White House Commission on

Complementary and Alternative Medicine Policy

January 23, 2001

New York, New York

Opening Remarks

GROFT:  Good morning everyone.  If you could please take your seats we'll get started on this unbelievable agenda and list of speakers that I think will keep us busy.  We're hoping to get out of here around 9:00 tonight, but we're not sure.  So with respect to the people that are coming at the tale end of the day, we'll get started real briefly.

            I'm Steve Groft and I'm the Executive Director of the White House Commission, and it's hard for me to welcome you, but thank you for coming out because without you we wouldn't be here.  And the overwhelming response I think has led us into a number of situations that will be a little bit different.  First we felt we could give everyone about five minutes of presentation time, but we're going to have to reduce it to three, as you've been informed.  But we do look forward to your expanded comments, if you could either give them to us today or send them in to the office after today's meeting.  So we would appreciate them.  And any other supporting information or any other information you'd like the commission to look at, at that point please enclose that as well, because that does become part of our record that we will review as we prepare the report.

            The report is going to come in two phases.  The first one will be an interim report in July, that we hope about mid-July we'll have an interim report; primarily the recommendations.  So we'll just have you take a look and follow out Web site.  I think we've got information on the Web site within the background information.  Please look at it.  We'll have the highlights of the meetings and the agenda for all the meetings, so please just keep up with it.  And if you have any questions, there's a section there, if you could send us a message.  But after the interim report we are looking for comments from you, the public, about the recommendations, so please let us know what you think.

            We are required to be out of business by March 7, 2002, so that will mean in all likelihood we should have the report done in early January of that year.  So there will be a lot of creative writing between this time and that time next year.  But all of a sudden we started last June and the seven months that have transpired since that time have just flown by.  So I know how busy it's going to be the rest of the way.  And with a series of meetings to come in Washington, we do have a bit of a revised schedule of meetings.  On February 22 and 23 will be the next full meeting of the commission.  And then there will be a meeting on March 26 and 27, tentative, but it's looking like they are the dates.  Then May 14 through the 16th.  So just keep tabs on the Web site.

            Today, since we do have so many speakers, we're going to break you into panels, and you all received the agendas.  And we do have a panel coordinator from the staff.  They're floating around, so if after the meeting at any time you would like to speak with anybody, use the panel coordinator as your point of contact to get into the office.  I think we'd like to establish that relationship, so please check in with them.  And if you need to speak with me or Michelle Chang, the executive secretary, who just disappeared, we'll be happy to help you however we can.  So please think about that.

            We've reserved seats here in the front of the auditorium for the speakers.  And there's going to be a lot of motion as the day goes on.  And these seats are reserved for you as speakers for just the session until we break.  After that, if you're going to stay, we just ask you to move to the back of the room and make room for the next group of 50 or 60 speakers.  So it's going to be really, really hectic.  And we do have the timer here.  We're going to flash to you, and Michelle and I have a one minute warning that we'll put up.  So we'll ask you just to respect the time.  And as your presentation goes on, please focus on the recommendations.  We'd love to hear more about you and your institution or organization, but we really need to hear about the recommendations.  The time, three minutes goes by awfully fast, but if you use it wisely you can get everything in that you have to.  So we ask that.

            There will be a ten minute follow-up session of questions that, oh, five minutes.  They're compressing me.  So we'll be speaking quickly and we ask the commission members to make a very very brief questions to you and then for your response to be very brief as well.  And then you can expand on that after the meeting as well.  So it will take an awful lot of cooperation if we're to hear from everyone.  It's going to be a very busy day.  I think there's a lot of enthusiasm, even though the audience isn't large right now, I think the sum of the entire day you're going to find that there are a lot of people who will be coming through the door as we go on here.  And so we ask you to bear with us and we're looking for a cooperative spirit here today, I think that will carry us through. 

            And I would just like to introduce Dr. Jim Gordon who is the chair of the commission.  He'll take care of the rest of the introductions and get us started.  Thank you very much for coming out and supporting our activity.  We really do want to hear from you, and we need to hear from you.  Thank you.

GORDON:  Thank you very much, Steve.  One of the things that we do at the beginning of the commission meetings is we take a moment just to sit quietly in silence and center ourselves.  So if we can all begin that way, just sitting together in this space together and breathing together.  Thank you very much.

            I'm going to introduce my fellow commissioners and speak for a few moments, but first I would like to introduce Dr. Gilberto Cardona, who is the Acting Regional Director of the Department of Health and Human Services here in Region II. Dr. Cardona.

CARDONA:  Thank you.  I needed that.  I'm sorry I came late.  It took me over three hours to travel 20 miles from northern New Jersey, the George Washington bridge was impossible today.

GORDON:  Deep breathing is essential.

CARDONA:  Thank you.  I'm going to be brief because I'm late and because there is important business to be transacted.  So on behalf of the Region II of the regional office number II New York, the Department of Health and Human Services, please receive our welcome and greetings.  Our special thanks to the commission for meeting in our jurisdiction and to all the participants in the hearing. 

            The charge given to the commission is one of great importance, given the proliferation of complementary and alternative remedies in the market today.  It is an industry with very little regulation and open to . . . claims that are of doubtful validity.  On the other hand, we need to be open to legitimate alternative approaches to patient treatments.  Certainly I look forward for an exchange of information that will help us have a better understanding of the benefits and the risk of these interventions. 

            As a pediatrician I have been witness to a number of occasions in which these remedies have done more harm than good.  A case in point, some medications coming through Texas that have high contents of lead, after the use, lead intoxication in a number of children, one of which had to be treated quite aggressively.  So, but on the other hand, there are potential beneficial uses, so I do not want to prejudge the outcome of this meeting.  But I welcome everybody to our region.  We comprise the states of New York, New Jersey, Puerto Rico, and the Virgin Islands.  And being a native born in Puerto Rico, I'm used to complementary medicine and alternative medicine, because that's part of our culture. 

            So greetings, again, to all of you, and I look forward for a very productive day.

GORDON:  Thank you very much Dr. Cardona.  And we are very interested in public health concerns about complementary and alternative medicine, as well as the effectiveness of the therapies, so we'll be in touch and we look forward . . .

CARDONA:  I'm going to sit with . . .

GORDON:  Wonderful.  Thank you very much.

            Let me begin by introducing the other commissioners.  The total number of commissioners is 20, and at first we thought we were just going to have a few at the New York meeting, but everyone wanted to come.  And so the people here are all extremely eager to be here and to listen to everyone.  And they knew ahead of time it was going to be a long day, as well.  And they're a distinguished group, and you can, Steve, they have access to the bios of the commissioners.

GROFT:  Yes.

GORDON:  So you can look at the bios.  We don't have time to introduce everybody in depth, so I just want to make sure you know who they are.  And you can check the bios out.  And in addition to having the opportunity to speak today and to listen today, you can also, if you want, get in touch with the commissioners through the office, through the White House Commission Web site.  To my extreme right, and that has nothing to do with political orientation, Dr. Effie Chow.  And next to her, Dr. David Bresler.  And next to him, Charlotte Herr, Linnea Larson.  And you've met Dr. Steve Groft and Michelle Chang.  And Dr. Conchita Pasz, Dr. Joe Fins, Dr. Ming Tian, George DeVries, and Dr. Veronica Gutierrez, at the extreme left.

            And the way we're going to be working today is we're going to have each group of six or so will come up.  Each person, as Steve said, will have three minutes.  And then we'll have five minutes to ask questions.  And we're going to choose only two commissioners probably will have a chance to a question of each panel.  And if there, as Steve said, if there are other information you would like us to have beyond what we've said, please make sure you submit it to us in writing and be in touch with us.  And again, the way to be in touch with us is through, and I'll be mentioning this throughout the day, so you'll forgive me if there's repetition, but as new people come in, there will be a commission staff member.  And the staff are really the heart of the commission.  They're the ones who make it possible for all of you to come.  They, and for this meeting in particular, Michelle Chang, arrange people for the panels, and contact you all, and they will be your conduits to the commission.  And so each of you will have an opportunity to meet with staff.  For those of you who are not speaking, you can get in touch with us directly through the White House Commission office. 

            I just want to say a couple of words about us being here in New York.  This is the one, two, three, the third of our town hall meetings.  And we have two kinds of meetings.  We have meetings of the full commission in Washington, D.C., where to a significant degree, to a major degree we set the agenda.  For example, our next meeting is on professional education, licensure and credentialing on February 22 and 23 in Washington, D.C.  So we decide pretty much who is going to come in.  We ask people for written testimony, as well as to come and appear publicly.  We have a particular focus on that topic.  We also, incidentally, do have time for public comment on any aspect of the commission's work at all of our meetings.

            The town halls are somewhat different.  In the town halls, you all set the agenda.  We have some thoughts, we have ideas, we know people in the community, we invite those we know.  And we thought we would invite the people whom we had in mind to come, and we would have plenty of time left for the occasional person who might also want to talk.  So we invited about 60 people, I believe, and there are about 70 or 75 more who have said, we want to talk, which is wonderful.  This is exactly the process that we want.  We want to hear from you, whether you're a practitioner or somebody who is coming for health care or an interested citizen or an advocate, whether you think that these therapies and these approaches have something wonderful to offer or whether you're extremely critical of them.  We want to hear all the voices.

            And the recommendations that we make, Steve spoke about our interim report.  The interim report is going to be focused on a relatively small number of recommendations to the President and to Congress about legislation.  And we want your input on those issues.  But it's not only that we want your input, we want to remind you that legislation doesn't happen unless you want it to happen.  That the reason there is an office, and now a national Center for Complementary and Alternative Medicine, the reason there is funding at the federal level, there reason there is a White House Commission is because people want it to happen.  Because so many Americans are using these therapies, practicing these approaches, because people want a more effective, a more inclusive, and a more humane approach to health care.  And if the recommendations that we make are going to go anywhere, it means that you all have to be our, not only activists on behalf of us, but activists on behalf of yourselves.  You're the ones who have made it possible for there to be a commission, to be a national center, and you're the ones who are going to make it possible for the kinds of recommendations that we make based on what you tell us to become law.  So this is a completely collaborative piece of work that we're all doing together.

            And we look forward to continuing the collaboration.  We hope that when we issue the final report, which Steve said will appear in March, that that will be a kind of synthesis of everything that we've heard, and we hope a blueprint for widespread change.  So we look forward very much to this day.  And as Steve said, again, we want especially, we want to hear your recommendations.  That's what we're looking for.  We want to hear a little bit about the situation that you're in.  About where your knowledge and where your wisdom comes from, the experience that's brought it out, and especially we want you to tell us what you would hope that we would urge Congress and the White House to enact and why you would hope that we do that.  So without further adieu, let's dig in with the first panel.  Thank you very much.

Panel 1

Panel Coordinator, Dr. Joseph Kaczmarczyk

CHANG:  Thank you.  Would the following panelists please come up to the stage.  And note also that Dr. Joseph Kaczmarczyk is the panel coordinator for this panel.  So if you have any questions or comments, panelists, you need to see him afterwards.  Dr. Ansel Marks, Margaret Buhrmaster, Caroline Rider, Stephen Lockwood, Simone Charlop, and Martin  Rossman.  Thank you.

GORDON:  And when I call the panelists, I'm just going to go down the list as it is in the agenda.  So we'll begin with Dr. Ansel Marks please.

MARKS:  Dr. Gordon, distinguished commissioners, speakers, and guests, thank you for inviting me today to speak about the work of the Board and Office of Professional Medical Conduct.  I do not speak for Commissioner Novello, however I can tell you that the commission has given us strong support in the work we have done. 

            The mission of the Board and Office is enumerated, and I've provided you with copies.  But in part, the mission includes the following verbiage:  to protect the public from medical negligence, incompetence, illegal, or unethical practices of physicians, physicians' assistants, and specialists' assistants.  To deter the incidence of professional misconduct by physicians, to promote and preserve standards of medical practice which conform with applicable laws and regulations, and to respond to express public questions and concerns over the quality of medical care, which is a good segue into what we're doing here today.

            The Public Health Law Section 230 provides for a board for professional medical conduct.  The board consists now of 186 members.  It is the largest board in the world of its kind.  And the reason for its size is in part the law itself, which provides for extensive due process rights of physicians who are alleged to have committed acts of misconduct.  The board is very diverse.  It includes approximately two-thirds physicians and one-third public members.  It's ethnically diverse.  It is geographically diverse.  It's diverse as to physician's specialty.  As a matter of fact, this underscores the fact that the whole process includes the entire medical and lay communities in its work.  This board and the law is sensitive to complementary and alternative medicine.  As a matter of fact, the law provides that at least two members of our board be physicians who provide complementary and alternative medical care.  And actually there are more than two, and we are currently soliciting additional qualified candidates to serve on the board.

            At a recent annual meeting, an entire seminar was given to alternative medicine with distinguished members of the alternative medical community making presentations to our board, which meets in plenary session, at that time annually, now bi-annually.

            This Board and Office is a reactive board.  We have no agenda where we go after certain types of misconduct, other than for major fraud cases.  So since we are reactive, in the year 2000 we received approximately 7,000 complaints.

            My time's up?

MAN:  Yeah.

MARKS:  I will leave it with the thought that this Board and Office is very responsive to the agenda today.  We're here to listen and learn and also to answer any questions.

GORDON:  Thank you Dr. Marks.  Three minutes is indeed very brief for everybody.  And we're really sorry about that. And we welcome, as I said before, we welcome any of your thoughts.  And as you look, as you, Dr. Marks in particular, and as others look at what appears on our Web site, we welcome your comments and your thoughts.  So I think particularly in this area of licensing, of credentialing and disciplinary actions, we're going to be having a whole meeting on the 22nd and 23rd, so anything else you'd like to call, or if you'd like to call me personally I'd very happy to talk with you.

MARKS:  Thank you doctor.

GORDON:  Thank you.  Next is Margaret Buhrmaster.

BUHRMASTER:  Good morning, and welcome to New York State.  As the old saying goes, I'm from the state and I'm here to help you.  And I mean that. 

            I'm Margaret Buhrmaster.  I'm Director of the Office of Regulatory Reform, New York State Department of Health.  The Office of Regulatory Reform was created four years ago in an effort to mediate and facilitate the processing of health regulations and make them more user friendly, more outcome based and to try and develop sensible, rational regulations without overregulating people in the health care industry.

            A year ago our office agenda was expanded to take a look at complementary and alternative medicine.  And we expect over the upcoming years to be the facilitator and researcher in this process in New York State.  We've received a number of inquiries in our office over the last year with very serious interest in this subject.  And they've been received from all sectors of the health care industry, CAM providers, traditional medical doctors, facilities, educators, and, of course, consumers.  And what we have learned is this is an area of health care with a great deal of conflicting information and the subject elicits a great deal of emotion, as we all know.

            Today I'm not prepared to discuss specific recommendations, but I did want to say that we're looking at this from the perspective from what the state's role, the state government role should be in regulating or, as the case may be, not regulating CAM techniques or anything in the complementary area.

            There are several areas that we're giving very definite attention to.  One is CAM education curriculum.  We've been working with some of the medical schools and realize that there is a genuine interest in providing adequate CAM education for new doctors, and also a continuing education for doctors.  One of the big problems is finding the proper or appropriate education.  And that's the credibility of the information that is being passed on.  And I think that's discussed by people who have varying opinions on the subject.  That how do you get credible information.

            We found that probably the area with the broadest interest of concern is the issue of safety and education information on herbs and nutrients.  And we really feel that that should be handled at the federal issue, but we're trying to become informed on it.  We hope that we'll be able to dialog back and forth with you and collaborate on this process.

GORDON:  That will be wonderful.  Thank you very much.  Caroline Rider.

RIDER:  Thank you very much.  Thank you for all the time, effort, thought, and concern you're giving to this project.  It is very important for America.  Second, the most important thing I have to say is please do what you can to help us as consumers get, if we are in a state where we don't have it, or retain if we are in a state where we do have it, the freedom to purchase complementary and alternative health care services through providers that we choose, trained the way we want them to be trained.  Please, please don't advocate the spread of the traditional regulatory model for these services.  Please don't try to apply uniform standards of education, training, or licensure to all CAM practitioners.  Let the practitioners disclose their qualifications to me as a consumer and let me choose.  Our present regulatory tools are clumsy, expensive, and not tremendously effective.  Moreover, they take away the consumer's right to make a choice, informed or uninformed as the consumer chooses.

            Although I can sort of see the logic in theory of having some specialist who is going to cut me open with a knife and do fancy things to my insides be qualified and overseen by other similar specialists who work for the state and have the power to license and de-license.  In practice, in my experience that power operates more to limit the supply of practitioners and increase their costs than it does to uphold the quality of the work done, albeit the regulation is done with the best of intentions.  And it certainly does not prevent the actrogenic(?) illness or death.  How much less sense then does it make to apply that clumsy, expensive approach to those complementary and alternative health care services which have low risks of direct harm and/or side effects.  Please, let my CAM practitioners be legal.  Let them disclose their qualifications to me when I go to see them in their office, and then get out of the way and let me choose for myself.  In the same vein, then, please don't have government required education and/or training for each modality.  Let the practitioners themselves figure out what they should do.  Let their professional associations debate these questions.  Let the public vote with their feet.  There's a very low risk of harm, so big brother is not needed.  And the complementary and alternative health care field will develop, evolve, and blossom into ever more effective ways of helping people heal and be well, much faster and less expensively if the government does nothing more than make them legal and mandate disclosure.

            Performance standards and practice guidelines set and supervised by regulatory authorities are not needed for the CAM community.  As in many other fields, practitioners and their professional societies will develop peer certification, will publicize them.  Over time the public will choose some certifications as being more valuable than others.  The government should let this process take care of itself.

            I do not have the ready unfettered access to complementary health care services that I would like to have.  Because of a threatening regulatory climate there are too few practitioners in the Hudson River Valley where I live.  Let me emphasize that I'm not some irrational wild woman or some knee jerk anti-science gook.  Indeed, my undergraduate degree was in biochemistry with honors.  I did my own research on the ATP . . . activity of dystrophic muscle in the mouse.  Though I am now a practicing attorney and a ten year professor of management, I still subscribe to and read Science News.  I think that western methods of scientific research are very useful for some problems and not for others.

GORDON:  Stephen Lee Lockwood.

LOCKWOOD:  Thank you Dr. Gordon and distinguished commissioners.  I'm here to speak in support of federal legislation to protect CAM, or complementary and alternative physicians.  I'm an upstate New York health care attorney, and I've represented several CAM physicians.  The problem is that the state schemes that are set up to regulate physicians have a discriminatory impact upon CAM physicians, mainly because the regulatory staffs are uninformed and uneducated on complementary and alternative treatment modalities.  And so they view CAM therapies as being different from conventional therapies and then prosecute the CAM physicians.

            The effect of these disciplinary proceedings has a chilling effect on the patient's right to access CAM therapies.  And I think what this legislation would really promote is the people's and the patient's constitutional right to choose what kind of treatment modalities they want.  Now we all know here that there's two different paradigms, the conventional and the alternative paradigm.  The one doesn't accept the other, certainly conventional doesn't accept often the alternative paradigm. 

            I'd like to give the New York State as an example.  In 1994 New York State passed the Alternative Medical Practices Act which was widely hoped by many of us to settle out the situation.  But it really hasn't.  Although the Act mandates, and as Mr. Marks said, that at least two complementary and alternative physicians be on the Board of Professional Medical Conduct, it does not mandate that any CAM physicians serve on either the investigatory panels or in the hearing panels that assess the disciplinary proceedings of CAM physician.  So it's just flawed because you're not being evaluated by anybody that knows anything about your therapy.  And it's tremendously costly to defend, and it just raises havoc with a physician's life, his family and his patients.  And in these types of proceedings too, and this not only affects CAM physicians, but no one ever knows who raised the complaint, who your accuser is.  If you're charged with a crime you get to face your accuser.  Not so in these disciplinary proceedings.  I'm encouraged to see that the state is aware that it needs to educate itself as to CAM therapies, but I think federal legislation is necessary because only a few states have enacted laws to protect complementary physicians, and they're really not sufficient, as New York's is a good example.  If you pass federal legislation it could be part of a patient's bill of rights.  It could design to protect CAM physicians from discriminatory disciplinary actions, it could mandate education in CAM therapies for regulatory bodies and physicians.  And it could require that CAM physicians serve on the investigatory panels and on the hearing panels that assess.

GORDON:  Thank you very much.  Simone Charlop.

CHARLOP:  Good morning . . .  I am Simone Charlop.  I have been a recipient of alternative health modality for many years. 

PEOPLE:  We can't hear.

CHARLOP:  How about now?  I have a recipient of alternative health modalities for many years.  I have seen remarkable results, both personally and with other people who avail themselves to these procedures.  Some of the results were practically instantaneous, and some times it took a few weeks, and sometimes there were no observable benefits.  But the same can be said of allopathic medicine.  But the alternatives to which I refer achieve their results without harm and without leaving chemical residues in the body or using invasive techniques.  I believe that methods which facilitate the flow of block energy or offer harmless supplements to enhance wellness are the methods I want for my body and for my family.  As to a definition of harmless, the easiest way to determine what is acceptable to your body is muscle testing, a procedure developed by a chiropractor many years ago.  And for those of you not familiar with this technique, I would suggest that you avail yourself of learning that.

            And I know I am capable of deciding which practitioner is best for whatever the particular problem may be.  I want to continue making these decisions for myself without any interference from anyone.  That is the real issue.  I decide.  It is not of interest to me if the person I choose to see is licensed or registered or sanctioned in some way.  In fact, I have no idea how you could possibly develop any standards or definitions that would cover people who do this work.  Many combine many different modalities and then add their own particular tweaks and embellishments.  That is what is so exciting about the field.  Everything is individualized since every person brings his or her own history. 

            I, of course, do research before I see a practitioner.  I learned about his or her training and years in practice.  I speak to other clients and have a consultation with the practitioner.  Then if the person seems right for me we work together.  One of the questions people ask me is, do I see a regular doctor?  The answer is yes.  When I broke my leg it was set by an orthopedist. 

            But the important point is that I made the choice about that care.  I would like to acknowledge and praise the focus of this hearing.  The new recognition of alternative practices and complementary medicine is a step forward.  It should be encouraged, but it should not be an excuse for the development and promulgation of new regulations which limit or deny access to methods used with success for hundreds of years and for stifling creative healing.  Thank you and blessing.

GORDON:  Thank you.  Martin Rossman.

ROSSMAN:  Dr. Gordon and distinguished commissioners, thank you for doing your work and for allowing me to speak to you.  I'm speaking today on behalf of the Academy for Guided Imagery, a post-graduate training organization co-founded and directed by Commissioner David Bresler and myself.  We've been doing research over the last couple of years on mind/body/spirit interactions in medicine, which has come under the CAM rubric, although we feel that it belongs in a much wider arena.

            And our research indicates that there's a pressing need to provide education about mind/body/spirit effects at all levels of the American health care system.  We believe that mind/body/spirit effects differ in important ways from other modalities currently considered in the CAM arena.  First, because it's not a modality.  It's really the context in which all other therapeutic interactions must work.  It's inherent and immediates all therapeutic interactions.  Secondly, there's already a significant body of published peer reviewed research that clearly demonstrates that mental, emotional, and spiritual factors significantly affect a person's health and well-being.  The resistance to disease, the progression of their illnesses, the amount of suffering that they experience in the outcome of medical interventions. 

            Over the past two years we've been reviewing and assessing this literature and feel that literature already exists to support the following statements:

            1.  That the accuracy and completeness of information a patient is given and how they interpret it significantly affect their medical outcomes;

            2.  The way a health care professional communicates and interacts with patients can have significant affects on their medical outcome;

            3.  That a person's attitude that believes expectations and hopes about illness and healing materially affect their medical outcomes;

            4.  A sense of connection with people, nature, and something larger than themselves has significant effect on health outcomes; and

            5.  The skills of relaxation, imagery, stress management, meditation, assertiveness, and the ability to manage emotions can directly influence all of the above and it can be easily and inexpensively taught. 

            Because this literature is so strong yet unknown to most medical doctors, and even other CAM practitioners, we'd like to submit the following policy recommendation to the commission.  That:

            a.  This literature be collated and reviewed by an independent panel and if it's agreed that these statements have already been proven, that an emphasis be placed on educating health care professionals and the public about what is already known in this field if choices have to be made about spending resources on education or research.

            In the past 12 years the Academy has developed effective educational and evaluation methods in this field to teach both professionals and the public to work with consciousness in a way that honors both what is already known, and the underlying mystery of mind/body/spirit interactions.  We would like the commission to know that we stand ready to assist the educational effort we recommend in whatever way we can.

GORDON:  Thank you very much.  I have a specific request, Marty.  Please, feel free to applaud.  I have a specific request.  Is if you've put together that information, if you could submit that to us.

ROSSMAN:  We will submit it.  It's a bibliography of 193 selected articles that are appended to each statement, and we'll submit it to you.

GORDON:  Wonderful.  That would be very helpful.

ROSSMAN:  Thank you very much.

GORDON:  We have time for questions.  So who would like to ask any of the panelists a question, real quickly?  Anyone?  A question.  Yes, Effie.

CHOW:  The gist of this panel, thank you very much for the enlightening delivery, seems to recommend independency, the general gist.  And so do you see education, if you see legislation and regulation as not necessary, what about education of people who will know how to choose then, if you think that is, make comment about that?

RIDER:  Yes.  Actually, the one, if I could append one comment, I appreciate it and I applaud and I support the comments that have been made on this panel about a light hand on regulation of interventions that have been time tested and that are generally safe.  And also I do think that good education and some form of evaluation and training is also necessary, because even these techniques, in unskilled hands or incompetent hands or unethical hands can be harmful.

CHARLOP:  I would say that that's certainly true.  On the other hand, education doesn't necessarily have to mean government required education, government specified education.  I think if you take the situation of acupuncturists before they were generally licensed, it would take a bold person to assert that they were neither trained nor educated and that they were not evaluating themselves and each other.  I think that they were doing that, and that was part of why they have been early recognized.  So I think that education is, of course, necessary, but I think that all responsible professionals do that, will do that.  And if it's clearly legal, they will also reach out to educate the public.

RIDER:  I think also that there are many people who know about many methods and this information keeps spreading.  And as practitioners become comfortable, if the imprimatur of being, practicing medicine is removed, then more and more information is going to get out there and is going to circulate.  And I'm not sure that it needs anything formal.  I think people are very smart and there are articles that are in mainstream publications now.  There will be more and more of those, and people will learn.

GORDON:  Other questions from other commissioners?

LOCKWOOD:  May I respond to that real quickly?

GORDON:  Sure, please.

LOCKWOOD:  Thank you, Dr. Gordon.  I think we should recognize that the relationship between the patient and their physician, or their healer, it doesn't have to be a physician, is really sacred.  And that they should be allowed together to determine what the evaluation and treatment modalities are, and we really ought to keep government out of this, for the most part, except to promote a patient's right to choose and promote these therapies.  These physicians, CAM physicians, are very brilliant people.  And they've developed these techniques.  They know.  So the patients can learn from their physicians, and vice versa.

GORDON:  I have a question, Dr. Marks.  What's the major concern that you have about CAM therapies and CAM practitioners, sort of part one.  And the other is, what about the concern that was expressed by one of the other panelists about not having these CAM practitioners on the disciplinary boards?

MARKS:  Let me answer the second question first, and I address this to Mr. Lockwood's comments.  We make every every effort to have on investigative groupings alternative medical physicians.  We have a cadre of over 750 experts, physicians, in the state of New York, including many credentialed and qualified alternative practitioners.  We call upon them to review cases with us.  Additionally, we make every effort, when there's a judicatory panel, a hearing panel, although the law doesn't require it, to include as one of the two physician members on a three person panel, to include an alternative medical practitioner, if possible.  So we do address those concerns.

            Regarding the issues of concern that our office has concerning alternative medicine, I would say that we hold all physicians in the state of New York to national standards of appropriate practice.  These standards are promulgated by experts in the field.  We rely very heavily on these external experts to establish the appropriate guidelines to practice.  One of the underlying themes that we do worry about is when an alternative medical practitioner diverts a patient from traditional medicine, instead of complementing traditional medicine, diverts them from traditional medicine with adverse results.  That concerns us deeply.  When an alternative practitioner complements traditional medicine, certainly we're highly supportive of that action.

GORDON:  Let me as you a follow-up question.  There are certain areas, for example, many different kinds of chronic illness, where conventional medicine may have some benefit, but you may come to the end of the benefits, or there may be areas where there is real disagreement as this whole new field emerges of complementary or alternative treatments.  And so there may be people who elect, given the choice between the treatment that doesn't seem to have too much effectiveness or hasn't proved to effective that's conventional and that's regarded as standard of care, and another treatment offered by a physician that may not be standard of care, but is a nontoxic treatment that may be helpful.  Does the board try to accommodate, to make that kind of choice more possible for consumers?

MARKS:  Yes.  We are sensitive to the issue that you raised.  We recognize that patients have rights, inherent rights that transcend other statutory mandates, if you will, even transcend that.  So we have to deal with this conundrum, and there are countervailing forces that are operative.  And we have to take both the patient's right to select the kind of therapy they want from the practitioner they want, and our requirement under the law, under the police powers of the Constitution of these United States, to make sure that patients get appropriate medical care as measured by national standards.  So we have those countervailing forces that impact on us.  And it is a conundrum that we have to deal with, and we deal with every day, and we try to deal with it fairly.

GORDON:  I think it would be very useful for us if you could give us some, I don't mean here, because it's too long, give us some examples of these conundra.  And if you have any thoughts about what kind of suggestions we might make, not only to you but to other, what kind of guidance would be helpful to you, and perhaps to other boards as well.

MARKS:  I certainly will do that, doctor.

GORDON:  Great.  Thank you very much.  Thank you all very much, and we look forward to hearing from you again.

CHANG:  Would the panelists who are leaving, make sure you touch base with Phil Kaczmarczyk if you have any further comments, and the same with our commissioners.  If there are questions for this outgoing panel, to see Dr. Joe.

Panel 2

Panel Coordinator, Dr. Joseph Kaczmarczyk

CHANG:  The second panel, would you please come up now.  Grace Marie Arnett, Camilla Rees, Joseph Loizzo, Kevin Chen, and Leo Galland.  Again, this panel being coordinated by Dr. Joe.

GORDON:  We'll begin.  Grace Marie Arnett.

ARNETT:  Thank you Dr. Chairman, members of the commission and the excellent staff that you all have.  My name is Grace Marie Arnett and I'm President of The Galen Institute, a public policy research organization based in Alexandria, Virginia, that's devoted to ideas that advance a more vibrant consumer-driven health sector.  Many Americans are increasingly frustrated with the U.S. health care system because they face barriers to care.  Access to care . . .

GORDON:  I think you ought to come a little closer to the mike, they may be having a little trouble.

ARNETT:  Is this a little better?

GORDON:  Yes.

ARNETT:  Thank you very much.  Many Americans are increasingly frustrated with the U.S. health care system because they face barriers to care.  Access to the care consumers want, sometimes complementary and alternative health treatments, is often blocked by either financial obstacles or by a lack of information about the full range of treatments available.  Americans are frustrated with a system that puts someone else, either private or public sector bureaucracies, in charge of deciding what health they will or will not receive. 

            In addition to oppressive regulation and licensure requirements, one core problem is the way we subsidize health care in this country.  Because of the way subsidies are structured, we literally give control over life and death decisions to bureaucrats and politicians who have never met us and who care more about a balance sheet than about our health and well-being.  Until we get financial power back into the hands of the American people, these frustrations will continue to grow.

            Let me explain about what I mean about subsidizing care.  People who are either poor or old or young are very likely to qualify for one of several government programs, Medicare, Medicaid, or the State Children's Health Insurance Program.  In these programs government officials make up lists of what treatments those who qualify are entitled to receive.  Those who have health coverage through the workplace are eligible for the health plan, or if they are lucky, the health plans their employer selects for them and the benefits that those plans provide.  It's virtually impossible for even the smallest plan to provide coverage that suits a particular need of each employee.  We are at a critical point when real policy changes are possible that will begin to put power and control back into the hands of individual consumers.  President Bush is proposing a tax credit worth nearly $2,000 to families to purchase their own health plans.  This is the first time that individuals, rather than bureaucracies, will have a chance to decide the shape of their health coverage.  It would dramatically increase opportunities for patients to have access to CAM treatments and to seek out information about them. 

            My primary recommendation would be that the commission investigate changes in tax policy that would lead to greater access to CAM in a new world, instead of having bureaucracies decide what treatments are and are not covered, people would be able to choose for themselves.

GORDON:  Thank you very much.  Camilla Rees.

REES:  Good morning, and thank you very much for this opportunity.  My name is Camilla Rees.  I speak to you today from the perspective of a patient who has had chronic illness for over five years.  I was very surprised when I learned being a patient in our health care system, especially the crushing realization that the insurance premiums I'd paid bought me and millions of others with chronic illness little value.  Most of what was helpful would fall into the category of CAM.  I suspect most individuals, including policy-makers, unless they have had experience with serious or chronic illness, do not realize there are deep rooted, misguided orientations in the health care system today that fuel costs and that contribute to poor outcomes that further fuel costs. 

            I will focus today on five issues I found to contribute to inefficiency and waste.  My overriding policy recommendation to you is to see that these qualitative issues become quantified.  I firmly believe the dialog with policy-makers needs to focus on the economic ramifications of the quality of care today, the root of the problem, and to associate CAM with the solution.  The five issues are:

            1.  Doctors seem to have very little education about to support health and focus narrowly on drug solutions.  Patients need information about how the human being works, not medical consensus on how to live our lives, but on what supports life across all dimensions and why.

            2.  The health care system is not oriented to looking for root causes of serious illness, including environmental causes that are very significant.  We need to have courage to work at the root level.

            3.  There exists a slow serial approach to treatment, based on a single practitioner's limited knowledge, instead of on a much broader body of knowledge that exists.  We need to lay out information as broadly as possible for each condition covering multiple perspectives and acknowledge the patient's wisdom and intuition are then crucial aspects of choosing the right solution.  We need acknowledgement of the value of multiple perspectives and then investment in information infrastructure.

            4.  Physicians who practice outside orthodox norms are marginalized, if not investigated, resulting in a fear base culture, patient hesitation and confusion, and often unnecessary duplication of medical support.  We need to stop private medical and dental associations from essentially using the power of the state through licensing boards to enforce narrow medical protocols, stifling competition in the name of fighting fraud.

            5.  The health care system is not . . . to results.  There is no health goal in health care and no accountability.  We need independent leadership in this sector to honestly highlight the structural flaws in the system, shine a light on their sources, understand their economic implications, and create vision for what the health care system could become.  Again, I firmly believe the dialog of policy-makers needs to focus on the economic ramifications of the quality of care today, the root of the problem, and associate CAM with a solution.

            Thank you very much.

GORDON:  Thank you.  Joseph Loizzo.

LOIZZO:  Thank you, Dr. Gordon and distinguished commissioners, for coming up and for inviting all of us to speak with you.  I speak with you as a complementary psychiatrist and founder of the Center for Meditation and Healing and Health Educational Center at the Columbia Presbyterian Department of Psychiatry.

            And I'm just going to read a brief canned statement which I think is, for some of you, will be preaching to the converted.  I think you already heard most of it, but.  From the vantage of complementary psychiatry, the single largest source of waste in American health care today has been neglect of complementary methods of teaching consumers and providers time-tested, evidence-based practices of self-healing and health promotion, such as stress reduction and meditative practices. 

            The disease fighting strategies and provider driven interventions of American medicine are best incomplete and at worst inherently wasteful because they are reactive rather than preventive, and because they systematically ignore the single most important variable in disease prevention and health promotion, consumer health behavior.

            While mainstream medicine has made remarkable strides in its fight against the obvious killers of modern civilization, heart disease, substance abuse, mental illness, and cancer, it has hardly begun to face the insidious killer behind all these masks, our own stress-driven, diseased-prone habits.  Fifty years of stress research have shown beyond any reasonable doubt that disease-prone habits of mind and action exert a pervasive corrosive effect on mind and body by destroying natural systems of health and healing, of defensive healing, and leaving us prey to diseases of all kinds.  Fortunately, stress research has also shown that stress reduction methods contain the healer, the killer within, and teach methods to unlearn disease-prone habits and build the natural stress, the natural self-healing competence of our body and mind.

            The most effective methods of stress protection to help promotion to emerge from the new mind/body medicine, such as Dr. Gordon's own memo, "Body Skills . . ." Herb Benson's "Relaxation Response," John Cabisens(?) MBSR(?) and so on.  Distill time-tested traditions preserved in Asian health care systems, such as Arivada(?), Chinese and Tibetan medicine, that were developed in societies without high cost, high technological medicine.  These deserve to be singled out as the cutting edge of complementary and alternative methods because they've been shown to be among the safest and most evidence-based of CAM practices, and also because they directly target the largest source of waste in American health care, the systematic neglect of the patient's responsibility and right to act in pursuit of his or her own health care.

            And my recommendations are briefly that in the short run that insurance reimbursement for mind/body programs that teach self-healing methods be pursued.  And in the long run, that public and professional awareness at all levels be pursued by building in stress reduction and self-healing education into all professional health education.

GORDON:  Thank you very much.  I want to make sure, is the level of sound okay for everybody?  A little louder?  Okay.  Great.  Kevin Chen.

CHEN:  Thank you, Dr. Gordon and commissioners.  I'm a research scientist who is interested in CAM research and also especially Chi-gong(?).  In the past few years I have witnessed many miracles among Chi-gong practitioners, such as disappearance of breast tumor in minutes, an incurable leukemia completely cancer free in two months.  And chronic arthritis pain disappear in one treatment.  I was really feel challenged by those miracles.  However, when I start theories in these . . . phenomenons in terms of research I found myself in a very disadvantaged situation. 

            Because there are huge obstacles there for us to conduct research in CAM.  That including first:   fear of losing credibility among peer and . . . agency.  Scientists, that other people tend to believe only what they consider reasonable and acceptable, and have a lot of prejudice and discrimination against the nonconventional medicine. 

            Second, lack of minimum funding to conduct . . . research.  If you are serious about effectiveness of CAM, you may have to use your own time and the money to do research.  Because . . . lack of minimum funds to do your research.  And even though we have $90 million of budget for in CAM this year, but that is only one half of one percent of $20 billion NIH budget.

            Third, lack of physical training and the knowledge of CAM among scientists.  Most of scientists don't know what they're looking for in CAM research.

            Fourth, it is very risky for original medical scientists to make a career transition from conventional scientific research to CAM research.  You may lose opportunity to publish, lose opportunity to get a grant, and to getting promotion.  You might even lose your job if you . . . in this area.

            And please allow me just to remind you of a fact.  If one-third of the university budget comes from the pharmaceutical company, just who will not risk lose those funds by supporting research that might conflict with those pharmaceutical industry.

            So in short, it is still very risk for scientists to get involved in CAM research.  So my recommendation will be dramatically increase the budget of funding the CAM research.  Both consumer and scientists need it.  The second, to avoid the influence of the various interests group . . . CAM into a different research institute, or add a special office for each institute to support CAM research.

            Third, establishing more centers for the study of CAM funded . . . so they can play actively in both education and research.  And decide what to do research independently.

            Fourth, establish some special mechanism to founding an NIH to encourage more scientists to make a career transition to become a specialist in CAM research.

            The last, pay more attention to education and training, and educate the current and the future scientists and the medical practitioner about various CAM therapies.  The CAM therapies really work as other . . . medicine and medical education.  Thank you.

GORDON:  Thank you.  Thank you for making so many succinct recommendations.  We appreciate it.  Leo Galland.

GALLAND:  I'd like to thank the commission for giving me this opportunity to speak.  Unfortunately I didn't receive the E-mail requesting me to bring copies of my presentation.  I'll be happy to send those afterwards, and I'll speak just directly without notes, which is the way I prefer to do it anyway.

            Briefly, there are two kinds of points that I'd like to make.  First I would like to support what I think is going to be the general tenor of the commission's recommendations, which is the recognition that what we're really talking about here is holism in health care in the real sense of the word, rather than the integration of techniques that are considered exotic into conventional medicine.  The aspect of conventional medicine, which I think is responsible for everyone being in this room is a particular perspective, which is the source of what alarms most of us about conventional medicine.  I'm a practitioner and a teacher, an M.D.  Which is the perspective that equates illness with disease.  It makes the disease the focus of intervention and is inherently depersonalizing.  And out of this perspective comes not only the depersonalization and the lack of respect for privacy, but the tendency for conventional medicine to be overly invasive.  And there's just a whole range of effects, including the lack of respect for the process of dying that come out of this disease oriented focus. 

            All alternative healing systems, whether they're ancient or modern, no matter how much they differ among themselves, share one perspective, which is the view that illness is the result of imbalance or disharmony.  And that's a perspective that is consistent with science and really needs to be incorporated into the approach that's taken. 

            Two concrete recommendations.  Number one, with regard to medical education, students need to learn about CAM modalities from the perspective of this alternative; that is, these are about restoring harmony and balance, they're not about treating disease.  When it comes to research, we can't allow CAM research to follow the rules that have been established to support the disease centered model.  Now with conventional clinical trials there are many patients that are excluded because of comorbidities.  After all, you can't have somebody with too many different diseases, it muddies the water.  Those are the patients that should be specifically selected for CAM research.  Those people have a lot of comorbidities. 

            Thank you very much for your attention.

GORDON:  Thank you.  I said it to Dr. Chen, but I want to say to the whole of you that we really appreciate your concision and the recommendations.  One of the things that I'm experiencing listening here this morning is the reinforcement and the elaboration of many themes that we've been hearing over the last seven or eight months.  And I think that it's, some people have said, well, three minutes isn't very much time to talk.  But I think for those of us who've been hearing so many people over this period of time, it's helping us immeasurably to get clearer about what the fundamental kinds of recommendations.  As we hear them again and again, worded slightly differently, with slightly different perspectives and slightly different information and glimpses of very power experience, I think it's shaping all of our perspectives and will be very important to us.

            We have some questions from the commissioners.

BRESLER:  For Dr. Galland.  When you say doing comorbidity research, do you have concerns that if we're using multiple modalities, multiple orientations and so forth, what kind of conclusions we can draw based on that?

GALLAND:  I think the conclusions, the end points should be global indices of health and quality of life, rather than surrogate end points that are narrowly defined, which is what tends to happen in conventional medical research.  And if you use those there may be issues about how do you compare one group with another, how do you control it.  I think those need to be dealt with, but I think it's possible to do it.

            In rheumatoid arthritis research, 90 percent of patients with rheumatoid arthritis are excluded from conventional research because of their comorbidities, and it doesn't make any sense that you then draw conclusions about the best treatment for the disease from the ten percent of patients who are permitted into the study and then try to apply that to the 90 percent who are excluded.

GORDON:  Do you have any statistics on the, have you taken, I know it's a general impression, but I'm wondering if you pulled together any data on those exclusion criteria that you could?

GALLAND:  I can get those.

GORDON:  I think that would be very helpful for us.  Other questions.  Just raise your hands if you have a question.  Anyone?  We have time. 

            Okay, I do have a question for all of you.  You talked a little bit about, different people have talked about research, and you've talked about funding.  Is it your sense that there are certain approaches for which reimbursement, and Dr. Loizzo mentioned already mind/body approaches, are there other approaches that you feel there's sufficient evidence that they should be reimbursed now?  And I mention this, and we have several months before we have our panel on reimbursement, but this is clearly a crucial issue.  And I'm wondering if any of you has any thoughts about that.

ARNETT:  Mr. Chairman, I would really strongly recommend that the commission not get so specific in its recommendations for coverage, because I think really what you want is a system in which people have the greatest flexibility to make their own choices.  And I assure you, when politicians begin to get involved, even though how well meaning they may be, it will become highly regulatory, very constrained, and once something is in place in a regulatory system it's very hard to get rid of it.  And for knowledge to evolve through the system.  So one of the reasons I'm making the recommendations about looking at how do you get money and control to the consumers, whoever controls the money controls the choices.  If they're in charge I think they will then begin to dictate the shape of the health plans that consumers are purchasing, so it's dictated by the market rather than by bureaucracies.

REES:  One thought that I had was it took me three years before I figured out that the root of my autoimmune problems was environmental.  And I would recommend that removal of mercury amalgams be reimbursed.

GORDON:  One of the things that I would like, and this is I suppose it's a sort of Socratic trick, if you will, is that when, if you have or if you can suggest to us someone who could give us the scientific justification for the recommendations that you're making, just as Dr. Marty Rossman sort of turned it back to him and said, okay, let's see this evidence for mind/body approaches, we'd really appreciate that.  And if it's not you, if there is someone who would submit that to us, that would be very helpful.

LOIZZO:  I do agree that working into, in fact, our center doesn't accept insurance reimbursement.  We're not, and as a clinician I don't.  And I think that that's part of the way that these therapies are going to fry.  As a psychiatrist, I also have kind of generations of understanding about the way psychotherapy has been treated by insurance companies, and I can just say that there's a lot of similarity between psychotherapy and complementary medicine because people value the relationship as a context, as a healing context, and the educational process.  And there's a way in which having that be a real consumer driven contract between two people who are not bound by some big institution is really freeing to that process.  And so I don't think insurance reimbursement is the way to go in general.  But I do think maybe picking up a few areas.

LARSON:  If insurance reimbursement isn't the direction, then how do the people who have the least options for receiving these services, such as the poor or the medically underserved, get treatment?

LOIZZO:  Yeah, no, I think that that's the reason why . . . as a least common denominator, I think that that's a way to go.  And then pick the one or two handful of things that are the most waste reducing, then I would say self-healing, giving people the message that what they think, feel, and do is important.  It's something that would help reverse the disease-based allopathic bias that doctor active or doctor driven bias of western medicine and help complement it most effectively.  So that's why I recommend.

GORDON:  Effie, do you have a question?

CHEN:  Yeah.  You may not be able to answer this right now, but the funding and the research is so important.  We believe in testing.  And you brought about that perhaps there are creative ways or recommendations for research.  And we'd love to get some written input on that.  Whether it's accepted protocol or recommended protocols to help with CAM research.  Because it is different.  And then the funding aspect too.  We'd like to have more written detail about what your recommendations are.  Really appreciate it.  Thank you.

GALLAND:  I just wanted to respond to the insurance reimbursement.  I like the concept of most waste reducing.  And I would say that nutritional counseling is the other area that can really have a major impact.

GORDON:  Thank you very much.  We appreciate your coming here and being with us today.

Panel 3

Panel Coordinator, Corinne Axelrod

CHANG:  Would the panel three now come up.  This panel coordinator is Corinne Axelrod from our staff.  Fredi Kronenberg, Elaine Stern, Kerri Ann Gruninger, Frank Lipman, Faye Shenkman, and Carole Margalit.

GORDON:  We'll begin with Fredi Kronenberg.

KRONENBERG:  Thank you, Dr. Gordon and commissioners, for providing this opportunity.  I'm the director of a complementary medicine center at Columbia and one of the NIH-funded specialty centers in CAM research in aging and women's health.  Women have long been the primary users of alternative medicine, and now take the lead in the use of CAM in this country, as well as others around the world, as using home remedies and using self-care measures for their families.  It is important that we look at women and minorities and how they use CAM and what they're using. 

            Increasingly, women seek alternatives to common surgical procedures, such as hysterectomy and cesarean sections.  They seek alternatives during many of the natural hormonal related life phases, during menstrual cycle, pregnancy, and child birth, natural hormone changes as they age, and during illnesses, such as breast cancer.  And in many cases they seek therapies that have fewer side effects than pharmaceuticals, or seek to avoid drugs entirely during pregnancy. 

            A number of years ago we conducted a survey through a popular magazine and got 15,000 responses from people around the country.  A third of these women were using, this was for women over 40, were using hormone therapies.  And what was interesting was that 72 percent of those were also using some other complementary methods.  And while women are not going to wait for scientific data, they're very good at coping with uncertainty and decision making in daily life, they do want to have information that remedies are safe and effective, and that their doctors are knowledgeable and able to either refer to CAM practitioners or have a dialog with the practitioners that's effective for them.

            Now in minority groups in this country who come to this country bring medicines from their own cultures and traditional medical systems.  And I think that women and minorities, it's different groups, obtain CAM goods and services in different ways.  In fact, there seems to be a two-tiered system here, in ways of obtaining these remedies.  Many women, particularly in recent years, buy products sold commercially at increasingly high costs.  Various ethnic groups, on the contrary, seek CAM therapies in their own neighborhoods from their own traditional healers and local shops, from local practitioners, and often at low costs.  Yet hereto there's not adequate research so that the conventional practitioners appreciate when these remedies are appropriate, sometimes better than western medicines, and then however when western medicine may be the best choice.

            The research that needs to be done, however, is not just randomized control trials, but studying systems of medicine, otherwise we'll never be able to test every remedy for every condition.  How do you study a system, like Chinese medicine, and know that it works and therefore can trust that and not have to look at every detail?  The research that's done really must remain true to the tradition being tested and not only by sort of the gold standard of randomized control trials.

            The danger that we have is in overregulating and overmedicalizing.  Overmedicalizing life and normal life processes and that one of the recommendations in terms of funding is that government agencies be able to cofund multi-disciplinary efforts.  This is not possible right now, and it's very difficult to get some of these kinds of work funding.  I think that the challenge is to make CAM accessible and not detract from what makes it successful and appealing, and that is often the ability to obtain these things outside of medical facilities.

GORDON:  Thank you very much.  Elaine Stern.

STERN:  I am an acupuncturist and a Chinese herbal medicine practitioner.  I've been in practice for 17 years.  And so I've been through the beginning of Chinese in New York State I think.  And I have printed in my statement some of the things that I treat and some of the conditions that I get good results with, but I think I'd like to kind of push ahead to the main recommendations and the main issues.

            As a practitioner I run into a few problems.  The first one is I'm increasingly treating more and more serious illnesses.  I treat many many women with a very broad variety of problems, and as I go along, I need the help of my western counterparts.  And this is a very difficult thing to obtain.  I need to see blood tests.  Sometimes I'm concerned that my patient isn't getting what they need from the western practitioner or there's a big division between the treatment they're getting from their standard western practitioner and the Chinese medical practitioner.  And I think this puts a lot of stress on the patient.  And it certainly makes it very difficult to have good integrated practice.  I think this is partly due to some attitude issues, and also because people are very busy, and because there is a lack of education on both sides.  I think many standard biomedical practitioners don't know anything about what I do, don't have any idea of what I can or can't do, whether it's safe.  So when the patients say, I'm going to see an herbalist, I'm going to see an acupuncturist, they don't know what to make of that.  It's very rare that doctors are open for me to call them and discuss the case, partly they're busy, but partly I think they just don't know what to make of what I do.  So that's one issue.

            I think another issue is that within my own field of, I specialize in Chinese medicine, but, of course people are interested in nutrition, and I had to educate myself about many other aspects of alternative medicine.  It's not easy to get information.  There's a lot of research being done.  There's a lot of exciting research out there.  Patients come to me with questions.  They read this in the paper.  There's not a, within CAM I think we need a more, some tool to create information resources.

            And the third issue has to do with research.  I was involved somewhat with Fredi with the research project she did at Columbia and is doing, and I think that one of the big problems is that the people who are skilled in research are not the people who are doing alternative medicine.  And we need some kind of organization, perhaps a board, perhaps a group of people who, someone from the biomedical side who is skilled in research can come over to this board, get the information that they need and work together.

GORDON:  Thank you very much.  Kerri Ann Gruninger.

GRUNINGER:  I'm present to testify as a patient that has used traditional and complementary medicine.  Over the past 15 years I've been diagnosed with numerous medical problems.  I would first try the routine route for the treatment of cancer and chronic pain and find that complementary treatments were also very beneficial in treating my health problems.  The practices of meditation, hypnosis, imagery, and yoga have become a part of my daily routine for over 15 years.  I was first diagnosed with Hodgkin's disease and chose traditional chemotherapy and radiation.  But I decided I needed to do something else to reach remission.  Through a close friend I learned meditation and self-hypnosis, which soon became a part of my morning ritual.  The psychotherapists back then worked with me on imagery and soon Pac Man was eating the bad guys that invaded by body.  Yoga at that point was a final part of my equation, creating a center and balance for both mind and body.

            In 1993 I was involved in an automobile accident.  Once again I chose the traditional realm of surgery, medicine, physical therapy, and array of tests and procedures.  Unfortunately, chronic pain soon became a part of my life.  To make story go on, less than six months after back surgery I was diagnosed with stage 2 breast cancer.  I was only 31 years of age.  My family has a history of breast and ovarian cancer, but I held the distinction of being the youngest.  My body had not yet fully recovered from surgery and hospitalization, that I had a new challenge in front of me.

            After the initial diagnosis of breast cancer, I chose to have surgery, followed by eight months of chemotherapy.  But I wanted other options for pain control and also to enhance my immune system.  I spoke to my oncologist who openly said to me he did not know much about vitamins and herbs, but was willing to learn.  I spoke to my orthopedist, who suggested narcotics, because that was his way of thinking.  I asked about acupuncture.  Unfortunately, during chemo my counts were too low to try acupuncture, so physical therapy, yoga, massage, and imagery were my choices. 

            Of great importance during my treatment was group therapy with other young women. Sharing laughter and hugs are great medicine.  During my course of chemotherapy I experienced chemical menopause, hot flashes I thought were for women in their 50s, herbal remedies were the only help.

            After finishing chemotherapy, my menstrual cycle returned and brought with it migraines, another new experience for which I utilized complementary medicine in the form of English fever, peppermint, and acupuncture.  Acupuncture has become a very important part of my treatment.  Through acupuncture my back pain is controlled, migraines are more manageable, my immune system functions at a higher level, and most importantly I feel better.  My current and previous acupuncturists are licensed M.D.s.  I tend to seek out an M.D. who practices complementary medicine.  My supplements, both vitamins and herbs, are also prescribed by an M.D.  But if I were ever to be admitted as an inpatient to the hospital again, my choice of complementary M.D. would not be allowed to treat me with acupuncture herbs as an inpatient.  However, I could continue my morning ritual.  Most importantly, if we are going to work together to find and create the best care for the patient, the hospital must allow the practice of nontraditional therapies.

            More research and funding is needed to find complementary therapies that are safe, but the patients should have the right to receive treatment that has been proved successful for their condition.  I am blessed by the fact that my physicians listen and take the time to do the research and work as a team that communicates and educates one another.

GORDON:  Thank you.

LIPMAN:  Thank you, Dr. Gordon and panel and applaud you for what you're doing.  I'm a private practitioner here in New York and I speak to you as a practitioner with 20 years of clinical experience, most of it in integrative medicine.  I'd like to share with you what that experience has taught me and how it could be helpful to the next generation of practitioners.

            I've learned from books, workshops, and master teachers.  But by far my best teachers have been my patients.  From the books I learned the science of medicine.  From my patients I learned the art of doctoring.  Getting to see real patients developing interpersonal skills and seeing that every patient is unique in how they present, how they cope with disease and how they respond to various treatments should be a major part of any teaching program. Clinical training should be the gold standard for practitioner training.

            Doing this in a multi-disciplinary setting where no discipline or system dominates is best for patients and practitioners alike.  I've gained tremendous insights and knowledge from working together with practitioners of other systems.  And in fact, most of my finest teachers have been nonmedical practitioners or nonphysicians actually, sorry.

            Finally, integrative medicine is more than integrating complementary therapies into a current model.  To me it is about helping my patients become more integrated.  To help them become more integrated I had to become more integrated.  What has helped me do that has been a regular, consistent yoga practice.  It has helped me be more present and centered, which improves my ability to listen to, to educate, and to treat my patients.  I feel strongly that teaching self-awareness techniques to practitioners should be an essential part of any training program.  If we as practitioners are to become educators and teachers of prevention and self-care, which is what this new model espouses, then we need to embody those teachings ourselves. 

            Thank you.

GORDON:  Thank you.  Faye Shenkman.

SHENKMAN:  Good morning.  My name is Faye Shenkman.  I'm the Director of the Wholistic Health Center at the New York College for Wholistic Health Education and Research.  I'm a practitioner of amitherapeutic(?) massage, a diplomat and Oriental herbalism and body work and have personally been involved in the field of complementary and alternative medicine since 1976.

            I'm here today to speak very briefly on the need to incorporate holistic modalities, such as massage, acupuncture, and herbalism, into the fight against breast cancer.  The public is distressed by increased cancer incidents and the absence of real treatment gains to the major cancers despite decades and billions of dollars spent since the initiation of the war on cancer.  Breast cancer has reached epidemic proportions.  It is the leading cause of cancer death in women throughout the industrialized world and in many developing countries.  There is a great deal of fear and no clear understanding of why the incidents of breast cancer has increased so substantially. 

            Many women who have cancer are exploring alternative treatment, especially if their recommended treatment is very difficult to endure or doesn't produce its desired effects.  Most oncologists are not familiar with alternative and complementary therapies used by many of their patients.  Chemotherapies side effects have become increasingly difficult for women to tolerate, as we all desire more gentle, as well as effective, treatments.  The FDA is seen as ignoring research on natural herbal products that have been standard treatment in Europe, for example, in favor of expensive technology and expensive drugs.  Many women feel helpless and frightened.  They do not understand why othologic medicine does not incorporate nontoxic herbal remedies, nutrition, and energy-based modalities that are standard in other nations that help to alleviate stress and diminish symptoms. 

            The United States is behind many European countries in integrating complementary modalities to enhance conventional othologic care.  We are also behind in the concept of preventative medicine.  The content to prevention of breast cancer in the United States is limited to early detection.  In other words, regular mammograms.  From a holistic standpoint, a great deal can be done to educate women and the public at large in ways to take responsibility for their health.  Oriental medical modalities, such as amimassage(?), acupuncture, and herbalism offer treatments designed to enhance the body's ability to defend itself against disease and alleviate stress, in addition to improving the quality of life and helping those who are sick to manage their symptoms and the effects of their treatments.

            It is imperative that oncologists offer their patients a supportive environment in which patients can feel free to discuss what complementary therapies they are using, and it is even more imperative that physicians are educated in these therapies so that they can understand how these modalities can enhance their own treatments.

            And I'd like to offer the following recommendations.  Medical schools should be required to teach courses in Oriental medicine, not simply introductory courses, but in-depth instruction in the fundamental principles of Oriental medicine so that they can understand the viewpoint and how diagnosis and treatment is made, not necessarily so they can practice it themselves, but so that they can make appropriate referrals, collaborate, and integrate their treatments with the CAM treatments their patients are already having.  Without an understanding of the concept of the energy system it is impossible for Oriental modalities, such as acupuncture, body work, herbalism to have any meaning to the western trained physician.

            And I'd also just like to add that I feel that the government should promote insurance reimbursement for CAM therapies so that many patients can afford to have these therapies.  Currently they cannot afford these therapies, such as elders, and have a lot of difficulty.  If Medicare would pay for massage therapy, for example, that would be very helpful.  Thank you.

GORDON:  Thank you.  Carole Margalit.

MARGALIT:  Good morning.  It's Sherri Margalit.  I am here today.

GORDON:  Oh, it's Sherri.  Okay.

MARGALIT:  I am here today as a voice for women whose cancers have recurred.  Today I am 51 years old.  It is my birthday.  I attribute the fact that I am alive and healed to my medical care.

GORDON:  Could you speak a little more closely to the mike.

MARGALIT:  I attribute the fact that I am alive and healed to my medical care, my family and friends' support and love, and to complementary treatments.  When I was 44 years old I was diagnosed and treated for breast cancer, with a mastectomy, CAF chemotherapy and saline implant reconstruction.  The disease was quite a shock, but after treatment, I wanted to go on with my life like it was before cancer.  That just did not happen.  Three years later I recurred with a local occurrence with the same breast cancer on the same side.  At that point, despite varied medical opinions I participated in a phase 2 clinical trial with high dose chemotherapies and stem sell rescue at New York Presbyterian Hospital, which was promoted as a cure and my best chance for long-term disease-free survival.  Of course, now we know that Professor Biswoda(?) of South Africa falsified his data.  But it has taken one and a half years to disprove his information, and by then many hundreds, perhaps thousands more women had participated in phase 2 clinical trials with high dose chemotherapy stem cell rescue.  Currently it has still not been proven that high dose chemo does increase disease-free survival.  We know that high dose chemo continues to be promulgated as a cure to increasing long-term disease-free survival and offered as treatment alternatives in government sponsored clinical trials.  Yet we also know the horrific, many times irreversible side effects of high dose treatments, despite the fact that these drugs at these dosages are ever proven effective as treatments.  During and after each of my medical treatments I employed complementary treatments to help sustain and heal my physical body, as well as my emotional, spiritual side.  I have had a 30 year history of following a vegetarian diet, practicing yoga, employing meditation techniques, massage therapy and herbal remedies.  Yet my background could not prepare me for dealing with such toxic substances and their side effects.  My body was stripped of its natural immunity, which has literally taken years to recover, and I am still wrestling with each winter flu season.  I continue to suffer peripheral neuropathy in my feet, as well as osteoarthritis in my back and knees, almost three years later, due to the Taxol(?).  I've had a fight with insurance carriers to give me a minimum of OT and PT services for fine motor and gross motor problems due to the chemotherapy treatments.  The transplant oncologists.

GORDON:  Did you want to conclude with a sentence or something?

MARGALIT:  Yes.  Basically I want to say that I put together my own umbrella of supplemental treatments which helped sustain me, but they were out of pocket, and because they were not covered by insurance and that the main thrust is that no IRBs should permit high dose chemotherapy on human participants without the supporting after-care services.

GORDON:  I want to thank you very much.  This is the first time we've heard this absolutely sensible proposal.  And it seems to me it's the kind.

MARGALIT:  It's so logical.

GORDON:  I'm just speaking and responding, it's exactly the kind of recommendation that this panel, and I appreciate personally and that I know we all appreciate, because it's so useful, so obvious and it seems so much a part of our medical responsibility to provide these kinds of services, so I really want to thank you.

FINS:  Dr. Kronenberg, can I ask you a question?  Thanks for coming.  Earlier we heard that consumers should have choice, and there are good choices and there are bad choices, and there are forced choices, and there are free and voluntary choices.  In the minority communities that you serve, how much of the choice for CAM therapy is promulgated by lack of access to conventional health insurance and it seems a low cost alternative?

KRONENBERG:  I think that you have several issues.  One is not a lack of access but, which includes lack of communication, fear of the system, etc.  So that does exist.  However, I think in an environment that would be best the western practitioners would be aware of when the traditional approaches are valuable and perhaps just as good as western medicine, and have that trust developed so that when western medicine perhaps is a best choice, then there will be a trust that that is something that can be used and that there will be a relationship there that makes that possible.  So I think there's several different issues going on, and access is one, but it's not the only one, because if there were access, it still might not be the choice for some people for whom this is what they know.  So it's complex and not one way or the other.

TIAN:  My question is for Dr. Kronenberg.  And I think you brought a very important issue first of all, like osteoporosis.  I think is very important, a big issue in women's health.  My question is, do you have any data to show CAM therapies, including Chinese medicine or other CAM therapies to not only should treat symptoms for osteoporosis patients, and also could show some outcome, like a bone density increase?

KRONENBERG:  I don't have those, those data, in terms of western herbs, for example, studies are going on right now, and there will be data coming out.  We've tried to collect some data from, there's a world literature that we don't have access to here, in other countries that are available through databases in other countries.  And some of those studies may not be what we consider to be the best quality research, but certainly by looking at what exists around the world, we can put together information on things that look to be reasonably effective and then conduct additional studies.  So I think that if you're saying, are there studies by standards of western medicine, there are few and far between.  Are there studies that exist there in the world where there are data that are worth looking at and provide guidance, yes there are.  And they need to be translated, made accessible to people so people can see that there is work that has gone on.

GORDON:  Thank you.  Other questions, we're wonderfully running ahead of time, so if there are other questions, we do have some time.  Joe, do you have another question?

FINS:  Ms. Margalit, if I could just follow up on your recommendation for the IRB.  Would that be something that would be tied to government funding, federal regulation?  How do you envision that playing out?

MARGALIT:  It's my idea that along with the application for the proposal for certain trials, whether they be phase 1, phase 2, phase 3 trials, the people who are enrolled in those trials could have a whole array of services offered to them.  And it should be part of the package that is submitted to the institutional review board and as well to the government agency, whether it's NIH, NCI(?), whoever is funding those trials.  It should be that patients participate in the trial, have side effects of varied types, and then because most of the trials are conducted as outpatient basis, they're left out in the cold.  And those transplant oncologists say goodbye.  So we're left to deal with a lot of these problems on our own, or with our personal internists or providers through our own insurance carriers.  And they do not cover the enormous amount of services that are required once you've had such tremendous shock to your system.  We're not only talking about traditional Chinese medicine and acupuncture and lyme therapy, we need basic water aerobics, we need nutritional, we need counseling.  This was like a post-traumatic shock syndrome to many of these women who go these trials.  It's an incredible experience.

FINS:  If you could just supply to the commission maybe the top three or four things you think must be covered because we can't, there are priorities we have to set, that would be most helpful for us as we deliberate further.  Thank you.

GORDON:  A couple of brief questions.  Ms. Gruninger, you said that you wanted to find M.D.s who used these therapies.  Tell us your thoughts about why you look to M.D.s who use CAM therapies.  Why you didn't immediately look to CAM practitioners or just what your thinking was behind making the choices.

GRUNINGER:  Originally, my original reason was because I went to my internist and discussed acupuncture with him, as well as my orthopedist and my oncologist.  When I finished chemo, everyone was backing it, but nobody had a name.  And I was still on quite a few medications.  My back pain increased due to chemotherapy and my immune system depleted.  I have bowel and bladder problems from my car accident.  And the name that was given to me was a physician, a licensed physiatrist who was not only an acupuncturist, but a chiropractor.  And that's who I felt most comfortable with, I guess at the time.  He actually did send me to an Oriental medical doctor who, when we sat down to talk and discuss all my problems and discuss the traditional medications I was taking, he had no clue as to what neurogenic bladder was or what, at the time I think I was on Levda(?) and he didn't know what it was, and he scared me.  It was like I had been to hell and back and this Oriental medical doctor, who I was referred to by a physician, didn't understand all of my conditions, and that was my reasoning.  I did the same with herbal medicine.  I saw someone in New York City that is fairly well known for treating pre- post- during, whatever cancer patients, with herbs and supplements.  And he is very well versed.  And the first thing he tells you when you walk in his door is you need to become educated.  You need to do your own research.  And I think that's so important.

GORDON:  I want to ask a follow-up question briefly of any of you.  One of the issues that's coming up in your response is what level of education about CAM therapies, let's take it the other way.  What level should CAM practitioners, level of education about conventional medicine should CAM practitioners have.  Because you're raising that issue with regard to one of the therapies.

GRUNINGER:  I think it's kind of hard.  I think as a patient with multiple levels of problems, I don't come to you to say to me, make feel better, I'm tired.  I come with multiple levels of problems.  And I think it's important that the practitioner that I go to understands those problems.  I have used massage therapy and reflexology and other things and have had no problem with it.  I do seek out other acupuncturists when I need just a balancing treatment or something.  I think it's important to do the CME courses that Fredi's center does back and offer to educate doctors about it.  I've been lucky that my doctors have wanted the education.  They've all been wide open to it.  My biggest thing is that who's going to let them in the hospital to treat you.  It doesn't matter.  My physician had credentials to treat at Presbyterian and he can't treat acupuncture.  My new acupuncturist is the head of Ruskin's Institute, he can't treat you with acupuncture in the hospital.  So I don't know what level you need to continue the care and make the patient feel good about their treatment and the choices.

GORDON:  I wonder if any of the others of you have a response.

SHENKMAN:  I'd like to address that if I may.  In New York State it's become a, for example, massage therapists, you have to be licensed, you have to be licensed to become an acupuncturist.  The curriculums in the schools and colleges in the state, about 20 to 25 percent of the curriculum are in western science modalities.  I think that the burden here really has to be on the western trained physician, if 20 percent of their curriculum was in CAM modalities, then I think we would see a true integration.

GORDON:  Thank you.  Anyone else?

STERN:  Yes.  I'd like to address this as someone actually involved in this whole situation.  I think that the schools do provide an increasing amount of western scientific and medical education.  I do think that could be a little better.  I think it could be a little more targeted towards actual clinical situations.  I don't think that the schools are really quite to the point, I teach it, I've taught, and can teach, that the students graduating, they don't really, we don't have in place a curriculum helping practitioners to integrate with western medicine.  So that a practitioner who wants to do this really has to self-educate.  And this is very difficult if you're busy.  So I do think the education could be improved, and I'm involved in that to some extent.  But I also think that from the western side it's not possible for someone to do everything.  It's not possible for a really good oncologist or really good western trained physician to be also totally educated in Chinese medicine or alternative medicine.  So that I think we need some place, and this was my recommendation, some board, someplace where we are working out how to educate CAM practitioners in what they need to know and to educate the western or the biomedical practitioners and what they need to know to communicate. 

            This is a model in China.  If I can have just one more minute.  In China that everyone is trained a little bit in each other's medicine before they specialize.

GORDON:  Thank you very much all of you.  We're going to take a 15 minute break.  It's now 17 of.  We'll start promptly at 2 minutes of 11.

Panel 4

Panel Coordinator, Corinne Axelrod

CHANG:  And if the following people can come up to the panel.  Starting panel number four.  The panel coordinator is again Corinne Axelrod from our staff.  And we have Ann Fonfa, Cecile Schey, Johanna Antar, David Molony, David Yens, and Prabhat Pokhrel.  Please.

GORDON:  We'll begin with those who are here.  Ann Fonfa.

FONFA:  I'm the founder of The Annie Appleseed Project.  It was formed to help educate, inform, and advocate for cancer patients and concerned others.  Our specialty focus is complementary alternative natural therapies.  Studies are showing that up to 87 percent of cancer patients are interested in this and that they rarely discuss the issues with their health care providers.  So the project is working to bridge that information gap, in one part by providing a Web site with lots of down loadable information, including relevant studies in patient perspectives.

            I'd like to talk about the need for a new research direction, often called the paradigm shift.  I would urge this panel to use its power to help create this shift.  I sometimes refer to it as the patient track.  Presenters at the last three conferences of the American Association for Cancer Researchers proudly offered very positive studies of green tea.  Yet no cancer patient that I know would take green tea alone.  We all combine elements and the study of natural, nontoxic combinations is part of the patient track.  Looking at what we do now would yield useful information of the highest quality.  Studies done on the patient track could look at combinations of therapies, such as antioxidants in chemotherapy or radiation.  It could examine the use of herbs in combination with dietary supplements.  Many of us juice daily and do detoxification routines, as well as mind/body medicine.  Patients' real life regimen should be studied under conditions approximating their use in our real world. 

            A study of patient use of coqueten/coQ10(?), along with anthrocyclene-based(?) chemotherapy regimens might be included for possible reduction of cardio toxicity, or the use of taxientonaphopoic(?) acid for possible prevention of neuropathy.  Pharmaceutical companies might have much to gain from such studies.  If it could be shown that the use of dietary supplements enhance conventional therapy this could benefit many of the stakeholders.

            As a cancer patient myself, I know the frustrations of having to make treatment decisions with little or no evidence of efficacy.  Yet in the nine years since I've been using natural therapies I've successfully achieved tumor reduction with three different regimens.  And if I can do it, so can other needy patients.

            I consider myself a highly educated patient, having attended a hundred conferences, meetings, events, journals, newsletters, books, and articles.  I've helped practitioners, many are open to new ideas.  Some say they oppose alternative medicine, a statement that clearly indicates ideology and not science.  At the same time patients are asking questions of their providers, and it's important to get answers.  And still nine years later I have to make decisions by my gut.  I ask questions at every meeting I attend on the various natural regimens.  The response is always, we have no studies on that, or that hasn't been studied yet.  And if I've been waiting for the studies it's nine years later and there are no answers.  Patients can't afford to wait.  We need the answers now so we don't have to waste our money and our precious time on the wrong things.  There are many possibilities, and obviously, as for my personal experience, many of them do work.

            I've heard it said in clinical trials, there are no unexpected effects.  Just because they were expected doesn't excuse the highly toxic and painful effects of conventional cytotoxic drugs.  Because we call them side effects doesn't reduce their damage, often permanent.  Great marketing idea to call them side effects, but they're not side effects of anything, they're there.  Often larger number of patients experience those effects.

GORDON:  Thank you very much.  Is it Johanna Frances Antar?  Yes, please.

ANTAR:  Thank you.  Thank you for allowing me to come here and speak to you today.  The nondegreed mere mortal that I am.  The best way that I can express my opinion on the situation of complementary and alternative medicine in this country is to tell you a story.

            I have a very dear friend that has been diagnosed with liver cancer.  One of those really fast growing kinds.  The doctors gave her three months to live.  That was over two years ago.  My friend decided to use alternative therapies to handle the growth of her tumor.  It obviously has worked because she is not only still standing, but she's feisty as hell.  That is the good part of the story. 

            Here's the not-so-good part of the story.  To receive her alternative therapies she had to go to a facility in Mexico.  Her church helped by raising some money to send her there, since her family is of limited means.  The types of alternative therapies that she needs to keep her tumor in check are either unattainable or not approved of in this country.  The practitioners to help her maintain these therapies are not approved of in this country.  All expenses for these therapies are out of pocket for them.

            Last week I was speaking to her husband, and I was telling him about another alternative therapy that they might want to look into, and he looked me straight in the eye and said, we can't.  We have no more money. 

            What is wrong with this picture?  Here we have a family.  A good family who has made an obviously good choice for her health care.  It has worked and continues to work for her.  They are not the new age fringe types you might consider or think about when you think about alternative medicine.  He's a cop.  She's a housewife.  They have three kids.  Two of them are adopted HIV babies.  They go to church on Sunday.  We're talking a family that any community would gladly have.  So why do they have to fly to another country to exercise their freedom of choice in health care, and why must they totally deplete the family's financial resources to exercise their freedom of choice in health care.

            This is America.  Some of us still believe in the words of the Declaration of Independence, that we are endowed by our Creator with certain inalienable rights.  That among these are life, liberty, and the pursuit of happiness.  To many many people being able to openly and easily pursue alternative medicines and therapies is our way exercising our inalienable rights of life, liberty, and the pursuit of happiness.  And for my friend it is now her only way of protecting her life, liberty, and happiness.  Alternative medicine must be made attainable and legal, and yet at the same time its basic nature and integrity must be protected.  Alternative medicine cannot be clumped within the traditional western medicine framework because that framework will put a choke hold on how alternative medicine operates.  It's time to start thinking outside the box in terms of integrating alternative medicines into our health care system so people may exercise their rights of life, liberty, and their pursuit of happiness their way.  Thank you.

GORDON:  Thank you.  David Molony.

MOLONY:  Good morning commissioners.  My name is David Molony.  I'm an Oriental medicine professional and Executive Director of the American Association of Oriental Medicine. 

            As health care providers we appreciate your efforts to gather information about traditional and modern methods of health care diagnosis and intervention.  We've been surprised at how many have come forth to comment before your commission, and I look forward to receiving a compilation of your efforts so we can better work with our patients as they wander the maze of alternative therapies.

            We believe that quality standards of care are best developed and assured through high standards of education and examination.  Our goal is to develop the professional doctor degree as a standard of practice of Oriental medicine in the United States, as it is also being dealt in the European Union and as it has been found to be the best practice in Asian countries from which it originated.

            Of course, in any field of medicine there is room for many levels of health care providers from vocational to professional, and many niches to be filled by varying levels of education, even within Oriental medicine.

            While standards vary from state to state.  We've come a long way since 1973 when no licensing existed for our profession.  Today we're licensed in most states.  One of our nationally credited exams is Chinese herbal medicine.  Recently there's been some misleading reports in the press about the dangers of certain Chinese herbs and we expect another the same this week.  The FDA has forced a recall and destruction of products for which there has been no reports of illness or injury.

            Nearly ten years ago a number of kidney failures were reported in Belgium after patients took a cocktail of drugs and herbs prescribed for weight loss, including the Fen-fen(?) drug combination.  Who prescribed them?  Licensed medical doctors . . . training who used their reading skills to create cocktails, much like a bartender would.  They knew little or nothing about Chinese herbal medicine, proven by the fact that those herbs are never used in that form for that reason or for that length of time so that any toxic results could not have been predicted.  Not only that, but they were also . . . because of misidentification, which once again goes along with poor education.

            Two more similar cases appeared in Great Britain in 1998, once again resulting from failure to seek the advice of a qualified Chinese herbal practitioner who might have noticed that the herbs being taken had been misidentified and misused, and/or combined inappropriately with conventional medications.

            How can such illnesses be minimized?  Simply by adopting the educational and examination standards that are already in place for Chinese herbal medicine in the United States and China.  Its an easy and effective choice.  While the FDA-approved drugs prescribed by medical doctors kill hundreds of thousands of people in this country, Chinese herbal medicine, in the hand of qualified practitioners, is not only effective, it's relatively benign.  In the hands of untrained individuals, however, we can make no guarantees.

            Please feel free to contact us if you have any questions.  Thank you.

GORDON:  Thank you.  David Yens.

YENS:  Thank you, Dr. Gordon and panel.  I seem to be somewhat different from the other people that I've seen up here.  And we're planning to address the questions of research.  How can it be done in a complementary and alternative setting.  And some things that we've been doing in the osteopathic profession to try to address this.

            As you probably know, members of the osteopathic medical profession are designated as physicians and surgeons, D.O.  Osteopathic medicine is a complete system of medical care with a philosophy that combines the needs of the patient, what the current practices of medicine, surgery, and obstetrics.  And I might mention a number of our people also practice complementary and alternative, acupuncture and a number of other things.

            The osteopathic philosophy emphasizes the interrelationship of structured function, as well as the body's ability to heal itself.  They focus special attention on the musculoskeletal system which reflects and influences the condition of the other body systems.  They use their eyes and hands to identify structural problems and to support the body's natural tendency towards health and self-healing. 

            So what makes it complementary or alternative?  The Natural Center for Complementary and Alternative Medicine considers the manipulation component to be alternative.  So we seem to have a foot in both camps.  Probably a nice place to be, although maybe not.  D.O.s are widely recognized for the incorporation of manipulative medicine into the spectrum of care, but it's this manipulation component that's very hard to study, as a number of the other things that we've talked about here.  And I'd like to take this opportunity to thank Dr. Galen who kind of introduced, to some extent, the approach that we want to be talking about. 

            While manipulative medicine is commonly associated with physical ailments, such as low back pain, this treatment modality can be used to relieve a number of other problems and musculoskeletal aptomalities(?) associated with disorder, such as asthma, sinus, carpal tunnel syndrome, migraines, menstrual pain.  A number of these issues are very complex because we have a number of different modalities that are used, depending on what the physician sees and their training and the type of procedure they use for treating it.  It's kind of a multi-method multi-treat type of analysis.

            So what we're proposing is the development of a national database system that would permit physicians utilizing an electronic version of something that we've called an osteopathic soap note that has been developed and is being utilized in paper version. The electronic version wold permit physicians to collect their data, input it into this soap note that would be designed to capture the nuances of the problems and the treatments.  And what's needed is support for developing a national database of this type that might not just be utilized for osteopathic but also for other types of medicines.  We have started.  The difficulty, of course, is the support for this type of database.  Thank you.

GORDON:  Thank you very much.  Questions from commissioners?  Yes, Effie.

CHEN:  Thank you very much.  I would like to specifically ask, you mentioned about there's research data.  Can that data be accessible to us?  And the other main question is, there's a belief system that if you take complementary medicine and supplements and build your body and you're being treated with chemotherapy radiation, that it would void out the effect of radiation and chemotherapy, and that in essence you're feeding the cancer cells and there's.  Can you make comment on that?

FONFA:  In the last five years there have been 20,000 studies on nutrition and dietary supplements.  The majority of them don't make it into the newspapers and they don't make it into the Journal of Clinical Oncology, or to some degree they do get into JNCI.  I believe, and as you know, no 100 percent agreement of anything in science and in medicine, the bulk of the studies indicate that it would be okay and enhance the normal cells of the body while not protecting cancer cells.  It's why I'm calling for a large scale, multi-center, randomized double masked clinical trial, so that we would know in a way that FDA and all else could accept.  But until that point, as a cancer patient, I believe that the evidence indicates that it is appropriate to take supplements during, before, during, after, very much so after therapy.  And my Web site shows about 40 or 50 of these relevant studies.  I'd be happy to provide the references for you.

CHEN:  Thank you.  We'd like some documentation.

GORDON:  I have a question that relates to that for both of, certainly for both of you.  Which is, what success have you had?  What have you done, I know, Ann, that you're very active in organizing, what success have you had in organizing and trying to get this obviously sensible study done?  How have you gone about it and what are the obstacles in terms of moving the agenda ahead?

FONFA:  One of the primary obstacles is the way that FDA conducts studies.  They don't like combinations of things, even though in conventional therapy we combine chemotherapies now, called polychemotherapy.  And that to some degree is researched.  In everything else they seem to reject it.  So it would be very difficult to find.  I've been asking for these studies, and I think they could be done in two ways.  A way to indicate where we are with this is to say at the end of every study, okay, patients, we know you did stuff.  Who did what?  Let's hear it.  And that would give us an idea of is that subset of patients, are they doing better, are they doing worse?  And develop studies from that.  There is a lot of objection right now to doing this combination study where an arm would be people who are doing chemotherapy with vitamins.  And I've always wanted to do an arm for people without chemotherapy, just vitamins.  And of course that's been difficult.

            However, there's a groundswell toward doing this.  And eventually I do think it will happen.  I've spoken to the people in the various oncology study groups, the eastern group, the Chicago group.  There's some interest in it.  Even the NSABP has expressed an interest.  Nobody stepped up.  Most of the time when I speak to physicians, it's in the hallways.  They're not comfortable talking about these issues in the mainstream of their conferences and meetings.  But it's changing.  I have a lot of hope.  But I've been living with cancer for nine years, and I don't know how much longer any of us will be able to discuss these issues.  And I regret every moment that cancer patients are lost.  Fifteen hundred a day die while we don't study things that might be helpful to them.

GORDON:  Thank you.  Do you have a comment, Johanna?  No.  Other questions.  George.

DE VRIES III:  Mr. Molony.  One of the charges of the commission relates to licensure, making a recommendation of licensure among acupuncture.  Certain ways we look across the country and in some states acupuncturists are fully licensed, in other states they're not at all licensed.  In some states it seems as if they're certified, potentially access to the acupuncturist is limited or they're underutilized through that certification.  Would your association support this commission making a recommendation related to minimum licensure statutes to support the licensing process across the country for acupuncture?

MOLONY:  Absolutely.  We have boilerplate bills available.  We have a number of bills in different states that are not only promoting licensure in the states where there is no licensure, but also expanding on what's presently there to encompass more of what people actually do in their practice.

GORDON:  I wonder if the licensure for practicing Chinese herbal medicine, have you talked with western herbalists as well and begun to think together about what requirements for licensure should be?

MOLONY:  We haven't really talked with them.  I'm a member of the American Herbalist Guild as well, because I was a western herbalist before I was a Chinese herbalist.  And we're real interested in working with them.  At the same time, they're working on developing their educational criteria, and they're about . . . 10 or 15 years ago.  Although they're rapidly advancing, they have a lot of work to do.  I look forward to working with them.

GORDON:  I'd very much like to see information about the licensing exam for Chinese herbalism, and also any generalizations that you can make.  Because I think this is really an important area for us because this is the oldest of professions, perhaps, or one of the oldest, but also very new to this country.  And so the more we can learn from your experience the better, in terms of how to, are there ways that we can facilitate appropriate licensure of people practicing a variety of different herbal therapies, and perhaps other therapies as well.

MOLONY:  One of the problems that was talked about earlier with polypharmacy or combining things.  In Chinese herbal medicine, the focus is on combining herbal medicines.  And so if the FDA asked us to run tests on each single herb and each single formula, I think we'd run out of money pretty quickly.  I think that we have to rely more on historical data and experience of qualified practitioners in order to advance herbal medicine in this country.

GORDON:  Charlotte, yes, we have time for one last question.

KERR:  I first wanted to say, Johanna, what a good friend you are.  If you're looking for new friends I'd like to be one.  And I would like to ask you, we often think in terms of complementary medicine what are we doing to add on?  Acupuncture, biofeedback.  You've talked about detoxification and I understand many therapies do do that.  But I wanted to ask you, I don't hear much about detoxification, frankly.  And I would like you to comment on that.  Also, any input on chelation and any specific recommendations in that area.

FONFA:  When I . . . detoxification, the primary system I'm discussing is coffee enema, although not totally.  And the reason that I am very interested in this, it was devised by Matt Scerson(?), and I think his cancer program in general is the most researched of anything we have, except for traditional medicine systems.  And I therefore think it's very believable, and I personally adopted it six years ago.  In addition, most of the alternative practitioners who practice combination regimens usually suggest it as one of the things.  It also involves detoxification is also hot baths working with certain bath salts, working with brushing the skin, working with the lymph system and stuff like that. 

            In terms of chelation, the only thing that I personally know about chelation is the very first conference on alternative and complementary therapy held by Marion Leib(?) Publishers in 1994, discussed chelation.  And I heard some very convincing stories about its use.  Most cancer patients don't do it.  We do, we might do things like protocolsuncorella(?) for blood detoxification or simpler kinds of things.  And I know there is some research being done with capsules of something that's a chelating agent, and I don't know personally, I don't know enough about it really to speak on chelation.  I'm interested in it though.

GORDON:  Thank you very much.  Thank you all four.  While the other panel is coming up, we're going to keep going on a continuing basis.  And at intervals several of the commissioners will break for lunch.  So if they leave, it's not out of lack of interest.  It's out of excessive hunger.  And so there'll always be a majority of us sitting up here throughout the panel.  And we encourage you, of course, to take a lunch break when it suits you, and rejoin us.

Panel 5

Panel Coordinator, Geraldine Pollen

CHANG:  Would the following people come up for their panel 5, which is going to be coordinated by Geraldine Pollen from our staff.  Jennifer Daniels, Charles Gant, Serafina Corsello, Arnold Gore, Edna Fishman, and Helen Choat.

GORDON:  I'm going to excuse myself for about five minutes, not for lunch though, I don't eat that fast.  But we're going to begin the panel now.  Linnea, would you, or David, would you take over then?  So we'll begin the panel and I'll be back in five minutes, with Jennifer Daniels please.

DANIELS:  Thank you for inviting me to speak today.  You have here a handout in front of you.  I'd like to share with you some suggestions for policy changes that if made would make it possible for me to do my work of helping people get well through complementary and alternative medicine.  Yes, I do use detoxification. 

            I am presently undergoing investigation in New York by the Department of Professional Medical Conduct for getting a patient better.  I advised a . . . diet and exercise for a diabetic.  His blood sugar fell from 465 to 138.  He became noncompliant, his blood sugar became high, he sought care in an emergency room.  My office is presently closed, as of October 14, as my defense requires too much of my time and it is too big a financial liability to expose myself to additional or future investigations, since insurance only covers the first $25,000 of legal fees.  Presently I have spent $35,000 over a 20 month period.  And I still do not know what OPMC feels I did wrong.

            I have, however, learned that OPMC is simply above the law.  There exist no mechanism to determine if OPMC is following the law or to enforce the law.  They are exempt from rules of evidence, and deliberations are held in secret.  So the first suggestion is OPMC should be bound by the rules of evidence.  This would make hearsay inadmissible and relevant facts admissible.  Second, deliberation should not be held in secret.  A shroud of secrecy merely permits the guilty to be exonerated and the innocent to be convicted.  It does not ensure the safety of the public, quite the opposite.

            Third suggestion is that a physician under investigation by OPMC should be able to request a review by three member committee whenever it is felt that OPMC is violating the law.  This committee should be composed of a lay person, an attorney with extensive malpractice experience, and an elected official.  It should not be under the control of the Health Department.  PL230 is written on paper and believed to control the OPMC.  After 20 months of litigation I found this whole body of law is disregarded, and OPMC acts as it wishes.  A few attorneys have enough experience with OPMC to know how they customarily proceed in certain situations.  But OPMC can and does change its patterns from time to time.  PL230 you can just hold a match to it.  It's not even considered.

            The fourth suggestion is, the purpose of OPMC is to protect the public health by disciplining doctors, dangerous doctors.  OPMC's jurisdiction should be limited to cases of irreparable patient harm.  This provides an objective standard of when a matter is the jurisdiction of OPMC.  There are 13,000 iatrogenic deaths a year in New York State, should keep them plenty busy.  It is inappropriate for OPMC to uphold the standard of care.  This is a job with specialty societies who issue board certification based on examinations.

            Since 75 percent of iatrogenic deaths are caused by doctors who adhere to the standard of care, physicians and patients need the flexibility to deviate from the standard of care when such deviation does no harm.  You also see attached my resume and the last two pages research documentation.  Thank you.

GORDON:  Thank you very much.  I want to say that we very much appreciate physicians who are going through difficult times with disciplinary practices, coming here and speaking with us today.  So thank you.  Charles Gant next.

GANT:  I've been licensed to practice medicine in New York and practice orthomolecular medicine and CAM for 20 years.  Over three years ago my drug free successful treatments of ADHD were widely publicized.  New York State Office of Professional Medical Conduct subsequently launched an investigation of my practice.  Since then I've endured two interrogations, an office raid, charges of negligence, incompetence, and fraud, and eight months of hearings.  My family and I have suffered enormous economic emotional stress, were it not for the prayers and support I have received, the gratifying effects of orthomolecular treatments in healing my grateful patients, good lawyers and expert witnesses who have generously allowed me to defer my economic debt, and a spiritual basis for my life, I could not have survived this hell.

            During the office raid the OPMC seized nine charts for which charges were drawn up.  Six of those nine patients eventually followed through with my CAM orthomolecular care and had good outcomes.  A patient's prostate cancer was reversed and arrested.  A patient with disabling severe fibromyalgia is relatively pain free and has the energy to work again.  A vegetative severely autistic child has been educationally mainstreamed.  A child with juvenile rheumatoid arthritis is medication free and mostly asymptomatic.  A teenager with chronic sinusitis and migraines on nine medications is off medication and has fewer headaches.  Another teenager with chronic severe gastritis and colitis is well.  These were the worst charts the OPMC could find in my office.

            The OPMC has broken New York State law in many areas.  Education law, section 6527 subsection 48 basically says that a physician can't be prosecuted for CAM care if it works.  My CAM care worked and I was prosecuted for it anyway.  Section 230 subsection 6 of the Public Health Law states that my jury shall consist of two physicians and one lay member.  The panel assigned to my case consists of two physicians and a physician's assistant.  Public Health Law section 230 subsection 10aII indicates that medical experts who practice CAM shall be consulted during investigations.  Only conventional physicians who have little understanding of CAM were consulted during my investigation.  My charges concern the care and treatment with nine patients with indefinite periods of time, but when it became obvious that my CAM care effectively treats human disease in six of the nine patients, the state has tried to block admission of this evidence and . . . charges as the case proceeds.

            A recent article in the Journal of the American Medical Association suggested that conventional medicine itself is the third leading cause of death, resulting in approximately one-quarter of a million deaths per year, deaths mostly from mistake free medical interventions conforming to accepted standards of care.  CAM is conventional medicine's answer, but what prevents conventional physicians from adopting technologies?  The chilling effect of prosecutions like mine and the other panel members here is the primary deterrent to physicians.  CAM will never be melded with conventional medicine till health care practitioners are free to practice CAM without fear of unwarranted investigation and prosecution.  And even if protective legislation is passed, there must be provisions dedicated to upholding existing law with clear punitive consequences for health care regulators who place themselves above the law.

GORDON:  Thank you very much.  Serafina Corsello.

CORSELLO:  Dear chairmen and honorable member of the CAM commission, I'm so sorry is an old CAM practitioner.  Here I am talking about legality again.  I tell my colleagues, this is the wounded soldier table.  So I am glad to have been given the opportunity to present to you my 15 year long survival to keep my license to practice medicine. 

            I'm a 68-year-old physician.  I came from Italy 39 years ago.  And after the many steps to legally practice medicine in this country I began my wonderful journey as a physician.  I've been practicing medicine for about 40 years, yet never harmed a patient.  In 1992 I was one of the 25 physicians honored to be asked by the National Institute of Health to set the structure of what is now called the Center for Alternative Complementary Medicine.  Twenty years earlier, in 1972 I had made the conscious decision to use as little pharmaceutical products as possible, in favor of nontoxic natural interventions.  I then began to encounter the scorn of my colleagues, but nothing prepared me for what was soon to come.  For 15 years organized medicine has brought me in front of their notoriously biased tribunal several times.  I've spent untold amounts of energy and money to protect my patients' right to receive safe and effective treatments.  I believe then, and still do, the synthetic chemical are often toxic and dangerous.

            This past May, the OPMC went for my jugular.  My attorney informed me they wanted to take my license.  Since then the OPMC has done nothing but defy the 1994 New York State Alternative Medical Practice Act.  They intentionally disobeyed the New York State law by going after a number of New York alternative physicians, including myself.  They continue to defy the law when they had, amazement, physician who admitted to not understanding any of the alternative treatments review my case.  When I requested review by an alternative physician they flatly refused.

            Finally a supreme court judge alarmed by the lack of due process halted the OPMC trial with an injunction.  The OPMC then tried to override the supreme court decision.  The judge was shocked and outraged by the disobedience and total disregard for the law and reaffirmed the state order. 

            It is extremely important for all of you to realize that a stake is not only . . . practice nontoxic and effective medicine, but the ability of the consumers to access the medicine of their choice.  The promise of access and choice is meaningless if thwarted by the state bureaucracy.  I believe the OPMC is a runaway agency that needs to be reformed to comply with the intent of the 1994 health law.  The purpose should be that of protecting the public against incompetent physicians, not to restrict the practice of medicine they do not yet understand. 

            Another compelling issue is that of the antiquity of the medical insurance industry against alternative medicine.  I'm told they spearhead many disciplinary actions.  Their minimalist approach to testing is in stark contrast to our comprehensive and humanistic view of medicine which Americans, much to the insurance company's chagrin, are willing to pay out of pocket.  Thank you very much for your time.

GORDON:  Thank you.  Arnold Gore.

GORE:  I'm Arnold Gore from the Consumer's Health Freedom Coalition.  There are not enough doctors with an M.D. who practice complementary and alternative medicine.  Although New York State has a law providing that doctors should not risk losing their license just because they practice nonconventional therapies, the Office of Professional Medical Conduct has not observed this law.  Although the law has been on the book now for six years and should be known to the entire staff, this discourages the alternative doctors that we need.  Diet and exercise have been shown to be effective in the treatment of diabetes.  But it is not often used, and New York State regulators are currently violating the Alternative Medical Practice Act by bringing a case against a doctor for using this medically and scientifically documented treatment.  You have just heard from that doctor.  And outside on the table I have form letters to Governor Petaki which you can pick up, and I would please ask that you send in.

            The Journal of the American Medical Association of April 15, 1998, published a study highlighting the dangers of prescription drugs.  Research has found 2.2 million patients suffered adverse drug reactions requiring hospitalization.  And of these, 106,000 patients who were admitted to the hospital died.  Others did not even bother going to the hospital to report their adverse reactions.  This is a tremendous understatement.  There should be a source of information on natural vitamins, minerals, and herbal substitutes for FDA approved prescription drugs which usually have dangerous side effects and are usually not very effective. 

            The most significant advancement in the treatment of cancer has been made by Dr. Stanislaw Brazinski(?) of Houston, Texas.  He has been in FDA clinical trials for over four years and has reported fantastic results.  But FDA has not granted approval of his antineoplastins as a new drug which can be prescribed by all physicians.  This fact is a disgrace to the integrity of the drug approval process.  Something must be done to expedite this approval.  Dr. Brazinski's most notable success has been treating difficult brain cancers.  His antineoplastins are an FDA sanctioned clinical trials for varying cancers.  And if you see his Web site, www.cancermed.com, you can link to protocols for the specific treatments.

            The latest report that I have received in October 2000 of 35 valuable patients, 39 percent of whom had gleoblastemal(?) multiform, and 36 percent haniplastic(?) glioma, had complete response.  Twenty-five point seven percent partial response, 22.9 percent stable disease, 31.4 total objective response of 48.6, and total positive of 80 percent. This is very consistent with his other reports, and something should be done to see that that is approved, even if it doesn't go through the regular process.  Thank you.

GORDON:  Questions from commissioners.  I'd like to get a sense from those of you who are grappling with the Office of Professional Conduct what you think, you've spoken in your testimony about the issues.  What do you think the dynamics are right now?  Where do you see your cases going?  And beyond that, what would you like us to look at more closely?  What would you like us to consider in terms of recommendations?

CORSELLO:  As I said, this is a runaway agency.  And like any runaway agency, needs supervision.  Why was the dynamics as a psychiatrist I can venture many many suppositions.  I will spare you my suppositions.  You're intelligent people.  You can come to the same conclusions.  However, the fact remains they don't know, they're not following the law.  How can a government agency be scorned for, of the law, be scorned of a supreme court judge?  The judge was so outraged that he screamed for five minutes on the phone.  Bless his soul.  He said, never in six years in his seat on the supreme court no agency, no district attorney ever dare to override his decision.  So I am still now in the brief sending lawyers, God bless them, you know . . . forgive me for those of you who are lawyers.  But nonetheless, back and forth, back and forth.  And every time they write a brief you know what that costs.  And this is where we are.  Telling the judge, who is a very fine judge, what are the points of law, because he doesn't want to make an unwise decision.  So I'm in the hands of this brilliant judge who saw immediately from the initial brief that there was total lack of due process.  What my destiny is in the hands of this judge.

GORDON:  So you're essentially saying that the Office of Professional Conduct is not operating according to the law.

CORSELLO:  Absolutely not.  You hear . . . and you're going to hear more testimony about this.  Absolutely not.  I'll send you my lawyer's bills, and you have only three minutes, I didn't know if I could bring any more evidence.  My colleague is already given you some very valuable points.  The fact is, they must, there must be somebody above them to tell them, follow the law.

GORDON:  Other thoughts, Dr. Daniels?

DANIELS:  My first question is where I see things going in terms of my case.  I'm not as affluent as some other people, so I am presently pro se, that is Latin for for yourself.  That means I am legally representing myself.  Now, the importance of legally representing yourself is not that I am any brighter than any attorney.  None of them are . . . anyway, so how can I be worse?  But you get to participate in these conferences with the judge, the prosecutor, and you're sitting where your lawyer would have sat.  And you're hearing what's going on.  It's appalling.  I'd like to introduce this testimony and photographs which would exonerate me.  The judge says, I don't think those are relevant.  And the prosecutors are, oh, no no, we can't have those.  What other evidence do you have, Dr. Daniels?  Well, I'd like to introduce some research saying I did the right thing.  The judge says, oh no, that would never do.  And the prosecutor says, oh, we can't have that.  What else do you have, Dr. Daniels?  We went through my whole list of 19 exhibits just like that.  And then they said, of course, Dr. Daniels, anything in those exhibits you may not refer to.  So I'm telling you, I realize it's futile, and my plan is to cop a plea.  I may get a license, I may not, but it will end the process.  And my plan is to continue to do services in New York State, perhaps without a license and perhaps not even in the healing capacity.  But I cannot do any  more than what the law allows.  And if the law is going to allow OPSC to do this, I have no way to oppose it, other than go to jail and fast.

GANT:  I come from a family of lawyers, and I was kind of the black sheep of the family.  Father, brother, brother-in-law, they're all lawyers.  But they did impress me when I grew up that we are a nation of laws and not of individuals and not of ideologies.  We are a nation of laws.  And I was raised with that kind of respect.  Having had that rug pulled out from under me, that total uncertainty, you don't know where you stand.  I have unbelievable respect when I hear about dissidents in other countries who don't have laws to protect them, yet they stand up to it anyway.  It takes unbelievable ego strength to be able to do that.  I know doctors who have attempted suicide, left the country, have been forbidden to practice alternative medicine.  It's very easy to give up, and I'm not going to.  I don't think that other panel members here are going to either, because we're fighters.

            One last thing I'd like to say is that this is not really about me or individuals.  It's not about even our patients, because that's relatively few people in New York State.  It is the deterrent effects of hitting one physician here or there which prevents the conventional doctors from emerging who want to step out and practice complementary and alternative medicines, that deterrent effect.  And it's clearly set up that way.  And I know of doctors and nurse practitioners who simply would like to, they've been trained, they've gone to courses, they're ready to do it.  They're afraid to do it.  And I can't blame them.

GORDON:  Effie, David, and Linnea, quick questions and brief answers please, we don't have too much time.

CHEN:  Have you folks taken action to possibly countersue?  I'm just interested in what the course of action is because I understand, for example in Vancouver, British Columbia, they were wanting to close down someone who was practicing Canatian(?) therapy and they sued the individuals, not the organization and they didn't hear anything more about them.  I was just wondering what kind of strategies you people have taken, when you're saying that they're obviously abusing . . .

CORSELLO:  Oh yes.  There's no questions about it.  I am told that civil servants cannot be sued.  They have protection of the law.  And in fact, the medical board that decides who to hit next is also exempt from lawsuit.  So we are at a loss.  I don't know if this is peculiar to New York State or is the law of the land.  Right now I'm defending my right to service my patients.  I'm 68, I can't go back to my country.  But I love my patients, and they love me.  And I'm not going to abandon them.  So this is where my energy is going day after day, for nine months now.  And for 15 years, but 9 months of intense.  When I finish, however, I'll . . . for the sake, for the right of justice in this country, the possibility of a punishment, some kind of action.  Perhaps patients.  Patients have the right.  Perhaps they should sue, because they've had much less of my time.  This has taken two-thirds of my professional time.  I'm a strong person, and I can function under fire, but no one can under the circumstances give full attention to patients.

GORDON:  Thank you.  David.

BRESLER:  Yeah, along the same lines there's been some discussion in California that following malicious prosecution, if people are exonerated that those agencies reimburse their legal expenses, because you probably have no hope of recovering your legal expenses.  Do you think that would make a difference at all?

GANT:  I'm closing on over $100,000, and I wasn't that good a money manager to begin with, and so luckily I've been able to defer some of my debt, but boy, that would be, that would exert, that would bring some pain, some consequence, something, some ouch, some repercussion consequence that perhaps could have a rippling effect through the illegal application of these statutes.

CORSELLO:  I have been to their kangaroo court just to be in the supreme court, I'm over $100,000.  I owe already $6,000 more to my lawyer, so it's a strategy.  I will send you . . . that will shock you.  That is right in the Internet. 

DANIELS:  There is no hope of winning because the person who must exonerate you is OPMC itself in its own court in secret, free from the rules of evidence.  So to have victory as a premise for malicious prosecution lawsuit means that no one will ever be able to file that suit.

GORDON:  Thank you all very much.  And I appreciate the recommendations that you've made.  And if there are other ways you would like to elaborate on some of the recommendations for openness and accountability and inclusiveness, that would be very very helpful.  So thank you all very much.  We really appreciate you coming.

Panel 6

Panel Coordinator, Corinne Axelrod

CHANG:  The next panel, could you please come on up.  Janet Susan O Faolain, Vera Smith, Monica Miller, Philip Shinnick, Patricia Connolly, and Gary Wadler.  Thank you.

GORDON:  Janet Susan, how do you say your last name?

O FAOLAIN:  Well, if you're going to say it the Irish way, it's O Faolain.  But in America they'll say O Faolain.

GORDON:  Okay.  I wanted to check to get my . . .  Please, O Faolain.

O FAOLAIN:  Thank you very much.  And it's wonderful to be with so many esteemed colleagues.  It's good to be here.  Thank you.

            I first realized many years ago that I wanted to be a dancer.  I went to college and studied with the best professors and instructors that money could buy.  But ultimately it was my uniqueness and skills that would land me job opportunities.  It was what I could do with my services primarily in teaching that made me sought after.  No one ever asked to see my license to dance or to teach dance, for that matter.  It was pretty much understood.  So I've led the life that most Americans dream of.  Absolute freedom of choice and pursuit of happiness in my work.  That is, until now.  Learning reflexology seemed a very natural extension of my dance career.  I'm already in the business of adjusting bodies, strengthening muscles and postures through movement.  I offer sound advice based on my experience in the trade.  When I was informed that I would have to go to massage therapy school and obtain a massage therapist license to do reflexology, this, in addition to my years of study already in the field, I was really angered at first, the confused.  Reflexology is not the same as massage therapy.  That's when I found out about all the other healing modalities that must lie in wait to be discovered because licensing is not available in their field.

            Natural healing practitioners, like reflexologists and polarity therapists, need not fear being accused of practicing medicine without a license.  They do not claim to be medical doctors.  We practitioners must be able to practice our art.  We are a vital part of society.  In some societies we existed before western medicine ever set a penicillin coated, pharmaceutically driven foot on it.  They have their place in the world, but so do we.  Must we be judged by their standards solely?

            My solution to the situation is simple.  Let the practitioners govern themselves.  Allow them to provide full disclosure of their pertinent information to their clients/consumers.  Perhaps their training was in an institute of higher learning or through time honored traditions passed from generation to generation.  Let the professional affiliations where they exist and referrals lend credibility.  Does it really make sense for me to get a cosmetologist's license to be able to perform reflexology?  I guess it would if I wanted to paint toenails. 

            Ultimately a consumer will pursue what brings them happiness and a sense of well-being.  It just makes things a whole lot easier when it can be done legally.  Thank you.

GORDON:  Next is Vera Smith.

SMITH:  Good morning ladies and gentlemen.  I'm here as a private citizen who is very interested in complementary and alternative medicine.  For the past three years I have been fortunate to participate in a health and wellness program on the upper west side.  The emphasis of the program is to maintain well-being and to prevent, as far as possible, the effects of serious illness.  More and more information has become available to help us maintain a healthy, productive, active life.  Unfortunately, this information is not readily available to the public at large unless you have access to professionals who are knowledgeable about the benefit of exercise, nutrition and supplements.  Many times information in newspapers and on TV is superficial and conflicting.  We need standards to evaluate products to know that they are accurately labeled.  People who are suffering from serious chronic illnesses should have available at the treatment centers access to facilities that utilize exercises that will stimulate the immune system and supplements that will lessen the harsh effects of many treatments.  Complementary and alternative therapies should be readily available for all to prevent the debilitating effects of aging.  As the population ages, it is really imperative that the tools needed to achieve optimum health are at our disposal to counteract the negative forces that affect our health.

            Some of the programs that I've participated in range from hands-on healing raki(?), meditation, reflexology, to exercises, chi-gong, modalities that would help improve the immune system.  Awareness of these specialties and affordable access through appropriate information would enhance the well-being of all.  These practices can and should be thought to health aid workers who can utilize the exercises to assist their clients become healthier and to function on a higher level.  Thank you.

GORDON:  Thank you.  Monica Miller.

MILLER:  I represent the Foundation for the Advancement of Innovative Medicine the preeminent advocate for alternative medicine over the last 15 years in New York State.  I wanted to bring you something important, and so I brought you a bit of the past.  This is information in relation to the 1994 law which the previous panel brought to your attention as the subject of scorn by the Department and the Office of Professional Medical Conduct.  Section 4 of the law insisted that there be an evaluation of the use of nonconventional physicians in the investigation and hearings of doctors. 

            I have brought you the report that was conducted pursuant to the Act.  I would bring your attention to page 4.  Here the evaluation panel is discussing the prosecutions that had taken place at that time, mainly Revichi(?), Adkins, Gonzalez, and Warren Levin.  And they say that the physicians practicing nonconventional medicine were not treated unfairly because the issues of these cases involved patient history, diagnostic procedure, record keeping, and referral to specialists.  If you are at all familiar with nonconventional therapies you're probably aware that it begins with the patient history, how the patient presents the problem and how the problem is assessed.  The homeopathic patient history will be very very different from the conventional patient history, to say the least.  A homeopathic physician lost her license entirely over the issue of record keeping after the law was passed.

            Advising patients, diagnostic procedures, referring to specialists, these all change when you're talking about nonconventional medicine.  And it was Gonzalez one of the cases they're referring to when they talk about patient histories and record keeping, gives lectures at NCI on the proper record keeping of oncology patients.  When he was evaluated pursuant to the charges of the board, the evaluation panel looking at him examining his practice over three days and over a hundred patient charts found no deficiencies.

            I would like to read you something from a current case involving nonconventional medicine.  The panelist is one of the three people, two doctors or a lay person.  The witness is the witness for OPMC prosecuting a nonconventional doctor.  The panelists' questions:  Doctor, does that mean they are practicing bad medicine because they don't choose to follow the course of treatment that you and your colleagues who agree with you would choose to follow?  The witness:  In many cases I think the answer is an unequivocal loud yes.  They are practicing bad, inadequate, ill advised medicine.

            May I continue?

GORDON:  Just for a few moments.

MILLER:  Panelists:  Am I to assume that there are other clinicians who are respected who would disagree with you?  Yes.  But he is the witness.  He is the prosecutor of the case against the physician, and he is basically saying, I don't agree with it so it is bad medicine.

            FAIM is undertaking reforms of OPMC.  We are talking to legislative leadership.  The name of our campaign is CPR, Crusade for Patient Rights, and we ask of you to please instruct the conventional community that CAM is not a speciality.  It's not a sideline.  It is a different paradigm, and it is different from the moment the patient walks into the room, for the benefit of all.  Thank you.

GORDON:  Thank you.  And I have a strong sense that we'll be talking with you further, both today and as we move ahead, looking at these issues of credentialing and licensure.

            The next group of speakers, I want to thank Philip Shinnick whom we heard in Washington for bringing these three, bringing this mini panel together to talk with us about some of the use of supplements to promote performance in sports and some of the issues they're in.  So let's begin with Philip Shinnick.

SHINNICK:  Thank you very much.  And I'd like to address the panel on the whole question of policy and your mandate and your executive order and try to talk about some recommendations.  I came to you before and I said that I challenge the idea of a good science makes good health.  I said that sports has created a crisis in sport in the United States which undermines the development of the whole personality and health.  And it's been a model for youth, but it perverts the historical process that brought meaning and health to millions of people.  This is the anabolic steroids and these synthetic drugs.  That it's synthetic drugs and steroids, and it's created sports heroes that are really a sham.  And I suggested that yoga, breathing, biofeedback, visualization, tai-chi, kung-fu, chi-gong, acupuncture, herb, homeopathy, these are things that should be available to athletes.           

            I'm an Olympian myself, and I brought three time Olympian Pat Connolly.  She's one of the founders of the Women's Sports Foundation.  She coached Evelyn Ashford.  Evelyn Ashford did not use drugs.  We're going to talk about the necessity on social policy to project out the future.  And we're going to, I'd like to ask the commission to think about recommending some sort of center that covers their mandates, a center that synthesizes existing information.  Dr. Wadler will talk about this in his speech.  Synthesize existing information to get into the educational process of youth, competitive athletes, and older people in sport and physical, cultural and arts. 

            We need to talk about more things than mind/body that synthesizes the whole personality to show how that can help in moments of stress and prevent disease and so forth.  But what I'd like to do is I'd like to forfeit my time because Dr. Wadler has a lot of very important things to say.  And I would hope the commission and the wellness panel will maybe address this issue and maybe ask to have some more people who are leaders in this field come here and talk about this and let us try to develop some social policy that will go into the future.  So I'd like to forfeit my time for Dr. Wadler and proceed with Pat Connolly.

GORDON:  Thank you.  Patricia Connolly is next.

CONNOLLY:  Thank you very much for listening to us.  I'm looking at the questions and issues of this commission through my own prism of experiences.  As an Olympic athlete, track and field and cross country coach, and my own business of exersage, which is a one-on-one approach to health and fitness to senior citizens that I learned while working with doctors, Buddhist monks, psychologists, athletic trainers, nutritionists, and chiropractors to help my elite athletes peak performances and world records.

            I also am looking at the changing kaleidoscope of these issues as a parent of seven children who were in California schools during the deregulation of physical education that resulted in an energy crisis of its own.  One full of hyperactive maladjustment, attention deficit disorders, obesity, early onset of menses, anger, and boiling point volatility in our youth.  This time was filled with rolling blackouts of common sense and the profession of physical educators was trashed. 

            It was as a coach that I sought to use and coordinate every resource that might be beneficial to the success of my athletes.  In the early '70s it was a perilous path, a virtual tightrope between closed-minded medical professions who thought anabolic steroids to be nothing more than a placebo and snake oil practitioners. 

            There has been debate whether athletes should be role models for our society.  But in reality they are a reflection of the society from which we come.  A society that cannot watch five minutes of television without seeing a commercial selling drugs.  A quick fix, no pain tolerance, pill popping society that wonders why the use of drugs by teens has increased in the past decade.  However, athletes are a unique group of goal-oriented people who have a strong desire and need to succeed.  It doesn't take long to separate those who must be well from those who use injury or illness as a break in indulgence and excuse to get workman's comp.

            Top performance in athletes have tangible incentives to heal faster than predicted, and they do.  They're willing to spend the time and endure the tedium of injury and illness prevention and rehabilitation routines.  As a result, they are unique group of people for HMOs and other health insurance companies to study in terms of the efficacy of various healing art forms.  Athletes and performers also resort to the quick fix of pain pills and succumb to the use of banned substances, as the show must go on.  They will experiment with every word-of-mouth performance enhancing routine, some eventually dangerous to their own lifelong health and well-being.  As risk takers they place themselves in a unique category, one that must be methodically studied before we use them as role models in the healthy life.

            For about 20 years United States Olympic Committee and other sports federations have been conducting tests to detect the use of performance enhancing drugs and substances by their athletes.  Most of these doping controls have been secretive and punitive with the pretense of deterring the increase of substance abuse and cheating.  Millions of dollars have been spent on laboratory equipment, collection, and testing procedures.

            And as my time is up, I am going to just condense to my two recommendations.  That you look into the possibility of coordinating research with data that already exists from the last 20 years, a data that we, as athletes, have not had access to.  As a coach I would like to know how many athletes in the Olympic games, the results, all the substance, how many were HIV positive.  There's so much data that has been collected already.  And to coordinate future research with these sports organizations for the ongoing programs that they are continuing to conduct.  So this is stuff that's already funded.  And if it's coordinated we can get the results.  We can certainly learn a lot more about us. 

            And secondly, I'd like to encourage you to support Senator Ted Stevens Senate Bill 1159, that was also sponsored by the Women's Sports Foundation, which will provide grants and contracts to local educational agencies to initiate, expand, and improve physical education programs for all kindergarten through 12th grade students.

GORDON:  Thank you very much.  I appreciate.  I love your metaphors too.  Thank you.  Gary Wadler.

WADLER:  Thank you very much.  I'm here today in a variety of roles that are linked by the relationship to the cascading problems of performance enhancing drugs and dietary supplements in sports.  It's a crisis that observes no boundaries, as it ranges from the grassroots to the elite level.  My testimony today is as an internist and sports medicine expert serving as medical advisor on drugs in sports for the White House Office of National Drug Control Policy.  My testimony is also as a member of the White House Task Force on Drug Use in Sports and a member of the Health Medicine Science Research Committee of the World Anti-doping Agency.

            For the past two decades I have worked to focus attention on the increasingly pervasive and multi-dimensional problem of drugs and sports, a subject of immense and ever growing scientific and ethical complexity.  It is imperative that we recognize that the abuse of drugs in sports is not limited to individuals or the exclusive domain of athletes.  It is a burgeoning problem that is threatening our youth, and as such threatens the public health.  Given the breadth of the subject, I would like to narrow your attention to the issue of dietary supplements, and particularly the so-called steroid precursor dietary supplements.  Ever since Mark McGuire's home run record was clouded by the revelation that he had used a dietary supplement, androstenedione, known as andro, there has been a predictable explosion of the sale of andro and related substances, such as 19 . . . antisdine dione. 

            These so-called steroid precursors are not only a problem for elite athletes.  Their use represents a far broader threat to the public health because the physiologic impact of steroid precursors goes well beyond their effect on muscle.  To understand their danger, we need to understand that short- and long-term effects of all things, the female hormone estrogen.  You may ask, why estrogen?  The simple reason is that the human body converts andro into estrogen for both males and females alike.  In fact, a recent study has shown that 300 mg a day of andro, the recommended dose on the bottles, can increase estrogen levels by as much as 80 percent. 

            Why should this panel be concerned about estrogen levels?  The answer lies in the fact that just one month ago an expert advisory panel of the National Toxicology Program of the United States National Institute of Environmental Health Sciences recommended that estrogen be placed as a known cause of cancer in humans.  That may put this estrogen/testosterone paradox in some perspective.  Because andro is converted to testosterone, this dietary supplement . . . interest to athletes who are seeking to increase their levels of testosterone without purchasing anabolic steroids, and thus violating the very strict Controlled Substances Act of 1990. 

            As we all know, to athletes testosterone means larger and stronger muscles, less body fat, and increased assertiveness.  To young men and women who are not athletes but are victims of our "perfect body culture" it means a leaner, more contoured or cut physical appearance.  Alarmingly, recent studies revealed that as many as 3 percent of teenage boys and 3 percent of teenage girls have used controlled anabolic steroids, and the rate of increase among these teenage girls is particularly alarming.  The marketing of andro is nothing less than a flying under the legal radar screen to achieve a steroid effect without violating the law.  It is a dangerous loophole.  There is no telling how many teenagers have used the over-the-counter dietary supplement andro and related substances, unknowingly placing themselves at the center of estrogen's carcinogenic effects.  And who knows what other health threats the rest of their lives. 

            And here's another twist in the road.  While andro has been primarily marketed to our athletes and young people, its immediate precursor, the hydroepiendrostrone(?), known as DHEA, has been marketed to the older population as yet another anti-aging miracle.  Claims have been made that DHEA is the fountain of youth, able to turn back the clock to increase one's sense of well-being and boost, if I might have his extended time.

GORDON:  We've given you Phil's extra time already.  So if you could just conclude, real briefly.

WADLER:  In fact, I'll just stop here.

GORDON:  Thank you.  Questions for the panelists.  Joe.

FINS:  For Ms. Miller, I'm concerned, as you must be, about the potential for conflict of interest where practitioners who practice a certain kind of therapy or promote a certain kind of drug are in the business of regulating their own business.  We heard a lot about self-regulation.  Is there any role for government, if you're critical of the OPMC, but how would you restructure it?  What should be the role of government and how would that be fairer to the diversity practitioners that are out there?

MILLER:  New York State differs from many other states in the licensing of physicians insofar as the disciplinary process is a peer review process.  The intent of the legislature has always been that since 1927.  And the intent, as you'll see at the back piece of the packet I gave you, was also greater peer review for CAM physicians.  In the case of Dr. Serafina Corsello, if the investigator of her case had been knowledgeable of CAM the report would not repeatedly say, I don't know what this is.  I don't have the time to look it up, so it must be misconduct.  Peer review is the essence of licensure in New York State.  It is the blending and the melding of governmental oversight, and collegial interaction.  The law can be strengthened in regards to peer review, both in the investigative and in the hearings stage.  But also rules of evidence have to be brought into play.

FINS:  Just a quick follow up.  My understanding is that OPMC changed some of its guidelines for the inclusion of pain specialists and parative(?) cure doctors to better inform the deliberative process about the use of opioids for pain management.

MILLER:  That is correct.

FINS:  Is that the sort of model that you would endorse or think should be endorsed?

MILLER:  That is getting in the ball park, yes.

FINS:  Thank you.

TIAN:  Regarding sports medicine issue, and I'd like to ask whether you have some data or some information to show to professional athletes, like U.S. Olympic athletes and also amateur athletes, what do you recommend dietary supplement, the nutrition stuff, instead of drug related to other things.  Because it's very important we need to provide the very important information to this very active few, because people do purchase a lot of things which is very important.  We want to make athletes safe and also effective.

WADLER:  There are a whole array of dietary supplements available.  Of all of them there's probably more that has any benefit at all, but probably relative low risk ratio, and that's creatine.  What I would ask the chairman specifically is to address the Dietary Supplement Health Education Act of 1994 and explicitly remove steroid-based supplements from that list.  I don't think anybody envisioned what was going to happen with Mark McGuire.  I don't think anybody appreciated the conversion to estrogen and testosterone and the effect on the public health.  With respect to the others, it's catch as catch can.  There's relatively little evidence out there.  There was a dietary supplement that was used by a total of 12 people that became a hundred million seller over night.  A product called HMD, with no evidence whatsoever.  Athletes tend to look for the magic bullet.  The assumption is, if it's a supplement and it's on the shelf, it must have been blessed by the government and it's safe.  That is a very dangerous assumption.

CONNOLLY:  In 1980 with a group of other Olympic athletes who were training, we did a study with Dr. Rob Krakovitz(?) out in California.  And we tested all kinds of supplements, from vitamin C to ATP in terms of performance enhancement.  Out of that study there were some things that we thought perhaps were helping us.  But one thing I have had 100 percent help with my training of my athletes that we discovered in that process, and that was magnesium and potassium aspartate(?) when taken before heavy exertion and training we do not experience cramps or cramping.

GORDON:  Doctor, I just want to add onto Ming's question, then we'll come to you, Effie.  Are there recommendations that you would make, either about supplements or about the studies that need to be done?

WADLER:  This is a problem and it transcends the United States.  We have, there have been 343 cases of dietary supplements producing positive urine drug tests in elite athletes in the Olympic movement.  And indeed around the world we have opened the pandora's box and enabled us to explode throughout the world.  I think as one, that's a crisis issue.  And that's the steroid-based supplements.  I think the others can be dealt with in due time.  But to me, that is absolutely a public health crisis, particularly now with the recognition of the danger of estrogen.  And that's a sleeper because most people are worried about big muscles, and nobody has thought about the estrogen effect.  And that goes for the older population in terms of DHEA, because it too becomes estrogen.

GORDON:  I'm wondering if you could provide us with, I appreciate your testimony.  If you could provide us with some more of the documentation in terms of either bibliography or even better from our point of view, some of the original papers on the subject.

WADLER:  Certainly.

GORDON:  Phil, you wanted to add something?

SHINNICK:  You know, there's a lot of information available.  And what I'm suggesting is that we have some sort of mechanism where we can synthesize the existing information and channel this into the educational process in high schools, grade schools, throughout the whole society.  And that has to be systematically done through the existing association.  And then there's a lot of questions that you probably personally would be interested in that have to be done too.  And that is the mind/body sensitization, which is when a human being integrates the emotions and the feelings and brings together, that they go to a different level.  And that different level can be defined by global physiology.  You can define it by brain waves and so forth.  And performance changes. 

            And I think the biggest frontier in all this is in CAM, where we have to take what's human about us and continue to develop along those lines and not in a mechanical way and not in a synthetic way, and it will benefit the health of all of our society.  And I think this is where the commission should be looking for, is the health of the whole society.  And of course this could possibly wellness, as you suggested before.  But we need to have the commission help us to bring togehter in some form, maybe it's a center for performance athletics and physical arts.  Because we're talking about dancers, we're talking about people under stress, we're talking about truck drivers, we're talking about anyone who performs.  There's all sorts of things that CAM can offer them, and it's just not there.  So this is more of a problem of bringing it together.  And what you see here is the start of this.  I've been doing this for 25 years.  As I mentioned, I was in China in 1976 and had an NIH grant in 1970 on drug usage, and we still haven't gotten anywhere.

GORDON:  Effie, you have a question.

WADLER:  I just wanted to ask, I have one other . . . the whole issue of fedra(?) has met over 50 deaths reported several years ago and there's been attempts to remove that as a dietary supplement.  That requires under law to be done, not by the government, by somebody bringing an action.