******************************************************************************* *** White House Commission on Complementary and Alternative Medicine Policy *** *** Meeting Transcript: Washington, D.C 10/05/00 Morning session *** ******************************************************************************* WHITE HOUSE COMMISSION on COMPLEMENTARY and ALTERNATIVE MEDICINE POLICY + + + Volume I + + + Thursday, October 5, 2000 8:30 a.m. Hubert H. Humphrey Building, Room 800 200 Independence Avenue, SW Washington, D.C. PARTICIPANTS: Chairperson: 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 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 William R. Fair, M.D. Attending Surgeon, Urology (Emeritus) Memorial Sloan Kettering Cancer Center Chairman, Clinical Advisory Board for 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 Wayne B. Jonas, M.D. Department of Family Medicine Uniformed Services University of the Health Sciences Tieraona Low Dog, M.D., A.H.G. (Private Practice) Charlotte Kerr, R.S.M. Traditional Acupuncture Institute, Inc. PARTICIPANTS (continued): Dean Ornish, M.D. President/Director Preventative Medicine Research Institute Clinical Professor of Medicine University of California, San Francisco Conchita M. Paz, M.D. (Private Practice) Julia R. Scott President National Black Women's Health Project Commission Members Not Present: George T. DeVries, III CEO/President American Specialty Health Plans Buford L. Rolin Poarch Band of Creek Indians Executive Staff: Stephen C. Groft, Pharm.D. Executive Director Michele M. Chang, C.M.F., M.P.H. Executive Secretary Joseph M. Kaczmarczyk, D.O., M.P.H. Senior Medical Advisor Doris A. Kingsbury Program Assistant Geraldine B. Pollen, M.A. Senior Program Analyst C O N T E N T S Page No. Opening Remarks Dr. James S. Gordon ................................... 6 Session I: Research Priorities and Public Input Dr. Leon Rosenberg, Institute of Medicine Committee on Complementary and Alternative Medicine Policy ..... 12 Panel Discussion ....................................... 24 Session II: Federal (NIH) Support for CAM Research Dr. Jeffrey White, National Cancer Institute ......... 46 Dr. Claude Lenfant, National Heart, Lung, and Blood Institute ............................... 56 Dr. Marvin Cassman, National Institute of General Medical Sciences .................................. 61 Dr. Steven Hausman, National Institute of Arthritis and Musculoskeletal and Skin Diseases ............. 66 Dr. Paul Coates, Office of the Director/Office of Dietary Supplements ............................... 74 Panel Discussion ....................................... 80 Session III: Academic Centers and Support for CAM Research Dr. Alfred Fishman, University of Pennsylvania ...... 106 Dr. Daniel Federman, Harvard University ............. 115 Dr. Joseph Pizzorno, Bastyr University .............. 121 Dr. William Meeker, Palmer College of Chiropractic .. 130 Panel Discussion ...................................... 141 Public Comment Suzanne Scurlock-Durana ............................. 165 Phillip Shinnick .................................... 168 Richard Pavek ....................................... 180 Linda Lazarus ....................................... 184 Sandra McLanahan .................................... 191 Antonio Martinez .................................... 195 Carl Sandler ........................................ 199 Session IV: Research Support and Collaborations Dr. Stephen E. Straus, National Center on Complimentary and Alternative Medicine ......................... 202 Panel Discussion ...................................... 223 CONTENTS (continued): Session V: Facilitating CAM Research and Regulatory Challenges Dr. Janet Woodcock, FDA, Center for Drug Evaluation and Research ..................................... 250 Dr. David W. Feigal, FDA, Center for Devices and Radiological Health .............................. 273 Dr. Joseph A. Levitt, FDA, Center for Food Safety and Applied Nutrition ............................ 283 Panel Discussion ...................................... 295 Session VI: Research in the Regulatory Framework Dr. James R. Winn, Federation of State Medical Boards ........................................... 311 Dr. Floyd Leaders, Botanical Enterprises, Inc. ...... 329 Mr. Robert McCaleb, Herb Research Foundation ........ 336 Dr. Anthony Rosner, Foundation for Chiropractic Education and Research ........................... 344 Panel Discussion ...................................... 355 Session VII: Outcomes Research Part I - Interface Between CAM Research and Regulatory Agencies Dr. Nicholas Gonzalez, Private Practice ............. 366 Dr. Ann McCombs and Dr. Devi Nambudripad Private Practice ............................ 378, 383 Dr. Jeffrey White, National Cancer Institute ........ 386 Panel Discussion ...................................... 389 P R O C E E D I N G S DR. GORDON: Good morning everybody. I am Jim Gordon, and I am the chair of the White House Commission on Complementary and Alternative Medicine Policy. On behalf of our commission and our staff, I want to welcome all of you. I want to welcome our commissioners as well. We have a group that comes from all over the United States, and they are here today. I want to welcome a new commissioner, particularly. Tieraona Low Dog, who is from New Mexico, and a physician and herbalist who will be here with us. Both George DeVries and Buford Rolin will not be here today. They are unable to come. Otherwise, I believe all the other commissioners will be here, and are here. That's great. The way that we are going to be organizing these sessions is we are going to have panels of people who are going to come and testify to us. Michele Chang, who is the executive secretary on my left, will be calling up the panels. The panels of people will testify. Each one will testify, and then we will all have a chance to ask them questions, and we will keep on going through the day with that format. Now, as you can see when you look at the schedule, and I think everybody in the audience, as well as here, has a schedule. For us, it is under Tab 1, the schedule. It is a very busy schedule. So we are going to set time limits strictly. I even brought a little clock to make sure it is at the very forefront of my consciousness throughout these meetings. So we will be setting time limits strictly, and we want you speakers to know what your time limit is. It is generally 10 minutes with a very few exceptions. They have the lights on the table, right, Michele? So you have the lights, and when the red light goes on, that means it is over. Not to put too fine a point on it. We welcome written testimony from all of you. We welcome communications after this meeting. Many of you may be communicating with us, interacting with us, as we move ahead. Remember, the Commission continues through March 2002. We have an interim report due next July, and we will welcome all of your feedback, not just the people who are coming to sit at the front table to speak with us, but all of you who are here with us today. There is a time for public comment, both today and tomorrow, right after lunch. If you would like to sign up, you can sign up outside at the table. Public comment, we are asking people to limit their time to 3 minutes, so we have some time interact with you, ask you questions, have a dialogue. There is going to be a press briefing here at 12:30, and any of you who would like to stay and see the press briefing are welcome to be part of it. When you speak, there is an on/off microphone for all of us up here and for those who are sitting at this front table, so turn it on when you are speaking, and turn it off when you are not. This is for the commissioners. When people come and speak, give their testimony, we have a chance for questions. I am going to ask all of you to ask brief questions. We have a lot of time for discussion among ourselves. We will have a lot of time when we are formulating the interim report and the final report to discuss the issues, to discuss the philosophical implications or the practical implications. So I want to remind all of us, including myself, to ask questions, not make statements. Our work here is to help these people, the experts who have come to us from all over the country, and we hope from all over the world, to answer the questions that we need to have answered, to give us the information that we need in order to formulate our recommendations to the President and to Congress. There is a schedule which is available to everyone. Does everyone in the audience have a schedule of our Town Meetings and future Commission Meetings? MS. CHANG: It still hasn't been finalized. DR. GORDON: It hasn't been finalized, but the next Commission Meeting will be on access to services and on issues related to services. CAM will be here December 4th and 5th. There will also be a Town Hall Meeting in Seattle on October 30th and 31st. Those will be the meetings that we will be having between now and December, and we welcome communication from you in the interim. If anyone would like to communicate with us. The best way to communicate is through e-mail, probably, and the e-mail is? MS. CHANG: WHCCAMP@od.nih.gov. Our web site is www.whccamp.hhs.gov. All that information is in the materials in the back of the room. DR. GORDON: Great. Thank you, Michele. Now, before we move into a brief introduction to today's session, I would like for everyone to just sit quietly for a minute so we kind of collect ourselves. [Moment of silence observed.] DR. GORDON: Thank you very much. Today we are going to explore issues related to research and complementary and alternative medicine, and we are going to be hearing from a wide range of people who are going to discuss a number of different topics, present a number of different programs that have been undertaken at the federal level, at the private level, programs of funding, of philanthropy. People from the CAM community and the conventional medical community who have been doing research in the field will be telling us how that research is going, what the challenges are, the progress that they have made, and what some of the vehicles for improving our approach to research might be. All of these hearings are done in the spirit of collaboration. Just as this commission is composed of people from a number of different disciplines and a number of different perspectives, so our work is a collaborative work. We are bringing people together to put our heads together, to open our minds, open our hearts, to work collaboratively to develop an agenda that will best serve the needs of the American people. That is our task here. This particular session is the first of two that we have planned on research initiatives. There will be another one after we have had the sessions on access to services, on education for health professionals, and on information to the public. We have had a committee that has worked on this, that has been instrumental in helping to put together the program. The committee includes Dean Ornish, and Wayne Jonas, and Bill Fair, and Effie Chow, and Buford Rolin. I have worked with that committee. We have put together a lot of the ideas. What has made this session happen is the work of Steve Groft, the executive director, Michele Chang, the executive secretary, and the staff that have been in touch with people who are sitting here who will be talking with us today, and who have helped to coordinate and pull together a vast number of people and a tremendous amount of information to make it possible for us to have these hearings. So without any further ado, let's begin with the first panel on Research Priorities and Public Input. We have asked Dr. Leon Rosenberg, the chair of the Institute of Medicine Committee on the NIH Priority-Setting Process to talk with us about some of the issues in involving the public in setting priorities for CAM research, and indeed, involving the public in setting priorities for all research at NIH. So, Dr. Rosenberg. Session I: Research Priorities and Public Input DR. ROSENBERG: Thank you very much, Dr. Gordon. I am pleased to testify before this commission and your very important task. Two and a half years ago, Ken Schein, the president of the Institute of Medicine, called me and asked me to chair a congressionally mandated committee of the IOM on the processes by which NIH sets research priorities. I blithely accepted, as I usually do when the IOM asks me to do something, and that set in motion the most challenging committee assignment that I have ever done. It was a fast-track study. We were given exactly six month from start to finish. We met the deadline, but some of us paid the price for having done so. It was rather exciting. The booklet that you have all received, "Scientific Opportunities and Public Needs," is the output of that committee, and the overheads that I asked that you all receive is really the distillate of the committee's report, which I would like to take a few minutes to discuss with you now. Some of my comments will be general about research, and some of them will be very specific about public input to NIH, which I judge to be the thing that you are most interested in here. As Dr. Gordon alluded to, the United States is the preeminent medical research establishment in the world. It is a source of great pride in the country, and it is the envy of the world. The federal government is the largest single sponsor of that research, spending close to $20 billion this year, the lion's share of which is budgeted through the National Institutes of Health, whose budget in this fiscal year is $17.9 billion and may be over $20 billion, depending on congressional actions in the next couple of weeks. Given the size of this public investment and the likelihood that it will continue to grow, it is not surprising that there is intense interest at NIH, particularly when one looks at the NIH mission statement, which is: "To uncover new knowledge that will lead to better health for everyone." So the question is, why this intense interest, and I think it is an easy answer. Every one of us wants to live a long and healthy life. Every sick person, woman, man, or child, wants researchers to find new ways to make him or her well, or to improve the quality of life for those who are disabled, without regard to whether the ailment is common or rare, acute or chronic, life-threatening, or self-limiting. So the NIH has an enormous task, and an exciting one, to be sure. It has done its job, in my view and in the view of the committee, very well. It is the leading federal agency supporting research related to improving the nation's health. The quality and quantity of excellent science NIH has supported, and the outstanding basic and clinical researchers it has trained for many, many years, have advanced both fundamental knowledge of human biology and better ways to treat or prevent disease and promote health, but the NIH budget, however large it is, will never be large enough to meet every need or fund every promising opportunity. Choices will be made, and therefore, priorities have to be set. When NIH writes about and talks about its priority-setting process, it starts with its objectives, to identify the public's health needs, reducing the burdens of disability and disease by developing better means of prevention, diagnosis, treatment, and rehabilitation. A second objective, to extend the basic knowledge base to lead to even better methods in the future. The third, to communicate to the public and to health providers the current state of scientific knowledge. So this is where NIH starts in its priority- setting processes. In order to define its priorities, NIH takes into account its many constituencies, and you and I know how many it really has. Research scientists, on the one hand; clinicians who apply research results as a second; organized voluntary groups and individuals active as advocates as a third; organizations and individuals who represent population groups with special health problems as a fourth; Congress as a fifth, and a rather important fifth; and of course, the media. So I don't think any of us would doubt that setting priorities at the NIH is an awesome task. Not only must the leadership of NIH answer to the Executive Branch and the U.S. Congress, but it must work with all of those constituencies that I mentioned before, making its fateful decisions, and it must also adapt to a changing policy environment in which scientific opportunities have grown more rapidly than the budget. Health problems have changed as the population's demographics have shifted, and globalization has exposed the U.S. population to new problems, such as emerging, or reemerging, infectious diseases. The study whose committee I chaired was set in motion because of sources of concern registered by many, in the second half of the 1990s, about how NIH sets priorities and how it was doing as it set them. Some members of Congress believed that there should be more of a correlation between the allocation of research funds and the magnitude of disease burden in the population. An increasing number of disease-specific interest groups campaigned for increases in NIH funding related to particular diseases: AIDS, breast cancer, Parkinson's Disease, diabetes, and so on. Some of these groups always feel that NIH doesn't listen well enough or doesn't respond to their input. The leadership of the health committees in Congress, on the other side, such as John Porter, have become increasingly uncomfortable with intervening in research priority-setting by NIH by using mandates or set-asides. And so, this was the background under which our committee was called into session. Our committee was charged very clearly by Congress, and I would like to read the charge to you: "The IOM will review the research priority-setting process of the NIH and make recommendations for possible improvement. The study will consider (1) the factors and criteria used to make funding allocations; (2) the process by which the funding decisions are made; (3) the mechanisms for public input; and (4) the impact of congressional statutory directives." That is what the committee was asked to do, and set out our proposal and our recommendations in a very short period of time. So we set to work in March of 1998, and we entered into a series of activities, panel discussions with the director of the National Institutes of Health, with a number of institute and center directors. We conducted a full-day session, a town meeting with interest groups at the National Academy of Sciences. We collected written statements from organizations and individuals, and had several hundred of those. We surveyed NIH constituents, researchers, clinicians, and advocates. We interviewed congressional staff, and we reviewed published reports and other information provided by NIH, insofar as we could. Let me address the four charges to the committee in turn. First, the one about NIH's criteria. What are the criteria that NIH uses in prioritizing its budget. NIH has published on this, and I hope that the Commission has access to their book on how NIH sets research priorities. Their criteria are very straightforward. There are five in number: public health needs; scientific quality of the research; potential for scientific progress; portfolio diversification along the broad and expanding frontiers of research; and adequate support of the infrastructure, that is, human capital, equipment and instrumentation, and facilities. Those are the criteria. Are they rocket science that can be quantitated to the fourth decimal point? Of course, not. They require a great deal of expertise and judgement, and that is why we attract as outstanding a group of people to the leadership positions of the NIH, starting with the director, as we possibly can. After its deliberations, our committee concluded that NIH's criteria, as explicitly laid down in their book "Setting Research Priorities," are generally reasonable and useful, both for allocating research resources and for enabling organized interest groups and Congress and members of the public to understand and evaluate NIH's program. The book "Setting Research Priorities" is not for evening, bedtime reading. It is a tough read, but it is a very important read if you really want to understand how NIH does its job. We had several recommendations concerning this issue of criteria, but I think basically what we said was, the Committee thinks your criteria are fine, but we think you should make them clearer, and we think you should pay more attention to how the public understands the criteria that you are using, and we think you should strengthen your analysis of health data and burden of illness as it relates to the criteria. The second thing we were asked to look at were the processes for setting the research priorities. These are decentralized through all of the more than 20 institutes and have to be decentralized because that is the way the NIH is structured. We felt that, in general, the Office of the Director of the NIH requires an increased capacity to analyze cross-cutting needs and opportunities. This means a more central role for the NIH director in priority-setting, which is a very controversial matter, as I am sure you know. We suggested that if the director was going to have this increased role, than he needed, or she needed, to receive, regularly, strategic plans that indicated what the various centers and institutes of the NIH were going to do with their budgets. Let me get to the heart of the matter here, NIH's mechanisms for public input. This is where, I believe, our committee made its most important contribution. We felt that NIH's interactions with various publics is weak compared with NIH's interaction with the research community. We suggested that there ought to be something done to make that better. So we had three specific recommendations: One, the NIH should establish an Office of Public Liaison in the Office of the Director, and where offices performing such a function are not already in place, in every institute and center. Second, we said that there should be established a Director's Council of Public Representatives chaired by the NIH director to facilitate interaction between NIH and the general public. Third, we suggested that the public membership of NIH policy and program advisory groups should be selected to represent a broader range of public constituencies than was the case in 1998. We also made some recommendations to Congress, but I think those are really not the heart of this discussion. I would say that, for this group particularly interested in the questions that I was asked to look at, what role should the public have in setting research priorities for complementary and alternative medical research, and how can public input regarding such research be increased, I think the heart there is in the recommendations about the public liaison offices and about the committee of public representatives, and about the broader constituencies. My own feeling is that your role, or the role of advocates for complementary and alternative medicine should be to inform, to advocate, to challenge, to discuss, and then to respect the authority and responsibility that goes along with the lead people in the NCCAM or in the other institutes concerned about broadening the research base. As far as the second question, how can public input regarding complementary and alternative medicine research be increased, I would simply say you must use all the mechanisms that NCCAM and the other institutes have now established. That means be sure that your voices are heard through the Office of Public Liaison, through the Committee of Public Representatives, through town meetings. Will that stop individuals or groups from going directly to Congress? No. Do I think that is the best way to move the priority-setting process forward? No, because in the final analysis, I think the system generally works. I think it is working better. I think NIH is really trying hard to hear more voices and to think more broadly. I am now more than willing to answer some questions. DR. GORDON: Thank you very much, Dr. Rosenberg. One of the reasons that we asked you to come is because you spent, albeit a brief, an extremely intense time looking at these issues. Our subgroup that was working on research decided that this was a wonderful way for us to begin to frame the whole discussion about research, since the movement to create a new medicine which includes complementary and alternative therapies is very much one that is a very large, popular movement. So the issue of public involvement is one that is crucial to our thinking, and, of course, we, as a White House Commission, represent the public and their interests. So what I would like to do is to ask the commissioners who would like to ask questions to please feel free to ask Dr. Rosenberg questions, or ask for his guidance and what he has learned in this process. Dean first. DR. ORNISH: Well, first, I appreciate your report and all the effort you put into the Institute of Medicine, which I found fascinating. I didn't find it too dense. I thought it was actually very eloquent. One of the issues that wasn't addressed in there was, in doing research that is innovative as opposed to incremental, it is sometimes more difficult to get NIH funding for it because there is a bit of a catch-22, that, without the funding one can't show that something is feasible if it has never been shown before, but if it has never been shown before, they are less likely to fund it. I am wondering, many of the complementary and alternative medicine approaches often fall into that category. Do you have any thoughts about that particular dilemma? DR. ROSENBERG: Well, I think the point you make is valid, but, as someone who has spent my life doing medical research, clinical and basic, I believe in the process. I value the need to ask a question and try to get an answer, and to get that answer through the collection of unbiased data. So when you ask me, how does one get your foot in the door with innovative ideas, I say by crafting a good proposal and by proposing a good study with which to answer it. There are all kinds of ways in which information about health and medicine are obtained: anecdotal; case studies; small, uncontrolled studies; all the way up to the rigorous, blinded, randomized studies that are the gold standard for improving a medicine or a new technology. The more work that is done at the top of that scale, the more likely one will have of convincing other people of one's ideas. I do not doubt that many of the things that are now called complementary and alternative will be tested properly, and find their way into their rightful place in medicine. I am really quite excited by the agenda of NCCAM and the work that I have read about under the leadership of Steve Straus. The studies that are ongoing about ginkgo, about St. John's wort, about glucosamine and chondroitin sulfate, I think these are all exactly where that organization should be going, and I think they indicate an openness and a desire for good science to be done about important things in the world of CAM. DR. GORDON: Thank you. Wayne? DR. JONAS: This, I think, is such an important theme, and I hope we don't shortchange this. This entire topic is right at the heart of the whole decision-making process, or recommendation-making process, that this panel is going to make around science and scientific research. I want to commend Dr. Rosenberg for this report. When this came out and I was at the NIH, I thought, this is fabulous; this is absolutely fabulous, because we were in an office that was started largely because many people felt that the NIH had not done its task around certain topics. The difference, however, between alternative medicine and what a lot of the disease advocacy groups were is that it wasn't about a particular disease. It was actually about a different world view, or about expanding our view to encompass more of the world. For example, focusing on disease, per se, a specific diagnosis, which is the way we go about doing research in the western world, was something that often caused a lot of confusion and, in many cases, false information, inability to do reviews, inability to set priorities in these particular areas, because many of the traditional systems that we were charged with looking at did not take these same kind of world views, did not have the same kind of disease classifications or interventions and this type of thing. You could extend that to the public, and I thought bringing the public into the decision-making process was key. So I was extremely happy to see this report. I guess my question is, in your view, how good has the follow-up on this report been? Has the process for improving this communication between the public and the NIH developed? Has it improved? Is it moving forward? Is there a way in which the Commission can say, this is working and in the area of complementary and alternative medicine, we should move into those areas, especially in the area of knowledge management? Because I think this is key. It is one thing to exchange data, which currently we are doing right here. It is another thing to exchange information in which you begin to understand and talk about the synthesis of data. It is another thing to begin to exchange knowledge in which you understand what someone's perspective is. That almost requires some kind of training program, if you will, cross-disciplines. I know this is going on in a lot of areas, and business, and this type of thing. I am just wondering if you could comment, what has the progress been in terms of moving some of this integration of the public and the NIH forward? DR. ROSENBERG: Wayne, I feel very upbeat about the recommendations that we made concerning public input. They have been the recommendations that have received the greatest attention at NIH. They were the recommendations that caused the greatest consternation when they were originally made, but sometimes that is the good news part of it, because the three recommendations that we made concerning Offices of Public Liaison, the Director's Committee on Public Representative, and a broader inclusion in institute boards and high-level committees, all of those have really been done in a very significant way in two years. I have been very impressed, both at the level of the Director's Office and at the institute and center offices. Is there unevenness still in that? Of course, but I believe there has been a really a major, good-faith effort to be more inclusive, to have more voices be heard in order that the people ultimately charged with making the decisions will have more information and will not be second-guessed as much when they do make their decisions. For, after all, the decisions still have to be made by the people who are entrusted with the responsibilities to be the best stewards of these public monies. The recommendations concerning the priority- setting process at NIH, strategic planning at the institute level, I think, has been well received, and it has been put into motion. The NIH's efforts to be more concerned about disease burden and the cost of illness has begun, but I wouldn't say it has gone as far as some of the other recommendations. So I think the score card is pretty good. It is not an A-plus, but it is pretty good, and I think it will still get better. DR. JONAS: One of the things that might be useful, just to follow up on that, and you don't have to do it here, but I think what would be useful for the committee is that, if there are some institutes that have kind of really moved forward in this area that we could look at, perhaps, as examples. I think this would be extremely useful, and perhaps we can talk about that after the meeting or sometime. DR. GORDON: Thank you. Joe. DR. FINS: Dr. Rosenberg, thank you very much for your comments. Your last criteria was the adequacy of the infrastructure, and I was wondering if you could comment on the adequacy of the infrastructure, that is, for funding and criteria related to CAM, and specifically the relationship between the social sciences and the more clinical and basic sciences. A lot of the outcome assessment issues will pertain to quality-of-life indicators, and I am wondering about the false divide between the social sciences and the more traditional and clinical sciences. DR. ROSENBERG: I think that the social sciences and the behavioral sciences are increasingly being recognized as important players in the NIH world, but I really think it would be wrong of me to try to tell you that I know the state of the infrastructure having to do with CAM. I do not. All I know, really, about CAM as it relates to the NIH, is that I have followed pretty carefully the affairs of, first the office, and now the center, and I have read pretty carefully the strategic plan of NCCAM, and the statements that I have seen from Steve Straus. As a standard bearer for the name, I think he is off to a wonderful start, and I think that the broad agenda that now is framed for NCCAM augers very well for infrastructure in terms of training, in terms of looking for centers around the country, in terms of broadening the horizon for expertise in CAM, and for visibility of the area. I think that is in a good direction. DR. GORDON: Are there other questions? Others who have not asked a question? Yes, Effie. DR. CHOW: Again, thank you for the great talk. You know, research for the general practitioner and the public is seen as this prodigal son, way up here, and sometimes the practitioners, particularly with CAM, are sort of afraid of research. Is there a program within NIH that would introduce research at a gentler level to reach the people so that they will become more amenable to research? There are a lot of practitioners out there that are getting terrific results, but when you talk about research, they feel, well, I don't know anything about that, and they are scared off. I think this public representation is wonderful, but I do wonder where the outreach is. Is it strictly to the universities or those that are well established? Or, is there a method to reach the community-based groups? DR. ROSENBERG: That is a very, very hard question to answer. When you say that practitioners are frightened about research methodology because they don't understand it, I am sure that what you say is true, but research has its metier. It has a beginning and it has an end. It has a process and it has a way of doing things. I think that clinical research, which is, after all, I think, the heart of CAM research, at least for now, also has a way of being done. I think there is a great deal of effort being made around the country now to educate young professionals into the methodology, into the statistical evaluation, into the epidemiologic precepts of what clinical research is, so that when a study is planned, it has a reasonable likelihood of producing significant results, so that people will understand the difference between an anecdote and a bona fide result. I think that in the world of CAM, just as in the world of traditional medicine, though I really don't like any of these words very much, I think that is not different. There is good science, and there is not-so-good science, and then there is non-science. I think that insofar as we can, we should want to foster good science, because that is what will lead to good health. DR. GORDON: I have a question or two. I am wondering, when you looked over the work that is being done at NIH, was there questioning of the balance that you describe here between basic, applied, and developmental research, and whether or not that meets the needs of the public, and whether the public input is continuing to justify that kind of balance? DR. ROSENBERG: Yes. We looked hard at the various divisions. We asked about the NIH's estimates of what fraction of its budget was for basic research, what for clinical research, and so on. I think we ended up saying we didn't think that that was Congress had really asked us to do. It didn't ask us to say whether there was too much clinical research or too much basic research. We felt that if you take a look at the overall improvement in health that has occurred through the NIH system over the past 50 years, the investments in basic research have been enormously important, as have the investments in clinical research. So I do not think the Committee ended up feeling that it needed to send a message that there was too much of this or too little of that as a fundamental issue for the NIH, and my own opinion is concurrent with that. DR. GORDON: One other issue that is related to that. A couple of the examples that you give in the report, which I enjoyed, and actually it was bedtime reading for me. I really was very glad to have a chance to read through it. A couple of the examples you gave were of some very important basic research projects that were government funded that then lead to the development of patentable drugs by private industry. What are the issues that we face here? I think one of the tasks of this commission, especially in the area of research is that many of the approaches and interventions of CAM or of an integrated approach to medicine are not patentable. I am wondering if you dealt with the issue of, given that these are public funds that are being spent on research, whether there should be a shift in the direction of those approaches that may not be patentable, whereas much of the basic research now leads to interventions that are patentable. DR. ROSENBERG: Well, Dr. Gordon, I think it is precisely on this point that many people, and I am one of them, feel that NIH should have a larger portfolio of clinical research directed at answering questions concerning modalities that are not going to be patentable and that will not have their research paid for by biotech or pharmaceutical or drug device industries. I think that that is why we can point to the enormous importance of the NIH study on aspirin years ago with regard to preventing coronary disease, and why I think the studies on St. John's wort and glucosamine and chondroitin sulfate are exactly in that same zone. There are certain things that will not be sponsored by the for- profit world, and they should be an important product of publicly supported funds. DR. GORDON: Great. Thank you very much. Wayne, you had another question? DR. JONAS: I just had one other thing. It sounded like the Committee was fairly universal, but I am wondering if there were some minority opinions about the wisdom of further centralizing and recommending further centralization of the prioritization and funding process, first in the NIH, and second, even more so in the responsibility of the director of the NIH. This is, I know, a very difficult thing because you always want to bet a winning horse, and I think everybody said, well, NIH is doing good, so we ought to give it some more. I have used and actually loved the prioritization document that was used, and used it for developing our own priority plan. So I think it is very good, but there is a risk in that, and I am wondering if that was discussed at all with the committee in terms of getting too unbalanced in, not only research directions, but types of research and domains of research. NIH is extremely focused, for example, on basic science research. Not in the area of complementary medicine, however, but in general, and providing more input from other agencies that also do important research for the public health. I mean, was this something that was discussed, the risks of that type of thing? DR. ROSENBERG: Wayne, it was discussed, not in great detail, but certainly in passing. It was why the Committee felt uniform in wanting to start out our report by saying NIH has been a remarkably successful federal agency, and when you have a remarkably successful federal agency, you take care of it, because not all of them are. So that was the bottom-line view of the Committee. There were many people who were concerned about what would happen to NIH as its budget goes up even more. We had the view, I think, that the only way you can tell anything about what is going to happen in the future is how an individual or an institution has done in the recent past, and we had the feeling that NIH in any way has fallen apart as its budget has grown. That doesn't mean it doesn't have plenty of problems, because of course it does, but we felt that on balance it can be an effective steward of these larger budgets. On the other hand, and now I will just editorialize here, I do not think that it is in the best interest of the American public that such an enormous fraction of the federal commitment to health research be at the NIH. That isn't to take money away from the NIH. It is to see to it that there are larger budgets for the Agency for Health Care Research and Quality, for the CDC, and for other named entities in the federal establishment. DR. JONAS: Just a very short question. DR. GORDON: Sure. DR. JONAS: Was there a discussion in the panel about complementary medicine and its role in this prioritization process? Did the topic come up during the discussion? DR. ROSENBERG: Yes, it did. If you look at the composition of the Committee, I think you could see the people who would almost be the voices for bio-behavioral, for sociologic, and for alternative medical approaches. We heard about it, and I think we paid attention, but we did not view CAM as a thing apart. DR. GORDON: Thank you very much. Effie, and then Tom. DR. CHOW: I agree that NIH has been doing a terrific job, and also, it needs more money in the research area. My comment is that, as shown up in the Town Hall Meeting, our first and only yet, in San Francisco, was that there was a lot of concern, and voices my own concern, too, is that the research protocols are inadequate to measure CAM, not only the practice, because it is theoretical as well, and as George said, it is behavioral. So perhaps there needs to be additional budget to really explore research protocols and instrumentation. We have instruments such as thermography and biofeedback and Kirlian photography, et cetera, right now, but that is also questionable, whether that is picking up the proper subtle energies that is being utilized in healing right now, or Chi, or Qi, or bioenergy. So I just want to throw out, perhaps NIH could take a look at, strongly into other than just biomedical research. What about field research? There was a strong research, emphasizing that part, and strengthening the protocols for that, and ground research and all. So CAM, I am afraid if we put it into the medical science model of research, may eliminate some of the benefits that CAM has proven, being able to practice. DR. GORDON: Effie, excuse me. Do you have a question? DR. CHOW: Well, I guess I am making a comment about focusing, perhaps, some of the direction in exploring alternative research protocols. DR. GORDON: Tom. MR. CHAPPELL: Thank you, Dr. Rosenberg. Do you think that the promotion of health versus the prevention of disease, as is described in the mission of NIH, can really hold its own in the prioritization process, or is the make-up of the whole NIH in its orientation, so disease-oriented, that we are really asking for a elevation of a point of view that is just altogether too difficult for the context to consider? I think you understand the fullness of my -- DR. ROSENBERG: I do. I do, and I wish to tell the Commission that this matter was explicitly discussed at our committee on more than one occasion, this distinction between prevention and health promotion. I think, though we had a very lively dialogue on the question, we came to the view that if we had turned the clock back 25 years and asked about NIH in terms of its interest in prevention as opposed to cure, we would have said the same things about prevention that you are now saying about promotion. That is not a criticism of what you said. It is a statement that time has moved on, that medicine has become much more oriented toward preventing disease than it was a quarter of a century ago. I believe that medicine will become, and health practitioners in general, will take a greater view about promoting health and all that goes on with that as time goes on, as we move more and more toward living long lives without as much focus on interspersed episodes of illness. MR. CHAPPELL: I guess, then, I hear you saying the benchmark is still disease. Even though prevention is a point of view, the benchmark is still disease because prevention is a point of view toward disease. It is not necessarily a point of view toward wellness. Wellness is the benchmark we are concerned with as well as prevention of disease, and they can be different metrics. DR. ROSENBERG: It is probably a dialectic discussion that we can't achieve in 1 minute and 35 seconds. MR. CHAPPELL: Sure, but it is still worthy of raising, I think. DR. ROSENBERG: Yes. DR. GORDON: We have time for one more question. Charlotte. MS. KERR: Doctor, thank you very much for your presentation. I want to say, first of all, your study, to me, and your report, was very clear, wonderfully clear. Just to restate the mission, as you said, that the NIH was to uncover new knowledge for the better health of everyone. I think it is true to say that at least there were two offices that were created and have moved on, the Women's Study Office and Alternative Medicine Office, as a result of intervention of members of Congress, predominately. Now, in light of your major recommendation, which I understand to be the creation of the Director's Council of Public Representatives so that there would be more input by the public, is it your assessment, or would it be your assessment, that those two offices, for example, of Women's Health and Complementary Medicine, that they were not created out of NIH itself because there was not enough input by the public? My point is that your solution and your assessment seems to be that the lack of public input would not have allowed something like this to be created on its own outside of NIH. How will this be such a major solution to bring forth the new creations of what is needed to improve the health of America? DR. ROSENBERG: I think you are implying that we thought that the COPR would solve all the problems, and certainly, I do not think that is true. We put it forward as an element of how the director of NIH, and how the Institute directors couldn't get input, could hear from more voices than they have up to now. I believe that is happening, and I believe that many people at leadership positions think it is a good thing that it is happening, but does that mean that I feel that it will replace the need, from time to time, for new organizations to be established by whatever means? I am not naive enough to think that Congress is going to leave all of its prerogatives to COPR, or to the offices of Public Liaison, or to anyone else, nor should they. I believe that the more opportunities there are for people to have their voices heard at NIH, the better it will be for the NIH, and ultimately for the health of the public. DR. GORDON: Thank you very much, Dr. Rosenberg. We really appreciate your coming and sharing your perspective, and the work that your committee, for the IOM, has done. We hope we will be able to be in touch with you and ask for your thoughts and advice as we move ahead. Thanks again. Do you want to call the next panel, Michele? MS. CHANG: If Dr. Jeffrey White and Dr. Claude Lenfant, Dr. Marvin Cassman, Dr. Steven Hausman, and Dr. Paul Coates could come to the speakers table, please. DR. GORDON: Thank you very much, all of you, for coming this morning. Each of the panelists will have 10 minutes, and then we will have about 40 minutes to ask questions, so 20 minutes only to ask questions. Is that right? MS. CHANG: Yes. DR. GORDON: All right, only 20 minutes to ask questions. So please, when it comes time to ask questions, would everybody please adhere to asking questions on the Commission. You can frame it with a couple of sentences, but we had a lot of time for Dr. Rosenberg. We are not going to have as much time with subsequent speakers to ask questions. So everybody be concise and interrogatory. The first speaker will be Dr. Jeffrey White -- welcome -- from the National Cancer Institute. Session II: Federal (NIH) Support for CAM Research DR. WHITE: Good morning, and thank you for the opportunity to discuss the NCI's perspective on the challenges and potential of complementary and alternative medicine in cancer research. I also extend greetings from the National Cancer Institute's director, Dr. Klausner, and the deputy director of extramural science, Dr. Robert Whittas [ph]. I am the director of the NCI's Office of Cancer Complementary and Alternative Medicine. The office was established in October of 1998, and has four main functions: first, to coordinate the NCI's growing number of CAM activities; second, to provide liaison to the National Center for Complementary and Alternative Medicine; third, to develop and implement an institute agenda in CAM; and last, to provide the NCI an interface with the general public in the CAM and conventional practitioner and research communities on these issues. As requested, I have provided a brief summary of NCI's current and planned CAM projects. Given the limited time, I will not be able to elaborate on them during my presentation but will be glad to respond to questions. Prior to addressing the specific questions posed in the invitation letter, I would like to state, up front, some principles we applied to developing NCI CAM initiatives, and then briefly, some challenges of CAM research. The determination of value for both conventional and CAM modalities needs to be evidenced-based. The same standards of evidence must be applied to both to CAM and conventional cancer research. Also, the principles for determining priorities should be the same as in conventional research, that is, credible evidence, testable hypotheses, quality of the science, availability of the necessary resources and potential to advance the field. However, since CAM is already in the practice arena, those methods that are more heavily used by U.S. cancer patients may be somewhat of a higher priority, the challenge of CAM research. CAM practices a loose association of modalities, many of which have few features in common. Consequently, thinking of CAM as a single entity is at times useful, and other situations may lead to dysfunctional solutions. For example, the same mechanism to support research for a well standardized herbal product may not be suitable for increasing research for a diet therapy used by a single practitioner. CAM regimens are often very complex and individualized. Consequently, these approaches are difficult to codify into protocols and transplant to clinical research settings. Many approaches lack uniformly accepted standards of practice, and therefore a study of one approach may not resolve the issue of efficacy. It is difficult to obtain meaningful preclinical information for certain CAM interventions, for example, complex, multi-modal interventions. So strategies to increase CAM cancer research will need to address many of these challenges. Some challenges common to CAM and conventional cancer research. Conventional cancer research is beginning to evaluate more therapies that are not directly cytotoxic, but rather have potential for slowing the growth of the malignancy or inhibiting its spread to other sites. Traditional clinical trials, designs that focus on tumor regression, may be less informative about potential efficacy of such therapies. Controlled studies assessing survival and quality of life may be more appropriate. These trials are more expensive and time-consuming, and often require complex logistics. At the same time, the percentage of adult cancer patients entering clinical trials is low, in the range of less than 5 percent. Secondly, the dependence on survival as the most significant end point of comparative cancer trials lengthens the evaluation process. Validated intermediate end points of clinical significance are needed to allow more rapid screening of modalities for potential efficacy. I mention these common challenges as areas of potential investment to increase the rate of evaluation of CAM therapies. I will spend the remaining time addressing the areas of particular interest described in the letter of invitation. I hope my use of examples will help illustrate certain points without implying the specific case is applicable to all forms of cancer research. I will be glad to expand on any of these points in the response to questions in the discussion period. It is important to note that the NCI's approaches to promoting and supporting CAM cancer research are being designed to attempt to capitalize on some of the strengths of our programs, for example, the NCI's designated P-30 cancer centers and cooperative clinical trials groups, and therefore may not be applicable to other disease types and other NIH institutes and centers. The question of potential contribution of CAM perspectives and approaches to conventional biomedical research. Some CAM approaches purport to promote the general health of the patient, rather than to directly impact the growth of cancer cells. Similarly, many systems within CAM advocate caring for the whole patient. This includes aspects of the patient's physical, psychological, and spiritual health, and can even extend to the patient's family and other support systems. This broadening of the focus away from the completely disease-focused approach is admirable, but appears to be diminishing in conventional medical practice. The potential for these approaches to improve the patient's quality, and possibly, quantity of remaining life should be more fully examined in cancer research. Other perspectives and approaches worthy of being investigated may come from the CAM community. We are endeavoring to open communications on these issues with the CAM practice community via the Best Case Series program, which is discussed in the materials I have provided the Commission for review. The question of overlap between CAM and conventional research. Much of CAM cancer research is closely related to conventional cancer research. Consequently, every effort should be made to grow CAM research in ways that access the resources of the larger and more research-savvy conventional community. There are several areas of overlap between CAM research and conventional biomedical cancer research, and I will briefly discuss five. First, nutrition. There is a growing awareness of the importance of nutrition in cancer prevention. Also, the therapeutic use of diet modification in cancer patients is slowly entering the conventional research realm, for example, low fat diet interventions in breast and prostrate cancer to prevent recurrence or progression. Research is in progress to assess cancer prevention potential for micronutrients, such as selenium and Vitamin E. Where does conventional diet research begin and end? Certain types of dieting, cancer interventions might be readily accepted as fitting the definition of CAM, whereas others would engender more debate in order to be uniformly designated as non-CAM. Reasonable people could disagree on the dividing line between CAM and conventional nutrition research. The analysis of plant and animal products for medicinal agents; what is CAM and what is conventional. Much of the work with such products could be considered CAM- related. Researchers doing conventional natural products work would be appropriate collaborators with herbal therapists to investigate the laboratory and preclinical activity of herbal extracts, and then providing quality control standards for clinical-grade products. Mind-body medicine. Behavioral research is expanding at the NCI. Recently, it established a behavioral research program in the Division of Cancer Control in Population Sciences. Support group interventions are components of the grant portfolio of this and other NCI programs, and certain of these interventions under investigation are CAM-related. Immune modulation is another area, as is symptom and side-effect management. These areas and others represent potentials for a collaboration between practitioners and researchers, as well as CAM academics and conventional biomedical researchers. NCI CAM programs are designed to encourage collaboration between these communities. However, we must recognize that there is a two- culture problem, both between practitioners and researchers, and between CAM and conventional paradigms. Therefore, we need to provide opportunities and resources that foster communication and collaboration, which hopefully will lead to a greater degree of mutual respect. Expanding federal efforts to research CAM. The NCI has implemented several programs to bring CAM products and practices into mainstream biomedical research. One example is the Best Case Series program which provides an avenue for CAM practitioners to present documentation of an effective CAM cancer therapy. We have recently implemented an aggressive advertisement program to increase the awareness of this opportunity among CAM practitioners. The Best Case Series program can expand if there is sufficient interest and commitment by the CAM practitioner community. Obstacles and possible solutions. The research community needs to see consistent support for specific fields of biomedical investigation. We must also encourage excellent individual researchers in institutions to enter the field. However, there is both the perception and reality of a limited potential for respected and vigorously supported CAM career in research for a CAM topic. Time is needed, and resources, to demonstrate a sustained growth potential for the field and consistent opportunities for funding. Both CAM investigators and CAM-knowledgeable conventional investigators are needed. I could cut my comments off at that point. DR. GORDON: Thank you very much, Dr. White, and thank you for your and NCI's leadership in this area. We will have plenty of time. I am sure we will be coming back to you for questions, to talk about some of the ways you have made it possible for CAM to come more into the NCI. The next speaker will be Dr. Claude Lenfant. DR. LENFANT: Thank you very much. I have submitted to the Commission a number of examples of our activities in complementary and alternative medicine. I would like to focus my remarks in response to the questions that were in your letter, although I have to say that many of the things that I felt like saying have actually been said by Dr. Rosenberg, and so I will perhaps amplify some of the viewpoints and the issues that he brought up. The first question in your letter is quite an interesting one, which is, what is needed to expand current federal effort to bring CAM products and practices into the mainstream of biomedical research. To me, that is probably the most important question that is before you and before us. When we look at the evolution of medicine and the mainstream of medicine, we have to go back where it starts. For example, if you look at something which is part of conventional medicine, such as nutrition, for years nutrition was ignored and disregarded by so-called conventional medicine, and it began to be in favor when it became part of medical education. Likewise, prevention, that was mentioned earlier, the mainstream of medicine has ignored prevention and preventive interventions for years, and largely because it was not really taught in medical school. My feeling is that one of the greatest hurdles that is facing the introduction of what is called complementary and alternative medicine, which, incidentally, was pointed out to me earlier, is a bad term, and I have to agree with that because it creates something different. Therefore, it is more difficult to fully use. A fact, that as long as Medicare education will not touch on the issue of what is today defined as complementary and alternative medicine, will be terribly difficult to bring it into the mainstream of practice. I also think that it will be very difficult to bring it into clinical research, because the questions just don't come up as easily they should. So it seems to me, that the issue of education and the training of investigators are very important issues to bring forth what is today called complementary and alternative medicine. The second point that I would like to make has to do with how we set our priorities and where this approach to medicine, complementary and alternative medicine, fits into a priority-setting organization like ours. I am sure I need not to tell this commission that the public has problems that we are concerned with that are enormous, involving a large number of patients, individuals, likely to develop the conditions which are of interest to us. As was quite correctly pointed out by Dr. Rosenberg, no matter what the extent of our resources, they are never enough to do what everybody wants to do. During the last few years we have seen a considerable increase in our budget, but the demands for the budget grows much faster than the budget itself. So we have to set up priorities, and I think that the input of the public is indeed very important, and perhaps, I should say, very significant in our activities. The work of Dr. Rosenberg has been, I think, extremely important and useful to us, and we have since adopted a practice to consult with the public and all the interest groups which have interest in some of the conditions that we have. The public voice of alternative medicine is not yet heard very well. I think that the various interest groups which would like to foster more work in alternative medicine, perhaps, should bring themselves to -- so that we hear more from them. It is interesting to me that once or twice a year we invite to come to our institute, speaking to our National Advisory Council, or representatives of our Council, I should say, to come once or twice a year. No one from this community has yet come forth to express their views, and I think that is something that needs to be done. Now, the main role that I think that the research enterprise can play with regard to complementary and alternative medicine is to validate whatever comes forth, the ideas, the suggestions. The validation of such possible therapeutic interventions is very difficult and requires some scientific rigor that as yet does not exist in that field. I think the reason is what I mentioned, that basically there is no education about it, and the people who are largely interested in these concepts, these ideas and the possibilities, are not researchers, are not people who are brought into that. I really think that is the problem that needs to be solved if we want to be successful in fostering more activities, and more importantly, more applications. That brings me to the last point that I want to make. When we seek to validate something, an intervention, because the demand exceeds what we can really do, we set some criteria as to how we are going to decide what needs to be done. There are basically, from our viewpoint, three important criteria. The first one is, that it is an issue of great public health, public importance. The second is doing what needs to be done, affordably. That may sound as a strange criteria, but it is an important one in the real world. The third one is, what will come from this validation being applied, and can it be generalized. These are very important questions. I have to say that when we want to apply this criteria to a question of complementary and alternative medicine, it is very difficult to provide a positive answer to all three criteria. So I will leave my comments here. DR. GORDON: Thank you very much, and thank you especially for addressing the questions that we posed. We really appreciate that. Dr. Marvin Cassman. DR. CASSMAN: Thank you very much. Thank you for inviting me. When Dr. White says he is from the Cancer Institute, and when Dr. Lenfant says he is from the Heart, Lung, and Blood Institute, it is immediately obvious what the broad goals of those institutes are. When I say I am from General Medical Sciences, nobody really knows. That is quite understandable because it doesn't really mean anything. The purpose of our institute is to try and understand the fundamental properties of biological systems, and that is usually using the tools of chemistry, physics, mathematics, and generally operating at either the molecular or the cellular level. Now, with regard to the interest of this meeting, that may put us a bit out of the range of your primary interest. Dr. Rosenberg said, and I think I agree with him, that at this point in time, clinical research is the heart of CAM and we don't do any clinical research, or, actually a very little amount, and I am not sure I would even call it clinical. So in fact, the systems, the biological systems with which we commonly deal, are non-mammalian systems. The well-known fruit fly, and the yeast, and so on. So the question, then, obviously arises, of what relevance is all of this to CAM? Indeed, at the present time, our investment in the areas related to CAM is pretty minimal. We are currently providing partial support to one of the centers, Centers for Dietary Supplements. I think Dr. Coates is going to be talking about those centers later on. We are investing in one of the projects in one of those centers. It is not a large investment, obviously, compared, certainly, to some of the others that you have heard and will hear around the table. So, what is there that could be of interest? There is one aspect, and I will just go into it briefly. One could argue that much of the fundamental research in biology over the last 40 years is putting things into bins, understanding the molecular mechanisms of biological systems, breaking them down into their components, as you would strip a car down into its individual units, understanding how they operate and what they are. That is where we have been. That is where we are, for the most part. We are now trying to put it back together again. There are lots of different ways of doing this. One of the ways is trying to understand how systems operate in time and space. After all, biological systems are not static. They respond to their environment and they interact with each other. So over the last two and a half years, in particular, we have begun programs aimed at something that I would call complex systems. This is an area which is fairly broad. It goes well beyond biology, in fact. It is sometimes referred to as the study of interacting systems that result in emergent properties, that is, the systems are not necessarily the linear combination, that is, the properties of the system cannot be considered as the additive combination of their individual components. I don't know, really, how true that is. Certainly, there are aspects of interacting systems that seem unusual relative to the individual properties, the individual mechanisms of the systems, but that doesn't mean they can't be understood in terms of their mechanisms and/or interactions. A simple example is that there are oscillating components in many biological systems, and they oscillate in a sine wave. If you have two of these and they interact together, and they are in phase, what you get is another sine wave. If they are 180 degrees out of phase, what you get is a straight line. The straight line doesn't look like the sine wave, but that doesn't mean that you can't understand it in terms of the properties of the elements that are involved. You just have to understand how they interact. We are in a very early phase of all of this. It is extremely complex. Not all of the tools have yet been developed. We don't really know necessarily how it is going to evolve, and right at the moment we are keeping an open mind as to the kinds of approaches that are going to be most appropriate in dealing with this next phase, I think, in the understanding of biological systems. There are a lot of different opportunities to do that and, in general, they still will require a basic understanding of the properties of the systems. You need to have measurable quantities that one can evaluate before you try to assess how systems operate. That involves, obviously, the interaction of many disciplines, and we are trying to bring other areas of science in even closer contact than they already are with biology to ensure that we can get a useful synergy out of all of the contributing individuals and disciplines and fields that are involved. I think that is really about all I can tell you at the moment, but I will be happy to answer any further questions. DR. GORDON: Thank you very much. It is actually very exciting to hear, especially about this new research interest. I think that a number of Commission members will want to ask you questions about it. Our next speaker is Dr. Steven Hausman. DR. HAUSMAN: Thank you very much for inviting me to speak. I am deputy director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Complementary and alternative medicine poses, I think, a rather special challenge for our diseases. We typically characterize them as consisting of the four C's: chronic; common; costly; and crippling. The problem with the chronic disease, especially with arthritis and the various forms of arthritis, is that they wax and wane. They are chronic. Conventional medical therapy finds it difficult to deal with many of these things, and when conventional medicine finds it difficult to deal with these things, then alternative methods of therapy tend to come about. People want to be cured of their disease, they want to be free of pain. In many cases, that is not possible. They try all sorts of things. I would only point out the use of gasoline and WD- 40 for the treatment of arthritis for many years. In some cases it worked because, naturally, the arthritis, of its own, tended to go away periodically, and occasionally people tended to associate that with the use of these alternative therapies. Copper bracelets are another thing. Our institute has been involved in complimentary and alternative medicine, although I guess we didn't call it that for many years, starting back even before we evolved as an institute, when we were a division of another institute in the Multi-Purpose Arthritis Centers Program. The Centers Program was responsible for funding what was known as the Arthritis Self-Care Program. This program really taught patients how to deal with their own disease. It was a wellness promotion program as well. It has been disseminated in recent years throughout the United States and throughout the world. The program is actually rather effective, and in many cases was shown to be equally effective as many of the drugs used for arthritis. More recently, we have been involved in osteoarthritis treatment, carpal tunnel syndrome, pain management, low back pain. I will probably get into those. We have worked closely with the National Center for Complementary and Alternative Medicine in the study that was mentioned earlier by Dr. Rosenberg in studying the efficacy of glucosamine and chondroitin sulfate. We decided that that was something that needed to be done. That has now been taken over by the NCAM. We are still working on it, actually, in our Contracts Branch. We have a new scientific director that leads our intramural program. He is a renowned rheumatologist and has been involved in conventional therapy, practices, and treatments for many years, but he also studies something with a fairly exotic name called thundergod vine, which is a Chinese herbal treatment for inflammation for rheumatoid arthritis, and it might actually be used for other conditions in the future. The area of low back pain is one that is especially amenable to approach. Low back pain is a chronic disease, a chronic ailment. Probably nine out of 10 people around this table have had it in the past, if not more. It causes many hours of disability, low productivity, pain, suffering, reduced quality of life. I think there is a vast opportunity to use regular and non-conventional modalities. We are currently a multi-center, randomized clinical trial on low back pain which is comparing conventional treatments versus some other treatments, including acupuncture. Let me address some of the questions that you posed. The first one, about expanding federal research. I think the existing mechanisms of federal research support can be used by CAM as well. These consist of, obviously, research grants, training mechanisms, and so forth. I think researchers trained in CAM areas could profit by receiving training in conventional research methodologies. This, in fact, to address Dr. Chow's question, would make them less fearful of getting into the system. You need to work with the investigators to get into the system to know how it works. In terms of the overlapping areas of research, I would point out that "Arthritis Today," a magazine published by the Arthritis Foundation, did a survey several years ago. They surveyed patients and primary care physicians. They found that 78 percent overall were interested in alternative therapies. This was even though 84 percent of the patients were seeing a rheumatologist and 89 percent of the patients were taking prescription drugs, which indicates, to a certain extent, that they perhaps were not working quite as effectively as they could. The patients' favorite therapies, other than Bayer aspirin, were prayer, meditation, glucosamine, magnets, metal jewelry, Qigong, Tai Chi, and so forth. Physicians actually recommended other therapies as well. Their favorites were capsation, which actually has been shown to work, biofeedback, meditation, yoga. They advised against, however, megadose vitamins, fasting, DMSO, copper bracelets, bee venom, and so forth. In most cases, we would be hard-pressed, in fact, to find any evidence, either pro or con, for many of these treatments. There are actually probably relatively few studies that would indicate whether heat or cold is better for some cases. These things need to be done. Clinical research is something that is paramount and absolutely necessary in the area of complementary and alternative medicine. If that is not done, then anything beyond that going into mechanisms will not be able to follow. Additional areas of opportunity. I have mentioned some of those, including the placebo effect is one. There is going to be an NIH conference on this coming up relatively shortly. There is the opportunity to test some of these interventions by existing mechanisms, such as the Small Business Program. Some things that have already been tested or are underway are things like topical aloe vera for skin conditions. I suspect that that is one of the most commonly used substances. You find it in everything from hair shampoos to skin creams, and so forth. Does it work? I don't know. People have aloe vera plants on their shelves and window sills, and they put it on cuts, and so forth. There are Chinese herbal teas for eczema, there are devices that can be used to increase bone mass, and there is some evidence that they, in fact, do work. Standing on a plate with a low vibrational frequency can, in fact, seem to increase bone mass. All these modalities have to be tested, however. What are some of the obstacles to the solutions? Well, obviously, validated evidence obtained, probably, through clinical trials. I suspect that few physicians would be willing to implement a new therapy without evidence of its effectiveness. You need more research in this. There is another, though, psychological aspect, and that is the reluctance of established investigators to even consider doing research in this area. One of the areas that we deal with is fibromyalgia syndrome. Many years ago, in fact, 15 years ago, fibromyalgia was not even recognized as a clinical entity. The American Rheumatism Association did, in fact, about eight years ago, establish diagnostic criteria. Several years ago, we convened an interdisciplinary workshop which brought mainstream investigators together with investigators from outside the field, people who had never been involved in any of these areas dealing with fibromyalgia, sleep research, neurological research, and so forth. We have gotten a number of very interesting projects, which are a little bit too soon to know if they will bear fruit, but that is the typical way to bring people into the field, interdisciplinary workshops, conferences, coming up with research recommendations. I guess, one thing I would have to stress is collaboration, collaboration, and collaboration. It is not going to work otherwise. One area can't do the research on its own. Another potential issue that might be an obstacle is a new policy regarding Medicare reimbursement for Medicare beneficiaries in clinical trials. There is a presidential order indicating that Medicare beneficiaries would receive reimbursement for those things that, in fact, are things that normally would be paid for by Medicare while the patients are in clinical trials. However, it is my understanding that the law will not pay for things that are excluded. Many complementary and alternative medicine modalities are not included in this. This might, in fact, provide a somewhat small obstacle, but obstacle nonetheless, to their participation. Our diseases are diseases also of the elderly, people who are elderly on Medicare. So you are talking about obstacles there. Finally, let me talk about the role of the public. It is clear there is a role of the public in setting research priorities. As a part of the entire mix, people should be invited to give their views, just as they are going to testify before the Commission. I will be happy to answer questions. DR. GORDON: Thank you very much, Dr. Hausman. We appreciate it. The next speaker will be Dr. Paul Coates. DR. COATES: Good morning. Thank you for the opportunity to speak with you today. One of the great things about being last in a panel such as this, is that pretty much everything that I wanted to say has been said. So my first remark is, I endorse it. I think you have heard about a lot of exciting possibilities that are already in existence at the NIH, and that we are thinking about other ways in which to accommodate the important needs of the CAM research community. Our office, the Office of Dietary Supplements, was created in the Office of the Director in 1995. I became director last year during a period of considerable growth. We have an exciting array of programs that we think can be useful to the community of scholars in complementary and alternative medicine. I think the biggest one, certainly the one that gets most of our attention and most of our dollars is the botanical or Dietary Supplements Research Center Program, to which Dr. Cassman alluded briefly. Let me use it as an opportunity to tell you why I think it is one of the ways to answer Question 1, which you developed for us. What is needed to expand efforts? It is interdisciplinary. No. 1 addresses an issue that Dr. Hausman just alluded to, the collaboration component. We think that this is an important way of developing important scientific evidence about botanical and herbal products that are used in quite common practice. The nature of these centers is such that we require quite a range of disciplines to be represented in a successful center, ranging from botany and pharmacognosy to physiological science, all the way to clinical science. We feel it is the combination of those things and the synergistic effect that you get when you have people from different disciplines approaching a common problem, where we think we are going to get the most excitement, and hopefully a lot of bang for the public buck. We couldn't do it ourselves. The initiative for this Centers program emerged from the Office of Dietary Supplements with some recommendations from Congress. I think it is important for people to note that that is a way to make your voices heard. We shaped this in collaboration with our other partners at the National Institutes of Health, largely in CAM, but we also enjoyed the participation of a number of other institutes and centers, in both the planning and in the funding of these centers. We now have four such centers that deal with different, we believe, overlapping but very different, approaches. The thing that you ought to know about is that these centers are designed to be interactive and to feed off one another so that at a number of levels, we feel as though we are going to be able to see the benefit of this sort of interaction. So that is one example. There could be others, but I will use that as my example of how I would like to think that we are contributing to expanding the federal effort to bring CAM products and practices into the mainstream. We will, obviously, keep checking the pulse of this program and see whether this is where we need to be investing further resources and effort, whether there are checks along the way that we need to be sure about. It gives me the opportunity to actually jump to your Question No. 4: What additional areas of opportunity exist for research on CAM intervention? It seems to me that those opportunities are almost limitless. When I think about the area of dietary supplements, a modality that is frequently used in CAM practice, our interaction with you is a big one. It is not all that we do, but when I think about the area of dietary supplements, they are in common use. It makes it a bit of a challenge to decide how to approach the science of dietary supplements, but at an absolute minimum, we feel as though there needs to be evidence for their use. How that evidence is developed, it depends a little, but we would like to have you recognize that, from our point of view, from the point of view of the Office of Dietary Supplements, those that are used in complementary and alternative medicine practice are the same. We approach them the same way as we do those that are used in other practices, that there needs to be an evidence- based approach to their use. It seems to me, that consumers, health professionals and, indeed, the dietary supplements industry will benefit from such a systematic approach to evaluating and, if necessary, developing the evidence for efficacy and safety of dietary supplements as they are used in this country. Finally, I wanted to mention something about the obstacles, conceptual and otherwise, and possible solutions to accomplishing the goal of integrating CAM products and practices. There is a suspicion that I think would be very nice to overcome. The suspicion that is not necessarily shared by everybody, don't get me wrong, but the suspicion that evidence to support the use of some traditional CAM practices is outside of the American medical paradigm and, hence, doesn't qualify. Likewise, the feeling, on the other hand, the products and practices that are in traditional use don't need to be evaluated in this manner because of their long history of use. There is an opportunity to see those impressions merge. It is something that I live with every day in my position as director of the Office of Dietary Supplements. I am not finding it insurmountable. It is, however, a challenge to our communication. It gets back to the issue of partnerships. I spoke briefly about the partnerships that we have developed within the NIH. That is part of why our office was created to encourage and coordinate research activities around our area of dietary supplements. We think that those partnerships can be expanded to include other organizations, the not-for-profit organizations, the private sector, including industry. Examples of this, from our point of view, include the fact that we co-sponsor workshops and conferences with the private sector, in areas where we think that the development of new knowledge will be important for all concerned. Likewise, we partner with other organizations to support conferences, not just within the NIH, but also internationally, such as next year's International Scientific Conference on Complementary Alternative and Integrated Research. Same month, also the International Society for Technology Assessment in Health Care. We would welcome the opportunity to hear your views about where our programs are going because they are such an integral part of where you are going. Thank you. DR. GORDON: Thank you very much. Before we get into questions, I just want to thank all of you for coming. You are all, I know, extremely busy, and I thank you for coming and sharing with us, not only your programs, but your perspectives. I regard this as an important step in the dialogue and the collaboration that we are trying to expand. Let's go around. Who would like to begin? DR. ORNISH: I also want to say how much I appreciate everyone coming here and how grateful we all are. The NIH budget in its various forms, and the different divisions and ventures that you all represent, there is so much evidence showing that behavioral approaches, mind/body approaches, alternative medicine approaches, things like that, play important determinants in health and well-being, and yet, the relative amount of the NIH budget in each of the different branches, a relatively small percentage of that, is going to these kinds of approaches. Each of you has talked about the importance of doing good science. I certainly completely agree with you, and yet, good science is dependent on adequate funding. I know the budgets for the NIH have been increased substantially and are going to be increased even more, but the relative ratio of how those budgets are spent doesn't seem to be changing. I am just wondering, do any of you have any thoughts about whether that should be changed and, if communication, how? DR. COATES: Let me take a crack at it. We have noticed in arthritis that the number of projects being submitted in that area are increasing. I think our program staff have to work with the applicants to make sure that the projects that are submitted are high quality. We, in fact, have just hired a psychologist on our staff to work with those applicants and to increase that area of research in our program. So that is one step you can take. Another step, of course, would be to have more workshops and conferences that bring that aspect of it into play. The Arthritis Centers program has had a number of psychosocial studies throughout the years. Things like that are useful and have proven their worth, I think. Health services research in arthritis is something that didn't exist 20 years ago and now has its own journal or two. DR. LENFANT: Dr. Ornish, I am sure you know that the world of behavioral medicine was actually invented in our institute. It preceded the creation of the Society of Behavioral Medicine by a few years. We do increase, actually, this component of our program quite significantly. Perhaps not for something that relates directly to what you are interested in here, but is quite relevant to it, is that we can come up with all the best prescriptions and ways to treat patients, but unless they comply and adhere to the prescriptions given to them, nothing is really going to happen. One thing that we see, certainly, in many other areas of medicine is the ever-increasing gap between what we know and what is applied and used by the patients, and therefore, that is the reason why we focus so much on adherence and compliance research. DR. GORDON: Do you have any thoughts, while you are discussing that point, of how we can make more of what we know in this field, in complementary and alternative medicine, behavioral medicine, available to patients, what role your institute or others could play? DR. LENFANT: Yes. Once interventions are validated, there are a number of educational programs, which are developed for physicians, and the public as well. One thing that has happened during the last few years is that in the old days, if you want, what physicians were saying was almost the voice of God, and everybody would start bowing and listening, and doing what they said. Today, the voice of the patient is very important, and that is why we, all the time, have a component in public education for some of our activities, because we know that the patients are going to go to the physicians and really engage into a discussion, which, in our view, is going to result in a better dynamic between the physicians and the patients. DR. GORDON: Any other responses to Dr. Ornish's question before we go on to the next one? [No response.] Okay, thank you. Dr. Fair, Bill Fair, and then Joe, and then Tom. DR. FAIR: It seems like every major society meeting that I go to, like the American Urologic, American College of Surgeons, there is always a session for young investigators about writing NIH grants and how to prepare for grant funding. It would seem to me that that would be a reasonable approach, also, for CAM practitioners. I guess I will ask Jeff, are there any of the institutes that have similar programs to encourage grant proposals from CAM practitioners at major CAM meetings as there are at major medical meetings? DR. WHITE: Well, yes. We have twice done exactly what you are talking about, and we certainly now have opportunities to expand beyond that. The two specific situations in which we have done it have both have been at the Comprehensive Cancer Care Conferences, Dr. Gordon's conferences, in 1999 and in 2000. In 1999, we had a session, one of the concurrent sessions and a 2-hour session, in which we talked about NCI- and NCCAM-funding opportunities for complementary and alternative medicine where we had individuals there that were actually describing the process and answering questions, and working with the interested people at the conference, and getting into the process of grant application. In 2000, we opened it up beyond the NIH. Actually, we did it in 1999 also, but more emphasis in 2000 in non-NIH funding opportunities. We brought in the American Cancer Society and the Department of Defense to speak about opportunities there for complementary medicine research. DR. FAIR: I think you need to do this more conventional medicine, also to get more physicians involved in this. The comment has been made several times that physicians are reluctant to use treatment until it has been proved to be effective. I don't agree with that at all. We recently have the example of autologous bone marrow transplantation in women and it is still being done today with no evidence of effect. So I don't think physicians are totally driven by what has been shown to be effective. I think the more information that we can get out to young physicians, particularly to interact with CAM practitioners, that will be the best way that we can stimulate the acceptance of some of these things, as investigational procedures, among the young physicians. DR. GORDON: Thank you. Would anyone else like to respond to the issue of encouraging young physicians or other investigators to do CAM research? [No response.] DR. CASSMAN: I am not going to speak for the National Center for Complementary and Alternative Medicine, and I hope that you will have the opportunity to ask Steve later on. As part of our own role as an office, we feel as though we have an obligation to encourage and support research training in these areas. So it is not strictly CAM practice, but that part of it that relates to our program, we certainly try to encourage people to recognize the opportunities. One way of providing opportunities is by providing funds. As institution, the NIH, over the last few years, has increasingly recognized its role in developing clinical academic careers. This could surely be considered part of that. DR. GORDON: Thank you. Joe. DR. FINS: Thank you all for your comments. There is a population of people who are users of CAM, and that is the dying or the terminally ill. Dr. Hausman talked about collaboration. Indeed, a lot of what your institute is working on could be considered palliative care, and pain and symptom management. I am wondering if you all could briefly comment on the relationship for synergy for the needs of this population, the dying and the terminally ill with the burgeoning palliative care research establishment and those kinds of interests, and their relationship, and whether or not these kinds of issues, palliative care under CAM or traditional medicine, should be explicitly mentioned in your mission statements for your institutes and your respective offices. DR. WHITE: In the mission of my office, we broadly describe it to include cancer patient management, and we mean also survivorship issues in that. I think there are several research initiatives that NCI is involved in that address these kind of programs, most of them not directly through my office but through either the Division of Cancer Control and Population Sciences, and the Survivorship Office there. So there are certainly initiatives, and actually, there is an initiative that is coming out -- Dr. Straus made mention of it -- from the NCCAM, that addresses specifically end-of-life issues, soliciting grant applications in that area. This is an area that we plan to sign on to, to give NCI support. DR. GORDON: Thank you. Tom. MR. CHAPPELL: Thank you. Dr. Coates, could I inquire about the botanical research? Is it seeking exclusive compounds, or does the research incorporate blends of herbs at this point, or are we still looking for evidence of single-herb solutions? DR. COATES: Both of those paradigms exist in the Centers program. Indeed, two of the centers are enthusiastically pursuing the issue about single-active principles and mixtures, with the hypothesis being tested, that mixtures of similarly acting compounds in an extract, for example, may actually have synergistic properties over and above the activity of a single one. I have no idea how that will turn out. This program is pretty new, but I am very enthusiastic about hearing this as an approach. DR. GORDON: Thank you. George, and then Effie. DR. BERNIER: Yes. I would like to thank you all very much for participating today. I have a question for Dr. White. We have learned, in the last few months, of a number of really exciting clinical trials that have been underway and initiated with a combination of the National Center for CAM and the support of the NCI. You have indicated today that there are a number of areas that do not seem to lend themselves to CAM research activity. What do you view as the biggest impediment to expanding the field of CAM clinical research? Is it attitudinal, or is it the nature of the beast? DR. WHITE: Let me just think of some, and then I will see if I can rank them for you. Certainly, there are attitudinal problems or awareness problems, as we have discussed before, about education of what CAM is. There is also the two-cultures problem that I have just alluded to, in which we are basically talking about practitioner communities, often, versus research communities. That is conventional and complementary and alternative. Those are two cultures on some level. If you are talking about taking interventions that are already in practice, bringing them into a research environment, there are several problems. One is that within CAM, a lot of CAM is individualized, either patient to patient, which is a relatively unusual process in clinical research, but also individualized by practitioner. A practitioner of acupuncture may do acupuncture very differently from another practitioner. So finding a way to develop protocols that are uniformly agreed upon by the practitioner community and the research community, I think, that is a challenge. Most of the challenges, I think, develop or can be dealt with by collaborations and by education. I think there is a cadre of investigators out there that are willing to address a lot of these issues. If they are teamed with the appropriate individuals in the practitioner community, I think you will see a growth in the quality of the research. DR. GORDON: Effie. DR. CHOW: Thank you for your innovative kind of comments. I appreciate it. In the 1970s and 1980s, there was a concern about poverty and minority/ethnic programs. I had the pleasure of working with Dr. Lenfant, in that, the Heart, Lung, and Blood Institute had an advisory group on minority/ethnic representatives, and dealt with the problems. I know the NCCAM is doing a great job, but in relationship to your specific areas, do any of you have an advisory group on CAM within your institute? Does the Cancer institute have that? DR. WHITE: I do have an advisory group, an internal NCI advisory group, on complementary and alternative medicine. DR. CHOW: I guess my question is, do you people feel it is feasible to have an advisory group within your institute? I would love to see that because it will bring you closer to the people and the practices. It is such a diversified field of complementary and alternative medicine. Do you see it feasible to have an advisory group? DR. LENFANT: Well, that, I think, is an interesting question. Our view would be that it would probably be a mistake to have an advisory committee just for that, because to me it would amplify the distraction between the so-called alternative and complementary medicine and conventional medicine. I think it would be more useful to bring, which we do, actually, individuals, who have interest in these approaches and make them engage into constructive discussions with others. So the notion of having a committee just for anything that you are interested in is, at least in our area, somewhat counterproductive. DR. GORDON: Yes. DR. COATES: If I can address as well, I agree with Dr. Lenfant. A standing committee devoted solely to that would probably not be as effective as they could, but over the past five years, I can think of probably about 15 different advisory group meetings that we have had, virtually all of which were indisciplinary, meaning they not only working scientists, but members of the lay public in the actual meeting. I think those things are very useful when you are talking about a specific area to get as broad a level of input as possible and our advisory council as well. DR. GORDON: Thank you. I would like to ask a couple questions, and then Wayne, and then Joe, and then Tieraona. The first, is one of the things that we have had a particular focus of, at our Center for Mind-Body Medicine, on cancer. Many, many people call us with questions, both about treatment and research for many illnesses. With Cancer, at the NCI I can speak with Dr. White. There is a Best Case Series mechanism which researchers can enter fairly easily. There is a panel, a CAPCAM panel, which is a combined effort of NCAM and NCI, of researchers, clinicians, members of the public, who are interested in CAM research in cancer. It is much easier, or at least seems much easier, to advance research in the area of CAM approaches to cancer, and particularly with researchers who have never worked with the NIH before. I am wondering if any of the other institutes, or any of those of you who are here, are considering extending more of a hand out into the community. Have you thought about that, or do you have any thoughts about what you are doing? Do you have comparable mechanisms to NCI's mechanism? DR. LENFANT: The Heart, Lung, and Blood Institute, thinking what you started from, which is what I would say behavioral approach is, we have a large program in our institute with 10 or 12 people who are doing just that, and therefore, they have extensive communications with the interested community. If it comes to all the components, which we do not have a special group, but the fact that they can become involved very easily in the discussions which are taking place in the institutes, I have to admit that I am not sure that it is always very successful when you have one voice, or two voices, among 12 or 15 people. It is a delicate balance of all these voices, and it is difficult. That is also true for all the recipients in their approaches. DR. GORDON: Thank you. Anyone else? [No response.] DR. GORDON: One of the things that I would just like to mention is, I think that it is difficult enough, even when the mechanisms are in place, to reach out, to bring first-time researchers in the area of CAM. I just think that all of us, we need to consider mechanisms for ways to bring these people in. The other specific question I had was for Dr. Cassman. What I am wondering is, is attention being paid to some of the fundamental research questions that are raised by some of the CAM therapies? For example, taking a look at something that was discussed earlier, the use of combinations of herbs, the notion of synergy among herbs, or the whole plant product versus an extract, in fact, a synthetic version of an extract of a plant, and also issues related to energy, so- called energy medicine, and looking at some of those phenomena. I am wondering if you are considering those. DR. CASSMAN: Well, to some degree. For example, our involvement with one of the centers is to look at bioavailability issues of how complex herbal systems with multiple components actually find their way through the body to wherever it is they are going, or whether they are excreted. There are technologies that can be used for that. We are certainly interested in that. The extension of natural products chemistry has not been very active recently, but it is an area in this field, particularly, that I think we would have a great interest in. In terms of field issues, let's take the effect of magnetic fields. That is an obvious one, I would think. In fact, there is a great deal going on of that. It just doesn't happen to be in my institute. It is perfectly reasonable, I think, that it is in the Environmental Health Science Institute. There is a lot of support. It has more to do with the organization of NIH than any interest we may or may not have, but because of external fields and their effects, this came largely as an outgrowth of the concern about EMF, electromagnetic field strength, on systems and the deleterious effects of that, but it has extended to other issues as well. As I say, there is a good bit of support in it. It just doesn't happen to be in the General Medical Sciences Institute. DR. GORDON: Thank you. Because we only have a minute left, I am going to take the liberty, and Tieraona is here for the first time and has not spoken, giving her the priority to ask the last question. DR. LOW DOG: What I have been listening to, part of it is about education and collaboration, and about how we get complementary and alternative practitioners into doing research. I certainly don't think we need abandon the control trial in biologics, botanicals. Dietary supplements fit well within the double-blinded, randomized control trial, even combinations. However, what I have also been hearing from a number of the Commissioners is that there is a number of our modalities that don't fit well into that gold standard. Some of them are difficult to double-blind. Many of them have individuation of therapies and perhaps we need to look at some of the psychotherapy models, other things like that, that actually also have individuation of therapy by nature of its field, but have to fit within some sort of standardization to be able to submit to trials. I would like to know the feasibility or where we would look in this country, but in Germany they had a series of seminars that were put on at a medical institution that was available just for CAM practitioners. It was over a three year period and it brought them in to teach them from the very basics how to do research. They worked with them on the problems of research and individuation in that. What they ended up with and what their whole goal was, was to develop a strong core of experienced and dedicated CAM practitioners, not just collaboration, but people that spoke that language that could then go and do the research and do quality research. I wondered is there a method or a mechanism or who would take up that sort of ball in the United States because I think that is very important. I think that that would really contribute to the growth of better research and address some of the considerations that CAM practitioners have. DR. COATES: Let me try and address that a little bit. Since Dr. Straus I don't think is here I could probably speak for him and say that probably the NCAM is one of the organizations that perhaps is good way that should be approaching it. I say that because it turns out that we have just published recently, along with 12 other institutes at the NIH an announcement for planning grants to train minority-serving institutions, investigators at those institutions in clinical research. A similar thing can probably be done for complementary and alternative medicine research. In fact, we specifically included not only M.D.s, but also osteopaths, chiropractors, doctors of naturopathy and so forth in the announcement specifically by name. So I think it is feasible. It is not going to be easy by any means, but it can be done. DR. GORDON: Thank you. We have time for two brief questions from Joe Fins and then Wayne Jonas. DR. FINS: Secretary Shalala recently wrote an article in The New England Journal of Medicine a couple of weeks ago about research protections and balancing access versus protections and having good layered review. I am just wondering in your experience, you know, intramurally and extramurally, the adequacy of the training of IRB members to competently review such protocols that are perhaps out of their normal disciplines. Let me target, is there a need for training along the lines of the sort that the Secretary proposed for IRB members, including CAM modalities as a supplemental to that perhaps new mandate? DR. LENFANT: I have to speak to that because we have been involved with an overall training trials in alternative medicine and I am not aware personally of any hurdle at the IRB level. In the past, the review groups were assessed to scientific merit of those things, are in great need of broadening their views. Should I put it that way? That is a real problem that we have to deal with. What we have done in such specific instances was to bring as part of the review group, individuals who are experts and have interest in issues of alternative and complementary medicine, but it is a very difficult process. I have to admit that. But you see that is a point that I was trying to make earlier. As long as you don't educate where education begins, it is just not going to work. You know that the nutritionists to accept nutrition as something of any importance in medicine. DR. GORDON: Thank you. Wayne. DR. JONAS: I want to thank the panel for coming. I think for those on the Commission who are not aware of it, these folks, as well as a number who are not here at NIMH and a number of other institutes really are the people that are moving forward in this research area without a mandate. I mean, they are doing it on their own with their own efforts, using resources from their own institutes. I just want to commend you all and congratulate you all for those efforts. I would like to make a request and that is that some of the comments that were made, especially by you, Dr. Lenfant, and Dr. White at the beginning and others, perhaps didn't have enough detail to make them about some of the issues that address the specific questions, the obstacles, the issues that you addressed. If we could get some of those in writing because a lot of those were not in here, I think it would be extremely helpful. Jeff, your summary was fabulous. I would love to see that in writing. This applies to the others as well. Also, in the training areas, if they could give us some specific suggestions as to how your agencies, centers and institutes can do training because that is, obviously, a common theme across all of these areas. I have a specific question for Dr. Cassman and that is that I would be really interested to know how we can incentivize or motivate or bring the basic scientists, the good core, molecular and cellular biologists out of the woodwork in this area. Because as I go into the institutes, Scripps and various other institutes that are doing core basic science research, what happens is that they talk about the exciting kind of low level laser work that they are doing, for example, like this. Then later on, either over dinner or a drink or as I walk out of the room, they come and say, you know what, this really might have applications in terms of acupuncture. I have actually read some research over in Japan where they used this type of thing and showing amazing results. But I don't know how to do this kind of research. I said, well, why not? Well, my director wouldn't hear of it. Okay? There is still a taboo, if you will, communication taboo. Part of it is training and part of it is just stigma in the basic science area. I would love to hear are there some ways in which this community can be really incentivized and brought into doing good science in these areas. DR. CASSMAN: Everything you said is absolutely accurate. It is difficult. It is not unique by any means, to complementary and alternative medicine. It is true for any new discipline that is emerging. I am not saying this is new, but at least coming into the scope of fundamental research that we are particularly involved in. We have some programs that attempt to make that a little bit easier. We have a program, for example, that is called High Risk/High Impact, which actually solicits applications that are outside of the mainstream, if you will. We go out of our way to try and ensure that that is supported. I think the bottom line really is, and I have heard it mentioned by others as well, you need a definable research question that can be addressed in a manner that is measurable. If you can't do that, there is no hypothesis to be tested at this stage. If it is just information gathering, you are not going to find very many good fundamental scientists interested. There has to be something there that one can actually quantitate in some sense. It has to be measurable by whatever, you know, as long as it is a modality or a tool that can give reliable and reproducible results. Once you have that and once you have a question that can be addressed, there is really, I don't think, any particular barrier to that. But that is hard. It is not easy in any form and I think you are going to have to work very hard to find out what questions are amenable to that approach. Again, I am talking now just from the point of view of my institute and many of the people that we support and deal with. We primarily deal with the question not of what, but how. I think Steve Hausman said earlier you need to demonstrate that there is a phenomena that can be investigated before you ask yourselves how are you going to do it. Why is a higher authority echoed? We don't deal with that. But how is an important question and we need to have a definable process. We need to have a definable question and a methodology that tests it, that is quantitative and reproducible before anybody will be interested. DR. GORDON: Thank you very much, Dr. Cassman, and thank you all. We really very much appreciate your contributions. I would like to echo what Dr. Jonas has said. We welcome not only clarification of specific issues that you raised, but any other comments you would like to give us in writing and we would like to feel free to call on you, either formally or informally, for further advise and suggestions. Thanks again. We will take a 15-minute break. We will come back precisely at 11:05. [Recess.] DR. GORDON: This next panel is on academic centers and support for CAM research. Once again, we will ask each of you to speak for 10 minutes and then we will have a time for questions from the Commission. The first speaker is Dr. Alfred Fishman. Session III: Academic Centers and Support for CAM Research DR. FISHMAN: Thank you very much for inviting me. I am in the terrible position of being forbidden to use slides. [Laughter.] DR. GORDON: We are doing some research on stress. [Laughter.] DR. FISHMAN: The second problem is that I agree with almost everything I have heard before, which really disarms me. My charge, as I understand it, was to give you a brief a description of what we have done at the University of Pennsylvania to remedy some of the questions that the people are receiving about, how do you do research and how does it fit into an academic health center. About 3 years ago, our dean-CEO, after some preliminary discussions, decided that there should be a central move on the part of the administration to find out, where do so-called complementary alternative therapies fit into the academic health center. I don't have to reaffirm for you the mission of the academic health center, which bridges education, clinical, and research. He asked me to lead the effort. I refused. My background is entirely one of research, clinical investigation, and there are people here, whom I can give you references, who will at least testify that that was my previous life. After awhile, I became interested, and the approach that we took was to set up a working group which consisted of eight people, who were really practitioners of complementary alternative therapies, and eight hard-nosed scientists, and two administrators. When we first started to meet to discuss, where do these complementary alternative therapies fit, we were arranged just the way we are seated right now. All the people who believed in CAM sat on the left. All the others, the right, and I sat here. By the end of the year, it was impressive, if nothing else, to see that they didn't care where they sat. They began to understand each other, and that outlined one of the problems, of course, with the acceptance of what CAM has to say. What we did is we went through a process, which was dictated by the dean, as though we were setting up an institute, a center or a new department. Therefore, we went through reviews. Dr. Jonas, for example, was present at one of the reviews. What we did about the halfway mark, we convened a retreat and we discussed in open forum, probably 100 people, the head of the Institute of Medicine was there, Ken Schein. Roger Bolger was there, who some of you may know; leading people who were hard-nosed. We presented what we thought we were trying to do and the commentator at the end was Dr. Osborne, who is head of the Macy Foundation and everybody gave us applause. After that, we took a proposal and went up through the university channels, departmental chairman, institute directors, administrators. We went through all the command performances, right up to the president of the university. The end result is that we were accepted. We came up with two volumes and I have sent copies of that and I have also provided a brief summary of our conclusions. What I would like to tell you now in a few words is what we have come up with as a basis for discussion. What we have come up with is that there are certain general considerations that have to be taken, clinical, educational and research and the most important is they are all interlocked. Dr. Lenfant stressed the point of education. It is just as important to have wrapped into it the clinical and the research and they have to interrelate. So as a general concept, we said we have to develop all of these simultaneously. The general approach is the institute will remain committed to a scientific approach to CAM, as it is for everything else, but it also believes that the scientific approach is applicable to any one of the topics that we can raise in CAM. I will defend that in the discussion if you would like to challenge that. We did heavy research on the Cochran Collections, which are informative, the American College of Physicians, reports on evidence-based medicine. We see no problem with incorporating these into the scientific establishment that we call so-called Western medicine. In clinical practice, we recognize that practitioners have a different responsibility from those of an academic educational institution. The academic educational institution has to be rigorous in what it recommends. So it is how staff uses it, patients get it, et cetera. The private practitioner, who is well-educated, knows what it is that the education has provided and then can use his or her own head. I mean, if you find out that there are certain therapies that work in your particular practice and they do harm, et cetera, we see no particular reason why we should try to inhibit that. We took a poll at the start of our study of 1,500 physicians, who related to our health systems. We found that one-third were using or practicing so-called complementary therapies. We have made a breakdown of what they did. Many of them were in nutrition. In my department, when I headed rehab medicine, we did acupuncture. So there was a lot of activity and each step in the process, the faculty has given us our blessing. I don't have many copies of these two volumes, but we did provide you with a two-page summary of what the results were. We said up at Penn that we would not build a big theater, where we would practice complementary medicine. We said that we would do that as a distributed virtual system, recognizing that different people will do different things at different places. We took advantage of the fact that we have a woman's health center. We developed a program there. WE have a cancer center. We have developed a program there. We have a rehabilitation program for wellness. We converted that from a rehabilitation entity to one that would promote therapies, such as tai chi, massage, et cetera, but probably our biggest contribution was we described a method by which you could incorporate all these. We set a steering committee, which still exists, and we heard the question before, what does an IRB do. If the IRB gets an implication it doesn't know how to handle, it goes to the steering committee. That steering committee includes people who understand CAM and if they don't know, they can know where to go get people who understand it. So we have got an advisory group to the process. The credentialing process is exactly the same as if you were to do brain surgery. The departmental chairman says I would like to credential, allow, this person to do any one of the techniques. Great. The steering committee looks at it and says this is fine. Has it been approved? Has it got state licensure? Has it got this? These criteria varied from place to place, but the mechanism just fits very smoothly, as long as you have got the steering committee, so-called, which offers advice, which is taken by the departmental chairman, by IRBs, by everybody else. With respect to education, this has been great fun because what happened is we have punctuated our curriculum by putting into the curriculum at the proper place, where complementary alternative therapists have to be considered. So in pharmacology they see certain things that have to do, for example, with depressants or antidepressants, et cetera. We have minimized the number of lectures. We have responded to students. There is one group of 100 students now, who have a Qi Gong program, which is prevalent. We have hired licensed yoga instructors to train our physical therapists so that they can do in rehab medicine some of the things we have been talking about. In the back of this book, we have gone through the credentialing process as an example for acupuncture, for massage, tai chi. Each one of these has gone through the standard process. So I may be oversimplifying it, but truthfully we haven't seen any problem. With respect to research, we have done something that I think may interest you. We have formed partnership with our Center for Epidemiology and Biostatistics, which is very much concerned with outcomes research. Now, you can measure anything in the form of therapy by getting a population and testing its outcome or you can look, as some of the people have done, join forces with the University of Health Sciences, which is committed to the exploration of the contents of herbs. We have got several people now working, who are physicians, finished their residency in medicine, who are now taking master's degree in epidemiology and biostatistics for outcomes research, two year program, and they have partnered. For each one of these people what we have done, we have one CAM person, who really is a mentor, and we have a partner in epidemiology and biostatistics so that each person who comes into the program has a partnership of somebody who knows the business and somebody else who knows how to evaluate. So far that has been very successful. We now have several other people that have come up the road, who are doing this. We even have a program called the "For School" program, where a third year student, who becomes interested, can take a year out of research under proper mentoring in this particular institute. Am I running out? DR. GORDON: Yes. DR. FISHMAN: Then I won't tell you all the obstacles we have. I won't tell you how we solved them. But there were obstacles. There were many things to be overcome, but we can leave that for later. DR. GORDON: I think we will be coming back later, particularly to some of the issues you just raised about how you are facilitating research. Thank you very much. Dr. Daniel Federman. DR. FEDERMAN: I think it is interesting that I am paired with Dr. Fishman because we have a very similar outcome, but a radically different almost opposite process. Instead of starting centrally, as they did, the other process could be described as recognizing what had started individually and what we did was recognize something that had already been created by an entrepreneurial young faculty member. In our system, that is a much more likely way for something new to get started than the rational approach that Al referred to. [Laughter.] David Eisenberg was the young man in internal medicine, who was trained in China and in Chinese after his training in this country. His paper on the prevalence of use is really one of the sentinel events in the development of the field. He had patiently on his own acquired independent funding. Although the focus this morning has been entirely on the federal government, I don't think we should neglect the importance of private philanthropy in getting things going to a point where federal funding, based on other criteria can be used. He had established an NIH-funded program. A lot of things happened at our school in that way. Primary care, aging, ethics, AIDS, nutrition, substance dependence, domestic violence are now all established school programs, but started with the energy of one or two people. The diversity of our institutions plays a role. We have a VA, a health maintenance organization, several cancer centers, several specialty and general hospitals. Somewhere out there someone gets a good idea and starts. The other thing I would like to emphasize as potential solutions to your concerns are the roles of young people, not bearing established prejudices about everything, but much more open and much more interdisciplinary in their thinking. Therefore, educational efforts, courses for medical students and students in other disciplines are a way to think about interdisciplinary research emerging in the future; whereas, if you go to some established person and try to change his or her habits, it is much more difficult. Finally, seeing that the field was maturing, that we were being left out, that the clinical use was very widespread and that we had somebody in our own institution who was ready to lead, we went through the step of creating a division, not a department but a division, a division that is interdepartmental. It is inter-institutional and it cuts away from some of the competitive disincentives, which are very strong in our school. The establishment of the division went through some of the steps that Al talked about, including the appointment of real opposition, people who didn't want it to happen, and getting them involved in it. We had several open meetings, where the opposition was deliberately invited and given plenty of time to speak. We set up a delphi process and had three cycles among faculty about what should the division do, where should their research emphasis be, what should be some of the principles by which it operates. Now it was finally anointed by the faculty and is up and running, although I don't think our programs are quite so mature as what you heard from Al. A couple of comments on your questions. The principal obstacle has been skepticism on the part of established faculty and a reluctance to look as though you are getting soft or wimpy or crazy among your friends at distant sites; a big issue. I can imagine some of the letters that Dr. Fishman received. They were probably written by the same people. Expanding federal support, I think that this is a place where public interest, a perception of what patients and doctors are doing and an enhanced role for public expression in NIH priority setting. I thought Lee Rosenberg's talk was terrific. A big contribution from the CAM philosophy for us has been the wellness emphasis of very weak components in most medical school curricula. So the emphasis on wellness, starting with what patients want, the real attention to symptom relief, also very weak in traditional medical school curricula, and a response to neglected populations, these have all been part of it. I think bringing practitioners and researchers together in common settings is a very important part. We are doing that through meetings of our division, through meetings of a center for clinical work at Beth Israel Hospital and likely to be replicated at other hospitals soon. We have heard anecdotes disparaged. I would like to point out that good, well-written anecdotes should not be disparaged. Anecdotes were the first basis of the field of pharmacogenetics. Clinical observations of a drug doing something funny came out of clinical practice. Its modern expression in the Genome Project is quite another thing. But pharmacogenetics got going and clinical genetics got going from perceptive observations, written up well and then leading to the question that the scientists in the previous panel you have got to measure something and you have got to be able to do something, but they can start with well-described, alertly observed observations. The overlap areas, we have talked a lot about them. The one that hasn't been mentioned educationally adequately is ambulatory medicine and education. The medical schools are just getting going in the area of ambulatory education. That is a place where quite different attitudes about symptoms, about what really bothers patients, about what commissions can do, they are quite different from what happens in the acute inpatient settings and it is a place where CAM could play quite a role. Finally, there was the point about the public role in setting priorities. A lot has been said about that already and I have tried not to repeat what has been said before. DR. GORDON: Thank you very much, Dr. Federman. Actually, I had thought the difference was between Quaker origins and Congregationalist origins. DR. FISHMAN: There is a whole book that everybody should read on Puritan Boston, Quaker Philadelphia. Do you know that one? DR. FEDERMAN: On the other hand, there should be something to measure. One dollar was put into Philadelphia and one dollar into Boston for investment over the years. Boston did far better than Philadelphia. [Laughter.] DR. GORDON: Thank you, Dr. Federman. The next speaker will be Dr. Joseph Pizzorno. DR. PIZZORNO: Thank you. I am going to talk about three things today: first, about how Bastyr established its successful research institute; second, about the problems we have run into in doing natural medicine research. Finally, I am going to give you five policy recommendations about ways we believe that you could help make it work better. So first off, in terms of Bastyr University, as you know, I am the founding president of Bastyr University and led the institution starting in 1978, with a concept of science-based natural medicine because we could see that centuries old traditions of natural healing had a lot to offer, but until we brought them up to modern standards of education, research and clinical practice, it would never be accepted by mainstream society. We have worked hard at Bastyr University to do that. So because of our science orientation, of course, research has always been important to us. Of course, there was no money for doing that. Nonetheless, we started doing research in 1983 and we did that basically by allocating student tuition money. Because we are a tuition-driven institution, we do not have the blessings of state, federal, local foundation support for our institution. It all came out of student tuition. But we felt it was important. We invested in it. We also got some of the companies in the natural products industry to support research. They were primarily product oriented but at least it was something to get us engaged. Since then we have now developed a fairly large and I think a very sophisticated natural medicine institution, a research institution that has done quite a number of studies and quite a few have been published in peer reviewed scientific literature. I believe that a key to why we have been successful in doing good research that is relevant in this area is because we have used cross trained professionals. Dr. Leanna Standish, whom you will be hearing from tomorrow, has a Ph.D. in research. She also has her degree in naturopathic medicine and also a degree in acupuncture. Dr. Calabrese, who has done a lot of work in this region was trained as a naturopathic physician and went back to the University of Washington and got his master's in public health and his master's thesis was outcomes research in CAM. So what we have done is we have drawn to the institution people, who understand deeply both sides of the equation. I want to stress that. While I think there is value in bringing CAM professionals to work with center researchers, there is also a lot of limitations in that particular model. So, what are some of the problems we have run into? First off, exclusionary language in existing legislation and rules. By the way, I will give you a handout with all of my presentation on it. There are three problems here. First off is a lot of legislation in Congress and the rules passed by various departments dealing with health care research is of exclusionary nature. That means it only covers M.D.s and D.O.s doing the research or those doing research in medical schools. As a CAM institution, there has been a tremendous number of doors closed to us. Second, in situations where there is nothing explicit in exclusionary language, there have not been mandates so as to allow de facto exclusion. While I have many medical doctors, who are great friends of mine, many who are here today, in many situations, that gatekeeper role is played by M.D.s, who were not interested in CAM research. Finally, even when allowed, it wasn't funded. So the barriers have been substantial. Examples: In the service area, Indian Health Services, has restrictive rules that don't allow CAM practices. The National Health Service Corps has exclusionary language that specifically excludes natural medicine practitioners. In their research, the Centers for Disease Control has no mandate. The Agency for Health Care Quality and Research has no mandate or funding. The Health Care Financing Administration/Medicare has specific exclusionary language and the graduate medical education legislation has exclusionary language. If you look at the Balanced Budget Act of 2000, which is funding several areas of health care and health care research, there is, again, exclusionary language. CAM professionals and institutions are specifically not included. This also goes into quasi-governmental agencies, such as, for example, the Howard Hughes Research Institute, which has close ties to the NIH. Its goals are lofty to strengthen and expand the nation's pool of medically-trained researchers and so provides fellowships for medical students and for young faculty to be engaged in research. It is restricted to only M.D.s and D.O.s. So, lots of problems. I actually have a several page list of all the agencies and all the problems, but I think you get the idea. It is easy to fix. You can do enabling legislation that simply says go through all the federal legislation and remove exclusionary language and replace it with inclusionary language. You can make these kind of changes. Next is an area which I notice has not gotten much attention with the Commission that I think is very important. That is that natural medicine and public health are natural partners. If you look at the philosophies of CAM and public health, it is remarkable how similar they are. Patient education, prevention, healthful living, self-help, personal responsibility for health, we all have the same conceptualizations. The main difference is that natural medicine professionals do it on a one-to-one basis; whereas, public health tends to do it on population-wide areas. We believe that there is tremendous opportunity to engage in research that very specifically looks at how to more carefully bring together natural medicine and public health concepts and initiatives for the betterment of public health. In Seattle, we created an initiative to create an institute to do just that. I will be giving you a copy of what that proposal looks like. Next is a significant problem and that is if you look at most of the research being done today, it is isolated therapeutic research, not integrated care. Natural medicine, the reason people go to natural medicine practitioners is because of our completely integrated personalized approach to providing health care. That is not the research that is being done. Most of the research being done right now is by M.D.s and Ph.D.s, who have been trained in the drug approach, which is fine for drugs and for agents, such as dietary supplements and some herbals that fit the model. But that model does not work very well. There are substantial problems in trying to fit natural medicine interventions into conventional, randomized, placebo-controlled trials. So, for example, individualized treatments for standardized protocols, combination treatments for single agents, homeopathy, blinding in certain modalities; for example, contrast hydrotherapy for peripheral vascular disease, how do you blind that? So I think you get the idea. There are lots of problems. So one thing we would like to recommend is that you establish a consensus conference on developing research methodologies that will work for CAM. I am not talking about something which is different or unusual or not appropriate, but the idea is to get together people who come from, for example, the Institute of Medicine, senior editors of leading journals, The New England of Medicine, Lancet, et cetera, experienced CAM research professionals. Let's get them together for a several day conference and figure out methodologies that we can agree will answer the questions we want to actually ask and will be of the kind of quality that will be published in peer reviewed scientific journals so people can hear this information. Finally, we have to increase funds to academic health centers. It is well documented now that funding in academic health centers in conventional medicine has resulted in huge advances in medicine. That is great. We need to do the same thing in CAM institutions because this is where the body of understanding of this medicine lies. But we don't have the infrastructure and the training that has to occur is basically happening with very limited resources. So look at CAM educational institutions where you do education, research, clinical sciences and that also have collaborations with conventional medical institutions. Finding these institutions I think is incredibly important. So in summary then, my policy recommendations are five: No. 1, remove exclusionary language from existing legislation. No. 2, specifically mandate both inclusion and funding of CAM research. Next, establish an institute for integrated CAM/public health research. Third, fund research into all senses of healing, not isolated therapies. Fourth, fund a consensus conference on CAM outcome research protocol. Finally, establish a formal process for funding the creation of CAM academic health centers. Thank you for your attention. DR. GORDON: Thank you very much. Thanks for being succinct in presenting a great deal of material. Dr. William Meeker. DR. MEEKER: Thank you. Good morning, ladies and gentlemen. I am very honored to address this prestigious commission and I wish you all the best of luck in your work because it is not easy work. The CAM movement and the values it represents are congruent with the desire for a more human-oriented health care system and I think ca research as the potential to help that transformation. It also is interesting to note that CAM research is helping the move to evidence-based health care. Demands for evidence of the effectiveness of CAM has actually highlighted the lack of evidence for many established medical procedures and products. So ironically, in some respects, CAM actually may help make all of medicine more scientific. In my very limited time today, I want to make two major points and put them in some context for you. The first one is that the professions that value it the most will accomplish the best CAM research because it is their professional duty. It is the obligation of chiropractic, for example, to develop its research capacity and conduct research in its training institutions, just like all the other health professions. My second point, which is a logical extension is that the federal government has a duty and the obligation as an agent of the public to assist the development of research capacity of the CAM professions just as it has for the other health care professions. The chiropractic profession already has a large role in health delivery in the U.S. With over 60,000 professionals now and growing, chiropractic is the third largest doctorate health profession in the United States and is by far the largest, most popular, best organized and most regulated of all the CAM professions. Between 11 and 15 percent of the U.S. population visits a chiropractor every year. This translates to almost 200 million annual patient visits to chiropractors, which is about 30 percent of the total of all visits to all CAM professionals. Economically, this means somewhere between $8- to $9 billion in health care expenditures. For some contrast, you should know that visits to primary care medical doctors is just around 400 million visits, or just a little twice as much. The Council on Chiropractic Education accredits all the 17 U.S. chiropractic training institutions, which is in turn approved by the U.S. Department of Education. After years of work, the Chiropractic Health Care Section is now officially part of the American Public Health Association. Spinal adjustments and manipulations have been studied in over 70 randomized controlled trials and the procedure has been approved as a treatment recommendation for back pain by the Agency for Health Care Policy and Research, which is now Healthcare Research and Quality. Chiropractors also deliver a huge proportion of all other types of CAM procedures and products. Patients are a cross section of U.S. demographics and present predominantly with musculoskeletal complaints. Studies also show that patients are very satisfied with chiropractic care and they are willing to pay out of pocket for it if they have to. Thus, I would submit that chiropractic is actually a mainstream health practice and a considerably large one at that. In fact, a well-known CAM researcher at a famous medical school once told me that if we consider CAM to a rom, then chiropractic is the elephant standing in the middle. It simply cannot be ignored any longer. For additional perspective, the implications of the word "integration" must be understood as it relates CAM professions, particularly chiropractic. I think there is a major distinction to be made between procedures and products and professions. For example, chiropractic is a profession. The spinal adjustment and manipulation that chiropractors use is a procedures. Procedures and products in professions require different forms of research. They require different types of disciplines to be brought to bear. Notice that effective new procedures and products are relatively easy to integrate into conventional medical practice and there are established pathways and a history of doing that. That process, which is rarely as scientific as we would like to think, does define the progress of medical innovation. On the other hand, it is an entirely different thing to integrate professions, especially health professions that have historically been at some odds. Although integration already occurs at the health consumer level, because patients choose and integrate the health care they want within the limits of convenience and cost, it is not happening on any large scale at the doctor-to-doctor level, at least not yet. So the conclusion is this. If true CAM and conventional medicine integration is what we want and is supposed to be the end result of CAM research, then the research agenda must be very broad and deep. Indeed, it must be interdisciplinary, multiple disciplinary and interprofessional. Social, as well as clinical and basic sciences must be used. These attributes need to be elaborated explicitly in all federal policies designed to facilitate CAM research. To reiterate my first point now, the best CAM research will arise from the professionals that are most interested in it and from their institutions, but those professions need help, just like the other health professions. Let me be very clear here. The primary responsibility for chiropractic research lies squarely on the shoulders of the chiropractic profession. It is not a choice that we have. It is a professional obligation and a duty. We accept this and the chiropractic and CAM professions must develop their own inquisitive research cultures and in so doing, they must continually strive to not prove, but to improve their practices. So if you believe as I do that research is a profession's ultimate responsibility and if you believe as I do that the best quality research will arise from the profession that values it the most, then I hope you will logically agree to my second point, which is that the federal government, which represents the will of the public, can and should assist the CAM professions and institutions in every possible way to develop their capacity to engage in high quality research and education. The government has many powerful ways to do this and all of them should be brought to bear, just as they have developed the research capacities of all the other health care professions. Chiropractic does not have an adequate research infrastructure. Chiropractic is not plugged into the standard research bureaucracy of the federal level. Federal funding for research institutions began only six years ago, with a program established at the Health Resources and Services Administration. This has amounted to approximately $350,000 per year. Not a lot of money. In 1997, only three years ago, the NIH Office of Alternative Medicine awarded a five year center grant of $2.7 million to the Palmer Center of Chiropractic Research, which I head. I am very grateful for this unprecedented support, but it is not much money, considering the size and impact of our profession of chiropractic. Our institutions are still tuition dependent and we are used to that, but, needless to say, resources for research are meager and what advances have been made are poor bootstrap labors of love. There is an active scholarly community and peer reviewed and indexed journals in chiropractic, but the efforts needs to be much bigger and more productive. Barriers to a larger research capacity in chiropractic, and I dare say the other CAM professions as well, include the aforementioned isolation from the wider health care and scientific communities, ignorance on the part of non-chiropractic health scientists, the lack of scientific career training, mentorship and job opportunities for CAM scientists and particularly the lack of chiropractic representation in research policy making and political circles. To give just one very interesting example, it may surprise you to know that there is just one person, one single individual only working in the entire federal research bureaucracy who has chiropractic training. This has just happened in the past year. Only in the past two years have just a small handful of chiropractors been appointed to ad hoc roles on NIH study sections. To give another example from the private sector, the very authoritative Pew Health Commission's fourth report, entitled, "Recreating Health Professional Practice for a New Century," never once uses the word "chiropractic," even though it alludes to CAM and recommends that health education programs require interdisciplinary competence in their students. Chiropractors are not tracked as part of HRSA's health care work force projections. I do acknowledge that the National Council on Complementary and Alternative Medicine now has two chiropractors on its council. I am grateful for the support that I have gotten through that particular center. But it is just not enough. It is not nearly enough for what we need down the road. So, what can be done? I am going to give you a list of things that are beginnings, I think. This is most important. No. 1, train CAM scientists. Provide programs, incentives, pre and post-doc positions and career tracks for capable and interested young people. No. 2, create ways to encourage interdisciplinary, multidisciplinary and inter-professional collaborations between CAM institutions and tax-supported universities. No. 3, apply the entire universe of research project and program funding mechanisms to initiate, encourage and support chiropractic and CAM research, including bricks and mortar. No. 4, call for interdisciplinary conferences to explore scientific states of the art on CAM topics and establish rigorous research agendas. Support the agendas with targeted research funding program announcements. No. 5, encourage the National Library of Medicine to include CAM topics and references in its indexing systems. No. 6, to establish academic CAM clinical centers. No. 7, support CAM training institutions in the broadest possible sense, like all other health professions in order to eliminate the dependence on tuition and provide the resources to develop a more effective and consistent research culture. No. 8, ensure that chiropractors and other CAM professionals are routinely appointed and otherwise included in research policy making efforts. This would include the hiring of chiropractors at the same level as other doctors in the Department of Health and Human Services, as administrators and investigators. Finally, consider that CAM professions and their institutions could benefit from special attention in order to jump start their research efforts; perhaps something similar to the Centers of Excellence program in HRSA's Bureau of Health Professions. In summary, I want to thank the organizers once again. CAM professions as distinct from CAM procedures and products will, if supported properly and fairly, eventually produce the best quality CAM research. I think the full financial force and creative power of the government and should be brought to bear in this way. Thanks very much. DR. GORDON: Thank you very much. Thank you all four. These are wonderful examples and really heartening examples of the way, from very different perspectives, the agenda of a more comprehensive approach to medicine is being advanced. I have a couple of announcements and then we will begin with questions. First, this is a very important announcement. Lunch for the Commission members will be in Room 634F and the news briefing is going to be in Room 405A, shortly after this meeting when the morning session concludes. So we will conclude here at 12:15, and lunch will be immediately following for Commission members, and the news briefing will begin promptly at 12:30 in 405A. Also, if commissioners could bring Tab 6, not just the tab but the material behind Tab 6 to lunch, that would be helpful. Tom. MR. CHAPPELL: Thank you for all of you being here and presenting your experiences. I have been paying attention to how innovation happens in each of your situations. I see some interesting ways that are evolving. I guess I am aware that we all are dealing with a consumer-initiated and -driven reality. I am aware that there is a champion-led approach to this. However we call that champion, each of you has decided how that champion model works in each of your situations. It has been sponsored by the highest authority within your systems, so that there is permission for this to happen and it is supported and resolved by professionally integrated collaborations and sufficient resources. Each of you, though, has had a different way of applying those principles. I guess, Dr. Federman, I am interested in the champion model at Harvard in this case. To what extent did the sponsorship of this by your level need to continue to assert the protection from the gatekeepers that you were speaking about? At what point in the evolution of the process did you integrate versus the point at which you kept the project separate? DR. FEDERMAN: I was asked by the dean to bring it into the mainstream of the school so that all of the school's strictures about how to organize a division, et cetera, were met and that it had a high level champion to get it established. It would not probably have reached that point without the dean's office intervening. I am likely to spend, as I projected, about another year or two in this same capacity but a diminishing role as the other hospitals join in establishing centers as a common seminar program, continuing medical education course and approach to credentialing practitioners, which is much further along at Penn than we are. But we see kind of benchmarks, which would both be accomplishments and clues that I would do less. But it did take a dean's office sponsorship and someone with an external credibility, not a practitioner, not an advocate. In that sense, rather similar to what Dr. Fishman was asked to do. So I picture it will be about three years of work on my part to bring something that was well along into an official and then autonomous status. Does that answer your question? MR. CHAPPELL: Yes. Thank you. DR. GORDON: Dean. DR. ORNISH: Yes, I first just want to say how inspiring it was for me to listen to all of you and particularly hearing what Drs. Federman and Fishman have been able to accomplish in their respective institutions, which I know are not always the most open to change. DR. FEDERMAN: Just ask your question, please. [Laughter.] DR. ORNISH: My question is since you brought in an opposition from various sources, did you win them over or did you overrule them? What was that process? DR. FISHMAN: We didn't even engage in the battle. It was very interesting. I told you about how the working group met and then by the normal process of creating a department, we did nothing out of line with the way you create a department or an institute or a program or anything else. When we presented it, we had opposition, but none of it voiced. We would sit around the table like this. I knew there were faculty members there who wanted no part of us. On the other hand, the group as a whole listened to reasonable discussion and were impressed by the fact that our procedures as so-called scientific medicine made it possible to do research, that it was not unconventional. We could examine everything the way they were accustomed to and even the basic scientists, we had no formal opposition and I think, for example, I talked to Wayne. He sat at the retreat we had. The discussion was constructive. People voiced reservations. The head of the Institute of Medicine raised questions. June Osbourne raised questions but none of it became antagonistic. It was a surprising experience. DR. FEDERMAN: Poetry is said to require the willing suspension of disbelief. We have achieved, I would say, the reluctant or unwilling suspension as the level of welcome. [Laughter.] DR. GORDON: Thank you both. Yes, Tieraona. DR. LOW DOG: I have two questions. One was for either of the two gentlemen here. You know, complementary medicine, we talk about it as if it is sort of a single entity, but it is really many, many different modalities. Some institutions are very reputable and have some evidence behind them and some are fairly borderline. I just wondered how you approached what you are bringing into your institution. DR. FEDERMAN: The organization of Harvard is useful in this regard because the clinical practice is entirely based in the hospitals and both regulated and planned there with the medical school having no role in that. So we are not involved in the credentialing of practitioners. We are not involved in proving the pharmacopoeia at any hospital. We are not involved in what clinical care the patients can get. So each of the hospitals is making those approvals independently. The research agenda, the IRB status, the acquisition of funding to support research, that will be in the division and under the medical school. Then project by project review will be the way in which the delimiting of the effort will be achieved. DR. FISHMAN: We take in a more deliberate approach. Remember what I said is we have not resorted to any unconventional way of introducing a new therapy into our health system. We found that we could keep the same way a departmental chairman says he or she would like to have acupuncture. Great. The chairman has never heard of acupuncture. He goes to the steering committee. He includes people who know. The steering committee evaluates what you have to do, et cetera, et cetera. He goes back. The chairman says to the applicant, this is what you have to show me. Where did you get your approval? How much experience have you had, et cetera. Then it is transmitted right up to the board of trustees in the usual way. I have outlined in the back over here, two appendices. We did this for acupuncture with a very deliberate detail, every step in the process for credentialing. Massage therapy, the same thing. We have just done this for yoga and for tai chi the same way and we have introduced it into our clinics. DR. LOW DOG: That is great. See if we can bring that back to New Mexico. Dr. Pizzorno, I want to commend Bastyr for all of the work that it has really put forward. I wanted to know how much interface do you have with the medical school up in Seattle. Is there a lot of collaboration going on? Have you found that a friendly environment? Are we doing a lot of research collaboration, residents coming over, sharing med students? I mean, how open has the community been in seattle for your school? DR. PIZZORNO: You ask a very good question and the committee in general has been very receptive. The medical school has not. However, I have to say that is changing and I think it is changing for several reasons. One is because so many faculty and students at the University of Washington Medical School want to be engaged with us. I have been giving a lecture on alternative medicine there for the last 15 years, I guess. At the last meeting, I had about a dozen medical students come up to me and ask how they could take courses at Bastyr. So there is a lot of pressure building from within. Second, the research committee there now has become receptive and Dr. Standish will be talking tomorrow about now we actually have some collaborative studies with the University of Washington. In addition, Children's Hospital, which is a part of the University of Washington Medical School system approached us and we now provide natural medicine services for children at Children's Hospital. So that door is finally opening and I expect that there will be some pretty exciting things over the next several years. DR. GORDON: Thank you. Wayne and then Bill Fair and then George. DR. JONAS: Thank you. Thank you very much for your statements, all of you. I am impressed by the amazing commonalities and the amazing contrasts between two of the most exemplar conventional research academic training and two of the most exemplar unconventional, if I can use that term, research institutes. The commonalities really are dialogue and training and dual types of education from what I hear. Those are things that everyone talks about, everyone needs and I think it clearly means that there needs to be education all around. There needs to be training all around in terms of research, especially, but other areas also. The contrast is also, I think, equally clear and in terms of groups that have really the infrastructure necessary to do the kind of research that we all hope can be done here and those that feel like they haven't got the dollar yet and so haven't been able to really see it grow and invest over hundreds of years really. So I am wondering if there could be perhaps a higher level dialogue since the dialogue in education is going on. I would be very interested to hear from you all if that has occurred or if there has been discussion of whether at an inner institutional level there could be a discussion about a dialogue and kind of mutual types of educational projects that have occurred at that level, rather than simply at departments bringing in practitioners or universities wanting to get more training people into the federal government, for example? Any comments on that? Has that occurred or would that be possible to occur? DR. MEEKER: Good question, Wayne. I think that - - DR. JONAS: I am sorry. Let me just say, again, thinking about it, is there anything that we as a council, thinking about federal regulations might be able to encourage that in some way to support you all on that, if there are successful or some interest? DR. MEEKER: The simplest and easiest thing would be to encourage that dialogue by some sort of a conference or workshop where that would be the specific topic, I think, as a starting step. But we have a number of relationships with the University of Iowa Medical School and Department of Bioengineering and the Department of Neuroscience. The point I am trying to make, though, is that all of these are rather entrepreneurial, individual-to- individual relationships that have built up over common research interests and also educational interests. There has not been any top down rational approach to this. It has been more like the Harvard approach. It has been people getting together a lot by chance, a lot by just outreach. They found an area of commonality. They like each other. They start communicating. They realize they can work together. They propose something. They develop it from the ground up. That is, I think, the way most things work. It would be nice to have something coming from the other side and have them meet in the middle. That has not happened very much yet. DR. FISHMAN: Could I make a comment on that? Wayne, Dan and I have been talking about this also. I think that the center at the NIH has done a great job in tackling the present situation. It has created centers. There are ways by which the centers can communicate. We took the tact that we would have to take the same pathway that I saw at the NIH when I was growing up in the Heart, Lung, Blood Institute. We would have to train young people, include it in the educational program. So we never applied for any funding from anybody. There was no source of it. What we did within the institution is we teamed up with the Center for Epidemiology and biostatistics, found they had a couple of empty training slots. We stole a couple of training slots from some other people, got people the same way we began with the Heart, Lung, Blood, to start from below and work our way up. I think the time will come when there should be a meeting of people at universities, who want to exchange ideas. This is a tactic that is very good. We had a national registry on pulmonary hypertension where everybody was doing their own thing, brought them together in the project and suddenly they were talking with each other. They were investigating. So I am not sure we at that stage yet, but I think it is a definite stage to aspire to. DR. GORDON: Thank you. Joe, go ahead. DR. PIZZORNO: I think it is critical. There has got to be close collaboration between the natural medicine institutions and the conventional medicine institutions. As you may know, we just took a huge step in this direction and actually appointed a medical doctor as our academic dean, who was the associate dean at the University of Washington School of Medicine and having run them on campus a few months ago has had a huge impact on helping to open that door at the University of Washington, School of Medicine. It needs to happen and I think a way that you could facilitate that would be, I hate to say this, but a lot of these things fall to money and if you could provide a grant or something for these kinds of collaborations, I suspect you would see more happening. DR. GORDON: Actually, we don't hate to say it, we very much appreciate your saying it. That is exactly what we are looking for from all of you and everybody who will be sitting at the table and people in public comment. Our mandate is to recommend legislation and legislation comes with appropriation most of the time. So please tell us if you thoughts about how we should be recommending the money be spent. So, thank you. Bill. DR. FAIR: Yes. I, too, found the panel very informative. I wanted to ask Dr. Meeker, who gave a nice overview of the barriers, if you will, to acceptance of chiropractic nationally, particularly in the research area, on a smaller scale, what do you do at your institution to introduce students to research methodology because it seems to me that is where you have to start. You know, you just can't say up here we want chiropractic research. You have to go back to where you are and say we know how to do good research and then work for the others, get the funding from a higher level. DR. MEEKER: A very good point. We train students basically as consumers of scientific information, not necessarily the creators of it. We hope that practitioners will be able to read peer reviewed journals, be able to extract what is relevant to their practice, change what they do for the better and to keep up with the field in that way. We don't necessarily expect the average chiropractor to be able to conduct any sorts of experimental research, other than perhaps to do well done anecdotal case studies and have them published. We do not have the capability currently because of resources to develop a separate track of more directed research training, although we are working on ways to do that, do some mechanisms that we hope may be funded by NCAM. I agree with you. This is a very important aspect. I personally wish we could do more. We have the same problem, I might add, with our faculty. Most chiropractic faculty members do not engage in research. We have to go out and hire people with D.C. degrees and Ph.D.s in various areas. Those are our most productive faculty members because they have been apprentice to the scientific process. This, I think, is our biggest need. We need ways, training programs and career tracks, so that people that have a natural inclination in this direction see that they can have a job and a career doing it. That has not existed in the CAM profession so far. It has been very bootstrapped. DR. GORDON: Thank you. George and Joe and then we are going to break for -- DR. PIZZORNO: Can I respond to that question also? We fully agree we need to train the students and the same as Dr. Meeker, we train the students in the understanding of scientific method, but also as an accredited institution, we always go for work study monies. So we have had a huge number of students use work study monies to actually work in research with the practitioners and Ph.D.s doing the research. In addition, for several years now, we have had a Ph.D. program in CAM research on the drawing board, but have not been able to find the funding to bring it forward. We actually like to create researchers within the CAM institution that have that deep understanding of what our philosophy is about, but also how to apply scientific methods to that. DR. GORDON: Thank you. Dr. Federman. DR. FEDERMAN: I support the idea of a consensus conference, both the preparation for it and the publicity of the outcome. DR. GORDON: Could you turn on your microphone, too. Your voice is clear but I think it will help with the recording. DR. FEDERMAN: I support the idea of a consensus conference. I think both preparing for it and reporting it could have a good stimulating impact. But another one, legislation may be a little heavy handed for this, but if the new center for CAM and other NIH institutes proposed granting programs cooperatively, that might be a way to connect CAM with existing institutional strengths. The NIH is sometimes criticized for the relative autonomy of its institutes, but a collaboration between CAM and the new center and some of the other institutes with funding specifically of interdisciplinary research might be something to recommend. DR. GORDON: Great. Thank you. Dr. Fishman. DR. FISHMAN: I think there is an easy solution for that, truthfully. I approached the school of chiropractic in Philadelphia about doing a project on low back pain. We had some discussions, but after awhile there wasn't enough research interest, although the school had a wonderful population of patients and physicians and we could match it in our Department of Rehab medicine. We could never get off the ground. So I think that fundamentally the research orientation isn't there and if one could promote that by partnering, because I really believe that with the experience of a school of chiropractic, doing it right the way they think and a school that is doing it the other way, we could really get something solved in a rather remarkable way by just measuring the outcome, you see. That just hasn't been done. DR. GORDON: Thank you very much. George. DR. BERNIER: Dan, I would like to pursue a little bit the medical student education component. You, obviously, had a long and rich history of problems learning the new pathway. Did that facilitate the introduction of CAM literature and studies into the student curriculum or was it all done in the third year? DR. FEDERMAN: The question is what has our experience been with introducing CAM-related material in the first two years. That is one of the advantages of our current structure. Through the dean's office,, we have more control over the individual courses than used to be true. So we have been able to give them a mandate to bring more of that information from other disciplines as well, aging and ethnics and substance dependence, into the first two years and, yes, that has started to work. We have more experience with this now than before. Previously, it was strictly in the third year. It has moved into the tutorial experience of the first one. DR. GORDON: Okay. Joe. DR. FINS: As a follow-up question that is about process, could you address what you think are the substantive core components of an undergraduate medical curriculum in this? If you don't have an answer to that,, is there a way that we could ascertain that so that perhaps down the road we could set standards. DR. GORDON: Joe, we can bring them back for a much more extended discussion when it comes time for education. That might serve us better, rather than trying to answer it. You are welcome to answer it real briefly. DR. FISHMAN: I can tell you the best answer I know is that we have just put together an education grant to the NIH, which provides in great detail where it comes in year one, year two, year three, postgraduate, Internet, on the web, et cetera. So that is available. DR. GORDON: Great. Bill, you had a brief question. DR. FAIR: This can be answered "yes" or "no" by the panelists. Do we need a program similar to what I perceive as extremely successful M.D., Ph.D programs in medical colleges? Do we need programs that would direct training M.D. with chiropractic or whatever? DR. FEDERMAN: Yes. DR. MEEKER: Absolutely yes. DR. FISHMAN: No. If you will accept the premise that I think that we are all hearing, that we are doing scientific approach in research. We have got the machinery set up. There is no reason why somebody who wants to get a Ph.D. in some aspect of what we are now calling complementary, that will become conventional medicine once it has been proved. Then they can go through. Or else it is a research question. So it is a question of finding a mentor. Who is going to teach you? What courses do you have to take? Who will measure what you are doing? So the machinery exists in all of the research institutions that I know. DR. FAIR: Well, the M.D., Ph.D. program provides an incentive and the funding for both the student and the institution. DR. GORDON: So we have a no because you don't think it is going to be necessary because things are going to come together and we have three yeses. Is that right? DR. FISHMAN: I would just say one thing. Put more money into the M.D., Ph.D. program, which allows for this and encourages it. There is also the Duke program has just sponsored a year out program. The Sarnoff [ph] program is available. Any dean's office has a whole list of opportunities if you find a mentor, if there is a good question and you get the support for it. DR. GORDON: Yes. DR. MEEKER: I have to say what this question comes down to, because of the "yesses" and "noes," really is, who is going to get to control this particular aspect of research. Really, it is. If you believe that the best research is going to come from the professions that value it the most, and I am not talking a product, a pill. I am not talking about some kind of procedure. I am talking about professions. Then the answer has to be, unquestionably, yes, we have to do this sort of thing. These things do not exist in naturopathy. They do not exist in chiropractic. They do not exist in oriental medicine. Now, the question you want to ask yourselves is, do you think they should? DR. GORDON: Any other last words from panelists about this? [No response.] Thank you very much. This has been a great discussion. We look forward to seeing at least some of you again as we continue. Thanks very much. Thank you, for the commissioners. We will be meeting back here at 1:30 promptly. [Lunch recess taken at 12:15 p.m.] + + +