My name is Jackson Petersburg.  I am co-director of Center Point, formerly Northern Lights School of Massage Therapy, and the Minnesota Center for Shiatsu Study, and I have been in private practice for the past 22 years.

Mr. Chair, members of the Commission, let me begin by saying what a privilege it is for me to be participating in a process that I am convinced will impact on the very nature of the health care delivery system in this country.

I originally intended to start by giving a brief history of my own profession, citing some of the major factors that may have influenced how massage therapists were and are educated in this country.  Unfortunately, that would have taken up all of my allotted time.  I will instead give you a very condensed version of the salient points of this history.  In a nutshell, war, drugs, sex and a defining moment in time.

After World War II, the development of analgesic drugs started to replace manual methods of pain control.  There also seemed to be a proliferation of massage parlor activity, which slowly eroded the reputation of legitimate therapists.  This tainted reputation lasted well into the end of the Twentieth Century and heavily influenced the development of municipal massage parlor ordinances that are still in effect in many cities and towns across the country that do not have some form of statewide regulation that supersedes municipal jurisdiction.

Technically, I am still practicing illegally in the State of Minneapolis.

To my knowledge, we are the only emerging health care profession regulated by municipal law and this is still a problem in Minnesota.

In addition to drugs and sex, the other primary factor that influenced massage therapy education after World War II was the conscious decision by massage therapy organizations not to align themselves too closely with the conventional medical model.  In hindsight, this proved to be a defining moment for the profession.  I think that it severely slowed down the development of educational standards for the profession, while at the same time, allowing the profession to develop in a much more organic way.

The most balanced educators who emerged out of this process managed to create a system that established boundaries and ethics while at the same time retained the experiential energy and heart of the profession.

In my experience, I do not think that this history is decidedly different from that of many complementary and alternative professions.

Finally, what national trends do I see in massage therapy education that may also apply to other CAM professions?  The first trend that is especially evident across the country is that cutting -- the cutting edge education will never be contained by either state or municipal laws.  This is evidenced by the fact that training institutions across the country are developing degree granting programs varying from an AA degree to PhD programs that far exceed the requirements of existing laws.

Another trend that is closely related to this is that free-standing training programs are establishing some form of articulation agreements with colleges and universities to streamline this process and also allow them to participate in research that otherwise would be too complicated and costly to do on their own.

And the third trend is the rapid growth of programs across the country being developed by trade and technical schools who are scrambling to create curriculum and find qualified faculty to teach their program.

COMMISSIONER GORDON:  Thank you.

Barbara York?

                                                              BARBARA YORK, PRESIDENT:

                                                MINNESOTA TOUCH MOVEMENT NETWORK

I believe that the best practitioners of complementary and alternative medicine are those who realize that this work is best met with experience, personal study and the time to know their client.  Because of the variety of practices, I do not believe that uniform standards can be applied in this field.  It has been said that you cannot put your foot into the same river twice.  By the same token, every session with a client is a new experience for both parties, no matter how exacting the technique may be.   We must remember that this is a uniquely subjective work.

Though I have practiced for over 18 years and I personally chose to pursue 1,000 hour accreditation course and passed the national certification exam for massage therapist, I still believe the best lessons come in hands-on experience, whether as an apprentice or a seasoned practitioner for over 30 years.  Essentially learning is never finished regardless of certificates and testing.  The true lesson is with the client.  Without respect for that, any education is worthless.

As a Jin Jin Jitsu practitioner, I participate in an ancient art that was passed down from generation to generation by word of mouth as many of our practices have been.  Jin Jin Jitsu is a Japanese phrase which means "the art of the Creator through compassionate man."  The study of Jin Jin Jitsu is a way to expand awareness and understanding.  The practice is considered a demonstration of the art.  The responsibility for usage of knowledge received is within each practitioner.  I believe each person in this room is equally wonderful at Jin Jin Jitsu, the only difference between us is in awareness.  n similar fashion, I have a book called Primitive Remedies which was collected by John Wesley, the founder of the Methodist Church.  It was a record of parishioners remedies, which he collected and shared as he traveled his church circuit.  He did not present himself as a trained healer.  Many of these remedies are practical and based on principles recognized by contemporary healers.

I would like to quote from the introduction to Primitive Remedies.  "Wesley's concern was for the common people and it was his purpose to give them a plain and easy way of curing most diseases; to set down cheap, safe and easy medicines; easy to be known, easy to be procured, and easy to be applied by plain, unlettered men."

The field of complementary and alternative medicine remains this simple.  It is safe.  It is accessible to the consumer.  It is uncomplicated, despite the sometimes confusing emphasis on technique.  The Minnesota Complementary and Alternative Health Care Freedom of Access Act of 2000 provides a legal environment in which CAM practitioners can practice regardless of their education and training as long as they practice within reasonable conduct guidelines.

I encourage the Commission to consider this simple, profound approach of honoring both the consumer and the practitioner.

Thank you.

COMMISSIONER GORDON:  Thank you.

(Applause.)

COMMISSIONER GORDON:  Rose Haywood?

                                                       ROSE HAYWOOD, ACADEMIC DEAN:

                                                   MINNESOTA COLLEGE OF ACUPUNCTURE

                                             AND ORIENTAL MEDICINE OF NORTHWESTERN

                                                             HEALTH SCIENCES UNIVERSITY

Good morning.  My name is Rose Haywood.  I am academic dean, Minnesota College of Acupuncture and Oriental Medicine of Northwestern Health Sciences University.  I am going to start with my recommendations for the commission regarding Oriental medicine.

Members of the public need to be informed about educational standards for the practice of Oriental medicine across different provider categories so that they can make better informed choices.

COMMISSIONER GORDON:  Rose, could you come a little closer?

MS. HAYWOOD:  Yes.  Is that better?

COMMISSIONER GORDON:  Yes.

MS. HAYWOOD:  So they can make better informed choices of practitioner.

Members of the public should be able to consult an Oriental medicine practitioner without the need for medical doctor referral.

Oriental medicine is safe, effective and inexpensive and should be reimbursable by insurance companies when practiced by Oriental medicine board certified professionals.

The educational standards for the practice of Oriental medicine that have been established by the Accreditation Commission for Acupuncture and Oriental Medicine should be adopted as the standards for all categories of providers wishing to practice this medicine.

Some discussion of my recommendations:

Patients have the right to safe and effective health care.  The key to safe and effective health care is education.  Oriental medicine is a comprehensive system of health care including the treatment modalities of acupuncture, herbology and Oriental body work.

Its theory and practice grew from Oriental traditions that evolved over 2,000 years.  Its modalities cannot be practiced effectively without understanding the complete paradigm.  This requires rigorous professional education.  Fortunately, we have this.

Our accreditation commission has established minimum hours for programs of study.  1,725 for the master of acupuncture, 2,175 for the master of Oriental medicine.  These are minimums.  Most programs are much longer than this.  Our school's, for example, is typical at 2,800 for Oriental medicine and 2,350 for acupuncture.  And only graduates from accredited schools may take our national board exams.

Why so many hours?  Accredited programs provide comprehensive training in Oriental medicine, theory, diagnosis and clinical practice.  They provide sufficient hours of Western biomedical sciences for graduates to recognize conditions that require referral to Western medical providers.  These hours are recognized minimums to ensure safe and effective practice.

Oriental medicine is a very safe system when practiced by properly trained practitioners certified by our national boards.  Please see my safety record of acupuncture appended information.

When Oriental medicine modalities are practiced by other providers, sufficient training is essential.  Without knowledge of Oriental medicine theory and proper training, acupuncture becomes a mechanical procedure, less effective and maybe harmful.

Practicing Oriental herbology without proper training can have serious consequences.  Practicing without enough education compromises safety and efficacy.  It also damages our profession.  Patients may not benefit from treatment and blame the medicine rather than the practitioner's training.

Practitioners of Oriental medicine and Western biomedicine should work together in a spirit of mutual respect and cooperation.  We welcome other practitioners who wish to practice Oriental medicine provided it is respected as a comprehensive system and provided they meet educational requirements as established by our accreditation commission.

Thank you.

                                                                               DISCUSSION

COMMISSIONER GORDON:  Thank you.

Is Michael Green here? 

Okay.

Wayne, do you want to begin with questions?

COMMISSIONER JONAS:  Is there an attempt in Minnesota to license homeopaths?

MS. __________:  No.  The decision was not to license homeopaths, rather to work with the national professional organizations in terms of a registry and certification exam.

COMMISSIONER JONAS:  They would fall under the Minnesota law as nonlicensed practitioners then?

MS. __________:  That is correct.  Although there are also some that are physicians who then are accused of practicing outside the scope of the license and we still need to address that in this state.

COMMISSIONER JONAS:  Okay.  So at this point if you are licensed then you are at risk for using homeopathy in your practice more so than you would be under the current Minnesota law if you were not licensed and practicing full-time homeopathy; is that correct?

MS. __________:  That is correct.

(Laughter.)

COMMISSIONER JONAS:  Okay.

COMMISSIONER GORDON:  Just a quick follow-up on that.  Why did you decide to not go for licensure?

MS.           :  The reason is there are different training models that are still being worked out both nationally and internationally for homeopathy and within homeopathy there are a number of different types of homeopathy and there has not yet been concurrence on the best education process for that.  The best result was to develop national certification recognition of specific types of training to ensure that there was minimum training in the biomedical sciences in homeopathic philosophy and in the use of the naturimedicas and remedies.

COMMISSIONER GORDON:  So what you are saying is that the national certification includes knowledge of biomedical sciences?

MS. __________:  That is correct.  The schools that exist currently require basically the same biomedical training that you would have for a premed program.

COMMISSIONER GORDON:  And you were saying there are different schools of homeopathy.  How does the certification take that into account?

MS. __________:  The International Council along with the Homeopathic Association under NACH, the National Association of Certified Homeopaths or Society of Homeopaths, the National Councils for Homeopathy and the American Institute of Homeopathy, which deals with the medical portion of practitioners, decided that there were basic educational requirements they could agree on but because currently there are different situations state by state, some states -- for example, Arizona, only license medical practitioners.  It was decided that it was best to start with basic educational kinds of requirements and recognize that at the national registry so we currently have a registry for unlicensed practitioners and for medical practitioners.

COMMISSIONER GORDON:  I think this is Michael Green.

Do you want to follow up on that?

COMMISSIONER JONAS:  Yes, I just want to follow up briefly and yet make sure I understand this correctly.  Acupuncturists now have gone the other route, however.  They are licensed, certified and do not really fall under the jurisdiction of the new Minnesota law.  They have their own licensing regulations.  Is that correct?

MS. HAYWOOD:  Yes.  Our licenses -- the Minnesota license, we are under the Board of Medical Practice in Minnesota.

COMMISSIONER JONAS:  And are there acupuncturists who could practice underneath the Minnesota law without a license and still be covered by this?

MS. HAYWOOD:  No.

COMMISSIONER JONAS:  Or once you are licensed you do not fall under -- you cannot, therefore, be a nonlicensed practitioner and so it is divided in that way.

MS. __________:  I would like to respond to that.  There are a couple of groups of people who are practicing acupuncture without the level of education we are recommending.  There are certain groups of chiropractors that are practicing with from two to 500 hours of training and MDs.

COMMISSIONER JONAS:  And MDs, right.

MS. __________:  Yes.

COMMISSIONER JONAS:  So this -- is the law then -- is it perhaps a disincentive for some of the emerging practices that no longer -- that do not yet have licensing status to obtain that?

MS. __________:  It is not my feeling that is true.  I think there is actually a higher bar that we are establishing professionally for people that are unlicensed because we want to be able to give education and full disclosure to the consumers of our practices as to what they can expect from them.

COMMISSIONER JONAS:  I see.  So in the disclosure area especially it is a higher standard in the unlicensed area.

MS. ___________:  Yes, that is correct.

COMMISSIONER JONAS:  But any sense of a disincentive that is going on for licensing?

MS. ___________:  The disincentive as -- one of the things we looked at with the Minnesota model was that by licensing all of these different areas, including homeopathy, they were actually increasing the cost to the consumer of delivery of the services and that by trying to put it under medical practices board where the philosophies are substantially different in a number of the areas with the alternatives then we are really working at odds in terms of providing options for the consumer.

COMMISSIONER GORDON:  I do not understand why it would increase the cost to consumers.

MS. __________:  Because in order to have a board exist at the state level there are costs that are passed back to the practitioner for maintaining the cost of that board.

COMMISSIONER GORDON:  I see.

MS. __________:  Which are several thousand dollars a year.  You start running into professional reliability issues in terms of insurance costs.  You start running into difficulties with reimbursement issues.

COMMISSIONER JONAS:  You do not see any licensed acupuncturists then saying, "Gee, I am going to give up my license and just become a lay practitioner," or something like that?

MS. __________:  Well, acupuncture has been recognized as a reimbursable medical expense by many existing insurance plans.  They have received funding and they have a long history in terms of some of their clinical data than some of the other practices have.

COMMISSIONER JONAS:  I can see as a physician, though, if I wanted to be a full-time classical homeopath, I might say, "Gee, I am going to take my shingle down and no longer make any diagnosis," if I preferred that.

MS. __________:  That is currently going on.

COMMISSIONER JONAS:  Is it?

COMMISSIONER GORDON:  Okay.  Michael Green is here so please talk to us.

                                                                      MICHAEL GREEN, MD

Although I am listed under education, the main thing I wanted to talk about was reimbursement, although the other is covered in the handout.

In addition to the general problem of lack of reimbursement for CAM evaluation and treatment, existing coverage is complicated by the use of coding systems poorly suited for describing conditions treated and treatments given by nearly all CAM systems.  Although many patient presentations can be described by ICD-9 codes, its emphasis is on physician-centric diagnoses, Western diagnoses rather than patient-centric symptoms and signs found in most CAM systems.

Even though, for example, the CPT system lists two codes for acupuncture, it does not reflect other modalities used as part of acupuncture treatment, let alone treatments from other CAM systems other than perhaps chiropractic and osteopathy.

Similarly, the current standards for documentation for the evaluation and management codes are poorly suited to most CAM systems where there is a heavy focus on patient's history and review of symptoms and often the physical exam and decision making process is fairly limited by Western medical standards and because of the way the E&M code is determined, CAM E&M is usually heavily under valued.

I hope that the commission can recommend that the coding systems used for medical reimbursement and review be revised to better reflect the very different paradigms of the CAM systems.

On education, vis-a-vis what was just brought up, there is a lot of organizations that have come into existence to define and control what is legitimate complementary and alternative medical care and training and this may obscure what are significant differences in philosophy and therapies among what appear to be very similar groups of practitioners and the one of physician acupuncturist, chiropractic acupuncturist, and licensed acupuncturist is an example.

In my own area, my own training includes a number of techniques that are not really considered Oriental medicine.  They look like acupuncture and they use the same needles.  They use the same equipment but they are based strictly on Western medical principles.

How to work this into trying to compartmentalize different paradigms under labels is something that I would really ask the commission to be careful about because of the risk of mislabeling certain practices and thereby making them difficult from a licensure or a reimbursement or other basis.

                                                                               DISCUSSION

COMMISSIONER GORDON:  Thank you.

Joe?

COMMISSIONER PIZZORNO:  First, I would like to ask Lynn Lammer --

MS. LAMMER:  Lammer.

COMMISSIONER PIZZORNO:  Lammer.  Okay.  The -- after Val Ohanian's name it is RS, Hom (NA).  What does that all mean?

MS. LAMMER:  It stands for registered homeopath, North America.  The first registry of the Society of Homeopaths existed in England and still does to this day.  We started the North American one to recognize the unlicensed professional homeopath in this country.

COMMISSIONER PIZZORNO:  And then from Michael Green, we heard testimony at the last -- two weeks ago that the international standard for acupuncture for medical doctors was 300 hours but also in talking to some of the acupuncture accrediting people I was told that the World Health Organization actually has two standards, that 300 hours was the minimum standard for acupuncture medical doctors and 1,500 was the recommended standard for full practice of acupuncture.

Could you comment on those different standards and what they mean?

DR. GREEN:  Yes.  There is a fundamental difference in philosophy and training, I think, implied by that.  For someone to sit for the national board exam, the NCCOM exam for acupuncture in the U.S., the assumption is that when you finish your education you are ready to begin full practice as a fully qualified -- fully experienced -- you know, you are done effectively.  Although clearly there is continuing education involved.

The philosophy in the sort of medical acupuncture community has been a minimum educational standard for safe and effective practice with the assumption being that you will accumulate additional information, additional experience, additional education in the process of honing your skills.  So there is a very different philosophy involved and I think that accounts somewhat for the difference in hours.

COMMISSIONER GORDON:  Go ahead.

MS. HAYWOOD:  If I could respond to that briefly.

COMMISSIONER GORDON:  Please.

MS. HAYWOOD:  The American Association of Oriental Medicine also adheres to pretty strict continuing education practices for Oriental medicine practitioners over and above just your graduation.  So I think that is pretty normal for all professionals.  And we would still be recommending 2,700 to 3,300 hours as a -- you know, in terms of professional development, and that is what we are looking at for the future.

COMMISSIONER GORDON:  Okay.

Linnea?

COMMISSIONER LARSON:  This is to Margery Wells.

In your testimony you said that you -- and I want to clarify this.  Would you recommend that those trained in medical acupuncture not be permitted by law to practice the "modality" of acupuncture due to -- you said those who do not have traditional Oriental medicine training should not be allowed.

MS. WELLS:  Sure.  I think I understand the question.  It is delicate because what I am advocating essentially is that patients, the health care consumer has a right to know what is the level and extent of education and training, and that there is a distinct difference between a different licensed health professional who is practicing acupuncture and someone who has actually trained extensively in Oriental medicine practicing acupuncture simply because the methods of diagnosis are so different.  The clinical experience is so different.  They are two totally different paradigms from which to function and from which to view the patient.

DR. GREEN:  Can I address -- I am sorry.

COMMISSIONER GORDON:  Do you want to ask a question?

COMMISSIONER LARSON:  Yes, I just want to follow it up.  So basically you are making a statement about a philosophical basis for treatments and can I then extend it to, therefore, a reimbursement rate, you know, basis?  Would you receive less reimbursement than someone who is trained as a physician in acupuncture?

MS. WELLS:  Would a licensed acupuncturist receive less? 

COMMISSIONER LARSON:  Yes.

MS. WELLS:  Absolutely not.  A licensed acupuncturist potentially should receive more.  I mean, there -- and it is kind of the reverse of that right now.  I know -- I personally have physician friends who are being reimbursed.  Well, this was several years ago, 125 bucks for a five-minute acupuncture session with no differential diagnosis in the TOM paradigm.

COMMISSIONER GORDON:  I would love you to give me the name of those insurers.

(Laughter.)

MS. WELLS:  I can tell you the name of the physicians.

COMMISSIONER GORDON:  As somebody who has --

MS. WELLS:  I can tell you the name of the physician.

COMMISSIONER GORDON:  As somebody who has been practicing acupuncture for 25 years I have never been reimbursed --

MS. WELLS:  What state are you in?

COMMISSIONER GORDON:  In Washington, D.C.

Go ahead, Michael.

DR. GREEN:  I would like to caution that, as I mentioned, there are systems of acupuncture that are not Oriental medicine.  They use the same needles and the same equipment.  It is not sticking the needles in people that is necessarily the defining piece.  It is the philosophy and I could give examples but I think it is important to make the distinctions about what system one is using to treat, not necessarily the implements that one uses to make -- to do the treatment.

COMMISSIONER GORDON:  I had a quick question and then George and Wayne.

We have had this discussion at town halls.  We have had this at meetings in Washington.  Very similar kinds of discussion.  And the point I would like to ask for your opinions about is -- and I raised this also once in Washington.  In medicine I am licensed to practice medicine and surgery.  I am unlikely to do much major surgery.  I think it would be a disaster for my patients as well as for me.  But that is based -- I have the license and I use my judgment about what I can do and what I cannot do.

And I am wondering if there might not be a way to think through this, that there are some people who are clearly more qualified in Oriental medicine than others.  Some people who are -- for example, I know something about Chinese herbal prescribing but when there is a life-threatening illness I have a colleague who spent 40 years in China doing Chinese herbal prescribing who is also an oncologist and I definitely refer people to him.

So I am trying to think what you think about this and I also work a lot with addicts and ear acupuncture of HIV positive addicts is very helpful and a licensed acupuncturist will not do it because the reimbursement is very low and the need is so great.

So I am wondering if there is not room in this house for many mansions of people knowing -- at different levels of skills doing different kinds of work.  That is both an opinion and a question.

MS. HAYWOOD:  I would like to address that if I may.  May I address part of what I understand is the question there?

COMMISSIONER GORDON:  Sure.

MS. HAYWOOD:  What practitioners of Oriental medicine would wish -- I mean, we do not all agree on this by any means but, however, addressing the previous question a little bit as to whether medical providers should be entitled to practice Oriental medicine is a question of definition of terms as Michael correctly points out.

And it is also a question of level of education and what the Oriental medicine profession would like to see is that if one is going to practice the full paradigm of Oriental medicine that the practitioner receive the full education that an Oriental medicine provider has, which is 705 -- the minimums of 705 hours of theory and diagnosis, 660 hours of clinical training, and if you are going to use Oriental herbs, 450 hours in just herbology in addition to the Western clinical sciences. 

So medical doctors would already have the Western biomedical sciences, therefore they would need all of those hours on top of that to practice the complete paradigm.

If the type of practice that Michael is describing is going to be practiced by Western medical providers or whoever then it needs to be spelled out exactly what that is so that members of the public do not run away with the impression that this is Oriental medicine.

COMMISSIONER GORDON:  So you are saying as long as people spell out what their training is and the scope of their practice is appropriate to the training --

MS. HAYWOOD:  Exactly.  And also there needs to be a review of the training of all providers who attempt to practice Oriental medicine as a whole or any of the modalities of Oriental  medicine to ensure that the number of -- the requisite number of hours matches what they are claiming to be able to do.

COMMISSIONER GORDON:  Thank you.

MS. HAYWOOD:  We would rather see all people -- all practitioners practicing any of the modalities of Oriental medicine receiving the full training, which we have to have.

COMMISSIONER GORDON:  Okay.  Michael and then Jackson?

DR. GREEN:  Yes.  I would like to bring up the example of family practice, which is my training.  In the training for that I spent a little time working with all kinds of specialists, surgeons, ear, nose and throat specialists and so on.  I learned about the kinds of conditions that are easy to treat and difficult to treat, much like your comment about surgery. 

I would not begin to try and represent myself as a surgeon and yet I am competent and trained in doing minor office surgery.  The same thing for ears.  The same thing for prenatal care for very simple obstetrics.  And yet I would not handle anything very complicated in those areas.

I think the same thing can be applied.  I mean, I would love to see licensed acupuncturists treated as if they were medical specialists, which I believe they are, but that does not mean that all of what fits into that specialty is practiced only by those specialists. 

There may be some differentiation in complexity and it is usually the board of the individual who is practicing it who sets those standards so that the family practice board defines what ought to be roughly the range of training of a family practitioner in areas like surgery or obstetrics.

I mean, obviously there is a collaboration.

COMMISSIONER GORDON:  Thank you.

Jackson?

MR. PETERSBURG:  I want to just expand the conversation kind of back into my realm and maybe some of the other modalities that we have not mentioned so much but one of my major concerns and I think one of the reasons why I certainly was attracted to the education field is that I am not convinced that people who are exclusively eclectically trained have a basis in, you know, things like contraindications, when to refer under appropriate ethical boundaries and so on and so forth.

COMMISSIONER GORDON:  When you say "eclectically trained" you mean?

MR. PETERSBURG:  Well, let's just say that there was no formal education process that may have looked at all the various aspects of the profession and I think also that there is a real difficulty in helping define their own scope of practice and what the limitations are in the scope of practice and when to refer inappropriately.

And I am not an advocate of a tiered system within my world.  I think there is a baseline of education that anybody should have when they are practicing and touching people professionally. 

There is a lot of other concerns in addition to physical harm that are involved in that that I think a lot of people do not think about but I think there is going to be another level that will emerge here in advance studies that will start to concentrate above and beyond the basics, whether it be energetic models or structural issues or whatever it is within the professions.

This, to me, I think is where we are heading but we have a real dichotomy certainly in this state, if not in the country, between people who, I think, are much more libertarian minded in terms of any kind of regulation and/or training and people maybe go way in the other direction than somebody who is going to kind of sift out in between.  This to me is a great issue.

COMMISSIONER GORDON:  Wayne and then, George, if you have questions.

COMMISSIONER JONAS:  Well, again I am interested in the impressions of both the licensed and the unlicensed groups about the current status of the Minnesota -- what the Minnesota model is going to do.  I mean, it is almost like, well, if you got in quick before the law occurred then let's keep our licensing but everybody else did not quite get in and it is okay, homeopaths or energy practitioners and this type of thing.

I am just concerned about what kind of precedent that sets and what will be the direction of that.  Will groups continue to want to obtain licensed status? 

What I may do is open up my rehab practice in the morning and have my license up there and do rehabilitation medicine and then in the afternoon go to my next door office, take all those things down, have to have higher standards of disclosure and documentation but practice massage therapy and then refer to myself back and forth.

(Laughter.)

I am just very confused about what the licensed practitioners feel about the current particular law.

COMMISSIONER GORDON:  Please.

MS. WELLS:  I think that as John Mastel said earlier, it is a certain factor of competition. 

If you are coming into a massage therapist that is ineffective even though trained but could care less about dealing with you, you are going to know very quickly that you do not want to go back and that in many of these fields it is so much about the rapport between the practitioner and the consumer, and that it is not something you can just dispense.

I have pharmacy friends who know that even though they are handing a package over the counter that there is a big difference if they have a rapport with the client, you know, even though they have high levels of education.

So I think that sensitivity to -- even if a person has disclosed they read a really great book this weekend and they would like to practice on you and would you please pay them for the time that if that person was willing to go back to them for their time, not what they do, but to spend the time with each other in that sense of there is a healing presence.

COMMISSIONER GORDON:  Other comments on that?  Yes, Jackson.

MR. PETERSBURG:  If I could just comment and make one more statement which I was not able to do in my comments about this existing law.

Because of our profession being managed on a municipal level, what it does not afford for us because it does not develop educational requirements and it does not require scope of practice, is that the municipalities are still not convinced that that will protect the public and so we still are governed by municipal laws even though this exists and has some other things that we have to abide by.

And I think it is -- it clearly is one of the weaknesses of the structure and does not do the job for us to allow our practitioners to move from one municipality to the next municipality without having to fulfill the licensure requirements of each municipality so in that respect I think it falls very short.

COMMISSIONER GORDON:  Lynn?

MS. LAMMER:  I think it is important to point out that licensure does not necessarily mean that there is competency to practice.

(Applause.)

MS. LAMMER:  I think the Minnesota model goes farther than licensure in terms of protecting consumer interest because of the very detailed types of disclosure that are required.

It will also force practitioners to become more educated in order to keep their clientele and be effective.  If you do not produce results, even with a good relationship, people are not going to come back.

COMMISSIONER GORDON:  Thank you.

Okay.  Thank you all very much.  We are on time, which is nice.

(Applause.)

COMMISSIONER GORDON:  We will take a break and we will come back at ten after 11:00 in 15 minutes.

(Whereupon, a break was taken.)

                                                                                    * * * * *

                                                  EDUCATION OF HEALTH PROFESSIONALS

COMMISSIONER GORDON:  Okay.  We are going to begin the next panel now and we will begin with Mary Jo Kreitzer.

                                                                   MARY JO KREITZER, PhD

                                      DIRECTOR:  CENTER FOR SPIRITUALITY AND HEALING

Over the past several months as the Commission has held hearings, I suspect that you have often heard quoted statistics from the Eisenberg study on the high utilization of complementary and alternative medicine.  Today I want to highlight a different study that will provide a context for my remarks and policy recommendations.  Dr. Jon Astin in this study that looked at the profiles of people who use CAM therapies found that fewer than five percent of the population uses these therapies strictly as an alternative.  The remaining 95 percent are seeking care that draws from the best of healing traditions, both complementary and conventional.  This has very significant implications for how we educate health professionals as well as CAM providers.

The University of Minnesota is strongly committed to preparing health professionals who are knowledgeable about CAM and who can help patients evaluate options.

Additionally, there are biomedical providers, physicians, nurses and others who are returning to school to acquire new skills in CAM because they want to expand their knowledge base and repertoire of skills.  Many of these health professionals are keenly aware of the risk of reducing these healing traditions to tools that are provided in a reductionistic way.  They also recognize that many of these complementary and alternative systems of care are based on world views that are entirely different than the biomedical model in which they were educated.  There is a need to educate healers who are capable of being bicultural, to practicing in a way that embraces multiple world views.

From a policy perspective, there are four recommendations that I urge you to consider.

To date, schools that are developing programs to educate health professionals in CAM are doing so as a result of demands from students, consumers and at times faculty.  Curriculum is optional and often elective.  Accreditation requirements and board exams need to be changed so that CAM becomes an integral part of required education.

Academic health centers need funding to develop curriculum for both the basic training of health care providers as well as funding to develop specialized programs to educate health professionals who want to acquire additional skills in CAM. 

There are only a handful of graduate and fellowship programs in the country.  I serve on the policy board of a foundation that provides fellowships to physicians who are seeking mid-career change and over the past three years 25 to 30 percent of all applicants who are seeking training in CAM areas are seeking training in those areas and there are not enough training programs to prepare physicians. 

To create a team that is truly interdisciplinary we need to address a need to also train CAM providers.  Present CAM education programs do not include information on working with biomedical providers or working with an interdisciplinary team. 

Federal funding to date has been limited to conventional health professional training programs. 

And, lastly, there are a few clinical sites where students from different healing traditions can learn together.  We need to create and fund models where students can observe, learn and work in tandem.

Thank you very much.

COMMISSIONER GORDON:  Thank you and thank you, also, for all your work on pulling together these wonderful sessions.

(Applause.)

COMMISSIONER GORDON:  Bill Manahan?

                                                                       BILL MANAHAN, MD

                                                                    ASSISTANT PROFESSOR

                                                       DEPARTMENT OF FAMILY PRACTICE:

                                                               UNIVERSITY OF MINNESOTA

The core idea of the training is to expose students and physicians to the office practices of multiple CAM practitioners so the physicians can experience what is really going on in the world about which they know very little.

Here are some typical comments from medical students and physicians who have taken the course over these past couple of years:

"This course was wonderful.  Every medical student and every physician should take this same thing."

Another one, "I think that I broadened my mind to the level of confusion but I trust.  I trust things will sort themselves out some day in my psyche."

Another student, "I am awed by what is out there.  The practitioners we visited have so much training, have such good credentials, and they really want to help people optimize their health." 

Specifically speaking to a recent student and the psychiatric talk that we just had, this student stated -- she gave her final presentation at the end of the three weeks on mental health problems and exercise and she -- her starting statement and her ending statement was, "How could I be starting a residency in psychiatry in four months, gone through four years of medical school, taken two extra electives in psychiatry, and never heard the word 'exercise and fitness' with any psychiatric thing, and goes into the web and picks up thousands of scientific articles on exercise and mental health." 

This is another student just this last time, the same thing with otitis media.  She is going into pediatrics and presented the same -- presented her final paper on otitis media and CAM and says, "How could I go through four years of medical school, starting a residency in four months, and never heard the word 'food allergy' related to serious otitis media?"

(Applause.)

The reason I believe this course is so powerful, and this is the key to my presentation, is because the primary faculty are the CAM providers in the community.  They teach the students as they are taking care of their own patients.  The students get a chance to talk to the patients and discover from them strengths and weaknesses of our own present medical system.  The course also acts as a bridge bringing together CAM providers and physicians or physicians in training. 

The students also act as ambassadors for allopathy bringing to the experience some humility, compassion and a desire for learning from the CAM practitioners that has frequently been absent in our previous relationships. 

The course is primarily for medical students but is also taken by residents and by practicing physicians and it consists of 30 half days over three weeks, 15 of those half days spent in the office of other practitioners.  Much of our work is done by e-mailing each other about our thoughts and feelings about the rotations.

With all due modesty, as my recommendation, I believe this course is one of the best ways I have ever experienced to educate physicians about CAM and educate CAM providers about physicians.  I suspect that the health delivery system would be markedly changed if we had every senior medical student, every third-year resident and every physician in training do a similar three week course.

COMMISSIONER GORDON:  Thank you, Bill.

(Applause.)

COMMISSIONER GORDON:  Erin O'Fallon?

                                                       ERIN O'FALLON, BA, (MD in May 2001):

                                             UNIVERSITY OF MINNESOTA MEDICAL SCHOOL

I took this class with seven other medical students and I believe I speak for all of us when I say it was one of the most powerful and thought provoking courses during our medical training. 

We feel that every medical student would benefit from this exposure and training.  We agree the course is valuable for a variety of reasons.  Although focused on complementary and alternative medicine, it definitely enhanced our perspective on allopathic medicine.  By glimpsing the world of allopathic --

COMMISSIONER GORDON:  Do you want to come a little closer to the mic?

MS. O'FALLON:  Yes. 

By glimpsing the world of allopathic medicine from the outside, we more clearly understand the strengths and weaknesses of our chosen field.  By considering the alternatives we developed critical thinking skills that applied not only to new and novel ideas but developed our ability to look more critically at our own practices. 

Secondly, we felt that our visits with different practitioners allowed us to begin to build a meaningful understanding, rapport and level of collegiality. 

Last, the course increased our interest and confidence in discussing alternative therapies with our patients.  Since we know that many Americans now use a wide variety of healing practices, we know that our ability to discuss them candidly and knowledgeably is vitally important.

Our brief exposure to the vast field of complementary and alternative medicine served well to show us how much more there is to learn.  We felt that continued courses during residency training, and as part of continuing medical education would be invaluable.  Continuing education is required because the scope of complementary and alternative medicine is huge.  We also recognize that at different times during our careers we would comprehend and integrate our knowledge of CAM in different ways.

Of course, as with the field of medicine as a whole, the continued expansion and evolution of knowledge and treatments demands keeping your information refreshed and up-to-date.

I personally plan to continue to educate myself about CAM and its relationship to allopathic medicine and I sincerely hope that my colleagues at all levels of their training would benefit from opportunities similar to the course that I took.

I also hope the future of medical education holds an increase in understanding of CAM by allopathic practitioners and I hope that collaborative training, dialogue and respect between our many fields and practitioners will enhance the medical care that we can offer in the future.

Thank you.

COMMISSIONER GORDON:  Thank you.

Patricia Cole?

                                                                       PATRICIA COLE, MD

                                               DIRECTOR OF FAMILY PRACTICE RESIDENCY:

                                                      HENNEPIN COUNTY MEDICAL CENTER

As a family physician and an educator, I am proud to be involved in graduate medical education but I am deeply aware that our current system is not serving patients, nor is it serving the medical students who come to us for training.

Many, many patients deeply know that issues of spirituality and relationship are essential to their healing and we do not teach that much. 

Our physicians are burning out.  I recently encountered a colleague of mine who trained with me 25 years ago and he has had a quadruple bypass.  He listens to patients.  He values taking time but he has not ever learned how to care for himself.  I think it is essential that we do our education differently. 

Now in residency training that is the opportunity where students, doctors in training, not only are exposed to fascinating new ideas like Bill Manahan's course but really need to acquire the skills and ideally begin a path towards integration of those skills into their final practice and the challenge for those of us trying to create programs is how can we bring change into sometimes stodgy old systems that prefer to do it the old way.

There needs to be total system change really.  Our nurses need to be empowered to be doing more healing.  We have to have our environments be healing ones.  We need to be relating to the community so that we can de-medicalize so many conditions that are offered to physicians as if we had answers to domestic violence and chemical dependency and so on.

In my prepared recommendations you have a list of ways that I think this Commission can be helpful.  I want you to strongly say that to the medical community and then let us figure out how it is we are going to teach it.  Please demand that it be part of our evaluation and board certification exams.  Money for CAM demonstration clinics, we have heard about them earlier, these are essential practice sites if residents are really going to learn how to acquire and integrate the skills that I believe they need to care for our population.

Thank you. 

COMMISSIONER GORDON:  Thank you.

Mary Johnson?

                                                                  MARY JOHNSON, PhD, RN

                                             DEPARTMENT OF NURSING:  ST. OLAF COLLEGE

Nurses have a very unique position and a high trust level in the minds and hearts of patients.  They are present at very pivotal times in the lives of people who are in the process of a healing journey and, therefore, in the basic nursing education I believe that information and evidence, legal and ethical issues, and cultural differences concerning CAM practices needs to be incorporated into the nursing curriculum.

Prelicensure, students need to understand the premises that support healing practices and develop skills in assessing and evaluating their clients' use of complementary and alternative therapies. 

Nursing theory and practice has embraced the philosophy of providing holistic care to the whole person ever since its beginnings with Flossie Nightingale. 

CAM therapies provide a means of operationalizing and of demonstrating this kind of care.  Students who learn the therapeutic use of touch and massage, relaxation techniques, and guided imagery as part of their nursing skills set become more comfortable and competent in nonjudgmentally obtaining and recording information about other healing practices that their clients might be using.

Nurses need to have the ability to assess and evaluate their client's use of complementary therapies and to develop comprehensive and individualized care plans.  Knowledge concerning the information about CAM therapies, research programs and cultural differences needs to be included. 

You all know that there is a nursing shortage going on now and it will be probably lasting for many years.  I have found that by incorporating the use of CAM therapies into nursing practice, many advantages come from that for the nurse themselves in terms of job satisfaction, meaningful work and centered living.  At a time of these increasing shortages, nurses need to provide opportunities and need support from other nurses and from their organizations to continue this kind of practice.

So I would recommend that you speak to nursing national organizations for the inclusion of this kind of information in their educational curriculums and to encourage the Board of Nursing in many nurse -- in many states to expand nursing scope of practice to include some of these complementary therapies.

COMMISSIONER GORDON:  Thank you very much.

Janet Dahlem?

                                                                       JANET DAHLEM, MA

                                         DIRECTOR:  HOLISTIC HEALTH STUDIES PROGRAM,

                                                                COLLEGE OF ST. CATHERINE

I am the program director and assistant professor at the College of St. Catherine in Minneapolis of the Holistic Health Studies program and I have been in that position for 11 of its last 17 years in existence.  So that particular program, academic program, while serving a lot of professionals, our primary audience has been historically the health care professions so that is to which I want to speak.

I collaborated on a study in 1999 aimed at our health professions division faculty and 78 percent of that faculty, some, of course we know very, very conservative faculty, have stated that they felt like students coming out of their disciplines would not be adequately prepared if they did not have education in this particular area. 

So to really deal with the demand for education of professionals in this field, the College of St. Catherine is in its final stages of launching and looking at the development of a master's program in this field in addition to the current certificate program.

So my -- the recommendations that I want to speak to are both in policy and action and I want to read those to be able to get through all of those.

My first action recommendation follows my colleague of Mary Johnson, which is to really ask of you from the federal level to enact federal policy and legislation that will make recommendations and mandates to the states at that level which would require the licensing boards of the different health professions to examine, expand their professional practice acts to allow individuals within their professional scope of practice to legally practice and receive reimbursement for using complementary and alternative therapies.

Secondly, my second action recommendation is to establish a national financial incentive program to encourage academic institutions offering education to health professionals to develop programming and curriculum in this field of holistic, complementary and alternative health care to really continue to meet the growing demand from the educational standpoint.

Our academic institutions that offer health professions degrees need financial incentives, much as the NIH has historically done with research.

And, also, in terms of one of my other policy recommendations that I want to speak to, because the philosophies and theories of some of the holistic health practices are so different from those of conventional medicine, academic institutions need to root curriculum in the historical and cultural traditions from which many of the practice evolved.  So this may mean to include partnerships between academic institutions and centers that work to promote the health of cultural communities to guarantee that the voice of cultural ways of knowing are central on our agenda, and I cannot say this enough. 

I really, in closing, want to say that I do not want us to recreate a Euro-centric model of health care but -- and I know that that statement reinforces what you all are attempting to do as well.

So thank you very much.

                                                                               DISCUSSION

COMMISSIONER GORDON:  Thank you.

Questions?  Linnea?

COMMISSIONER LARSON:  I thank all of you for your testimony.  This is directed to Dr. Manahan and to Dr. Cole specifically.

I have been involved and actually wrote a curriculum in alternative and complementary medicine for family practice a long time ago and I am very well aware of what you have been doing and then also your commentary, your opening commentary about how many of your colleagues are in grave distress. 

So my comment or my question actually has to do with having both trained medical students and residents and having been -- my having seen their eyes opened to "Oh, my goodness, why didn't I learn this before" and then seeing the grave distress of the practicing physicians, what happens?  Is there any follow-up that you do in the training of these medical students and residents?  Follow-up after it?  How do they really integrate these practices in their own lives and in learning how to collaborate with the alternative practitioners?

DR. COLE:  This is a tough one.

DR. MANAHAN:  We both would like the other one to answer that because there is probably not a very good answer and I probably could sum it up.  Just last week when I was precepting, I had one of the second year residents who was -- just loved the course two years ago.  And I said, "How is it going?"  And he said, "That is but a distant memory in my mind."  And that is why it needs to be -- and Pat and I have talked about that, at third year level of residency and probably out at five years of practice.  It is almost like three times it needs to be offered because the residency training overwhelmed them with biomedicine and, no, it was pretty distant.

DR. COLE:  I am fortunate to have some extraordinarily motivated first year residents in my program that want to do CAM as their career and last night speaking to one of them, she was totally exhausted.  There is nothing like working 80 to 100 hours a week and being up working all night, 36  hours in a row, four days every other -- every fourth night, to take away any sense of wholeness. 

She said, "You know, I have done the Helm's course.  I can put the needles in."  She said, "I am not sure it would be a good idea for me in this state to be putting needles into anybody.  Drawing blood, yes.  Doing medical things, okay.  But not healing." 

And that is a tragedy really.  We not only do not model it but we haze them to the extent that we sap even what they know what to do before they come in because exercise goes, relationship goes, spiritual life goes.  It is an enormous problem.

DR. __________:  If I could add just a couple of comments to what Dr. Cole said.  We did recently receive at the university one of the R25 grants from NCAM, a $1.6 million grant, to do a better job of integrating CAM into pharmacy, nursing, dentistry, as well as expand our graduate program.  So I think there is hope and I know I serve on curriculum committees with both Bill and Pat and we really are making an effort to do this not only in the undergraduate but also in the residency programs.

We are developing a survey that I think will be quite interesting that we intend to do at the baseline of this grant period at three years and five years to look at how do attitudes and practices and beliefs change. 

We also are in the process of developing an inner-life of healers program that will be addressing many of the kinds of issues that Pat so eloquently spoke of that we hope will be available to not only students but also practicing health professionals.

COMMISSIONER GORDON:  One thing I just want to follow up on, which is kind of information for you, Linnea, is that I have seen the -- I have taught medical students at Georgetown complementary medicine for 20 years and one of the things that is important, I feel, is to be with students in the first year and to give them not only the kind of rich experience that you are describing but our experience is really focused on students becoming self-aware and learning self care.            And we do that with first year students.  I have been doing that for all these years with a small group and we are hoping to do that with all first year students as time goes on. 

And I think that this part is one that goes along with the knowledge and the experience of the CAM practitioners.  They have to learn about and experience themselves. 

And my observation that we have not done -- I sort of was -- had a little chagrin because I realize we have not done our follow-up study that we should have done but many of those students are now practicing integrative medicine.  I do not know the numbers but a large number are and some of them are running programs as well.

And I think that that may be one of the -- you know, it is not just the students who spent a month with me.  It is the students who in the first year had this very powerful and supportive experience that helped them deal with some of the viscidities of residency training a little bit better.

DR. __________:  I think as faculty become more aware and are about to take those teaching moments, if there can be encouragement and a real understanding of what it means to do self-care, if we can be truly modeling it, I think there is some hope. 

COMMISSIONER GORDON:  Go ahead?

DR. __________:  It is not just self-care.  I think self-care goes hand in hand with the understanding of how to collaborate, that it is not on your back --

DR. __________:  Absolutely.

DR. __________:  -- and that is what we are not training and treating, et cetera.  So five years out you have forgotten it all because you did not know how to ask for help.

DR. __________:  Right.  Right.

COMMISSIONER GORDON:  Joe?

COMMISSIONER PIZZORNO:  I would like to follow up on what Linnea just said and I think your training program is fantastic having the medical doctors to be to actually spend time with practitioners and see what they actually do makes a lot of sense.

One concern I have, and I see a lot of medical schools now doing various forms of kind of familiarizing the students with the CAM practices, but I have not heard anybody talk about actually developing specific training programs and how to collaborate with CAM practitioners, and I think there is a specific skill group there that is needed and I wonder if you are doing anything along those lines or have any ideas for how that might be accomplished?

DR. MANAHAN:  Well, I think the key -- and I maybe did not make that as clear as -- personally I do not think the average MD or DO will be doing much in complementary and alternative medicine.  What I see is just the pharmaceutical type of medicine that is now practiced is overwhelming at some level and I think the whole point of my course would be not to teach them how to do these things but to learn what is out there and to be -- and that in itself teaches, I think, and I think Erin could answer that better.

I think they all start thinking a much more collaborative thing.  I just think it has to be -- the bulk of medical -- of training of doctors does not happen in medical school.  It happens in residency and that is where we need to do more of the collaborative -- you know, of where -- of sending them out and getting them.  Once they have the experience out there then they just automatically, I find, want to start using it more.

MS. O'FALLON:  I would agree with what he said.  I know a lot of my classmates were eager to refer some of the problems that alternative practitioners told us they were really good at it; when we met the chiropractors they said, "Boy, we love it when we see patients with chronic low back pain or headaches."  And we said, "Wow.  Great.  That is exciting to know."  Because what we have seen in Western medicine was not, you know, enthusiasm about treating low back pain, it was apprehension.  So we thought, "Wow.  We had no idea there were other practitioners that were excited about it and had good responses in these other areas."

So at least in terms of being eager to refer or to collaborate in that sense, even if we were not ready to take on more training in those areas, I think that succeeds in an area.

COMMISSIONER GORDON:  Wayne, any questions?

COMMISSIONER JONAS:  I think most of the issues around this have been addressed but I did not hear -- and I wanted to ask one thing that I did not hear.  I assume it is somewhere in there.  And that is, is there any discussion of evidence-based underlying some of these practices or discussion of dangerous practices that may be seen as students are rotating out through these areas?  Is that part of the course?

DR. MANAHAN:  What I tell them on the first day is that for four years minus three weeks they learn about the dangers of alternative and other practices, and during these three weeks that I think we can afford to trust them to mainly give the positive aspects of it and so I would say, "No, I do not do a lot with that aspect of it."

COMMISSIONER JONAS:  I would disagree actually with that.  I think what they learn is a lot of propaganda about the dangers but they do not actually learn what the dangers are, which can only come, you know, in looking at what goes on in actual practices.

DR. __________:  I would just say, though, Dr. Jonas, that what Bill has described is one course in the medical school.  We actually have identified CAM as one of ten threads that are woven throughout the entire medical school curriculum and so what he has described is one elective in the third and fourth year. 

We just had a clinical inquiry session last week where the focus was on low back pain and it was very much looking at the evidence-base for what chiropractic brings, for what massage brings, for what osteopathic medicine brings.  So our focus very much is how do we do this in an evidence-based way.

So I think Bill's course offers sort of a wonderful enrichment to students who want to get a more in-depth experience.

COMMISSIONER JONAS:  I hope that your expanded course now that you have this grant and expanded program can begin to bring these things closer and closer together.  This is not an issue unique to complementary and alternative medicine.  I mean, in regular medical school there is -- we learn about evidence-based medicine and have journal clubs and things like that and then you go out into practice and, you know, a lot of that goes by the wayside but in any case I hope that that occurs.

There is another issue that I did not hear a lot about and then I am -- and it is really related to what you said about the nursing and that is the holistic perspective.  Even going around and seeing different practices does not necessarily help you understand that there may be a different underlying perspective, perhaps even a common one about looking at the whole person, which, you know, as you said, has been part of nursing practice for years and I am just wondering if there is any interaction with bringing in the nursing perspective as a Western-based holistic assessment.

DR. __________:  I would say that this is probably something we want very much to avoid, is to try to make CAM therapies be the next pill that one could take or the next treatment that one would use, that is more of a how you do what you do than it is what you do.  And that kind of philosophy is -- I think, in nursing, is trying to take that idea, that paradigm and work with it in terms of collaboration because nurses need very much to work with other health care professionals in a collaborative kind of model.

And I think many times they are facilitators of collaboration between patients and doctors and other health professionals so it is the broader perspective.

COMMISSIONER JONAS:  There is already not very adequate communication between the physician and the nursing side on these areas and that is already in the Western conventional system.

DR. __________:  This is true.

COMMISSIONER JONAS:  It would be lovely to bring that in and to bring the holistic perspective in.

DR. __________:  You know, if I could just tell you one interesting experience we have.  We have a graduate program now in complementary therapies and healing practices, and I taught the research topics class last semester, had ten students and no two students were from the same discipline.

When we began the program we had 37 students a year ago last fall.  This spring we have over 151 students enrolled in courses within the graduate minor.  And I would say the strength of it are two things:  The interdisciplinary nature and the holistic nature.  The fact that it is very much addressing the care of the whole person.

COMMISSIONER JONAS:  I think these kind of educational models would be extremely useful for us to see.

Again I want to thank you, Mary Jo, personally for organizing this.

I was hoping I would see some new things coming to the heartland and I have to say I have.  There is really some expansion and lateral thinking that is going on here.  It is wonderful.

DR. MANAHAN:  Dr. Jonas, I gave a little bit of a glib answer on your question of evidence-based.  The key thing I also mention on the first day is the whole course is really about critical thinking and so I think that when Erin mentioned about critically starting to look not just at the offices that she and the other students are going out to visit but looking critically at our own biomedicine and what we are really doing and what science is.

MS. DAHLEM:  I would say --

COMMISSIONER GORDON:  George? 

I am sorry.  Go ahead.  Go ahead.

MS. DAHLEM:  I just want to add one other thing in terms of one of the emphasis in our program at the College of St. Catherine within a holistic philosophy recognizing something that we have learned from some of the cultures.  Of communities of color what we have learned is that too often individuals of color have to leave their culture at the door when they see a provider and so I just want to emphasize again that part of the holistic framework has to really emphasize and hold as center of the agenda the concept of culture.  And some of us have hardly a beginning knowledge of what that means to not be Euro-centric based and also to embrace and understand and look at different cultural ways of knowing.

So part of that holistic philosophy really has to embrace that, to continue to embrace that.

COMMISSIONER GORDON:  George? 

Let's give George time and then come back.

COMMISSIONER JONAS:  Okay.

COMMISSIONER DeVRIES:  Dr. Manahan, you know, part of the White Commission, our mission is to provide recommendations and one of the specific areas is related to education.  And if we were to ask you, you know, given what you have learned in terms of creating really CAM education for medical students in medical and/or residency training, if you had to distill it down to three or four mission critical items that you thought these are the critical issues for creating successful CAM education inside of a medical school or residency program, what would you distill it down to?  What would you share with us?  What do you feel are those critical points?

DR. MANAHAN:  I think the critical point is open-mindedness and attitude.  It is not skills and it is not even necessarily knowledge.  It would be more attitudinal, and that is why I felt that -- I have learned through this program how attitude changes so tremendously as they are in the offices of the other practitioners.

We started -- I could -- we could lecture with the best lecturers forever and it would not do what it does with these students and physicians when they are in the offices of the other practitioners. 

And one of the more common comments is about they are so holistic, they are so compassionate, they are -- one of my most common comments of students when they are -- is leaving the course is, "Now I have -- I -- now I have the energy to go into residency and the passion that I had when I started as a freshman medical student."  And it is their attitude.  It is not that they learned a few more techniques or anything.  And so I would put it down to one thing.  It is somehow about attitudes of -- there is a broad world out there and we need to be more collaborative and the word that Linnea used. 

COMMISSIONER GORDON:  George, anything else?

Wayne?

COMMISSIONER JONAS:  I just wanted to mention one thing that you may or may not be aware of just so -- you may want to contact them. 

The American Medical Student Association Humanistic Medicine Group is currently attempting to put together a month-long rotation based on a retreat series that they currently run for medical students around the country in which they bring in and teach and help students experience self-care, learn evidence-based skills and how they might be applied to traditional and complementary practices, cultural sensitivity in terms of how to manage that, patient management issues. 

And they are currently looking to do this as a third year type of rotation for a month, and then that would be followed up by, you know, other types of electives that might be taken such as your course or overseas courses or things like that.

You may want to contact with them.  There is a number of things missing with that.  I mean, it is pretty clear that other disciplines need to be brought in besides medical training or medical students.  However, since it is the American Medical Student Association trying to do this, that is what they are focused on.

But that -- just for your own information and I can tell you the individuals who are involved in trying to organize that if you are interested.

DR. MANAHAN:  Is that the one Polly Delavid is doing?

COMMISSIONER JONAS:  She is, yes.  Right.

DR. MANAHAN:  We are part of that.

COMMISSIONER JONAS:  Okay.  Good.

COMMISSIONER GORDON:  I had a question for you, Mary Johnson, and that is, is -- do you see -- is your program now currently functioning as the kind of model you have described and, if so, are you gathering some data on stress levels, job satisfaction, et cetera?

DR. JOHNSON:  That is a wonderful question.

Nursing curriculum are very, very variable throughout the nation and I think that a holistic framework is probably part of all nursing programs but how much they integrate CAM therapies is pretty individual.

I have been doing a survey on my nursing students.  I teach at St. Olaf College and Gustivas Adolfus College.  We have a Minnesota Intercollegiate Consortium.  And I have been collecting data for the last five years on students' perceptions of the integration of our holistic framework and they have, as Bill mentioned, have talked a lot about how this has expanded their perspective and helped them see what a benefit it is for clients. 

And then we do on a one year and five year, we ask about satisfaction with the program and this has come through as one of the high points of satisfaction from nurses. 

As far as employer satisfaction, we have very high ratings.  You know, it is hard to know how that compares to others but I think as this movement continues, this should be something that should be very much integrated into our evaluative process.

COMMISSIONER GORDON:  I think from our point of view, it will be useful to have any kind of data and obviously from our point of view if there is data that compares people who have been through this program with those who have not that would also be very helpful because, as I think Wayne was saying or perhaps it was Wayne who was saying earlier, one of us was saying earlier that we -- or George was as well that part of our task is to make recommendations for educational programs and the more data we have about what happens, even if you do not have it now -- I mean, as time goes on if that data can be accumulated it becomes very powerful.

DR. JOHNSON:  That is true.

COMMISSIONER GORDON:  And I think one of the things I want to say both in appreciation and as a reminder to all of you, it may feel like you are doing just one program but one program that has a really successful outcome and that then becomes a model can become very, very important nationally.  So I urge you to collect that kind of data, and from the people who go through your programs, and to do the follow-up data and to --

DR. JOHNSON:  And to write up the evidence.

COMMISSIONER GORDON:  And to write up the evidence.

DR. JOHNSON:  Okay.

COMMISSIONER GORDON:  Exactly.  Okay.

DR. JOHNSON:  I will try to do that.

COMMISSIONER GORDON:  All right. 

Thank you all very much.

(Applause.)

                                                                                    * * * * *

                                                                                 RESEARCH

COMMISSIONER GORDON:  Robert Patterson, please?

                                                                  ROBERT PATTERSON, PhD

                                   PROFESSOR, PHYSICAL MEDICINE AND REHABILITATION:

                                                               UNIVERSITY OF MINNESOTA

The belief of the practitioner and the patient may be very important for the success of the healing process.  Western medicines standard for scientific research studies, the randomized, placebo-controlled, double-blind study, limits or minimizes the influence of belief.  In most cases this requires telling the subject that he or she will be receiving the "real treatment" half the time or they have a 50-50 chance of getting the "real thing."  This creates doubt in the mind of the patient, which in turn may affect the healing process.

The recent NIH conference on the placebo presented many studies suggesting the real healing occurs from the placebo.  I believe most traditional Western scientific researchers think that the placebo only results in an imagined healing. 

As a result of this, I would like to present an example of the difficulty I encountered in trying to carry out a Qigong study on patients with torticollis treated in our clinic with botulinum toxin every three months to relax the neck muscles. 

In our study we wished to have a Qigong master apply a nontouching treatment approximately one week before the patient's scheduled visit for the botulinum toxin injection.  We had two very exact measures to measure the head position using electronic tracking system.  The second measure was the opportunity for the patient to cancel their scheduled botulinum toxin injection because they would not need it due to the relief given by the Qigong practitioner.

The IRB would not approve this study.  They required a sham control group.  I responded in a letter describing the need to respect the belief process.  I was rejected again after two appeals. 

The following is, in part, the written response I received:

"We are, however, concerned about the apparent legitimization of a therapy by an IRB approval of a study of the therapy, especially when the design of the study is flawed.  The combining of IRB approval and a likely positive outcome, even if the therapy is without effect..." that is kind of interesting if you think about it "...misleads both the current subject and the general public.  The latter through news reports, journal reports and word of mouth."  As an aside, there goes my academic freedom.  "Being misleading about the efficacy of the therapy is a risk." 

In my 21 years as a member myself of the IRB at the University of Minnesota, I have never heard this argument being made before about any other study. 

Just two months ago another similarly designed study by somebody else who is in this room was submitted to the IRB with the initial response being similar. 

Guidance on this issue for IRB panels is given in the Federal OPRR institutional review board guidebook.  Section 4-1 discusses this issue.  Suggestions for OPRR policies:

(1)  For minimal risk studies the IRB shall not require changes in the study design.

(2)  The only risk considered shall be the risk directly affecting the subject.

Thank you.

COMMISSIONER GORDON:  Thank you. 

Thanks for bringing this to our attention.  

Janice Post-White?

                                                       JANICE POST-WHITE, RN, PhD, FAAN

                                              ASSOCIATE PROFESSOR, SCHOOL OF NURSING

                                                               UNIVERSITY OF MINNESOTA

I am going to address the need for rigorous credible research in CAM both as a research professor at the university and the Integrative Medicine Program at Children's Hospital and Clinics so I am going to emphasize pediatric cancer.

There are a few studies documenting the safety and efficacy of CAM therapies, particularly in children.  The aim of evidence-based practice is to provide the best care based on the best available research.  Research on CAM is needed to determine efficacy, effectiveness of CAM in comparison to standard of care, the mechanism of action with a physiologic or theoretical model, as well as dosage, provider effectiveness, and cost.

Pediatrics must be included in the integrative medicine research agenda.  It is inaccurate to assume that studies in adult patients will be applicable to children. 

CAM intervention research, however, has unique characteristics that make standardization of the intervention more challenging, control of a patient's self-practice is difficult, and randomization is sometimes unethical.

CAM interventions are not generalizable.  What works for one individual often is not helpful for another.

Despite the scientific strength in randomization, the power of the intervention lies in matching that intervention with the strengths and beliefs of the individual. 

We need to be open to new models.  However, CAM intervention studies also need to test standardized interventions with consideration for the dose of the intervention, the intensity, frequency and the actual utilization.

Outcome measures need to be sensitive to that specific intervention and meaningful to cultural and ethnic groups. 

New methods of analysis will consider individual outcomes, not just group means. 

And qualitative analysis will better determine how CAM affects individuals as a whole. 

Funding is desperately needed for large scale powered efficacy and effectiveness studies and trained researchers to conduct them.

Ideally, efficacy studies precede effectiveness.  It will not matter if it is cost-effective if it does not make a difference.  It is the efficacy studies that I believe will create organizational policy and insurance changes. 

Meanwhile, establishing databases that document clinical outcomes and reflect risks and benefits as well as treatments and responses and costs will offer insight into use, trends and outcomes. 

I also propose that the integration of CAM intervention research within cooperative group clinical trials will ensure credibility, access, adequate sample sizes and efficiency in recruitment, data collection, follow-up and analysis. 

In the forthcoming grant renewal in Children's Oncology Group funded by the National Institute of Health the CAM subcommittee is designing group-wide protocols to test the effects of specific CAM interventions on outcomes in children with cancer.  This is a pioneering collaboration to determine which CAM therapies demonstrate efficacy and are compatible with conventional cancer treatment.

As a cancer CAM researcher and mother of an eight-year old survivor of leukemia, I can assure you it is the clinical trial mechanism that saved my son's life.  However, the effects of cancer do not end with the treatment.

Imagine the effect on clinical outcomes if we can identify CAM therapies that could reduce late effects and toxicities as well as improve function and resiliency.  We have more than double pediatric cancer survival since the 1970s.  Imagine where the science of CAM could be in the year 2030.  It is time to critically test some of our more promising CAM therapies.

COMMISSIONER GORDON:  Thank you, Janice.

Chris Hafner?

                                                            CHRIS HAFNER, BA, Dipl Ac LAc

                                            CLOUD RIVER TRADITIONAL CHINESE MEDICINE

It is my belief that the greatest benefit that complementary and alternative medicine has to offer us is in the opportunity to see ourselves from other perspectives.  In Chinese medicine it is said that nothing brings greater suffering than the stagnancy engendered by the attachment to a single point of view.  There is great wisdom in adopting another perspective when it is appropriate to do so and there is great advantage in having a collection of ready perspectives from which to draw.

CAM represents a diverse collection of perspectives on a wide range of human health issues, from the treatment of illness and the prevention of disease to the optimization of health and well-being.  This diversity of perspectives is the very definition of CAM and is its greatest value.  It is perspective that guides the CAM practitioner in making a diagnosis and forming an appropriate treatment strategy.  It is perspective that directs the safe and effective use of treatment modalities.  It is perspective that helps to shape, guide and provide focus for the healing intention.  It is perspective that is ultimately responsible for whatever benefits a system of medicine is capable of yielding. 

Yet, as important as perspective is in defining a paradigm, it is seldom acknowledged and CAM paradigms often remain unarticulated and poorly understood.  If we hope to create policy that will ensure the maximum benefit of CAM in an integrated system of health care, we must recognize where this benefit lies.  The benefit is in the perspective.  We must do everything we can to clearly define and understand CAM perspectives so we do not lose sight of them in the process of integration.  As we develop methods of research to determine safety and efficacy, we must do so in a way that maintains the integrity of CAM perspectives.

This will probably be very difficult to do using standard research models that tend to focus on mechanism.  If we are to determine the validity of any CAM perspective it is my opinion that we must do so not in terms of conventional medicine.  The validity of a perspective rests not in how well it agrees with our own, or whether we can even understand it in terms of our own, but whether or not it consistently leads to positive outcomes. 

Safety and efficacy of a given therapy are dependent upon its appropriate use.  Appropriate use, in turn, is determined by the guiding principles of the perspective.  We must encourage and support CAM research within the CAM community itself so that CAM perspectives can first demonstrate the validity of the guiding principles.      If guiding principles of a CAM perspective can be demonstrated to be internally consistent then it would be much easier to go on to demonstrate safety and efficacy without having to research the mechanism. 

In this way, we may be able to meet the standards set by our society for the safe and competent practice of health care without having to compromise the integrity of CAM perspectives.

Thank you.

COMMISSIONER GORDON:  Thank you. 

Mary Ellen Kinney?

                                                                  MARY ELLEN KINNEY, RN

                                          COORDINATOR OF COMPLEMENTARY THERAPIES

                                                   RESEARCH:  UNITED HOSPITAL (ALLINA)

I am working on a research study entitled "The Effects of Therapeutic Massage and Healing Touch on Cancer Patients."  Through this study, I have gained a great appreciation for the scientific process, and the subjective comments from scores of our research subjects support its value in their lives.

In fact, one woman could not wait to tell me her story when after receiving healing touch, she rapped on my door and burst into my office saying, "Look at me.  Look at me.  Today is the day in my chemo cycle when I am always admitted to the hospital but that is not what it is about.  It is not about the diarrhea or the nausea or the vomiting or the mouth sores.  Can you see it?  I a living for the first time since I was diagnosed.  It is my spirit, Mary Ellen.  My spirit.  Look at me."            She spread her arms and twirled in front of me.

In addition to recognizing and appreciating her obvious vitality, my thought was, "What am I witnessing here?  And just how do we measure that?"  How do we measure the ineffable using the construct of our current scientific methodology? 

The goals and philosophy of CAM include wholeness, wellness and healing.  These are inherently expansive concepts that lead to questions of consciousness, interconnectedness, transcendence, healing and spirituality. 

If we ask the questions that CAM prompts, then a methodology that supports the research to find the answers is required.  The current methodology of the randomized double-blind study is serving us well in some arenas but it is based on a reductionist model and reductionism and holism do not resonate.

When we look at the woman in my office, the results we obtain from a randomized controlled trial may be valid but they are certainly incomplete.  We can measure her episodes of diarrhea and vomiting, the number of antiemetics and pain medications she uses, and measure her endorphin, T cell and cortisol levels. 

We can measure length of inpatient stay and even quality of life but if we listen carefully to what she told us, we still have missed measurement of what she identifies as the underlying key to her experience, her spirit.

This calls for advancement to another level of reliability and validity in research methodology.

We are already practicing and benefiting from an integrative medicine and our healing practices have moved beyond what can currently be measured in a reductionist manner.

Science must evolve along with medicine to continue answering the questions and assuring safety and effectiveness for the people seeking wholeness. 

I have great hope and confidence science will answer the call.

COMMISSIONER GORDON:  Thank you. 

Milton Seifert?  Is it Seifert or Seifert?

COMMISSIONER GORDON:  Seifert.

                                                                      MILTON SEIFERT, MD

                                                                           EAGLE MEDICAL

DR. SEIFERT:  I am a mainstream family physician in general practice, in the town in which I was raised.  My office and high school and ancestral home are within a 50 yard radius.  In one sense, I am a domain expert on localness, specifically the localness of Peter Senge.

The town is Excelsior and means "ever upward."  It is the title of my testimony and it is an image for a bottom-up system change.

I have two other images on the table before me.

When the work of this White House Commission is completed, I assume it will have created a set of policies that address care, education, outcomes research, organization, systems and governance.  These policies will need to be integrated and cohesive and definitely not at cross purposes.

Guidelines for the research and development of each policy will be chosen and I would like to suggest some options, mostly based on a bottom-up approach.

For organizations and systems, the 4C2A formula means comprehensive and continuing, coordinated and customized, accessible and accountable. 

For care and education, the emphasis would be on partnerships where the partners have equal power.  Also, there will be a replication of the 4C2A formula.

For outcomes research, a health status assessment that measures and treats both health and disease with equal intensity.  Policy would direct that this be a part of daily care and this would produce evidence for the base.

For governance, the intentional logic of Harvey Wheeler where a system of rewards largely replaces regulation and punitive methods while it produces higher performance and greater patient safety.  It would give concepts like the 4C2A formula the force of law. 

But there need to be some priorities and the main priority would be for a partnership. 

A project supported by the NIH, SBIR grant asked patients how they got well and they said, "We got better because you and your staff listened and cared; this allowed us to put in trust and become a partner in the relationship; this led to willingness to change and we changed our lifestyles in our life." 

A recent review of the literature on informed consent showed that both mainstream medicine and complementary medicine are saying the same thing, that you have to have an intimate relationship with the patient before they can choose what you are offering. 

I have an image of the top down approach.  You can have it that way with the top down but it takes an awful lot of support and eventually the support will not be enough and it will fall down. 

(Laughter.)

COMMISSIONER GORDON:  Okay.  Thank you.

(Applause.)

COMMISSIONER GORDON:  Frank Wiewel?

                                                                   FRANK DENNIS WIEWEL

                                                                 PEOPLE AGAINST CANCER

Cancer:  You hear about it.  You read about it and you see it on TV but there is one thing you never hear.  You never hear the truth about cancer. 

You are never told the truth about cancer incidence.  In 1960 it was one in four; today it is one in two.  This year 1,500,000 American citizens will get cancer. 

Despite these horrifying facts, the cancer establishment claims progress against cancer.  You are never told the truth about cancer incidence.

You are never told the truth about cancer death rates.  Death from caner is on the rise.  This year over 750,000 American citizens will die, notwithstanding the best conventional treatment.  You are never told the truth about cancer death.

You are never told the truth about cancer diagnosis.  The public is told that the earlier the diagnosis the better the chance of a cure.  It is a lie.  Through the use of scare tactics, many forms of cancer are now being diagnosed at a much earlier stage producing a "statistical cure" but no real survival advantage.  Radiation from mammograms and x-rays is a major cause of cancer.  In the Canadian Breast Cancer Study, routine yearly mammograms for those ages 40 to 50, as recommended by our National Cancer Institute, produced a 52 percent increase in the rate of cancer.  You are never told the truth about cancer diagnosis.

You are never told the truth about what causes cancer.  Recently the FDA found 60 to 80 pesticides in the average American food basket.  They did not tell the public and they did not do a thing about it. 

You are never told the truth about how you can prevent cancer.  We can lower our risk by eliminating carcinogens in the food, the air, the water and the environment.  There is also good scientific evidence that we can significantly lower the risk of cancer with exercise, dietary changes, nutritional supplements and stress reduction.

You are never told the truth about conventional cancer therapy.  For decades the cancer establishment has relied upon the crude and primitive treatments of surgery, radiotherapy and chemotherapy as their only weapons.  These therapies are dangerous, toxic, ineffective and highly profitable.  There is an ongoing and deliberate sophisticated hoax being perpetrated on people with cancer.

You are never told the truth about what innovative cancer therapies can do.  There are promising new methods of treating cancer that are safe, effective and cost effective. 

Amazing discoveries about the power of nutrients to prevent and treat cancer are made every day.  Nutritherapy is the use of nutrients in therapeutic doses to resolve disease.

Nutritherapy is the future of medicine.  Chemotherapy and radiotherapy are the past.  However, nutritherapy will never be approved under the current FDA medical monopoly scheme.

The White House Council on Alternative Medicine has the opportunity to tell the truth and demand reforms of the current system.  The Commission has the opportunity to bring together physicians and researchers and people with cancer to discuss new directions in the war on cancer and research new strategies for cancer prevention through the use of the mind, body, diet, nutrition, detoxification and through the high tech biologicals.

What needs to be done?  For people with cancer, we need to tell the truth.  We need to conduct good scientific research and tell people there are innovative and alternative therapies which are safe, effective and cost effective.  We need to tell people that you can do more for yourself than any doctor. 

We need to dismantle the FDA and the National Cancer Institute.  They cannot be reformed.  We need to reestablish all of the National Cancer Advisory Boards and Citizen Chairman Advisory Boards.  These boards should be controlled by people with cancer, not physicians and cancer researchers with a vested interest.

Thank you.

COMMISSIONER GORDON:  Thank you.

(Applause.)

                                                                               DISCUSSION

COMMISSIONER GORDON:  Questions?  We will begin at this end with George.

COMMISSIONER DeVRIES:  Pass. 

COMMISSIONER GORDON:  Okay.  Wayne? 

COMMISSIONER JONAS:  Let's see.  Where do I start?

(Laughter.)

COMMISSIONER JONAS:  One of the recurring issues is, in fact, who sets priorities in terms of research and research design.  It is frequently mentioned that we need to establish efficacy before effectiveness and there is a whole hierarchy, et cetera, et cetera.  And I guess one of the questions I have is how -- and then, you know, when this established -- when this gets established and people begin to say, "Well, I really want to test a theory as opposed to the outcome," which I think Professor Patterson was -- what they were saying, you need to be blind to not just look at what happens.  And this is an ongoing debate, which I do not think we have resolved at this point in terms of research.

I am wondering if you have some suggestions as to how to approach this again focusing on research.  You mentioned a grounded theory, a multi-modular approach.  Now that is not what is currently taken actually at the NIH.  In fact, there is an explicit policy to test efficacy first and establish that and then if that looks promising then to move on to other types of things.  And it is not that any particular research design is abandoned, it is just that things are expected to be followed in a certain order.

And I guess I heard this mostly from you, is that this seemed to be a reasonable order and yet there were a lot of caveats in your description there, and I am wondering if you could comment.  Should we change this hierarchy in some way?  Should there be an alteration of research structures and how would we bring the patients, if that is what is recommended, into more of a control position, if you will, in the area of research prioritization, design and execution?

I mean, is there a way that patients can actually be brought into that, including brought into some of the hierarchical structures that the government has like the NCI and the FDA?

COMMISSIONER GORDON:  That is a question.

(Laughter.)

DR. POST-WHITE:  When I said that "efficacy should precede effectiveness" from a scientific model, I believe that but I do not think in any one of them that we should follow Phase I, Phase II, Phase III with exclusion of grounded theory, research, qualitative methodology, capturing the spirit in Mary Ellen's study.  Those things, I believe, need to be occurring simultaneously. 

It is not that we cannot be collecting outcomes and effectiveness of interventions in comparison to standard care at the same time that we are testing mechanisms of action and actual efficacy of the interventions but I think in order to eventually get funding that we need to be able to prove that long-term these interventions make a difference.  We need the efficacy studies.  We cannot just ignore the efficacy studies, I guess, is what I was trying to say. 

And I do believe that we need to bring consumers into this model because with any research design that you do you have issues of randomization, recruitment, retention.  Those issues are magnified in CAM research.  They are very unique in complementary and alternative medicine partly because of the commitment we are asking of the patients and the expectations that we have for them and the change that we are requesting of them.  They need to be full participants in that model of care as well as documenting research outcomes so I would support that at any level.

COMMISSIONER JONAS:  I guess I am -- go ahead.  I am wondering how to do this.  I mean, how do you bring -- right now we put consumers on advisory panels.  Okay.  That does not work.   There is some -- I am looking for suggestions as to how consumers can be more integrally -- be more integrally brought into the process and if there are models of how that has occurred successfully.

DR. __________:  The grounded theory approach in the real world is a group of consumers talking about the use of Dove soap or Buick automobiles.  We have -- I have two examples from our own practice.  Our patient council met and they looked at the SF36 and eventually determined that there was no measure of spiritual health.  We also asked them to help us develop a language of negotiation so that we could better do the relationship work and when it was all done we no longer had hypochondriacs or neurotics or schizophrenics or psychopaths.

COMMISSIONER JONAS:  So, in other words, the consumer group said this particular measure is not capturing what we are -- what is important to us?

DR. __________:  And they re-languaged the medical language in a way that they could help themselves more.  So there is no reason why medical practice cannot be a laboratory practice when you bring together care and research and education.  The multi-method research of Crabtree and Miller is in a book called Collaborative Care that came out of an NIH conference and at that conference there were a group of patients, a patient advisory council that advised the conference. 

COMMISSIONER JONAS:  Thank you.

COMMISSIONER GORDON:  Frank, did you want to say something?

MR. WIEWEL:  Yes.  One recent example of this was that we held a conference in the United States Capitol with the head of the National Cancer Institute, the head of the Food and Drug Administration, the head of the National Institute of Health and the head of the Office of Technology Assessment, and I addressed this group and I said, "We are having a problem here and that is that the people want to know why we are not living longer and feeling better in the treatment of cancer." 

Well, the rules were changed somewhere along the line.  About 80 percent of the people did not live longer or feel better using the current treatment methods.  We changed the standard by which we measured.  We are now measuring tumor response so the tumor gets smaller and the patient dies.  We claim success but the people want to live longer and feel better and they were left out of that dialogue.  And the National Cancer Advisory Board is essentially researchers and doctors who are giving money to each other.  The system is corrupt.  It cannot be reformed. 

You need to put all citizens on who are treating people with cancer, the people with cancer are the ones who will tell you "I want to know if we can live longer.  I want to know if I will feel better."  Those are the two questions every physician is asked.  "Will I live longer?  Will I feel better?"

The size of the tumor is unimportant.  It means nothing.  It is the standard by which we judge in these advisory boards and the National Cancer Advisory Board by the National Cancer Institute and clinical trials.  So I think you have to do the ground-up.  You have to do it with the people.  What do the people want?

COMMISSIONER GORDON:  Okay. 

Joe, do you have a question?

COMMISSIONER PIZZORNO:  This is for Frank Wiewel.

You made several pretty strong assertions in your presentation today but when I looked at it I did not see any references.  Do you have any research to back up the numbers that you are -- you have in the statement?

DR. WIEWEL:  Yes, they are all real.

COMMISSIONER PIZZORNO:  So where would I find those numbers?

DR. WIEWEL:  I will be happy to send them to you. 

COMMISSIONER PIZZORNO:  Good.  I would like to see them.

DR. WIEWEL:  They are surprising and I think that is why people ask for that but they are all sound, solid, scientific assertions.

COMMISSIONER PIZZORNO:  Then they should be in the paper because it would be easier for people to follow up on what you are saying.

DR. WIEWEL:  I will be happy to send them to you.

COMMISSIONER PIZZORNO:  I think those of you involved in cancer research, a lot has gone in terms of quality of life and survival in conventional cancer research in the number of -- in the last several years.  In fact, there are often now primary outcomes in studies also so I do not think it has been completely ignored.  In fact, it is an integral part.  I do not know if you want to comment on that. 

DR. POST-WHITE:  Except that was top down.  Quality of life was added because cooperative groups were mandated to add the quality of life estimate measure to their outcomes and what is wrong with that is that the quality of life instrument does not capture the real quality of life of the patients and the families.  We need more sensitive instruments.  That is a start.  It is a great start but we need to find out from the consumers or from other people what goes on in your life when you have cancer, what measures do you think would capture this, what should we be looking for.  I think we need more than quality of life and we need something more specific if you look at all the quality of life instrumentation in terms of the sensitivity and specificity.  It is not there.

COMMISSIONER GORDON:  Let me make a request that sort of goes along with some of the questions being asked.  If -- Janice, this was occasioned by what you were just saying.  If you have suggestions and concrete proposals, for example for better quality of life measures or for better guidelines -- Dr. Patterson, you gave us a couple of suggestions -- but really organized sort of programs for better IRB guidelines, better quality of life measures, those are the kinds of things that we may be able to propose because they are really -- in a sense they may be difficult because there may be resistance.

In another sense they may not be so difficult because I think people are looking -- we are really looking to see a way to have guidelines that are more reflective of what the actual situation is, what the actual needs are, whether they are the needs of patients or the needs of researchers trying to look into this field so we would really appreciate that kind of guidance from you.

Yes?

COMMISSIONER JONAS:  Yes, I would just add to that because we have discussed these issues actually in our first research forum.  I am sure we will discuss them at the next one also.  It would be very nice if we had some examples to go along with those and specifically I do not mean just grounded theory and multi-modal research.  I am familiar with the research of Crabtree and Miller and those groups. 

But an example of how the public has been brought into the entire process of research from square one to the end, from putting together and thinking about how to design what measurements to occur, the approval process in terms of the IRB, et cetera, as well as the data collection and analysis and the interpretation aspect, which is also an end product of that.

And if there was a way or a model of where this has actually occurred throughout the entire research cycle, this I think would be useful for us to look at because I do not know of any place where that has actually occurred.

COMMISSIONER GORDON:  I would just add that even if it has not occurred, it would be great if it has, if it has not occurred, perhaps we are in a position, if not to make it happen, at least to significantly raise the visibility of these kinds of models so we would ask you for that.

DR. POST-WHITE:  And that is what I think I was proposing with the Children's Oncology Group Cooperative Model is that what we are proposing is R01 initiated research that would become a clinical trial model.  We are working with the CAM subcommittee and the end-of-life subcommittee to determine what those outcome measures from the consumer, from their clinical practice, what would be relevant to them and then how can we as a cooperative group add a spirituality assessment or a qualitative analysis piece or some sort of methodology that expands the quality of life.

COMMISSIONER GORDON:  Great.  Janice, I would appreciate it if you would send it to us.  Also send it to the Cancer Advisory Panel at NIH, CAPCAM and send -- copy me on that as well.

And I want to give Linnea a little chance, Wayne.

COMMISSIONER JONAS:  I just want to ask Dr. Patterson -- I am sorry.

COMMISSIONER GORDON:  Okay.

COMMISSIONER JONAS:  Were any of the patients asked what type of design they wanted in your torticollis study, whether they would prefer to be in a study that looked at standard therapy with additional energy or Qigong or sham?  Was that ever brought into the discussion?  In other words, the population you were going to do the research with, were they ever surveyed or a focus group done asking what kind of a design would they like?  Would they like a sham arm in that in order to get that kind of information or would they like just a standard care arm?

DR. PATTERSON:  No. 

COMMISSIONER JONAS:  I am just wondering what you think they would prefer.  Do you have a hunch?

DR. PATTERSON:  It is always, you know, a problem, you know, actually going to people and talking about research that is not approved.  That is sort of a touchy area.  I mean, you could.

COMMISSIONER JONAS:  You can bring individuals in a focus group who may or may not participate in a study just to get an idea of what -- you know, what is the preference in terms of design.

DR. PATTERSON:  Yes, that would be good but I might add that the point I was trying to make and I have served on the IRB a long time, this has come up, it has just come up again, is that there is a real bias against this stuff and they want to dictate the design and you saw -- maybe I went quick -- is that most of the stuff does not have any real risk in any reasonable way. 

So when I addressed to the committee chairman on my study what the risk was, it is me speaking about the results.  You know, I am tenured with academic freedom and now they tell me that they are going to stop me from talking right at the head and it has happened again.  It is not a rare thing and basically they do not want this to go on.

COMMISSIONER GORDON:  So where does this sit now, the issue?  Is it --

DR. PATTERSON:  The study had to be modified after the many appeals and the current one that I referred to that I -- it was ironic on the current study that is under consideration now by the IRB, which I was on the panel and I was actually representing the study, has not been approved yet. 

COMMISSIONER GORDON:  It has not been approved.  Would you keep us posted?  Seriously, I think this whole -- it is a very important example for us to take a look at. 

DR. PATTERSON:  When I said that, there is a potential approval with stipulations but they want to change the design.

COMMISSIONER GORDON:  I understand.  You mean eliminate the Qigong?

DR. PATTERSON:  Oh, no.

(Laughter.)

DR. PATTERSON:  In the current study that is open right now. 

COMMISSIONER GORDON:  Yes?

DR. __________:  We have a long running patient advisory council.  It goes back to 1972.  And as a general practitioner I can understand research design if I am a part of that team designing the research and so can the patients.  And it was the inter-study that brought the SF36 to that council meeting and it was there that they said, "So where is your spiritual health?"

The same idea of patient advisory council could serve the work site very well, too, because there are a lot of issues not only about insurance but about health status of the work site that would benefit productivity and the bottom line for industry. 

So those are two places where the patients could have a major say so in directing policy and research design and their own care. 

COMMISSIONER GORDON:  Great. 

Linnea, you had -- no? 

Any more questions?

COMMISSIONER JONAS:  And I think one thing that was implied or actually stated was stratification by risk also was important.

Something that is extremely low risk or it is being used for something in which if the alternative was not used, it would not create undue risk for the patient is a different situation than something often in oncology where there may be high risk consequences to not going forward with a particular therapy or providing standard of care. 

So again those are --

COMMISSIONER GORDON:  Wayne, I am wondering if when we do the next research panel if we could not focus on this whole issue.

COMMISSIONER JONAS:  I think we should.  I mean, you know, the whole issue of efficacy versus effectiveness, theory versus patient involvement in risk is important.

COMMISSIONER GORDON:  Yes.

COMMISSIONER JONAS:  It can be very sticky.  I mean putting back patients to bed, for example, seems like a very low risk strategy but when they actually tested it in a controlled trial it did damage to them.  They were worse, the ones who went to bed than the ones who had free rein.  So it is not always easy to tell up front what is risky and what is not. 

COMMISSIONER GORDON:  Thank you.  Thank you very much for a very stimulating discussion.

We are going to take a break for lunch.  We will return and begin promptly at 1:30.

(Whereupon, a luncheon break was taken.)

                                                                                    * * * * *

                                                              A F T E R N O O N   S E S S I O N

                                                CULTURALLY-BASED HEALING TRADITIONS

MS. CHANG:  Welcome back.  We have got all the commissioners back from lunch and we would like to call up the next panel. 

Okay.  You will have to forgive me if I mispronounce your name.  Okokon Udo, Michele Strachan, Thupten Dadak, Master Chunyi Lin, Jose Reyes, and Sabina Pello.

COMMISSIONER GORDON:  Are we all back from lunch?  Okay.  Great.

All right.  We will begin the afternoon panel. 

Okokon Udo?  Is that right?

COMMISSIONER GORDON:  Okay.  You are first. 

                                                                  OKOKON UDO, DIRECTOR

                                                    CENTER FOR CROSS-CULTURAL HEALTH

MR. UDO:  I have submitted my testimony and I will be reading the introduction and the conclusion.  In my introduction, which seeks to highlight something of the cultural beliefs and practices of different sections of our communities comes a lot of stories and I will read a quick story here about the Yoruba of Nigeria.

Among the Yoruba, a traditional healing ceremony takes place in a special center adjacent to the healer's own house and may last for days or weeks.  When the healer deems the patient fit to return to normal society, an elaborate discharge ceremony is performed.  The rituals are done at a river in a deserted place.

The patient takes off her old clothes and puts on a new white dress.  Nest her head is shaved and some small cuts are made in her scalp.  The healer, her assistant, and the patient wade into the stream waist deep.  The healer then takes one of three doves to be used in the ceremony and uses it as a kind of sponge, wetting it and rubbing it over the patient's body, drawing out her illness, transferring it to the dove.  The dove is then drowned and its body thrown downstream along with the patient's disease, which has been absorbed.

The second dove is then killed and its blood smeared over the patient's head and upper body.  The vitality and calmness of the dove is thus transferred to the patient.  The patient is washed and her bloodstained dress thrown downstream with the body of the second dove. 

Back on shore the patient is rubbed with medicines and another dove is killed and its blood splashed over her body and then washed off.  The patient then stands on the body of the dove and an incantation is invoked.  The body of the last dove is then thrown downstream with the declaration that the dead bird carries the patient's sickness with it and that just as water never flows upstream, so the patient's sickness will never return.

The story is illustrative of the kinds of forms of healing that are being practiced in our community, which is changing very rapidly.

And in concluding my testimony I want to draw attention to a quote from a physician by the name of Deborah Prothow-Stith and in a rather related way make the application to the story I have just shared.

And she says, "One way or the other the children among us are going to get our time, and our attention, and our money, and our resources, and it is only through public policy that we determine that."  And I think it is going to be only through public policy that we determine when we spend the money that will help bring about healing for the different sectors of our community.

Thank you.