[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

          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.

          A centralized federal media point of contact.  This is not the CAM Central is going to have all the information available.  They are the clearing point for this.  People call in, the media, whatever, personal, professional, they call in and say, where can I get this information.  Boom, they have got a list right there that can put them in touch they need to be in touch with, and it moves on.

          Then last but not least was facilitation and implementation of the recommendations that we put together.  If we don't light a fire under the burner on our recommendations, they are going to get tabled.  They are going to get thrown in the trash can, they are going to get thrown in the desk drawer, and they are going to get gone.

          So, what are we going to do?  Coordination and centralization.  What we propose is to try to put the office at the highest level possible, and it depends on who decides to put the office in.  It depends on where they want to put it, what they want to name it, but we would like to see it put at the executive level.

          Now, DHHS is fine, but if you are going to shoot for the stars, you might as well hope to hit the moon.  Let's go for the Executive Branch in the executive offices.  It can be temporarily fostered in a variety of the offices there, the Office of Domestic Policy.  That is one of them.  The President could say, I am going to put in an office of CAM, whatever he wants to name it.  It could be there temporarily.  It is not permanent there until you get some legislation that would hold it there and fund it.

          Let's move on to the next one.  Basic curriculum.  I am getting calls from the University of Miami Medical School.  I am getting calls from California, Arkansas.  They want to know, how do we put together a curriculum for our medical schools -- dental, they don't even seem to be interested at all -- but medical schools.

          This office could coordinate that effort.  They could show these people how you could put together a nice, integrated CAM curriculum in the undergraduate, graduate, and post-graduate.  They would be able to help the scholarship programs.  They would be able to help with post-graduate training, development of public education.

          I have often thought, let's just enroll everybody in the United States in the Nutrient-of-the-Month Club, because that seems to be the basic nutritional advice that people give.  What is hot today, oh no, let's have kava-kava, all this different stuff.  What worked best for Ms. Bessie down the street doesn't necessarily work best for Joe next door.  Let's get it coordinated.

          There is a rift, conventional versus CAM; CAM versus conventional.  I hope that this office will bridge that gap.  We are going to have to bring in the commercial ventures.  Tom is in nutrition.  There are many other companies.  There are many great companies out there, but like Beth said just a minute ago, there are some real sleazes out there.  Oh, you didn't say that, did you.  There are some real sleaze companies out there the put out a lot of claims that they can't back up.  Let's get them off the market.

          Planning and convening workshops.  We can talk, talk, talk, but we are going to have to do some action sometime, but planning and convening conferences, that lends credibility to what you are doing.  I like it.  Bring all these different health care professionals together with CAM, and let's talk it out.  It has been a real intriguing here, because there are straight MDs on this, and then there are CAM all the way, and then there is a mix of in between.  It is really neat that we have been able to sit down and talk.  I think this office would promote that to the nth degree.

          Being the central contact point for the media.  This is not to supplant NCCAM's mandate.  They are there.  They have got their research purpose.  This is to basically take the pressure off of them.  They don't have to do all of it.

          Last but not least, put to work, put into motion the things that we have come up with.

          [Audio interruption.]

          DR. WARREN:  To recommend that the President, Secretary of the Department Health and Human Services, or Congress should create an office at the highest possible and most appropriate level, with sufficient staff and budget to perform functions that include, but are not limited to, coordination of federal CAM activities, a federal CAM policy liaison with conventional health care and CAM professionals, organizations, institutions, and commercial ventures; planning and convening conferences, workshops, and necessary advisory groups, centralized federal CAM media points of contact; and facilitation of implementation of the White House Commission on Complementary and Alternative Medicine Policy recommendations.

          Questions?  Yes, Joe.

          DR. PIZZORNO:  By the way, I think this is outstanding.  Two recommendations.  First off, on page 2, I think we should add a No. 6 on the list of responsibilities for this office, and that would be assisting the evolution of emerging professions.  I think this is a critical area.  While we agree that all professions may not want to emerge, there is a lot of ferment going on right now, and they need assistance.

          Then second is, I believe we need to formally state that there be an advisory body for this office.

          DR. WARREN:  I believe I left out, in my ramblings, the possibility of an advisory body for this.  It is mentioned in your document about the advisory body.  It will be trans-departmental, right underneath that, on page 2, Joe.

          DR. PIZZORNO:  Thank you.  Then in that advisory body, I just wanted to specify that it be a conventional, CAM and members of the public.  Just specify that, conventional and CAM being included.

          DR. GORDON:  So Joe, you are asking that that be part of the recommendation as well?

          DR. PIZZORNO:  Yes.  It would be specifically noted in the recommendation.

          DR. WARREN:  David?

          DR. BRESLER:  Again, I very much agree with your idea about having such an office at the highest level that we possibly can, even if we are parking there temporarily while more permanent arrangements are made.

          I wonder if your group has considered the possibility of thinking even bigger, that at the executive level, if there were something like the Center for Mind, Body and Spirit, that our guiding principles may apply not only to CAM and health care delivery, but to education and other interests of the government.  With this administration, there may be an opening or an opportunity to develop such a center that would encompass our guiding principles at a very high level.

          Again, I think this is something your group should take a look at as well.

          DR. WARREN:  Are you suggesting that the title of the office be the Center for Mind, Body and Spirit?

          DR. BRESLER:  All I am suggesting is I think there is an opportunity, given the current climate, and the current administration has great interest in spirituality, and great interest, I think, in our guiding principles in a lot of areas of government.

          I am just saying it should be considered that if we are interested in getting support at a very high level in the administration, what we are doing may have a broader appeal, not just to CAM but to other issues as well.  I think it ought to be thawed out by your subcommittee to take a look at that possibility.

          DR. GORDON:  David, I am not sure, as Don is not.  Are you saying that that would be part of the office, separate from it?  Or, you are not making decision about that?

          DR. BRESLER:  I am saying one of the possibilities is to have an executive decision to create it within the executive division of government, just by presidential decree.  I think there is an opportunity to look again at our guiding principles that I think might have a lot of appeal to this administration in other areas of government as well.

          If a decision is made that we need to take a look at the integration of mind, body, and spirit for the welfare of the American people, certainly CAM is a great illustration of this, but there are other areas of government that could benefit from our guiding principles as well.

          I am saying there might be broader appeal, a chord that we could strike to get such an office at a very level.  All I am suggesting is that your group take a look at it.

          DR. WARREN:  Well, we just had the Office of Homeland Security established.  Would that be a good place for this to be asked?

          DR. BRESLER:  We ought to consider all possibilities for it.

          DR. WARREN:  Joe.

          DR. FINS:  I fully appreciate the need to have some sort of centralized process to bring a lot of the recommendations to fruition, to operationalize them.  I think it is almost an inevitability, coming out of the process we have been engaged in over the last year and a half.

          I am, though, concerned.  Joe was beginning to get to some of these.  I think it needs to really be in the recommendation a little more specificity for the office for a couple of things.  One is accountability.  This has the potential to be a highly political appointment.

          I think Dr. Straus at NCCAM has done a wonderful job because he has been perceived first as a scientist and has brought tremendous credibility to that endeavor because he is not an idealogue.  He is interested, he is engaged, but he is not, in that same way, ideological.

          I think that this office could reflect the personality, the idiosyncracy of its director and do a disservice to science, and it could do a disservice to CAM if someone was too far out there.  So I think we need to think carefully in this recommendation, how do we avoid the kind of excess.  I think this Commission has found a balance because of the fact that there are 20 of us or so on this Commission, and together we get it right.  I don't think any of us individually get it right, but collectively we are going to try to get it right.

          So, how do we bring that to this person who, in a sense, becomes the single legacy of this body downstream?  I think that I would like to suggest a couple of ideas.

          One is, that the advisory body that is going to be part of this gets constituted first, and that advisory body makes a recommendation to the President or the Secretary on who the nominees should be.  There is no advise-and-consent process here because it is not at that level of government.  It doesn't go before the legislature.

          So I think that this advisory body should make a recommendation, and that any future appointees would also be brought forward before that body.

          The second point is that perhaps there should be specific mention of who should be on this advisory body, such as representatives from the Institute of Medicine, organized medicine, leaders in CAM, and the public, maybe a retired senator or congressman who has got some time on his or her hands to contribute to this.

          So we really have a body that would have the standing to say that it wasn't a political or idiosyncratic appointment, but someone who really is a good political choice, and also a good scientist, investigator, clinician, et cetera.

          I also think perhaps there should be some sort of sunset clause in this, a five-year trial, which would get us into the next administration, or the second term of this administration.  With these safeguards, I think that the people who would really find this offensive might be less offended, and the proponents of this office would actually have an office that would be more effective, because you have built consensus from the get-go into the appointee, and not nominated someone in this very ideologically complex arena who would not initially have the backing of a broad range of American people.

          Just an idea.

          DR. WARREN:  Tom.

          MR. CHAPPELL:  Thanks.  Good job.  I have been feeling the need for this throughout our whole process.  Otherwise, you just wonder where the recommendations are going to go, how are things going to get implemented.

          I just wanted to speak about the importance of leaving the recommendation open.  I actually want to affirm the way it is presented here, because I am concerned that if we try to qualify it, I know as an executive how I would feel about the recommendation if it came to me.  I am an executive.  We are asking an executive to consider something.  I don't feel like something in a straight jacket.

          DR. FINS:  But, Tom, most companies have boards.

          MR. CHAPPELL:  I have got the floor.

          I just really want to discourage further qualification.  I think the recommendation that Joe is making is helpful, but I am in opposition to your recommendations, Joe.  I really think that they are confining, controlling, manipulating, and we just have to have faith.  If we want this in the Executive Branch, we have got to let the Executive Branch make its choices and do its thing its way.

          DR. KACZMARCZYK:  Tom, if this recommendation came to you as an executive, how would you react to it?

          DR. WARREN:  As is?

          DR. KACZMARCZYK:  As written.

          DR. WARREN:  As Written.

          MR. CHAPPELL:  Oh, as written.  I find it quite reasonably open, helpful, constructive.  So I am not concerned about its present draft.  It is guiding, informative, but, I don't feel, constraining.

          DR. WARREN:  George.

          DR. BERNIER:  Don, I share with you a realization that there should be a central focus in the federal government to provide the sponsorship for this program.  You have observed, in your ramblings, that this is a marvelously diverse group, this group that sits around the table.  It is very clear to me that there are a significant number of people who feel very, very strongly that there has to be a research arm.

          In fact, as we debated yesterday, some people think it is the most important that we have in CAM, and others felt that there were other issues that should take its place.  I am, personally, one of those that feel that we have a wonderful opportunity to utilize a research program to, once and for all, judge the quality and the efficacy and the safety of agents before they necessarily get into the market and not be useful.

          So I think we need to have a central focus.  I think it would be a shame to play down the impact that this organization is going to be able to bring to bear on the shaping of the research program for CAM.

          MR. DeVRIES:  There really is a very strong need.  I think we all agree on this in terms of, once this Commission is out of business, basically come March, that this office would in a sense facilitate the implementation of the work.

          With all due respect, Joe, I certainly understand your recommendation, but I have to support Tom, because I think this is so important.  I think we want to be very careful to give President Bush the broadest range of options to, hopefully, cause him to do something with this and to move forward.

          So I appreciate and support Tom's recommendations.

          DR. WARREN:  Something Joe just handed me, there is a middle way.  Leave the recommendation fairly open to executive decision or appointment, but fairly prescriptive in its basic proposal.

          This is usually the way that these things are created anyway.  That is basically what you are alluding to right now.

          DR. PIZZORNO:  But we are leaving in the advisory board, right, in the recommendation?

          DR. WARREN:  Yes.

          DR. WARREN:  Go ahead, Steve.

          DR. GROFT:  Joe, if I may just interject something here.  Traditionally, in the government, in the search process for senior executive level people, there would be a search committee put together.  It would include people from the outside and inside the government, you are going to get both, especially at a very, very high level.

          There are many factors that go into the selection, one of which is the element of trust and knowledge of an individual, that whoever the selecting official is going to be will want someone that they know of and that they can trust, who will implement the policies that they feel are appropriate.

          So I think for us to add an outside advisory group, while it would be welcome, the same as what currently happens in many, many positions, nominations are put forward to members of the government.  I think, following the traditions of how executive level personnel are selected, I would suggest that we leave that up to the executive level itself.

          I think the message is clear of what we want them to do, what we would like them to do, and then they go through the vetting process.  Similar to what happened to the selection of you as members here, there were many, many nominations put forth, I am told.  I think the White House personnel system goes through a process.  The decision is made first, where do you want to put the office, who is going to be the selecting official, how do we get the selecting group that will make the nomination, and then they move forward.

          So there are a lot of opportunities for public input.  Having sat on lower level selections and groups, there is a process, and I think it works, just to add that in.

          DR. FINS:  May I respond if I could, Don?

          I appreciate that point, Steve, and I respect Tom's response as well.  I would just make two points.  One is, that every CEO serves at the pleasure of their board of trustees, and they serve in that regard.  So there is accountability.

          I think the point, Steve, you just made about there is an executive search process and search committees that go forward, I think with this particular office, given the ideological dimensions of the discussion, and we talked about transparency a lot in the last couple of days, I think to make process transparent will actually foster trust in this director or secretary, whatever the position is.

          If Tom could engage me for a moment, I think that having a little bit of additional safeguard here and a little more transparency would actually foster the goals of this office.  It would make that individual have more credibility, and be perceived more as an even broker.

          Will it mean that the extremes of the CAM movement are thrilled with the appointment?  Probably not.  Would it make that person more effective in an integrative role?  Probably yes.

          And the second unrelated point, but it is along the same lines, is, I would suggest that this office not be called the CAM Central, but the Office of Integrative Health Medicine or Health Care, or something like.  In other words, to really bring in the spirit of, if this person is a coordinating entity, then the idea is to coordinate, to integrate, not to separate.

          So there are two points on the table.  One is the transparency, and the second is the integrative name versus a CAM name.

          DR. WARREN:  Jim.

          DR. GORDON:  I think the discussion is bringing up some important issues.  I think, to most directly address the point that Joe and Tom and George and Steve have been talking to, I don't think we should make this office so different from every other appointment.

          I think that is a real mistake.  I think it is important to have the advisory board.  I think it is important perhaps to say what we are looking for in the person, but the head of NIH doesn't have this, the Attorney-General doesn't have it.  It is just strange.

          DR. FINS:  They have Senate hearings.

          DR. GORDON:  I'm sorry?

          DR. FINS:  The attorney-general is confirmed by the Senate.

          DR. GORDON:  Can I continue?  That is not a bad idea.  I am not averse to that at all.  What I am looking for is a process that recognizes the dignity of this office on its own, and that it has as much dignity and as much stature as any major office in the government.

          And so, to single it out for that kind excess, in my mind, or unusual scrutiny, doesn't seem fair or reasonable.  So that is No. 1.

          I think it may be helpful to go back to the committee, though, in light of what you are saying, and ask for some guidelines about the kind of person, the kind of qualities that we are looking for in this office, if you understand what I am saying, and maybe that is implied in the description here.  There just may be a few more things that we want to have put in.

          I also think that I would like to hear a little bit more about the deliberations, Don, your thoughts about where the office might go.  It sounds like what you have said is, let's just give it back to the Secretary and the President, and let them make the decision about where it should go.

          Are you being more specific?  You are saying at the highest level, but highest, I don't know quite what that means.  It sounds like you had some thoughts about maybe it should be in the Office of Domestic Policy in the White House, and maybe it should be level of the Secretary, and maybe at the level of the Surgeon-General.

          So I would just like some clarification about where are you with that.

          DR. WARREN:  What we talked about was the possibility of placing this at the Department at the Secretary level, and we decided that that was really restrictive to what this office could do, because it would deal only with HHS and their agencies.

          We feel like it would probably be best placed in the Office of the President, in an office of its own.  I don't think it is up to us to name that office.  I think we should allow the President to name it.  I mean, I would let the President name the office.

          But we feel like that is the level it should be at.  We also feel like, and we talked about this in our meetings, about having a dual advisory board.  One advisory board would have public input.  They would have practitioners on there, but there would be public input.  This public input and these advisory board comments would then be given back to an advisory board of all the intergovernmental agencies that have an interest in this.  They would make their recommendations back to that public board again, and ultimately the public board was the one that would then report to the President.

          DR. GORDON:  Is the analogy here to the Office of AIDS Policy, for example, that is now in the White House?  Is there an existing analogy at this point?

          DR. WARREN:  There is a pot full of them.  Basically, this is for coordination.  You have got Homeland Security.  That is a coordination office.  You have AIDS Policy.  That is a coordinating office.  There are some others listed in this material you have gotten today.

          I am going to digress a minute.  I keep hearing this thing about transparency.  There is not a board in organized medicine, there is not a board in organized dentistry that is transparent.  I don't know about the other boards, but I can tell you about those.

          Everybody has got their finger in the pie, and you never know what deal has been cut under the table.  This board right here is the most transparent board I have seen.  We all have our little agendas, but there are no deals being cut under the table.

          How are you going to guarantee these people --

          DR. GROFT:  For the record, everything is done in open session, and there are no closed sessions here.

          [Laughter.]

          DR. WARREN:  I mean, there are conversations.  I haven't cut a deal with anybody.

          Effie.

          DR. GORDON:  It answers the question.  I am just wondering if it might not be spelled out, some of those analogies.  It sounds like you are making a pretty clear recommendation, which I wasn't clear about to begin with, that it should be at the level of the White House.  I just think maybe we need some thoughts about that, because you also raised some concerns about it being at the level of the White House, because although there are advantages, there may also be disadvantages because the occupant of the White House changes.

          So I think we ought to have some discussion about that, and I think if that turns out to be the recommendation, I would just suggest that we develop the analogies so that the White House now, and Congress, will understand why we are making that recommendation, and how it might work.

          DR. WARREN:  Ti?

          DR. LOW DOG:  With Joe, and Tom, and George, and everybody, isn't it possible, since we have raised the issues under Challenges about uncertainty how people are going to view it and all of that, somewhere in the background or the challenges, couldn't there be a just a couple of sentences that this position is going to be extremely important, and then qualities.

          I don't think it needs to go in the recommendation, but I think that there is certainly room to put a little bit of this in the background of the challenges, because I think it is part of the challenges that have already been addressed, and how would you address the challenges.  I think there is room for a couple of sentences.  I don't think I would put it in the recommendation, in the background kind of place.

          Recognizing the challenges that we see with this, it is going to be critical to the directorship.  And then leave it.  But I don't think I would put it in the recommendation.

          MS. CHANG:  Donald, just a time check.  According to the schedule, you have 15 minutes left, unless the Chair wants to cede some of his time.

          DR. WARREN:  Gosh, then I can slow down my speech, then, can't I?

          Effie.

          DR. CHOW:  Again, I agree with what Tom has said and what Jim has been expounding on.  There are several things I just want to note here, quickly.

          In the recommendation, I think this is one thing we all are fairly unanimous about.  And thanks, Beth.  She has also confirmed the importance of this -- that we should state it in the draft recommendation the import of this particular recommendation.  All of the others are important, but I think this is unanimous.

          The other is just a plaint about the executive officer.  I agree with Jim that we should make specification, but not too tight.  I think it is really true, we shouldn't bind them, but the executive officer must have knowledge and experience with CAM.

          I say this because I get calls from people who are stepping into positions of $150,000, and he says, "I don't know anything about CAM."  He is being paid to find out about CAM, and I am volunteering my time to give them the expertise of 30 years in CAM.  I am sure some of you are also in that position.  So I think that specifically.

          Now, in speaking to David's comment about body-mind-spirit, if we are clear about our overall guiding principles and definition of CAM, it includes body-mind-spirit.  I don't know whether you are referring to having a separate office or within this CAM Central, but that inherently and very specifically could be spoken to as a guiding principle of what CAM Fed is.

          Also in the recommendation, I think we should put a time frame urgency to this, like when do we want it.  This is the most pressing and urgent time frame, immediate development, whatever that immediate is.  Within six months, within a year, what is the reasonable time frame for urgent?  This is urgent, urgent, urgent.

          Did you want to make a comment on that?

          DR. GORDON:  I just wanted to add something to that, that one of the things that we have talked about before in here is putting this recommendation -- and Steve may want to address this, but he and I have talked about it before -- is putting this recommendation out ahead of the rest of our recommendations, so we begin to lay the groundwork for that central office.

          So I just wanted to mention that, that that was a possibility, that we have discussed with the full Commission before as well.

          DR. CHOW:  I would venture to say that it should be developed to coincide with this Commission moving out of office, and that that should start when this goes out.  I know that that may be too soon, but it may not be if it is presented with urgency, and because of, I think, the people speaking.  We have heard the people, and it is coming from the people, too, as well.  It is not just coming from us.

          Then, just a couple of other things, minor or major things.  Will this office also keep in touch?  I know it can't keep in touch with all the private things that are going on, but we should also know some key private institutions or associations where we can refer people when people come in and want information.  Or government, they should want to know.  The different departments of the government should want to know what is happening out in the field.  So that, we should include some knowledge of what is going on, the key institutions to consult with that.

          Then, in planning conferences, I think that is a great activity.  I would add in there, promote conferences.  We don't have to do the organization of the conferences at all.  It is also, money wise if we work and co-partnership in that sense, that we promote and foster appropriate conferences.  Thank you.

          DR. WARREN:  Joe Pizzorno.

          DR. PIZZORNO:  I think the positioning of the office is incredibly important, and I need to understand a little better about what the options are.  When looking at something which is so clearly focused on health care, you made one example of the Office of AIDS being in the Executive Branch.

          Are there are other examples, or if we put it in the Executive Branch, are we isolating it in a way which is too unusual?  Can you just kind of give us some examples of places of where offices like this can end up?

          DR. GROFT:  The Executive Branch, it is all the departments, HHS, Labor, Energy, they are all part of the Executive Branch, the Executive Office of the President, for example.

          DR. PIZZORNO:  I understand, but the subheading, it is like there is one which is all about health.

          DR. GROFT:  Department of Health and Human Services.

          DR. PIZZORNO:  Right.  So, do all offices like this usually end up there, or NIH, or do they end up somewhere else, too?

          DR. GROFT:  It depends on the responsibility and functions that are identified either in legislation or the Executive Order.  So if there is a research bent, it could be the NIH, it could be the CDCNP.  Regulatory, it could be FDA.  If it is reimbursement, financial, Social Security or HCFA.

          DR. GORDON:  Steve, what about the issue of the distribution between HHS level and White House level?  I think that is what Joe is asking.

          DR. GROFT:  Again, when you get up to the White House level, and there are a few people here who have had that experience, it is really of national significance -- with a great deal of, I hesitate to say, the political clout of the Office of the President -- to get certain things done in a hurry.

          You see the White House establishing advisory groups regularly, unfortunately too frequently for some of us for some things.  They get a response, for a rapid response in getting an answer back to the President very quickly for an action that needs to be taken on the part of the President.

          DR. PIZZORNO:  So, the Office of AIDS, where is that located?

          DR. GROFT:  It is in the Office of the White House.  You have got an Office of AIDS Research here at NIH, and I believe there is an Office of AIDS down at the Department, at HHS.

          You can have a whole straight-line function from the White House down, you can have that at the Department through all of the agencies.  Then it is distributed out through FDA, NIH, CDC, and the likes.  So it depends on the activities on how it goes.  Once you start the thread, it can be stretched.

          DR. GORDON:  I know Sandy Thurman, who occupied that office.  There are certain real advantages to being at the level of the White House, in that you are much more closely connected at the highest levels of government.  There may be some disadvantages, though, unless there are comparable -- and this is maybe what Steve is referring to -- unless there are comparable offices at other levels of the bureaucracy.  Here, we do have NCCAM, but there may not be anything at the level of the Secretary of HHS, and there may not be anything in any of the other agencies.

          What I am thinking, Steve, is if we should be offering the committee some more information about the pros and cons of the various levels.

          I don't know, Joe, how much that was looked into.  Maybe you can talk about that a little bit.

          DR. KACZMARCZYK:  I can assure that during the working group's meetings, the issue has been widely and extensively debated.

          To answer Joe Pizzorno's question, let me say that the working group looked at, where do you want the influence; where do you want the coordination to occur, at what level.  You can do that across departments by putting it somewhere in the White House.  You can do it within HHS if it is put in the Office of the Secretary or some component within DHHS.  The working group thought, given the Commission's mandate, it would be better to put it in the Executive Branch, specifically in the Executive Office of the President where there are other offices.

          Moreover, then you can look at how it could be created.  You can put it in an existing office, or you can create a new office.  If you want to create a new office in the Office of the Secretary, there are examples.  There is the Office of Women's Health, there is the Office of Minority Health, both of which arose as recommendations from task forces.

          If you want to put it in the Executive Office of the President, there are existing offices there where it might fit.  The working group considered those.  If you want to create a new office in the Executive Office of the President, you can do so following the examples that have been cited so far, such as the Office of National AIDS Policy.

          Does that answer your question, Joe?

          DR. PIZZORNO:  Thank you.  That made it very clear.  I appreciate that.

          DR. WARREN:  This is where we felt we get the maximum punch for the buck.

          David.

          DR. BRESLER:  It seems to me that this is one of the most important recommendations that we are going to make.  We are a presidential commission.  I think we ought to tell the President exactly what we want him to do about this.  I think the less ambiguity and confusion that is in this recommendation, the better.

          I think we ought to tell him what we want to name it.  Let the President change the name, or somebody else change the name.  I think we need to be extremely specific and extremely strong in this recommendation.  We need to tell them that we want this work to continue after the Commission expires, and that by putting it in the Executive Division, this is a way to continue it quickly, but that we want to find a permanent home in government.  This should, I think, go in the recommendation as well.

          We ought to be as specific as possible, as unambiguous and as clear as possible, including the name of the office and our vision for what it is going to do and how it will be.

          DR. WARREN:  Tom Chappell.

          MR. CHAPPELL:  I concur that we ought to try to name this office.  We have tried different names.  We have tried "integrative," we have tried "collaborative," we have tried "complementary" standing alone without "alternative."  It is really hard to come up with something that seems to fit all occasions, quite frankly, but I would like, nonetheless, to ask if the committee could either comment on its discussion on this point, or at least to take it back and give it further consideration, and to recommend a name.

          DR. WARREN:  We tried that.  We tried to come up with various names that would make a great acronym.  We will take suggestions.  If you will write your suggestions down and e-mail them to the North Pole.

          MR. CHAPPELL:  Let me speak to what the advantage of "integrative medicine" is.  It suggests a working relationship, collaborative tone, a collaborative view going forward, as would "collaborative" as a name.

          I know that it doesn't speak for all occasions, but I also think complementary and alternative medicine has become a symbol in itself that has negative connotations to a broader community.  I think it is worth the search for something other than CAM, and I think concepts like "integrative" or "collaborative" are more productive.

          DR. WARREN:  Why don't take naming the thing, take it back to the workgroup.  Let us hash it out, and we will give you a new recommendation.

          Joe Fins.

          DR. FINS:  Thanks, Tom, for that.  We are buddies.  I think that is the spirit that we have to go forward in, that there is this kind of integrative, collaborative, diverse view.  I just want to make, I think, a factual statement about the Office of AIDS Policy, and that the hazard, to some extent, of having something in the Executive Office, the Office of the President.

          What happened was, as I understand it -- maybe someone here knows something more about it -- that it was initially sort of freestanding, and then in this administration it got put into the Domestic Policy slot, which meant that AIDS was not an international problem.  It was sort of part of the isolationism of the early part of this administration, which, of course, has now been changed.

          So I think where you put the office really would flux depending on which administration it was in, the priority of the administration.  If you have a sympathetic administration, you might get demoted in the next administration.  So I think that is an issue.

          The other thing, Jim, you raised the question, and maybe Steve or Joe knows the answer to this, at what point does rank require confirmation?  Is that an assistant secretary?  I mean, obviously, the secretary level.  Are assistant secretaries confirmable?

          I think this is information that we would need to know.  If the rank is there and it requires a confirmation, that would give it standing.  It would also give it accountability.  I just think that kind of information, we would need to have to make a more thoughtful decision about this.

          DR. GROFT:  Let us get back, and we will give you the whole structure of the Executive Branch and the level of appointments, and then who confirms and things like that.

          DR. FINS:  Thanks.

          DR. WARREN:  We talked about the director of this.  If we could have a director that was a career person in CAM, in conventional, interested in both, and then have that person being the main honcho.  If we want to put an appointed member, they are a figurehead.  They would have to go through their confirmations, or whatever they have to go through, but they are a figurehead.  The main chore is done by the permanent office.  That is just something we threw out, a possibility.

          DR. GORDON:  I think we need to look at it, because, for example, the surgeon-general, who is appointed and has to go through hearings, is not a figurehead.  So I would see it more along those lines, of that kind of person with real authority, who obviously wouldn't do all the chores of the office but would be in charge of the office.  I think that is important.

          So I think there are many ways to think about that position.

          DR. FINS:  Jim, just one little, quick follow-up.  I think there are people who are special assistants to the President, who also have assistant secretary rank.  So you may be able to have your cake and eat it, too.

          Is that incorrect?  No?

          Well, I think, anyway, we should get this information about the range of bureaucratic possibilities that could exist.

          DR. WARREN:  Effie.

          DR. CHOW:  I wonder how many people realize -- I think you can confirm this, Steve -- there are about 200 commissions, White House commissions.  My point is that there are either 10 or 20 only that are appointed by the President by Executive Order.  This Commission was appointed by Executive Order.

          So we are the top 10, or 20?

          DR. GROFT:  I think it is very, very few at this level.

          DR. CHOW:  I heard that from the representative of the White House Commissions.  We need to keep it at that level.  I think if we put it any lower, I think we are giving a message that, ourselves, we don't feel it as important as when the President made this Executive Order.

          In every position, we are going to have the negatives we have to deal with, but I think that is important, to see the positive.  I don't think there is anywhere else we can put it under, the appointee of this.  Then perhaps later down the road, because we are really speaking for the future, not only now, but the future as well.  So short term and long term.

          So that, we go into the Executive Office, of course there is this instability, but then we would build in recommendations to deal with that instability, to develop it down the road, just like having other offices.  So that within a short time, we should have CAM things through the different agencies, and so forth, established.

          That is why I keep talking about that we are speaking for the people.  Not only that, we are one of the few executive-appointed commissions, and we have to keep looking.  This is why I was happy to hear Beth saying, don't confine yourself; really speak out if we need to say that it is controversial, or if we need to ratify that we feel it is controversial.  We still need to speak out on it.  The same with this office.

          DR. WARREN:  Thank you, Effie.

          Veronica, do you have any comments as a member of the committee?

          DR. GUTIERREZ:  I would like to say that I appreciate Joe Pizzorno's suggestion about assisting the evolution of emerging professions.  When I came on the Commission, I thought that was one of our primary directives, and I am glad he caught that so that wasn't lost.

          I enjoyed working with this committee very much, and I have stated many times, I would like to change the CAM designation, also.  I like "collaborative."  I like "integrative," but I would like to leave the word "medicine" out of what we are doing, because we are taking health care in a completely different direction, and I would like our name to reflect that.

          DR. WARREN:  Thank you very much.  Anybody have any other comments?

          Effie.

          DR. CHOW:  I just want to confirm, also, Veronica's statement.

          DR. GORDON:  Don, are we okay now?

          DR. WARREN:  Well, I just want to say that we are going to take all these recommendations back to our committee.  We will work it out, hash it out, and we will have something to give you much substantive.

          DR. GORDON:  We have one recommendation, and there have been many suggestions to take back to the committee, and I just want to make sure we are onboard with them.

          I just want to check, was there unanimous agreement about the need for this centralized office at some location?  Any dissent from that?

          [No response.]

          DR. GORDON:  Okay.  Joe.

          DR. FINS:  It is not a dissent.  I mean, it really isn't.  I think it is really the details of the safeguards and the structure, but I think the concept is agreed to.

          DR. WARREN:  Is there a unanimous agreement that we need a centralized office?  And we will work out the details?  Is there?  Show me your hands.  I want to know.

          [Show of hands.]

          DR. WARREN:  So we have got a unanimous from this Commission that we need a centralized office.  We will get the details for you.  Thank you.

          DR. GORDON:  Okay.  Thank you.  So that is clear.

          There were two additional pieces that there seems to be general agreement to in the recommendation.  One, was that the office was concerned with fostering the evolution, assessing really, and fostering the evolution of emerging professions, No. 1.

          Second, that there be an advisory board with a diverse composition reflecting all aspects of the health care community and the public as well.

          Good.  So those are clear.

          David suggested looking at the possibility -- and I gather it is something separate from this office, but that is still not clear -- of a center for mind, body, and spirit.

          DR. BRESLER:  What I am saying is, given our current administration's interest in spirituality in various ways, it may have a particular appeal right now to get us moving quickly.

          DR. GORDON:  But I still can't figure out, David, if that is part of this office, or separate from it.

          DR. BRESLER:  I am saying if there were such an office of mind, body, and spirit, what we are talking about could be a subset of that office.

          DR. GORDON:  Okay.  That is a suggestion that David raised for consideration.

          There were a number of thoughts about how to help shape the direction and the spirit of the office, and, basically, the way things came down is, people wanted more background on what the various options are for the office, although the committee's clear sense, and a general sense, although not absolute around the table, was it would be best to have it in the White House.

          There was a desire to have more information about the pluses and minuses of those different locations, and about the process of nomination and confirmation that related to different locations in the federal government.

          There also were some suggestions that we may want to elaborate a bit more, although many of them are spelled out quite clearly here, on how the office would function to bring people together.  There is a sense that I mentioned, and Tieraona elaborated on a bit more, about the kind of spirit with which it would coordinate and work with the various agencies.

          There was considerable discussion, and an understanding of a need for much more discussion about the name of the office and the pros and cons of the different names.

          I think I would like to add, too, Don.  So if you could come back with why and why not.

          The last suggestion that was raised was serious consideration to not having "medicine" in the title.  I assume you are wanting to have "health" or something like that in the title, rather than "medicine."

          There is an understanding that whoever is going to be in charge of this office needs to be personally and professionally knowledgeable about CAM.  We don't want somebody who doesn't have a knowledge, who is brought in.  I have heard that from a number of people around the table, regardless of the profession from which the person is coming.

          Then the issue that Effie raised, and that we had a little bit of discussion about, is the time frame and the sense of urgency.  I just wanted to get a little bit more discussion about that now.

          Steve, I wondered if you wanted to say a couple of words.

          I think it would be useful to hear Steve's perspective on how something gets moved ahead in the bureaucracy.  I know a lot of concern that has been expressed around the table is that if there is nothing in place by the time the Commission ends, it is going to be very difficult to move things ahead.  I think that we heard that yesterday, and we have heard it at other meetings as well.

          So, Steve, do you want to address that?

          DR. GROFT:  Thank you, Jim

          There is always that concern that when a commission goes out of business, that you write a report, and it rests somewhere.  For how long, you don't know.  As I mentioned very early on, in my previous experience with commissions, if there isn't an implementing office, or an office with responsibility to follow up on the recommendations, nothing can be done for many years.

          I think you are expressing an urgency that, even though this activity will terminate on March 7th of next year, that something be in place that will continue to look at the recommendations and have some accountability back to the public for what the Commission recommended.

          To me, it is very important for an activity to continue, regardless of the funding level, regardless of the permanence.  The permanence, for example, manifested with the director, may not occur for another year, but an acting director could be put into place.

          There are a number of options that are available, even if a decision is made, administratively, to put it within the Department, while not optimal, at least as a resting place for others then to debate the issue of where it would go, including the issue of who would be the permanent director.

          So there are a number of issues that need to be discussed, and decisions made yet, but I certainly would recommend that the activity be continued somewhere.  I think there are so many different recommendations.  NCCAM has responsibility within the NIH for certain activities.  I think it is much broader than just research.

          DR. GORDON:  I just want to add something.  Again, for Steve's response and everyone else's, the possibility in December, early on in that meeting, since there is consensus that we need an office, since there are questions about exactly where and the name and structure, that if we can come to a consensus in December, and if this makes sense to us, put it out as a commission recommendation and try to move that agenda ahead between December and March, so that hopefully we would have an office in place with some structure by the time we gave our report.

          Steve, is that something we can do?

          DR. GROFT:  Within a commission, one does not have to wait until the final report is issued to arrive at recommendations that there is agreement, especially if it is unanimous agreement, that the commission feels something needs to be done immediately.

          I think that is a very strong message to go back to the administration, all aspects.  Congress as well, that we do feel that there are certain things that need to be done, and done quickly, to make sure that these activities are perpetuated.

          DR. WARREN:  I think the ball is rolling.  I think it is just a matter of fleshing everything out, since we do have unanimous consensus on this.

          DR. GORDON:  I would like to, though, hear if there are any other comments on this issue, because I think this is an important one.

          Linnea, Effie, and Veronica.

          MS. LARSON:  Thank you for the excellent summary.  I do want to make a comment.  I don't believe that there -- well, maybe there wasn't a consensus on an office at the White House.  I really do feel a need to have real clarity on the pros and cons, and the governmental functions: what does Congress do; what can they do; what does the Executive Branch.  Have everybody be very clear about those rules and regs.

          DR. GORDON:  Thank you.  That is what I was hoping I was saying, and I appreciate your clarifying it.

          DR. GROFT:  And we will get that information and bring it back to you in a package for the next meeting for further discussion, and perhaps resolution.

          DR. GORDON:  Effie, Veronica, Joe, and Joe.

          DR. CHOW:  Maybe this is an appropriate time, maybe it is not, but I would like to throw it forth.  We put a lot of thought into this.

          For a commission, the recommendation for this office to continue, and to continue in the spirit which we hope it would continue in.  I think there needs to be a continuum of certain members to this office, this CAM office, CAM Central.  Let's just use that.

          I would like to throw out, and this isn't throwing it out with little thought.  I put a lot of thought into it.  Having been involved at the Secretary's Office as an advisory group to the Secretary, and having been with the major organization policy levels at national levels, I would like to recommend, and I am happy to do it more appropriately later, that the Chairman and the Executive Director continue for an interim time as part of our recommendation, for six months to give a good continuation to the development of this office, and that there should be a certain number of the commissioners here, whether it is six, eight, or half of the commissioners that formulate the first advisory board, and then adding to the thing, also for an interim time, for six months, whatever, to carry forth and add new members immediately to whatever number of advisory council.

          I would like to make that a strong recommendation, to give what we have put out, all the energy that everybody has done, the diverse opinions, and knowing where things are, to give it a good, fine start.

          Thank you.

          DR. GORDON:  Thank you, Effie.  Veronica.

          DR. GUTIERREZ:  Having had a few minutes to think about David's suggestion of mind, body, spirit, I think it would be an excellent idea to have an office, a subset of some sort.  We had so many of the public testify of the benefits they have received from all the providers that could be in that classification, not licensed, not certified, but definitely contributing to the health of the community.  I hate to see them fall in the cracks in our effort to structure them more, formalize professions.

          So being on the committee, I would like to peruse that and make sure we preserve those concepts.

          DR. GORDON:  Joe.

          DR. FINS:  I just wanted to float a name, which I think Veronica and I were talking about, and it is Office of Integrated Health, which is OIH, sort of simple.  Not a good acronym, but it is simple.

          The other thing I just wanted to the mix -- Tieraona said this -- is the issue of the advisory body, and I see I have lost the battle to have a vetting process, but I would suggest that there will be an advisory body in place, and essentially that advisory body will probably have some input into who is selected.  The first nominee, or whoever, would probably use a more informal process.

          I would like something substantive in the background section, and a passing reference to it in the recommendation, about the kinds of outreach, specifically, to the organizations of organized medicine, as well as the organizations of the colleges of the various CAM groups, just so that there is, as it were -- it is not the right metaphor -- legislative intent here, that we really did want to, in the very best inclusive, pluralistic kind of way, to create a advisory body that was qualitatively good and diverse, and it wasn't completely political.  I think that would, in the long term, help the person who will head up this entity.

          DR. GORDON:  Thank you, Joe.

          Joe Pizzorno.

          DR. PIZZORNO:  I have been doing a lot of thinking about this comment you made about releasing this early.  I think it is important that we look at the pros and cons.  Obviously, a pro is that we all agree that it needs to be done and we want to get it going as soon as possible.

          A con I could think of would be, without the rest of the Report that supplies the substantiation for this, that it might be too easy for it to be discounted.  So I would like to request of the committee that at the December meeting you put together pretty rigorous pros and cons, so we can think this through in the most effective manner.

          DR. WARREN:  There is quite an elaborate process to just get this thing to the table first.  If you just start the ball moving right now, you are going to flesh it out before it ever gets to the decision of where to put it, what to name it.  We are going to try to name it in this.

          You could get all that detail done, and have all the initial baby steps being taken, and then when it is time to know the information, it will be ready and it will click right then.

          DR. PIZZORNO:  So I just want to be clear, my concern is those initial baby steps won't be taken because it is not taken seriously enough, because we haven't shown the documentation for it.  I don't know, it may be an unnecessary concern.

          DR. WARREN:  They are taken by interested parties, and if you have got an ally or two, that sure does help.  Let them make the incremental steps.

          George.

          DR. GORDON:  We have five more minutes.  I think Linnea was first, and then George.  Sorry.

          MS. LARSON:  I want to second that, and maybe clarify what Joe Pizzorno is saying.  I have some familiarity with having an expeditious process, especially within government.

          However, I think for the members of this Commission, having the pertinent information before the December meeting, so we have enough time to bring both logic and heart to those deliberations, then to say, we have now marching orders that we all agree on.

          DR. GORDON:  I think Joe Kaczmarczyk, and Steve and Michele, and others can help provide that background.

          Linnea, do you have a sense of how much time you would like, when you would like to have that information to consider it?

          MS. LARSON:  I think that if we just get the information, then we can read it -- and I think that everybody here is a speed reader -- well, you can get it two weeks before.  That is enough.  I am talking about understanding the government and the process and the mechanisms.

          DR. GORDON:  Okay.  Great.  Thank you.

          George and Charlotte, and then we are going to have to stop.  We have to stop at 10:15.  So, George.

          MR. DeVRIES:  Thank you.  I appreciate Effie's recommendation that there be a continuity from the Commission over to this new office, but I would say that the Executive Order and what we have been appointed to is the White House Commission on Complementary and Alternative Medicine Policy.  I think we want to give the White House the broadest latitude in terms of what they decide, in terms of going forward, and that these appointments would all be the prerogative of the White House.

          I think obviously the White House is going to be interested in having a certain level of continuity, and those commissioners who are interested, I am sure, would have the opportunity to express interest to the White House to participate, but I don't think that we should create any prerogatives in our recommendation for this office.  I think that that should really be the prerogative of the White House to decide how to go forward.

          DR. GORDON:  Charlotte, and then Effie.

          Steve, do you want to say a word?  Just briefly, go ahead.

          SISTER KERR:  Just very quickly, I just wanted to say for myself I am not sure I am clear or have decided on the name in terms of "complementary" or "integrative."  I need to look up the root of the words again, and maybe we can put that in our handout.

          To me, "complementary" more has some emphasis about uniqueness and individuality, diversity, all in a relationship.  I am not so sure we want to integrate.

          DR. GORDON:  Maybe, then, what we could say is, just as Linnea is asking for the details about legislative choices, or rather choices of location for an office and the issues of moving the process ahead, maybe we can have a detailed discussion of the advantages and disadvantages of the different names that you are considering, and why you are doing it.

          Steve, did you want to say a word?

          DR. GROFT:  Yes.  I thank Effie for her words of support.  I think when I took the position, that I made it very clear that I would not remain in this status with any activity.  I think for me to try to stay in the position that I was recommending as the Executive Director would not be appropriate.

          I have created quite a burden for my existing office, the Office of Rare Diseases at the NIH, with my absence.  They have not filled my position with anyone else.  I have to and want to honor that commitment to return back to that office.  There are many exciting things that we initiated and never got to complete with my absence.

          I love all of you and I love what we are doing, but I really have a very, very strong emotional and personal commitment to the Rare Diseases, that I have to return to as of March 8th, but there is the opportunity to continue, and there are several staff members who would welcome the opportunity to continue in whatever function is necessary.

          So that is where I am coming from.  I feel better being able to work with you and feel free to make whatever recommendations we have to make.

          DR. GORDON:  Effie.

          DR. CHOW:  My naming names, I guess it shows the appreciation of the good leadership we have had.  I am sure there are other good leaders in the group as well, but I think that we need to state in our recommendation, as part of the clarification, that there should be a continuation.  Don't leave it to them to decide that they feel that there should be a continuation, because it doesn't happen all the time.

          So I just want a strong statement about the need for carrying through with some commissioner being temporarily on to facilitate.  They don't have to stay on.

          DR. GORDON:  I wanted to thank you, Effie, for your support as well.  I think the issue of continuity is one that you have addressed in the recommendation, and I think what you are hearing is, if there are any more explicit recommendations about how to maintain continuity, that might be helpful, understanding also, that it is always the prerogative of the administration to make its own appointments.

          DR. WARREN:  I just want to thank everybody for agreeing on one thing.

          DR. GORDON:  We are going to have to stop now.  Joe, go ahead, quickly.

          DR. FINS:  Just looking at the International Report, and if there are any lessons on how other countries have done this, if they have done this, or if they have gotten ahead of us, just to have that.

          DR. GORDON:  Great.  Thank you all very much.

          Don, thank you, and thank you, Joe.  This is really well done and well discussed.

          We are going to adjourn for 15 minutes.  We will start again at 10:30.

          [Recess.]

            New Issues and Recommendations

          DR. GORDON:  You have in front of you a list that Ken Fisher has prepared for all of us of new issues.  Now, what I would like to do, since we have a number of new issues, is essentially make sure that we understand what we are talking about with the new issue, and then refer it back either to the appropriate group to consider, or in the case of the General/Cross-cutting Issues, have a general understanding that all groups need to consider these particular issues.

          Does that make sense to everybody?  We can't address them in detail in this short period of time, but we need to be clear about what we are talking about, and we need to be clear that we do want to send them back to the groups to take a look at.

          Does that make sense to everyone?  Good.

          As I go down this list, let's go through them.  Let's make sure we understand what they mean, and if the people who raised these issues want to say a few words about why they raised them to clarify what the issues, that would be very helpful.

          Let me go to (b) under No. 1, because I know Joe Fins is very much concerned with (a).  Glossary and List of Acronyms.  Everybody clear about this?

          This is going to be a staff function, right, Michele?

          So this will be a staff function.  Jim, do you want to say something about this?

          MR. SWYERS:  I just wanted to say that I have already putting together a short list.  What I would like to do is send it around to everyone and say, what are the other things you think should be on this.

          I am also putting together a style sheet for the Report, because it is important.

          DR. GORDON:  And Jim would welcome, I am sure, input about what he is sending out and areas that you think he may not have covered as well.

          MR. SWYERS:  In the next couple of weeks I will e-mail that to everyone.

          DR. GORDON:  Great.  Thank you, Jim.

          Budget Issues: Research and Coverage.  Ken, do you want to tell us exactly the context this came up in?

          DR. FISHER:  Fortunately, all I did was write it down, Jim.  I think that was one that was brought up in the course of the discussion of Coverage and Reimbursement, and it had to do with the different types of research.  I don't remember who made that recommendation.  It might have been Joe.  Health services research, I think it was.

          DR. GORDON:  Effie?

          DR. CHOW:  I may not have made the total discussion, but I remember I brought up the issue about the fact that when we talk about there is research being done, or there are activities being done, and then talk about the increment: wow, we have increased by 800 percent our budget.  Yet, it is a very small percentage of the major budget.

          DR. GORDON:  Thank you, Effie.

          So what we are talking about here, and probably this goes both to the Research Committee, and also to Jim Swyers for background, is some sense of what the budget has been, and what the overall budget for research is.

          Thank you very much, Effie.

          Joe, we are going over No. 1, and I wanted to make sure you were here for some of the issues, and make sure that these issues are understood and addressed.  The first one is transparency.  Ken has listed: disclaimers; conflict of interest; declaration of sources of support; and vested interests.

          Do you want to say a couple words about how you see this issue being addressed in the Report as a whole?

          DR. FINS:  I think that it is in several different arenas.  It could be, obviously, in the research arena.  I think the evolving standards, that are still inadequate, probably, regarding industry-based support for biomedical investigators should be something that the CAM community of researchers endorse.

          I think we talked a lot about the Internet sites and the Good Housekeeping Seal of Approval, or whatever we are going to call it, about transparency.  People are not obliged to join into that, but if they met certain standards that the editors agreed to, they could get that kind of endorsement.

          I think that a more generic point about transparency relates to the deliberative process that will take place in government down the road on an issue where there is some polarity.  I think it would behoove us to say somewhere in a generic form that the more open, the more apparent the process is, the selection of nominees and composition of groups and all, the more likely that it will engender the kind of consensus that will be necessary to move this forward.

          DR. GORDON:  Thank you.  Again, one of the reasons for having these as overarching issues is so we don't say them every moment, but we articulate them at key places so that they are understood as being part of our perspective.

          Fourth, is informed consent for CAM treatment.  Again, do you want to address this one?

          DR. FINS:  I think Veronica made just an absolute stellar point.  Let me just step back for one second, because I think it is a structural comment on the Report itself.  The Access and Delivery section that Linnea and I had the privilege of moving forward, I think we might want to call that Regulation.  Access and Delivery was really more covered in Coverage and Reimbursement.

          I think that we need a couple of things.  One is regulation regarding organizational life, the JACO accreditation of institutions.  We have done nothing there.  Informed consent is a kind of legal authorization for treatment, and I think that the issue is, what is the threshold at which practitioners would need the consent of patients to practice their art.  I think it is something we really haven't talked about.

          Clearly, anybody who touched somebody without their consent, it is a tort; it is a violation of privacy, but at what point do we suggest that there is a formal, legal, written informed consent process for treatment?  I don't know if it is a problem, but I think it is something that we might want to get some information on.

          DR. GORDON:  Don, go ahead.

          DR. WARREN:  Aren't we talking about contract law?  If somebody gives you a written informed consent, that it then goes to contract law?

          I don't know all the ramifications of that, but that is a contract between individuals, as long as you do that person no harm.

          DR. FINS:  It goes back to the Schloendorf case in 1914, which Benjamin Cardozo in New York State, before it went to the Supreme Court, articulated the basic modern notion of informed consent, and it really took place in the 60s.  It does come out of contract law, but it is a derivative.

          The question I would just ask is, just to know what are the practice patterns as far as whether CAM practitioners get consent for their modalities in a formalized way, whether we think it is necessary, whether we think it improves safety.

          We are talking about empowerment on the one hand.  We empower the consumer to make good choices, so they need to be informed.  On the other hand, we don't want to overly want to restrict access.

          DR. GORDON:  Joe, what I would like to recommend is that you and Linnea take that back to Access and Delivery.  The other issue that you raised is separation of Regulation from Access and Delivery, which I think is fine, but I also think that Coverage is still a different section.

          DR. FINS:  Absolutely, but I think we need to do more on the regulation piece.

          Can I just ask, to help Linnea and myself, if all of you who are CAM practitioners could send Michele

-- or, I guess it will be our working group, still -- just a brief note about what your own practice is regarding informed consent, whether when you do a manipulation, Don, you get an informed consent.  If you can point us to any information about the practice, and the CAM modalities you practice, it would be very helpful.

          DR. WARREN:  Do you want copies of that informed consent?

          DR. FINS:  If you have stuff, yes, absolutely.  Thanks.

          DR. PAZ:  One of the understandings, even as a practitioner in conventional medicine is that we have to get informed consent from everybody who walks in our door.  That is the number one thing we have to get, regardless of their insurance, or lack of insurance.  We have to get informed consent from everybody.

          If we do a particular procedure in addition to that, we have to get informed consent from that in particular as well.

          DR. GORDON:  Thank you, Conchita.

          We have a whole lot of issues.  The purpose of this time now is to make sure we are clear about what the issue is, and to get it back to the appropriate working group.

          The final issue here is: Populations using CAM versus vulnerable populations migrating to or using CAM.  Joe, I think this is yours again.  Anyone?  Linnea?

          MS. LARSON:  It was a request for more information about, is there any more data on what populations use it, particularly an ethnic minority, in its research for substantiation within the Access and Delivery, so recommendations naturally flow from the documented evidence.

          DR. GORDON:  Great.  Thank you.  So that is essentially a request for information from the staff and/or any of us who have information to give to you and Joe for your committee.

          MS. LARSON:  Right.  This is a procedural issue.  What Joe and I have done, with Michele, is information goes to Michele first, and then comes to us.  So she is always aware of what the pathway is.

          DR. GORDON:  Thank you very much.

          We will move on now to the specific sections.  The first one was a general request, which came from a number of people for history, evolution, and future directions of CAM.  So this goes, really, to Jim Swyers.  Perhaps I will work with you some on this as well, Jim.

          MR. SWYERS:  I think we have already started some of this.

          DR. GORDON:  The second has to do with an increased focus on wellness in this discussion, and that was a general sense of the Commission.  We got it, right?  Or, do you need more information on this?

          MR. SWYERS:  Yes.  I have struggled with what to do with wellness, because I think it does need to be in the introductory section, and since we are going to have a whole separate section on wellness, and because it has recommendations.

          DR. GORDON:  I think it can be part of the definition and the introduction, because so many of the CAM systems are focused on wellness.  I think that is one of the ways that it comes in.

          MR. SWYERS:  I think we can give a brief overview of wellness, and then refer back to the more specific stuff.

          DR. GORDON:  Linnea, go ahead.

          MS. LARSON:  I am back-tracking, but I would really like it if you, in History, would add the important work done by Eugene Taylor at Harvard, with a great article on alternative therapies that looks at the history of spirituality, religion, and medicine in the United States.  Specifically, the other information I think is extremely important is the medical historian, Roy Porter's, work.

          MR. SWYERS:  I'm sorry, what was Eugene's last name?

          MS. LARSON:  Taylor.

          DR. GORDON:  It is in Larry Dossey's journal.

          DR. CHOW:  If it is paper that could be distributed to us, I would appreciate that, too.

          For the focus on wellness, I think there was a discussion that there is a separate component because it is so important, but also that it needs to integrate into the other divisions somewhat, too.  So that is important, that it isn't suddenly, here is a component, and then nothing speaks to is in the other divisions.

          DR. GORDON:  Right.  Is that clear, Jim?  What Effie is saying is, I think she is sort of elaborating on the point that wellness is both separate but also needs to be integrated into a number of the discussions, including the definition discussion.

          MR. SWYERS:  I agree.

          DR. GORDON:  Great.  Joe.

          DR. FINS:  On the wellness issue, I think, Jim, it would be helpful to distinguish between the relationship among issues like health promotion and wellness.  The way I would distinguish it is, health promotion is sort of what the government tells you to do about what to eat and everything; wellness is the assumption of that responsibility by the individual.  I think that kind of distinction in the evolution doesn't make them oppositional, but synergistic.  Something along those lines would be very helpful.

          DR. GORDON:  Thank you, Joe.

          Other suggestions or thoughts about this issue?

          DR. WARREN:  Wellness is the existence in the disease process below the clinical threshold, isn't it?

          DR. GORDON:  I'm sorry, is what?

          DR. WARREN:  Isn't wellness functioning within a disease process below clinical threshold?  In other words, we are all sick to a degree.  We just haven't noticed it yet?

          DR. GORDON:  I think there are many definitions that come in, including wellness as part of an outlook, even in the midst of illness.  So I think that is an important element as well.

          I think what we need to do is, any other thoughts about this, please send them to Jim, and it will be re-presented in December.

          More discussion of similarities among principles of White House Commission IOM Report, Healthy People 2010, and other authoritative reports.

          Do you want to say something about that, Linnea?

          MS. LARSON:  I don't know if it was discussion, it was contexturalizing the report, specific areas in the report that make mention of crossing the quality chasm or whatever, in whatever reports, and then the similarities between some of the statements that we have made, specifically guiding principles, and there were three different sections.

          So it was contexturalizing this, connecting it.  I don't think it was discussion.

          DR. GORDON:  I appreciate that.  That is exactly why we are having this discussion, is to clarify some of these issues.

          Do you understand that distinction, Jim?

          MR. SWYERS:  I agree, and I think it is important to put this report in with those larger issues, because it basically says we are not doing something different, we are actually supporting those efforts.

          DR. GORDON:  Right.  Effie.

          DR. CHOW:  I think the example was -- what was it -- the Pew Foundation.  There was a lot in there.  It is almost like we are promoting the Pew Foundation guidelines.

          I wonder if it is big and a lot of good content, could it be as part of the appendix, instead of into the body of the recommendation area and discussion area.

          DR. GORDON:  Joe.

          DR. FINS:  We are taking a report that was based on generic manpower issues, and we are adapting to the CAM context.  We are contexturalizing it.  I think what we are trying to do with all of these relationships is to show that we are not out there alone, that we are building upon very solid, bipartisan, nonpartisan, non-ideologically driven work.  Going back to Chantilly, there is a lineage here.

          I think that that just gives it the weight of prior scholarship, and unrelated scholarship.  The IOM report is not really about this issue, but we are seeing similarities, and we came to it in a common fashion.  So that, there is a reality check, as it were.

          MR. SWYERS:  Actually, I think it is about this issue.  It is just not specific.  It is at a much higher level.

          DR. FINS:  It is not about CAM, per se, but it is about the failings of the current health care system, right.

          MR. SWYERS:  Yes.

          DR. GORDON:  I think we have the sense of the group here.

          Under Information, Development, and Dissemination, here are some of the issues that were raised.  If you look at dietary supplement regulation, broad use of surveillance of epidemiology, of adverse reactions.

          Does somebody want to try to clarify these issues, because it is exactly what we are looking for here.  Joe, do you want to say something?

          DR. FINS:  The AER system, a lot of this requires reporting of events.  What we have said a number of times is that you can have an adverse event not recognized because of the poor educational infrastructure amongst conventional practitioners.  CAM practitioners may not identify an illness state.

          So what we are suggesting, I think, is some sort of an epidemiologic process of surveillance to identify problems that might be out there before they become a public health threat.  It seems to me that FDA and CDC might be best positioned to assume that role, and that, as I said earlier, a report of those kinds of adverse events should be reported in MMWR, in Morbidity and Mortality Weekly Review.

          Those are nitty-gritty kind of suggestions, but I think that the general need to have a safe monitoring system would be something that we should encourage.

          DR. GORDON:  Tieraona.

          DR. LOW DOG:  We are going to work on this quite a bit in our group.

          Again, I want to make just a couple of issues about adverse event reporting.  One, the legislation, at this point, remember, is that dietary supplements are categorized as foods.  So we have to be careful with what we are recommending because of their legal categorization.

          So they are not pharmaceutical drugs and they are not held to that standard.  We want to look at the OTC model for over-the-counter drugs, and see what that model is for adverse event reporting, and perhaps piggyback on that.

          We talked last night, a group of us, about looking more at poison control centers, and bringing them more into this loop, and then coordinating them, perhaps with CDC as a surveillance organization that would keep a monitor on it and look for patterns of trends, if there are any trend patterns.

          So we are definitely going to address this and include the surveillance, and present that to the group.

          DR. GORDON:  Tieraona, great.  Just a question for you.  Under (a), are you clear about these issues and how you would like to handle them, or that you were going to handle?  Do you need any more guidance on them?

          DR. LOW DOG:  Actually, I have talked to the appropriate staff members working, and we are going to be in touch with Scott and Lauren.  I mean, we know all of these people, and we are going to run some of these thoughts and ideas past them to make sure that we are consistent with legislation and the spirit of DSHEA, but also maximizing the safety of the public.

          DR. GORDON:  Thank you.  Joe Pizzorno.

          Ken, do you want to say something first?

          DR. FISHER:  Just quickly, the second part of this No. 2, two or three people mentioned, what is going on at the local area; how does a hospital or a pharmacy chain respond to adverse reactions.

          If anybody has any information about a hospital program, an institution program, a pharmacy chain, we are going to go and look and get this information, but if you have any input, please send it to Corinne.

          DR. GORDON:  Thank you, Ken.  Joe.

          DR. PIZZORNO:  A couple of things.  I think a reporting system is critical.  I think I am going to go along with Tieraona, that I don't know if we should call it an AER, because if we do that, we are going to emotionally and philosophically wipe out the people that are actually reporting that.

          The second is, we need to suggest that there be training for people who work in health food stores, and those who do multi-level marketing, because a lot of these products are being sold through those pathways, and these people do not have a clue about how to recognize these events.   So we need to ensure that while we have a reporting system, that those who actually need to report it, know how to actually do it.

          DR. GORDON:  If we are okay, that brings us to letter (b) there.  Joe?

          DR. FINS:  (a)(2) is a slightly different issue.  It is surveillance, but it is also, how do you set up a system.  In other words, assuming nothing is going to go wrong, how should individual institutions set up, formulate, integrate herbals, supplements into established formularies.

          Maybe we can talk to JACO, NCQA, maybe the pharmacy, people who run journals like P & T, formulary and therapeutic pharmacology journals.

          DR. GORDON:  I don't know that that comes under this section here, Joe.  This is really about information dissemination.  That is another issue.

          DR. FINS:  Well, it got put here.

          DR. GORDON:  That may be part of Access, if you want it, but it doesn't come under information.  Information is different from setting up a formulary.

          DR. FINS:  I think it is Access and Delivery regulation, but it was here.  Maybe it is a separate issue.  But in other words, as we truly integrate, let's package it for No. 5, okay.

          DR. GORDON:  You may want to consider it under Access and Delivery, as well as what the implications are for information.

          Let's go to (b), if we are okay on (a) at this point.  Again, this work is about making sure we understand what is down here, and getting it back to the workgroups.

          Let's start with (2) under (b), which Joe Pizzorno just brought up.  Anything more anyone want to say about that, education for health food store and similar retail employees?

          And I am glad you brought up multi-level marketing.  I think that is a really important area.

          Tieraona, go ahead.

          DR. LOW DOG:  For clarification, just since we are working on this.

          DR. GORDON:  Sure.

          DR. LOW DOG:  Joe, this says "Education for health food store and similar retail employees."  Were you relating this, then, to adverse events?  So the education is in that area.

          DR. WARREN:  And the possible drug interactions.

          DR. GORDON:  Joe.

          DR. FINS:  Along those lines, if we can't put the material on the label, if that runs into problems -- and I think Beth Clay's suggestion from earlier, about we get a little more legal input about what we can and cannot do -- we might be able to put information into health food stores, like in a little brochure; if you are taking this or that.

          DR. FISHER:  It is already a provision of DSHEA.  It is part of the implementation.

          DR. LOW DOG:  Part of the difficulty, and we would like to raise this as part of a recommendation, is encouraging groups that have already worked on this to continue to standardize language that would then be used, so that there is an industry standard.

          They did this for Chaparral.  They have done this for, actually, a number of products.  But that is the main problem.  It is already in place, as long as we, again, suggest full implementation of DSHEA.

          One other thing that is not listed here, but it is very relevant.  With your permission, could I just raise it to see if there is any dissent?

          DR. GORDON:  Sure.

          DR. LOW DOG:  In addition to the full implementation of DSHEA, we would like to look at the possibility of making a recommendation, that after 12 months of the release of the dietary supplement GMPs and full implementation of DSHEA, however that appears, that within some time frame, that we ask for an independent study by, perhaps, the Institute of Medicine to look at it then, when the GMPs are in place and the DSHEA has been fully implemented, that there be an independent body to evaluate it and look how it is working: are there weaknesses; are there flaws; is it fine.

          DR. GORDON:  Tieraona, if you feel you want to make that recommendation, bring it back and let's discuss in December.

          DR. LOW DOG:  I don't have to ask for the group to --

          DR. GORDON:  No.  I think it is a question of saying you want to consider that area; give us the pros and cons, and some of your thoughts about it, so we have some real time to discuss it.

          DR. LOW DOG:  So we don't have to ask for ideas for recommendations today, we can just go do it.

          DR. GORDON:  I think it is an area you can just explore.  Is there any objection to exploring that area?  I think it is really a question of, we need to time to think about it.  Give us why, what your thoughts are, possible groups.

          DR. LOW DOG:  I guess I wasn't sure on the process today, so I didn't know if I needed to raise it to the group before we could go explore it.

          DR. GORDON:  I appreciate that.

          We have one more here: Herbals as endangered species.  Do you want to say a couple words about that?

          DR. LOW DOG:  I just think that it is important in this document that we be mindful that a number of these plants are threatened and endangered, and there needs to be some language in this document about that.  If we are environmentally sensitive, which CAM is to be, I think we just need language.  We will work on that and present it.

          DR. GORDON:  Great.  Thank you very much.

          One thing about the issue of the review of DSHEA, I would just suggest you raise that with the lawyers with whom you are talking as well.

          Moving on to Research, letter (a): More money for CAM research, per se, versus modification or recommendations for altering priorities within CAM research needs.

          Does somebody want to address this one?  Gerri, do you want to talk about this one a bit?

          MS. POLLEN:  Well, I am not even sure I am clear on it.

          DR. GORDON:  That is why I was asking for your clarification, if you have one.

          MS. POLLEN:  My only question here is, does this refer to recommendations to NCCAM and other NIH institutes on priority?

          DR. FISHER:  No.  It came up in the discussion, later on, after Research, or maybe at the end of Research.  Basically, somebody said -- and I won't point my finger at her right now -- "We are making lots of recommendations for lots of research, and the pie is only so big.  Are we going to make the recommendations for all this research, or are we going to suggest prioritization within all of these categories."  That was the question to the Commission.

          DR. GORDON:  Let me address a couple of pieces of that, and maybe I can answer part of it.  One is that I specifically, and others of us, agreed, including Wayne, we said, you guys take on prioritization.  They have spent a lot of time thinking about priorities over the years.  Give us back a schema for prioritizing CAM research and addressing CAM research questions.

          That is one piece of it, and I think the committee has clearly said, okay, we will take that on.

          The second piece has to do with, are there areas where one wants to make recommendations and say it is time to devote research monies that go, right now, in a conventional direction to a CAM direction.

          That is a question, and that is a question that was given back to the committee.  Just, for example, do you want to take some of the money that goes to research on pharmacotherapy for heart disease, and devote it to a program of lifestyle modification.  That is a question that went back.  So that is the second question.

          I think those are the two fundamental questions that were raised.  I don't know if there were any others that were in here.

          MS. LARSON:  This is not more money, but there was a specific request that Wayne provide, in the body of the document, his thinking on levels of research.

          MS. POLLEN:  That is his diagram.  We will include that.

          DR. GORDON:  Joe.

          DR. FINS:  People in the Senate are talking about doubling the NIH budget over a 10 years or something.  That has been in the process.

          DR. GROFT:  They are in the process.  They are almost done with that.

          DR. FINS:  No, but they were talking about another doubling.

          DR. GROFT:  We can talk about that.  That is a whole big issue.

          DR. FINS:  We can talk about that some other time, but I think what I am trying to say, I think it would be helpful if this subcommittee tried to lay out the options about what the range of research need is, so that we know whether or not we are talking about existing money or new money, in the context of the deficit, et cetera, just to really flesh out the priorities in research.  Then I would subcategorize the research areas into basic science, clinical practice and health services delivery.

          DR. GORDON:  Thank you.  I think that falls well within the mandate that we have given them at this point, and that Wayne and the committees agreed to take on.

          The second issue has to do with protection of CAM researchers, and this is something we heard testimony about in the very first hearing.  What was said, partly by me and partly by others, was, we need to have some statements about how practitioners inside of institutions, as well as in private practice, can proceed with CAM research; what kind of protection is going to be provided for those people; and what kind of responsibilities do they have in order to move the research ahead.

          Gerri?

          MS. POLLEN:  I just wanted to repeat what I mentioned on Thursday, which is that the Federation of State Medical Boards is preparing a report, and we do want to see that, because they are aware of this problem.

          DR. GORDON:  I understand that, but I believe that, after our dialogues with them, there are still some issues.  We should take into account what they have to say.  I think we are going to have a very strong independent position.

          I have been talking with NCI about this for a number of months.  I think we need to take into account what they are saying, and it is imperative for us to develop a position on this that we can present to the federal agencies.

          The one thing I want to add is, again, this is one of those issues that the sooner we can get clear about it, the sooner we can begin to discuss with the federal agencies how to help move the research agenda ahead.

          MS. POLLEN:  Yes.  I agree that whatever we do would be built on, but not necessarily stop at, what the Federation is going to propose, which we don't know yet, and that we already have another recommendation that speaks to what the research entities can do on their side, so there is a place for people to go, and that will be developed, also, further when we see how both sides look.

          DR. GORDON:  I didn't understand that last --

          MS. POLLEN:  Well, we do have a recommendation in your material now about the NIH institutes and other agencies setting up a process for receiving data for evaluation, which is the other half of this.

          DR. GORDON:  Similar to the OCCAM and the CAPCAM.

          MS. POLLEN:  That is exactly right.  That is in there now.

          DR. GORDON:  Great.  Perfect.

          Tieraona, did you want to say something?

          DR. LOW DOG:  Well, I am not quite sure how to phrase it, but it seems like the reality, in private practice anyway, for CAM researchers -- because this is what this says here, protection of CAM researchers -- is that in their own minds they are not really doing research.  They are just treating, based upon their own beliefs of what they believe is going to help, for different disorders.

          Because I am on this committee, we just need a little guidance.  What are we being asked, really, to do?

          DR. GORDON:  What I would say, and I am glad you brought up this issue, there are two separate issues.  There is the one issue that has to do with those who are willing to do research.  Then there is the other issue of practitioners.

          It is important.  Either we try to fit everybody in under the Research, which I don't think is applicable to some people, or we say, I think, that this is part of Access and Delivery.  We did not address it in Access and Delivery, but it is a different issue.  There are people who are going to say, I am not prepared to do research, but I want to offer certain services.  This comes under Regulation; it comes under Access and Delivery; and there is a piece that comes under Research.

          The other thing I want to add, Gerri, and I think this is clear to you; I want to make sure it is clear to everybody, is that the state medical boards do not necessarily have jurisdiction over other than physicians.  So that, there are going to be non-physicians who are doing research who are going to need the guidance, regardless of what the state medical boards say.

          Joe?

          DR. FINS:  I think there is a lot here to build infrastructure, because if a non-physician practitioner, even if it was a physician who was not affiliated with an institution, that had an IRB, wanted to bring a research protocol forward, he or she would have to partner with either a faculty member who would be a physician, or a practitioner at a dental school or something like that.

          DR. GORDON:  No.  Actually, that is not true.  You can create your own IRB.

          DR. FINS:  But they have to adhere to federal regulations.

          DR. GORDON:  Yes, but you don't have to have anything to do with a medical school.

          DR. FINS:  Well, but logistically, there is a tremendous start-up cost to --

          DR. GORDON:  No, not true.  I have done it.  It is actually very simple.

          MR. SWYERS:  I am part of an ad hoc IRB, and there is some cost, but it is not exorbitantly expensive.

          DR. GORDON:  I think what we need to do, and what you are saying makes this clear, the committee needs to make clear how this process can go as well, because people don't know.

          Gerri?

          MS. POLLEN:  I think this is something which I already have thought about that, that the Research Committee and the Access and Delivery Committee have to communicate, because there are so many pieces to this.  I have already talked to Michele about that, that it involves both groups.

          DR. GORDON:  Thank you.  Let's move on to Access and Delivery.  The first issue, Tieraona, is one that you raised.  Do you want to clarify this a little bit?  It comes up under Access and Delivery and under Coverage and Reimbursement.

          DR. LOW DOG:  It wasn't a "rather than" access to products.  I want it to be included under there, because everything we had focused on, again, was just access to providers.  I just felt that we had left out a huge chunk because the thing that drove DSHEA in '94 was that people wanted access to supplements, and they wanted free access to it.

          So a part of this was making sure that they are getting safe products and labeling and all of that, but nowhere under Access did we really talk about, specifically, access.

          Included in that, when we are talking about access and demonstration projects and things like that, I wanted to throw out, again, possibilities.  When we are talking about populations that don't have money, looking at food stamps to be able to buy prenatal vitamins, food stamps to be able to buy calcium if you are an older person.  Many poor people who need to take food stamps often do not have great diets.  So, looking at the possibility of that under Access.

          DR. GORDON:  I would like a little bit of discussion, also with George, since this is an issue with George DeVries.

          Are there clarifications, Joe, Linnea, George, on this issue?  Anything you would like to ask, or anything you would like to say about this at this point?  George.

          MR. DeVRIES:  The access to products, I think it really belongs under both because I think, Tieraona, you are absolutely right, there is an issue of access to products, and it needs to be dealt with on the Access and Delivery side.

          On the other hand, I think, clearly, there is an issue of coverage and reimbursement of these products.  While we don't see it much under third-party reimbursement, I believe, over the medium to long term, it will become an issue that will be on the radar screen.

          DR. GORDON:  Joe.

          DR. FINS:  I think the prenatal vitamin issue is really a discreet example, that if we could cost out how much it would actually intrude upon the food stamp entitlement and what percentage of that it is -- I don't know what the numbers are, but we might want to look at that -- and then figure out that we should embellish that entitlement to make sure that that minimal set of supplements is included.

          DR. FISHER:  We already have this information, or we can get it.  I can just tell you that I was the chairman of a committee that discussed this, and wrote a report for USDA, which basically, they rejected, in which we said multivitamin/mineral preparations should be provided to people who get food stamps.  We had economic data and a whole lot of other stuff.

          DR. LOW DOG:  Could you make sure they get it?

          DR. FISHER:  Yes.

          DR. GORDON:  Joe.

          DR. PIZZORNO:  I would like to raise a new topic that kind of cuts across Nos. 5, 6, and 7, Access, Delivery, Coverage, and Wellness.

          I have been looking at the corporate wellness programs, and there are really great data there.  Unfortunately, there is also a huge problem, and that is while a corporate wellness program is a good idea, people don't tend to do them.  And so, the corporations then provide incentives.

          Well, it turns out that there are substantive federal law that inhibits incentives engaged in wellness programs.  I think we need to look at that and fix that, because it just makes so little sense.

          DR. GORDON:  Joe, do you want to work with the Wellness group?  I think that may be the most direct place for it.

          DR. PIZZORNO:  Do you think it belongs in Wellness, or does it belong in Coverage, or does it belong in Access?  I am not sure where it belongs in.

          MR. DeVRIES:  A suggestion would be to give it to Access and Delivery because they are dealing with regulation with delivery of access to service and products.  This sounds like an access and delivery issue.

          DR. PIZZORNO:  So I am happy to work with the committee, but I am not sure which is the appropriate one.

          MS. CHANG:  If I could just make a suggestion.  I think on that one, given the amount of new issues that we have been asked to deal with in Access and Delivery, I would recommend that you actually work with the Wellness group first, and they will bring it to a point at which it may become obvious that it is an access and delivery issue.  At that point maybe we can carry it to the next step.  It seems like there may be a lot of background information that fits better there.

          Also, I have to say that, other fleshing out the issue around the demand side for both products and services, I am a little bit at a loss as to where access and delivery -- we need a little more from Tieraona about what you mean in terms of access and delivery of products that are not Coverage and Reimbursement, again, trying to separate the two issues, which I know is difficult.

          DR. LOW DOG:  I would be glad to.

          DR. GORDON:  Wonderful.  Let's move on to (b) under No. 5: The role of health navigators in service delivery.

          This is an issue that was raised, actually, in another section, but it seemed to me more relevant to access and delivery.  There is a whole group of people who are being trained in a variety of different places.  This is something I am involved in doing myself, and I would be happy to talk with more about it.

          To help people, especially people with chronic and complicated conditions.  Certainly, this is true of people working with older people.  It is true of people working now with cancer, helping them move through the system and get what they need, and put together CAM and conventional approaches.

          Linnea?

          MS. LARSON:  That actually derives from that wonderful concept from Miles.  Does that more appropriately belong in a descriptive part in Education.  Like, we envision that these people can come from multiple licensed disciplines, but have, also, these additional trainings.  Then you position of it in terms of, they may provide this function within these settings.

          Just a point to consider.

          DR. GORDON:  Joe.

          DR. FINS:  It also could go under Wellness, which is controlling one's own destiny.  These navigators are in place before you get sick.  You are adopting a health/illness model.  Why not make it an empowerment thing in wellness itself?

          DR. GORDON:  Charlotte.

          SISTER KERR:  I really would love to hear what you are doing, because when I read that little background information -- I forget which section -- the two people they cited were nurses and social workers.  I thought, well, nursing is going to say, we have been doing that, Brothers and Sisters.  But then, it got into somewhat what Linnea is saying.

          Also, this is an unfinished conversation for me, I believe every practitioner should be a navigator.  This kind of putting it off; kind of, I can't be bothered; I am not going to be the one to sort out the drugs with you today; go to the peasants and let them do that.

          MS. LARSON:  I would very much second her position.

          SISTER KERR:  Praise the Lord.

          DR. GORDON:  I am very happy to talk about it at length, but probably now is not the time.  So the question is where to put it, because it does have to do with wellness, it does have to do with access, it does have to do with education, and it also will have to do with definition, I think, as well, because we are talking about a function that we feel is very important.

          Joe?

          DR. FINS:  There is a group in different parts of the country, patient ombudsmen, patient advocates, patient representatives, who basically serve this function, admittedly, in the hospital context.  Maybe we can reach out to them, their organizations, and see if they have any ideas on that.

          DR. GORDON:  I think that is fine.  We still have to decide where to put it organizationally first.

          MS. CHANG:  Can I make a suggestion that it seems like it needs to be developed in Education, as far as defining what we are talking about, and the qualifications and training for these individuals, but then when we are ready to use it in the system, and how would we incorporate this into the system, then it belong to us in Access and Delivery.

          DR. GORDON:  What do the Education facilitators feel about taking on that one?

          DR. BERNIER:  We would be very happy to do that.

          DR. GORDON:  Okay, great.  Well, then let's proceed that way.  Thank you very much, Michele.

          Next is under (c): Private sector programs/projects on integrative service networks.

          Tom Chappell raised this.  Ken, do you want to elucidate this a little further?

          DR. FISHER:  Tom Chappell's comment was that in this section under Access and Delivery, there were lots of recommendations about what the federal government should do.  His thought was, what about what is going on in the private sector, and what about private sector/public sector collaborative efforts, if I captured what he said to me.

          MS. LARSON:  I think that he asked specifically for recommendations that did a partnership between foundations and government entities.  I also think that there may be a place in the background section that speaks to some of the models of delivery, such as -- I am just using this as a device -- Beth Israel in New York, that actually is highly dependent on foundations for their sustenance, and who rely secondarily on insurance reimbursement, and very little service to underserved.

          DR. GORDON:  George.

          MR. DeVRIES:  I am wondering if there are two aspects to this, because in terms of delivery systems, I think, Linnea, you are absolutely on the right track, but I know within the health insurance industry it is a common term of delivery systems.

          There is a whole variety of delivery systems within health care plans related to how services are actually, shall we say, paid and provided by a health plan to members, whether it be a group model like a Kaiser, whether it be a network model, shall we say a medical group model.

          There is a variety of models, and I am wondering if maybe Coverage and Reimbursement should, from a narrow sector, look at how these models and built and established, and perhaps what the opportunities are for CAM to participate in different delivery models.

          MS. LARSON:  I need a little bit further clarification.  Delivery in terms of coverage.

          MR. DeVRIES:  Yes.  It is delivery in terms of coverage.

          MS. LARSON:  So a PPO versus an HMO, and then the mechanisms.  So have a descriptive section within Coverage and Reimbursement, and then we can as a group work out some mutual recommendations after we have the description.

          MR. DeVRIES:  Right.  I mean, the issue being, though, even on the reimbursement side, sometimes you have different models within an HMO, where the HMO like Kaiser actually owns the hospital.

          DR. GORDON:  What I am wondering, then, is if the two of you can work out the distribution of this issue.  Does that seem fair enough?

          MR. DeVRIES:  It sounds good.  It sounds good.

          DR. GORDON:  Thank you.  Moving along to (d): Regulation of CAM organizations.

          Ken, do you want to expatiate on this?

          DR. FISHER:  I think that is Joe Fins'.

          DR. GORDON:  Joe?

          DR. FINS:  It is related to what George just said.  It is sort of middle-level organizational life.  It is not the doctor-patient dynamic, it is not national policy, but how do organizations like hospitals or integrated delivery systems, as George was saying, maintain revenue streams to stay viable without a massive infusion of extramural philanthropic support.  That is one issue.

          The other issue is, how do you actually maintain quality.  I think we need to hear from NCQA Joint Commission as these entities move from the outside, freestanding, and get integrated.  We have talked about practitioners moving from the outside to the inside, now organizations are moving into other organizations and truly integrating.

          So I think it is a regulatory area that we really have not covered.  I think that if we really think a lot of CAM practices will be occurring in integrated settings, then we need to help those institutions welcome those new players into their universe.

          DR. GORDON:  Linnea.

          MS. LARSON:  Again, a point of clarification.  I believe when we were discussing this the other day, Joe, that you said we need to have the input and look at the credentialing bodies of institutions, and we need to have that in part of the background to say, this has been what has occurred, and these organizations need to have CAM professionals advising them as to what is going on.

          So it is not explicitly the regulation of CAM, it is mutual.

          DR. GORDON:  George.

          MR. DeVRIES:  I think we are actually on two separate issues.  We are on, shall we say, the governmental regulation, whether it be provider entities, or even health plans.

          There is a whole second issue, which is accreditation.  It is accreditation of hospitals and provider groups, delivery systems, as well as accreditation of health plans that provide benefits.

          So I am wondering if maybe we split into two different, because they both apply under Access and Delivery, as well as Coverage.

          DR. FINS:  I agree with that.  There was excellent from, I believe, a doctor from California who brought CAM into his hospital.  I think that might something we should just go back and have a look at.  That whole session was very rich in these issues.

          DR. GORDON:  I think what you may see in some of the testimony that has come from the CAM groups, there will be information on how credentialing has happened in some of these areas as well.

          Veronica?

          DR. GUTIERREZ:  I think this goes both under Access and Delivery and Education and Training, but I would like to revisit the information on Title VII and VIII.  I would like an opportunity to review the legislation to determine the legislative intent, see if it is appropriate to the present consciousness on health care, and then have a further discussion in December.

          DR. GORDON:  I appreciate your repeating that.  There are a lot of issues that we raised that we said we are going to go back.  These are just new issues that were not part of the initial ones.  So that one is already back to the group.  So we will expect that.  Thank you.

          Moving on: Spirituality and bereavement in wellness.

          Anyone want to add?  It was pretty, I think, that there was a general feeling that these issues needed to be treated as part of Wellness.  Even though they were new issues, I think we had an agreement around the table, and a kind of understand of the dimensions that this might take on.

          Are there any specific thoughts that people have that they want to tell back to the committee at this point?  Linnea.

          MS. LARSON:  One of my concerns, and this has been a concern for a number of years, and this is just to throw it out to the group, is, I have been concerned about what I loosely term the "medicalization" or the "psychologizing" of the wisdom traditions, and the failure of those distinct groups to really honor the systems of which they have derived.  I would really like to have some kind of a commentary on that.

          DR. GORDON:  Okay, great.  Other questions related to this?  And this will get back to Dean and Corinne, right?

          Charlotte.

          SISTER KERR:  What do we want to say?  Do we just want to make a statement?  For example, many times through many of the recommendations, we felt we needed to footnote so that the reader will be able to know what brought us to that moment.

          Is it simply that this subcommittee wants to make a statement that we honor the domain of spirit in the human person or the cosmos, and that that has to be given attention and healing, period?  Is that all we want to say?  Then maybe some footnotes that say people are doing research in this.  Or, do we want to make some big statement about it?  People talking about the health center with body, mind, spirit; what do we want to say?  Or, do we just want to acknowledge that this exists?

          DR. BRESLER:  If a physician reads in a medical journal of an intervention that has, in a randomized, clinical trials, been proven, and two independent verifications of that result, one could consider it malpractice if they didn't provide that particular intervention to their patients.

          I think if we look at the literature on spirituality, and look at the evidence for it being an effective intervention, I think we could make a lot stronger position, based again, on evidence.

          DR. LOW DOG:  It is always awkward finding yourself talking in this fashion when you are a deeply spiritual person yourself.  I think we want to include the importance of it, but I think spiritualism is something that varies from person to person in how they address it, what they do with it.

          I know that there are many, many, many professionals across all barriers that are deeply spiritual and bring that into their practice, including physicians.  There are many of them.  When I was on my surgery rotation, one of the most profound moments I had, at 11:00 at night, making rounds, was seeing a surgeon that had come in at 6:00 in the morning, who was the old curmudgeon of the hospital -- I had been asked to prescribe some Haldol because a woman had been very agitated -- and he had gone in and was reading the Bible to her.  Late at night, reading her the Bible, this man who would not consider himself CAM or spiritual or anything.

          So I think that it moves in very profound ways, and I think that we want to address it, but I think that we want to be careful in how we do that, because spiritualism and religion, I think, are deeply personal.

          I know when we were bringing spirituality into the medical school, some students really embraced it, and some really had an almost violent reaction to it.  So I think that we want to just keep that in mind when we move forward.

          DR. GORDON:  David.

          DR. BRESLER:  I want to make a suggestion.  I have always said that the way that we scientists feel comfortable in talking about faith healing is, we have a term for it, we call it the placebo effect.  I think we could make a very good argument that we ought to develop a specialty in medicine called "placebology," because it is a very potent intervention, which is very strongly evidence-based as being very effective in this domain.  I think maybe this something we need to look into a little better.

          I think there are a lot of research questions that are very appropriate to ask.  Why is that some health professionals are better at evoking the placebo effect in their patients?  Is this something that could be trained for all health care professionals to use this kind of intervention?

          Again, I think this is something that the subcommittee might want to consider.

          DR. GORDON:  I think you are getting an answer that people don't just want a simple response, they want a more nuanced response.  One of the things that was brought up yesterday very clearly was the issue of transformation, and there was a general feeling, both on Dean's part and from around the table, that this was part of this domain.

          So I think there is a sense, Charlotte, that the group wants more than a simple response, that spirituality is important.

          SISTER KERR:  I would just like to respond.  This is two requests.  One is, with the faith-based initiative work going on at the White House, this area, and Dean is very sensitive to it, this point that Tieraona is making, where we get all in this muddle; is everybody going to have to be genuflecting or something in America.

          So, what data can we get from them, if any, to make these distinctions, because they must be having to make them.  The second is, I think this Wellness Committee needs some input from other people, and I really want all of you to consider that because I think we need input.  I am quite serious about this.  Some people need to get in on this committee before the next conference call.

          And who would that be, if you would like to raise your hand?

          PARTICIPANT:  I will do it.

          SISTER KERR:  Hey, we are going to have a party.  Who is our coordinator?  Corinne?  Is she here?

          So Steve, will you take the lead on that?

          DR. GROFT:  As I mentioned before, we will be putting out to everyone the list of teleconferences, the schedule, so that people can participate whenever their schedule permits.

          DR. GORDON:  Joe.

          DR. FINS:  I would just urge in linking up, in any way, with the Office of Faith-Based Initiatives, given the concerns that many Americans have about separation of church and state.  That is not to say spirituality and religion doesn't have a place in the healing presence, but I think that that is a contentious issue.  I think it is just something we should be careful a formal alliance with.

          DR. GORDON:  Effie and Jim, and then we really need to move on.

          DR. CHOW:  The gist of the conversation here now, and it hasn't always been, is, you are lumping spirituality with religion.  Spirituality is not religion.  It is the spirituality of being.  It is universal, and it exists in everyone.  CAM is eliciting that spirituality.  Let everybody practice whatever religion that they need.  So I would like to really clarify that.

          DR. GORDON:  Thank you, Effie.

          Jim.

          MR. SWYERS:  I would just like to say I write quite a bit about this issue, and I think one way to address it is that, first, it is the patient's preference because a lot of patients are asking for this.  Also, there is a lot of data showing that beliefs, spiritual/religious beliefs do impact health.  So we can say those kinds of things.  That way, it is coming from the patients, not so much from the Commission saying, we think this is important.

          So I can help with that if anybody would like me to.

          DR. GORDON:  Joe, we have really got to move on.  Everybody can participate on this conference call.  I think this is the place where we are going to have time to articulate this.  It is clear it is an important subject and we need more input.

          Thank you, Charlotte, for raising it.

          Finally, last, is No. 7(b): Education and communication programs on wellness.

          Ken, do you want to elucidate that a bit?

          DR. FISHER:  I think that was one that Charlotte brought up as a new issue.  I took it to mean

-- Charlotte, if I am not putting words in your mouth -- that somehow, in the whole discussion of wellness, there needs to be reference back to information development and dissemination about wellness, not just about CAM.

          SISTER KERR:  Well, this was the Big Bird metaphor that Tom got in on.  It may dovetail with just a presentation of the Report to the public, but what will be primary concepts that we want to be teaching as a result of this work.

          To me, this is the fire of the committee, the spark we need; how are we going to tell our story.  It includes everything, from being on "West Wing" and "ER" to we are talking about, how do you put this into the public view domain.

          So it may be very concrete things.  We have to brainstorm on this.  This goes back to the committee.  You know me, I want to do it before Dan Rather.  One minute on how you brush your teeth and gargle with salt and water.  I think we would change the morbidity data in six months.

          PARTICIPANT:  But you would put Don out of business.

          SISTER KERR:  Don would not have business.

          But anyway, we need to think about this, all the way from the presentation, probably, to Congress, to the manifestation of the goodness of this committee for the country, and understand this is an energetic phenomena, from mass consciousness of healing.

          DR. GORDON:  Thank you, Charlotte.

          I think the other point that came out that I am now recalling as you are speaking, is that this is an aspect of the way we are going to be introducing the Report, as well as part of the Wellness section.  This is a tone, this is a feeling that needs to permeate the Report, as well as the presentation of the Report.  So we need to deal with it right up front, as well as throughout.

          Thank you all.  I just want to say something before we take, maybe, a couple deep breaths and move into our discussion of the events of September 11th and their effect on us.  Two things.  One is that we will have a discussion for, really, only about 25 minutes.  What I want to do is give an opportunity, just for each person to go around and to say where he or she is, very briefly, just so we can share that with one another.

          We will probably conclude with a few deep breaths after that, and then Steve said it would just take about 10 minutes to tell us where we are headed over these next few months.

          Before we go into this discussion, though, I just wanted to say how much I have appreciated this process of the last few months, as well as of the last few days, how much good work everybody has done.  From being in my role as chairman, just seeing how respectful everybody is of everybody else, and especially where there are disagreements, how well we have learned to listen at the same time that we state our own opinions.  I am really struck by that.  It has been very moving for me to feel the change in the energy in the way we are with each other.

          So I just want to thank everybody for that, as well as for just moving through this huge agenda that we have done over these last three days.  So thank you all.

          Jim.

          MR. SWYERS:  Can I have just 30 seconds?  Yesterday, we took a poll of people's priorities for the guiding principles.  I used kind of a basketball poll scoring system.  If it got a first-place vote, it got five points; if it got a second-place vote, it got four points.  What we came out with was wholeness, evidence of safety and efficacy, health and healing partnerships, and preventions.

          Out of fairness, I want to give Drs. Bresler and Fair a chance to comment on this, but I think this is kind of the way it is going to play out.  So I just wanted to let you know that that is where it is falling out.  And this may change.

[At this point, the Commission took some time to share personal impressions from the tragic events of September 11^th, afterwhich the meeting adjourned at 1:00 p.m.]

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