR. BERNIER: Well, as someone who has done double-blind and triple-blind studies in the university setting for a long time, I can tell you I wish it were that simple. We have a document called the Physician's Desk Reference. It contains some 10,000 medications that are very commonly used by American physicians. Do you know how many medications in that document have ever been scientifically proven to be more effective than placebo? Less than 10 percent scientifically. Does that mean that those medications are not efficacious? Not necessarily. It is just that the placebo effect is so strong that it compares with many of the medications that are used in the P

DR. We use those medications in the P

DR. The language that they use is very interesting. It says, "Possibly effective in the treatment of --" which means it has never been shown scientifically to be more effective than placebo. Do you feel that the double-blind test is an absolute acid standard for what should be utilized, what we should write policy for, for access?

DR. KURTZ: Let me say first that we are critics of medicine. Much of contemporary medicine falls short of evidence-based medicine, so we would bring a similar indictment against some of the traditional fields, and surely in the area of medicine, there are constant revisions and changes, which indicates that medicine is not fallible. But I do think a double-blind test at least is a first stage. The thing that intrigues us about acupuncture -- and I know of many critics in China -- claims that it works, is whether it is a placebo effect and whether it has been tested by proponents or by neutral observers, but, of course, the same thing applies to traditional medicine. The other thing is do you have a coherent theory and can you explain what is happening and why.

DR. BERNIER: Wait. Let me stay with this point for just one second, if we could. In 1972, at UCLA, we did a triple-blind study in acupuncture in which the people sticking the needles in didn't know whether they were sticking real or placebo points. The people receiving who were receiving the treatment didn't know whether they were being treated with real or placebo points, and the people evaluating the data didn't know whether they were real or placebo points. The experimental team was kind of mixed about it. Several of them were very skeptical, several were open, but it didn't matter what their opinion was, because this was a very tight scientific design, as tight as you could determine. When we analyzed the data after the study had been conducted, we found quite reliably and repeatably and predictably that when we would stimulate acupuncture points we would get a reliable result, not so with the placebo. It didn't matter what our biases were when we did that kind of study.

DR. KURTZ: Well, I hope that your account is correct. The only way that you are going to persuade the scientific-based medicine is if there could be independent replications by totally neutral researchers without any commitment either way. I think that is true of science in general. You have to replicate in any laboratory worldwide.

DR. BERNIER: But are you saying then that 90 percent of the medicines in the PDR, we should not have access to those, those shouldn't be utilized because they have never had that done?

DR. KURTZ: I am saying that medicine itself is open to revision and reform. This is not a defense of the medical establishment. As it is, it is a defense of a method of inquiry, and that is the most effective method and I think people who argue for alternative therapies should appreciate this method and trying to use it. I reject the claim here that we should abandon those methods. They have been, by and large, effective where they are used.

DR. BERNIER: Just one other point as a scientist. If we want to talk scientific method, the first thing that we are taught as scientists is you can't prove the null hypothesis, you can only reject it. Negative studies don't prove anything, and I would take exception with your comment that nobody is reporting negative studies. Because you can't find the phenomenon, it doesn't mean it doesn't exist.

DR. KURTZ: But if you can't replicate it, why should you accept it? You say negative studies. How many studies have been done, have you reported in our literature where an effort to replicate it turned out to be negative completely? I mean you need that.

DR. BERNIER: It doesn't prove anything. You cannot prove the null hypothesis, you can only reject it with positive findings. I am sorry, I will stop here.

DR. GORDON: I think the important thing here is not so much to debate as to elicit what the ideas are of the people who are presenting information to us.



MR. Miles, thank you for your very thorough submission, and I want to expand on a couple of questions that you ask here - should CAM be integrated with conventional medicine. You suggest that we actually should frame a different question, and that is, should government policy promote the appropriate availability of complementary and alternative practices. Then, you talk about ways that we can do that with better educational programs, legislative relief, and benefit program redesign. This is very helpful to my thinking because I continue to, as a businessman, look to the consumer to ultimately define choices, so I am in a different context here with scientists, and I often have trouble making the transference of what works in the marketplace with what the world of "shoulds" are. But I do want to just ask you to talk a little bit more about whether you see CAM as a coexistence, a parallel, or is it integration what we are looking for, is our role to help promote and give sort of equal opportunity, equal research, equal access, or is integration truly a valuable goal in your opinion?

MR. MILES: The way I would approach that is that our current system is based on competition, the different practices are seen as competitive with one another. The groups that I have worked with where they become collaborative is where they get the best outcomes, in other words, how can these practitioners work together, not as competitors with one another. So, I think that is a shift of model, and I think that what you might call the corporatization of medicine in the last 10 or 15 years is a move in the wrong direction, because it tends to put practitioners into kind of a time and motion study approach to doing the work, and I think being with rather than doing to is a huge factor. One of the drivers of that is the reimbursement system.

MR. CHAPPELL: Right. I mean health insurance is not even the right name for reimbursement for promotion of wellness. Health assurance is the right product.

MR. MILES: Well, we have lumped insurance together with prepaid care, and prepaid care is not insurance. So, I would try to figure out some kind of way. The movement toward the medical savings account is kind of a step in that direction, of separating routine care from insurance, because people, when we introduced health insurance back in the forties and fifties, we didn't introduce it as insurance, we introduced it as benefits. That is a totally different concept. You buy insurance on your house or your car, you don't think of ways to collect benefits. So, somehow, from my point of view, we have created a public expectation that they can live their life any way they would like to live it, and this insurance system is going to rescue them, and somebody else is going to pay for it. I think until we deal with that straight out, I think we are going to have a hard time integrating CAM, integrating anything else, because the public expectation is that they are a victim, and somebody will rescue them.

MR. CHAPPELL: That is what you call benefit program redesign.

MR. MILES: Right, and if we don't deal with that kind of basic belief system in the culture, I think we are kind of plowing ourselves uphill.


DR. GORDON: Effie, George, and then Joe.

DR. CHOW: Thank you very much. I have a couple of questions, and, Berkley, I appreciate your whole animation towards this and your pursuit of this in your own personal dollars and time and everything. You mention about accepting that which has been practiced in other countries. Can you elaborate a little bit, because we are seeking scientific evidence of this, and what you are saying is that the existence of it, and the value of it in the country is where it is, it has shown value. It is enough that at least we can begin to use it. Can you elaborate on that?

MR. BEDELL: I sure can. First of all, I think that

MR. Kurtz' criticism is wrong. My God, how could you invite anybody except him that would be more definitive in objecting to alternative medicine? You are doing that. It seems to me that you have done so. But we come from a completely different concept. Forgive me. I care about the patients and the people and those that are suffering from disease, and I believe, maybe you don't, I believe we don't have very good treatments for most degenerative diseases. I don't believe we have got very good treatments for cancer or Alzheimer's or Lou Gehrig's disease, and right on down the list. Under those circumstances, I think that if there is a non-toxic treatment where it has been beneficial to others, I believe that we are worrying about "scientific- based medicine" where we say that the scientists, but we are not really talking about the scientists, we are talking about the pharmaceutical industry, the NIH, the FDA, the AMA, the whole group, including my friend here or new friend,

MR. Kurtz, who are all trying to say that you can't do anything different until we spend years and millions of dollars and go through a whole lot of tests to find out that it satisfies the scientists. They don't worry about -- it is not the people that have to be satisfied, it's the scientists that have to be satisfied. I would argue that we are a country here to help the people, and I would argue that you were put on this committee to be of help to the people, and I would hope that you would recommend policies that made it possible at least for those treatments to be tried. That's all we need to do. We need to open up the system, so that it can be tried. If we had a perfect system of health care here, where everybody was doing well, that would be fine, but I think you know we spend twice as much as any other country in regard to our health care. In many areas, we are right at the bottom of the list, if you really look at measurements of life expectancy, all these sorts of things. Under those circumstances, surely it makes sense to remove the monopolistic system we have today and try to make it possible for these things to be treated, and that is my whole plea to you folks. You know, you can do as you want to, and you can say we ought to have this barrier and this barrier and this barrier because the scientists want us to satisfy them. I think you are here to satisfy the people.

DR. CHOW: Thank you. Just to clarify, I know you are not against scientific research, what it is, is that you just want faster action because you are seeing people dying and that you want what has been used, to be used while we do science.

MR. BEDELL: That's right. Why should we only let the people that have the money go to Europe to get these treatments, and why shouldn't we at least, we are trying, as I said, we are sending doctors in to check their records to find out whether the things work or not. They have got to submit those records to oncologists here to have them review it. We are trying to find out, but you can be damn sure I am not going to do some double-blind studies that take seven years to find out. If you were my age, you wouldn't want to do that either, Effie. [Laughter.]

DR. CHOW: Well, at my age I would like to see things expedited, but, of course, there is caution and there is quality, and I know you are interested in that. We would like to get what studies you have already, Berkley, you know, that you find would be helpful.

MR. BEDELL: They are on the Internet, but we will be glad to.

DR. KURTZ: May I respond to that?

DR. CHOW: May I make a statement, first of all.

DR. KURTZ: Oh, please.


MR. Kurtz or

DR. Kurtz?

DR. KURTZ: Either way.


DR. Kurtz --

DR. KURTZ: I am not an M.D., I am a professor.


DR. Kurtz, yes. I really appreciate your point of view because when I get skeptics, I like open skeptics, and that is what I feel you are is an open skeptic, and I like your comment saying that you should have not strong negative skeptics and not strong proponents judging, and I think that is a very balanced view, so I appreciate that. Now, I put in one thought, though. In CAM, and I think maybe a lot of people don't understand that of CAM, that it is not just another therapy, but we are talking about that we treat individuals very individually and that all the components that combine together doesn't add up to - - one doesn't make two, it makes 10. When you talk about double-blind studies, that is what we are struggling with is a research that would be suitable for this, and so how would you -- and maybe you can't answer it here -- but do you think there needs to be new research or revised research protocols that would be acceptable to you as a research methodology?

DR. KURTZ: Well, first, I think the patient comes first. Obviously, we are not concerned with pleasing scientists per se, but helping patients, and what is the best way of doing that? We argue that the most effective way -- I mean, for example, take laetrile, now, would you permit that in this country verbatim, anyone can do it at any time, or are there difficulties, shouldn't that be pointed out, and there have been nostrums that have been used, that have been injurious. I think the FDA being taken off herbal and supplementary food in 1994, that was very unfortunate that that act was repealed. I hope this commission will argue that there ought to be some monitoring of herbal and food supplements. But in any case, what is a protocol used, you need tight protocol. You can't delude yourself that you have the results. You want to see if they are effective. Now, maybe five to seven years is too long, so perhaps if there is some way of being fair to the science, I think that would be useful, by all means. So, I think it has to be rigorous protocol and replication.

DR. GORDON: Can we move along a little.

DR. CHOW: Thank you very much.

DR. GORDON: George, and then Joe, then Wayne, and then Veronica.

MR. DeVRIES: Actually, I think Effie touched on what I was going to ask, but Berkley, you and I have had discussions about the foundation and your organization. Maybe you can describe some of the steps you are taking and some of the outside, sort of third-party organizations you are working with to help substantiate the validity of the results that you are finding from the various treatments in centers in Europe.

MR. BEDELL: We have visited 50-some clinics in 14 different countries, and there is always a medical doctor, an M.D. on the team that goes in, and the main thing we are looking for is to go through their patient records to see what we can find. We are using something that was used at the NIH called Best Case Series. What we are really looking for are a number of phenomenal cases that can be documented, and what we are doing now, in fact, I just approved it today, that we are now going to -- we have had those from two clinics now translated into English, and we are now in the process of having those submitted to oncologists here in the United States. We want to find out whether or not these things work. We are not trying to sell laetrile or anything like that, we are trying to find out. Where we have the difference is that in my opinion, that if you have something that is clearly non-toxic, and where there is evidence that it is beneficial, that it should be more up to the patients than it should be a bureaucrat at the FDA to decide whether that patient can avail himself of that treatment. We just plain disagree in that I believe we have got such tremendous controls. When I was in Congress, I was the chairman of a subcommittee, the Agriculture Committee, and we had the same problem there, that it took more money and more time to prove that crabgrass was effective than it did -- to prove that a treatment for crabgrass was effective than it did to satisfy that it was safe. I said, "My God, you shouldn't worry about that." I said, "If it doesn't work, people are going to quit buying it anyway." Now, it is a little bit different in medicine because you might hurt people, but my argument on medicine is that since it doesn't work very well for the crabgrass, we maybe ought to be a little more open to letting them try something if it doesn't hurt anybody or anything. That is where we have got our big difference. I don't know how well I answered your question, George. I get too emotional about all this, but, you know, people are dying, they are going to continue to die, and I tell you I wouldn't be very happy for me to find out that a friend had Alzheimer's -- which I just did -- or to find out somebody has got pancreatic cancer, or this sort of thing, and I think under these circumstances, it is time for us to quit being so darned careful, careful, careful, careful, let's do something about it, and I believe we had better do something about it pretty quickly, and I believe you folks have a tremendous opportunity here to recommend that the system somehow be opened up with adequate safeguards, that these things are not frozen out of our system.

DR. GORDON: Thank you, Berkley. Joe, Wayne, Veronica.

DR. FINS: Congressman, I thank you for your enthusiasm and your comments. I just want to ask you, and maybe

DR. Kurtz can also comment on this, but it seems like there is really not a fundamental disagreement, it is just a matter of getting it done a little quicker, and I wanted to ask you, Congressman, about the issue of what happens when you have things that are maybe toxic, and maybe have an element of risk, but also have benefit, what kind of mechanisms can the government engage in - if you find something in Germany in the clinic that has some associated toxicity, it would seem to me that based on what you have said and your prudential method, that you would want that to be validated and have adequate safeguards, but from what your testimony said, there was not adequate access at the NIH and other federal agencies to conduct that in a responsible way. Is that what you were --

MR. BEDELL: Well, I think that you have got a completely different situation if you have a toxic medication, assuming it is significantly toxic, you know, I guess aspirin is toxic, but if you had any significant toxicity, I think you have a completely different situation, I think you have to be much more careful about what you do. Fortunately, those that we have seen have had almost little or not toxicity to the treatments we have seen.

DR. FINS: So, for more toxic therapies, you would endorse going through the convention Phase I, II, and III trials and the FDA process?

MR. BEDELL: Well, I wouldn't endorse anything the FDA does probably, but the Access to Medical Treatment Act that I talked to you about, that was one of the requirements, that there be no evidence of toxicity, which I support. I would not recommend that you people recommend that toxic treatments can be used without further tests. I believe it is a completely different situation when you have something that is --

DR. FINS: Professor Kurtz, if I could just follow up, using sort of the ethical doctrine of proportionality, balancing risks versus benefits, how does that limited recommendation of the congressman sound to you, where is no toxicity and there may be benefit?

DR. KURTZ: How do you know there is no toxicity? That is the real question, unless you submit it to some kind of test. Take ephedrine -- I am not a pharmacologist - - which apparently is very dangerous, can cause strokes and heart attacks, how do you decide that it is toxic or not? Who is to decide that? You listen to what the Germans say, is that what you do, you have a German Commission, or do you allow the FDA -- I think that act was a great mistake. I don't think the free market is sufficient -- and I think the gentleman here suggested it was -- for determining which herbs or dietary supplements should be available.

MR. BEDELL: Could I reply to that?

DR. FINS: I would like you to if the chairman would allow it. I would like the rebuttal, if it is possible.


DR. FINS: Thank you.

MR. BEDELL: I think you determine toxicity if you have got enough patients that have been treated, and there has been no toxicity. I don't know how else you would do it any differently than that. It seems to me that is the best way to prove it.

DR. FINS: Let me ask you, just to get concrete for just a moment here. Would you both be in favor of some recommendation from the Commission to set up a mechanism within some federal agency to do the peer review in an expeditious manner for things that had some evidence of benefit and what we would classify as minimal or non- existent toxicity just to expedite the process? Would both of you gentlemen agree to that?

MR. BEDELL: No, I would not.

DR. KURTZ: I would.

MR. BEDELL: I don't trust the Federal Government. I think that FDA is too tied to the pharmaceutical industry.

DR. KURTZ: Well, do you trust the pharmaceutical industry?


DR. KURTZ: Okay. Then, who is going to decide? They manufacture the drugs.

MR. BEDELL: Wait a minute. I have been a businessman. Business is motivated by profits and money. Does anybody think that is different for God's sakes? Does anybody here think the pharmaceutical industry is mostly concerned about helping people rather than making money, if there is some way they could help people and lose money, that that is what they would do? Do you think that they don't want to continue to sell their products no matter what? That's just the reality. That's not something radical, you know. I am a businessman -- I was a businessman most of my life. We tried to sell fishing tackles.

DR. FINS: So, we are not going to solve it this afternoon, but I thank you both for your exchange. Thank you so much. [Applause.]

DR. GORDON: Wayne.

DR. JONAS: Well, now, I am very confused.

MR. BEDELL: It is not the first time I have confused you, is it? [Laughter.]

DR. JONAS: I appreciate both your passion. It is tremendous actually in finally, I think, getting at the heart of a number of issues, literally at the heart. Berkley, what I am confused about is are you a Republican or a Democrat? [Laughter.]

MR. BEDELL: You know what I am, Wayne.

DR. JONAS: Well, you seem to be shifting a little bit, so I am thinking if we don't end up with a president, maybe as a neutral party, you could step in and assist here. In many ways you have answered a number of the questions. I really do think good, rigorous science has to be done. That is why I am involved in research. In many ways, conventional medicine, for all the tips of the iceberg of success it has, which are very good, there is a huge carcass of failures, because they have not used good scientific medicine and research, and actually they have only recently figured out or begun to figure out how to do it, and they still don't know all the ways to do it, and that is why we are looking at a variety of methods. Controlled trials, randomized, controlled trials, never mind properly double-blinded ones, have only been around about 50 years, so we are still trying to figure out what they do and what they don't do. I think the important thing is that we apply proper rigorous methods to get the kind of information that we need. We don't do laboratory research on new psychotherapies in mice, for example, you know, nor can we double-blind invasive surgical procedures, and so you have to do the most rigorous methods you can for the particular goals. So, I think clearly differentiating those goals and applying good research methods are important, and it seems to me that often what happens is that there are different audiences that prefer different types of information even if they are all rigorously done. What I am confused at, not from that, but from the issue of what should the role of the government be in this area, because on one hand, if we need a neutral party, if we truly can't trust those with vested interests and biases, then, I see no other place except the government that can at least begin to do that kind of balance, but on the other hand, I agree with Berkley that I am not sure if they can, even that. So, that is what I am in a dilemma about, do you feel like the government should, in fact, have a role at this, and if so, how should those priorities be set, should we go after the controversial things, should we go after the biggest killers in the society, should we go after the things that are the most popular, or should we just leave the government out of it and let the free market determine it and pull off the government regulations? I guess we could make recommendations from this panel another way, couldn't we.

DR. GORDON: Response, Berk?

DR. JONAS: Perhaps

DR. Miles, maybe you would like to address this.

MR. BEDELL: No, I think the government has to be involved. I have been part of the government, I think they have to be involved. I think the question is how should they be involved, and my argument be that the government is there to represent the people. I think the people need access to non-toxic treatments that may be better than what they are now getting, and I think the government should be there to try to help the people rather than to prevent them from getting what might be best for them, particularly because of the fact that in our capitalistic system, the system operates in such a manner that the motivation for corporations is to make money, and the motivation for corporations is to get the government to do what they want them to do in order that they can make more money. I have been there. That is what it is. I think you folks have, I would hope, should have a different perspective of what you are here for. I don't think you are here to make money, I think you are here to help the people, and that is why I feel the way I do.

DR. JONAS: So, you do think the government should be involved in trying to forward our understanding and information in these areas.

MR. BEDELL: That's right, but mostly I think the government ought to remove the roadblocks that they are now placing in the way of having an opportunity to find out whether there is a better way to treat disease than what we are now doing.

DR. GORDON: Thank you very much for a very clear answer on that.

MR. MILES: One of the factors in that is that since most of these medical practices are regulated at the state level, not at the federal level, there are a lot of regulations at the state level that prohibit or limit the ways that practitioners can work together, and they are thought of in the terms that the only reason that practitioners would work together is because they were going to split fees or they were going to do something like that to increase their revenue potential, but a lot of practitioners are trying to work together now in collaborative ways, and they are running into these kinds of legislative barriers. So, the recommendations around that kind of thing can be --

DR. KURTZ: I wonder if I could add that I think the general welfare of the people is one of the purposes of the Constitution of this country, and we cannot abandon that. Obviously, this is a free market economy, but regulation is important and necessary. It has to be prudential, so that we disagree on how much regulation, but I would also -- I would not abandon the medical professions. I have seen a strong indictment of medical professions. People in the health care industry are concerned about the public good, and have devoted their lives to it and do the best they can, and we simply should not say they are opposed to any further changes.

DR. GORDON: Veronica.

DR. GUTIERREZ: To change the pace here a little bit, my question is for Richard Miles. I noticed twice in your memo that you made reference to the difference between routine health care and catastrophic insurance, and what I am asking is that we are having a meeting on this very subject in May 2001, and you must have given quite a bit of thought to concepts of how to separate the two, and I would like to have that information.

MR. MILES: Okay. I definitely can put some thought to that, because I think if we don't separate the two, we will perpetuate the public concept of benefits, which means that I am going to get all these services and somebody else is going to pay for them. That is a major responsibility shift. Most of the self-care lore in this culture has been lost in the last 40 years. We used to have all kinds of ways of taking care of things with Aunt Maisy's remedies or whatever, that worked to a certain extent. A lot of that has been lost because the public attitude is that I can go to a high-tech expensive professional and somebody else will pay for it. That is a huge attitude shift. Another factor that I would add to the discussion is most of the research that we are talking about is research to validate technologies. That is not necessarily research to improve someone's health. If we could shift our research paradigm and say, okay, what can we do to improve people's health, because most of the technology validation research that we do is product oriented, which feeds into the market economy that we are talking about. So, if you want to do something that is really valuable for people and helps them improve their health, and it doesn't develop a product, or doesn't develop something you can market, there is a tremendous tendency not to pay much attention to it. One of the things that I mention in my document there, that I didn't get a chance to talk about, is the whole concept of a health advocate coordinator kind of person that knew about CAM practices and knew about conventional medicine. I think a person like that out in the world would change the system dramatically, simply people would have somebody to go to talk to who could explain some of these things and indicate the options, because I think that public options and people having the decisions to make, having the option to make the decisions about the kind of care they want, would revolutionize the system. It doesn't work now because the question is not will this help me, the question is, is it covered.

DR. GORDON: Tieraona, did you want to ask a question? I couldn't tell. I know Bill does, and then we really need to end because we are running overtime again.

DR. LOW DOG: I guess I just want to clarify that with DuShea, in 1994, it actually did increase access or guaranteed access for dietary supplements and botanicals to assure the American population that they would have access to many, many substances. Now, there were some problems obviously with the FDA, because they have to prove harm, so it is sort of things are already out in public, then, we have to come back, which was some of things about ephedra. But I guess the notion of non-toxic is always something very interesting to me as somebody who deals with botanicals and their pharmacology, is the notion of something being non-toxic, I think it was [Paracelsus] who said, "The dose determines the poison." Toxicology is not real simple, and, you know, women consumed alcohol during pregnancy for hundreds and hundreds of years, and it took until 1972 to be able to understand the fetal alcohol syndrome was caused by consumption of alcohol during pregnancy. That was a toxicity, a teratogenicity that was never noted for more than a thousand years, so I think we have to be diligent with new products and new substances that we bring in. I think people need to have the access. I think that is what the purpose of DuShea was, but I think that we need to be careful when we talk about toxicity, because was it in somebody who is pregnant, is that in a 3-year-old, is that somebody with liver failure. I think when we are talking about something going out to the American public where you just go buy it off a shelf, it is not going to be under the auspices of a health care professional in Germany that is administering it, I think that we do have some obligation to be diligent with our admissibility of those products. Would you agree?




DR. LOW DOG: Good.


DR. FAIR: I would again like to congratulate

DR. Kurtz. I think that was a very open presentation and I enjoyed it. My problem -- and I don't know exactly how to phrase this question -- but my experience of working for 16 years at a major cancer center was that we can always do something. When Berk was impassioned there about people are dying, we have to do something, I saw that all the time from radiation therapists, from chemotherapists, you can always take another bottle off the shelf. Fortunately, surgery is getting a little bit more restrictive because it was the oldest specialty, and we have gone through all that nonsense about removing half the body, and so forth, but the other cancer therapies are still to that point, and that is what led us to things like autologous bone marrow transplantation in women with breast cancer. Insurance companies were sued, PPOs were sued, you have to pay for this. Physicians testified this was the only chance, one that we now have four studies, and we showed that it doesn't have any effect at all. So, my question is that this same kind of passion that Berk evidenced there, given the fact that it is not limited to complementary medicine, and that it is not just avarice that is driving this, it is not the pharmaceutical firms or the physician that is saying if I give more chemotherapy, I am going to make more money, it is truly an effort to try to do good. But what kind of legislation would you recommend that would cover those kind of unnecessary use in CAM therapies, and yet we could extend it to conventional therapies and protect the public in that way, because these are toxic therapies, they are not benign therapies.

DR. KURTZ: Yes. I think public education. I agree that preventative medicine is central, and there has to be full public education from the earliest grade schools on, so I would put health education in grammar school, high school, throughout the colleges. It is the informed citizenry in one sense. It has to know whether or not he or she wants this treatment, so it depends on informed consent at the same time. This is changing. The state of the art is changing. I think people do not recognize the fact that medicine itself is fallible. There are great achievements and successes, but we need always to be willing to revise the therapies at any one moment. Incidently, the hospice movement that was discussed earlier, I don't know, is that alternative medicine? I think we all support the hospice movement.

DR. GORDON: If you two would be very brief, we are 10 minutes behind, so we will lapse a few more minutes, if that is okay with everybody. Yes? Okay. Then, George.

DR. BERNIER: I have a question for

DR. Kurtz. In your letter to us, you said that -- you sort of held things back, I guess -- the question was should CAM be integrated with conventional medicine, and why or why not, you said, "I do not think it should be integrated. I deplore the effort to do so."


DR. BERNIER: I guess my question is, if, in a validation process, we found that a third of modalities in fact survived a good scientific test, and recognizing that there are a variety of skills that are involved in the practitioners, would you then feel that CAM medications are not to be part of the mainstream?

DR. KURTZ: Well, I said that merely using CAM as a generic term, alternative medicine is a generic term, does a great disservice because there are so many things under that rubric. I mean you have therapeutic touch, you have psychic healing, so many things. Now, some of these alternative therapies may very well work. Those that work should be integrated, but those that do not -- and I think you have a lot of enemies out there of alternative medicine because they are afraid that if put this in, what seems to perhaps have some evidence, that you have to put everything else in. That is why I am against the term CAM to include everything on this list, and I think it is a great disservice to do that.

DR. BERNIER: I would urge you to look at it as if a great many may well get to be validated.

DR. KURTZ: Well, if they are validated, yes, integrate it. That is part of scientific medicine.

DR. GORDON: Thank you. Tom.


MR. Miles, in this paradigm that you are envisioning in your report, would you make room for patents and exclusive marketing on discoveries?

MR. MILES: Well, that is a huge question.

MR. CHAPPELL: As you know, a natural substance cannot be patented.

MR. MILES: Right.

MR. CHAPPELL: But I can add camomile to echinacea and have a discovery that is patentable.

MR. MILES: The whole question of patenting and the whole idea that is coming up in bioengineering and that kind of stuff, just gets to the edge of, from my point of view, a very dangerous place.

MR. CHAPPELL: Could you help the Commission on this?

MR. MILES: Because I think we ought to be getting closer to nature rather than further away from it, and the idea of taking things and manipulating them a little bit, and then calling that a product that I can patent -- well, perhaps the most dramatic example I am aware of right now is a farm in Ontario where Monsanto has put this genetically engineered corn in next to this guy's farm, and the pollen is blowing over into his farm, and Monsanto has sued him for stealing their patent. He has sued them back for polluting his farm. Well, that is the level that this thing is going to get to. Again, as I said earlier, this thing of managing living systems, we have this kind of hubris that we are going to be able to manage life, and I think we have carried that about as far as we can carry it, and we are up against some really major barriers around that. If you look at most of the major social environmental problems that we have in this culture, it is the result of that hubris. In other words, the air quality is going down, the water quality is going down, the farms are becoming contaminated, because we think we can take science and technology and fix nature. Well, we are not being very successful with that, and my point, the same thing in the field of medicine, is -- well, I mention in my report that I see kind of a spectrum. At one end of the spectrum is immediate, traumatic, crisis- type care. The other end of the spectrum is chronic degenerative issues. As you move across that spectrum, you move away from the effectiveness of conventional medicine and toward its ineffectiveness, because chronic degenerative disorders are systemic problems, they are not diseases. They are not something that can be fixed. So, when you get over to that end of the spectrum, rehabilitating the system or rejuvenating the system, or whatever you want to call it, can be a very effective way to deal with some of those chronic disorders, but you don't fix the disorder. You revitalize the person, so to speak.

DR. GORDON: Thank you. Thank you all three. I think these are wonderful examples, each one of which illuminates a certain area that we need to grapple with as a commission. So I really appreciate your coming and sharing and talking with us.

DR. KURTZ: Thank you for having me.

DR. GORDON: We will take a five-minute break, and then we will have the final panel come out. [Recess.]

DR. GORDON: This is the second part of the panel. With the first part of the panel, I hope you were able to see that what we are trying to reach for and look at are broader views, not necessarily views that agree with another, or even views that complement one another, necessarily, but differing views of how CAM can be integrated into service delivery systems, really views that have to do with world view and ideology even more than they have to do with practical considerations. So that is why we have asked these two groups of panelists to come and to kind of expand our vision and help us take a broader look, and raise some of the issues that got all the discussion going. So in that spirit, I would like to ask Donald Kendall to be the first speaker.

DR. KENDALL: Thank you. I would just like to clarify that I am a member of the National Guild of Acupuncture and Oriental Medicine, which was set up under the auspices of the Office and Professional and International Union of the AFL-CIO. This is a professional guild for licensed practitioners of Oriental medicine and acupuncture. We are a new organization and what we are trying to do is to get everything organized on a national level, not to compete with our professional organizations, because you have to be a member of one of those organizations to be on the Guild. So the Guild thanks you for inviting us. I would like to share some of our thoughts on integrating complementary and alternative medicine into conventional care. Now, of course, we are promoting health and well being through the utilization of acupuncture Oriental medicine, but one of our goals is to recognize the real- world -- I am going to use the words -- "coherent theory" of physiology on the physiological basis of acupuncture and Oriental medicine that has been confused over the years because of one interpretation of what the ancient Chinese said, which was fundamentally flawed, and more recent, and some older, interpretations that are more in line with modern understanding of physiology. Now, we submitted answers to five questions, and after a little introductory march here, I am going to answer those, but not in the same order. I want to answer Question 4 first, because it is the most important item of those five questions. Oriental medicine is a physiologically based primary health care approach that historically, maybe 3,000 years or more, has always been part of world medicine, a major base of world medicine. There is a very rich diversity in this field, I mean, a wide range of modalities. This is why there is sometimes some confusion on who does what and different techniques or different approaches. It involves herbal medicine, nutrition, heating therapy. It involves manipulation, articulation of joints, specialized massage and pressure techniques. It involves other physical things like cupping and scraping, lifestyle counseling, exercise therapy, rehabilitation, movement and breathing exercises, movements like tai chi and gao lin exercises, and breathing exercises like qigong, preventative care, and then a very sophisticated needling therapy that is called acupuncture in the West. This is totally a Western name. Acupuncture is obviously used to treat ailments in our system by stimulating certain critical locations on the body in order to control and regulate many physiological things, including the circulation of blood and vital substances, regulating autonomic systems, and endogenal mechanisms to restore physiological balance. This includes restoring somatic, visceral, immune function and homeostasis, as well promoting pain relief and tissue healing. So one of our primary goals is to try to put our profession on a solid foundation that uses the same recognized world body of physiology. There is only one human physiology we know of. Now, the difference in Chinese medicine, or in Oriental medicine, we have a different view of it. We are looking at the organization of the body in terms of visceral-somatic relationships, in terms of somatic-somatic relationships, in terms of visceral-somatic relationships, to explain how this works, and also how the treat diseases, to restore function of the body. Fortunately, acupuncture research and neurophysiologic research over the past two decades have provided us sufficient insight, enough information now that we have been able to explain how the logical insertion of needles can bring about a medically significant reaction in the body, a restorative process in the body. [Alarm.]

DR. GORDON: It's time, yes.


DR. GORDON: We will come back. We want to find out how you are integrating this into your work with the unions.

DR. KENDALL: Sure. No problem. Thank you.

DR. GORDON: Thank you. Candace Campbell.

MS. CAMPBELL: The American Preventive Medical Association was founded specifically to lobby at the federal level for health care freedom. We work to increase the flow of information about CAM therapies to consumers and practitioners, as well as increase access to those therapies. We do not promote one type of practitioner over another or one therapy over another. Our goal instead is to increase patients' awareness and access to the full range of health care options. We led the effort, for instance, to pass the legislation that created the National Center for Complementary and Alternative Medicine at NIH. We did that for two reasons, first, because it was ineffective as an office, and second, because we believe there is a crying need for more and better research into CAM. Part of that legislation created this White House Commission, as you know. We were also painfully aware of the fact that there was not coordinated, concerted effort to achieve an integrated health care system. In fact, we discovered that not only was the federal government not doing everything it could to ensure that consumers have access to a full range of treatment options, it was also getting in the way of access and education regarding CAM. People often call our office looking for help. They want help finding a practitioner who uses natural therapies, who knows about nutrition, who offers alternatives. Typically, these people have already been through the conventional system and they feel either abused or disappointed. Often, they are angry because their regular doctor didn't tell them they had other options. Sometimes they share stories that break my heart. A mother who is facing the loss of custody of her children because she feeds them a vegan diet and doesn't want to vaccinate them; a father whose daughter was killed by radiation therapy for a brain tumor, even though the hospital's Tumor Board was well aware of a safe, effective, but experimental therapy undergoing clinical trials, and knew that radiation had never worked in these types of cases; or an elderly man faced with driving hundreds of miles for a life-saving, off-label therapy that his own physician is now afraid to offer because his colleagues in that state have lost their licenses for doing so. Physicians call us frequently, too. They call us when their medicine board starts harassing them for using alternative therapies or unconventional diagnostic tests. They are harassed for getting kids off Ridalin, or for daring to treat cancer patients with something other than chemo and radiation. Medicine doctors in this country who are using CAM are running scared. It is pathetic. Instead of being praised for getting people well, they are being harassed, censured, and shut down. I am not talking about cases of malpractice or quackery. I am talking about good doctors doing everything they can to help patients, and their patients are happy and healthy, and enjoying an improved quality of life. It is both embarrassing and frustrating to me that in a nation such as ours, built on the bedrock principle of individual freedom, built by founding fathers who risked their lives to get the government off their backs, that we are now beleaguered by a medicine dictatorship that is more interested in maintaining its own power base than in seeking out and incorporating the best the world has to offer patients. In my naivete, I used to believe that doctors or researchers discovering and innovative therapy would be met by colleagues, or the FDA, or NIH, saying, Hey, you could be on to something here. Let's pursue it. No. Instead, they hear, That is unapproved. That is not what I learned in medical school. That is not the way we do it here. Or, worse yet, if you keep doing that, we are going to through you in jail and take away your license. A significant part of the problem we are facing today is due to the fact that we have created and are now propping up a tremendously wealthy, powerful, successful, and dare I say, monopolistic allopathic medical system that is doing everything it can to stifle the competition. Let's not encourage by sicking the federal government on the competition. Let's not encourage that by making criminals out of the people and the companies who are doing their best to offer patients something better. Let's take the high road and force the system to put patients first by investigating and validating, and then incorporating a more thorough range of health care options. Let's make our anachronistic federal programs reflect advancements in science. If the existing system does not accommodate new products and therapies, let's change the system, not abandon the products. My hope is that this commission will seize the great opportunity I believe you have. You can start by recommending passage of the Access to Medical Treatment Act that Berkley recommended. You can go further by recommending that the FDA and the Justice Department be prohibited from prosecuting practitioners or suppliers unless there is evidence that they or their products have been seriously harmful to patients. Our health care system is confronting a huge challenge. You have a chance to shift the health care paradigm in ways that can ensure that Americans truly have access to the entire toolkit, not just the hammer, for health promotion and disease treatment, and I hope that you will not miss this window of opportunity.

DR. GORDON: Thank you very much, Candace. Michele Forzley.

MS. FORZLEY: Good afternoon. Last but not least, here I am, talking about the law and the business side of CAM this afternoon. I chair the American Bar Association Commission on Complementary and Alternative Medicine. I really have just two points to share here this afternoon. The first one is that I want to bring to your attention that some international law and related materials restrict what policy recommendations can be made on access and delivery, or they can be aspirational, and at the very least, they can be extremely helpful reference material. I have heard of a number of instances this afternoon in discussion that I know you can find answers to from other countries and systems of operation. An example is the International Convention on Economic, Social, and Cultural Rights, which is both aspirational and helpful, in that, an international standard of health is enunciated and access is defined. The standard is that every human being is entitled to the highest attainable standard of health conducive to living a life in dignity. The United Nations Committee on Economic, Social, and Political Rights, which administers this treaty, is helpful by defining the elements necessary to achieve the standard, one of which is access. The U.N. defines access to include non-discrimination, physical access, economic access, and information access. Now, keep in mind that when the United States ratifies an international treaty, that treaty becomes domestic United States law. I have selected the area of intellectual property rights as an example of how international law can set an outside policy limit. I have done so because right now an ethical, legal, and public health debate rages with respect to access to drugs, most notably in the news on AIDS. That same debate, part of which is based on intellectual property law, can arise with respect to botanicals, herbals, and indigenous medicinals. Of the many treaties that may have an impact, two that absolutely do are the Tripps Agreement and the U.N. Convention on Biodiversity. These define rules on plant variety and exclusions from patentability for diagnostic, therapeutic, and surgical methods of treatment. I would urge the Commission, therefore, to forthwith make an international analysis an integral part of your work, not only on access and delivery, but for all elements of the mandate of the Commission. The second point I want to make is that access and delivery of CAM are impeded by the lack of basic business skills, governmental support services, and information on capital formation and funding sources. I base this statement on the results of the Business Model Pilot Study, which I did in Boston earlier this year, and my 24 years of experience in developing and teaching business courses. I will explain in light of two study conclusions. The study began with a question of whether any CAM organization was making money, and, if so, under what model did they function. First, there is confusion over what people are delivering and the difference between and healing and a business model; are they delivering wellness or sickness treatment services, products or services, education or health care. No entity can succeed financially unless it decides what it is delivering and who wants it, or basically who wants access to it. In business parlance this is called the five Ps of marketing, or Marketing 101. Another study conclusion is in the area of credentialing and licensing. Access and delivery will not be fully implemented, if my study findings are correct, until harmonized national standards are established. I would add even that internationally harmonized standards should be established. I know of no other industry that would tolerate such a hodge-podge of essential professional regulations as licensing and credentialing. I think it is telling that no respondent would share credentialing guidelines, claiming them as proprietary. This is like saying, well, we want employees, but we won't tell you what the job description is. For this reason, I have invited JACO [ph] to address the Conference on CAM Law and Regulation at this summer's annual meeting of the American Bar Association. The resources to fill the lack of basic training and support services are already in place in the public and private infrastructure. They simply need to be redirected toward the CAM community. This was done in the 80s with the entrepreneur. It was done in the 90s for companies going global, and now it is health care's turn. Thank you for the opportunity to share my views.

DR. GORDON: Thank you very much. Do we have questions from commissioners? Who would like to begin? While you are collecting your thoughts, I want to ask

DR. Kendall, I would like you to address the way this particular CAM benefit or acupuncture, and perhaps Chinese medicine, is being integrated into programs for unions.

DR. KENDALL: For unions?

DR. GORDON: Yes. How is that happening? Can you tell us a little bit about it?

DR. KENDALL: The parent union, the Office and Professional International Employees Union has several guilds, one of them for medicine doctors, one of them for podiatrists, and one for, I think, some other health care workers, and of course the new people are practitioners of acupuncture and Oriental medicine. The way they can help has to do with the fact that they have a lot of experience in trying to integrate things into the system. The AFL-CIO union, for example, has a 13- and-a-half-million member base. If you include their family members, they represent about 45 million Americans. They are well trained in lobbying the federal government and state agencies as well. So one of the problems they have had in this field of trying to get some kind of parody within the medical care system, is lack of some hard core focus on the part of our practitioners. A lot of different schools of acupuncture, Oriental medicine, from minimal training from 1,000 hours up to 4,000 hours. So we have had a wide range of standards, when we really should have some kind of uniform standard. So the thought was, when the union approached us - - actually, not me; I am just a member, but approached

DR. Preevy [ph] and

DR. Wright who is the vice president -- it became obvious that this would be an opportunity to get some voice in this medical field because it has been difficult. We have been doing this for 25 years, and are still really not into the system. Patients can't get reimbursed for everything. Now some insurance companies are starting to cover it. The federal programs, basically, don't recognize it, don't cover it. All the research that is done --

DR. GORDON: I am wondering, though, if you have used the AFL-CIO, if the AFL-CIO has said, yes, we want this to be included in benefits for our members, or if you have negotiated with them about this.

DR. KENDALL: One of the things when they approached us was -- in fact, I think the main insurance carrier they have does include acupuncture. They have some other ideas on how to make this Oriental medicine available to their 45 million family members. Certainly this is one of the ideas.

DR. GORDON: Is there an active movement among union members to bring not only acupuncture, but other CAM benefits, health promotion, into insurance plans?

DR. KENDALL: Well, we would have to talk to the parent union, but I think the answer is there is definitely a growing trend, that people want to have the ability to go to alternative therapies, even though some of these may be offered by medical doctors, simply because there is no single medicine system that can cure everything because people are just uniquely different.

DR. GORDON: I am wondering if there is somebody at the level of the parent union whom we also could be talking with to see what they are doing and the directions they are going in.

DR. KENDALL: Yes. We can do that. We can get you in contact with the -- in fact, I think the president of the union is right here in Washington.

DR. GORDON: I would hope so. That would be great.

DR. KENDALL: We know it is the lobbyist center.

DR. GORDON: That is exactly the kind of thing we would like to hear. We hear from your side what you are trying to achieve.

DR. KENDALL: We are trying to do something from the professional side, and then you are saying what about the delivery side and the interest of the consumers.

DR. GORDON: That would be great if you could help us with that.

DR. KENDALL: We will definitely give you some contacts on that.

DR. GORDON: Thank you.

DR. KENDALL: In fact, might even set up a meeting with you.



MS. Campbell, if I may. I was reading through your testimony, and you used the phrase about medical dictatorship.

DR. KENDALL: I didn't use that phrase, I think.



MS. Campbell did.

DR. KENDALL: Oh, oh.

DR. FINS: You might have wished you used that phrase. [Laughter.]

DR. FINS: But I want to ask you, just to get beyond the rhetoric and all, there is a lot in your testimony about self-regulation of CAM practitioners by CAM practitioners. How can we create a neutral body so that there is an honest broker who is neutral? What would you envision, sort of neutral regulation? Because I think, just to argue the other side, the skeptics out there, some of whom you have heard of from this afternoon, and other policymakers, say, look, we have to maintain the safety of the American public at the same time giving them access to CAM therapies. So what kind of mechanism would you suggest us to think about that would balance these conflicting needs, access and regulation? Obviously, you are not thrilled by the Federation of State Medical Boards. Is there anything that can be done with them? Are there alternatives?

MS. CAMPBELL: Well, I think there are two angles to answer this. First of all, there is a trickle-down effect from the federal government to the states. So whatever the FDA does, the state medical boards tend to abide by. So if you fix a problem at the federal level, you tend to fix it at the state level, even though the states have the constitutional right to regulate the practice of medicine. The FDA has inserted itself tremendously in that process. I think if you do things like get the federal government, in this case specifically the FDA, out of the business of withholding information, vetting how much and when information can be shared, that would free things up tremendously at the state level, solve a lot of problems for practitioners. You can look at ways that the federal government discriminates against different types of practitioners. For instance, there is a bill that I don't think has passed in this Congress yet that would allow for Medicare reimbursement for nutrition education for diabetics. It is probably a great idea. It will probably save billions of dollars, but the way the federal government has drafted that bill, the way that the sponsors have drafted that bill, is to restrict reimbursement only to registered dieticians. I would argue that somebody with a PhD in nutrition, maybe a chiropractor with training in nutrition, should also be allowed to be reimbursed. So there are little ways through the federal insurance program where we could eliminate discrimination, which then would have a trickle-down effect at the state level, with HMOs, with insurance companies.

DR. FINS: That is a good example to just kind of get more specific. Who would set the standard of whether or not -- a PhD gets accredited, gets reimbursed, but a masters degree wouldn't, or a bachelors degree wouldn't, or someone who has been practicing in a naturopathic way without any kind of degree for 25 years and is esteemed in their community. What kind of body would set the standard that would allow us to say, that person gets reimbursed, that person is credentialed. What kind of mechanism would be neutral?

MS. CAMPBELL: Typically, that happens at the state level, and it should probably stay there. I think if it is legal in a state, if someone is authorized to offer health care services in a state, the federal government should honor that. If a state decides that unapproved therapies are accessible, then the FDA should honor that.

DR. FINS: So, would you be satisfied -- I mean, some people have suggested this at our other sessions -- that the Federation of State Medical Boards, each state, have some representation of CAM practitioners to kind of balance? Or, do you think that would be inadequate to give access to the practitioners that you represent?

MS. CAMPBELL: Well, I think I share the concern of one of the acupuncturists who spoke earlier, who said that it is very uncomfortable for, say, an acupuncturist to be under the authority of a medical board, because whether it is true or not, there is a huge perception that they are not understood and they are second class citizens. I understand that boards are normally a factor of payment. If you don't have enough acupuncture in a state to support a board, you have to be under the medical board. I don't think that is an insurmountable problem, but I would worry, I think, on the part of practitioners, that if they are stuck under the Federation of State Medical Boards, they are not going to get a fair hearing. So there would have to be a separate body. I think emerging professions need to do more in terms of setting credentials for their own practitioners. Again, it is not rocket science, it just hasn't been done yet. In the past, the federal government has done a tremendous amount to help this burgeoning allopathic medical community. Those resources have not been dedicated to these other types of practitioners. We wouldn't have the hospital system, the internships, that we do now without federal support. So if the federal government treated them fairly equally and turned resources toward that, I think the system would develop just as the allopathic did.

DR. FINS: Just, historically, it has been a 70- or 80-year process.


DR. FINS: With the evolution of the first medical boards, I think, in the 30s. So there is a lot of catching up to do here to get regulatory parity.

MS. CAMPBELL: It is not fair to expect the CAM community to do it all on their own, because the biomedical model was not developed with its own resources.

DR. FINS: Thank you very much.

MS. FORZLEY: I would like to talk about the word "harmonization," which is something that is used in international law, and it is used within the European economic commission. It may provide a course of action. There could be a federal body, whether it is Congress or this commission, or some other entity, that establishes guidelines for what should be the requirements for licensing and credentialing at national level. This is being done in Europe at this time. So that, a German acupuncturist can qualify under the French rules, under the Italian rules, and maybe the British rules. So the methodology, legally, is called "harmonization." It is not making the laws the same from state to state, but it is harmonizing them. It also is very valuable when you get to the discussion on education and training on how to come up with a national system that doesn't remove states' control over who practices what within their borders but gives them higher level to work under. That is the way of an international treaty, by the way.

DR. GORDON: Thank you. Effie.

DR. CHOW: I just have a simple question of

DR. Kendall:


DR. CHOW: In here, you elaborated on the organization is to promote health and well being.


DR. CHOW: And your definition of Oriental medicine focused on the treatment. Can you elaborate where is health promotion in there? Or, did I misread it?

DR. KENDALL: Oh, in the definition? Promotion wasn't in the definition. The only reason I provided a definition is, I know there may be some members on this board, not you of course, that haven't heard of the wide diversity of modalities that is included in Oriental medicine, with acupuncture just being one of those. So that was just a strict definition of that.

DR. CHOW: But, do you feel that Oriental medicine, one of the primary function is health promotion?

DR. KENDALL: Oh, is, yes. Right.

DR. CHOW: I didn't see it in the definition. I just wanted to clarify.

DR. KENDALL: Well, all of these are used to promote health, all these modalities.

DR. CHOW: Thank you.

DR. GORDON: Wayne.

DR. JONAS: I had a couple questions. First, I want to thank

MS. Forzley for this nice summary. It looks like a very nice beginning, and I think it would be very useful to have a systematic comparison of what goes on in a variety of countries. I assume this is an ongoing project and you are looking at other countries like Australia, and perhaps some of the Asian countries?

MS. FORZLEY: Yes. Actually, I didn't mention in the report I wrote for today the Interview Project, which has done some specific one-on-one interviewing with providers from other countries. I have talked to the aromatherapy industry in Australia, the physical therapists people in Germany, and a psychiatrist that practices CAM in South Korea. I think a lot can be learned from that. Plus, the group of lawyers I put together to try to move the International Research Project forward have reported just what happens in their own countries, just from their own experience. That was another source of information. I think there is a lot to learn there. Also, because in many other countries, legal systems have had to learn to incorporate cultural traditions without infringing on them somehow, and so much CAM comes from cultural tradition. We really walk a very funny road when we try to regulate a tradition.

DR. JONAS: Right. I have a question, really, for any of the panel members, related to this. And that is, a lot of the attempts to regulate medicine, whether it be in states or in other countries, is based around the idea that unregulated medicine is harmful. I am wondering if anyone has ever actually looked at this, using good research methodology, to see what the evidence is for harm in countries or in situations where there is very little regulation and perhaps extensive, should I say, free-for-all type of medical practice. England comes to mind as a fairly unregulated situation compared to other more regulated situations, to actually see if harm actually occurs in those situations, or, does the market and do the public do a fairly good job of regulating themselves. Has anyone actually looked at that systematically?

MS. FORZLEY: Well, the most systematic review of this question I have taken so far is looking at the concept of consent to treatment, and I compared it internationally in other countries. Depending upon the type of legal system in which you find yourself, there will be a different analysis of consent to treatment. The Brits think very differently than the Australians on this. The French think even more differently. The French think that we have a contractual relationship between a patient and a provider, as opposed to a consensual relationship. So you take everything out of tort. So we don't any longer have a question of harm in the negligence sense of the word. We have now a breach of contract, which is a very different approach. So I believe that further analysis of that question would be very helpful, but it again, brings us back to how cultural traditions treat things, because law and health care, and some of the principles of it literally come from our culture. The other comment I can make is I think that we really ought not to do everything ourselves, that there should be some effort made to work in conjunction with our brothers in the EC, and in other regions of the world because I don't the United States grappling with CAM issues. Lots of work is being done on CAM in other countries from a regulatory perspective. In some countries, different entities are regulated. Here, for example, if you take something like an herbal preparation, it is not subject to the FDA anymore, but you now have Federal Trade Commission regulations that impact it. So that is an approach we can take, and if I can ever get to the provider of it, I might have a claim against them. What the French do, as an example, is they regulate the dealer, they regulate the store. So herbs can only be sold at herb stores. You can go to a pharmacy for patented drugs, and then you go to an herb store for an herbal product. The seller is regulated. The Brits do things like, instead of regulating the acupuncturist, they allow the local level of regulation to limit what can be done. The only way you can open up a shop to provide acupuncture is to go get a local license from the London authorities, which I have described in my paper, you have to demonstrate a national certifying board that regulates before you can then get a business permit. So I think there are a lot of approaches we can take beyond what we now do. I don't think medical boards are the only body that can do it.

DR. JONAS: I think it would be very interesting, maybe, to take a limited number of conditions or patients and try to systematically examine, is there increase, decrease, alterations in harm specifically from of these regulatory approaches which are quite radically different. Candace, along those lines, do you know what is going on in Minnesota? I don't.

MS. CAMPBELL: No, but Diane Miller does, and you can ask her.

DR. JONAS: Okay. We will hear about that tomorrow.

MS. FORZLEY: I don't know that they have had enough of a track record yet with that.

DR. JONAS: No, I don't think so.

MS. FORZLEY: But I know a lot of states are watching.

DR. JONAS: I just wanted to get a clarification of what the law actually is, because I have heard very contradictory statements about it.

DR. KENDALL: With respect to your question on harm, in regards to acupuncture, it is a surgical procedure in the sense you are inserting a surgical device into the human body. There were cases early in Europe, early use of acupuncture where they had fatalities from inserting needles that got into the organs. There was, a few years back, a fatal pneuma thorax in England. There have even been a few accidents in Japan, a couple in China. The incidence is very low, but there is always that probability if you don't understand the human physiology, as far as what is under the skin, and you are dealing with needles that are an inch long, two inches long, three inches long, four inches long, 14 inches long. There is possible risk. Then there was one other incident that just happened last year, where in Belgium they did research where not using an herbal specialist included a toxic herb in a kidney test research, and the subject ended up with kidney damage.

DR. JONAS: It would be interesting, and that is a good example, to see, for example, in countries where they regulate the practitioner, compared to countries where they regulate the needle, compared to countries where they don't regulate it all, if it makes any difference in terms of harm.

DR. GORDON: Candace, thanks as always for your coming. I really appreciate hearing what you have to say, as well as your efforts on behalf of moving health care ahead. I had a specific question about what you were saying about intervention by the FDA or the Department of Justice. Do you have a standard that you would want to share with us now, and maybe even elaborate on later, for the kind of freedom that you think should be given to practitioners, and when intervention is and is not necessary, so we can consider it.

MS. CAMPBELL: You mean intervention on the part of the FDA or the Justice Department?

DR. GORDON: The FDA or the Department of Justice, yes.

MS. CAMPBELL: Well, I think I would agree with Berkley and the broad picture that if we know that a substance is non-toxic, for instance it has a history of use, I think acupuncture is a perfect example. How many years did it take us to change the classification of acupuncture needles? I think they were in the same class as heart-lung devices. There is not a lot of common sense, and there is an awful lot of regulation. I think it might be hard to change a huge bureaucratic system that functions on a very rigid model of testing. So what we might have to do is have a separate body, not the FDA. If you are talking about non-patentable substances that can't go through the drug approval process, there is just no economic incentive for anyone to do that. At some point, there will have to be testing, there will have to be clinical trials. NIH can only do so much, but you can leapfrog way over that dilemma. If something has been used for 30 years in Germany safely, why does that same company have to go through 10 years, $300 million to get FDA approval? There ought to be something in between that can address access without all or nothing. Right now, we have all or nothing.

DR. GORDON: I guess what I am looking for is, not necessarily on the spur of the moment, but your guidance about what kinds of regulation. And again, raising the same question that Wayne and Michele Forzley were talking about, should it be regulation of the practice, or the practitioner? Because the Access Act, in my mind, seems to focus on regulation or freedom for the practitioner and the patient, and does not focus so much on the modality or the practice that is being used.

MS. FORZLEY: The Access bill really leaves it to the practitioner to determine. The latest version of the bill has a lot more language about what level of proof there must be for a practitioner to safely offer an unapproved therapy, and I think that is a question worth answering. We can't just throw it wide open because everyone will have a different level of what they feel safe using. But I would be happy to give you some feedback on what we think would be a feasible solution to that.

DR. GORDON: I think that would be particularly useful, especially in the spring as we come to issues of licensure, focusing on education and licensure. Then again, coming around to reimbursement.

MS. FORZLEY: In terms of the Access bill, if I can add one thing quickly, there is already plenty of regulation of MDs doing alternative therapies. There is the threat of malpractice, there are the state medical boards. I am not really worried about what would happen to an MD who crosses the line. There is more than enough disincentive there for someone who would think of it. It would be unethical. One of the things the Access bill does that is critical to this increasing flow of products is, get the FDA out of the business of stopping interstate shipment, because right now that is a huge barrier. Sure, they are not regulating the practice of medicine, but if you can't ship something across state lines, you have to live in the right state. Interstate shipment may only be the label on the bottle that qualifies it as interstate. So that is a huge barrier right now, that is the FDA's.

DR. GORDON: Joe, did you have your hand up?

DR. FINS: I just wanted to talk about something

MS. Forzley said a few moments ago about the different countries having different cultures and the relationship of regulation to those national cultures. Just again, to make a plea for us as a commission to probably ask some anthropologists to talk about the anthropology of CAM therapy in the United States and the regional differences across the country to make sense of what this phenomenon is. Your legal analysis here has really demonstrated there is heterogeneity from different European countries, and I think we just need to be comprehensive to make some better sense of what motivates this and how we can be responsive to the people and do it safely. It was reminder to remind us. So thank you for that comment.

DR. GORDON: Any other questions? We are going to close in a couple minutes. [No response.]

DR. GORDON: Okay. Thank you. Thank you very much. Thank you all. We will adjourn for today. We will begin again tomorrow morning at 8:00, and we look forward to seeing you then. [Whereupon, at 6:10 p.m., the meeting was recessed to reconvene the following day, Tuesday, December 5, 2000, at 8:00 a.m.] + + + CERTIFICATION This is to certify that the attached proceedings BEFORE: White House Commission on Complementary and Alternative Medicine HELD: December 4-5, 2000 were held as herein appears and that this is the official transcript thereof for the file of the Department or Commission. DEBORAH TALLMAN, Court Reporter PERFORMANCE REPORTING Silver Spring, Maryland Phone: 301.871.0010 Fax: 301.871.0020