DR. STEPHEN GROFT

Since this is a Town Hall meeting, there will be people coming in and leaving as the day progresses, so that there will be a lot of activity. So, please, feel free to get up and walk about between your seat and the back of the room.

Even though we set up a format like this, we want everyone to relax and make a very informal session in many respects. I think we have a lot to do and we have approximately fifty-one or fifty-two speakers and so, there will be a lot of back and forth movement, and we hope that you just bear with us with this transition.

I am Steve Groft, I am the Executive Director of the White House Commission, and this is our first Town Hall meeting, and I will not spend too much time because I know other people are speaking this morning. We'll also be addressing our goals and aims, and other activities. I really just want to give some of the logistics and then I'll turn the meeting over to Dr. Gordon, who is the Chair of the Commission. Since it is a Town Hall meeting, we do have some formal presentations and people have requested time, and so we are going to try to establish a system that will have two tables working at any particular time. One active with the speakers and the other will be the speakers to follow. So if you are a speaker, we have several people from our staff who are working in setting the speakers up, Gerry Pollen, in the back of the room, Dr. Joseph Kaczmarczyk and Doris Kinsbury, all from our staff. So if you have any questions about where you go, we've segmented the entire day into sessions, and so if you look at in your background information you'll find the time approximately that you are expected. So sort of drift off when it comes close to your time if we're not at a break. If you are speaking after the break, take time and be ready when the break is over to come up and get yourself all set, so we can go on. These are very long days and very tedious for everyone. I would like to mention also the fact that there may be not a lot of questions coming from the Commission members. That does not mean they are not interested. I think the realities are such that we know we have so many speakers with so little time that we want to hear from you. You have probably heard a number of these individuals speak, I think probably the collective speech of this group are probably in the thousands, if you look at their résumés. So it is a very active group, and there are members of the Commission, and I'll have Dr. Gordon introduce them as we go along.

So, if there are any questions or you want to expand... I believe we contacted all of the individual speakers, either directly or through their answering services or machines and we are asking people to limit their comments and then, if you want to expand them, to send them to the Commission and we will create the file and make sure all the Commission members have ready access and copies. They will give copies of all your shortened comments and for the next year we will have the file available for anyone who would like to look at it. So if it is important for you to expand, and we are open for comments between now and when the report is finally written, of which we are planning to have an interim draft report available July 2001, that will be available for public comment. So with that, I would just like to make one other quick thank you and that's to Michele Chang, our Executive Secretary, who has done a lot of work, a tremendous amount of work. I received a phone call when we left yesterday from Washington, Wednesday night, at 11:02 and I heard this voice, it was my wife, who said "Are you still at work?" And when she (Michele) said no, she gave me the phone, so I was in a daze, but there have been a number of wrong hours and I am very grateful. First, that she is on the staff, as the other members of the staff, but she's done a tremendous job just getting this meeting together.

Don't think that the few number of people here right now are very refreshed on what the whole day will be like, because several people did ask for particular times to accommodate their schedule, so there is going to be a lot of movement all day long. So with that I'd like to turn it over to Dr. Gordon and take care.

DR. JAMES GORDON

Okay, thank you very much, Steve, and good morning everyone. I'm very glad to be here and to be with you. The concept of the Town Hall meeting is one that all of us, all of the Commissioners and all the staff on the Commission have very much embraced, and the basic idea, which we hope will be manifest in here today, is that we are here to learn from you. During the Commission meetings, all of which will be in Washington for two days at a time, we're going to be inviting specific people to come in to address specific subjects and that's based on all understanding of the field or collective understanding of the field. In the Town Hall meetings, we're coming out to learn about all those things which we have not already been thinking about considering or anticipating. We're coming to hear your perspectives on issues and problems and concerns in the way, not only to integrate specific modalities that are regarded as complementary alternatives into medical care, medical education and medical research, but also how these modalities and how these approaches can expand our view of what health and healthcare and medicine should be. And this is an extraordinary challenge for us, it's very exciting, because we feel that we are in a position, all of us collectively, are in a position to really shape what healthcare is going to look like in the next century.

And it's a challenge and an adventure for us, and as you'll hear as we introduce ourselves up here, those of us who are up here have been working in this area for many years, as have many of you, and I see many old friends and familiar faces in this group and I'm sure I will as the day goes on as well. We see this as an enterprise that we are all involved in together. This is the fruition of many years of work for many people and we welcome your thoughts and your suggestions. One of the things that we are particularly in need of is solutions, or perspectives that will help us find solutions. So as you make your remarks, and I may say this several times during the day, please offer us your thoughts, not only about were we've been, or where you've been, or where you are, but where we go from here. This is an ongoing process and it will conclude in March of 2002. There'll be a number of meetings in Washington, DC, and you have the schedule of those, there'll be a number of Town Meetings as well. And the next Town Meeting will be in Seattle on October 30th and the 31st. The next Commission Meeting will be on October 5th and 6th in Washington, DC. All of those meetings are open meetings. We invite you to come to any or all, to be part of this evolving process.

We also, as Steve Groft mentioned, invite you to submit your comments to us in writing. At this meeting today, you only have a few minutes. We don't pretend that it does justice to your thoughts or to your work, or to your perspectives, so we ask you to make the comments here very succinct and understand that a lot of what's going to happen is going to be in the back and forth that goes on here. And also that you should all understand is that if youwant us to take a look at something in writing, please send it to us. If you want us to understand your work and its implications for healthcare in more depth, please send it. We are reading everything that comes to us, we are paying attention to it. We have a wonderful staff who are involved in this work, we have or will have twenty one Commissioners who are all passionately interested in this subject, and we will be looking at what we get. And the other thing is, if there's something else you want to say later on in the process, in a public meeting, take a look at the calendar that's in your folder, and please come to other public meetings.

And also, please invite other people. You can invite or call up people who you think might be interested and ask them to come, later this morning or this afternoon. We'll be here all day and probably a little bit into the early evening and we want people to come, we want to hear from everyone who wants to talk with us.

I think that's all that I have to say at this moment. Everything is being recorded here, so we will have a record of everything that's said. The general rule is going to be that we ask people to come and we have a specific time-frame for each speaker and Michele Chang, our Executive Secretary, is a precise and dignified timer, but a strong one, and so we hope she's saying "It's time" and you should pay attention to the timer here as well. And then, after four speakers, generally speaking, the format will be we'll have a back and forth if we have questions to ask you.

We will take a break at some point in the morning. There is no break scheduled but rest assured that we will take one at some point, probably an hour and a half or so from now approximately, at a convenient time. The other thing is that there is open time. Many people, I think fifty one people, are on the schedule for today. In addition, we have almost two hours of open time during the course of the day. If you are not scheduled to speak, and you would like to speak, please contact Michele and she will put you on the schedule. Okay, and then you'll either be on the schedule for this morning or for this afternoon.

All right, without further ado, I 'd like to introduce a couple of people who are here from the local area, who would like to say a few words, and then I'll go ahead and introduce the other Commissioners.

First is Dr. Mitchell Katz, who is the Medical Director of the Department of Health Services in San Francisco.

DR. KATZ:

Good morning to the Commissioners and good morning to the audience. Our mayor, Mayor Willie Louis Brown asked me to please come. He would have liked to come here himself, he's very interested in medical issues and the use of alternative therapies. I'd like to welcome you all to San Francisco, to applaud the Commissioners, who are very prestigious group, to look at these important issues. I not only act for myself as a Clinician but the first rule of medical training is to listen to your patients. And what I've learned in listening to my patients is that they recognize the limits of conventional medicine and they are looking, and interested in all other treatments that might improve their health and that I think that as practitioners we have to recognize both our strengths and our limitations and be open to looking at other ways of caring for our patients.

So, thank you very much for the opportunity of welcoming you all.

DR. GORDON:

Thank you. The next speaker is Catherine Dodd, who is the Director of the US Department of Health and Human Services here in Region IX.

MISS DODD:

Thank you, Dr. Gordon. Welcome to Region IX, which makes up the states of Arizona and Nevada, California, Hawaii, Guam, American Samoa, the Commonwealth of the Mariana Islands, the Republic of Palau, the Federal States of Micronesia, and the Marshall Islands.

We have the largest region, but we probably also have the region with the richest complimentary and alternative fair peace, when you really think about the traditions, especially the traditions of the Pacific. As you can see, I returned from Hawaii late last night, so I bring you Aloha greetings and, while I was in Hawaii, one of the things I did was visit several domestic violence centers that are using traditional Hawaiian beliefs to treat both the perpetrators and the victims of domestic violence. They call it ho oponopono which means to make right and kearalalokahi which is the pathway to harmony. So it was a visit in Hawaii, a short one with rich experiences looking at a complimentary and alternative way to treating a very serious problem in our country. I am honored to represent the Clinton Gore administration and Secretary Donna Shalala at this first and kind of historic meeting of the White House Commission on Complimentary and Alternative Medicine. As I flew home, I was thinking about what to say today. My background, my education training is as a registered nurse. On my way to Hawaii I got a cold and so, at the end of the first day, I went to Long Stroke store and I bought throat coat tea , zinc, zinc lozenges, vitamin C, and the only chicken soup I could find. It was a pretty good handful of alternative fair peace for an upper respiratory track infection. I am a believer in all the things we have available to us and I'm very excited that this administration is the first to take them seriously, and really secure and put creative meaningful health policy as we begin this new century. So, I want to welcome you, I want to enthusiastically support the efforts of the Commissioners and the work of all of you who are providing input to the Commission. Thank you very much for coming to Region IX.

DR GORDON

Thank you. And our next speaker is Steven Ottenstein, who is the White House Liaison for the Department of Health and Human Services, and has been over the last year and a half instrumental in helping to put together this commission.

STEVEN OTTENSTEIN

Good morning. I wanted to first thank Catherine and her staff for all her support to this commission and all the important initiatives that she's been working on with the Secretary and the rest of DHSS since she's been here, and I also want to take the opportunity to thank Chairman Gordon and the other members of the commission that are here today, and Dr. Wayne Jonas and Michelle Chang who have really been of tremendous help in getting this entire Commission started. This morning, when I woke up and started to get ready for the morning and brush my teeth I realized that the Tom's of Maine products I usually use at home were not part of the hotel package that is given to us while we are here, so I really realized that we have to get out because the Chairman of the Tom's of Main company is one of our Commission members, I really realized that this kind of products and new services need to get out there, so it's really important that this Commission move ahead with these findings and get these things out there. And as know, an estimated 42% of all Americans utilizing CAM interventions so, we are spending 207 billion dollars, and these figures are really amazing, and that is what really led President Clinton and the Secretary to sign the executive order in March, which established this Commission.

Also, yesterday, when I was on my flight over here, there was a really interesting article for those of you who are interested on healing through mineral springs in Virginia and West Virginia. However the years, these springs have become more than interest to folks in how they are helping people in very different medical areas. So anyone who is interested, is on the US Air's magazine, so you really see that it's finding its way everywhere.

When Secretary Shalala swore in the Commission members in July, she highlighted the President's executive order that it called for a report which will maximize the benefits of CAM and it will address the important areas that kind of gone over and it will be delivered to our new Secretary in December of next year for submission to the President, and an interim report will be given in July 2001. At the swearing in the Secretary took a group photo and I wanted to present this to the Chairman today, of all the members and this is for you. We'll also have signed photos for each of the Commission members for the next meeting.

As the Chairman mentioned, there will be another meeting in Washington on October 5th and 6th to discuss the coordination of CAM research with traditional biomedical research and an additional Town Hall meeting in Seattle on the 30th and 31st, and another meeting in DC will be held on December 5th to discuss the delivery of CAM interventions and future Town Hall meetings will be planned for New York, Atlanta, Houston and Des Moines, so we're trying to get out throughout the country and get the importance of this Commission out there.

Also, I wanted to highlight that the President is planning to announce an amendment to the executive order next month, which will increase the Commission's membership from fifteen to twenty, and he'll name additional members at that time, so we're looking forward to getting that executive order amendment signed and getting the new members on board as soon as possible. And although there is a lot of work to be done by next September, the Secretary and the President, and Catherine's office and support are all confident that the Commissioner's report will lead to improved safety and more accessible therapies for all Americans. I also wanted to give a thanks to Senator Harkins' office. A member of his staff was supposed to be here today but because of some pending legislation was unable to join us. But without his efforts and his staff's efforts really I don't think any of us would be here today. It was a really striving force behind this whole issue and I really have a lot of thanks for him and his office for getting this Commission established.

DR. GORDON

Thank you very much, Steve. As we said earlier, Steve Ottenstein was one of the people who moved this Commission ahead. One of the major tasks in creating the Commission, of course, was selecting the Commissioners, and I'd like to introduce the three Commissioners who are here with me today and give each of them an opportunity to say hello to you as well. First is Dr. Effie Poy Yew Chow, who has worked in this area for twenty five years. I know we worked together for about 25 years, and she's been a major force in the Bay Area in healthcare. Effie...

DR. EFFIE POY YEW CHOW

You know, this is such an exciting day. One is at San Francisco, it's leading the Town Hall meetings throughout the nation, and the most important excitement is that we are in an era of change, and this Commission indicates the possibilities in making great changes in our health care for the future, and changing from a disease emphasis system to a health and wellness system. So I guess I urge all of you, and the presenters and the general public to really give some good thought to this and make some really good recommendations as how you see that this evolution we're going through right now can really make a significant change. Not just band-aids, not just a complementary alternative medicine therapies and systems put into a medical system, but really create a system that is innovative and really will look after people, their lifestyles and give them the total good life that we're looking for. And so time is brief, and this is the message I want to give, be brave to say and recommend what is in your heart and what you want for the people. And that's what we're here for, to listen to what you have to say and put it in this document to the President, recommending policies to making a big change in the system. Thank you for coming.

DR. GORDON

Thank you, Effie. Effie has been the founder of the East West Institute and I think East West Director for many years. East West says a great deal about a major portion of the Commissions work, which is bringing together all the healing traditions, bringing together all of the world's healing traditions and making them as available as they can be for Americans.

The next Commissioner who flew out from the East Coast is Dr. Wayne Jonas. He was formerly the Director of the Office of Alternative Medicine and had a major hand in shaping some of the programs that are now becoming so important in medical research, and medical education across the country. Wayne...

DR. WAYNE JONAS

Thank you, Jim. It's a great pleasure to be here and I am really happy to see this finally get going, and specially the first Town Hall meeting. I think the core of what we are about is hearing what's going on in the country, because this is really a publicly driven phenomenon. This is a phenomenon that the public has moved forward with rapidly, and we are about catching up. Our healthcare system, our scientific system, our medical delivery system is about catching up and figuring out how to properly integrate these areas. When I was at the NIH and we were trying to get research going here, since it was the only federally official location for complementary alternative medicine we became then the lighting rod, if you will, for everything weather it had to do with research or not, and Jim was the Chair of our Advisory Council at the time and it was clear that these phenomena was more than just research, that there were educational issues, that there were practice issues, safety issues, all of which needed to be addressed, and so we sought a larger form for that and then, with the work of a number of the staff of the White House, and also in other places in the Government this finally came to fruition. So I'm very happy to see this. I hope that this integration process, this bridging of the gap, will result in a transformation, I think, not just a transformation of our own healthcare system but of other healthcare systems too, in order not only to maintain the quality of the scientific rigor and efficacy that we had in Western medicine, but that will also integrate and understand that we are moving towards a global medicine in a new age.

DR. GORDON

Thank you, Wayne. Before I introduce the other Commissioner, the fourth Commissioner who is here this morning, I'd like to introduce Ms. Harriet Ishimoto, from Congresswoman Nancy Pelosi's office.

HARRIET ISHIMOTO

Really, it's a pleasure for me to be here on behalf of Congresswoman Pelosi and I'd like to share her greetings with you. First of all, she'd like to welcome all the members of the Commission and all of you who are participating today in this inaugural Town Meeting. What she says here is: "There is a growing consensus in this country that we must explore medical options that are outside of current Western practices. Such interest is long overdue. For some patients, complementary and alternative medicine therapies can be the most appropriate course of treatment. We must understand which practices are effective, when they should be prescribed and how this information can be made available to patients and doctors to be incorporated into common usage. By gathering today, you are helping to expand a body of knowledge about alternative treatments and to make their promise a reality for millions of Americans. The work before you is of great importance. Your efforts in this meeting will help to improve the quality of healthcare in the United States. Thank you for all your leadership on this issue, and please accept my best wishes for a successful and productive day. Nancy Pelosi, member of Congress."

Thank you so much.

DR. GORDON

Thank you, Harriet. The final member of the Commission who is here is someone who lives and works in the Bay Area, and he's also someone who has been a major force in creating the new model of healthcare that is beginning to have an extraordinary powerful influence on all of healthcare in this country. And that is Dr. Dean Ornish, who has done groundbreaking work with reversing heart disease with a comprehensive and integrated program of healthcare. Dean...

DR. DEAN ORNISH

Thanks, Jim. I also want to join my voice to welcome everyone who is here today and how delighted I am that this is happening. It's really just so great to be a part of it. And as Jim mentioned, for the last twenty three years my colleagues and I at the non-profit Preventive Medicine Research Institute, were able to show that heart disease is reversible through making intensive changes in diet and lifestyle. I think, one of the reasons I am on the Commission is that our work is an example of something that back in 1977 was definitely not in the mainstream. But because of the research that we've been able to do to show that first, that it was medically effective, and more recently, that is also cost effective. And, as several speakers have said, the issue is not should Americans be using alternative or complementary approaches. So many already are, but with few exceptions, most of them don't really have any signs to find out whether they work or not. And my particular interest is to use science to help find out what works, what doesn't work, for whom, under what circumstances, so that people can make more informed and intelligent choices. And also then to try to change the models of reimbursement through insurance and Medicare and so on, to try to make this approaches available to the people who most need it, which in turn also influences medical education and medical practice. So thank you for being here today. It should be a really interesting day.

DR. GORDON

Thank you. We invite our invited dignitaries to stay as long as they can, although we understand you may have other things that you have to do. The way we are going to be arranging this is we are going to call people up in groups of eight, and each panel of four will testify. Then there will be an opportunity for us to have a back and forth and ask questions, and when that panel is finished we'll invite the next four people to come up, so there'll always be eight people sitting up here. Because this is in the interest of efficiency. With that, I'd like to invite Marilyn Schlitz, Beverly Rubik, Catherine Dower, May Loo, Deborah Kesten, Corinne Giantonio, Savely Savva and Adam Burke to come sit here. (We are missing one person, but that's okay, we'll find her later on).

The first speaker is Marilyn Schlitz, from the Institute for Noetic Sciences & California Pacific Medical Center. Good morning, Marilyn.

MARILYN SCHLITZ

Good morning to all of you and everybody here and again, I want to echo everybody's welcome. I am so glad that you have decided to initiate the Town Hall meetings here in our first city. Welcome to San Francisco. I'd like to make four quick points. The first is to celebrate this moment in American history. I think since the times of the Flexner report and the growing sovereignty of American medicine, we've seen alternative and complementary practices ostracized, marginalized, sometimes criminalized, and so this is a great opening. Part of the opening, I think, is the growing influence at the National Institutes of Health of the National Center of Complementary and Alternative Medicine, watching that budget grow from 2 million dollars under the Office of Alternative Medicine into something that's now somewhat competitive in the National Institutes of Health programs and at now, this White House Commission. The second point I'd like to make has to do with recommendations to the President as he submits his budget, and that is that we need more funding. While we've seen a steady growth of resources allocated to complementary and alternative medicine, within the National Institutes of Health, the percent of funding allocated to something that represents a major demand within our country, I think, is something that we need to address. So I would advocate more funding for both basic and clinical research. I think that at this point, we have many more questions than answers, and that CAM is being used, we do not really know the benefits or the limitations of it. It's absolutely necessary that more funding be allocated. I just looked at, for example, this recent set of clinical trials and St. John's wort were on the one hand we are finding that, as alternative and complementary medicine practitioner have been telling us, it seems really effective for the treatment of depression. On the other hand, it seems to complicate medical outcomes for AIDS patients who are using a variety of different modalities, particularly this protease inhibitors. So I think that there are both positive and negative things we'll learn through research in the area of complementary and alternative medicine. It's very important for creating a new model of medicine in the 21st Century. The third point I wanted to make is in the area of the mandate or ambition of our research program in the area of CAM. And here I think that it is probably easy to think about spending money on things like ethno-pharmacology or the use of botanicals. Indeed, if we look at the pharmacopoeia of the United States of America we find that at least, the last time I looked, the majority of medicines have been derived from native American plants. So it's not new to us to think about converting botanicals into pharmacological agents. I think what's important is that we also remember that there are a range of modalities within the sphere of complementary and alternative medicine that don't so easily fit within the Western medical scientific model. Here I refer to Gigong and some of the aspects of distant Gi, for example. The whole area of distant to intercessory prayer is something that is probably the number one modality used by people in the area of CAM, and yet because the philosophical assumptions of it, don't fit within the materialist or physicalist paradigm of the National Institutes of Health mandate. It has been, again, a marginalized area. So I advocate for a broad mandate in terms of our research agenda and in terms of presidential recommendations to make sure that areas of frontier science are honored and privileged. The National Institutes of Health has just offered an RFA for the frontier grants, and this will be in the area of bio-fields, distinct healing, but it's a very small pool of money. It's a noble beginning, and I really hope that we can make that a priority and address it as something that really requires a significant amount of funding. People are using these modalities, just because they don't fit doesn't mean we shouldn't address them. Another point about that is that I think it requires us emphasizing an educational program within the pre-review process. Because the pre-review process is where the quality of the science is evaluated, and if the people doing the evaluation are operating from a specific set of assumptions based on cause and effect, based again on this physicalist views of the dominant paradigm, we may miss some very important things that are intrinsic to the sphere of complementary and alternative medicine. So, I think that we really do need to broaden the scope. And fourth, I would like to honor the integrity of CAM. My concern as I watch the whole bureaucratization, and maybe as I watch the government come into the conversation there is this whole way in which these alternative practices could become co-opt in a way that doesn't do service to the richness and diversity of the practices or the practitioners. I would say this is true in a number of areas. If you look at the reasons people choose to go to alternative practitioners, the number one thing they say is because the Doctor listens to me. There are relational aspects of this, which we don't find as we are moving into a managed-care medical model. So, I really argue that this is our opportunity, as Ms. Chow mentioned. This is the time of possibilities for us to really radically revamp the system, such that we honor the relational dimensions. I also think that in this context of treating these indigenous practices or these alternative practices on their own terms, there are many physical assumptions built into these modalities. Again, I say QiGong, or acupuncture or a variety of shammanistic practices, or... I mean, we can really just look around the world and we can see that there are healing modalities that don't fit within the Western scientific box, and that doesn't mean they are not right. It means that they are operating on a difference of ontological or epistemological assumptions. The nature and reality is different, and if we can educate ourselves and educate our pre-review processes and educate our policy makers to honoring the pluralism that represents the very core of our American heritage, I think that we really do stand a chance of revitalizing the medical model and creating a new system for the 21st Century. So I just want to summarize the four points. One is I do think this is a unique moment for us to build a new model of medicine, we can integrate all the best approaches. I think there is an imperative that we need more funding for research in these areas, we just don't know enough. I think that it's important that all modalities, all perspectives, all philosophies, be integrated as we develop our research agenda. I think that it is really important that we not be prejudiced against things that don't make sense to us at this moment, because they may make perfect sense ten years from now. And finally, we need to honor practices on their own terms, We need to embrace the best of what is unique about America at this moment in human history, which is that we have every tradition available to us and why not really develop and integral model that accepts what is really truly good and beneficial from all of them, even when it doesn't fit with our assumptions. And finally, I just want to with you, Commissioners, God speed and good luck as you take your journey across America. It is a bold and important process you are involved in and I wish you well. Thank you. DR. GORDON:

Thank you. And thanks for the good wishes too.

UNIDENTIFIED SPEAKER

Good morning. I am really delighted to be here. I'd like to congratulate all of you for being selected in this most distinguished Presidential Commission. I think this is a most welcome format to examine the larger issues and take us beyond what HHS has already achieved into the next stages of transforming medicine. Thanks for coming to San Francisco to hear us. I look forward to a productive relationship with you and to following your continued fine work.

One of my areas of expertise is in bio-electromagnetic medical applications. And in this area, I travel the world examining and gathering information about this promising area of energy medicine. There are bio-electromagnetic medical devices that provide therapy for various conditions and diseases through the application of extremely low level energy to the body, that is electro-magnetic energies. And when these treatments are repeated, for example, weekly, sequentially, and typically in a short course of treatment over a few weeks, they stimulate natural healing to occur, or they actually accelerate natural healing. In other words, they gently move the body into a healing state, which of course is one of the key characteristics of CAM medical modalities.

Moreover, there is some evidence that specific electro-magnetic frequencies may actually activate certain cell receptors and produce pharmaceutical like effects, without the side-effects of chemical drugs. With bio-electromagnetic medicine, we are at the dawn of a new medical frontier in which devices that look very much like those used in Star Trek or other science fiction movies that are used to resuscitate, revive and regenerate tissue, are becoming a reality. This whole area could some day transform medicine from its primary emphasis on pharmaceutical delivery to electronic medicine, and even digital medicine that delivers subtle but potent bio-information to the body, promoting regulation even through computer interfaces. There are significant developments in this area, mostly outside of the United States, and one of my concerns is that we are lagging behind the rest of the developed world in this area. Australia, Japan, Canada, Germany, France and England are some of the countries that are considerably ahead of us in device development of this type, and in granting Government approval to this type of medicine.

Moreover, most of this device-related energy medicine modalities are unavailable in the United States, because they involve CAM devices not yet approved by the FDA. In some cases, they are lumped together with other less worthy devices and relegated to quakery by so-called skeptics. This is a concern to me too, because some of these therapies are inexpensive, safe, extremely promising, and simply unavailable to the American public. Only the very wealthy can afford to go abroad to receive these therapies. It's clear that there is some confusion in this area. There is a lot of devices out there, and some very excellent modalities are being discarded along with the insubstantial. I would like to suggest that some new programs in research and education tailored to sorting out the weed from the chaff, need to be developed.

Some of these energy medicine devices evaluate how acupuncture meridians of the body conduct low level pulses of electricity or, in other words, how the bio-field reveals information about the energy reserves of the patient. There is, for example, the electro-dermal testing according to V, also called EAV, VEGA, there are many names. Many of these are professional products in the global marketplace. These devices have been proved safe and effective diagnostics in the developed world outside of the US. They get practitioners instant access to patient assessment that is very inexpensive and non-invasive compared to our conventional diagnostics. Although there are occasional continuing medical education programs that address these in the US, there is no standard curriculum, to my knowledge, existing in any university setting and there are serious obstacles to FDA approval of these devices.

There is a whole other area of laser therapy and light therapy which has been proven effective to heal skin once rapidly, even the cubital ulcers in bed-ridden patients and the foot ulcers in advance cases of diabetes. Not only lasers, but light-emitting diodes are also used, which are very inexpensive, safe and effective. These are extremely low level lights that do not even heat up tissue, they are not like lasers used in surgery at all. And there is a rather sad history in America under light photo therapy. Decades ago mavericks in this area were imprisoned and removed from practice. There was, for example, a radiation of blood that was used as a successful form of treating septicemia and other infections before the advent of antibiotics. Now, these procedures are unavailable in America. Although it could be a practical solution to antibiotic-resistant infections, which of course is one of the problems of our era, with AIDS and newly-created organisms from antibiotic resistance. Today, most phototherapy devices are illegal in America, relegated only to research, even though some of them have an impressive research database, safety record and considerable clinical use abroad.

Physical therapists, for example, typically use these in other developed countries, but there is little if anything on phototherapy and the education of PTs in the United States. Moreover, it is prohibitively costly to prove the safety and efficacy of these devices in our country. There may also be historical biases operating in FDA's regulatory affairs, because of the long historical association of color therapy with quackery. I would like to congratulate the National Center for Complementary and Alternative Medicine and the recently RFA on frontier medicine that will fund up to four centers to study novel areas of CAM, including this area of energy medicine. And as a former member of the Program Advisory Council of the OAM, I advocated this type of program for several years. The frontier medicine grad program is indeed a first step, and is a wonderful start for the more maverick medical modalities. But we need much more attention and funding to a few areas of complementary alternative medicine that have been largely neglected by NIH thus far. These are the frontier areas of medicine, as Marilyn Schlitz mentioned, particularly those in which the United States is falling behind the rest of the developed world. Whereas we have a giant pharmaceutical industry that can easily afford to conduct the various stages of clinical trials demonstrating safety and efficacy, there is no large Lobby and no wealthy corporate counterpart in the CAM device arena. Just as the Federal Government has taken up orphan drugs because no private industry could do this profitably, it seems to me that federal aid would be well spent in assisting private enterprises in developing and testing devices and in ushering them through the FDA approval process.

I recently learned that NCCAM dedicates 1% of its budget in SPIR grants. I'd like to recommend that the Center make a special effort to fund frontier medical applications in CAM therapeutic device and novel diagnostic industries. And since we are talking about extremely low level energies supplied to the human body, in some cases much less than the ambiance electro-pollution from our cell phones and other potential environmental hazards. The safety issues with these therapeutics should be of little concern. I would also like to recommend some new policy making for FDA regulatory affairs in the realm of these devices that will accelerate the clinical assessment and help the US achieve a leadership position in this area.

Furthermore, it seems the FDA is particularly difficult on foreign medical products. I heard this from my colleagues in various parts of the developed world, as the foreign manufacturers of CAM medical products simply get bogged down in the FDA problems. Let me tell you about a specific example in which I was involved. I was consulting for a Japanese firm that had a medical adhesive tape with semi-conducting substances imbedded in the adhesive that quelled inflammation and accelerated wound healing. Because the FDA said they did not know how to categorize this truly novel medical device, it was confiscated at the border, and held there for over a year.

[END OF TAPE I PART I SIDE A]

[TAPE II, PART II SIDE A]

the various stages of clinical trials demonstrating safety and efficacy. There is no large lobby and no wealthy corporate counterpart in the CAM device arena, just as the federal government has taken up orphan drugs because no private industry could do this profitably, it seems to me that federal aid would be well spent in assisting private enterprise in developing and testing devices and in ushering them through the FDA approval process. I recently learned that NCCAM delegates 1% of its budget in SBIR grants. I would like to recommend that the center make a special effort to fund frontier medicine applications in CAM therapeutic device and novel diagnostic industries. And since we are talking about extremely low level energies supplied to the human body, in some cases, much less than the ambione electrode pollution from our cell phones and other potential environmental hazards, the safety issues with these therapeutics should be of little concern. I would also like to recommend some new policy making for FDA regulatory affairs in the realms of these devices that will accelerate clinical assessment and help the US achieve a leadership position in this area. Furthermore, it seems that FDA is particularly difficult on foreign medical products, I have heard this from my colleagues, in various parts of the developed world, as the foreign manufacturers of CAM medical products simply get bogged down in the FDA problems. Let me tell you about a specific example of which I was involved, I was consulting for a Japanese firm, that had a medical adhesive tape with semi-conducting substances that were embedded in the adhesive, that quelled inflammation and accelerated wound healing. Because the FDA said they did not know of how to categorize this truly novel medical device, it was confiscated at the border and held there for over a year. The Japanese lawyers were not well prepared to deal with this difficult situation, as a result the clinical trial that I wanted to set up on wound healing has not yet been done. Therefore, I would suggest some new policies facilitating FDA's regulation on CAM devices would be extremely helpful.

Conventional medical education in America emphasizes biochemistry, physiology, pathology, and anatomy. But education in physics is lacking in pre-medicine and medicine. And that a means that a knowledge and an application in this area of energy medicine is also lacking. And that may be at least be part of the reason why biological medical devices…

Excuse me, we're coming to the end..

…alright…at any rate, let me just summarize or move forward…in some cases, 20% of bone healing device for example, is utilized in only 20% of the cases, when indicated even though it's non-invasive or expensive, and instead orthopedic surgery is done to accelerate non-union bone fractures. So even with FDA approval there are problems. OK, since I'm running over time, I have the text of this in 8 copies for all of you, and Thank you very much…

Thank you very much, Beverly, next speaker is Catherine Dower.., it's nice to see you

CATHERINE DOWER

It's nice to see you too, Good morning, thanks very much . Good morning to all of you, I'm Catherine Dower, I am the Associate Director of Health, Law and Policy at the UCSF Center for the Health professions. And the Center is a national non-profit research and policy center that addresses the issues of about 200+ health care professions in this country today. The center was established to help assist the health care professionals, health care profession schools, care delivery organizations, and public policy makers respond to the challenges of educating and managing the health care work force that can improve the health and well being of people in our communities. The center is particularly committed to the idea that the nations health will be improved if the public is better informed about the work of health care professionals. This is why we have a very active communications department; we do a lot of work through the mail and on our on-line website. So even if we focus just on the people who provide health care in this country, as the center does, and leave aside for the moment the delivery and financing issues, we face numerous opportunities and challenges, these include technological advances, tele-health, tele-practice, work force shortages, mal-distribution, particularly in rural and some inner city areas, lack of racial and ethnic diversity in the professions, inadequate training for needed skills such as cultural competence, and evidence based practice, and an outdated regulatory system. So emerging professions face these issues, and more, in my perspective the environment to which emerging professions seek to enter is not particularly embracing, as you all know, and is not unique however to complimentary and alternative medicine. Virtually every profession that has sought legal and financial recognition over the past century has faced opposition. Some of the opposition is grounded in legitimate public protection concerns, and some of it has been based on economic or political concerns; so the positions have opposed the nurse practitioners, the dentists the dental hygienists, the ophthalmologist opposed the optometrist, the list goes on every day, each day, in every state legislature, across the country.

Today consumers are driving a new movement and that is this, we have an array of choices of health care practitioners, and diagnostic and treatment modalities. The consumers are actually using these options. However, as consumers indicate their desire for using these options, the policy makers, who we hear from constantly, ensures the costs all the time to researchers, educators, health care practitioners, who are struggling to address, essential issues of accessibility, safety, efficacy, and cost effectiveness too. Some of the most pressing questions are what are the qualifications of the providers, and how can their qualifications be evaluated. These questions are asked not only for the individual professional level, but also at the profession level. So that is where we are focusing most of our attention. The center is, I just want to tell you about the new project at the center, funded by the Arcave Foundation, we're going to work with an inter-professional task force to create a model, for evaluating developing professions, including those in the CAM world. The model will provide a template for practical information, the policy makers, consumers and insurance companies, etc., can use as they seek to understand and integrate emerging professions in Health care. We expect that the model, its still in progress, but we expect that the model will include criteria, such as education and training pathways, and how to report those options, a professional description