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 Volume I

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 Monday, December 4, 2000
 8:25 a.m.
 (Morning Session)

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



James S. Gordon, M.D., Director
The Center for Mind-Body Medicine

Commission Members:

George M. Bernier, Jr., M.D.
Vice President for Education
University of Texas Medical Branch

David Bresler, Ph.D., LAc, OME
Founder and Executive Director
The Bresler Center, Inc.

Thomas Chappell
Co-Founder and President
Tom's of Maine, Inc.

Effie Poy Yew Chow, Ph.D., R.N., DiplAc (NCCA)
Qigong Grandmaster
President, East-West Academy of Healing Arts

George T. DeVries, III
Chairman, CEO of American Specialty Health

William R. Fair, M.D.
Attending Surgeon, Urology (Emeritus)
Memorial Sloan-Kettering Cancer Center
Chairman, Clinical Advisory Board of Health, LLC

Joseph J. Fins, M.D., F.A.C.P.
Associate Professor of Medicine
Weill Medical College of Cornell University
Director of Medical Ethics
New York Presbyterian Hospital-Cornell Campus

Veronica Gutierrez, D.C.
Gutierrez Family Chiropractic

PARTICIPANTS (continued):

Wayne B. Jonas, M.D.
Department of Family Medicine
Uniformed Services University of the Health Sciences

Charlotte Kerr, R.S.M.
Traditional Acupuncture Institute, Inc.

Linnea Signe Larson, LCSW, LMFT
Associate Director
West Suburban Health Care
Center for Integrative Medicine

Tieraona Low Dog, M.D., A.H.G.
(Private Practice)

Conchita M. Paz, M.D.
(Private Practice)

Buford L. Rolin
Poarch Band of Creek Indians

Julia R. Scott
National Black Women's Health Project

Xiao Ming Tian, M.D., LAc
Director, Wildwood Acupuncture Center
Director, Academy of Acupuncture &
Chinese Medicine
Wildwood Medical Center

Donald W. Warren, D.D.S.
Diplomate of the American Board of
Head, Neck & Facial Pain

Commission Members Not Present:

Dean Ornish, M.D.
Preventative Medicine Research Institute
Clinical Professor of Medicine
University of California, San Francisco

PARTICIPANTS (continued):

Executive Staff:

Stephen C. Groft, Pharm.D.
Executive Director

Michele M. Chang, C.M.F., M.P.H.
Executive Secretary

Doris A. Kingsbury
Program Assistant

Geraldine B. Pollen, M.A.
Senior Program Analyst

Joseph M. Kaczmarczyk, D.O., M.P.H.
Senior Medical Advisor

 C O N T E N T S

 Page No.

Welcome and Introductions
  Dr. James S. Gordon ................................  7
  Dr. Stephen C. Groft ............................... 15

Session I: Overview of CAM Utilization
  Dr. James S. Gordon ................................ 19

Commission Discussion ................................ 37

Session II: Clinical and Cost Effectiveness of
            Selected CAM Services

  Chiropractic Practice
  William Meeker, D.C., MPH .......................... 43

  Naturopathic Medicine
  Konrad Kail, ND, PA ................................ 48

  Patricia Culliton, LAc ............................. 54

  Joyce Frye, DO, MBA, FACOG ......................... 59

  Massage Therapy
  Tiffany Field, Ph.D. ............................... 65

Panel Discussion ..................................... 69

  Dennis Awang, Ph.D., SCIC ......................... 103
  Christopher Hobbs, LAc, AHG ....................... 106

  Dietary Supplements
  Alan Gaby, M.D..................................... 111

  Patsy Brannon, Ph.D., RD .......................... 116

  Integrated Overview
  Harley Goldberg, DO ............................... 121

Panel Discussion .................................... 132

CONTENTS (continued)

Public Comment

  Francine Butler ................................... 158
  Nancy Dolores Kolenda ............................. 162
  Diana Chambers .................................... 164
  Rustrum Roy ....................................... 167

Panel Discussion .................................... 170

  Dr. David Murray Blalwas .......................... 181
  Kathleen Golden ................................... 185
  Natalia Egorov .................................... 189
  Dr. David Edgar Molony ............................ 191

Panel Discussion .................................... 195

  Dr. Bruce Dooley .................................. 213
  Dr. Salvatore D'Onofrio ........................... 216

Panel Discussion .................................... 219

Session III: Use of CAM for Selected Health

  Addiction and HIV/AIDS
  Howard Josepher ................................... 224
  Denise Drayton .................................... 228

  Jeanne Andrews .................................... 232

  Heart Disease
  Richard Collins, M.D. ............................. 236
  Walter Czapliewicz ................................ 240

  Hospice Care
  J. Donald Schumacher, PsyD ........................ 245

Panel Discussion .................................... 251

Session IV: Issues in Integrating CAM in
            Service Delivery

  Richard Miles ..................................... 278
  Health Frontiers

CONTENTS (continued)

  The Honorable Berkley Bedell ...................... 283
  The National Foundation for Alternative Medicine

  Paul Kurtz, MA Ph.D. ............................. 288
  Committee for the Scientific Investigation of
  Claims of the Paranormal

Panel Discussion .................................... 293

  Donald Kendall, OMD, Ph.D., LAc
  Office of Professional and Employees
    International Union ............................. 332

  Candace Campbell
  American Preventative Medical Association ......... 335

  Michele Forzley, JD
  American Bar Association .......................... 340

Panel Discussion .................................... 345

Adjournment ......................................... 368

 P R O C E E D I N G S [8:25 a.m.]


Dr. GORDON: Good morning, everybody. Welcome to this meeting of the White House Commission on Complementary and Alternative Medicine Policy. At the beginning of our meetings, we sit for a moment quietly and bring ourselves into the room. So I invite everyone who is here with us today just to sit for a moment. [Moment of silence observed.]

Dr. GORDON: Thank you. It is nice, especially before a rich and complex meeting, to have a little time to sit and be quiet with each other. What I would like to do is to begin by asking each of the new commissioners, and we do have some new commissioners, to introduce him or herself and say a couple of words, and then Dr. Steve Groft, who is our executive director, will be explaining what the work is that we are going to be doing today, and then I will be giving an overview of the development of CAM services and, in particular, some of the surveys of use of CAM services. Then, we will be moving into the testimony for the day. It is wonderful to have all the commissioners, the commissioners who are here. Our friend and colleague, Dean Ornish, and his wife Molly just had a baby, and so Dean is not here today. We send our good wishes and our love to him, as he does to us. Then, we will be moving ahead. David, do you want to begin.

Dr. BRESLER: I am David Bresler. I am a professor in the medical school at UCLA. Effie Chow and I were just reminiscing that it was 1969 when we took our first acupuncture course together, so this is my 32nd year of doing acupuncture. We started our research at UCLA in 1972, and we were the first medical center to get an NIH grant to begin acupuncture research. Back then we used to laugh hysterically about thinking that one day American medicine would take a real serious look at acupuncture and it would be integrated into traditional care, so that a primary care physician seeing a headache patient or a patient with other types of pain would recommend acupuncture first, and we fell on the floor laughing about the prospect of this. Here we are today talking about this is a very real possibility. I am very excited to be here. I also have an interest in guided imagery, homeopathy, and many other aspects of complementary medicine which we have been doing some research over the years. So, it is great to be here.

Dr. GORDON: Thank you, David. Veronica Gutierrez.

Dr. GUTIERREZ: I am a chiropractor from Washington State. I have been in practice for 36 years. One of the things I would like to achieve through my time and service on the commission is to raise the public awareness about the role of chiropractic as it relates to health, wellness, and quality of life.

Dr. GORDON: Good. Thank you. Linnea.

Ms. LARSON: My name is Linnea Larson. I have worked as a social worker and a family therapist primarily in medically under-served areas. I have a particular interest in providing these services in those areas and a particular another interest in the relationship of these modalities to hospice care.

Dr. GORDON: Thank you. Don.

Dr. WARREN: I am Don Warren. I am from Clinton, Arkansas. I am a general dentist. I practice holistic dentistry, I am a biologic dentist, and that I disagree with some of our colleagues that mercury is a poison, I think it is. I use homeopathy, I use cranial manipulations through the Sutherland cranial technique of osteopathy. I believe that chiropractic is a big factor in holistic wellness, and to me the opportunity of being on this commission is an opportunity to make a difference, and I look forward to that challenge. Thank you.

Dr. GORDON: Thank you, Don. Ming Tian.

Dr. TIAN: My name is Xiao Ming Tian. I specialize in acupuncture and Chinese medicine. I am involved with clinical work in Bethesda and also I am involved with NIH, am an NIH clinical consultant on acupuncture. This program has been set up 10 years ago as a daily basis to provide service for NIH patients. Also, I do clinical research with Georgetown Medical School NIH-funded. I treat fibromyalgia patients, and spend more time, more energy to study Chinese herbal medicine to treat osteoarthritis, fibromyalgia, osteoporosis, and sports injuries.

Dr. GORDON: Thank you, Ming, very much. Just so everybody will know everybody, we will go around with the other commissioners who we have gotten to know each other, but we are just meeting the new commissioners, many of us for the first time this morning. So, Conchita, would you like to begin.

Dr. PAZ: I am Conchita Paz. I am in private practice and family practice in Las Cruces, New Mexico. I am happy to be on this commission.

Dr. GORDON: We will just come right around, Buford.

Mr. ROLIN: My name is Buford Rolin. I am health administrator. I work with the Poarch Band of Creek Indians in Alabama and I am very active on the National Indian Health Board and the National Congress of American Indians.

Ms. SCOTT: Good morning. My name is Julia Scott. I am president and CEO of the National Black Women's Health Project.

Dr. LOW DOG: Good morning. I am Tieraona Low Dog. I am in private practice in family medicine in Albuquerque, New Mexico, where I work in an integrative medical center, and I have a special passion for herbal medicine. SISTER KERR: Good morning. I am Charlotte Kerr. I have been a practitioner of traditional acupuncture and faculty member for 24 years, and before that, Assistant Professor of Nursing at the University of Maryland. I am real happy to be here and look forward to hearing from everybody. Thank you.

Dr. JONAS: I am Wayne Jonas. I am a family physician and researcher at the Uniformed Services University of the Health Sciences in Bethesda.

Dr. FINS: I am Joe Fins. I am a general internist and medical ethicist at Weill Medical College of Cornell University and New York Presbyterian Hospital.

Dr. FAIR: I am Bill Fair. I was formerly at Memorial Sloan-Kettering and Emeritus there, and also at Cornell. Currently, I am chairman of the Clinical Advisory Board of Health, spelled H-a-e-l-t-h, a complementary medical center in Manhattan.

Mr. DeVRIES: I am George DeVries. I am chairman and CEO of American Specialty Health. We are a health services organization for complementary health care nationally.

Dr. CHOW: Hello. I am Effie Chow. I am president of East West Academy of Healing Arts in San Francisco and I practice Chinese medicine and am Qigong Master and I greet all of you and welcome, and I look forward to hearing from you.

Dr. BERNIER: I am George Bernier. I am vice president for Education at the University of Texas at Galveston. I am a hematologist/oncologist by background.

Dr. GORDON: We have one member who will be coming later, who is Tom Chappell, who is the co-founder of Tom's of Maine. He will be along fairly soon. He is flying in this morning. I am Jim Gordon. I am the founder and director of the Center for Mind-Body Medicine here in Washington, D.C., and a clinical professor at Georgetown Medical School. It is great to be with everybody again. I now turn the meeting over to Steve for a few words.

Dr. GROFT: Thank you, Jim, and welcome to everyone especially to the presenters who I guess we have asked to give a five-minute presentation. Many of you have traveled a great distance just to provide us your wisdom and experience and knowledge on CAM interventions, so I do thank you. It is an awful lot to ask for you to travel that far just for a short period of time, but I think your expanded comments and recommendations that you will provide will be extremely helpful to the Commission. I think if you just look at what you have seen the members of the Commission carry into the room is a massive document. We had our first meeting in July, a very, very thin thing, and the second meeting was about like this, and I am not sure where we are going by the end of March of 2002, but we are going to try to reduce the volume, but I want you to know that the information you see here is what you generate, it is not what we generated, so we thank you for doing that. It is extremely helpful. You know the issues as well as anyone else, and we really are looking to you for the expertise. The focus of this meeting is access to, and delivery of, CAM services. We originally had scheduled reimbursement to go along with this issue, but I think as we got into it, we realized how large both of these sections were, and so we are separating out the reimbursement. We will talk about that later on in the spring, so it will be quite a busy time the next two days. We are going to be using a representative sample of CAM interventions, and, please, what we have today and what is presented, there are many, many more interventions that we could have selected, but I think we tried to look at those that have some evidence of clinical effectiveness and cost effectiveness, that we might be able to use it as examples for the Commission's report. We wanted to look at model delivery systems or systems that could be utilized to integrate CAM services into conventional medicine, again, to be utilized within the report itself. So, you will see the focus of the meeting shifting a little bit as we go along, and we tried to keep it somewhat coordinated. Michele Chang, who is over here to Jim's left, is the executive secretary to the Commission, has taken a tremendous role of putting this meeting together, and

Dr. Joe Kaczmarczyk, who many of you know from his days with HRSA, has been the program analyst, policy analyst, has done a great deal of work, the bulk of the work just to get this meeting together and to talk with most of you in the audience about the presentations and the need to come and give us that information. So, I would like to thank both of them. Two other people, who maybe you have seen, Doris Kingsbury, who is around, I am not sure, she may be outside, and Geri Pollen, if Geri is in the audience -- we have got a great working schedule. I am not sure where we have been or where we are going, but we are here today. Again, if any of the staff members, if you have any concerns or needs, both the commission members and the audience, please see one of us and express your concerns or needs, and we will try to respond to them as well as we can. For the commission members, we are at the point where we have to start to thinking of recommendations. We need to develop an interim report by July. We will talk more about this later on. So, start to think about what recommendations you might want to see. We have had two town meetings, town hall meetings, we will have a third one in January. This is our second major issues, so by the end of these two sessions, we will have some idea of what we might want to think about for further discussions. We also need your guidance, if the format that we are presenting, if this is adequate to give you the information you need or however else you would like us to structure the meetings, so we will have time to discuss this as the two days go on here, so we are looking forward to your comments. One last person that I would like to introduce is Jim Swyers. Jim is a medical writer/editor who will be helping us write and edit the report, so you know we are getting serious once we start employing a writer/editor we are starting. I think we are ready to go and Jim is ready to go, and so we are anxious for a good session these next two days.

Dr. GORDON: Thank you, Steve. Session I: Overview of CAM Utilization

Dr. GORDON: Just a couple things I wanted to say about planning of future sessions. Everybody here signed up I believe for at least one of the committees for future sessions. This morning when Tieraona and George DeVries and I were talking, I realized how much they knew and how valuable their contributions would be in the area of education and licensure, so I asked if they would volunteer to be on those committees, and they graciously agreed. So, what I want to do is encourage everyone here on the commission to please jump in, we really need everybody's thoughts and everybody's input to formulate these sessions just as we have done for this session, so come ahead if you are interested in participating. Also, we are going to have one of the issues that was raised in the last commission meeting was having time for us to get together both informally and also to have more discussion, so most of you were here at breakfast this morning, which was great, just to have time to hang out with each other, and at the end of the second day we are also going to have some time to review what has happened in these two days. A number of people said that that would be useful to do. So, if you look on the schedule, you will see that there is time. The other thing I want to say is that we are going to make -- one of the great things about the way the commission is evolving is that so many more people from the community are coming and wanting to participate, and we have two full agendas of public comment, and we are going to do our best to add on some more time for those of you who also want to be involved in public comment, and I think that this is a very exciting development as the commission gathers momentum. I just want to say a couple words about the Seattle meeting, which a number of us were present at in the town hall, and that it was, I think we all agreed because we talked about it afterwards, a very inspiring experience in that we saw a whole community which had not only moved ahead to offer CAM and make CAM services much more available to the citizens, but that it truly had taken major steps toward integration at every level from the provision of services in the community to research projects jointly undertaken by CAM institutions like Bastyr and conventional medical schools like the University of Washington, to a public agenda set by the Washington State Insurance Commissioner mandating coverage of CAM services. In a way, most impressively of all, at least to me, the passion of the King County Council for creating a more integrative medicine that would truly serve all the people in King County. Several of them came and testified and they welcomed us to their council chambers, and, in fact, they are the ones that are responsible for pulling together the entire meeting, so it was very exciting and a real example, I think, and the summaries and transcripts of that meeting are being put up on our web site now, so everybody can take a look at them. The other thing I want to say, both to the commissioners here and also to everybody in the audience is that these town hall meetings are immensely valuable and they are valuable to us in shaping our recommendations. They are valuable in terms of helping us to decide who we will invite here to Washington, and several of you are here because we have heard you in Seattle and now we want all of the commissioners to hear you. They are also valuable, and this is really important, for helping communities to organize themselves and to get together. One of the things we heard from the people in Seattle was how useful planning for the meeting and working together was, not only in presenting material to us at the meeting, but also in advancing through thoughtfulness about integrative medicine in the community as a whole. So, we urge all of you, our schedule of our meetings of our town halls is all up on the web site, and I would ask all of the commissioners, as we come to areas near you, to work with people in those areas to help to bring them in. I am going to open the meeting fairly briefly and give a little bit of survey of some of the surveys on CAM usage. This meeting, as Steve said, is really about services and service delivery and access to services. So, we thought it would be useful to begin by sharing, that I could share a little bit of my perspective on the evolution of CAM services, and share with you some of the studies, some of the information from some of the many studies, and as Joe pulled together the abstracts and the papers for me, I saw how many studies there are now on the usage of CAM services in various communities for various kinds of illnesses at various ages. It is a rich literature. I want to recommend both to the commissioners and to people in the audience I think a kind of nice summary of the surveys, which I hope we will be able to provide that to everybody. There is a paper by Jackie Wooten and Andrew Sparber called appropriately enough, "Surveys of Complementary and Alternative Medicine," and it is in the current Review of Alternative Medicine from 1999. It gives I think a very nice survey of all the surveys with some of the essential findings in the surveys. I am not going to try to be encyclopedic in 10 minutes this morning. What I want to do is hit on a few highlights and then we can take a couple minutes if people would like to add thoughts to this overview. As David was speaking earlier this morning and introducing himself, I was thinking back to the work that he and I began to do almost 25 years ago, and that I began to do at NIMH in the early 1970s, looking at this new field of holistic -- what we then called "holistic" medicine, and often still do call "holistic" medicine -- and thinking about the change is really quite extraordinary because, on the one hand, it is something that all of us felt in our bones might well happen and yet at the same time, we are both surprised and delighted that it is happening at this level, that we really are interested in creating a much larger vision of what medicine can be. What we have seen in recent years is an acceleration of this process, an acceleration in people using these therapies, in the integration of these therapies into medical school and other professional school curricula, in the coverage of these therapies by insurance companies, and in the development of research and of integrative progra

Ms. I just want to touch a little bit on some of these developments and indicate how they relate to our mission as a commission. Two of the more important studies in this area that have been done in recent years were by Eisenberg and his colleagues, the initial study on 1990 data, and the second one on 1997 data, on the use of alternative therapies by Americans. I am sure these figures are familiar to most, if not all of you, but I am just going to go over a few of them very quickly. The 1990 survey, which was published in January 1993 in the New England Journal of Medicine, showed that 34 percent of all Americans had, in 1990, used one or another alternative therapy as part of their health care and that they had then made 427 million visits to alternative care practitioners. The 1997 survey, the figures were 42 percent and 629 million visits. That was more visits then to all primary care physicians. An American spent more money on that care, and the estimates vary from 27 to 34 billion out of pocket than they did on visits to primary care physicians out of pocket. Now, there have been a number of other studies that have been done, John Astin's study, for example, which also appeared in the Journal of the American Medical Association. The numbers of people using alternative therapies -- and the definitions differ slightly, however, I would hasten to add that whatever the definitions, they include all of the therapies that are going to be presented this morning, on which data are going to be presented -- the numbers differ slightly, but the number of 40 percent stands as a reasonably reliable number across all populations. One thing I do want to add, though, that was noted in the second Eisenberg study, and I think is very important for us here, is that that number is based on phone surveys of English-speaking people, and that there is a huge group of people in this country who do not speak English, for whom what we call "alternative or complementary medicine" is, in fact, primary care, and I think one of the charges of the Commission is to address the needs of those people and to understand the importance of the contributions that those people make to our health care system, as well as the needs that they have from our health care system. There are a few myths. One of the other things about the Eisenberg study that is very interesting is that in the last seven years, some of the things that have shown up are some of the usage of alternative therapies has increased somewhat, but the usage of some therapies has gone up at a much greater rate. For example, there is 130 percent greater usage of megavitamin therapy in 1997 than in 1990, and 380 percent greater usage of herbal therapies and almost as great an increase in usage of homeopathic remedies. So, this is another area in which we need to pay attention, understanding that some therapies are increasing steadily as, for example, the use of chiropractic, but that other therapies that were used very little are now being used a great deal more. There are a few myths that have come up and that I think that the survey data, taken as a whole, tends to dissipate. One is that people who use alternative therapies tend to turn their back on conventional medicine. I think it is pretty clear from the surveys that that is not true at all, that in the Astin survey, for example, only 5 percent of those people who used complementary or alternative therapies felt somehow in opposition to, and totally disillusioned with, conventional medicine. The rest of the people saw these therapies as very much a part of an integrative approach, so I think that is a myth or, if you will, a red herring that we are talking about something that is in opposition even though there may be reasons why people move away from conventional therapies. The second myth is that this is essentially an upper middle-class movement, and I think partly because of the way the surveys are done, that people have tended to believe that, that it is better educated, mostly white people who use these therapies. When you look at other populations, when you look at rural poor populations, or indeed a population of homeless young people in the city, in this case in Seattle, Washington, who have access to CAM services, the utilization goes way up. So, for example, 70 percent of runaway and homeless kids were using CAM therapies. When you look at minority communities -- we will hear some testimony later in the day from a program with which I work, ARRIVE, in New York, which is about 80 percent minority, HIV-positive, mostly, although not all, ex- prisoners -- the vast majority of those people are using complementary and alternative therapies because they believe they work and because they have access to them. A third myth that sometimes comes up is that these are therapies that are used by the worried well or by people who are in life-threatening situations. Some of the interesting surveys are on people coming in for cardiac surgery and other kinds of surgery, which showed that prior to the surgery, anywhere from 70 to 80 percent of the people who are coming in for surgery are using one or more complementary or alternative therapies, particularly nutritional therapies and use of megavitamins. I also think it is important to say that when you look through the surveys, that although an earlier survey by Ernst and Kastle, that showed a very variable use of CAM therapies by people with one particular life-threatening illness, cancer, and their range was from 7 to 64 percent, more recent surveys, for example, Mary Ann Richardson's survey from the Journal of Clinical Oncology this July, or another survey, which was done in M.D. Anderson, or another survey by Kelly at Columbia Presbyterian Hospital on children, people with pediatric cancers, are showing that the figures of usage are anywhere between the high 60s and the low 80 percent of people with cancer are using these therapies. So, it seems like especially in the area of life- threatening illness that there is a significant increase in the use of these therapies. The same is true with HIV and AIDS, and not only, I would add, among perhaps the better educated gay population, but also among people who are IV drug users who tend to have less education, that there is a major trend. I was recently speaking at AIDS Day in New Jersey, and many of the programs there, there is close to 100 percent desire to use CAM therapies and up to 70 to 80 percent of the programs, and there is some interesting surveys that have been done on that, as well. Now, not only are CAM therapies being more widely utilized, but physicians are increasingly willing to refer to CAM therapists. A couple of studies that have been done, one by Berman in the Journal of the American Board of Family Practice and another by Astin in the Archives of Internal Medicine show an increasing willingness of physicians, particularly of primary care physicians, to refer to complementary and alternative practitioners. Eighty to 90 percent are willing to refer to people who work with hypnosis and biofeedback, imagery, and other mind-body therapies. About 40 percent are referring now in both of those surveys to acupuncturists, and these physicians are also extremely eager for information about the therapies. The data on medical schools show that the physicians to be in allopathic medical schools are also very eager for these, to learn more about these therapies, and the study that was published by Wetzel and Eisenberg and others in JAMA in 1998 showed that 64 percent of all medical schools were offering at least elective courses in these therapies, and I would imagine, based on my own observations, the figure is significantly higher now. Now, a few problems arise, and these are some of the problems that we are going to be addressing here, a few of the sort of areas that we clearly need more information. One is -- and this is the primary purpose of today's meeting and, as well, of tomorrow's -- is we need more data on effectiveness and cost effectiveness, and this is why we have called in all of you whom we have called in to present to us. We have asked you the question: Are these therapies working, in which areas, what are the limitations, and what is the data on cost effectiveness, so- called? We also need to work much more on the issue of integration, and this is something that we have talked about, talked continually about, but I think is central and I think we are going to be called on to make recommendations in this area. Here are 40, perhaps 50 percent of the people in the United States using these therapies with life- threatening illnesses like cancer and HIV, up to 70, 80 percent of people, how well are these therapies currently integrated, and we are going to hear today about some models of integration, and we are going to be asking those of you who are presenting data on those models how we can improve on it, what are the lessons you are learning, how well is it working, what more would you like to do. In many areas, integration is not working terribly well so far. As I reviewed the studies on treatment of HIV, it was very, very interesting and very disheartening that very few of the people who are HIV-positive talked about their use of CAM therapies to their physicians. There is an interesting study, some of the studies as low as 17 percent, and when you ask people, as I have done, why not, they say because every time I start to bring it up, my physician seems very uncomfortable, and I don't want to upset him, and I don't want him to be angry with me. On the other side, there is a very interesting study that I read for the first time by Winnea showing that only 26 percent of physicians who are treating HIV-positive people are asking them whether or not they are using CAM therapies even though 36 percent of the physicians themselves use CAM therapies. So, there is something of a disconnect, and I think on both sides we have to consider how do we encourage people to talk with their physicians, how do we encourage physicians to talk with their patients, and how do we encourage more integration. This is not only confined to the area of HIV. There was another study on surgical procedures, cardiac surgical procedures. Only 17 percent of people getting ready for cardiac surgery told their physicians about the CAM therapies they were using, and, of course, many of those people were using therapies that might affect coagulability, so they might make for an operative risk by not talking about the use of therapies. The other thing that I found interesting is that 48 percent of those people did not want to talk, deliberately did not want to talk, and did not want to ever talk with their physicians about their use of CAM therapies because they were afraid of the response that they might get. So, I think there are a lot of possibilities for us today. I think, number one, we are being asked very strongly by the people who are using these therapies, we are asked for help in determining which of them work and which of them don't work and in which situations. We are asked by the people who are providing coverage for the people who are using these therapies how can this be done, what is the cost effectiveness, how can we still survive as an entity and provide coverage, how can we provide standard medical coverage and coverage for these therapies. We will come back to some of these issues when we focus on reimbursement in the spring. Right now what we are focusing on is what is the data that we have, but I think we always need, as a number of you have said in the last meetings, we always need to have in our mind how is this going to fit into a schema of reimbursement. If these therapies are effective, what kind of models of integration should we be recommending? This is an important issue, and we will be hearing from some people with models of integration. If physicians are interested, what kind of information, what kind of education do they need, and physicians do seem increasingly to be interested, what kind of information, as, for example, the information that is being presented to us, and what other information do they need to be presented with. Finally, how can we encourage, since we know that if these therapies are available to people, if they are available to people with cancer, they would use them, if they were available to poor people and people of color who are HIV-positive, they would use them, if they are available to homeless people and homeless children, they, as well as middle-class people with significant education, will use these therapies. So, the final challenge and where we come down to with this meeting, is how do we, having sorted out or having helped sort out which of these therapies seem to be most effective, how do we not only find out the information that we need to determine more definitively which are most effective, but as we determine this, how do we make sure they are available in an integrative way to everyone in this country. Let me conclude with that, and if there are any additions or comments, we can spend a couple minutes on them. Charlotte. Commission Discussion SISTER KERR: Just a quick question. When you mentioned the 380 percent increase, and you said it was herbal and homeopathic, did they separate that?

Dr. GORDON: No, those are separate. It is 380 percent for herbal. There is about a 300 percent increase for homeopathic. SISTER KERR: Is there, by any chance, any relationship to when marketing began with the herbal products?

Dr. GORDON: The suggestion has been that the relationship is to DuShea, in part, yes, and therefore to marketing, as well. That was a suggestion made by actually several different surveys that showed that increase in herbals. Wayne.

Dr. JONAS: Just along those same lines, which, Charlotte, I think you are getting at is kind of behind the statistics are the reasons why there is the increased access or utilization, and I think if we are going to address access, we need to begin to delve into those. Along those lines, as you know, Jim, there was a book that has just come out on the social dynamics of CAM use, and this was actually the result of a conference that the OAM sponsored, we sponsored with the University of Toronto about two years ago, which looked at a number of surveys, as well as detailed qualitative assessments as to why individuals actually were interested, how they were using them, how are they getting information about them, and what the influence circles were, so I think this would be important information. I am sure we will get some of that.

Dr. GORDON: Thank you. One thing that I just want to mention, and I am glad you reminded me, is that a couple of the factors that are really important are, number one, people coming up against the limitations of what is available in conventional medicine, but also, and equally importantly, it would seem a different kind of relationship with CAM providers that people perceive and often find. John Astin certainly talks about a congruence of world view, and I think in another sense -- and this again gets to the whole reimbursement issue -- time spent is a major issue, and I think we do have to pay attention to that, that regardless of what people are doing, they are spending more time, they are listening more, they are paying attention more to the whole person who is in front of them, and that is one of the shaping factors. Joe.

Dr. FINS: Jim, did you come across any data linking increased utilization of CAM therapies with decreased access to health insurance and sort of the overall question of access in general, because I have increasingly heard of some who are disenfranchised, marginalized members of our community turning to CAM, not as an alternative, but as a substitute for proven convention therapy, and I think we need to put that on the table because I think we wouldn't want to see this as a substitute, but only as an alternative, as an integrative approach, and not as a substitute.

Dr. GORDON: I haven't come across that. Have you, Wayne, or has anybody else?

Dr. JONAS: Yes, actually, a couple of the surveys that you mentioned, very few -- and this is why actually I mentioned getting behind just the statistical data to try to find out why people are doing this, and in some of the homeless data, there is evidence that they don't have access, they don't go and seek the conventional types of care, and yet, they seek remedies on their own of a variety of types. So, whether that is due to the fact that they would or not, I don't know. On the other hand, individuals that do have health insurance, then, it is often the lack of reimbursement then is actually an interference with them. They would say "I would go get it if, in fact, it was reimbursed." So, I think it could work either way.

Dr. GORDON: I would actually interpret the homeless data somewhat differently. The people I work with, the reason they don't go is not because they don't have access to it. They don't like the way they are treated, because poor people, street people know you can always go to a hospital, and hospitals are often places that street people sleep even when they don't go for care, but they often don't feel they are cared for when they go there, and I think that that, rather than the absolute denial of access, is the major factor. The people I work with, a lot of them do live on the street, and that is what they will say, and not just street people, but sort of working poor people. I think any of us, well, we know if you go to a city hospital system, you wait for a long, long time, and if you can go to a clinic -- and we will be hearing from some of the clinics here and also in New York where people go where they see someone within 20 minutes or half an hour instead of waiting four or five hours, but I think we might want to take a closer look at those issues, too, and see what is going on. Thank you. We can come back and discuss this context and some of these issues at the end of tomorrow afternoon as we pull together everything that we will have learned in two days. Let's call the first panel.

Ms. CHANG: If the following speakers can come up to the panel, we will take four at a time here -

Dr. Meeker,

Dr. Kail, Patricia Culliton, and Joyce Frye, and Tiffany Field actually. We will have to get another chair, sorry about that.

Dr. GORDON: We need another chair and a little more table. It is wonderful to see you all and we welcome you, and I think we will try to provide a little more table space from now on. Beyond that, we are very glad to have you and we are going to be forced to ask you to be brief in your oral testimony. Let me explain to everyone that is partly because there are so many people from whom we want to hear, partly because we want to have the commissioners have an opportunity to have a dialogue and to take more time with dialogue about the issues that are raised. Also, we do welcome -- and I want to say this again to all of the people who are presenting -- we do welcome not only the written testimony that you have given us so far, but any additional written testimony that you have. We will be reading it and integrating it. Let's begin with Bill Meeker. Session II: Clinical and Cost Effectiveness of Selected CAM Services Chiropractic Practice

Dr. MEEKER: Good morning, everybody. Thank you very much for inviting me once again to address this panel. I am very honored to do that. As you know, I am going to make some very brief commentary related to the things that I submitted already and hopefully, in our discussion later, will be able to give you a chance to kind of dive into some of the details. I do want to say right up-front, though, that there are three very, very key references I think that the Commission should be aware of, and I mentioned them in my report. Two of them are government-sponsored monographs, one by the U.S. Government, the Agency for Health Care Policy and Research, Monograph on Chiropractic. Another one, sponsored by the Canadian Government VIRGE made to this panel entitled, "The Effectiveness and Cost Effectiveness of Chiropractic Medicine on Low Back Pain by Pran Manger and a team of economists, and then finally, a very recent monograph put out by the National Board of Chiropractic Examiners, which is a major survey and job analysis of chiropractic practices based on a random survey of practices in the United States. I think these are very key documents that would be very useful to the panel as you look into this profession. I also have a summary report of the Manger report here to pass out if anybody would like to have that. I was asked to address the clinical effectiveness of chiropractic practice and to summarize the data regarding some specific health conditions, the populations, the practice settings, and the type of practitioner. I want to say right up-front that chiropractic is a very mainstream profession already. Chiropractors see about 25 million patients a year in the United States. I also want to make the point, as I did once before, that when we are talking about CAM in general, we have to make a distinction between CAM professions and CAM procedures and substances, because the issues for an entire profession, a CAM profession, may be a little more -- well, I don't want to say a "little more complex" -- I think they are quite more complex than simply dealing with innovative or new procedures or behaviors or substances that might be part of the CAM constellation of things. We have to keep that distinction in mind as we talk about integration and cost effectiveness and effectiveness in addition to everything else. Chiropractors, of course, use spinal adjustments, spinal manipulations is their primary signature treatment. Chiropractors also deliver a great deal of other forms of care especially exercise and nutrition advice, health promotion, preventive advice, physical therapy modalities, et cetera. So, when we talk about studies on the effectiveness and cost effectiveness of chiropractic, we are really talking about packages of various types of procedures, and it is very hard to distinguish one thing from the other, so most of my commentary is going to be today, I want to talk about effectiveness studies. I am going to be talking about randomized controlled trials of spinal manipulation or spinal adjustment only. We are not talking about chiropractor care as a package. That has not been studied all that much, although there are some studies out there. When I talk about cost effectiveness studies, however, we are comparing usually chiropractic care to medical care for some specific types of conditions. Usually, those have been workplace injuries, very often are for low back pain or neck pain. In terms of the types of patients that go to chiropractors, it pretty much is a cross-section of demographic categories in the United States. Chiropractic patients come from all walks of life, all age and occupational groups, educational levels, economic levels, et cetera. Patients less than 18 years old account for approximately 12 percent, and patients 65 years and older make up approximately 15 percent of the chiropractic patient population. My goodness, that time sure does go fast. There are about 70 randomized trials of spinal manipulation or adjustment for various types of conditions, mostly head pain, back pain, and neck pain, and about two- thirds of those have shown advantage to manipulation. Manipulation has been rated as an effective treatment by the United States Government, by the UK, Denmark, New Zealand, Australia, and Sweden, and I think a few others, as well. In terms of cost effectiveness studies, there are approximately 40 studies in this area. Those have all suffered from various methodological problems, and suffice as to say that at this point, it looks like chiropractic and medical care is about the same cost except that chiropractic patients tend to be much more highly satisfied with their care, a great area there for additional work. I will try to quickly summarize. Let me say this about integration just quickly here. Chiropractic is very well integrated at the health consumer level and, to some extent, at the reimbursement and the delivery systems levels, but when it comes to true interdisciplinary practice, it is very, very rare and we have a lot of work to do in that regard, but when we are talking about interdisciplinary practice, it is really a different animal than talking about integration at that level, you are talking about a much different animal than integration at the health consumer level.

Dr. GORDON: Next is Konrad Kail. Naturopathic Medicine

Dr. KAIL: Good morning. Naturopathic medical education trains family practitioners in preventive medicine and natural therapeutics. There are four accredited schools in North America which teach primary alternative mentalities of lifestyle modification, clinical orthomolecular nutrition, botanical medicine, energy medicine, physical medicine, psychological medicine, minor surgery, and obstetrics. These schools teach about 200 classroom hours per modality. The scope of practice varies according to the jurisdiction and the licensure. The broadest scope jurisdictions include prescription and controlled substances and all routes of administration including intravenous. It has only been recently with the advent of the National Center on Complementary and Alternative Medicine that we have actually had funding to be able to look at outcomes. However, a Medline search of peer-reviewed literature showed between 300 and 7,000 citations in the peer-reviewed literature for these various modalities, however, all of these studies look at individual modalities, however, naturopathic medicine combines these modalities into treatment protocols. That has never been studied at all. Also, there is a relative paucity of controlled clinical trials available for review. There is also only a short history of limited third-party reimbursement to look at utilization and cost effectiveness issues. A 1996 study by Emsley, et al., published in Complementary Therapies in Medicine, compared the efficacy of orthodox medicine and manipulation, homeopathy, botanicals, and acupuncture in a variety of conditions. On a scale of 1 to 5, with 1 not being effective and 5 very effective, manipulation scored about 2.14, botanicals 2.9, homeopathy 2.9, and acupuncture 3.6 compared to orthodox medicine, which was 2.48. Orthodox medicine was rated most efficacious in severe, acute problems, but ranked less efficacious in less acute and chronic diseases. The same study showed varying results when broken down by specific diseases. Patients of naturopathic physicians tend to regard them as their primary care physicians, although many also see allopathic physicians because of insurance reimbursement. Ninety-seven percent of those surveyed said if insurance was no issue, their naturopathic physicians would be their first and primary choice. Potential cost savings come from several areas. Because patients are educated about how to stay healthier through lifestyle intervention and because the nutritional, botanical, and homeopathic medicines that are prescribed by their naturopathic physicians become a home medical chest, so to speak, for patients to treat themselves, patients require less office visits, and that greatly reduces the cost. A survey done by John Weekes in 1996 showed that respondents actually used less pharmaceutical medication and actually avoided surgery and other procedures. When you look at numbers of visits and duration of care, the average number of visits per year of naturopathic physicians was 2.6 when compared with 2.4 visits per year to orthodox family physicians. Sicker people required more visits, and duration of relationships was similar to family practice medicine. The American Association of Naturopathic Physicians showed that when looking at cost comparisons of allopathic and naturopathic care for an acute problem, such as otitis media, minimal care costs were similar. When looking at extended care for the same problem, the cost differential was large. Naturopathic physicians rarely need to refer patients for insertions of ear drainage tubes. When looking at allopathic and naturopathic management of chronic diseases, the cost differential varies depending on the disease. For example, the cost of treating hypertension is almost identical in the two systems, but when looking at rheumatoid arthritis, the cost differential is large when comparing allopathic and naturopathic treatment. Unfortunately, few third-party payers reimburse for naturopathic medical care. Most patients still pay out of pocket for alternative care. The Abbott Northwestern Hospital consumer study done by National Research Corporation found that most people spent between 100 and $300 out of pocket in expenses for alternative care between 1993 and 1995. Botanical and homeopathic therapeutics were rated as the most satisfactory of alternative treatments with dietary and chiropractic services being less satisfactory, however, in general, consumers were well satisfied with their alternative medical experience. Naturopathic medicine is a stand-alone primary health care and is most effective in areas where allopathic disease management is least effective, that is, in prevention of disease and in chronic disease management. The two systems of medicine complement each other well, and the American public would greatly benefit from their integration. Naturopathic medicine must be able to apply the same level of scrutiny that has been applied to conventional medicine in order for it to be proven safe and efficacious by use by the American public. I urge you to recommend greater funding for the National Center for the Complementary and Alternative Medicine, which is still funded at less than one-tenth of 1 percent of the NIH budget. I also find it unfortunate that the vast majority of people who need this medicine the most have no access to it. I am referring to the elderly, the poor, and the disenfranchised who are unable to pay out of pocket for these services. It is extremely important that you recommend inclusionary language for alternative medicine in entitlement acts, such as Medicare, Medicaid, Indian Health Service, and CHAMPUS for the military. Only then will third-party payers reimburse for these services to any great extent. Only then will the great majority of Americans be able to realize the right to choose the physician and health care services they want. I will conclude with a quote from the U.S. Preventative Services Task Force. "Lack of evidence of effectiveness does not constitute evidence of ineffectiveness." Thank you for your time and attention.

Dr. GORDON: Thank you, Konrad. Patricia Culliton. Acupuncture

Ms. CULLITON: Thank you. Good morning. Thank you very much for having me here. I am going to speak on acupuncture, cost effectiveness and clinical efficacy, and hopefully have a little bit of time to mention some policy ite

Ms. When

Dr. Kaczmarczyk sent me a list of questions to answer for this commission, I looked at it and said, well, give me three years, a hefty budget, and turn me loose, I would love to find out the answers to these questions, but unfortunately, I had one week, and so I will do what I can. Many of you on the panel know about acupuncture, and so I don't feel that I need to spend a lot of time talking about the clinical efficacy of acupuncture with its 4,000-year history and rapid growth in the United States, but it might surprise you to know that there have only been 79 NIH-funded projects to research the use of acupuncture, half of those being done in the early seventies with people like you, and when the United States kind of first discovered acupuncture after we opened our relationships with China. Thirty-eight studies have been done since 1992 with the funding of the Office of Alternative Medicine, so as the naturopathic data is similar to the acupuncture data in that it is in its infancy in being developed. We do know that there are clinical efficacy studies. The National Institutes of Health held a consensus development conference on acupuncture in 1997, so that puts it in a different status I think than a lot of other alternative modalities, but in that consensus conference, only two areas of utilization for acupuncture were considered to have definitive data, and then there are several other areas that had positive trends. So, again, I also would strongly recommend further research dollars for the research relative to the clinical efficacy of acupuncture, but clearly, we have a very good beginning to that from everything from angina. A lot of people think that acupuncture is useful for musculoskeletal pain and analgesia, but there are also good data on acupuncture for such things as breech version and nausea and vomiting, dysmenorrhea, bladder disorders, et cetera, so the whole wide range of what acupuncture might be beneficial for, and, of course, the development of clinical pathways, et cetera, is yet to be accomplished. Relative to cost effectiveness, there are no major cost effectiveness studies that have been done yet on acupuncture. There are several studies that were clinical studies that in the analysis of data, we are able to discover that people in the experimental group that received acupuncture had significant financial savings than people that were in the control group. Again, I would love to be involved or I would highly recommend that a large clinical effectiveness study or cost effectiveness study for acupuncture be implemented. Because this is a policy commission, I thought, as I said, since so many of you are familiar with acupuncture data already, what I really wanted to devote most of my attention to is the consideration of some policies. I think it is extremely important that medical education, nursing education include an overview of all complementary medicine, and as

Dr. Gordon said, that is happening already, but in 1957, all the practicing physicians in China were required to study acupuncture for two years. They weren't happy about it, but it certainly changed the health care delivery system in China after that. I am not saying that I want you to request that all physicians suddenly go back to college for two more years, but to strongly recommend that CME courses and CEU courses be available specific to acupuncture, but for CAM modalities in general, I think is just absolutely necessary at this point. Public education, some of the surveys that have been done on acupuncture, Eisenberg and the Paramor and the Robert Wood Johnson Foundation study, all done in 1997, say that less than 1 percent of Americans have ever tried acupuncture, and a 1999 landmark study said it is up to about 2 percent of Americans, but that a very small portion of the United States has even tried acupuncture. Since we do tend to think that the data supports clinical and cost effectiveness, I would like to see a public education program implemented, as well. One thing that is very dear to my heart is public health, and I would like you to consider a school loan forgiveness program for those people going to acupuncture school, that would commit themselves to work in public health agencies after graduation. I know I just have a few seconds, but I want to say that I am involved with the National Acupuncture Detoxification Association, as well as other acupuncture organizations, but thousands of Americans right now are being deferred from prison into acupuncture programs for first-time felony cocaine offenses. Forty percent of the drug courts in the United States use acupuncture as their primary treatment. The estimates are that it is between 30- and $40,000 per year for a one-year incarceration, and thousands of people have avoided incarceration by the use of acupuncture in the drug court program. That cost savings is staggering, and nobody has really looked at those numbers, but we can just extrapolate those numbers that just relative to public health, the cost savings to the American health system I think are absolutely staggering. I encourage you to consider that. Thank you.

Dr. GORDON: Thank you very much. Joyce Frye. Homeopathy

Dr. FRYE: Good morning and thank you for the opportunity to join you today. According to the World Health Organization, homeopathy is the second most widely practiced form of medicine around the globe. The International Homeopathic Medical Organization LIGA has thousands of members in five continents in over 40 countries. Unfortunately, although there are an estimated 2,500 medical practitioners using homeopathy in the U.S., research on both clinical efficacy and cost effectiveness has suffered from limitations that are common to all of the CAM practices. Thus, our assumptions about the advantages of fully integrating homeopathy into the U.S. health care system are augmented with international and historical data, as well as a 200-year collection of thousands of case histories. The most useful summary of clinical efficacy is provided by the meta-analysis of 89 placebo-controlled trials published by Lynde, et al., in Lancet September 1997, indicating that patients using homeopathy were two and a half times more likely to have a therapeutic effect compared to placebo in a variety of conditions. References to a number of additional studies on treatment of specific conditions are included I believe in your handout. The most complete data on cost effectiveness comes from the French Government report on 1991 Social Security statistics which demonstrated significantly reduced costs using homeopathic versus conventional medical care. The total cost of care in the office setting for a physician utilizing homeopathy was approximately one-half of the total cost of care provided by conventional primary care physicians even when factoring in the cost of fewer patients seen per homeopathic physician, the overall cost per patient under homeopathic care was 15 percent less, and savings increased the longer a physician had been using homeopathy. Additionally, in a further review of the data, the number of paid sick leave days by patients under the care of homeopathic physicians was three and a half times less than patients under the care of conventional practitioners, and while homeopathic prescriptions, which are reimbursable in the French health care system, represented 5 percent of all medicines prescribed, they represented only 1.2 percent of all drug reimbursements due to their lower costs per prescription. These data are particularly compelling in view of France's number one rank in overall health system performance, and number three rank in life expectancy according to the World Health Organization compared to number 37 and 24 for the U.S. respectively. In the U.S., a small study surveyed 27 physicians specializing in homeopathy and compared them to the 205 general and family practitioners in the 1990 National Ambulatory Medical Care Survey. The comparison tables and charts from that study are also provided in your handout. Again, although spending more time with patients, they ordered fewer tests and prescribed fewer conventional medicines for similar conditions. Homeopathy also compared favorably with naturopathic and acupuncture services in a Seattle study that concluded that homeopathy was the least costly and that patient visits to homeopaths were less frequent than to other alternative care professionals. Patient satisfaction with homeopathic care tends to be high if for no other reason than the time a practitioner takes in listening to the story. However, a California study also surveyed patients regarding their clinical course. Eighty percent of them had previously sought conventional care for their condition. After four months of homeopathic care, 60 percent reported improved overall health status and outlook, 70 percent reported at least partial improvement in their chief complaint, and 80 percent planned to continue homeopathic care. Homeopathy is effective for a variety of health conditions throughout the continuum of care from pregnancy to the end of life without regard to age, gender, or occupation. With respect to our colleagues, the organism is certainly best equipped to respond to a homeopathic medicine when it is also well nourished and in musculoskeletal alignment, however, we see homeopathy as the first therapy to consider in many circumstances. We have no data comparing costs from one setting to another, and I would propose that the most appropriate setting, degree of collaboration, and type of practitioner vary with the type and acuity of the condition being treated. Consider the following framework. For minor viral infections and traumas, the most appropriate care setting is usually in the home. An estimated 3.4 percent of the U.S. population was using homeopathy in the 1997 Eisenberg study. It is difficult to assess how many physician visits might be avoided all together if public awareness of homeopathic self-care was widespread. That, in turn, would decrease the accompanying long-term sequelae of inappropriate antibiotic use, increasing antibiotic resistance, and iatrogenic illness. For more serious acute conditions, homeopathy may provide complete care in the hands of the primary care provider. Indeed, in the flu pandemic of 1918, where over half a million Americans succumbed and the average mortality was 30 percent, less than 1 percent of patients treated homeopathically were lost, with some homeopathic physicians reporting treatment of thousands of cases. In the realm of obstetrics, I have used homeopathy to treat nausea and vomiting, to arrest preterm labor, to convert breech presentations, to facilitate labor, thereby avoiding numerous hospitalizations, procedures, and intensive care days. The framework goes on through the entire continuum of care. I would like to just cover what we perceive as the current barriers.

Dr. GORDON: We need to move very quickly, though.

Dr. FRYE: Okay. Patients confuse the "h" words, holistic, herbal, and homeopathy, thinking that they are synonymous. The number of homeopathic medical practitioners is very limited due to expensive and prolonged postgraduate education and lack of CME accreditation. Insurance policies and billing codes are biased towards procedures rather than time spent, and nonmedically licensed practitioners, who wish to practice homeopathy, are similar to their counterparts in Great Britain and other countries, have uncertain legal status in the U.S.

Dr. GORDON: Thank you, and we will come back to the recommendations in the discussion period. Thank you very much. Tiffany Field. Massage Therapy

Dr. FIELD: Thank you for inviting me. I am going to talk about massage therapy, which I guess could be classified, along with acupuncture, as one of the oldest therapies. If one goes back to Hippocrates in 400 B.C., he said that medicine was the art of rubbing. That has been pretty much forgotten. Massage therapy disappeared from the hospital scene. Perhaps you remember if you were hospitalized in the forties, you routinely got a back rub at least to avoid bed sores, but in the fifties, much of that disappeared from the hospital networks. According to Eisenberg and a number of those other epidemiology studies that have been done, massage therapy is among the top half dozen or so of the alternative therapies that are being sought by the American public, and the field of massage therapy itself is one of the fastest growing professions at least in the United States, so there is some sense of movement of the field being reinstated as a therapy. There is not very much research on the effectiveness of massage therapy. Much of the research that has been conducted has come out of the touch research institutes over the last decade, and we have conducted approximately 83 studies in different areas from growth problems, for example, reducing prematurity and low birth rates associated with pregnancy, stress, and anxiety, enhancing the growth of preterm babies whose agenda once they are out of medical jeopardy is to gain weight. A number of studies in the psychiatric area including attention deficit disorder, autism, depression, related addictions, such as eating disorders and smoking, and then a number of pain syndromes including migraine headaches, low back pain, fibromyalgia, premenstrual syndrome, and so on. Much of our recent work has been focused on autoimmune problems, everything from asthma to diabetes to dermatitis, and immune problems, namely, HIV and cancer. I think the most exciting findings aside from the preemie growth studies, which I am going to elaborate on a little bit for the cost effectiveness part of this, but aside from that, I think the most exciting data are the data associated with the HIV and breast cancer studies showing that not only can we increase natural killer cells and natural killer cell cytotoxicity, such that the immune- compromised HIV victim, for example, will be less likely to die of opportunistic infections, but also in a recent study just published, we were able to alter the disease marker, the CD-4/CD-8 ratio in adolescents with HIV. So, I think those are some of the most exciting data that are coming out of the efficacy studies. With respect to cost effectiveness, there has been very little done mostly because the studies have focused on subjects who are clients who are not hospitalized, and so the cost savings cannot be determined, the hospital cost savings. So, the only study that we have cost effectiveness data on is the preemie studies where we are able to actually determine the costs of hospital savings and the cost of the treatment, and to give you an example of that, eight years ago when 470,000 preemies were being born for a year in the United States, if they were to receive the massage therapy for the 10-day period that they did in our studies, they would be discharged six days earlier at a hospital savings of $10,000 per baby. If you multiply that by the 470,000 babies, you have a $4.7 billion hospital cost savings. Now, an interesting wrinkle in that is that the other part of the equation that could not be determined is cost savings associated with using elderly volunteers to actually do the therapy, in which case we had reductions in stress hormones in these elderly people, we had fewer trips to the doctors' offices, and variables like that, that reflected that their health was better following giving these preemies the massage therapy. So, that is basically all I can say at this point. The research continues. Fortunately, the Center for Alternative Medicine has funded some new projects in the area of massage therapy, and the massage therapy associations are trying to get research training to the massage therapists, so there will be more people doing research. Thank you.

Dr. GORDON: Thank you very much. Thank you all. It was really extremely valuable and helpful to us. For questions, the way we will do it is if the commissioners will raise your hands, and I will go around and just pick people in the order in which you raised your hands. Remember, we have set aside more time. We have about 20 minutes to ask this panel questions, so please make the questions brief and to the point, and let's engage them in discussion. We have them for 20 minutes or so. Who would like to ask questions? Veronica and then David. Panel Discussion

Dr. GUTIERREZ: I would like to direct my attention to

Dr. Meeker, and I would like to know how Palmer College and the consortium plan to address the clinical benefits of chiropractic care in patients without ailments, that is, the quality of life issues.


Dr. Gutierrez knows, Palmer has more the NCAM-supported centers in the United States, focuses chiropractic care, validity, effectiveness, and safety. We address quality of life issues in all of the clinical trials that we are involved in right now, and we are looking, at least in a clinical sense, and we are also embarking on a very interesting basic science series of studies using some animal models to investigate what happens when we have spinal dysfunctions, fixations, et cetera, what happens to the physiology of the body when it happens. We have discovered there are some very interesting effects that we have been able to create, and now we are working on whether or not we will be able to reverse those sorts of things. So, this is a very intense area of research, and we are looking at that as quickly as we can with relatively limited resources right now.

Dr. GORDON: David.

Dr. BRESLER: We know that one of the things that will impact greatly on access and delivery is the extent to which we can teach patients self-management. I would just be interested very, very briefly on comments about how each you feel your professions are addressing this issue. In pharmacotherapy, for example, we have over-the- counter medications that people can take for themselves and prescription medicine that they have to see professionals for. How much is chiropractic and naturopathic, how much within your professions is there a dedication to teaching self-management of your techniques to the public?

Dr. MEEKER: There could be a long discussion, but the quick answer is that chiropractors are very interested in preventing the kinds of problems that arise, and primarily we are interested in the locomotor system, the way people move in their environment, and this, of course, leads to considerations of general fitness, symmetry of movement and ergonomics, and the impact of those things on lifestyle, the effect of smoking, for example, which affects the spine, and the effects of nutrition, as well.

Dr. BRESLER: But there are some simple manipulations, for example, that you could teach patients to do to each other. For example, is there interest within the profession to do that?

Dr. MEEKER: I am not necessarily in favor of that. I think that it takes some skill to be able to figure out what needs to be adjusted and to be able to deliver the appropriate adjustment at the right time. I think there are some safety issues with respect to that.

Dr. KAIL: Many of the therapeutic agents that people commonly use are available over the counter, so many patients, almost all the patients that naturopathic physicians treat are self-medicating at home. The Weekes study that I mentioned also looked at training of home care for people, and it did show that the great majority of patients were treating themselves at home now, when they had to previously go to the doctor for care once they had been educated by the patients. This also gets in the lifestyle issues. The biggest thing that reduces chronic degenerative disease is not taking any modality, it is changing lifestyle, and education about lifestyle and awareness about lifestyle actually increases compliance in the patients. In my own study of my own patients, I got about 92 percent compliance in people following medication use at home, treating themselves at home, and following their lifestyle progra


Ms. CULLITON: Self-care is an integral part of Chinese medicine and acupuncture and dietary recommendations, exercise, such as Qigong and Tai Chi, but also I think just in general acupuncturists teach their patients how to do acupressure for self-care between visits. But if I could just take a little extra time, and I don't know if it's in your book, the two pictures that I sent the pre- and post-, if you could find that in your books, a self portrait of a 16-year-old girl with Downs syndrome, ADHD, and nystagmus, and one week after wearing a acupressure tab, there was a second self portrait which I think, if we want to talk about public health and public education, you know, who needs randomized controlled clinical trials when you can see how this one child, who was affected after one week, but the important part of this is that this was a technique applied by her mother. The acupuncturist did an education session in a public school, taught the teachers and the parents how to apply an acupressure tab on the ear for their children, and so this kind of public education is what I was referring to earlier, as well.

Dr. FRYE: The National Center for Homeopathy has affiliated study groups, which encourage anybody who wants to learn about homeopathy to get together in a small group, and it supports them with educational materials and conferences and volunteer regional coordinators, so that they can learn about how to use homeopathy for themselves and their families. The most common sales of homeopathic products, though, are in the combination remedy realm where people just pick up a bottle of allergy or migraine, or whatever the combination might be, and actually, the teething product is the second overall leader in sales in that category, but the feedback from the manufacturer on that product is that only 11 percent of the people who use it know that they are actually using homeopathic products. So, we do have a big problem of translating the use of the product to understanding the bigger paradigm of homeopathy and how to use it more specifically.

Dr. FIELD: A lot of our massage therapy studies are self-massage. All of the chronic illness in children's studies, the therapies are provided by the parents on a daily basis just before bedtime, so they can have intensive treatment. A lot of self-massage is taught in the adult studies. For example, we just completed a carpal tunnel syndrome study that was entirely administered by people to themselves during the course of their work hours. Then, of course, you have all those gadgets you can buy at Brookstone, chopper image, and brush yourself in the shower, and so on, just as long as you stimulate deep pressure receptors. We don't get any of the effects we talk about unless there is stimulation of the deep pressure receptors. Some of that you can get in exercise and sports, and so on.

Dr. GORDON: Thank you all for your comments. Wayne.

Dr. JONAS: Thank you, Jim. I basically have three questions targeted to different individuals. First, Bill Meeker. There are some good examples of integration, maybe not a lot, but there are a few good examples of integration. Could you help the panel and kind of pointing to some of those? You don't necessarily have to do it here, but if you could provide us with some examples of that, but if there aren't any, then, let me know right now. My question actually to you is slightly different than that, unless you wanted to respond briefly to that.

Dr. MEEKER: Go ahead, Wayne.

Dr. JONAS: Okay. Was there a perception prior to some of the direct cost effectiveness studies that have been done in chiropractic, that chiropractic was more cost effective than many of the conventional therapies, was there a perception of that putting satisfaction aside for a minute?

Dr. MEEKER: Satisfaction aside, studies go back to the 1960s, comparing cost of chiropractic care versus cost of something else, and most of the studies before 1990 do demonstrate that chiropractic care is probably less costly. Studies since 1990 using much more sophisticated techniques now have been a mixed bag in terms of which have turned out to be better. I think we can say that chiropractic care has now risen to the dubious level of perhaps being as expensive as medical care.

Dr. JONAS: This really relates to my second question, is that there is a perception usually prior to direct quality trials that, gee, this is cheaper, I can do it and my patients are satisfied, which is usually the case. In acupuncture and naturopathy and homeopathy, where there have been no direct assessments of cost effectiveness, I guess my question to you all is where do you think those studies should be directed, should we look at modalities, for example, which are easier to look at, and you can look at the cost add-on to that, or should we look at whole systems, because I know these systems have their own philosophy and their own approach, which is much different than simply adding on a modality. I think the lesson from chiropractic is when you look at a whole system, you get very different answers than when you are looking at a different modality. I wonder if there is any suggestions or comments on that.

Dr. KAIL: From the naturopathic perspective, again, we never practice single modalities in individuals. It is always a whole system or a protocol which always includes lifestyle management, as well as various agents that might be applied to any given condition. So, I think taking the modality approach really does disservice to the power of medicine. I think you have to look at the whole syste

Ms. We certainly have been pushing in that direction at NCAM, trying to develop protocols that will look at whole systems, which is very difficult methodologically as you can see, but we need to overcome those difficulties and come up with new methods to look at whole systems and how it affects things, because I think that is really where the cost effectiveness is going to be demonstrated.

Dr. JONAS: I would wonder about that given the chiropractic data that is more sophisticated now than some of the others and developed. Also, one of the main problems is there is heterogeneous types of practices, so if there is, in fact, something that you are going to practice, that has to be systematized in some way. Go ahead.

Dr. MEEKER: Can I follow up? I should say this. There is not one single randomized controlled trial that has used the proper economic variables and analyses of chiropractic care that I know of in the world. Economists argue vociferously with each other about the proper models to apply, as well, so this is not a simple question.

Dr. JONAS: It isn't simple. In fact, it is very hard to do cost effectiveness studies in general in any area, and I think what a lot of you are referring to is not just cost effectiveness, you are talking about cost-benefit, not just, you know, does it work for this particular thing, but what is the overall benefit that you are getting including satisfaction and other types of value issues that can be incorporated into cost issues. Then, I had one question for Tiffany. What are the barriers to delivery of massage therapy in areas, such as neonatal or intensive care units where there has apparently been demonstrated quite remarkable, dramatic cost savings?

Dr. FIELD: In neonatal intensive care, which I am most familiar with, there has been a no-touch or minimal touch policy. It is sort of shades of where we were two decades ago when we stopped feeding these babies because we thought that we shouldn't be feeding them, and similarly, now, we think we shouldn't be stimulating them because they will get physiologically disorganized. So, it goes against a whole grain of education that these neonatologists have had, and it is going to take time and more data. There was a study that just came out showing not only is there weight gain associated with this kind of treatment, but there is increase in bone mineral content and the actual growth of bone. So, this will be more convincing and with the FMRIs that are going on, that will be more persuasive to neonatologists.

Dr. JONAS: You are saying it is largely a conceptual barrier then.

Dr. FIELD: Yes, we need underlying mechanism studies is what we need to persuade the physicians that these things are working.

Dr. JONAS: Interesting.

Ms. CULLITON: If I could comment on that, though,

Dr. Jonas, I think there is also an issue of hospital privileging and credentialing for non-physician or nurse providers to come in. I know I have been going through that in Minnesota where I run a program, and you can get a lot of people within a system to say yes, we would like that, and then there is still another barrier of actually getting permission for the massage therapist to come to the site.

Dr. GORDON: Tiffany, I wonder if you could help us get some data on the controversy, if you would, about the sort of different views of growth and development and of what interferes and what facilitates it.

Dr. FIELD: Uh-huh.

Dr. GORDON: Thank you. Joe.

Dr. FAIR: For

Dr. Kail. I was struck by the study that was in your handout, the Emsley study, and I want you to comment on the quality of the data and whether or not there is a confusion between patient satisfaction, patient perception, and efficacy. For example, in one of the slides, pneumonia is treated conventionally, you know, somewhat better than alternative therapies, but not dramatically better, on a five-point Liker scale. Was this actually asking patients their perceptions of efficacy or was it a true marker of efficacy?

Dr. KAIL: I believe most of this is patient perception because I think most of this was done through surveys of the patients. I don't think there was any real hard markers of efficacy really established in the study, but as I said, there is very positive studies, and this one seems to be one that represents at least something that is out there around efficacy that looks at a whole lot of different modalities rather than a single modality.

Dr. FAIR: Because there is a sort of statistical awareness that when patients are asked, they tend to over- inflate patient satisfaction in a whole range of surveys including in the airline industry, they will overestimate the true efficacy of the experience. So, I am just wondering if you could make some concrete recommendations of the kinds of studies that you did bring a lot of this together, of the kinds of data that will be more convincing and more helpful in organizing the assessment of the disease categories that you are outlining here. How would you design studies and what kind of data would you like?

Dr. KAIL: Well, I think you are going to have to do clinical controlled studies of a whole system, but you need to step-wise it. Again, it is hard to do with a placebo, for instance. So, I think comparing it to conventional care in a step-wise fashion where, for instance, such as if you want to treat a clinical condition like, let's just say allergies, to pick one, that you start with what is parallel to conventional. So, they start with using antihistamines, decongestants. Well, you start with doing similar things using natural agents. Then, they step up to doing some kind of desensitization procedure. Then, you step to doing a desensitization procedure using a natural agent. You compare them across the board for just medication use, symptom decline, and any objective parameters you could, antibody levels, cytokines, chemokines, something like that, and there are some trials that at least we are proposing to do that are going to look at those kind of issues, but I think looking at step-wise models that really compare conventional with the alternative models, I think that is the best way to get at that without trying to use a double- blind crossover placebo-controlled trial. I just don't think that those methods are going to work for looking at this medicine.

Dr. FAIR: Thank you.

Dr. GORDON: I have Tom, Bill, Charlotte, and Effie, and then we are pretty much going to have to stop after that.


Dr. Kail, I would like to explore your recommendation that the CAM be supported by Medicare reimbursement, Medicare/Medicaid. As you were saying in your report that both modalities, that is, allopathic and naturopathic integrate well, but I would like to understand, I think more specifically, how the orientation towards prevention of disease or promotion of wellness can be broken down into a reimbursable segment of time and services. Can you help me understand, in your report, for instance, when you talk about the different treatments and modalities that are taught in the institutions of lifestyle modification, nutritional supplementation, herbal prescription, we are not just talking about chronic problems, but prevention. How do you envision that reimbursement, what would that look like in your opinion?

Dr. KAIL: As there are now, there are new codes that look at interventions that are more preventive. There are codes that you have for time allowed for discussion and education that are not being used by the insurance industry right now. They are still sticking to pretty much the old allopathic definitions of what time and reimbursement is used, but there are new codes that have been specifically set up for looking at time in educating patients on how to do lifestyle intervention. In my own case, I usually spend an entire office visit talking about those issues, and after screening a patient, giving them information about what is appropriate for them to do, and then asking them to do that. But I think you have to build it into the office visit, which requires more time. You have to get away from the 10-minute office visit. I schedule 30-minute office visits for all my patients because a large part of what I do is convincing them to take better care of themselves. So, that is reimbursable under most insurance schemes right now if you are looking at 30-minute visits, but it does take time to educate patients. You have got to give them a reason to do these things, and that is where the objectivity comes in of what you can measure, but it is an educational effort, and I think that is the best way to do it, is build it into the office visits as far as time.

Mr. CHAPPELL: Should I assume that Medicare and Medicaid are standards, in your opinion, for reimbursement?

Dr. KAIL: Well, I think that is a standard of acceptance.

Mr. CHAPPELL: That is my real question. Are we looking for credibility or economic sustainability?

Dr. KAIL: I think the credibilities may come more from the research side. I think the economic stability is going to come from the reimbursement side, but you don't get one without the other is the problem, and I think that inclusionary language will allow more people to come forward, so that insurance companies can get better data. Right now, for instance, some of the insurance companies that have been reimbursing are not reimbursing for certain programs anymore. I can give you one example. There was a program that put a cost of $7.00 per member per month for reimbursement for alternative services. That was not well advertised, and even though there was a cohort of people that had access to this care that were seniors, because it was poorly advertised to the seniors and because it was such a great expense and not well sold to the buyers, it was an underused program that was not continued because of lack of use. Well, had that been a different thing where it would have been more like 50 cents per member per month, which some plans have advocated, and it was well sold to the people that were buying it, the employers, et cetera, they would have had a better outcome and they would have continued that longer, and they would have had better statistics to use for their own utilization statistics. That is proprietary information. There are granting mechanisms that the NIH have come up with now, that hopefully, actuaries and other people will allow a pool of information to stay in a non-proprietary fashion where we can get those utilization statistics out, but reimbursement is not going to come until there is better figures on utilization, and I think forcing that a little bit by inclusionary language in Medicare and Medicaid is the fastest way to get that to come forward.

Dr. GORDON: Thank you. Bill.

Dr. FAIR: My background has been entirely, professional background, entirely in medical schools, so I am interested in education, and I will address this question to Patricia, but it is really a global question to the panel. That is, how do we go about this education? You had mentioned, I believe, that training physicians in acupuncture, clearly, medical school, as jam-packed as it is, we can't train physicians to be acupuncturists and naturopaths and chiropractors and massage therapists, and so forth, so is this education better spent in terms of training medical students and physicians in the effectiveness and perhaps a cost benefit of these things as opposed to delivering the modalities themselves, or just how do we get this training and what kind of training should it be?

Ms. CULLITON: Well, I agree with the second half of your statement or totally of your statement. No, I do not think that in medical schools we should try to incorporate into medical education that everyone become an acupuncturist and a homeopath, et cetera. It would be impossible, unless we want our physicians to go to school for 20 or 30 years.

Dr. FAIR: But Andy Weil, for instance, who started this integrated fellowship, that is an example of that type of approach.

Ms. CULLITON: That is an example, and my division in Minneapolis is an example of a different type of approach where we are actually within the Department of Medicine at an academic institution, but all the providers are non- physician providers. Salaries are significantly less, et cetera, but there is also a wider depth of knowledge of a particular intervention when somebody has studied strictly Chinese medicine for five years. So, my recommendation is that medical education should include overviews of what is out there, clinical and cost effectiveness, appropriate referrals, et cetera, and if physicians have a dream, have a path, I know there is an American Medical Acupuncture Association, and a lot of physicians really have taken very seriously into studying acupuncture. Those options would be available, but that isn't part of the curriculum that I am talking about that I would like to see in medical school education. It would be much more the overview of how to interact, appropriate referrals, those types of things.

Dr. MEEKER: I agree with you. I think that the time is spent learning about those things with one additional thing, and that is training in interdisciplinary practice. A few health commissions have recommended that interdisciplinary behavior be explicitly taught in medical school, and I think that there is a big need for that. It is difficult now even, and I think with respect to the CAM professions, there is even a greater need to train all health professionals, not just medical doctors, but CAM professionals, as well, in how to interrelate to each other.

Dr. FAIR: So, you would recommend then that the various modalities under the CAM umbrella, if one could categorize all of them, would be an integral part of the education of medical students and young physicians?

Dr. MEEKER: Not to the point of actually performing them, but, as you said, to understand them.

Dr. FAIR: Okay. Again, benefits and efficacy, and so forth.

Dr. MEEKER: Right.

Dr. KAIL: I think that distinction needs to be made very clear, though. I think there is a lot of allopathic physicians out there that go and take a couple courses in this and that, and then proceed to practice that without a full appreciation of all the other stuff that goes behind that culture. I think it is very important that we make a big distinction between this is informational, so that you will have an appreciation for this modality and know whether or not you want to recommend it to a patient as opposed to this is the level at which you can start practicing this. Again, I would recommend that if you don't have 200 hours of classroom, you probably shouldn't be reimbursed and you probably shouldn't be practicing that modality.

Dr. FAIR: This is my concern. I think in New York, an M.D., and I may have been off in the numbers, can get a license as an acupuncturist in something like 300 hours where it may be 3,000 hours for someone that goes the traditional route. I have no personal experience, but I just can't imagine that you could learn as much in a tenth of the time.

Dr. FRYE: I see the situation in homeopathy a little differently. We actually have two levels of certification. At this point they are not terribly well established or disseminated, but there is an acute care level, as well as a sort of specialist level, and I think that given that homeopathic medicines are included in the FDA Homeopathic Pharmacopeia, that having at least primary acute level of training in homeopathy in medical school, along with your traditional training in pharmacy or whatever you might use to treat a particular condition is appropriate. Certainly, going to the level of specialist training in medical school would be far too time-consuming, but I think acute level of training is entirely possible.

Dr. GORDON: Thank you. We are going to have a chance, I think this is a very important issue to come back to this for the education panel.

Dr. FAIR: I have one question for Tiffany also. What are the barriers to massage in cancer patients, because I hear this a lot from massage therapists and also some physicians, although it is sort of lessening from physicians, but there was a time not too long ago, 20 years ago, when children with abdominal tumors, for instance, they would post signs on the bed, "Do not palpate," and I think this is still imbued in some of the massage therapists' philosophy. Am I correct?

Dr. FIELD: My understanding currently is that the contraindications are coming from the massage therapists, not from the pediatric oncologists. The argument they make, the massage therapists are saying that basically, they are concerned about metastasis and the spread of cancer by the increase in blood flow and lymph, and so on.

Dr. FAIR: Is that real or theoretical? I guess that is my question.

Dr. FIELD: It is certainly not real, it hasn't been tested, but the oncologists will say, well, for the same reason that you are concerned about the cancer being spread, we are concerned about blood flow spreading the immune cells. So, there is still a lot of controversy about that.

Dr. GORDON: Charlotte. SISTER KERR: I heard important speaking this morning on at least three points, and one was that caring time and listening healed touch was essential to healing, physical, mental, or spiritual, and that it was essential to empower people to heal themselves. Tiffany, I was very edified to hear about your study with the elderly and the babies and to see the mutuality and the healing, and what I wanted to ask you and anyone on the panel is since the role of the prophet is one of imagination, what could you imagine could be done? I am looking specifically at grass-roots level at this moment of public health in your particular area that might have a significant effect within a local community. For example, I could imagine that mothers sharing massage, you know, would decrease postpartum depression and probably a million other things, but a massage co-op, you know, in the community, come in and you borrowed a massage. So, I am wondering -- and it could come from other members of the panel -- is there anything there you could tell me now or, if not now, if you could give it to me later for the panel.

Dr. FIELD: Well, I would like to say that I think that our elderly are a wasted resource and are beginning to present a lot of problem related to depression and touch deprivation, and so on, to the medical community, and I think that preschools, for example, could use elderly volunteers in a very big way. That would get a lot of touch going. I don't know if you know, but a lot of mandates are out there now that children should not be touched even in preschool because of concern about the legal aspect of sexual abuse, and so on. I can't imagine an elderly person being accused of sexually abusing a preschooler. I mean it is less likely than, say, a young man or something. So, I think that that would be one way to get grass-roots preventive care going for both sides, the elderly and the young people.

Dr. KAIL: I think partially it is a quality of information problem. A lot of people are doing self- care, as we said, but a lot of it is based on poor quality information that is just in the lay press or especially multilevel marketed stuff. There is a whole lot of bad ideas being put out there by people that are uneducated and a lot of poor recommendations out there by people that have no training. So, I think there needs to be some venue at the community level where people can tap into to get quality information about health care practices whether they be alternative or conventional.

Dr. MEEKER: One last thing on this area. In terms of prevention and health promotion, wellness care, I think one of the biggest problems in clinical practice is that doctors of all stripes don't get reimbursed for that time, and if there was a way to recommend that billing codes, reimbursement systems, et cetera, would start to recognize that this an important part of clinical practice, that perhaps we could start changing doctors' behavior, that would soon start changing patient behavior, as well, but I think one of the biggest barriers is at the reimbursement level.

Dr. GORDON: Effie.

Dr. CHOW: All the discussions that have taken place leading to this sort of more global and visionary question that I have is that we discuss about health promotion and education and teaching self care, and care, and giving time, and all that, is it appropriate to try and look at integrating this into a medical model or in your ideals and your dreams and your goals, what would you see your profession, how does it stand, as separate or integrated in a different way, setting a different parameter or paradigm, or trying to squeeze it into the mold that we have as a health care system? I know you don't have time to answer this, but I certainly would like some written things back, but if you have some comments, I would really appreciate that.

Dr. KAIL: Just a brief comment. I think that naturopathic medicine is inherently focused on prevention and self-care issue. I think that if there was an opportunity to have those issues addressed first in the medical model, that that would go a long way, whether that be integrating that care somehow by having them come in as gatekeepers, and send them out to other people, I don't know, but I think that some venue where early on in care those issues are addressed at a stronger level than they are now would facilitate the whole process.

Dr. GORDON: Thank you. Tiffany, are you planning to replicate the study on preemies?

Dr. FIELD: Well, we have done several replications, and now there are approximately five replications in other parts of the world using the same paradigm.

Dr. GORDON: Could you give us that data, as well?

Dr. FIELD: Yes.

Dr. GORDON: That would be very helpful. Tieraona, I know you want to ask a question.

Dr. LOW DOG: Real quick. Thank you. I think this is for anybody, but especially for Konrad. In Western medicine now, with the consort statement and a lot of work being done on trying to improve quality trials and trying to improve evidence, we are now looking at taking away many things, we are not paying for as many things, and it is changing the way physicians practice medicine as we move more and more towards evidence-based medicine. While I realize that there is just an absolute shortage of funding for CAM therapies in general, so it puts us in this place of a bind, is it a bit premature, are we putting the cart before the horse a little bit to want to include things that are not yet proven, it doesn't mean they are ineffective, but not yet proven to be reimbursed by an already overburdened system, such as Medicare and Medicaid?

Dr. KAIL: I think that is the catch-22 question to end all catch-22 questions, how can you find out the information without large bodies of people having access to those types of care. I think we are going to have to spend a few dollars to let some at least controlled groups have unlimited access to that care to see what happens. I think you can do that in a controlled fashion, but I think that is going to have to come first, so that a good segment of the population, especially the poor people, I mean there is a perception that is starting to change that it isn't white, Anglo-Saxon, Protestant, higher educated people, but I would like to see some more trials in specific populations, the elderly and the poor folks, small children, et cetera, that come forth. But I think we are going to have to spend some dollars and give some open access to at least a few groups in controlled situations in order to get the data we need to know what to spend more dollars on.

Dr. MEEKER: I think, Tieraona, that there are issues of equity, too. Chiropractors are not reimbursed in the Medicare system now even though spinal manipulations is one of the most studied forms of care for back pain at least, and is recommended by the U.S. Government, and yet we are treated as third-class citizens in the Medicare system. So, I think what it really comes down to when we are talking about some of the stuff is not whether something needs to be proven or not before it is included, but whether or not the things that are already paid for actually have evidence, as well, and is equity being applied to the entire situation.

Dr. LOW DOG: I would just like to say be careful of what you wish for because you might get it. I spent about seven or eight years trying to get medical assistance reimbursement for acupuncture in Minnesota, and we have it now, and I am glad that we do, but we get $12.00 reimbursement, we probably spend $20.00 on paperwork, and we would go broke if we only had a practice of people receiving medical assistance. It is a wonderful gift to be able to offer that to an expanded community, but I think we have to be cautious in what we ask for.

Dr. FRYE: I think it is important to us while looking for evidence, too, that we try to avoid doing just the quick and dirty studies that give us, yes, this modality works for this indication, where it is important to do more longitudinal kinds of studies to show whether doing this now actually helps to prevent further disease from developing five or 10 years from now.

Dr. GORDON: Thank you very much. We are going to break now. I would invite you -- would you send us that information about the $12.00 reimbursement and $20.00 paperwork, please?

Dr. LOW DOG: Sure.

Dr. GORDON: And anybody else who has examples of that kind. Our charge is to make legislative recommendations, and we want to hear about it. Thank you very much. We are going to take a five- minute break only and then we are going to start the next panel. We are a little behind time. [Recess.]

Dr. GORDON: We are going to begin with the next panel now. The first speaker will be Dennis Awang. Herbs/Botanicals

Dr. AWANG: I think the Commission for inviting me. I am neither clinician nor an economist, so my contribution to clinical and cost effectiveness would be related mainly to my familiarity with the literature in herbal medicine and for 24 years I was associated with the Bureau of Drug Research and head of the Natural Products Section in Health Canada. As such, I was involved in developing methodology for analysis of commercial herbal products and for providing guidelines for the regulation of these products. As you probably know, the system for regulation in Canada is somewhat different from what is in the United States. However, it would seem to me obvious that the potential for herbal medicines contribution to health care would seem to be fundamentally related to the ability of the consumer to have access to safe and efficacious products. As it is now, judging the difference between different commercial products is very hazardous and limited mainly to the familiarity of the consumer with the manufacturer. It seems to me also that the prime imperative for the health care system, and indeed for the regulatory agencies, to ensure that the consumer can have access to safe and efficacious products. The large interest of physicians, health care professionals in herbal medicines recently has been concerned primarily with the ability to be assured of a consistent therapeutic medicinal effect from these products, and the plain fact is that knowledge of the nature of active principles and the mechanisms of action is severely limited. Attempts have been mainly concentrated on trying to characterize the substances chemically, but there has been such a glaring lack of success in identifying these active principles that I think the recent trend to develop into biological assays would seem to me to be the most promising combination, combination of chemical and biological assays to establish some basis for real standardization of these materials. As it is now, there is very few examples where one can be confident about standardization for consistent effect. I believe that the best contribution or recommendation I can make is that a system, such as that proposed by the World Health Organization for guidelines for the assessment of herbal medicines, be instituted to ensure proper identity and quality of both raw materials and finished products. Most of the adverse reactions, for example, that have been recorded have been due to substitution, adulteration largely due to misidentification or linguistic confusion, and it seems to me that it is not wise to leave the establishment of the identity and quality of these materials to manufacturers, as the FDA has recently suggested regarding the Aristalochia problem. There is such a very broad range of scientific competence and technological capacity in this broad spectrum of manufacturers, that it seems to me that sort of reliance on manufacturers to ensure the identity and quality of these materials is wrong-headed. Also, I think that the effort that has been made by the United States Pharmacopeia to establish sound monographs, and there are a number of agencies that have been involved in this, but I think that the approach of the United States Pharmacopeia is commendable, and I think that once they can get the proper group of people together to establish reliable, accessible assays and characterization of these materials, that we will advance the process considerably.

Dr. GORDON: Thank you very much. Christopher Hobbs.

Mr. HOBBS: Good morning and thank you very much for inviting me today. I have certainly heard a lot of good things from other presenters and certainly agree with a lot of it. I am an herbalist and a licensed acupuncturist in California and Oregon. I have got a foot kind of in both worlds because my mother and grandmother were herbalists, and my dad was a scientist, so recently, for the last almost two years, we have received funding from a large pharmaceutical company, and we have been sifting through the literature on a hundred herbs in great detail. So, I am pretty familiar with what literature is out there and what science is being done. Of course, the quality varies quite a bit, as you know. But, for instance, right now I am working on garlic. In our database we have about 2- to 3,000 abstracts to sift through. Now, looking at all those abstracts, a lot of them are animal studies, a lot of them are in vitro studies, how many human studies have actually been done of good quality on herbs, how many herbs out there could you say that there really is good science, a medical researcher would be satisfied with the amount of evidence? I would have to say that there are very few herbs probably that have met that kind of international scientific standard. Maybe hypericum or St. John's Wort, ginkgo has a lot of evidence, and a few others, but when you really look at the vast majority of herbs, for instance, in the Chinese Pharmacopeia, there might be 5,000 herbs in the Chinese Pharmacopeia. How many of those herbs have actually been looked at scientifically with good science? I would say very few especially with human studies. I have submitted written comments, and I am in the process of looking at more studies on efficacy of herbs as far as cost effectiveness in our health care system, and I would be happy to put together another summary after I go home. I didn't really have much chance. I was only called at the last minute, so I haven't had a chance to write up the studies, but there are an increasing amount of studies out there. Actually, on herbs, generally, when you look at the vast amount of research, it really is mind-boggling. I had no idea until I started really looking out there. We researched 26 international electronic databases and accessed a lot of foreign material, and there really is a lot out there to sift through. Now, I have a few other comments just about herbalism in general. My feeling and my recommendation is that well-trained herbalists really should be involved in studying the safety and efficacy of herbs on a scientific basis because I would say that it is possible that many scientists have the view that herbs do not work until it is proven that they do work, whereas, an herbalist might have the feeling that they work, my feeling is that they work until it is proven that they don't work. So, I think that the questions that we ask in designing studies are very important. Obviously, as Dennis was saying, the quality of herbal products is so important as when you really start looking at the cost effectiveness of herbal medicine, we have to take into account the quality of the herbs that are being used. Now, a trained herbalist would know when to harvest the herb, what season, what part of the herb. This is a long history, a long tradition, and this type of traditional knowledge has been passed down from generation to generation, and can be quite detailed and quite complex, although it is again difficult to study scientifically. Another thing is that I certainly agree that herbs, as far as cost effectiveness and integration, work a lot better when used in a traditional system. For instance, many people today are using ginkgo for better memory, so they go into the drugstore and they buy a bottle of ginkgo for better memory, and this isn't always going to be that effective, whereas, if you go to a licensed acupuncturist or a herbalist that has traditional knowledge and traditional training, this is all integrated into a system whereby a person -- again, I spend at least a half an hour, maybe an hour with patients, and I consider myself their health coach. I really encourage people to believe in their own innate healing powers. Herbal medicine really is a gentle medicine in the sense that after all the years I have practiced, I have seen really very few side effects. Yes, there are side effects, and I would never say that just because it is natural, it has no side effects, that is not true, but generally speaking, herbs are far safer than drugs. Thank you.

Dr. GORDON: Thank you. We understand we put you under time constraints, and we would very much appreciate you sharing those studies with us. It would be very helpful to us as we move ahead.

Mr. HOBBS: Thank you.

Dr. GORDON: Alan Gaby. Dietary Supplements

Dr. GABY: Thank you for inviting me. I am a medical doctor, and my hobby over the past 25 years has been collecting and looking at studies in the field of nutritional and herbal medicine. I have been amazed at how many studies there are that are not known about in conventional medicine. Some of them are double-blind, placebo-controlled trials, some of them are case reports, some of them are uncontrolled trials. What we are dealing with here is substances which are commodities, so therefore they are usually quite inexpensive, and with a few situations where this is not true, they are generally quite safe. Having been in practice for 17 years, I have not had a single patient have to go to the hospital because of an adverse drug reaction, and most of the people come in specifically because they are looking for other ways of treating their conditions. There is a legitimate concern in conventional medicine that people will forego proven therapies and use these instead, however, when people are guided appropriately, and when they use their own common sense, this doesn't occur. There are only some situations, there are just a few situations in conventional medicine where doing nothing is dangerous. For example, if somebody comes in and their joints hurt, and they are taking an anti-inflammatory drug which is giving them an ulcer, and you put them on niacinamide or glucosamine instead, and their joints don't hurt anymore, there is no danger of foregoing conventional therapy. If somebody has migraine headaches and you put them on magnesium and vitamin B6, and they don't have any migraines anymore, there is no danger in them going off of their beta blocker. There are other situations where there would be danger, for example, in congestive heart failure, but even in that condition, if somebody is appropriately monitored, and you can demonstrate that their ejection faction has gone up and their New York Heart Association Classification has improved, then, one can cautiously wean an individual off of their medication. So, nutritional therapy has a large body of evidence behind it, and it fits very much the allopathic model. It is just that we are using different substances. Interestingly, there appears to be more resistance against nutritional supplementation among academia than there is among some other CAM approaches. As a matter of fact, there was a study published in the Archives of Internal Medicine by a conventional Ph.D. who provided evidence that there is a bias against micronutrient therapy among academia. In support of his argument, he showed that textbooks almost universally neglect mention of vitamin E for the treatment of intermittent claudication even though there is evidence that it works as well as the drug that is conventionally used. In addition, there is uncritical acceptance of adverse reactions, case reports where somebody is on six hepatotoxic drugs and they happen to take a vitamin, and they develop liver toxicity and they blame it on the vitamin. So, if we are going to move forward, we need to utilize the research that has already been done. This is one area of CAM where we actually could develop an effective and cost effective approach right now based on what has already been done. I have given 10 examples in the handout. I just picked those because they seem to be reasonable examples. For example, $1,000 a month for growth hormone for a short child, 75 cents a month for zinc, which according to one study works approximately two-thirds as well as growth hormone. $3.50 a month to prevent kidney stones using magnesium and vitamin B6. $200 or more per month using the brand version of potassium citrate. So, there are many situations where one can clearly demonstrate cost effectiveness. On the other hand, there is the possibility of over-utilization, because there is an inherent block against using prescription medications. People don't love to take their prescription drugs, where often they love to take their supplements. So, we need to develop, in order to ensure cost effectiveness, situations where it is appropriate to use nutritional supplementation, and perhaps Medicare and other insurance companies should pay for them as an alternative or as an adjunct, and that there are other situations where it may not be appropriate, such as the walking well who want to take their supplements as opposed to the walking wounded who are already spending thousands or tens of thousands of dollars. As a final 23 seconds worth, I want to mention something slightly off of my scope here, and that is the identification of food allergy in the treatment of conditions. I saw people that have spent thousands of dollars on care that didn't work and in one visit they were cured of their chronic problem because they had a food allergy which was not identified. So, we need to teach this in medical school, and the cost of care will come down by billions of dollars.

Dr. GORDON: Thank you. Thank you for your superb timing, Alan, and also for these examples, very useful. Patsy Brannon. Nutrition

Dr. BRANNON: I, too, want to thank you for the invitation to speak to you about nutrition as a complementary and alternative medicine. I am a registered dietitian and a research nutritional biochemist. I want to start by discussing nutrition as a very broad continuum in health care. It ranges from self- selected diet or dietary supplement choices by consumers with no consultation with any health care provider of any sort, to medical nutrition therapy in conventional health care ambulatory and acute care settings. The recent Institute of Medicine report on the role of nutrition and malnutrition in maintaining health in the nation's elderly defines two tiers of nutritional services, and I think this is an important distinction to consider as you consider complementary and alternative medicine. The first is basic or general nutrition education or advice that can be provided by a variety of health care professionals including physicians, dieticians, nurses, chiropractors, dentists, physical therapists, clinical social workers, physician assistants, pharmacists, psychologists, and others. The second tier, however, is nutrition therapy or medical nutrition therapy, which involves nutritional assessment, evaluation of nutritional needs, intervention, counseling, enteral, parenteral nutrition, and other modalities, as well as follow-up care. This is generally provided primarily by registered dietitians in a health care team of physicians, nurses, pharmacists, physical therapists, and psychologists. Beyond these two tiers, however, exists the vast majority of information going to consumers about nutrition, and that is through the mass media. There are recent survey data that suggest that this is the primary source of information about nutrition for consumers and that fewer than 5 to 9 percent of consumers seek nutritional advice from a health care professional, such as a dietitian or a physician. I am going to focus my remarks today on nutrition therapy in part because I knew Alan was going to speak about dietary supplements and, in part, because this is the area where we have the best research base evaluation of clinical effectiveness and cost effectiveness. This is not to say that we don't need to evaluate basic nutrition education, Tier 1 services, and that need remains high, and it is also not to say that we don't need to determine clinical effectiveness of other dietary interventions because we do. Nutrition therapy is strongly supported by observational studies, consensus documents, systematic review, and extensive clinical trials of a wide variety of size for the following conditions: dyslipidemia, hypertension, diabetes, by reference obesity, and osteoporosis. Evidence with less robust clinical trial data also exist for heart disease, predialysis kidney failure, and under-nutrition. Less robust data, relying primarily on observational data and epidemiological data, with less robust clinical intervention data exists for Alzheimer's, osteoarthritis, cancer, and other conditions. The cost effectiveness of nutritional therapy has been examined in several contexts. There are two Lewen reports, one commissioned by the American Dietetics Association on Medicare benefits, and study was done in 1997, and I will leave a copy courtesy of the American Dietetics Association for you. This estimates that a net seven-year cost to cover all Medicare beneficiaries for the nutritional therapy for the diseases for which there is strong data would be $370 million, an estimate savings including decreased hospitalizations and patient benefits at $1.2 billion for the same period. Savings is greater than the cost by the third year of this seven-year analysis. Another study done by Lewen for the Department of Defense on tricare system estimates a net savings of $3.1 million per year by providing nutrition therapy. A recent medical cost nutrition containment study that was done by the Oxford Health Plan on an expanded pilot program for the Elderly at Nutrition Risk in New Jersey and New York, which included 160,000 elderly patients, estimated a $10.00 savings per dollar invested in the program. In a study by Gallagher and co-workers reviewed research on malnutrition in hospitalized patients and estimated a $4.20 benefit per dollar invested. The clinical effectiveness I won't have time to summarize, but it is extensive. The cost effectiveness data are here for these studies, and the delivery was primarily by dietitians with adults in acute and ambulatory care settings. We have one study that suggests there is a high degree of patient satisfaction with nutrition therapy, but more studies are clearly needed. We have a number of barriers to nutrition therapy, and I am going to echo the themes that have already been sounded. The lack of recognition of nutritional therapy by dietitians and other nutritional professionals by Medicare and Medicaid in private practice health plans is clearly a problem. Recommendations. We have legislation currently in Congress, H.R. 1187 and S. 660 to provide outpatient medical care coverage for medical nutrition therapy for diabetes and kidney disease, and we need this legislation, as well as to consider expanded Medicare and Medicaid coverage as recommended by the Institute of Medicine report for the other chronic diseases for which nutritional therapy has been documented effective. We need to reevaluate reimbursement systems, and we need to think about the research that is needed on efficacy, safety, and cost effectiveness, particularly on plant, food components, and phytonutrients for which many questions exist. Thank you.

Dr. GORDON: Thank you very much. We will look forward to the study. Our final speaker on this panel we are actually giving 10 minutes to because he is talking about integration, so you can either take them all or take less as you choose. Harley Goldberg, who will talk about integrating a number of CAM approaches. Integrated Overview

Dr. GOLDBERG: Thank you very much. I am the medical director for Complementary and Alternative Medicine for Kaiser Permanente in Northern California, and I appreciate your inviting me to speak, and take a slightly different view. We have heard some very compelling statements by a large number of presenters here, and I think you appreciate the difficulty of wrapping and lumping all of these issues together and calling it CAM when they actually need to be looked at independently in a case-by-case basis in order to evaluate effectiveness. For the very reasons that your commission has been executed by executive order from the President, for the same reasons our executive director appointed a director of Complementary and Alternative Medicine to provide information on complementary and alternative practices to our physicians, to our members, to our health care providers of all types to coordinate a research program, to evaluate what education and training would be appropriate for providers that we were going to integrate into our program, and to identify what would be the appropriate access and delivery systems, much more than I could possibly cover in 10 minute, much less five. So, we have taken a few steps to move forward and because of that, I was asked to discuss how we have gone about addressing these issues. By no means have we solved them all, but I will explain to you the steps that we have taken in order to try to grapple with the issues. First, our history. I explained briefly in your handout what Kaiser Permanente is, so that you can appreciate the size of the organization and the complexity of trying to answer some of these questions, but initially, we also did a survey much as

Dr. Gordon reviewed the surveys at the outset of this meeting. It was published in the Western Journal of Medicine in September of 1998. I will be glad to make that available to you if you need it, but it basically gave the same kinds of illustrations of data that you reviewed and showed that there was a very strong interest amongst our members and our patients, as well as amongst our physicians and clinicians in complementary and alternative medicine, and it outlines by breaking down, modality by modality, the percentage of interest. Suffice it to say that 50 to 75 percent of our members were using, and are interested in using, various CAM modalities. How you define that always changes the numbers. In addition, however, what was really surprising to us was the same percentage was true for our physicians and health care professionals. That actually is what generated the appointment of my office, and the way we have recognized drivers for this issue basically is that there are two drivers. Members have a belief in, and demand for, CAM services. Physicians have a request for evidence, physicians and all health care providers have a request for evidence and safety and effectiveness in order to know how to meet those demands. Therein is the tension, and to address that we basically chose which CAM areas to evaluate based on the prioritization of member interest and how to evaluate them was based on the physician requests for summaries of the evidence on safety and effectiveness, not unlike the discussions we have heard earlier today. I guess I should say overall our approach to complementary and alternative medicine as an integrated health care delivery system is no different than that approach that we take to our overall program. Our strategy is to incorporate services that are safe and effective treatments, providing the best access and most efficient service, through integrating that in our health care delivery system. That means we have major medical centers and satellite facilities with providers of all types integrated throughout the State of California. So, we approach CAM in precisely the same way. In order to do that, our advisory panel was appointed with representatives from education, research, executive offices, and clinicians involved in actually practicing modalities that were the primary areas of interest. This advisory panel directed the process and made policy recommendations as we move along. The areas of interest that were revealed in the survey were grouped into general categories with all the difficulties that that might incur. Those were manual therapies and movement programs, traditional systems of medicine. Subsets of that would be acupuncture. Mind-body approaches to medical care of which there are many, and nutritional supplements, herbs, and dietary approaches, as well. Given the magnitude of these areas, we prioritized our work by differentiating, perhaps arbitrarily, treatments that were for treatment of disease, and then methods for health promotion. Those treatments that were used for treatment of disease were evaluated for safety and effectiveness, and, when warranted, would be considered for integration by physician referral. Because of the nature of the fact that there is a disease state involved, we felt it incumbent upon us to be fully responsible for appropriately working up diagnosing, et cetera, and rolling treatment into that. For those methods that were identified primarily as health promotion, they would be evaluated for integration into an integrated health education program that we have, that is integrated into all of our facilities, and that would be by self-referral as distinctly different from treatments for diseases. The advisory panel then commissioned standing committees on education and research. The Education Committee has basically two charges, one to provide the summary of information to our physicians and health care providers, and the other to produce information along with our Health Education Department, in another language, if you will, for membership, as we term the public or patients, all the same people. The advisory panel commissioned multidisciplinary work groups for each of those areas that were lumped, if you will, to evaluate the evidence for safety and effectiveness for each of these areas. Essentially, this amounted to performing systematic reviews, and as several people have talked about, how much literature there is out there, that is a daunting task. Having been at it for a while, I can assure you that it is not as easy as it is to say, and we can talk about that a little bit more at the end, if you like, but systematic reviews basically drive the information. All of this discussion is trying to put ourselves on a foundation of what works and what is safe or not safe, or what doesn't work or why, and that all skirts an issue that we need to talk about at the end about belief, which may be that interface between the public's demand and the clinician's need for evidence-based, placebo-controlled, randomized trials. Having said that, the systematic reviews drive the information that the Education Committee puts out for members and for clinicians. It also informs the research agenda that is driven to answer the questions unanswered, and therefore becomes the foundation of the work. It is also used, this information is also used in consideration of what services to deliver. In general, to be considered as a treatment for a condition, that is, a treatment for disease, that is, we require that there is reasonable evidence of safety and effectiveness. In addition, we ask that a quality assurance system be available before we take the next step of considering integrating something into a treatment program for treatment of disease. Who provides the service and where is actually determined by very practical issues in the context of our overall integrated health care system, and we can talk about numbers of examples if we have dietitians involved and dietary care. If we have various practitioners of manual therapies involved, where do those people actually live are they in the Ortho Department, in Physical Therapy Department, are they in Primary Care, et cetera. There are answers actually to all of these issues, but, in fact, what happens when you look at it carefully is that there are many answers. It depends on the size of the facility, if it is a small facility in a rural area versus a large medical center in a major area versus whether or not there is a specialty care process involved or primary care process involved. Suffice it to say, it is not one answer, and it is not a simple answer, and it is not a restrictive answer. It is a "both and" answer, in other words, we can have, as we do, physical therapists in our primary care modules, as well as in our Orthopedics Department, as well as in a free- standing department and how we integrate who sees them, when and how is dependent on how the patient presents with their clinical condition and where. So, we are considering systems further to deliver services when there is evidence of safety but effectiveness is unknown, which, as has been stated before by panelists, is largely the case. When that is the case, actually, what we are looking at is a self-referral system that is at patient's cost, and something that hasn't been talked about much, but should be, because it drives all of this really is who pays. You have to identify that, and basically, we are looking at various models to try to answer that. It is not easy. There are many ethical issues involved. It is very difficult to sometimes determine when a therapy is a treatment of disease versus for health promotion. We want to encourage health promotion, at the same time, who pays is an issue when you have a single dollar, if you will, pot to pay for all services, and I sit down in the Chiefs of Medicine peer group meeting to discuss implementation of all of medical care for that department, and they look at me knowing what I am doing and say you are the guy who wants to take some of the money, this is essentially taking another primary care provider out of the office or someone off call or someone out of the ER in order to provide these other services. The only way to answer those questions is with good evaluations that show that we have equally or more effective care that helps them and helps our member and our patient most importantly, provide them the best health care available. So, my policy recommendations, if I may quickly, is that we need to fund an organized systematic reviews in a coordinated fashion on specific CAM methods and by clinical conditions. This will be the basis of the evidence-based approach in forming the educational materials, and the research agenda. We need to increase research on clinical implementation of specific CAM treatments for specific conditions involving CAM practitioners and experienced researchers, and we need to compare that to standard care that is largely nonexistent right now. Creating and supporting public and clinical information systems out of that, and then accelerating the research focused on belief and mind-body medicine which lies at the interface of these two driving forces. I would like to acknowledge that one of my colleagues, David Sobel, who is the Director of Health Education, was asked to come and present mind-body medicine, but was unable to attend, so his materials are in your packets. Very clear cost effective analyses are done on mind-body approaches, and I think there is little question about the effectiveness and safety of those approaches.

Dr. GORDON: Thank you very much, and we will be asking David and some of this colleagues perhaps to come back at a future session. Questions from the commissioners. Veronica. Panel Discussion

Dr. GUTIERREZ: I would like to ask

Dr. Goldberg two questions actually. The first is which services are you providing based on guidelines versus clinical necessity, and secondly, what services require gatekeepers at the present and who fills the role of the gatekeeper?

Dr. GOLDBERG: Guidelines versus clinical necessity? I am sorry, I don't understand. We developed these recommendations. You could call those guidelines. Those are driven initially to be looked at by clinical necessity, but to answer your question about which services, specifically, we provide acupuncture services in the context of chronic pain progra

Ms. There is actually multiple answers here because there are answers around what we do as an integrated base coverage in our entire system versus other methods of delivering systems as supplemental riders by self-referral and/or access through affinity programs, if you appreciate what I am talking about. Those are just health care delivery systems issues, but I will presume your question is about base and then I will say that right now we are integrating acupuncture as one component of our chronic pain delivery systems, and that is a multidisciplinary program that is one aspect of it. In addition, manual therapies are provided through our Physical Therapy Departments. Health education programs have a whole array of choices of mind-body approaches. That will be where I would stop for now. Is that answering the question you are asking?


Dr. GOLDBERG: I think there was a second half, but I am not sure I got it.

Dr. GUTIERREZ: I was asking who plays the role of gatekeeper?

Dr. GOLDBERG: Oh, right. That is the differentiation between if a service requires physician referral and if a service is available on self or patient referral. Basically, if it is a specific treatment for a clinical condition, it requires a physician referral, and the primary care provider, if you will, is the gatekeeper although referrals can come from any specialist or any provider in the system.

Dr. FINS: This is a related question for

Dr. Goldberg. What kind of consensus was generated, tell us a little bit about the process, were consumers participating in this process, was there disagreement, where were the fault lines, where do people sort of disagree, and how did you read those bright line distinctions which look good on paper, but were probably difficult to achieve?

Dr. GOLDBERG: Right. I appreciate your sensitivity to that. Basically, we selected, as I said, the areas that we would evaluate based on the surveys, which were done of tens of thousands of members, and the summaries of those surveys, which is actually in that article I referenced in the Western Journal of Medicine, September of 1998, Nancy Gordon and David Sobel, lead authors, basically, we used that as our guide to start with, and then we used multidisciplinary clinicians, so depending on the thing we were evaluating, clinicians involved in that service, as well as some clinicians experienced in epidemiologic systematic review process to evaluate the data. So, we didn't actually have members involved in reviewing the evidence because we didn't feel that was where they could be most helpful, but they were involved in selecting what we chose to review first. So, actually, my request of this panel is that the Commission provides funding and support for systematic reviews that would be done to help Christopher and to pay Christopher to review herbs for us, and so then I don't have to repeat what he is doing. Obviously, he is doing a much more thorough job perhaps than we did on the beginning of our herbs. It is scattered throughout and it is the same evidence data, and if we had respected people doing that work for us as a whole, the whole country and world would benefit.

Dr. GORDON: Let me say who I have. I have George Bernier, George DeVries, Bill, Tieraona, Ming, and Wayne. Anyone else? Okay. David afterwards. Go ahead, George, and then George.

Dr. BERNIER: I would like to ask you about the educational process. Since that is one of the areas that we have been asked to really comment on, you have had the opportunity to develop educational processes for people at various levels. What would your idealized system be? How could you best educate the population --

Dr. GOLDBERG: When I asked that question to our director of Physician Education, her answer was eight times, eight different ways repetitively meaning to say that what we do, in fact, is provide information in written format on paper electronically, in summarized versions, in full guideline versions including the bibliography of all the work we did, the evidence tables that we created, the summaries of that clinical information. In addition, by video conference presentations which we do on a quarterly basis for our system as a whole, et cetera. Members also, and public, in addition, want education, and basically the answer is that it is an entire effort that must be conducted periodically and repetitively on each of the areas of interest. Is that answering your question?

Dr. BERNIER: Yes. Thank you.

Dr. GORDON: George.

Mr. DeVRIES: This question is directed to

Dr. Awang,

Dr. Gaby, and Christopher Hobbs. Do you have recommendations on improvements that could be made to labeling regulations for herbal and dietary supplements based on some of the concerns that were expressed?

Mr. HOBBS: One recommendation I have is to talk about a traditional medicines category because again there are so many herbs out there that are being sold and being used, for instance, 5,000 herbs in the Chinese Materia Medica, probably in this country, commonly used 500 herbs or maybe at least 100 or 150 herbs in the common herbal practice, and we can't have the level of evidence that we would like in the next few years. This is going to take years and years. It is difficult to study herbs because they are not monosubstances, they are so complex. So, a traditional medicine category basically would look at the historical and traditional, the best evidence in historical and traditional medicine, which is vast, and it goes back several thousand years. Hippocrates already talked about using Vitex Agnus-Castus for hormonal imbalances, Dioscorides, which is a Greek physician in the first century A.D., talked about St. John's Wort for mania. So, this has been around for a long time, but if we have a traditional medicines category where the best evidence of traditional use and efficacy is taken and reviewed, and then manufacturers are able to put these types of recommendations on their label, to better educate consumers how to use these medicines or herbs, because they are out there on every level. They are in the drugstores, they are sold everywhere, and multilevel marketing, and so forth, and frankly, a lot of the advertising and a lot of the information that is going out is not very good, it is not high quality, and on the web you can read anything. What I have seen out there is just ridiculous. So, obviously, we can't study scientifically and prove all of these herbs that are being used right now, today, in a very short time. We have to have some system, so that manufacturers and some guidelines, and American Herbal Products Association is working on this, American Herbalist Guild, some other organizations are working on recommendations to the FDA for a traditional medicines category.

Dr. GABY: My answer is similar. In relation to nutritional supplements, there is a lot that is already known as far as adverse effects, other interactions, for example, with drugs or nutrients, and there is also a lot that is known on efficacy. Apparently, there is a law about what you are allowed to say for efficacy, but you can always say what the strength of the evidence is, for example, an uncontrolled trial showed that something works, or

Dr. Jonas' double-blind study showed that niacinamide is effective for osteoarthritis. If you are taking more than a certain number of milligrams, see your doctor. If you are taking so-and-so drug, do not take this without seeing your doctor. This would greatly enhance both the effectiveness and the safety, and it would probably greatly reduce the number of visits to doctors without causing harm to people.

Dr. AWANG: First of all, I would like to say that there is a lot of information that can be put on a label, and a lot of information has been put on a label. Much of the information is unreliable. I think at this point of the state of regulation of these materials, which I think just about everybody agrees they are pharmacologic agents, not nutritional supplements, that the most useful information you can put is warnings against possible adverse effects or toxicity, and recommendations as to use, but that is a very difficult area because if you are not going to allow claims about treatment of disease, conditions, and so forth, then, you are severely limiting what you can put on the label. In fact, the pharmacologists, in an article some time ago said -- I will read it here verbatim -- "Rather than claims to treat disease, one sees vague suggestive comments on herbal product labels and advertising material." For example, Saw Palmetto is supposed to promote prostate health rather than treat symptoms of benign prostatic hyperplasia, which I think everybody knows is what they are buying it for. So, at this point, I mean you see so many labels of Saw Palmetto saying 85 to 95 percent fatty acids. Now, I have serious doubt that you can rely on that content in the vast variety of products that claim that. What has happened is that when the original clinical research was done, and the material properly characterized, the estimation was that the fatty acids ranged between 85 and 95, so everybody else does that, as they do for 24 percent of flavonoid glycosides and 6 percent terpene lactones for just about every ginkgo product you see. So, unless this area is better regulated, I think the usefulness of the label is severely limited.

Mr. HOBBS: May I make just a quick comment?

Dr. GORDON: Yes. One thing I want to say to everybody is for this panel, we have 15 minutes more and we have to end.

Mr. HOBBS: Just that the label is more than what is on the bottle. Remember that many manufacturers use magazine articles, advertising on the web, and so forth, to advertise, so really we have to consider the wider conception of the label is a lot more than just what is on the bottle.

Dr. GORDON: Bill.

Dr. FAIR: My question is to

Dr. Brannon. First of all, thank you for this nice handout. As I look at the mosaic of nutrition, I see there is the proper eating portion, which I guess is nutritional therapy, and then I think there is a role of supplements and some diseases, vitamin E in heart disease, or Saw Palmetto, but I keep getting more and more questions from people recently about some of these approaches, what I guess you would call taking function foods and desiccating them or lyophilizing them and putting them into a capsule or a drink, I guess 2-Plus or something like that is one, and it is often sold through a multilevel marketing system. My specific question is, is this a valid approach, is this something that should be considered as a way of increasing access to good nutritional habits if people say they don't have the money or they don't have the time to eat the way you would tell them to eat?

Dr. BRANNON: I think that we are going to see more and more functional foods, so the issue of whether it is appropriate or not is probably a lot less important than how we are going to handle it. You are going to see more, and I think it is being driven by consumer demand, benecol-containing margarine is a good example of that. However, what we are missing -- and I think it is a thing that we are missing in all of nutrition -- is how does it fit with what the diet as a whole is. So, some of these foods, if a consumer thinks that they are going to use benecol-containing margarine in a high fat diet that has a lot of other saturated fat without any of the rest of the aspects that we know are part of a healthy diet for an average American, that is a misconception, and it is not one that, as I looked at the literature available, the literature available addresses very well. So, when I said I thought there was limited data on dietary supplements -- and I would put functional foods as maybe an unusual category of a dietary supplement -- in the context of the diet as a whole, it is hard to know, looking at these studies, what the rest of the diet looks like. I think that is part of the efficacy problem that we have in evaluating nutritional therapy.

Dr. FAIR: If people are skipping adequately eating, can they make up for it by taking pills or drinks?

Dr. BRANNON: Well, that gets to the fact that for many of the issues we don't know what the bioactive food components are really, and I would point to the recommendation that still holds up, which is increasing the consumption of fruits and vegetables decreases your risk of cancer. The hypothesis that was beta carotene mediated doesn't appear to be true, and, in fact, we have some evidence that beta carotene in high levels is not safe and can actually increase the risk of cancer. So, what it is, is that there are many things in foods, and this is, I think, an important fundamental principle as we move forward, that small amounts of many different substances together can be more effective than large amounts of any single substance, and we frankly don't have data that evaluate that.

Dr. FAIR: My question is still do you have to eat the fruits and vegetables to get this effect or can you get it in a capsule or a drink that is supposedly made from the juice of all these fruits and vegetables put together?

Dr. BRANNON: I don't think we have enough data to give you a yes or no answer on that.

Dr. GORDON: Tieraona.

Dr. LOW DOG: It is sort of on the tail end of that. You know, listening to all of this and talking about access and delivery, there is such a big spectrum, isn't there, from just talking about food and how you prepare your food and eating a healthy diet to taking megavitamins or orthomolecular medicine, heavy nutritional supplements, and there is also the same argument with herbs, using whole herbs, which again comes back to whole foods and recognizing that there is probably lots of things in there that work together to make it the whole more than just the sum of its parts, and then there is standardized extracts, there is this huge range, and part of what we are trying to figure out is how to make recommendations, how do you make recommendations that will enhance the access delivery in health care of people here. I guess I would like some ideas from you all when there is such a broad spectrum, from whole herbs, whole foods to minute dietary supplements, ancient wisdom that has been around forever, and now new scientific technology with very complex kinds of things. How do we begin to address that, how do we begin to make recommendations when it is so big and so vast? Chris.

Mr. HOBBS: My feeling is we will never understand, we will never get to the bottom of the complexity and the mystery of herbs and foods. Also, to address your question, will juice powders give you the same thing as a whole food, no, they will never give you the same thing as a whole food. They can approximate it, they can help supplement if a person is not eating any fruits and vegetables, then, a juice powder is probably better than nothing at all. As far as herbs go, my feeling again is that go back to the traditional herbalism, there is still, even in this modern science of all the studies and all the science, there is still a place for traditional medicine, there is still a place for a traditional system of medicine like traditional Chinese medicine, Ayurveda, because it deals with whole substances, it deals with the whole herb in a context that is very, very ancient, and it also deals with people. We are not considering so much that -- standardization just hasn't have to do with the herb and identifying the chemical constituents and the pharmacological action. It also is how does that herb or food interact with the person or the patient. This is what traditional medicine studies, so each person is evaluated, each person is looked at in the context of that system, and then the herb and the food is applied. So, I think, just to sum up, I think we have to go back to traditional medicine and we have to promote the study of traditional Chinese medicine, Ayurveda, some of these systems that looks at the whole person and the whole food and the whole herb in the context of an ancient practice, and we can fragment these herbs and study them to death, but we will never get to the bottom of all the mysteries that are included in there, although I think we should try.

Dr. BRANNON: I would also like to comment in the sense that I think that in the absence of knowing about effectiveness, that it is important we know about safety, and one of the guidelines for food, in particular, in diet, is that people make food choices for a lot of reasons, and as long as the food choices they are making are safe or don't have an adverse effect, then, how much should we worry about that particular food choice. I would argue that in this context, we should probably worry about the food choices or supplement choices for which there are adverse effects.

Dr. AWANG: I would just like to make a brief comment about the whole versus extract thing on the traditional versus modern usage. I feel fairly confident that you can't take enough ginkgo leaf to affect your memory, but because the modern evidence for it is for highly concentrated extract, a 50 to 1 extract of ginkgo leaf, and that is what has been shown to be useful in Alzheimer's and memory, and so forth, but I don't think you are going to get it in corn chips or in a food drink. Also, ginkgo itself has toxic materials in it, and you have to remove the ginkgolic acids and the ginkgo toxin, so one has to be very careful about that, as well.

Dr. GABY: Just so we don't overlook what may be most important in the discussion of standardized herbs and concentrated nutrients and Juice-Plus, which probably should be called Juice-Minus, we talk about functional foods when our real policy, since the evidence is that eating whole foods or avoiding dysfunctional foods promotes health, we can create a policy which is somewhat outside the scope of medical care, but within the purview of the public health, to promote the use of whole foods in our society, and as a public policy, it is very simple to do that. That would be to tax junk food and to give a subsidy to whole food. [Applause.]

Dr. GORDON: Harley.

Dr. GOLDBERG: Just in response to

Dr. Low Dog's comment, we cannot do randomized clinical trials on very specific questions and get quick answers, it is a long process. However, to answer questions quickly, you can use epidemiologic data and other types of studies on populations which have been done, for example, the Chinese data on the use of soy in menopausal symptoms, et cetera, and get good, relatively quick answers to begin the process, so the short answer has to come from other types of studies than randomized clinical trials, and the spectrum of types of trials that are used and how they are weighted in terms of evidence and what that means is standard and is available, and we ought to use it.

Dr. GORDON: Ming. I think we are just going to have time for Ming and for Wayne, and we are going to have to end. We need time to digest our whole food lunch.

Dr. TIAN: My question is, I think that herbs are very important, easy, and also very complicated, and are we talking about the medicinal herbs or are we talking herb, because in this country, FDA regulates herb as a food supplement or a dietary supplement, so if it is a medicinal herb, you should go to pharmacist or industry to do that. When we do the herb, I think it will be very important to address the issue, what are the herbs commonly used, and also very safe, if you experts can list this, to submit a list or with any scientific support. Number two, if the herbs with any health claim, as FDA requires, any label, you have to put that on it, but you can't say that is a cure or prevention or treat any disease, but again, what kind of a health claim would be reasonable to put on the label to guide the American public, and the medical profession, and to tell people which one is useful and what is dosage, or you want to use serving size, whatever you want to use, but that is very important. I think American public and also medical professionals are a little bit confused, a lot of them are confused. They don't know which herbs you should take, so that is very important. Number three, you know, WHO already has the guideline for herbal medicine, they call "herbal medicine," what we call "herbal remedies," whatever you call, it is the same thing. Then, should we adopt that guideline for the United States, otherwise, how do we evaluate such a big issue? That is my question. Thank you.

Dr. GORDON: All in 30 seconds or less.

Mr. HOBBS: Oh. Well, first of all, there again we talked about traditional medicine and whole herbs. That generally can be thought of as being maybe a little safer than when you start purifying herbs, like Dennis mentioned, ginkgo, 50 to 1 extract. Once you start isolating compounds and purifying them, then, you get into a whole different ballgame. I think, in that case, then, if you are using science and you are using fractionation to isolate compounds, this is closer to drugs, is it not? Then, I think you have to have more safety data, you have to have more efficacy data, and because it is a different context now. You are getting into modern science, you are getting into more pharmacy, and so forth. Then, it requires more science, more efficacy studies, more safety data, and more very specific labeling guidelines, whereas, with traditional medicine, then, you are working with a practitioner who understands the whole herbal medicines and applies it to a system of practice. So, it depends. I think there is a very real division here between modern scientific herbal medicine, fractionated herbal medicine, and traditional herbal medicine, but I think both are necessary and both are applicable, and both can be effective in our country.

Dr. GORDON: Wayne.

Dr. JONAS: Thank you. One short question also to

Mr. Hobbs. How do you know when you have a qualified herbalist?

Mr. HOBBS: At this point, there are about five schools of herbal medicine in this country, also naturopathic physicians, which there are three approved schools, also study herbal medicine. Nowadays, chiropractors have some herbal training. But really anybody can call themselves a herbalist. There are no guidelines. In fact, I believe that herbal medicine is not a real career choice in this country. There are no real guidelines for it. There is no official terminology or definition for what an herbalist is. So, we are trying to do that now. The American Herbalist Guild is the only national organization in this country, and we currently are working on registration. So, we are developing educational standards, we are talking about registration, that you take a test and you put your name on a registration roll, so at least a person knows that if you are a registered herbalist in the American Herbalist Guild, you have a certain modicum of training. But other than that, it is going to take time, because there are so many different traditions, are there not? There is traditional Chinese medicine, Ayurveda, Western herbalism, and so forth. So, this is going to take time to integrate it, but it is a very exciting time in herbal medicine today because all of these influences are coming to this country, Ayurveda, Chinese medicine, so we are working all this out right now as we speak, but I certainly agree with you it is not easy.

Dr. GORDON: Thank you very much. I apologize to Charlotte and Tom.

Dr. JONAS: This is a yes or no answer.

Dr. Goldberg, I really appreciate what is going on there. I am a little skeptical about systematic reviews, having done many of them, sort of like counting chad, it depends on who is doing the counting and whether it has been poked all the way through or not. [Laughter.]

Dr. JONAS: I have a very specific question. Does your system provide acupuncture, does it make it available, acupuncture, for the treatment of chemotherapy-associated nausea and vomiting?

Dr. GOLDBERG: At this moment we don't. We recognize that we need to move in that direction, and it is a matter of developing access and delivery systems, and we are working on that right now.

Dr. JONAS: Related to access and delivery, which is what we are talking about, in the area of nutritional therapy, for example, for hypertension, how much time and how many visits are allowed for the nutritional treatment of hypertension?

Dr. GOLDBERG: There isn't a limit.

Dr. JONAS: There is no limit.

Dr. GOLDBERG: Just like how much time and how many treatments are available to the physician for the treatment of hypertension. They come in, they get a diagnosis, they get a treatment plan, they get followed up, but they may not move to the same level of nutritional therapy that

Dr. Gaby is talking.

Dr. JONAS: I am sorry?

Dr. GOLDBERG: They may or may not depending on the nutritionist's treatment program. It may or may not be the same level of treatment that

Dr. Gaby is talking.

Dr. JONAS: So, it will be kind of an individual consultation with a nutritionist.


Dr. JONAS: And it will depend on those skills and that type of thing.

Dr. GOLDBERG: Right.

Dr. GORDON: Thank you, Wayne. One thing I would like to mention to the commissioners aside from apologizing to those of you we couldn't include in this time, we will have time to address questions of licensure, education, research, and other issues in subsequent sessions. I think if we can focus even more, discipline ourselves to focus on access to services and service delivery, that will help us move ahead, and we can ask the people on this panel, if we want them back, to address some of these issues, for example, how do you know who an herbalist is, and how do you proceed with that. We can ask them back for the panels on education and licensure, et cetera. So, we are going to take a break now. We will return at 1:35. [Lunch recess taken at 12:25 p.m.] + + +