MEDICINE POLICY




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LOCATION:  Hubert H. Humphrey Building,

           Ninth Floor Meeting Room

           200 Independence Avenue, S.W.

           Washington D.C.  20201



DATE:      Thursday, July 13, 2000






JAMES GORDON, M.D., CHAIR, Director, The Center for Mind-Body

  Medicine, Washington D.C.

GEORGE M. BERNIER, JR. M.D., V.P. for Education, University of

  Texas Medical Branch, Galveston, Texas

THOMAS CHAPPELL, Co-Founder and President, Tom's of Maine,

  Kennebunk, Maine

EFFIE CHOW, President and Founder of East-West Academy for the

  Healing Arts, San Francisco, California

GEORGE T. DEVRIES, III, Chair, President and CEO, American

  Specialty Health Plans, Sand Diego, California

WILLIAM R. FAIR, M.D., Director Prostate Diagnostic Center,

  Memorial Sloan-Kettering Cancer Center, New York, N.Y.

JOSEPH J. FINS, M.D., F.A.C.P., Assoc. Professor of Medicine,

  Weill Medical College of Cornell University, New York

  Presbyterian Hospital, New York, N.Y.

CHARLOTTE R. KERR, R.S.M., Traditional Acupuncture Institute, Inc.,

  Columbia, Maryland

DEAN ORNISH, M.D., President and Director, Preventive Medicine

  Research Institute, University of California, San Francisco

CONCHITA M. PAZ, M.D., Las Cruces, New Mexico

BUFORD L. ROLIN, Poarch Band of Creek Indians, Atmore, Alabama

JULIA SCOTT, President, National Black Women's Health Project,

  Washington D.C.





PETER REINECKE, Legislative Director for Senator Harkin

KAREN SANTORO, Ethics Counsel, National Institutes of Health





STEPHEN C. GROFT, Pharm.D., Exec. Director

MICHELE M. CHANG, M.P.H., Exec. Secretary

STEVEN OTTENSTEIN, Liaison from the Department of Health and Human

 Services to the White House Commission on CAM

                  P R O C E E D I N G S

                                               (2:15 p.m.)

              DR. GORDON:  Good afternoon,  I'm Jim Gordon and I'm the chair of this Commission.  I thought before we begin we might take a moment to sit quietly and take a deep breath.

(Pause for moment of silence.)

              DR. GORDON:  We're going to go around and introduce ourselves.  And the purpose of taking a deep breath is to remind ourselves to relax.  We have a lot of work to do together, but that work needs to be done in a spirit of openness, and of collaboration, and calm, as well as with enthusiasm.

              So what I'd like each of the commissioners to do is to begin to go around and introduce yourself, and say a little bit about who you are, and little a bit about some of your hopes for participating on this Commission.  Would you begin then, Buford?


              MR. ROLIN:  Thank you, Jim.  My name is Buford Rolin.  I am health administrator for the Poarch Band of Creek Indians, in Atmore, Alabama.  I am presently serving on the board of the National Indian Health Board, which is for the 12 areas in the Indian Health Service.  The board members are appointed.  And I most recently, in December, completed a term as chairperson, well, two terms actually.

              And, basically I've been in health care as an administrator for the last 16 years.  I've had an administration background all my life, through the military forward, and I have not been active in health until 16 years ago.  And I'm really looking forward to this Commission and working with it and with you.

              I've had an opportunity to meet various of the members on the Commission and certainly am really interested in knowing more about what our roles and responsibilities are.  I'm here to represent our Indian community.  And as a lot of people have heard, Commission members that I have talked to, are familiar with the traditional medicine and practices of the Indian community.          So I look forward to bearing critical information to this Commission.  And I certainly want to involve the Indian community in this whole process, making sure the final report reflects our concerns as well.  Thank you.

              DR. GORDON:  Thank you.

              MS. CHOW:  I'm just very delighted to be a part of this prestigious group in answering some of our mission, which I think will be very important.  I am Effie Chow.  And I came from a long background in complementary and alternative medicine.

              In the late 1960s when we held the first training program for acupuncture for physicians at Stanford, I worked from then on and was faced with helping our masters get out of jail.  Back in those days, there were a lot of people being jailed, homeopathists being jailed, and the acupuncturists, and so forth.  And so I go back a long ways and I have fond memories of us struggling.

              This is a wonderful status right now.  I specialize in Chinese medicine and try to integrate in the last 30 years Chinese medicine and Western medicine.  I am president and founder of East-West Academy for the Healing Arts, with a base in San Francisco, with our international bases having different liaison aspects on different parts of the world.  We are now specializing in the area of Qi Gong, as part of the Chinese medicine.  It is a self-help program.  And so we're very excited about it, everything that is happening.

              I had the pleasure of being part of the first Office of Alternative Medicine Panel, too, so this development is kind of another step.  And I look forward to being a part of the great plan for the Nation.  I think we can really touch people a great deal.  Thank you.

              DR. GORDON:  Thank you.

              DR. FINS:  Good afternoon.  I'm Joe Fins and I'm delighted, as well, to be a part of this Commission and to have so many colleagues.  I'm a general internist and medical ethicist, and I teach and practice medicine at New York Presbyterian Hospital Weill Cornell Medical Center in Manhattan.

              I have a special interest in ethics and consultation and care of the dying in palliative care.  And my hope is really to better integrate complementary and alternative medicine into the medical mainstream and into medical curriculum at the undergraduate and post-graduate medical training levels, so I'm really delighted to be here.

              MR. CHAPPELL:  I'm Tom Chappell and I'm the founder of Tom's of Maine.  We are makers and marketers of natural personal care products and natural wellness products.  I've been part of the consumer movement for 30 years, interested in natural and alternative nutritional products, alternative health practices.  And I have come to know the concerns and orientation and interests of that consumer group which is, obviously, growing considerably.

              I am delighted to be a part of this Commission.  And my hopes are that the Commission will contribute to the ultimate raising of standards of products, the efficacy of what's marketed in the marketplace of products, but, most importantly, access of the alternative services and products to consumers.

              DR. BERNIER:  My name is George Bernier.  I've Vice president for Education at University of Texas Medical Branch, at Galveston, Texas.  I was born in Maine and raised in New England.  I am a physician trained in hematology and oncology.  And my biggest interest has been that of medical education.

              My own background is that I went to Boston College and Harvard Medical School, served on the faculties and Case Western Reserve University in Cleveland, at Dartmouth Hitchcock Medical Center, in Hanover, New Hampshire, then spent nine years as dean of Medicine at University of Pittsburgh, and prior to this as dean of Medicine at the University of Texas.

              My hope is that by participating in this Commission that I'll be able to play some role in heightening the interest in medical education in complementary and alternative health care.

              DR. FAIR:   Hi.  I'm Bill Fair.  I was trained as a neurologist.  My background is at Stanford, Washington University, and Memorial Sloan-Kettering Cancer Center.  I would like to say that none of those institutions are known as bastions of complementary and alternative medicine.

              My interest in CAM was stimulated from my own experience five years ago I was diagnosed with colon cancer.  And going through a year of chemotherapy and a total of four surgeries, I came back with another recurrence and at that time was told I had more or less expended all of the known curative options in allopathic medicine.

              At that time I was looking around for things to do and some advice.  And my good friend, Dean Ornish, was instrumental in suggesting I go out and see Michael Ernst's program at Commonweal.  Many of you may know that.  The mantra of the institution is almost "expand life even if you can't extend life."

              And that struck a very responsive cord and I came home and talked to my family and said, "This is what I want to do, is not to take the therapies."  They had offered me an experimental therapy.  But I wasn't going to just sit there and wait for the other shoe to drop, so I began looking at what could be done in the area of complementary and alternative medicine.  And I was really delighted and surprised to know there was as much science out there as there was.

              And as a result of that, I became extremely interested in this.  I left Memorial Sloan-Kettering, in April, and was involved in a venture of establishing a complementary medical center in Manhattan, which was opened by the end of the year.

              And my hope for this committee, this sounds a bit grandiose, but I honestly think we need to change medicine.  I think that complementary medicine should not be looked upon as another specialty that the patient has to go to.

              From a patient's viewpoint, and I speak from that primarily, it's a bewildering array of choices out there and I think we need to bring these complementary and alternative medicine techniques into the practice of every doctor.  And I think, hopefully, that this committee will set the first stage and we can accomplish that.

              DR. GORDON:  Let me introduce myself a little bit at the end, but I want to introduce a couple of people now.  First, the two on my left and my right, will you say a couple of words?  And then I also want to introduce another one of our Commission members who can't be here today.

              MR. GROFT:  Thank you very much, Jim.  I'm Steve Groft, and I've been given the opportunity to serve as the executive director of this Commission.  By training I'm a pharmacist.  And the last 18 years of my life has really been devoted to orphan and rare diseases, except for the period of 1991 to 1992, where I had the opportunity to establish the Office of Alternative Medicine at NIH.

              And I must say that year has turned my life around tremendously.  Energy that I never thought existed continued to flow into me, and I don't know how I got here, to be honest.  But I am here, and I'm really pleased with the Commission.

              The task in front of us is tremendous.  We have a year's period to get it done, but I think the opportunities are great and we do have a growing group.  If, you the audience, knew what we went through to get the people here and what they went through to get here, I think you'd be very proud of them.  So it's my thanks to them for agreeing to serve with the Commission and giving up so much of their lives and their schedules next year or year and a half to get this report done.

              You'll hear from me later on but not too much.  This is their Commission and we are here to work with them and to listen to you, the public, to give us direction as well, for what has to be done.  So I thank whoever it was that gave me the opportunity to do this, thank you.

              MS. CHANG:  My name is Michele Chang, and I'm serving as the executive secretary for the Commission.  I spent the last 10 years in Federal government with the Centers for Disease Control in prevention, working on tobacco issues.  And I spent a year with Senator Harkin's office, during which time I had a great opportunity to help with the conception of this Commission.  And I'm really pleased to now be serving the Commission itself more directly.

              I am trained in public health policy and management and I am also a certified massage therapist, so I am really looking forward to what we will be learning over the next two years together.

              DR. GORDON:  Peter Reinecke will be introducing himself a bit later, and bringing some words of welcome to us.  I'm very glad to be flanked by Steve and Michele.  They are a wonderful core of this staff that's going to be working with us and serving all of us as we move a head with the Commission.

              I want to introduce now Wayne Jonas, who cannot be here this afternoon.  And from time to time I may bring up some points.  Wayne left some papers with me about some of his concerns.

              Wayne was formerly director of the Office of Alternative Medicine, and is an associate professor of the Uniformed Services University of Health Sciences.  He is a family physician who, for a number of years, has been working with complementary and alternative therapies and has a particular interest in homeopathy.

                And he has a wonderful grasp of the field and of some of the issues that will come up as we try to bring recommendations to fruition and try to take a look at what's happening in the Federal Government around the Country.  Wayne will be with us at the next meeting and sends his regrets.

              DR. PAZ:  I am Conchita Paz.  I'm a family practitioner from Las Cruces, New Mexico.  I have lived there for about 10 years.  I did my medical school in the University of New Mexico and my residency over at Creighton University in Nebraska.  When I got on this Commission, over the last year, actually, I have been helping with developing some policy for a Hispanic population.

              And part of my interest in this is to make sure that some of the older cultural kinds of folks in these United States are also looked at as far as the complementary medicine.  Because, for instance, in the Mexican culture, they have the curandismo, that is also very strong, especially in New Mexico where we have a large population.  So some of the other issues involved with alternative medicine, I'd like to see, you know, to be a part of from the very beginning.  Thank you.

              MS. SCOTT:  Good afternoon.  My name is Julia Scott.  I am president of the National Black Women's Health Project.  We are a national membership organization that focuses on wellness self-help and health advocacy.  And I figure I got on this Commission representing a constituency.  And I think that most people in the room would agree that the person who ends up doing most of the negotiating and obtaining of health care falls to women.  And so it's a fairly large constituency.

              Our organization focuses on African American women, but we also participate in the broader women's health community, so that's part of the reason why I'm here.  In addition to that, I think a large number of our constituency uses complementary and alternative medicine and they are looking for ways to discuss this with their practitioners, and who use it, to a large degree along with medicine as practiced in the United States, and are finding a lot of resistance.

              So I just think this Commission is a wonderful opportunity to really put this issue, that so many people want, on the front burner.  So I am very happy that this Commission was put together.  My hopes and my interests for being on the Commission is that I hope that we can be helpful in moving acceptance of CAM by buyers and especially the payers of the health care system.

              I think it's a wonderful opportunity to raise the consciousness of the Country about how an important this is for people in their daily lives.  I also think it's important to develop a policy that will broaden access into new areas.

              I'm very concerned for, especially, people of color and people living on low incomes, to make sure that this doesn't become one of those things that you can only obtain if you are of an economic base or a social class.      And most important, I guess, is that we all want to be sure that these alternative and complementary methods are safe and effective.  This Commission has a great opportunity to move all of this forward and I look forward to being a part of that.

              MR. DEVRIES:  I am George Devries.  And I'm the chair, president, and CEO of American Specialty Health.  And that was a company, and I helped co-found that in 1987.  We are one of the largest health service organizations for complementary and alternative health care nationally.

              We, specifically, have created specialty health plans and networks and administrative systems for complementary health care.  And then we go and we work with health plans across the Country to help them offer complementary and alternative medicine benefits and other types of programs for their base of members.

              In many ways we function a lot like a vision or a dental plan, except we focus on complementary health care and we work specifically with chiropractic and acupuncture, massage therapy, dietetics, naturopathy, and other areas of complementary and alternative health care.  I think the White House Commission has some tremendous opportunities.

              And among those that I'm most excited about are really the focus on safety and efficacy of service and products, and helping to increase the credibility of complementary and alternative health care, as well as focus on research and education.  And all of these areas, as they are enhanced and improved, will certainly lead, I believe, to better coverage for all Americans through complementary and alternative health care.

              We really have seen, I believe, probably even just a very modest beginning, the tip of an ice berg, so to speak, of actual coverage of complementary and alternative health care among governmental payers as well as private payers, employers' health plans, insurance companies and others, so there is tremendous opportunities as we look to the future.

              SISTER KERR:  My name is Sister Charlotte Kerr.  I'm a Sister of Mercy, I'm a nurse, I'm an acupuncturist, and also a woman, the ground upon which I stand.  Since 1977, I have been a practitioner of traditional acupuncture and a faculty member of the Traditional Acupuncture Institute in Columbia, Maryland.  Before that I was an assistant professor of nursing at the University of Maryland.  And I have served with some of the distinguished panel here on the National Institute of Health Advisory Council.

              My hope, as a Commission, is that we will continue to heal and to serve the citizens of the United States through complementary and alternative medicine.  And my continued hope is that we will be able to offer complementary and alternative medicine to the citizens in ways that forwards individual and cultural healing and does not just add on techniques to our present health care system.  I'm sure I have many more hopes and I will leave it with those two for today.  Thank you.

              DR. ORNISH:  My name is Dean Ornish.  I'm an internist and a member of the faculty, a professor of medicine, at UCSF, and founder and president of the non-profit Preventive Medicine Research Institute.  And I feel very privileged to be with such a distinguished group of people.  I'm particularly delighted to have Jim Gordon as the chair.

              And for me this Commission represents a real dream manifesting, I think that's probably true for many of us who have been in this field for a while.  For the past 23 years, my colleagues and I, including Dr. Sandra McLanahan, who is here, and several others, have conducted a series of scientific studies demonstrating that the progression of even severe heart disease often can begin to reversal when people make much more intensive changes in diet and lifestyle.

              And it really integrates traditional and non-traditional approaches than had been thought possible before, without bypass surgery, angioplasty, a lifetime of lipid-lowering and other drugs, and so on.  And we have published our findings in a number of journals and presented at scientific meetings, and so on.

              And I think our work is a model of a scientifically-based approach that may be helpful to others in building bridges between the so-called conventional or allopathic and alternative medical communities.  The idea that heart disease might be reversible was a radical concept 23 years ago when we first started doing this work, and now it's become pretty mainstream.

              Since looking at the medical effectiveness, for the last seven years or so, we've been looking at the cost effectiveness of these kinds of approaches.  We are a non-profit institute.  We train hospitals and other sites around the Country.  And we've been able to demonstrate that most people who are eligible for bypass surgery, angioplasty, were able to safely avoid it by this integrated medicine approach.  And the insurance companies found they save an average of almost $30,000 a patient by doing that.

              And recently, after six years of going back and forth with HCFA, which has become very familiar to me, they agreed to do a demonstration project to look at 1,800 people, at the various sites that we train, to see if we can show this in the Medicare population.  And I have come to learn that the primary determinant of medical practices is less science and more reimbursement.  And if we can change reimbursement, we can ultimately change medical practice and medical education.

              And we're also finally doing a study-in-progress with Dr. Fair and his colleagues at Sloan-Kettering, to see whether the prevention of prostate cancer might be affected with similar kind of intervention.  We began that three years ago and our preliminary data there are encouraging.

              And I think his own story is an example of how these approaches -- again, we focused on heart disease as a model but the implications go far beyond that.  So I'm thrilled to be here and very much looking forward to working with such a distinguished group.

              DR. GORDON:  I'm Jim Gordon.  And I am so pleased, as I listen to all of us go around the room this morning, as you say who you are and why you're here, and it feels like an extraordinary opportunity for all of us to work together and to work for everyone in this Country and, indeed, around the world.  Because it's important to remember that in many ways the United States is still the leader.  And as we go here in this room, as we go in this Country, many other countries will pay serious attention.         I'm "trained", that's an interesting word, trained as a psychiatrist.  I went to Harvard Medical School and did my psychiatric residency, and then spent 10 years as a researcher at the National Institute of Mental Health, where I created the first national program for runaway and homeless children, and worked on a preceptorship program for medical students in complementary, holistic, integrated medicine.

              And I spent a great deal of time beginning to get to know many people in this field, partly working for a special study on alternative services for President Carter's -- remember President Carter? -- Commission on Mental Health.  So it's wonderful to be back with the Commission.        I have founded and directed a non-profit here in Washington D.C., called the Center for Mind-Body Medicine.  And our work is really helping to transform medicine in this Country and helping to revive the spirit of healing in all of health care.  And that's the work that I see that we are going to be doing here, in a variety of ways, on the Commission.

              I've been interested in this area for 35 years.  I began my studies with an interest in Chinese medicine in the mid-1960s and I've spent time with healers all over the world.  And I hope that one of the things that we do here is bring some of the wisdom of all of those healing traditions in a kind of wonderful celebratory marriage with the best of our science.  And then the fruits of what we learn here together, we'll then be able to make available to everyone in this Country.  And that's my hope for our work together.

              And now I 'd like to introduce Peter Reinecke, who is going to say a few words.  I'll let Peter just say it for himself.  One question first, is there anyone who needs assistance with sign language, we have interpreters?

(No response.)

              DR. GORDON:  Okay, thank you.

                    WELCOMING REMARKS

              MR. REINECKE:  I'm Peter Reinecke.  I'm Senator Harkin's legislative director.  And I have worked with him for over 10 years, and also worked in the health care area on Capitol Hill for almost 20 years now.  But Senator Harkin was very thankful for the opportunity to talk to you all this morning and give you his rationale and feelings of why this Commission is so important.

              He has obviously been very active at the national level in trying to promote better attention to complementary medicine, and primarily in the area of additional research.  But his thought for this Commission was really to catch up public policy to the people and the use of complementary and alternative medicine therapies.          So, first, just to say again, thank you from Senator Harkin to the Commission for taking time out of your busy schedules to participate in this.  And, second, to say how great of an opportunity you have to have an impact on public policy and, hopefully, on health care delivery to all Americans.

              Third, to say that there is a broad interest in what you do and what you are going to come up with on Capitol Hill, both amongst Democrats and Republicans.  It is not at all a partisan issue, there is strong interest in all quarters of the political spectrum.  And I think that you will be received in that light, that this is not a political effort, this is a public policy health care effort.

              And, fourth, to make the point that it's so important for the Commission to have public input.  And so I'd urge you in your meeting today, from Senator Harkin, to develop a comprehensive plan to seek public input.  Because how this Commission Report will be received, in large part, will be determined by the extent that people feel that they have a stake in the process.  I can't underscore that enough.

              And, finally, just to go over a few of the questions, and I know that some are outlined in the paper that you already have, some of the questions that Senator Harkin had in mind that you might consider making recommendations on in your work.  And they are not in any particular order but they are relative to training.

              Should those being trained in CAM practices be eligible for Federal assistance in terms of loans, grants?  What can be done through Federal mechanisms and otherwise to encourage continuing education of CAM therapies among practicing physicians and other conventional health care providers?  What can be done through Medicare's support of graduate medical education to encourage integration? 

              And the second area of research, as Senator Harkin made clear in the morning, that it's his belief that that Commission is not, and that you have enough to do, that it's not necessary for the Commission to get actively involved in commenting on the research agenda for NIH; that there is a separate advisory council for that, and that that was not his intention in establishing this Commission.

              He was and is hopeful that you all will take a look at what can be done to encourage greater public investment in research on CAM.  As you know, a lot of the treatments and therapies are not patentable, and so we don't have that incentive built into Federal law.  And there has been some discussion amongst different experts about how to better encourage the private sector.  And if you all could help with recommendations in that area, I know that would be very well received on Capitol Hill.

              Third, on the delivery of integrated health care, that's been mentioned, I'm very interested to get the Commission's recommendations on what kind of criteria the Federal government should use for the inclusion of CAM therapies into Federal health programs and federally supported health programs.

              And, finally, in the area of oversight in coordination.  As some of you may know, there are many departments, including the Department of Health and Human Services, within the Federal government that have an interest and active agenda in the area of complementary and alternative medicine, whether it's the Defense Department, whether it's the Department of Veterans' Affairs, the Department of Health and Human Services and their entities, there is a great deal of activity going on.

              The question is, is that activity at an appropriate level and is that appropriately coordinated?  Again, that's something I think the Congress would be very interested in getting your input on.  Those are just a few of the questions.

               I think one of the big challenges that you face is going to be trying to limit what you look at because there is so much you could do.  But you are obviously very well qualified, and Senator Harkin is very pleased to see that diversity of experience and backgrounds of people on the Commission, because this, in particular, needs to have input from a very broad array of expertise and personal background.

              And so, again, to say thank you.  Senator Harkin is very excited about this and he is committed to making sure that, in working with his colleagues, you all have the resources you need to finish the job.  And, again, to make sure that your report, when it does come out, gets the attention it deserves on Capitol Hill.  So thank you, Jim, and members of the Commission. 

              DR. GORDON:  Thank you very much, Peter.  Senator Harkin has indeed been, as he would say of others, he has been the torch bearer for this whole movement in Congress, and Peter has been with him every step of the way.  And I just want to thank you publicly for your guidance and support, and you are really making this all happen.  Thanks so much, we owe you a debt of gratitude.

              MR. REINECKE:  Thank you.

              DR. GORDON:  And I'll look forward to our continuing debt of gratitude.  We now have a presentation on ethics from Karen Santoro and this is for Commission members.  Thank you, Karen.


               MS. SANTORO:   Good afternoon.  Welcome to Government service.  The purpose of this portion of the meeting is to provide an overview of the ethics rules for Government employees now that you are serving this Commission.  I'd like to start by showing a video tape.  It's about 20 minutes.

              It was produced by the Office of Government Ethics, which is an independent Federal agency that is responsible for writing and interpreting the ethics rules for Government employees.  The video tape specifically focuses on advisory committee members, such as yourselves.  And then after the tape, I'll wrap up by noting two developments since the filming of the tape, and I'll answer any questions you may have.

 (Whereupon a video presentation is given.)

              MS. SANTORO:  Let me encourage you, if you have questions about your individual circumstances, to contact Steve after the meeting.  Are there any more general questions?

(No questions.)

              MS. SANTORO:  I know that's a lot to comprehend, but let me just give you the additions since the tape was filmed.  In the section on resolving conflicts, you heard about disqualification, waivers, and divestiture.  Well, the Office of Government Ethics now has some regulatory exemptions.  They have decided that some financial interests are so insubstantial, they are not going to present a conflict of interest.  And I'm going to mention two of them.

              The first is diversified mutual funds.  If you hold these types of funds, they will not present a conflict.  "Diversified" means they are not concentrated in any particular industry or sector.  So, for example, Fidelity Growth and Income Fund is a diversified mutual fund.  However, Fidelity Select Biotechnology Fund is not and would not qualify for the exemption. 

              The last exemption I want to call your attention to is an exemption that permits Commissioners, advisory committee members, to work on general matters that affect your primary non-federal employer.  Let me give you an example of this.

              Let's say the Commission is working on a policy for education of health care practitioners and the commissioner is dean of a medical school.  Well, of course, medical schools as a class are going to be affected by that policy.  This exemption permits you to go ahead and work on that policy.

              I have left a brochure at your places.  This is a brochure from the Office of Government Ethics.  It gives more detail about conflicts of interest.  And in addition to Steve, your committee management officer is well acquainted with the ethics rules and can provide you guidance.  Thank you.

              DR. GORDON:  Okay.  Any general questions?

(No questions.)

              DR. GORDON:  Please feel free to contact Steve with any specific questions and he can arrange a meeting or discussions with you.  Steve?

              MR. GROFT:  Essentially, all of you have indicated what potential conflicts may exist.  And we do have that, that was involved with your clearance.  So, in essence, you've been given a waiver to work on the issues here, the policy issues that we will be discussing, without any concern about conflict of interest, so you all are in good shape.

              DR. GORDON:  Okay.  Steve, do you want to now, before we take a break, and we'll be taking a 20-minute break in a few moments, to indicate to us what the legislative charge is for the Commission?

              MR. GROFT:  I think if you read the Executive Order that has been given out to you and is in the back of the room, the goal and the charge for the Commission is to provide a report to the President, through the Secretary, on legislative and administrative recommendations to assure that public policy maximizes the benefits of complementary and alternative medicine to Americans.

              It's a very broad directive, but it is one that will take us quite a bit of time just looking at the four major issues that were spelled out in the Executive Order.  And there is a time limit.  We must be out of business by March 7, 2002, two years after the Executive Order was signed by the President.

              And I would like to add that it is the intent of the White House to expand this Commission to 20 members from 15.  We're hoping that this will all take place and continue to grow, so there will most likely be six more members who will be considered for appointment to the Commission.

              They are under consideration now, and nominations and recommendations and has been put forth, and the paperwork is still under review.  So it is the intent of the White House to expand the group and to give a little bit broader expertise.

              I think you all know that there are so many different interventions involving complementary and alternative medicine, and in order to give a good breadth of experience, the decision was made that we would try to expand the group.

              DR. GORDON:  What we're going to be doing after the break is, I'm going to give a kind of general overview of the tasks that we're going to undertake and some of the ways that we are going to pursue those tasks.  And then, this afternoon, we're going to address the first item on the agenda.

              This was the first of our four charges which is to develop a coordinated research to increase knowledge about complementary and alternative medicine practices and products.  And I'll talk a little bit about the format when we come back from the break.  But I think it's time for us now to break for about 20 minutes and then we will be back.

(Off the record for a brief recess.)

              DR. GORDON:  I just want to say a few words about how we're going to be proceeding.  First of all, we are actually ahead of time, which is quite remarkable.  I don't know if it will happen again, but it's important to note this occasion.  We have until 5:30 today, and if we finish a few minutes early, that's okay too.  I know a number of you have come from far away and we want to just take it easy, but we may well go to 5:30.

              Tomorrow morning, we'll begin at 8:30 and we'll go to 5:00 tomorrow.  That's our current plan.  There will be an hour of public comment tomorrow between 1:00 and 2:00, and you have that on your schedule.  And I encourage everybody here, who would like to make comment, to be in touch with Michele Chang and let her know.  And if there are other people you know who you think might like to say something, to this group at this point, please ask them to come.

              We apologize for not having had more advance notice.  We didn't have much advance notice.  And it's just wonderful that all of you were here, to be here.  And in the future, there will be significant advance notice, there will be a longer time for public comment, two hours for public comment each time.  And we are very eager to hear from the public.

              The form that we're going to take this afternoon is we're going to begin with the first topic.  And the way we're going to work is this meeting is really an organizational and a planning meeting.  And we want each of the Commissioners, and each and every one of you, to raise issues that you think we want to consider when it comes to research.  And don't be afraid of being wide of the mark, there is no such thing right now.

              We're going to use everything that we accumulate on these four topics and then with the staff, I'll work with the staff, we'll distill it.  We'll get it back to you and we'll use that as a basis for planning subsequent meetings, so feel free.

              The other thing I want to tell everybody here, that I've already mentioned to the Commission members but I want to make everybody here knows, is that in addition to the regular Commission meetings -- and we'll be coming at the end of the day tomorrow to scheduling the next meeting and perhaps even the next couple of meetings -- there will also be a series of town meetings at different places around United States.

              And those meetings will not be for us, Commissioners, to talk, but for us to simply listen and to ask questions.  And the plan would be for us to go out, and I would go to those meetings, and work with different Commissioners in different parts of the Country.

              And I would ask the Commissioners, as well as all of you, and all those who you know, and all those who you represent, to bring in people in that geographical area, or anywhere else for that matter, who would like to make suggestions, inform the Commission about the kind of work that they feel is important for us to consider.

              And the reason we're doing it this way is because we've initially thought of having different Commission meetings at different places around the Country, but we realized that by the time we got to do that, we'd be very far down the road in our deliberations.  So we want to open things up as much as possible right in the beginning, and have as much input as possible from all sectors of the public.

              And we welcome your comments in hearing the public comment tomorrow.  We welcome your comments on particular places that you think we should be having some of those town meetings.

              And the other thing is, this process is going to be open in an ongoing way to the public.  Steve Groft will talk a little bit about the Web site that we'll be having up very soon.  This is a process of continuing interaction and dialogue among all of us and with everyone who is interested in this field.  And we welcome it and we encourage it, and that's how this blueprint has developed, and that's how it's going to continue to evolve.

              This is, first and foremost, a popular movement, a movement of people who are looking for better health care, a movement of health professionals, on a large scale, who are interested in improving their own health and in being of service to the largest possible number of people.  And we're going to continue in this form.

              We're going to continue this emphasis on service to all, and at the same time making use of scientific methodology to evaluate those approaches and those techniques that should be included in those services and should be included in professional education and public education.  So this is a process which we're all working on together.

              And as everyone heard earlier in the day, we represent a number of different groups, a number of different constituencies, a number of different points of view.  And our work is to come to understand not only our perspectives but the perspectives of all those who have something to contribute on these many issues.

              So, without further ado, the first issue that we're going to address is the issue of research.  And if you look at the agenda, it's under number one, "Coordinated Research to Increase Knowledge about Complementary and Alternative Medicine Practices and Products."  So in this discussion, we welcome your suggestions about ways that we should approach this mandate of the Executive Order and of the legislation that established this Commission.

              How do we achieve coordinated research?  Perhaps how do we define "research"?  How do we define "coordination"?  How do we define the domain that research should be done in?  And I know these are huge, if not daunting areas.  Our task is to begin to take a look at the entire map and then to see what portion of it we can most productively focus on.

              Tomorrow we will have microphones for everybody.  Today Michele is going to perform the service of moving the microphone around from speaker to speaker.  So anyone who would like to begin, please feel free.  George?


                  OF COMMISSION MEMBERS

     Coordinated Research to Increase Knowledge about

     Complementary and Alternative Medicine Practices

                      and Products.

              MR. DEVRIES:  Related to research, and I know there has been discussion of legislation here in Washington, and I want to support this particular legislation which is potentially to, shall we say, incentivize or encourage the private sector to move forward with research especially related to efficacy and safety of botanical products.         And treating them almost like the drug law has, giving opportunities to those companies, that step forward to do research, to be able to market those particular products.  And, again, not only research that NIH can do but also supporting outside research also.

              DR. GORDON:  Thank you.  As people make comment, I'm going to sort of ask some follow-up questions.  And if others of you have follow-up questions, please feel free to do so as well.  And one of the follow-ups for everybody to be thinking about is what we should do to consider the issue that you are raising.

              So if you are talking about private sector research of botanicals and other substances, what kind of information do we as a Commission need, what kinds of people, whether individuals or groups, should we be talking to in order to get the information that we need to consider this issue?  Dean, go ahead.

              DR. ORNISH:  I'm a firm believer in research.  And I think that if we really want to integrate complementary and alternative medicine into the mainstream that research is a really good way to do that.  And then that gets it out of the realm of separate, to even stop thinking about it as alternative and just say, "Does it work or does it not work?"

              And so I think that to the degree we can focus on, to some degree, the kind of research that would be of interest, but I also understand that is something of consequence to focus on because that's an approved view of the NIH National Center for Complementary and Alternative Medicine, so to the extent that you can help me understand it's in the purview of this committee to address those issues, it would be helpful.

              DR. GORDON:  Okay, thank you.  The way I see it, and I have talked with Senator Harkin, among others, about this, is that we are going to define the broadest possible research agenda.  The research that NIH is going is one part of the research that's being done.

              And one of the people who I would ask, and I've already talked with him about this, I've asked Dr. Steve Straus, to come and talk with and present NCCAM's present research, future plans and issues.  So that will be very much a part of our discussion and a part of our understanding very early on.

              DR. ORNISH:  So just to clarify as a follow-up, so he'll say, "This is what we're currently doing."  And our agenda is to say "Okay, we can do things beyond that and what are some of the areas that we should focus on"?  Because as you know, so many people are using alternative approaches without really any studies at all being done on whether they are effective or not.

              DR. GORDON:  Right.  I think that what Senator Harkin and Peter were saying is, the basic idea is we're not going to micromanage the NCCAM research agenda.

              DR. ORNISH:  Okay.

              DR. GORDON:  But my hope is, and I think Steve Straus's is as well, that we're going to have a dialogue about research agendas.  He values our input and he values our thinking about the issues.  And the question is, ultimately, they can't do everything.  And how are we going to consider a whole variety of questions, some of which may fall easily into their domain, some of which may fall outside?  And I think one of the things that we can do is define what those different domains are.

              DR. ORNISH:  And also to determine whether we would recommend an increase in funding for them, for example, is that part of the scope --

              DR. GORDON:  That would certainly be a possibility, increase in funding in particular areas that we think need to be looked at in addition.

              DR. ORNISH:  Great, thank you.

              DR. GORDON:  Thank you for asking for that clarification.  But I wanted to follow up with George, if there were any ideas that you had when you talk about private sector research and private sector, how we should make more sense of that?

              Again, I apologize we only have the one microphone.  It's just a technical limitation.  I do a lot of work in Kosovo and one of the things that we have or don't have there is power.  So often the lights go off for long periods of time.  We're not only without microphones, we do without slides, we do without lights, we do without elevators.  So these are just some of the vicissitudes of modern life.

              MR. DEVRIES:  I'm sure there is a variety of ways to approach it.  But certainly if you look at the orphan drug law legislation, and how that has worked, if you potentially look at some of the major manufacturers of botanicals and some of the research that they've already done, for some are active in research, and then potentially considering some of the needs for additional research, that might be a good place to start.  And I'm sure through that process we'd find out a lot more to look at.

              MR. GROFT:  For several of you who aren't familiar with the Orphan Drug Act, there are several incentives involved in the act that are given to manufacturers.  One is the seven-year marketing exclusivity that is given to the company after the product has been approved, after it's gone through the process of receiving the Orphan Product Designation.

              Another incentive would be tax credits that are available to manufacturers.  So they are a couple of the incentives, and there are several others involving protocol development and things working with the Food and Drug Administration, so there are several options available.  And I think a broad subject like this is something that would be appropriate to look at.

              DR. GORDON:  Tom, and then Conchita, and then Bill.

              MR. CHAPPELL:  I'm going to build on the question of how to improve the research for botanical products by pointing out that in my experience we are not so much currently set up in our Country to increase knowledge as we are to fit the regulatory channels that govern the claim.

              For instance, one kind of claim may put you in the over-the-counter drug area, another claim might put you in the DSHEA bill.  Whatever, we're required to know as much as we can about a single herb, a single ingredient, not a blend.

              My concern is that our present way of marketing is dependent upon a regulatory system that is very narrow and very structured, and it doesn't fit with the consumer's mind.  So that the whole industry of dietary supplements, over-the-counter drugs, is driven by regulatory norms, not consumer thinking.

              The reason that we have a popular movement today is because the consumer thinks naturally, logically, and seeks to know more about ingredients.  That's why the term "self care" has evolved.  So if we're going to increase knowledge, we've got to connect that quest to a re-examination of the regulatory norms to try to build some flexibility into the category to which that research will ultimately be accountable.  Do you understand my point?

              DR. GORDON:  What, if anything in particular, do you think we need to look at?

              MR. CHAPPELL:  Blends of herbs.  I mean the Eastern orientation is based on blends, the FDA is based on single herbs.  Single herb, single claim.  So if our research -- I know that NIH is granting money to provide more knowledge about single herbs, but we also need to venture into this realm of blends, as well as re-examining the regulatory domain.

              DR. GORDON:  Thank you.  One of the things I also want to remind everybody is that as we develop next Commission meetings, we will be asking all of you at the end of this meeting tomorrow, to fill out which of the sort of subcommittees you want to be on in terms of working on research, or working on education, et cetera.

              So as we pull together an agenda, we'll be asking for input from all the people on those subcommittees about the contents of the agenda.  Let me go to Conchita, who is next, and then Bill, and then Effie.

              DR. PAZ:  Well, getting back to how to address some of these concerns.  Part of what I think we need to realize is that some of this, we don't need to reinvent the wheel, so to speak.  There has been actually some research that has been published and we might need to go back and relook at some of that literature that's already been out.

              However, there may be in other journals, like some of the nursing journals, some of the psychiatric journals, there may have already been some studies that have been already done that we might need to pull together to look at some of those data that is out there on some of these alternative medicines.

              DR. GORDON:  Let me stop for a minute and ask everyone to consider this question.  What data do we need at this point about the research that's already out there?   We have already said we're going to have Dr. Straus come to talk about NCCAM research and perhaps some about NCCAM data.  But what data do we need here to make our decisions?  Anybody.  I'm opening it now and then we'll go back to the order.  Bill?

              DR. FAIR:  I think when I start a research project, we start by finding out what we know about a subject.  And I think that what -- and maybe I'm the only one on the committee that is unaware of what the botanicals, for instance, what the problems are.  All you hear about is the lay press, where they point out the difficulties with the botanical problem.

              And I think it would help the committee, and I don't know who would do this, but for someone to present the committee with where we stand right now.  What is the scope of the problem, or is there a problem, or is this something that's a invention of the lay press primarily, to pick on one particular incident and build it up?

              Steve and I were talking before about my undergraduate degree is in pharmacy.  And I can well remember the discussions that went on when generic drugs came on the scene.  And I well remember my professor saying, "generic drugs, half the price twice the side effects."  And that was the concept.

              And now we know that you can standardize generic drugs and they are cheaper for the consumer.  And so I guess what I'm saying is, from reading the lay press, I think there is a problem with the standardization and purity of these botanicals.  But I'd really like to hear from someone who is knowledgeable to tell me really what the scope of the problem is.

              The second thing is what Tom mentioned.  I know my own institution -- which is trying to do a study on a mixture of herbs for prostrate cancer, which is eventually being done at U.C.-San Francisco -- but it was just because it was a mixture and it wasn't a single ingredient.  And as you know, in standard oncology it's axiomatic that you only use a drug in combination if it shows effect as a single agent.

              And not that I know much about Chinese medicine, but it's more or less standard in Chinese medicine that you use things in a mixture.  And I also understand that when a Chinese doctor would give a person an herbal mixture, say, they may also be prescribing something in diet and acupuncture, as a whole thing.

              And I think that it's important that if we look at these modalities, we ought to make some push that we just shouldn't take any one of these thing out as an individual aspect to be investigated without the whole process.

              We can test Chinese medicine against allopathic medicine if we include all of Chinese medicine, I mean, for treatment.  If we just take acupuncture out for Chinese medicine and test that against an allopathic treatment for a specific condition, we may not get a valid answer.

              DR. GORDON:  Great.  Tom?

              MR. CHAPPELL:  Shall I answer his question first or -- the problem, I think an industry problem right now is the whole notion of standardization.  Standardization is based upon identifying a particular ingredient in order to make a claim for that product.  But that ingredient or that active constituent, may not be the known, it may be a marker rather than the known ingredient that has the effect.  So standardization is a shallow, illusory way of creating a sense of efficacy.

              DR. GORDON:  So what are the things you are suggesting, is it that we call into question the use of standardization?

              MR. CHAPPELL:  It is.

              DR. GORDON:  I think it's kind of critical.

              MR. CHAPPELL:  It's going to beg the question of what are the active constituents that are contributing to the solution.  Because that's part of the problem of standardization, we don't know.  Echinacea, we don't know necessarily what is working, so the research could be developed in that regard.  What was your question that you were asking earlier, because I wanted to respond to it and I forgot it?

              DR. GORDON:   I was also asking what steps do we need to take in this particular area, the area of botanicals, for example.  I want to go to Effie, first, and then we'll come back.  Because I think all of these questions are -- incidently, and I see many of you are taking notes, that's great.  We're taking notes and we will have transcripts, and we will be giving this information back to all of you.  And we will be posting it on the Web site as we get the Web site up.  So nothing is lost, it's all a part of this mixture. 

              MS. CHOW:  William mentioned considering multi-disciplines in nutrition, and acupuncture, and maybe Qi Gong, herbs, and so forth.  Taken on its own, it may not be effective research.  And then moving down to isolate --

              DR. GORDON:  Effie can you speak a little closer to the mic?

              MS. CHOW:  Moving into the isolated concept that Tom just spoke about, is very real.  Isolating the compound from the herb may not work at all.

              And now to go back.  What do we know exists in research?  What research exists?  We need to do a survey of what we want to research, I think, first of all.  And then find what it isn't.  We can't research everything, so establish our priorities as to what area we should be researching.

              And then we need to do a survey on what has been done.  Again, falling back on Chinese medicine, I know that there is lots of research that's been done in China.  It may not be as stringent perhaps, but some of it are very stringent.  And we need to get that.  And I know there has been some collection of this.  And then take a look at what is good, what isn't, and then decide what we need to research.

              And we need to question our protocol for research because the energy concept in Chinese is "chi," just using Chinese medicine as an example.  That the energy there is constantly a question of whether our research protocols can measure exactly what chi or the energy component is.

              But I think we need to look at our research data.  There was strong discussion about outcomes research and ground research before isolating it into the double blind studies and trying to isolate.  So we need to do that, explore ideas.

              And botanicals is a big issue right now.  But there is a lot of spiritual healing, how do measure that, do research into that?  And also Qi Gong, and laying on of hands, you know, acupuncture and all that.  So I would say an assessment of what is existing and then critiqueing our research methodology.

              DR. GORDON:  I'm going to go to Dean for a minute.  And then I want to come back to this issue and return the question to you and to others, how do we suggest any suggestions for looking at chi, any suggestions for looking at spiritual healing methodologies that seem appropriate, because I think we're looking to move as far ahead as we can.  We don't have to do it all today, but if you have ideas -- Dean?

              DR. ORNISH:  Thanks.  I just want to build on what Effie was saying, and Tom, and Bill also.  That besides the data about research that's already out there, I think there is some real challenges when doing research in areas of what we call complementary medicine, behavioral medicine, alternative medicine, where we don't want to give up the rigors of good science but sometimes those methodologies aren't appropriate, and to the degree that we can focus on developing new research methodologies that maintain the integrity of science and in some ways I think give better data.

              An example that we struggled with, for example, is the most classically rigorous design, a randomized control trial, double-blind intervention.  Well, you can't do a double blind intervention with most alternative medicine interventions.  And even the fact of randomizing people after you tell people in great detail what intervention you are going to do, and then they end up in the control group.

              And so then they also start to change.  They get disappointed because they feel like they didn't get something that was helpful to them.  That disappointment itself confounds the intervention.  You get cross-over contamination, drop outs, all the kinds of things that out weigh, in many respects, the very kinds of biases that you are trying to avoid by doing randomized trials in the first place.

              Not to mention the ethics that come from having negative mind-body effects of disappointing somebody after you've told them that you think this intervention could be really helpful for them and they end up in the control group, which may have its own biases.

              So I think what Effie mentioned, and Tom, that this idea in science where you have isolated one independent variable, one dependent variable, keep everything else constant, is really a myth in many of these interventions.  We may think that we're only intervening in one area and only measuring one thing, but often times we're doing more than that, even if we're ignorant of it.

              And, finally, particularly in many -- Chinese medicine as you well know, and other systems, the interaction, even on a pharmacologic level in botanicals, the interaction, there are thousands of alkaloids that are present in a botanical.  We tend to focus on one as being the active ingredient, missing the fact that not only are the others often active, but the interaction between them is different than what happens when you just isolate one thing.  So those kinds of things, I think, are problems of this committee, at least I'd like to think so.

              And, finally, on a completely different subject, the challenges that come from trying to get insurance companies, Medicare, mainstream organizations, to adopt these kinds of approaches.  I tend to find that they either are completely rejected out of hand and only because of a lot of pressure do they finally do it, or they tend to embrace them non-critically simply because their consumers want them, without necessarily doing it in a more thoughtful way, which is why I think our committee would be helpful to them. 

              DR. GORDON:  I want to go on to Joe and then to Charlotte.  But before doing that, Dean, how do you tie in?  Is there a way that that fits, particularly in research rather than in service delivery?

              DR. ORNISH:  I think it's in both.  Particularly, let's talk about -- the research we've already talked about.  And I'm first and foremost a researcher because I really believe in the power of science to help people sort out what works, what doesn't work, for whom and under what circumstances.

              And while not everything that counts can be counted, as Senator Harkin said, a lot of things can be.  And while we may not be able to measure chi directly, we can -- we don't necessarily have to understand the mechanisms to understand that something is having an effect, that chi is having an effect, for example.  We should be able to measure the outcome of that, even if we can't measure chi directly.

              But also I think this committee can be particularly helpful from the standpoint of -- let me back up.  In dealing with insurance companies or HCFA, there is a certain bureaucratic mind set where people are often reluctant to take a risk on something new.  And it's understandable because if you say "no," you keep your job.  If you say, yes, it's a risk; if it doesn't work, your job may be in jeopardy.

              So it's this whole CYA syndrome, cover your butt, that I come across.  And if a well regarded commission like this one says, "We think this is something that's worth doing," in a way it provides permission for health services agencies like HCFA, or many private research companies, to go into the areas that provide them some degree of coverage in that area, that may enable them to take risks that they find otherwise have a harder time doing.

              DR. GORDON:  Thank you.  Joe, and then Charlotte, and then George, and then Tom.

              DR. FINS:  I want to just tack onto what Dean said and suggest that we have to move beyond the purview of the science into the social sciences and a have a less reductionistic approach.  I would be interested in moving the research agenda to the experience of the patients and their families more broadly construed using sociology, anthropology to understand.

              Maybe you can't identify chi, per se, with a positron emission tomography test, but you might be able to look at populations of patients whose lives have been improved through an enhancement of that entity.  I'd also like to look at issues of access.

              I think there is a lot of anecdotal information and access is a problem.  We need to really know what the scope and nature of that problem is.  Who are the people seeing, what are the practitioners out there, what are their specializations, what is their training, what is the expectation of families and patients?

              And this could be disease-based, you know, patients with breast cancer, with AIDS, with sickle cell anemia.  We could go through the list.  And we could look from diseases, instead of botanicals, up.  We can look from patients with diseases down to the various modalities and mix of modalities that they are using.

              And related to this, I think people are talking about the clinical trials issue, is that I, as a medical ethicist, interested in clinical research and research issues and the ethics of the regulation, I'm not sure that the research establishment is really adequately trained, that the average institutional review board in a medical school or in a medical center is going to be receptive to these ideas.

              And so I think one of the agenda items is really to find out how their training prepares them to adequately review these protocols and ensure adequate access, and at the same time adequate protections of human subjects who are being exposed to things that are a little bit off the beaten path.  So I think those are my thoughts.

              DR. GORDON:  Thank you very much.  Charlotte?

              SISTER KERR:  Your question was what do we need to know in order to do this number one task.  And I'm really, again, amplifying what everyone else has been saying.

              But, Jim, one of my most penetrating memories of work at NIH, in an ongoing conversation over at least the last 20 years, has always been this issue of paradigms and methodologies in research.  This conversation is the longest and the oldest for me and it continues, as far as I know.  Which comes to your question, maybe somewhere at the same place.

              Now my number one question, and I suppose from Steve at NIH, would be where are we now in the conversation of methodologies and paradigms?  So, basically, an update, because this same conversation goes on and on and on.  It is essentially a study of the part, in the reductionistic theory, not the whole.

              So I think that's the first thing I would like to know and not so much that we've got three studies on osteoarthritis, you know, whatever, which is important, but I'd like to know that.

              For myself, I just want to make a comment about something that's been said early on, is the study of chi.  My own persuasion is that until we -- of course this is the Nobel Prize for the person who is up for it -- as we all know in this room, the chi, concept of chi, is the fundamental starting point, in my opinion, of the theory and the application of Chinese medicine.  And, I believe it is the fundamental starting point for most of the energetic medicine which is the medicine of the future, or in the present, and acupuncture just being part of that.

              What I want to say is that if we have conceptual frameworks that embody some of what I'm saying, which are ones of relationship, if we have ones that believe what the physicists are saying, and as far as I know they are still saying, their philosophers, that were probability patterns of interconnectedness, then not only is our research going to be, it will be the place out of which we flow into research.

              But it then it has to inform our practice, it has to then inform the health care system, if you want to call it that.  It has to inform education.  For me, this still remains one of the most important points we need to converse on.

              DR. GORDON:  Thank you very much, Charlotte, for calling us to those issues.  I have a question for you and maybe for everyone, which is, do we want, in addition to Steve Straus presenting where NCCAM is, do we want other presentations, the state of the art of looking at a new paradigm of understanding chi, of understanding --

              MR. CHAPPELL:  Yes.

              DR. GORDON:  Yes.  Okay.

              DR. FAIR:  What is the problem with the botanicals, looking at them singly?

              SISTER KERR:  The botanicals, I hadn't really put that together.  To me, this conversation is gifting us again to call us back to have a look at the whole.  In this conversation it seems even more apparent than the individual, even though I think it's the same.

              DR. GORDON:  Let me go to George, Tom, Effie, and George DeVries.  That's who I have on the docket right now.

              DR. BERNIER:  Thank you.  I'd like to go back to the original question that was asked.  And that is, is it to be the scope of this group to decide what can be studied and what can't be studied?  Are we to put down a prescription for what can be studied?

              I've been personally very impressed with studies that I have read in the medical literature that have been comparing activity or outcomes with people who have been treated with one form of medication versus another.  And they have found in that literature that it is possible to come to a conclusion.

              But if we as a group say that it is not going to be possible for a whole area not to studied, I think that's very important for us to be up front about.  I think that's probably the single most important issue that we are dealing with under research.

              DR. GORDON:  Is there an issue that you -- I don't know that we have any particular -- is there some that you have seen that can or cannot be studied?

              DR. BERNIER:  I guess it was in Senator Harkin's talk to us today.  I think he was saying that it's NIH's job, not ours.

              DR. GORDON:  No, I don't see that.  It's not our job to focus on critiqueing their research agenda.  It's our job to consider -- there is a lot more research than is being done currently at NIH.  It's our job to think about some of the research issues in the broadest possible way.  And that's there in the Executive Order.

              I think what he doesn't want us doing is passing judgement on research grants that have been given by NCCAM to particular entities, or focusing at that micro level.  I think that our charge is very different.  I think the dialogue between us and NCCAM, and us and the Defense Department, and us and many other entities who sponsor research, I think will help to clarify some of the questions about what should be studied and who should be studying them.  And also, what's left over, you know, what other issues are not being addressed.

              DR. BERNIER:  I think the implication has been that there are some that cannot be addressed.  Several people from this group seem to feel that way.

              DR. GORDON:  I don't know that I've -- do you know which ones, because maybe we should talk about that?  I haven't heard that.

              DR. BERNIER:  I thought that's what the bottom line to Dean's discussion was.

              SISTER KERR:  Dean's not here.  George, you said this, you thought, was the fundamental issue.  And I didn't understand what you thought was the fundamental research question.

              DR. BERNIER:  I'm sorry.  What I was trying to say, and I don't think I made it so clear, was that if there are areas that are going to be considered to be out of bounds for research, for comparative clinical trials, for instance, that it's really important that that be identified up front.

              DR. GORDON:  I think my interpretation, and let me see if there is agreement, my interpretation is that there may be different methodologies that are needed to address different kinds of problems.  And that the same methodology will not fit with some of these issues that we're raising.  And I think there is a question of appropriateness of methodologies to some of the studies that we feel should be done, rather than that there is anything out of bounds.  Is that the sense of everybody?

              MS. CHOW:  Also new methodologies.

              DR. GORDON:  Yes, exactly.

              MR. CHAPPELL:  Related to the question of methodologies is the underlying assumption that there is a difference between illness and wellness.  And in this Country we have historically thought of medicine as something for illness.  Yet the popular movement, the self-care movement really thinks of wellness as the goal.

              And if we don't define the domain of medicine, complementary and alternative medicines and practices, we will continue to be dragged into this debate of whether it is reductionistic or holistic, and so forth.  It has to be tied to a new vision, a new definition of what it is we're trying to solve.

              And consumers are looking, the reason there is a popular movement is because they want to prevent, they want to take more responsibility for their health and they are going to become as preventative in their practices as possible.

              So I believe we need to wrestle with this question of wellness versus illness, or whether we're going to talk about wellness as the overall goal that includes illness.  And that's my first point.

              And, secondly, if we're going to increase knowledge, that knowledge has to exist at the FDA.  There is such a demand for pharmacognosies right now, or anyone involved in natural medicines, that they are moving to private industry, they are moving out of the research places, out of the universities, and out of the FDA.

              We don't have sufficient talent at the present time to assess these debates about DSHEA claims or over-the-counter drugs as they relate to -- because the talent in this specialty field has gone from the FDA.  We have to expect that as well.

              DR. GORDON:  Thank you very much.  So just to restate it, you are talking about possibilities of addressing research issues with regard to wellness and the wellness-illness continuum?

               MR. CHAPPELL:  I was saying that all the methodologies that we're debating here really are tied to the bigger question of wellness not illness.

              DR. GORDON:  Okay, thank you.  And we're going to Effie, George Devries, and then Charlotte again.

              MS. CHOW:  You stole part of my idea.  But I'd like to reinforce that because I think we maybe need to redefine "complementary and alternative medicine" and see this as a part of only the health care system, and that it really is a life system.

              We're talking about promoting health.  Like the Olympic athletes, you know, are using herbs and Qi Gong, and acupuncture, and all that.  So we need to study the super healthy to get the human being at a higher level.  And then, of course, a practice of having people come in for tune ups, you know, like cars coming for tune ups.

              And I think I'd really like to throw that out in order to say research, are we really talking about complementary and alternative medicine?  We're drawn into a medical model.  Are we really still talking about a medical model?  And so I would just like to throw that out.  Maybe it's something that we need to deal with, I don't know.

              I see it as a life system.  When we deal with the people in working with them, we don't deal with their pain, we deal with the relationship, right?  We deal with how politics is affecting them, too, and how economics is affecting them; this isn't medicine.  So, again, it goes back to social issues as well.

              DR. GORDON:  Thank you, Effie.  George Devries?

              MR. DEVRIES:  This is a question almost, for the Commission, more than a statement, which is we've talked about, shall we say, taking some latitude with how we're looking at the different subjects related to complementary and alternative health care.  And part of that is, as a Commission are we willing to look at some of the experience that other health care systems have had outside of our Country, taking more of an international approach than just an American approach?  Because I think certainly there are other countries who have perhaps more information, more experience, better backgrounds.

              And, in particular, with research, there has been some promising research in Europe related to herbal supplements.  We've actually looked at some research coming out of Asia related to traditional Chinese medicine.  And while we may not rely on these as conclusive, they may provide this Commission with some direction, some ideas and approaches that are interesting.

              DR. GORDON:  Let me say, on both issues that have been raised, the answer is, yes, we can expand.  And I think it's really up to us to judge the limits of the expansion.  We don't want to get so broad that we lose everything.  But on the other hand, issues of wellness and illness certainly, I believe, tie into our mandate on complementary and alternative medicine.  And, as well, issues related to how other cultures, human systems and in this context, the kinds of research that are going on in other cultures.

              And I just want to remind you all that we welcome and really need specific suggestions.  If there are particular research councils in particular countries, or particular individuals who have grappled with some of these questions, we need to hear, we want those names.  We don't have to have them now.  So please feel free, as you make your suggestions, to remember to send in follow-up information about people who you think are doing the most exciting work, because that's how we're going to form the panels.

              Let me go the Charlotte and then back to you, Effie.

              SISTER KERR:  After Tom spoke, I wanted to push the "pause" button.  And I feel a real need to pause because when you spoke about the popular movement, I don't know if you said it this way, but what I heard was the popular movement really is creating a new vision.  I was then able to go back to what I really feel.

              When I look even at our four mandates, I feel like I'm supposed to think about how to teach people in Western medicine about how to find an acupuncturist, or a chiropractor, or what echinacea is.  And I don't I hear philosophy and healing, I don't hear anything about ecology.  I am primarily a public health person, whatever else all I've done in my life.  I don't hear the talk of nutrition.   Even today we had something new on the horizon in terms of cancer research.  So some of what Effie and Tom are saying, we'll probably have to drop down into that again.

              I feel really happy about this conversatio because I really have been around a while and I'm not sure

-- I feel like I've been a part of this 20 years on that track or with it, I'm still not sure we're on the right track.  It may be the conversation of wellness and medicine again, but what we've done has been really important and wonderful.

              And I almost feel like a moment to pause and breathe again and say, "If I had to give directions to this wonderful Country, to other people committed to healing, what do we want to say to them and to myself?"  And I think it's a little bit different than I started to feel here.

              DR. GORDON:  We have Effie next and then Dean.

              MS. CHOW:  Go ahead, Dean.

              DR. ORNISH:  It may be easier with the microphone here.  I really appreciate your saying that, because, you know, the longer I'm in this field, the more I realize that sometimes the most healing things are the ones that are the most difficult to measure.

              And what I love about the battles with various agencies that we've had over the years, and insurance companies, is that the breadth of people who come together.  In this room, in this Commission being formed is a perfect example of that even.  When HCFA finally approved our demonstration project, the people who fought the hardest for it were people like President Clinton, but also Dan Burton, who ordinarily had nothing to do with each other, and everything in between.

              The Senate hearings on alternative medicine a couple of months ago, we have Arlen Spector and Tom Harkin, who are on different sides of the aisles.  I don't know of any arena that brings together a wider range of people who have a common goal here.  And that itself is healing.

              You know, the idea of finding common ground and creating community, of getting past the polarization that not only separates us and often brings the Government to a standstill, but I personally believe is a root of illness and suffering,  That what's happening around this issue of complementary and alternative medicine is a model of the very conditions that I think we need healing.  And I would love to somehow bring that perspective into whatever report that we bring as well.

              DR. GORDON:  That is certainly my hope that this perspective will inform every aspect of the report.  I think there is, again, and we don't need to think too far down the line except just to share our perspectives, that there absolutely needs to be this balance between the sense of connection and the sense of some of those things that count that can't be counted.

              And at the same time there need to be specific recommendations for legislation.  And I think if we can maintain, all of us, that balance, as a committee we'll be doing an enormous service.  Effie?

              MS. CHOW:  That's what my former comment was, that CAM, complementary and alternative medicine, is really about life and the promotion of connectedness in people and nature.  And nutrition is very important.

              But back to the research issue.  We've been talking about examining the herbs for what components herbs have, and what it works or not, and how it should be done.  I think in education as well, we have to do research into methodologies of how education can be given, developed.

              It perhaps doesn't take, also, the usual protocols of education, the rules and regulations of education, it has to be more creative and it has to involve more demonstration types of things.  So I would think research into methodologies of education.

              And then also systems integration.  China was given as a good example of how Chinese medicine is integrated with Western medicine.  It is totally not ideal, but we need to do research on the integrative aspect, the  systems approach.  So I just wanted to move into the broader picture.

              DR. GORDON:  Thank you.  Tom, before you speak, Steve wants to introduce someone who is in a significant measure responsible for all of us being here.

              MR. GROFT:  One of the nice things about a new position, it gives you the opportunity to work with different people.  And one of the individuals here at the Department and who is instrumental in getting all of you here, has been Steven Ottenstein, who is a White House liaison from the Department of Health and Human Services to the White House.

              And it has been so gratifying to be called down here and get someone who not only answers the problem but gives you feedback rather quickly.  And he just did want to mention the clearance about another Commission member.

              MR. OTTENSTEIN:  Yes.  Ms. Low Dog, who is the 15th member to the Commission has just cleared.  So, in addition to the other two, that was the intent to announce, we'll do the third one, which will give us actually 14 members.  And then Stephen mentioned that we're hoping to expand the Commission to 20 members.  So the additional six will be coming in the next few months.

              MR. GROFT:  I think now that we've launched, probably the appointments will come quickly.  And for those of you who came in yesterday, things happen very quickly.

              PARTICIPANT:  You mentioned two others?        

              MR. GROFT:  Dr. Tyrone (ph.), of Low Dog and the two others who were --

(Simultaneous discussion.)

              MR. GROFT:  I put these three people under considerable stress last Friday.  And my public apologies to these people.  We got them cleared and everything is okay, so thank goodness.

              SISTER KERR:  I think he just needs a round of applause.


              DR. GORDON:  Steve, did you want to add anything?

              MR. OTTENSTEIN:  Just good luck with everything.  I was glad everything that has happened and we are on the right track and, hopefully, we'll get the other members done shortly, and your report will be fabulous.  I'm looking forward to working with you.

              DR. GORDON:  Great, thank you.

              MR. CHAPPELL:  My graduate training is in religious philosophy, but I see the correlation here, as I look back over the globe, and my training is that we're the youngest society on the globe.  And in the case of alternative medicines, we're adolescents in comparison to the years and years and years of knowledge of many of these other modalities.

              And the reason that consumers are kicking back is that they know they can get what they want alternatively to the system that we've developed over the years here.  And so if we're going to increase knowledge, it's important to me that we find out what it is the consumers want answers to. 

              I'm on another board, and the dean of that board announced that the university was going to modify its curriculum.  And I asked him who was going to do the modifying.  And he said, "Well, naturally the academicians."  I would like more than the specialists determining what knowledge we want to determine.  I think consumers need to be consulted, and that's a very easy and practical process.

              DR. GORDON:  That's our plan.  And I'm hoping that we will have at least one or two of these meetings before the research panel to get some more of that input.  And, hopefully, tomorrow we'll have some, as well, from any people who are sitting out there or in the area.  Fortunately, in this area, most of us are consumers as well as practitioners, so we have that advantage too.  Let's see, Buford first, and then Joe.

              MR. ROLIN:  Thank you.  I just wanted to follow up on what I've heard here, and certainly Tom just alluded to what I wanted to mention here when he talked about the consumer and that aspect.  But from my perspective in dealing with this, in our community we're approaching this now from the holistic approach, in line with what Charlotte has said, which has to be inclusive of the methodologies.

              But we also have to get back to actually, when we are talking about all of this, bring in the nutrition aspect in all of that, and dealing with the wellness aspect as well.  And that's where we're beginning now, and we have to.  In order for the Indian communities to survive, we've got to.  And we've begun there to do that.          And I think it's important, not only for this Commission, to be aware of that we're dealing with the same issue with the public as well.  And we've got to do that.  I just wanted to make that comment.

              From the holistic approach, you know, that's going to get to spiritual, as we talked about earlier, and the mind, the body.  And it's going to bring in, as we've talked about, the botanical aspect.  We're going to find the methodologies to deal with all these issues.  But I just wanted to add that comment.  Thank you.

              DR. GORDON:  Thank you.

              DR. FINS:  I just want to say that on this historic day there is an element of paradox to this.  CAM has really come into its adolescence and it's a really momentous moment.  But just as complementary and alternative medicine poses some element of challenge to conventional mainstream medicine, the mainstreaming of complementary and alternative medicine, which I think is embodied in the formulation of this very panel, is going to be a challenge to what is the best of what Sister Charlotte had talked about.

              So I think that what we really need to do is really keep a focus on the public health, the interests of patients and consumers, and try to see this as an opportunity, as you said, to kind of recraft what it means to be a healer, whether it's conventional or traditional, but appreciating that there are risks and benefits to this mainstreaming process.  That we have to not throw out the baby with the bath water and can maintain what's best in what has brought this movement this far this quickly.

              DR. GORDON:  Joe, I have a question for you.  Do you see any of those specifically related to research that we ought to address?

              DR. FINS:  Well, as I'm thinking about mainstream academic medicine, there is still a skepticism and concern.  And I think that there is going to be resistance.  And I think we have to reach out to those communities to ensure that, as I think Dr. Ornish has done and others have done, to maximize the utility of this area.          And I think also there are certain proposals and grants that will go to entities that are outside the national center in other parts of the NIH where it may not be as responsive to this kind of inquiry.  And so I think that there may be resistances in other agencies and other parts of other funders in the private and public sector.

              DR. GORDON:  I would like to get just a little input and then we'll move on.  I'm wondering if we want to be asking the different agencies and private funders something about their criteria and why they are using those criteria.  And then perhaps amplify the criteria or develop new ones.  Is that something that --

              DR. FINS:  I think that would be an absolutely good idea because, outside of the select entity within the NIH, this could be construed as an orphan topic.  And so I think we have to engender support in these other agencies and in the private sector so that the research dollars and talent is there.

              DR. GORDON:  Okay.  Thank you.  Bill?

              DR. FAIR:  We talked a lot about having research integrate the various modalities and not looking at one particular approach.  And I would like to make a plea that we also integrate the results of modalities.  In other words, Tom used the term "illness," and I don't know whether that was a specific choice or not, illness as opposed to wellness.

              But, again, making reference to Michael Ernst, Michael talks about the difference between disease and illness.  Disease is a physiologic process affecting the body, and illness is the person's perception of that disease.  And physicians will tell you they may see two people with seemingly identical disease, and one does well and the other does poorly.  And we can't explain it solely on the basis of the disease process.

              And I think when we evaluate things, in oncology for instance, we're always looking for the response of the tumor.  But that may not really tell you the response of the patient.  I think that we ought to make an effort in research, when we evaluate the results of any of these modalities, we have to evaluate the total effects, not just using an isolated marker of effectiveness.

              DR. GORDON:  Bill, do you have any thoughts about how to pursue those kinds of studies or how to present, how we can get our hands around that and address it?

              DR. FAIR:  I think a lot of people know more about this than I do.  The most obvious thing that's receiving a lot of interest right now is the quality of life measurements at the same time.  But I believe that there are other things that could otherwise be measured.  Tai Chi.  I mean, maybe the tumor doesn't shrink, but the individual is much more supple and much more interested in life, and things like this.

              DR. GORDON:  One of the issues this brings up for me is the whole field, which has not been looked at very much, and certainly by the mainstream, but biochemical individuality and uniqueness.  And I'm wondering if this isn't an area that we also want to be taking a look at?

(Many nod affirmatively.)

              DR. GORDON:  I'm seeing some nodding heads, so that may one way to approach it, biopsychosocialspiritual individuality.  Okay.  Other issues or other comments?  We have some time.  Is there anything else that anyone would like to add or questions you'd like to raise about this point?  Yes, Effie and then Conchita.

              MS. CHOW:  Just one point.  Just to allow the practice to be practiced as spiritually as possible, instead of squeezing it into a certain mold to get outcomes.  The outcomes should be -- you know, if you squeeze a practice into a white-walled, sterile place, the results will be different.  It's very different then, say, in a natural habitat.  And that research should be done first to gather statistics, outcomes in its natural habitat. 

              MR. GROFT:  Has anyone run into any problems with institutional review board clearance of research?  I mean is this something that we need to look at as well?

              DR. GORDON:  Did "natural habitat" bring that up?

              MR. GROFT:  No, no, no.


              SISTER KERR:  I would think, absolutely, it's critical.

              MR. GROFT:  What I'm trying to get to would be the types of speakers and programs that we need to have come and talk and explain, you know, get to a common point of understanding about different things.  Not to divert from what Effie was saying, but looking at some of the potential areas.

              I was thinking of having HCFA come here and talk about what are the requirements to get a product eligible for reimbursement.  I think that's what we need to hear, also, as we go along.  So we do have some more time to talk about those things.

              DR. GORDON:  Steve, you brought up institutional review boards.  What is the kind of question you think we might or should be interested in?

              MR. GROFT:  I guess the question is, in any of your experience, thus far, has it involved difficulties in getting studies approved and accepted through IRBs?  Does this problem exist?

              DR. ORNISH:  We haven't found it to be a problem unless it's offered as a direct alternative to a more conventional intervention.  That's where there is a problem.  One of the best things about many of the complementary and alternative approaches is that they tend to be fairly benign, certainly in comparison to other interventions.  So it's more the withholding of conventional treatment, as opposed to the interventions, per se, that there is a problem.

                But I want to follow up, I was going to suggest the same thin.  But I think, particularly since we're here in the HCFA building, to have some of the people, the likely administrators, the chief medical officer of HCFA, come here and talk about what is their resistance to these approaches.  And many are of their issues are legitimate and many are just fear.

              I would ask people from Dr. Varmus, you know, a very vocal critic at the NIH of alternative approaches, to come, both, so that the critics feel included in the process, which I think is very important.  When people are included in the process, they tend to be less vocal in their criticism of the final outcome.  But also because I think it's very important to have a better understanding of exactly what are the concerns that are being addressed.

              DR. GORDON:  Dean, just a procedural question.  Do you think that HCFA would be appropriate to comment on research or should we wait until we talk about services?

              DR. ORNISH:  I think it's a bigger issue than either one.  I think it's more of a mind set, you know, resistance to approaches in general and this in particular.  And, you know, logistically it's just a few floors down and so I think it would be an easy thing to do.  At what point, I would defer to you on that.

              DR. GORDON:  But that opens up a very interesting issue of whether early on we should address some of the resistances.  So, let's say while we're doing the research panel, if we had two and a half days, what about spending a half a day addressing different areas where there are resistances, concerns, trepidation, whatever --

              DR. ORNISH:  I personally like that idea very much because there is nothing that clarifies your thinking as much as having somebody challenge you.  And that's really what the scientific process is all about.  This is why I'm a scientist, because I like the process of not having the true believers but having your assumptions challenged, having our assumptions challenged.  And I think it would focus our panel to have those people come early on so that we have a fair sense of the -- you know, we're not just preaching to the choir.

              DR. GORDON:  I wanted to ask if there are others who this might be a good idea as well?

(Many affirmative responses.)

              DR. GORDON:  Okay, good, thank you.

              MS CHANG:  Also, after that, there is also the need, I think, to consider hearing from other researchers out there that are not necessarily doing the kind of research that -- they are not part of a grants program.  These are people who are practicing CAM modalities in secret -- not practicing but researching them in secret.           And the CDC, for example, I wish Wayne were here to talk to us a little bit more, but the CDC, for example, has tried to do some type of what we call "investigative research," where you go out into the field and you are doing field studies in the environment, as Effie said.

              And the problem we're having is the resistance on the part of the practitioner to make known what they are doing because they are afraid that they are going to be closed down once the authorities become involved.

              DR. GORDON:  I just want to second that.  At our most recent cancer conference, one of the very interesting things that we had is people, who are doing what may be extremely promising work, presenting their data rather poorly, for two reasons.  One is that they are not expert in presenting data, which is a whole other issue that I think we need to address, how to help the CAM or health world present their data better.

              But the second issue is exactly the one that you mention, that people were afraid to say, "I'm treating cancer."  Because then they were using natural substances, these were foods, they were not supposed to be treating a disease.

              I'm going to be talking with Bob Wittes, at NCI, in the next couple of weeks about this issue, because they are concerned about it too.  They saw it at the meeting and want to move this forward.  I think it's a great idea for dialogue.  Conchita first and then let's go back to Charlotte.

              DR. PAZ:  That's interesting that you said that because what I was going to mention a while ago was that I think part of the bottom line is looking at some of the research and some of the people that are receiving alternative therapies, and sometimes we can lose focus as the fact that sometimes some of these may go against what we call "traditional" therapies.

              And sometimes, at least in my own practice, I've received some really adverse outcomes that have happened with people who have had some alternative therapies in places that I could not document.

              And so I guess what I wanted to mention was that sometimes in getting this information, it's really tough to sometimes get that kind of information from folks, because they don't want to divulge the fact that they weren't doing real well with whatever therapies they were doing, so they are coming to where ever I happen to be at with that outcome.

              And so sometimes we do have difficulty getting that information.  But also to realize that, you know, sometimes our patients health really does come first and we need to really keep that in focus.

              DR. GORDON:  Charlotte?

              SISTER KERR:  Having engaged in this point and even made comments, I now have the question, which is this.  What objective do we seek as regards all we've just been talking about?  What objective do you seek in doing this?

              And my second statement, I almost want to say something to you as chair, or you and Steve, I feel and I may be wrong, again I need to pause.  Are we just recreating what the NIH has been trying to do?  And, again, what objective do we seek?  What good is it going to do us as a Presidential Commission to be updated, having some questions answered on what's going on?

              Would it be then our objective to advise Congress, to then say what else we think needs to happen?  Because if that's so, it's almost like we're asking for, and I'll make up this word because I don't know what the right words are, an "executive summary" from all the people doing research, or people who affect research, like the things Steve brought up about who refused the study request.  When and why are we going to do all this as the Presidential Commission?

              DR. GORDON:  Why are we going to do all of this?

              DR. PAZ:  Yes.

              DR. GORDON:  I think because many of the issues that have been -- and I'll just give my add, I think answers will emerge from all of us over time, and from all of the people who will come in and talking with us.

              There are questions here that are not being addressed by anyone right now.  Many of the questions that we raised are simply not -- there is no forum for addressing them.  Whether it's the issue of combining herbs, or the issues of standardization, or the issues of resistance, or IRBs, just to pick out four, none of those are being dealt with.

              Most of what's happening at NCCAM is they are sponsoring certain kinds of research studies based on studies that are proposed by different people.  And they are doing some other things too, and it's clearly very important work, but it's not taking a broad look at the whole field or suggesting ways of modifying the way we are all thinking about research.

              DR. ORNISH:  Just to add to that, any form of healing, you have diagnosis, and then we have prescription or treatment.  And I think before we can make any recommendations regarding policy, we have to first know what's out there and what needs to be done.

              DR. GORDON:  Joe, and Tom, and Bill.

              DR. FINS:  Just to respond to a few things that came up.  One is whether or not we should have critics of CAM in to give us their point of view.  I would just say that we're discussing CAM as if it were sort of a homogeneous set of interventions, and there are some that are more contentious than others.  And I think we should know the distinction between things that are benign, moderately benign, useful and extremely useful.

              And another issue that is related to the research question is I'd like to know perhaps from medical journal editors what sort of information finds its way into journals and why, what the criteria are that they are using.  Because I think research, at least in the academic medical arena, is the coin of the realm and it confers legitimacy.                Acknowledging what Sister Charlotte says about the broader picture, if we want to integrate this sort of stuff into the mainstream, we have to get published in journals that are prestigious.

              And, finally, Dr. Paz said something that I thought was very interesting about tracking bad outcomes.  I think to be credible, we have to acknowledge the good and the bad.  And I'm suggesting, and perhaps Michele could comment on this, but the CDC has a weekly report, NFWR, that talks about bad outcomes.  Perhaps that's an expanded role for the CDC, so that we deal with the good and the bad.

              MS. CHANG:  Just to quickly respond to Joe, yes, the CDC and the FDA have for some time been looking at how to systemically begin to report the adverse outcomes.  And they are really struggling with it because there is currently no workable and efficient way to collect all the adverse outcomes, research them, assess them, and then publish them.

              As you know, CDC, most of NFWR is about what the Government has to do, a fast turn around on outbreaks and things like that, so it's not meeting the need right now.  So it's a very good point and I think we should hear from the folks at FDA and CDC who are working on this specific realm.

              DR. GORDON:  Thank you.

              MR. CHAPPELL:  I'd like to have us consider whose property this new knowledge or increased knowledge would be.  And if it's going to be public domain, then who are going to be the forces that want to prevent this knowledge from being brought to light?

              If it's not private property, if it's public property, then I'd like to know what are the forces in our society that would like to prevent this knowledge from being brought to light.

              DR. GORDON:  When you say "this knowledge" do you mean research?

              MR. CHAPPELL:  Increased knowledge.   Coordinated research to increase knowledge.

              DR. GORDON:  And could you say more about how you would look for these forces or how you would address that whole issue?

              MR. CHAPPELL:  Well, I'm thinking of the issue of private property.  Is this patentable?  If it's not patentable, what threats does a more approved and credible product or service --

(Sister Charlotte Kerr leaves.)

              DR. GORDON:  Excuse me one second.  Charlotte, good bye.  Great to see you.

              MR. CHAPPELL:  -- if it's not private property and not patentable, what threats does a public domain of an openly marketed product -- that is, by "openly marketed," I mean this knowledge is public domain -- what threats does that present to those base their illness business on private property, intellectual property?

              DR. GORDON:  In this context, in this Commission, how do you see addressing that?

              DR. GORDON:  Well, I guess I would just like us to identify the forces in our culture that would prefer that this kind of research not become publicly available and marketable.

              DR. GORDON:  How do you identify them?  That's what I'm asking.

              MR. CHAPPELL:  Those that base their businesses on private intellectual properties.

              DR. GORDON:  For example, would you like to have representatives of the major research enterprises and drug companies come and talk about how they relate to our discussion? 

              MR. CHAPPELL:  That might be helpful.  Are they proponents of the pursuit of this greater knowledge? There are lots of people who have businesses built on the lack of knowledge.  Even those in the -- well, I would just leave it at that.

              DR. GORDON:  Bill?

              DR. FAIR:  A number of speakers have commented on sort of our unclear understanding of what we are to do relative to CAM, and I should count myself among them.  And I find myself thinking, Gee, I wish Steve Straus were here.

              Because I would like to hear from Steve Straus what he views this committee could do to help the functions of the NCCAM, which is basically why we're here.  And if you will excuse a surgeon's approach to it, I'd see if I can get Steve here tomorrow, if at all possible, just for 15 minutes.

              MR. GROFT:  It's better to get this into a forum of formal presentation and give him time to prepare for the next meeting.  It's much better.  I think we want to get all the parties involved into a cohesive set of presentations to address all of the issues.

              DR. FAIR:  As I said, surgeons, it makes no difference whether you are right or wrong, just do something.


              DR. GORDON:  I like that.  Steve will be one of the first, if not the first people presenting at length at our next meeting.  And I talked with him about that, and he and I will be talking between now and then.  And so, yes, he is a very important person in this, and he is very eager to share with us his sense of where NCCAM is going and how we can help.

              MR. GROFT:  And I think it was important also to separate out NCCAM from the Commission.  I think that was one of the reasons why we did not invite Steve specifically to come here today or tomorrow and address some of the issues.

              I think it was important to hear from you and the public about the issues.  Steve is more than prepared to -- we've talked to him on several occasions about his willingness to participate as much as what we need.

              DR. GORDON:  I think it's really important too, Bill, the research agenda is much larger than NCCAM. 

              DR. FAIR:  Yes, absolutely.

              DR. GORDON:  And the research questions that we're raising go far beyond the current purview of any agency.  And those are the areas I think are most important for us to consider.

              DR. FAIR:  Well, that's why it will be important for him to be here because he's probably thought about this question more than any of us in this audience.

              DR. GORDON:  I know he's thought about it a lot, but he's been doing this work only for a certain number of months.  And I think that one of the things that's really important in this area is that gathered around the table are people who've been working in these areas for altogether, I don't know how many years, but it's a lot of time.

              And I think that it's very important that, as Steve Groft has said, that this is very much an independent entity and that our deliberations will, hopefully, be of use to all of the Government agencies. 

              MR. GROFT:  I think to remember, too, that after tomorrow we'll have each of you identify what working group or subcommittees you want to become involved in.  And part of that process will be us talking with different people on teleconferences, arranging for the next meeting.  And so I think we'll have the opportunity to get all these issues out then to express the concerns.

              DR. GORDON:  Are there any other comments or thoughts before we close this afternoon's session?

(No response.)

              DR. GORDON:  So just a reminder, tomorrow there will be time for public comment between 1:00 and 2:00.  And we welcome that.  And please let Michele Chang know if you are interested in commenting, we'd love to hear you.  And if you can't make it, or know someone who can't make it, who would like to submit written material, we'd love to consider that as well.  We have a statement by the President here that's just been handed out, each of you has a copy of it.

              I want to personally thank everybody for what was a wonderful discussion.  I really feel we've come a long way in defining the issues related to research.  And we have three more areas to cover tomorrow.

              And one of the wonderful things has been how we've used CAM.  CAM is our doorway, it's our specific mandate.  But I think what's coming out very clearly is that, while we consider CAM, there many other issues and concerns that have to be looked and understood.  And then there is a context to this work that we are doing, and we are being to establish that.  So thank you very much.  And thank you, Steve and Michele and Terri also for the staff work.

              MR. GROFT:  We do need to know how many of the Commission members will attend the dinner this evening.  And so if you could give Michele a quick nod or how about a hand count?

(All hands are raised.)

              MR. GROFT:  Everyone.  And are there any other guests we need to count?

(No response.)

              DR. GORDON:  And we'll see you back here at 8:30 tomorrow morning.  We'll look forward to it.

Whereupon, at 5:15 p.m., the meeting was adjourned, to be resumed July 14, 2000, at 8:30 a.m.)