Archive

 

 

WHITE HOUSE COMMISSION

on

COMPLEMENTARY and ALTERNATIVE MEDICINE POLICY

 

 

 

+ + +

 

 

Volume III

 

 

+ + +

 

 

 

Saturday, October 6, 2001

 

8:30 a.m.

 

 

 

 

Bethesda Marriott Suites

Salons I-III

6711 Democracy Boulevard

Bethesda, Maryland


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

 

David Bresler, Ph.D., LAc, OME,

Dipl.Ac. (NCCAOM)

Founder and Executive Director

The Bresler Center, Inc.

 

Thomas Chappell

Co-Founder and President

Tom's of Maine, Inc.

 

Effie Poy Yew Chow, Ph.D., R.N., DiplAc (NCCA)

Qigong Grandmaster

President, East-West Academy of Healing Arts

 

George T. DeVries, III

Chairman, CEO, American Specialty Health Plans

 

William R. Fair, M.D.  [Not Present]

Attending Surgeon, Urology (Emeritus)

Memorial Sloan-Kettering Cancer Center

Chairman, Clinical Advisory Board of Health, LLC

 

Joseph J. Fins, M.D., F.A.C.P.

Associate Professor of Medicine,

Weill Medical College of Cornell University

Director of Medical Ethics,

New York Presbyterian Hospital-Cornell Campus

 

Veronica Gutierrez, D.C.

Gutierrez Family Chiropractic

 

Wayne B. Jonas, M.D.  [Not Present]

Department of Family Medicine

Uniformed Services University of the Health Sciences

F. Edward Hebert School of Medicine

 

Charlotte Kerr, R.S.M.

Traditional Acupuncture Institute, Inc.

 

 

PARTICIPANTS (continued)

 

 

Linnea S. Larson, LCSW, LMFT

Associate Director

West Suburban Health Care

Center for Integrative Medicine

 

Tieraona Low Dog, M.D., A.H.G.

(Private Practice)

 

Dean Ornish, M.D.  [Not Present]

President/Director

Preventive Medicine Research Institute

Clinical Professor of Medicine

University of California, San Francisco

 

Conchita M. Paz, M.D.

(Private Practice)

 

Joseph E. Pizzorno, Jr., N.D.

Co-Founder/Founding President, Bastyr University

 

Buford L. Rolin

Poarch Band of Creek Indians

 

Julia R. Scott

President

National Black Women's Health Project

 

Xiaoming Tian, M.D., LAc

Director, Wildwood Acupuncture Center

Academy of Acupuncture & Chinese Medicine

 

Donald W. Warren, D.D.S.

Diplomate of the American Board of

Head, Neck & Facial Pain

 

                     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

 

Corinne Axelrod, M.P.H.

Senior Program Analyst


PARTICIPANTS (continued)

 

 

Geraldine B. Pollen, M.A.

Senior Program Analyst

 

Joan Albrecht

Program Assistant

 

Doris A. Kingsbury

Program Assistant

 

                     Consultant Staff

 

Kenneth D. Fisher, Ph.D.

Senior Scientific Advisor

 

Maureen Miller, R.N., M.P.H.

Senior Policy Advisor

 

James Swyers

Writer/Editor

 

                       Also Present

 

Beth Clay, Assistant to Rep. Dan Burton


    

                 P R O C E E D I N G S


                                            [8:21 a.m.]

          DR. GORDON:  Good morning, everybody.  Let's just sit for a moment.

          [Moment of silence observed.]

          DR. GORDON:  Thank you.  There will be a couple of items we want to talk about before we begin the session on a Centralized CAM office.  Before we move into our meeting, Steve and I both want to welcome, on all of our behalf, Beth Clay.  Beth is somebody we have known for at least 10 years.

          Beth, at least when I first knew her, she was working with the Office of Alternative Medicine.  She was one of the bright aspects of that office right from the beginning.  She was somebody who was not only extraordinarily competent, but extremely warm and inviting and embracing for the people who came with questions about what was going on at the office or about what they could do to help themselves.  She was really a force of warmth and of strength in that office, and, I think, was very important to its success and to the way it was able to reach out into the world.

          In more recent years, she has been the lead staff person for Chairman Dan Burton of the House Oversight Committee.  In that role, she has been both visionary and courageous in bringing to the attention of Congress, and of the American people, a number of issues that are of deep concern in health, and a number of issues that threaten the health of the American people, and a number of ways that we could improve our health.

          She has really been a major force.  She and Chairman Burton, as a team, have a been a major force in advancing the thoughtful and powerful attention to complementary and alternative medicine in this country.  So I am really happy to welcome Beth as friend and a colleague and a real leader in this movement, and a catalyst for change.

          [Applause.]

          MS. CLAY:  Thank you, Jim.  I appreciate that warm introduction.  It is my pleasure and honor to be here.

          I was honored three years ago to be asked to join the Government Reform Committee staff, to lead the investigation looking at the role of complementary medicine in our health care system.  During those three years, we have done numerous hearings, looking at the various issues of dietary supplement regulation, the role of complementary medicine in various aspects of life, including cancer issues and including end-of-life care.

          Through that process, we have been able to educate members of Congress about the issues that you are discussing and have been discussing for the last year and a half.  We have gone from having members of Congress who were completely opposed to even having a discussion about the inclusion of complementary therapies in our health care system to a particular individual who, at the last hearing, acknowledged the power of spirituality in our healing system.  That is a tremendous growth for members of Congress.

          Through this process, many of them have acknowledged that one of the base issues in this whole discussion is the lack of medical freedom of choice in this country.  One of the aspects, I get calls all the time from families dealing with major health issues, looking for their options, wanting to know what they can do here or if they are going to have to go out of the United States to get the treatment that they seek.

          We have done a great job with being able to point people in the right direction to great web resources such as the Center for Mind-Body Medicine, resources from the Cancer Conferences, and the NIH's web site does a great job of pointing people in the direction of where the research has been.

          As I have listened to the discussion over the last couple of days, I just wanted to make a couple of comments of things that I think are important.  One, that Congress is interested, and many members of Congress are very supportive.

          We had the discussion of, show me the science, which is very important, and we are seeing the science exist; we are seeing government agencies pull that science together of stuff that has already been done; we are seeing meta analysis being published.  I think that is very important.  We are seeing individuals want to make these type of treatments available to those who cannot afford to pay for them themselves.

          My personal perspective is the people who benefit the most from complementary therapies, including those options for wellness and prevention, are those who cannot afford to pay for it out of pocket.  Other aspects of government, other than the NIH, are very important, Bureau of Primary Health Care, Medicare, Medicaid, Indian Health Services, other aspects where government provides health care.

          Forty percent of Americans receive part or all of their health care through government programs, government funding, VA, DOD, Medicare and Medicaid.  It is very important to look at how do you provide those options in those environments, not taking away from other medical options, but enhancing the opportunity to look at nutritional counseling, therapies that are more natural, less toxic, or approaches that may take a little longer to see the change, but they oftentimes cost less and they have less of a taxing effect on the family and on the individual.

          Dean Ornish's program is a prime example.  He came to us -- or, actually I called him.  He was the first person I called because I had been following the science and what he had done. I said, "Dean, why aren't you covered by Medicare?"  And he told me, "Well, for four years I have been trying."

          So I picked up the phone and called Medicare and asked them what it took to add a new therapy.  After an hour of trying to explain to me how complicated it is, it comes down to having science publishing in good, peer-reviewed journals, showing safety, efficacy, and cost benefit, which he has done.  We are now working into demonstration project.

          As I listened to you all over the last couple of days, I wanted to make a couple of points.  Please don't compromise your core values and philosophies.  Please don't compromise that, but the American public is waiting for you to come out with a report that stands by the value system that brought you here.

          The recent surveys that have been published on CAM show that people sometimes turn to CAM because they are dissatisfied with conventional or allopathic medicine, but they also turn to CAM because of their own personal philosophical beliefs systems.  I think we have to acknowledge and respect the other systems of health care, Ayurveda, traditional Chinese medicine, Native American medicine, and chiropractic medicine as well, that these are separate systems with their own belief system and their own theories.

          If you want to participate in a naturopathic philosophy, you should be given that right.  If you want to practice chiropractic medicine in its entirety, you should be given that opportunity.  If your chiropractor is your primary care physician, if that is the philosophy you believe in, you should not be forced to turn to someone else as a gatekeeper to get there.  That is expensive, and it does not respect that we have acknowledged that everyone should not be discriminated against because of their race, their religion, or their creed.  And that happens as well in the medical system.  We have to respect that system.

          If our goal is to level the playing field in the educational arena, which you have had discussions about, I would like to see in this report an explanation of what the current status is for educational opportunities for scholarships and the different health professions, and the licensed health professions, for physicians, for nurses, for massage therapists, for naturopathic doctors, for chiropractors and acupuncturists.

          An explanation of what already exists in all of those fields and a suggestion of, if you want to level the playing field X or Y would have to be done.  You are not saying that everyone at the table believes that should be done, but you are laying it out there for a government staffer to understand where the field is and where it goes, if the goal is to provide the same level of opportunity for scholarship or student loan for a chiropractor or a naturopathic doctor as you do for an MD.

          If there is any reason to discriminate against any health care professional whose salutation is Doctor, I would like to know why.  I would really like an acknowledgement of why it would be okay to discriminate against a different type of doctor.

          The other thing that came up during your discussion, and it will be the last thing that I cover, is the Dietary Supplement Health and Education Act.  Our committee has been extremely involved in oversight activities, looking at the implementation of DSHEA.  It has not yet been fully implemented.

          We often hear in the media that with DSHEA the FDA lost the power to regulate dietary supplements.  Nothing could be further from the truth.  I have a list, seven points of regulatory authority that the FDA has.  I am not going to take the time to read them, but I will pass it around if you would like.

          They have seven points of regulatory authority.  We would like to see them fully implemented.  We are, at this point in time, waiting for the Good Manufacturing Practices specific to dietary supplements to be published.  They are with OMB at this time.  They should be coming out soon, and we are anxious and encouraging to have them fully implemented for us to be able to provide the FDA with the resources to do their job.  If you can assure that the quality of the product is there, if what is in the bottles is on the label, nothing more, nothing less, than the consumer has a better option with providing quality products.

          There are very good products out there, some very good ones.  Someone here at the table who does a tremendous job providing quality products.  There are some people out there that don't do a good job, but if you have a regulatory authority who is doing their job in enforcing that, the bad players either get out of the business or they come up to the standard.

          That doesn't mean that everything has to be standardized.  It is like cooking.  If you are going to make a stew, you don't have the measure to the exact amount what you are putting in the product.  If you are making a souffle, maybe you do.  So it is a matter of what you are looking for and what you are doing with the product.  Those things need to be taken into consideration.

          We have a wonderful opportunity with supplements in helping people understand the three-legged stool of health care.  With prevention and wellness is nutrition, physical activity, lifestyle approaches that can include nutrition with nutritional supplements.

          As we look at the worlds that cross, everything that is nutrition and lifestyle isn't CAM, but as you look at making educational suggestions for children, and if you set something along the lines of, it is important to recognize the need to educate children on nutrition, stress management, and whatever else you want to include in that, and incorporate in that educational system CAM options, you are not saying that you should only teach children with yoga and meditation, but that they should be given that opportunity where it is appropriate.

          It is not the Commission is making a decision that, everyone endorses yoga or meditation, but that those options ought to be included in the consideration.  There are a lot of things we would like to see out of the report, a suggestion specific to, what do you have to do if you want to include acupuncture in Medicare.  Tell Congress the specifics of those different things.  Go through the laws where you are going to need to include licensed CAM professionals in government programs, whether it is Public Health Service, Medicare, DOD, VA.

          When Dr. Fins, two days ago, mentioned using the hospice model as a model of how you integrate, he was on target with that, because in end-of-life care the hospice team, the patient is in charge.  The patient decides what treatment they are going to receive.  You have a doctor, you have a nurse, you have a social worker, you have a chaplain, you have a family member, caregiver, you have a volunteer.  It doesn't matter whether it is a CAM therapy or not, it is what the patient wants and what the end result is.

          I also want to take a moment to tell you what a wonderful staff you have.  I have known Steve Groft for 10 years.

          [Applause.]

          MS. CLAY:  When I first met him, he was coordinating a Biodiversity Program for the Office of Unconventional Medical Practices with the Fogarty International Center.  It is because of him five government agencies came together to do the Biodiversity Program.  I watched him do it.

          When I met him, he was so nice and so good, and I was so discouraged about how decent men could be, I swore he could not be true to who he was.  I swore he had to be a fake.  He proved me wrong, and I am pleased, and I can sleep at night knowing that you have got somebody like this as the executive director.

          [Applause.]

          MS. CLAY:  He is still nice.  And Jim Gordon, who has stayed true to his belief system through this whole process.  He brings people together.  We should all be proud of the work that he is doing, both at the Center for Mind-Body Medicine, in Kosovo, in Macedonia.  He is teaching us how to help people come through trauma.

          Yesterday, one of your public speakers didn't tell you what he did on Tuesday.  As a volunteer in the Veterans Administration, Dannion Brinkley has served 9,000 hours at the bedside of veterans, along with running an organization, being a best-selling author, traveling the world and helping people.

          Those are only the hours that are officially logged.  I can tell you, it is probably twice that, 9,000 hours of service to his country, helping veterans leave this world, using complementary therapies to make them comfortable, help them close their issues with their family members, when they have family available, because oftentimes veterans have no family.  That is an American hero.

          [Applause.]

          MS. CLAY:  So, thank you for this chance.  I would be happy to answer any questions.

          DR. GORDON:  If you have questions, yes.  I think it is a wonderful opportunity to ask Beth, because she is not only leading the effort, really helping to move the effort ahead in Congress, but has a wonderful perspective on everything that is going on in the public arena.

          Joe?

          DR. PIZZORNO:  Well, thank you for your inspirational words to start our morning.  Could you tell us about the legislation environment in which our report will be released?  And maybe some guidance you can give us on how best to position it so that the work that we are doing will have its greatest impact.

          MS. CLAY:  First thing, don't be apologetic.  You were created by Congress because we needed to hear the next step.  We had Chantilly 10 years ago.  We had the "Alternative Medicine: Expanding Medical Horizons" book report to the NIH on the status of complementary medicines.  That has been almost 10 years.

          I don't know how many of you have read that lately to see how much of that has been fulfilled.  I plan on going back and rereading it in the near future, so by the time your report comes out we can check off, take the checklist for the 55, I think it was, recommendations -- maybe it was 155 -- that have been fulfilled in the research environment; clear, concise recommendations of what needs to be done to integrate alternative therapies to fulfill the needs for education, licensure, research, and access.

          The environment is different because more people are accessing complementary therapies, or choosing to be alternative, across the board.  Now, the interesting thing is, there has been huge staff turnover in the seven years since DSHEA passed.  So part of it is a reeducation of what the issues are, because the average staffer on the Hill is probably under 30.  So I am probably the old guys.

          The report needs to fully explain the arena that you are working from: what are the CAM issues; what are the philosophies or the value systems; what are the principles for which there is consensus throughout the CAM community; what are the challenges for physicians as they choose to or not to integrate, to or not to make a referral; and is it appropriate to look in other systems as the medical doctor, the MD, as a specialist.

          When you look at, for instance, chiropractic medicine, this is a health care professional licensed in every state and territory in this country, and in many areas can be considered a primary care physician.  Just because their philosophy is different, the system from which they work is different, doesn't make it wrong.  We have the remember that.

          Chiropractors are trained.  They are professionals, and I would hope that any health care professional, if they are dealing with a situation that they cannot handle on their own, would make a referral.  Anybody that doesn't isn't living up to the standard of their system of medicine.  I think we need to put away fear and move forward with that.

          As you introduce your report, if you are clear, you are concise.  The report needs to be something anybody who has no background in CAM, no understanding of the field, can pick up and read and understand.  That is the most important part, give the background.

          DR. GORDON:  Great.  Effie, and then Tieraona.

          DR. CHOW:  Thank you very much, Beth, for a very inspirational delivery and sharing what you had to say.  Particularly, you said to not compromise ourselves, and to speak what is the truth.

          Now, you mentioned about making recommendations in, for example, school children as, say yoga or state what their different practices are, and it is up to their choice.  Can you give us some more wise advice?

          I think there is a feeling that we must not shake the boat here with our delivery, and that we want to soften our expressions and so forth.  Can you give us any advice on that?

          MS. CLAY:  You have a clear mandate, four points of issues you were supposed to cover.  Cover them, giving the history and the background.  If something is controversial, then say, this is a controversial topic, but this is the current state of affairs and this is where in the CAM community would like it to go.  Just lay it on the table for us.

          Yes, you don't want to be so outrageous in something that you state that nobody would respect what you are saying, but nothing that you all talked about has been outrageous.

          DR. GORDON:  Thank you.  One of the things I want to say is that Beth has been here -- you may have seen here -- but she has been here throughout, so she knows what we are doing in a way that very few people do.  So I think her advice really has tremendous weight and tremendous importance for us.

          Tieraona, and Tom had a hand up.

          DR. LOW DOG:  I want to appreciate your passion as well.  It comes through.  I think that, also, to remind us that when we say, do not compromise and speak our truth, that we do not all have the same truth, and we all have different beliefs.  So that each one of us will bring to the table our own unique belief and our own perspective.  So, do not compromise no matter what your belief is, I think, is extremely important in a diverse group such as this.

          You started out talking about respecting and including Ayurvedic and Native American.  Then we went on to talk about licensure and licensed practitioners, and who you could have as your primary care provider.  I think that anybody could choose any system of medicine, pretty much.  I mean, I have people in the State of New Mexico who just use Native healing, because we live in a state with many Native practitioners.  They use the Indian Health Services as their alternative medicine.  When they get sick, they have to go to the doctor, but that is not their primary choice.

          So I think many people are already doing this.  I think the issue that has confronted the Commission has been licensure versus non-licensure.  There are a lot of practitioners, who are good practitioners, who are not licensed, who choose not to be, who will be discriminated against because they are not licensed.

          If you are licensed, you can be part of the medical system.  So already, we have discriminated against, and you have restricted access.  So these are very tough issues that we confront.  They are not easy, looking at trying to include reflexologist and aromatherapists, and Reiki practitioners.  Many people would see their Reiki practitioner as their primary care, but they may not be licensed.

          So when you are dealing with licensed, non-licensed, registered, traditional, it seems like we are always going to have some people that are left out.  To me, it does seem that people right now do have choice.  If they can pay is the issue, but what are we going to be willing to pay for?  Because we are always going to leave somebody out of the picture.  We have heard all sides here.  We have heard everybody, licensed, non-licensed, registered, not.  We have heard it all.

          MS. CLAY:  Well, it is interesting because you look at it at different levels of bureaucracy.  One, the practice of medicine is regulated at the state level, and if you are going to he talking about a government program of reimbursement, more than likely you are going to be talking about someone who is regulated by their state within a licensed environment.

          I think that when you look at practitioners whose professional association either doesn't exist or hasn't come together with a national standard, then you talk about encouraging those professions to do that.

          When you get into someone who is a healer, and it is not a schooled profession, then that is a different environment, and I am not sure how to solve that.  That is not something I understand how to solve, because if you are talking about someone from in their own cultural system, I can read every book on the shelf and I can listen to 100 lectures, but if I am not within that cultural system, I am not going to pretend to understand that system completely to be able to make a judgement on that, and I don't want to dictate to another cultural system, such as the Native American community, how they should regulate something of that nature.

          We get a little squeamish in government when you talk about religion and government or religion and the practice of medicine.  Spirituality is very different than religion.  The only allopathic system left behind or afraid to acknowledge spirituality until recently, but the events of September 11th, what was the first thing everybody did.  We prayed.  We had a National Day of Prayer.  So when it gets tough, we go back to our core system.

          I don't have the answer on how you do it, except for making recommendations of acknowledgements where each profession is at this point in time, and what their challenges are going to be.  You don't have to tell them how to do their profession or how to regulate their profession, but what the challenges are going to be if they do not develop a certification or registration or licensure.

          DR. GORDON:  Thank you.  I am going to ask for real quick questions.  We have a very full agenda.  So Tom, and then Joe.

          MR. CHAPPELL:  Thank you, beth, very much for the presentation and your support.  You have jogged my memory on the questions of access and not allowing a gatekeeper.

          I just wanted to ask the Chair whether I missed one of the recommendations.  I don't recall our addressing this straight on, and I know that the sentiment throughout the process has been to honor more direct access and freedom of choice on the part of the consumer for a primary.

          Did I miss a recommendation here?

          DR. GORDON:  I will defer partly to Linnea and Joe, but it is one of the basic principles, freedom of choice.

          Do you want to speak to the recommendations, Linnea, that are there in Access?

          MS. LARSON:  I don't think we have addressed it.

          MR. CHAPPELL:  I don't think we did either.

          DR. FINS:  One of the issues that we talked about yesterday is, what is the definition of a primary care provider, and there are two definitions.  One is, somebody who you don't have to go through another doctor to get access to, and the other definition is, how comprehensive the primary care services that person provides.

          So I think defining more precisely is important.  There isn't a fundamental disagreement here, but the definitional issues, I think, are getting in our way.

          MS. CLAY:  I do hope you will put a full glossary and an explanation of what you are meaning when you use that, because language and the interpretation of that language will change the perspective of what the report says.

          MR. CHAPPELL:  Could we ask that that committee provide some clarification in the form of a recommendation?

          DR. GORDON:  Sure.

          MR. CHAPPELL:  And that it honor the value that -- I'm not sure that defining primary care is the right strategy.

          DR. GORDON:  My suggestion, Tom, would be that you work with Joe and Linnea on that issue.  That is, that you talk with them and have discussions with them, and give them your thoughts, and help them formulate it.

          MR. CHAPPELL:  Thank you.

          DR. GORDON:  Joe.

          DR. FINS:  Beth, thank you for your support, and also for your concern and regard for the needs of dying patients and their families.  I mean, it has just been consistent from the very first day or two, and you always remind us of our ultimate mortality and fragility.  So it is really very important.

          I want to ask you just a quick questions, and maybe we can talk more about this later, about the DSHEA issue.  One of the things that I think a lot of us have struggled with is the package insert and the labeling, and all that.  I think we all kind of appreciate how complicated a legislative package that is, and that it has not yet been fully implemented, and there is so much more to do there.

          Maybe we could get some counsel about whether or not increased information on the package insert would still be within the spirit of DSHEA, to give the consumer information about drug/drug interactions, the level of dosing.  In other words, if you are taking this supplement and you are also taking a statin to lower your cholesterol, that there may be a bad interaction; go talk to your doctor.

          With that distorting and changing DSHEA --

          MS. CLAY:  They are already doing that.  Companies are already doing that.  If you look at the label of the product, it will say if you have X, Y, or Z health condition, don't take this product, or consult your physician.  As information becomes available about supplement drug interactions, the manufacturers I deal with, and the I am pretty intense in reviewing these things, they do include that information.

          I think that it would be helpful for this Commission to hear, at length, from the best experts in the country on the Dietary Supplement Health and Education Act, and those are the lawyers who helped draft the law.  That would be Scott Bass and Lauren Israelson.  They are two of the finest experts in the country on these issues, and Lauren as well in international supplement laws.

          I would suggest in December that you have a significant period of time set aside for that so that you can ask the people who have been in the trenches for a long time, and let them help you come to an understanding of the law, where it stands on third-party information or packages and labeling.

          DR. GORDON:  Great idea.  Thank you, Beth.

          I have two.  The same would apply, also, to information about new research on benefits on supplements?  Or not?

          MS. CLAY:  Well, it is real interesting.  In the law, if a researcher publishes an article that makes a disease claim in the title of the article, the company has some restrictions -- and Tom, can address this -- of what they can and cannot use on that article.

          There are supplements out there that do affect the disease state, and a lot of people use them, but the companies are restricted from making that claim.  We made a decision on not being able to make a disease claim in DSHEA.  It says that clearly, that a company cannot make a disease claim on their product.  That is not to say that consumers don't know what benefits them and what the research is showing them in new products.

          I would like to also address the statin issue.  Do you know we would be saving about $45 billion a year in the Medicare population if we had allowed red yeast rice products to stay on the market.  It would not have the serious side effects that we are having with some of the statin products, and the whole antioxidant issue that is going to come up in the next publication may or may not be an issue.

          We are talking about $45 billion of your tax dollars that are going to go out for statins when we get a prescription drug benefit.

          DR. GORDON:  One thing that I might suggest is that the group that is concerned with regulation might want to, even before December, have a meeting with the lawyers and bring those formulations to us in December.

          I have a question, which I hadn't asked Beth ahead of time.  If any of the facilitators have a specific question, may they get in touch with you?

          MS. CLAY:  Of course.

          DR. GORDON:  That's great.  So that we can continue this dialogue.

          The other brief question I had, just for this morning, is, do you have any thoughts about what we are calling Coordinating and Centralizing Federal CAM Efforts that you would like to share with us?  Because that is the next topic that we are going to move into.

          MS. CLAY:  Personally, I think it is the best thing that could come out of this, is that as a congressional staffer, I have to know the federal system to know who to call.

          If you have a central office at a high level within the government that is going to coordinate not within just HHS, but within DOD, VA, EPA, other government agencies, National Science Foundation, is going to be the repository not of all the information particularly, but of who is doing what, and be able to report back and provide an annual report to Congress of what is going on in CAM so that we know where your tax dollars are going, we know the services that are available to taxpayers, to consumers, to the Medicare population, so that we can know what is happening.

          There is stuff happening in the government that we don't get reported.  We have to have had a conversation with somebody to know what is going on.  I get excited when I hear that some of the research that is being done is being done at the VA, which is an incredible opportunity for doing research because you have got a patient population that is controlled and tracked, and they are open-minded because what they want is a good resolution for our veterans.

          So those are opportunities, but we need to be centrally reporting that so that people can know about that.  Then you have crossover, you have integration, you have partnershipping.  Without someplace to go for that, that won't happen.

          DR. GORDON:  Thank you very much, Beth.  We are going to have to stop.

          Beth will be available, especially as we move ahead with looking at recommendations.

          Thanks again, Beth.

          [Applause.]

          DR. GORDON:  There is a question of order that Tieraona raised with me.  We had planned and we will move right into Coordinating and Centralizing CAM Efforts.  The question that she raised was whether we should put off, until after we deal with new issues, discussions of the impact of September 11th, or whether we should deal with that first.

          I just want to see a show of hands.  Her concern was that if we moved into that very deep heart and psychological space, it might be difficult to come back to new business.

          We are definitely going first with CAM Central.  After that, how many would like to go to new issues?  Let me see your hands.

          [Show of hands.]

          DR. GORDON:  Let's get a count on that.  Ten, okay.  We will go to new issues, and then we will spend some time on the events of September 11th.

          Steve, any other announcements before we move ahead?  Okay, let's move ahead, then, with Don and talking about CAM Central.

          MS. CHANG:  If Donald wants to come up here with Joseph Kaczmarczyk, then we can go ahead and continue.

          DR. GORDON:  Great.

          DR. WARREN:  I think after Beth's presentation, I can rest.

Session VIII: Coordinating and Centralizing Federal CAM

          DR. WARREN:  Well, we have the last but not least committee of Coordinating and Centralizing CAM Federal Efforts.  Our committee was Veronica Gutierrez, Wayne Jonas, Effie Chow, and myself.  Joe Kaczmarczyk was our facilitator.  Basically, Joe does a lot, a lot of work.

          I have thought about this.  We have heard testimony for the last two days.  Almost every single committee says CAM Central, and it seems like the more and more things we talked about, the more and more we heard about CAM Central.

          I need to know one thing.  Does the Commission feel like, right now, we need a centralizing and coordinating office?  Show me by raising your hands if you think so.

          [A show of hands.]

          DR. WARREN:  Well, darn.  You know, if you said no, I could quit.  My gosh.  Okay.

          We have got a lot of things we can cover with this.  We need a center at the highest level possible.  We need somebody to come in and direct all the coordination across the board.

          Gerri had a list in your handouts.  It was Appendix 4, in the Committee on Coordination of CAM Research.  It listed the Department of Health and Human Services.  It has eight different departments under it.  Agriculture, Defense, Education, Energy, Labor, Veterans Affairs, independent agencies.  All these things have research capabilities.  Consequently, they all have CAM research capabilities.

          Right now, we are looking at a situation in our country where we need CAM right now.  We don't need it six months from now.  We don't need it five years from now.  We need it right now.  We have things available in CAM that could help our country right now.

          Has it been shown to be safe, efficacious, and cost effective?  Most of us that do CAM have not been concerned about doing research because of the apparent success that we have had all these years.

          None of us have been trained as researchers.  We have gone out, we have seen what works in our practices.  Our research is clinical efficacy.  It has kept us in business.  We have techniques.  We have products right now that could be put into the VA, that could be put into the public health system, that could help these people get well now.  We need it now, not tomorrow, now.

          This office should be positioned, the way we looked at it, at the highest possible level we could see.  We thought, well, what is the highest level, DHHS?  If we put it in DHHS, what is it going to do?  It is going to be able to influence DHHS.  It is not going to be able to influence this other list.  It is going to influence only about the eight departments in DHHS.

          Then we thought about, well, let's park it in a foster home.  If we park it in a foster home, where are we going to put it?  We can put it in the Office of Domestic Policy.  Well, that may work for a while.  We can put it in the Office of the President.  The problem with that is it is not permanent, but, boy, does it have broad reaching manifestations.  We can get out there and we affect every single agency on this list.

          Then we thought, where else can we put it?  We could put it in the Office of the Surgeon General.  Well, that has not even been confirmed yet, so where are we going with that.  We need something.  We need an office that is funded.  We need an office that has FTEs, that have full-time employees that take care of this.

          Are we going to try to take over NCCAM's work?  No.  NCCAM is basically research.  We are not trying to take over their work.  There is so much more out there in this pie called CAM, that NCCAM isn't ever going to have to have something with a budget that is at least as comparable to NCCAM or more.

          Am I rambling long enough?  I need to ramble more?  We looked at the functions of this thing.  No. 1, we tried to prioritize functions, and we came down to five basic functions, but I don't want you to feel like this is the only function this thing is going to do.  It is not going to be limited by these:

          No. 1 was the title of our committee, coordination and centralization of CAM activities; No. 2, federal CAM policy liaison.  I see this as really tying all the loose strings together.  I love it.

          Planning and convening conferences.  Somebody was talking about CAM Central will get with all these different organizations and have conferences on CAM, conferences on efficacy and safety.