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*** White House Commission on Complementary and Alternative Medicine Policy ***
*** Meeting Transcript: Washington, D.C  10/06/00  Afternoon    session     ***
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 A F T E R N O O N  S E S S I O N
 [2:05 p.m.]
 DR. GORDON:  We will begin.  Public comment will
work the same way it did yesterday, which is where each of
you 3 minutes, and then there will be a time to interact
with the Commission after each talk.
 The reason we do this, as I explained yesterday,
is because unlike other panels, each of you is speaking on a
topic that may or may not have much relation to the others.
 We want to have an opportunity to interact with each of you
in turn.
 So let's begin with Rick Levy.
 Public Comment (Open Session)
 DR. LEVY:  I am Rick Levy, a clinical psychologist
in private practice.  Since 1966, I have been involved in
psychospiritual healing approaches as well as mind-body
treatment.  During the last 20 years, I guess, much of my
work is focused on developing the use deep hypnotic states,
plus energy-healing methods in treatment of catastrophic and
chronic illness.
 While being supportive of the wide range of CAM
interventions, I wish, today, to argue especially for a
focused inclusion of mind-body-spirit practices in the
Commission's thinking.  There is tremendous in various CAM
approaches, however I must argue that the role of mind and
spirit in the healing process probably still is being vastly
underestimated.
 In the near future, I will submit a relevant
research literature review to the Commission which focuses
on the mind-body-spirit interventions, but please let us
properly value and promote the scientifically based role of
mind and spirit in healing physical as well as psychological
illness.
 Now, I am talking about such interventions,
innovative methodologies like energy healing, oracle
meditation, regression, psychotherapy, relaxation
procedures, a wide range of alternative hypnotic procedures,
but also these mind-body-spirit procedures can include more
traditional mental health treatments which are applied to
new areas.
 Examples include using traditional hypnosis,
behavior modification, cognitive therapy, reprogramming
techniques, and psychodynamic psychotherapy to impact on
catastrophic illness such as cancer, and not simply to
assist in patient adjustment to coping with such illness.
 Currently, there are far too few properly trained
and credentialed CAM practitioners using such methodologies.
 I propose that this commission contact the relevant
professional societies to begin ongoing formal dialogue to
develop recommendations on how to operationalize the
entrance of CAM interventions into the traditional health
care communities.
 This is a most important recommendation and lies
at the heart of my testimony.  I represent, as an
individual, the scientifically informed practitioner
community, rather than the research community.  Of course, I
strongly support ongoing research, however now is the time
to directly bring to the public scientifically based CAM
interventions.
 People are suffering and even dying every day due
to being denied access to CAM.  In my clinical practice I
witness their plight each and every day, and it is
heartbreaking.  We must do a better job of making available
CAM procedures here and now to those people who need our
skills.
 This is why I strongly encourage this commission
to not only emphasize research but to also emphasize
development activities which promote CAM to those in need.
Here, I am only reinforcing what is part of the stated
mission of this commission.
 Specifically, I request that this commission begin
formal discussion to develop recommendations to this end
with the professional societies representing the relevant
traditional and alternative practitioners.  I, for one,
intend to be taking an active role in bringing a focus on
CAM interventions within the American Psychological
Association.  Thank you.
 DR. GORDON:  Thank you very much, Rick.
 Any questions?  Joe.
 DR. FINS:  Could you help me understand better the
boundary lines between conventional psychotherapy counseling
issues that a psychologist or psychiatrist might do, and
when does it veer into CAM, definitionally?
 DR. LEVY:  Sure, at least as I see it.  First of
all, I think that there are innovative methodologies that
simply are gradually coming into the mainstream, and that is
really what I was specialized in during my career, helping
promote them in.  But then you have got other methodologies
which are well established.  I use a lot of cognitive
therapy reprogramming methods in subconscious mind work,
treating people with cancer, for example.  I am getting a
lot of people going into remission with these combined with
deep hypnotic states and the energy-healing work.
 Now, when you have got cognitive therapy or some
of the behavior modification -- I will use systematic
desensitization work as part of a traditional hypnotherapy,
for example -- those aspects of it really are traditional
methodologies, but they have usually not been used to
directly impact on the disease process itself.  Yet,
combined with other methodologies, what I have observed is,
they are very helpful.  That is, I think, the boundary.
 DR. GORDON:  Any other questions?
 [No response.]
 DR. GORDON:  Thank you very much, Rick.  I
particularly appreciate your drawing our attention to
working with the professional societies.  I think that is a
really, really important aspect.
 DR. LEVY:  I come from a research background.  I
am the son of a famous cancer research scientist.  I grew up
in the NIH research community.  So I have all my sympathies
in that direction, but I am a clinician and I would like to
see this stuff get operationalized.  I am tired of being one
of the few people out there in my community.
 DR. GORDON:  Great.  Hopefully, you won't continue
to be.
 DR. LEVY:  Yes.  I do want to say this is the
first time I am addressing a body like this.  I used to do a
lot of legislative work in past years, and I hope to be
doing more of this.  I hope I am someone that you will see
around a little bit.
 DR. GORDON:  Thank you very much.
 Ingrid Lucis [ph].
 MS. LUCIS:  Good afternoon.  My name is Ingrid
Lucis, and I am the director of Government Relations for the
American Chiropractic Association.  Due to a scheduling
conflict, Dr. Bruce Nordstrom who was scheduled to be here
today couldn't make it, so I will be expressing the
Association's views.
 There is no question that as the public demand for
complementary and alternative care increases, research must
continue to ensure that safe and effective CAM services are
made available.  Therefore, the Commission, in its formal
recommendations, must encourage Congress to continue and
increase funding for the National Institutes of Health
Center for Complementary and Alternative Medicine.
 While investigating the best approach to expand
and integrate and coordinate research, the Commission is
reminded not to reinvent the wheel.  As you have heard,
currently there are many successful research programs being
conducted throughout the United States.  The Commission
should continue to query these programs as to what works and
what type of incentives they need to continue and facilitate
additional research into CAM practices.
 In gaining insight into the types of research
currently being conducted, the Commission may also wish to
contact professional organizations representing
complementary and alternative providers.  These
organizations are able to provide the Commission with
research organizations that are actively engaged in research
in CAM practices.
 On the chiropractic research issues, the ACA urges
the Commission to remain in contact with two of your
panelists, Dr. Rossner from the Foundation of Chiropractic
Education and Research, and Dr. Meeker from the Palmer
Center of Chiropractic Research.  As you heard yesterday,
both of these doctors are excellent resources in
chiropractic research.
 In encouraging research, the Commission should
also make formal recommendations to Congress to change
regulatory guidelines that restrict and deny reimbursement
for complementary and alternative health care in all
federally funded programs.  For example, the Health Care
Financing Administration announced a proposed national
coverage decision regarding Medicare coverage of clinical
trials and coverage of routine costs.
 The Commission should encourage Congress to
instruct HCFA to also provide reimbursement for
complementary and alternative practices in these clinical
trials.  However, in providing for clinical trials with CAM
procedures, HCFA as well as other researchers should
recognize the need for balance between clinical trials,
collaborative efforts, and case studies.  The acceptable
double-blind approach to research, although appropriate for
traditional allopathic research, is not appropriate for CAM
procedures.
 The ACA is encouraged by the agenda put forth by
the Commission and looks forward to working with you on your
formal recommendations.  Thank you.
 DR. GORDON:  Thank you very much.
 Are there questions from Commission members?
 DR. JONAS:  I just wanted to clarify a bit the
last statement about traditional double-blind procedures not
being appropriate for CAM practices.
 Is that an official belief of the American
Chiropractic Association?
 MS. LUCIS:  If I could ask Dr. Rossner to explain
that, please.  We were working with the Federation on this.
 DR. ROSSNER:  I guess, just continuing from our
remarks of yesterday, to temper the interpretation of
randomized clinical trials with a touch of realism, not to
abandon it as invalid.
 DR. JONAS:  What I heard is that it is
inappropriate for CAM therapy, so perhaps the language was
not exactly correct.
 DR. GORDON:  Thank you.
 Anything else?
 [No response.]
 DR. GORDON:  Thank you very much.
 Next, is Diana Chambers.
 MS. CHAMBERS:  Good afternoon.  Thank you for your
time.  I am Diana Chambers.  I am the president of a new
501(c)(3) organization called Friends of Health.  We are
committed to fostering the art and science of integrative
medicine, to addressing the whole person, body, mind, and
spirit, and to advancing the overall cause of integrated
medicine.
 Friends of Health does not speak for, practice, or
elaborate any individual modality, but we have enlisted the
collaboration of many of the major distinguished figures in
the field as members of our advisory board.
 Instead, Friends of Health seeks to create a new
attitude of cooperation and coordination among the
complementary and alternative practices themselves, and
between them all, and allopathic medicine.  Friends of
Health also plans to partner with a different constituency
in specific ways to advance the movement toward integrative
medicine.
 In response to some of the comments made yesterday
and today, given the breadth of representation of the
Friends of Health Advisory Board, we will seek, as suggested
by Dr. Claude Lenfant, to bring people from the diverse
alternative and complementary practices together to express
their views and to have a public voice, all the while
recognizing that members of the allopathic community must be
included in the gathering.
 Also, yesterday and today, we heard several
references to the inadequacy of the language we are
currently using and the frustration that this engenders in
us.  Friends of Health has begun a conversation on the
language and philosophy of healing, including
representatives from across the integrative healing
community as a service to the whole.
 One of the areas we are looking at is the role of
poetry, drama, and metaphor in communicating about ideas and
practices that may be novel in society, rather than assuming
that our usual approach can readily communicate the new.
 So I would like to share with you a poem by Edwin
Markham that touches on one of the core issues underlying
the work of this commission:
 "They drew a circle that shut me out;
 Rebel, heretic, thing to flout.
 Love and I had the wit to win.
 We drew a circle that took them in."
 Friends of Health is committed to drawing a circle
that takes in all the members of the healing community, and
it has been wonderful to hear that tone in the Commission.
 With regard to the specific focus of this meeting
on CAM research, Friends of Health is unique in having
established the services of a scientific advisory committee
to provide a continuing bridge to conventional science.  We
are fortunate in having been able to secure on this
committee the active participation of eight scientists and
physicians of the first rank.  Each holds impeccable world-
class credentials in their own field, and in addition,
brings a depth of reading, writing, and background in the
relation of modern science to alternative healing practices.
 I have several comments on your three questions
that you addressed to us, but as I am short of time, I will
do the last one only: How can we effectively integrate the
CAM and conventional research communities to stimulate and
coordinate research?
 This integration cannot be a shotgun marriage,
with reluctant conventional researchers brought into
participation merely by the promise of money.  As a lecturer
on this topic of integration, our chairperson, Professor
Rustin Roy, lectures on this topic at a major university's
college of medicine course, and it is clear to him that this
will be a stepwise process.
 First, it would be unproductive to attempt to
integrate conventional researchers hostile to the data and
the paradigm of alternatives.  Hence, documentary evidence
should be required from conventional practitioners of their
reading and writing and understanding of alternative
medicine.
 Short courses such as those from the University of
Arizona and other sources should be made easily accessible
to all potential collaborators.  In all such coordinated
research, it is absolutely essential that reviewers be
knowledgeable on both sides of the aisle.  Review of
alternative practices by persons ignorant of the theory and
practice of the modality being reviewed should be avoided at
all costs.
 Having said this specific comment, I would like to
close with a quote from Max Planck who said, "Science cannot
solve the ultimate mystery of nature.  In the last analysis,
we ourselves are part of the mystery we are trying to
solve."
 Thank you.
 DR. GORDON:  Thank you.  Thank you for the
reminder.
 Questions anyone?  Yes, Charlotte.
 MS. KERR:  I would just like to use my time and
ask you to speak to No. 1, the question you couldn't get in
your time.
 MS. CHAMBERS:  Okay.  The first question: What can
be done to expand the current research environment so that
practices and interventions that lie outside conventional
science are adequately and appropriately addressed?
 We feel this is of utmost importance.  It requires
a considerable reeducation of the communities of
conventional science and derivatively science-based
medicine.  Professor Roy, our chair, has learned in the 30
years of science and technology and society work that he has
done on the campuses, from Cornell, Penn State, MIT, to
Stanford, that only a very small percentage of our
practicing scientists are aware of the history, philosophy,
and social relations of science.
 We have seen some success by having presentations
by highly respected and distinguished scientists showing
data observed in alternative healing practices and
presenting the case for the scientific plausibility of the
same.
 We explicitly propose that exposure of the
medicine faculties of major universities to the views of
scientists familiar with both alternative medicine ideas and
data as well as fundamental science be strongly encouraged.
 This will require only a search for well-qualified bridge
builders and a small organizational effort.
 Another easily accomplished approach is to provide
modest funds to support well-designed national conferences
to cover the same ground.  For example, Friends of Health
recently cosponsored a conference at Penn State that focused
more narrowly on one modality of Qigong.
 Thank you.
 DR. GORDON:  Thank you.
 Joe?
 DR. FINS:  I just want to endorse your comment
about the arts and the power of -- and its translation into
an artistic forum, and just say that the play "Wit, the
Pulitzer Prize-winning play, has done a lot to give people
an opportunity to voice their frustration with conventional
practitioners.  I think, if we were to have a second phase
of "Wit," it would be when they went to the alternative
practitioner for assistance because they didn't find comfort
in the mainstream.
 But I was wondering, specifically, whether or not,
in your view, one of our funding priorities might be to
fund, maybe through NEH or something, the National Endowment
for the Humanities, funding for these kinds of activities.
Would that be something that your organization would
endorse?
 MS. CHAMBERS:  I think that would be terrific.  I
think that working with the language issue, we heard from
several people, how frustrating it has been and how we need
to find some language that is multilingual but which can
represent this movement toward integrated medicine.  I think
it would be great.
 DR. GORDON:  Bill?
 DR. FAIR:  Well, since we are waxing poetic, and
especially Edwin Markham, another poem comes to mind that
more or less points out the opportunity of this committee,
and that is:
 "For all your days prepare,
 And treat them ever alike,
 When you are the anvil there,
 When you are the hammer strike."
 I think this is a great opportunity for us to
strike for CAM.
 DR. JONAS:  We have been talking about science and
rigorous methodology, but what I heard from you, really, is
actually -- a quote from Harold Wallach here
-- that "Science is cooperative effort of scientists.  Thus,
it is what people within science make out of it."
 In other words, science is what scientists is do.
 It is not necessarily a thing that you can aspire to.  Out
of that also is the importance of credibility, which is a
social process.  It is not a process of good, rigorous
methodology.  It is really a who-do-know.  It is very much
like politics.
 MS. CHAMBERS:  Right.  Thank you.
 DR. GORDON:  Thank you.  Thank you very much.
 MS. CHAMBERS:  Thank you.
 DR. GORDON:  Next is Monica Lenz.
 MS. LENZ:  I would like to thank Dr. James Gordon
and all the committee.  It is the first time that somebody
gives permission to talk about my experience and about my
research on cancer.  It seems nobody is interested in it
because it is not the same research which is normally done.
 The group is a feminine white population of
cancer.  It took me one year to do it, three years to see if
it is correct.  At the end of this year, or beginning of
next year, it will be implemented in a larger group.
 You will ask how many people did I analyze.  The
only person I can analyze is myself.  It is impossible to
comment to another person.  I had cancer three times myself.
 I didn't take the normal treatment because my intuition
told me it is not for me.  I had to flee my country to go up
to Russia, where I hoped that nobody would get in my way,
and get me over to the chemotherapy and to the other
therapy.
 The doctors could not explain how I created the
cancer.  Interesting.  I worked with creativity, so I
created something.  If they would explain me how I created
it, I can decreate it.  Since they couldn't explain it, I
had to find out.  Day by day, I monitored and I got the
cancer away.  I got a new cancer, but it was faster to get
rid of it.
 So the point is, I don't come from a medical
background.  I am a philosopher, and in philosophy we are
dealing with life and not with death.  We know in
philosophy, the more intelligent the questions, the more
intelligent the answers will be.
 So my invitation is for all of you who do research
to put up new questions, to go into a higher level.  I
wasn't sick in the body.  I was sick in the spirit.  I
didn't live the life I came to live.  I thanked god every
time I got cancer again because it showed me, this is not
your way, girl.  Hands off.  You can do something more,
something better.
 Now, I will start with a group in Columbia, where
I live now, with children who can't pay the normal treatment
to get them off the cancer, but to get them off of society
who tells them, this is a deadly problem, a deadly sickness.
 I would say to each of you, cancer is a wonderful
experience, and it is not life-threatening.  It brings your
life back.  Thank you.
 DR. GORDON:  Thank you very much.
 Charlotte?
 MS. KERR:  Thank you.  Columbia where?  Columbia,
the country?
 MS. LENZ:  Columbia, South America.
 MS. KERR:  I had a feeling you were going to be
far away.
 MS. LENZ:  It is not so far, a few hours of plane
ride.
 DR. GORDON:  Wayne?
 DR. JONAS:  With great trepidation, I ask, what
did you do to decreate the cancer?
 MS. LENZ:  You know, I had, first of all, to think
what I didn't like in life, because there is one thing which
breaks the cycle of cancer.  If you find out what you didn't
accept, and accept it, then you stop the cancer as you stop
a car.  It is easier to stop it.
 What I did is my treatment because this is my
life.  I always do what I like to do.  You should better
ask, what did I not do.  I was singing with Pavarotti, of
course, on a CD.
 [Laughter.]
 MS. LENZ:  I was dancing waltz.  I threw away all
my dresses and got a new wardrobe because I started a new
life.  Somebody told me I should make an Indian treatment,
but I went on my trip to Russia.  I passed through France.
I said one must be crazy to do in France an Indian
treatment.  I am in France.  So, what did I do?  What I love
is the sea, so I made thalassotherapy.
  To get back to life, the most important
thing was the Buddhric, which is linseed oil with yogurt.
After one week, I wasn't tired anymore.  The worst thing is
to be tired, and to kick off everybody around me, family,
friends, because a year later I found out what is the bad
thing about it.  They are all afraid of their death, not of
yours.  You are feeling so bad, and you have all this energy
on you.  So you cannot even breathe.  I had the possibility
to do it because I was the instrument of my will, but I
speak here in the name of Bruna.
 Bruna was, in my seminars, the youngest person.
She was 12.  She passed away in the States with cancer,
having a normal treatment, and she didn't want to have it,
and nobody helped her.  So I hope when this session is over,
that we have, soon, out on the streets, a smorgasbord of
possibilities so everybody can choose what he likes because
it is a one-person treatment.  Everybody must have his
experience.  We can't multiply the experiences.
 DR. GORDON:  Great.  Thank you for reminding us of
the mystery, and also of the uniqueness and the playfulness.
 We have another panel coming up.  Thank you very
much, all four of you.
 Ned Hartfield, Boyd Landry, Richard Pavek, and
Thomas Deboroski [ph].
 So we will begin with Ned Hartfield, please.
 MR. HARTFIELD:  Thank you, Jim.  Before I talk a
little bit about our work, I would like for everyone to just
take about 20 seconds and experience it.  In order to do
this, I think it will feel nice after lunch break, for
everyone just to gently come up onto their feet.
 Coming up onto your feet, just take a nice big
breath in and lift the hands up to the sky.  That is
wonderful.  Now, just take that right palm and just place it
on the ceiling, and left palm, just place it down toward the
floor.  This is called the Heaven-and-Earth Stretch.
 Breathe in and just press that right palm to the
ceiling, left palm to the floor, feel that heart expand.
Exhale, soften the arms; inhale, lengthen.  Nice.  Exhale,
soften.  Just one last time.  Inhale, lengthen.  Press that
right palm to the ceiling, left palm to the floor.
Wonderful.
 Bring the hands back to heart center, and we will
just balance off on the left side.  Inhale.  Left palm, lift
it up toward the sky.  Doesn't that feel good?  Your right
palm to the floor.  Exhale, soften; inhale, lengthen, spine
lengthens; exhale, soften.
 Last time.  Inhale, lengthen.  Last time, go for
it.  Exhale, soften.  Bring the hands back to the heart
center and float the arms down, and come to your seats.
 My name is Ned Hartfield.  I work with the Life
Foundation International.  We are a team of doctors, nurses
-- my own background is in nursing -- and complementary
health specialists.  We have been working for 20 years in
Europe, teaching what we call body-heart-mind techniques.
 Body-heart-mind techniques are a series of
movements, breath work, visualizes, affirmations, and hand
mudras that help to transform emotional pain.  We have
compiled a lot of our teachings into a book which is a
bestseller in the Netherlands called the "The Dance Between
Joy and Pain."
 Each chapter takes an emotion, like grief, anger,
fear, and shows what movements, affirmations, techniques can
be used to transform the energy of that emotion into its
positive counterpart.  For example, grief can become hope.
Fear can be transformed into courage.  Anger can become a
great source of creativity.
 So over the last five years, our team has gone to
crisis areas of the world.  We have gone to places like
Bosnia, Chechnya, the south Sudan, Northern Ireland, into
Nairobi to work with some of the Rhuwandan refugees there,
teaching these same kinds of movement to help people heal
from emotional pain.
 One of our senior staff, who has been all over the
world, actually will be coming to the Washington area in
November on the 18th to teach some of the techniques here.
So anyone that is interested can see me.
 But I really wanted to do was to give the
Commission a gift and to, on behalf of the Foundation, just
applaud you for what you are embarking on.  I brought with
me on the table there a light in the lantern.  It is a light
that has been lit from an eternal flame of hope called the
World Peace Flame.  As our therapists have been working all
over the world over the last five years, we are searching
for a symbol of hope.  About a year and a half ago, we
invited leaders from seven continents to light a Flame of
Hope, and the air forces of the world helped us to transport
these seven flames to the United Kingdom where they were
united to form one World Peace Flame, the Flame of Hope.
 I have a candle that has been lit from that World
Peace Flame.  It is not lit right now, but the wick has been
lit.  I would like to give it to Jim and the Commission.
 As you meet over the next several months, please
light it when you have important meetings, and may it bring
immunity, hope and direction, and light, to the Commission
and your work in making complementary health possible to so
many more people.  Thank you.
 DR. GORDON:  Thank you very much, Ned.
 Charlotte?
 MS. KERR:  Bless you, more than even thank you.
That was very moving.
 How do you get support for going to these places
and doing this incredible work?  How are you able to do
that?
 MR. HARTFIELD:  We have training centers in the
Netherlands and in England where we offer courses.  So
people from all over Europe have come, many people with
cancer, actually, and other life-threatening illnesses have
come.  We teach these body-heart-mind techniques and we have
had amazing results from people, as the woman who just
spoke, similar results to that.
 We sell books like this, and tapes, and we get
contributions from loads of people that have benefitted from
our work as well.
 DR. GORDON:  Other questions?
 [No response.]
 DR. GORDON:  Thanks so much.  I look forward to
seeing you.
 MR. HARTFIELD:  Thank you.
 DR. GORDON:  Boyd Landry.
 MR. LANDRY:  Good afternoon.  My name is Boyd
Landry, and I am executive director of the Coalition for
Natural Health, headquartered here in Washington.  I think,
first of all, I would like to say I don't have a poem or
anything, but I do have one saying, and that is that there
are three stages in life.  There is youth, there is middle
age, and there is, hey, you are looking really good today.
 [Laughter.]
 MR. LANDRY:  As I have been here over the last day
and a half, and I have listened to some very compelling
presentations and very provocative presentations, I think
one of the observations that I have made is that vocabulary
and the usage of the vocabulary is extremely important.
 Descriptions of Western medicine and scientific-
based medicine as being traditional is wrong.  It is
conventional.  Science-based medicine has about as much
claim to the word "traditional" as humans have for being on
earth the longest as a species.  I think if you think of it
in terms of that, it comes to be very clear.
 Therapies that fall under complementary and
alternative have more claim to the word "traditional"
because they have been around a lot longer.  In terms of
research, and that is the topic of these sets of meetings,
the Inca civilization, Native American Indians, French
traders, and Old English herbalists didn't go through a
scientific model to prove what they already knew worked.
 I think that as long as we keep that in mind, and
there isn't a tremendous, or even a significant, amount of
harm, then people should have a right to access those
therapies, and those practitioners that provide those
therapies ought to have the free and open right to do it.  I
think that is ultimately what is important.
 We, as an organization, wholeheartedly favor the
medicine establishment's openness to natural health
approaches, however this must include a recognition of the
holistic philosophy behind natural health.  The value of
complementary and alternative medicine will be lost if
natural health remedies are forced into the allopathic box.
 For example, if CAM research is simply performed
to the allopathic model, looking at herbs and dietary
supplements as substitutes for conventional drugs to treat
illness symptoms, it may come at the expense of the focus on
wholeness and wellness which makes holistic therapies
distinct.
 I think that is the best way I can end my
presentation.  Thank you.
 DR. GORDON:  Thank you.  Can you just tell us a
couple words about your organization?
 MR. LANDRY:  We are a national organization that
represents natural and holistic practitioners that look at
their practice in a wholeness and holistic aspect.  We do a
lot of our work on the state level because that is generally
where these types of issues are typically discussed, but we
also would like to provide as much as we can to the
Commission as you embark on this process.
 DR. GORDON:  So it is a membership organization?
 MR. LANDRY:  That is correct.
 DR. GORDON:  How many members do you have?
 MR. LANDRY:  We have about 2,500 nationwide.
There are thousands and thousands of people, and they live
in fear daily because of the onslaught of conventional
medical lobbying, and persecution and prosecution that
exists all over this country.
 How we draw them out is, I think, one of the
things that you ought to look at.  Without fear of having
the Medical Board knock on their door, seize all their
files, seize all their records, and threaten to put them in
jail, and that happens.  There is a case in Michigan that
was just dismissed, where the woman's door was knocked down
and her home was raided by the Medical Licensing Board, and
she didn't do anything wrong.
 DR. GORDON:  I gather you were giving us a
recommendation, which was that in a case where no one has
done any harm, they should be allowed to practice, whether
or not they have any kind of license.  I am not trying to
put words in your mouth.
 MR. LANDRY:  That discussion comes later in a
future meeting.  I will have more and more to say about that
issue.  But with respect to research, I think that what is
important, because that is the topic that is being discussed
these two days, that to force these therapies into that
strict and reductionistic procedure which conventional
medicine utilizes would totally destroy what makes these
therapies distinct.
 It is what the public wants, and they will figure
out what works far faster than you can figure it out by
researching it.
 DR. GORDON:  Dean?
 DR. ORNISH:  Just two questions.  What research
methodologies would you recommend, then, if not that?
 MR. LANDRY:  Well, this country was founded on an
open and free market.  That is why the statement I made just
now, that the public would figure it out far quicker than
science would figure it out.
 It is very easy to find 300 or 3,000 people that
have hypertension, for example.  There is a drug out there
that purports to deal with hypertension and cure
hypertension, and you can determine whether or not that
works, but to find 3,000 people that have the same body
chemistry that will synthesize an herb or herbal product the
same to be able to get an actual study out of it, isn't very
likely.
 DR. ORNISH:  I understand what you are saying
about the limitations of science, but again, this is not to
judge, this is to try to understand.  What you are saying is
that we shouldn't do any research at all, that people should
just go in the open market and figure out what works best by
trying them out?
 MR. LANDRY:  What you ought to try and research is
how you can best give the public greater access.
 DR. ORNISH:  Well, access is a separate issue.  As
you say, we are focusing on research here.  So just to
understand your position, you are saying that we shouldn't
do any research, that people should have access to
everything and sooner or later people will talk amongst
themselves and figure out what works and what doesn't?
 MR. LANDRY:  Well, I guess, in essence, to answer
your question and not to go across the line I probably don't
want to go across, and that is that if there is a propensity
of harm, then something ought to be determined what that
propensity is.
 I don't know, there are 140,000 deaths a year that
are caused by adverse drug reactions.  I can't tell you that
there are very many, if any, from people dying of --
 DR. ORNISH:  No, I understand all that.  I am just
trying to get a clear answer to my clear question.  What are
you recommending?  We know what you are not recommending.
What are you recommending?  Are you recommending that there
should be no research, that the propensity to harm will come
out, that the propensity to benefit will come out by, just,
people talking amongst themselves that we don't really need
any studies at all?
 MR. LANDRY:  Well, I think practitioners are going
to study amongst themselves.  I don't know how to clearly
answer your question other than to say that the current
process isn't working.  Now, what is the magic crystal ball
answer?  I don't really know, but if you simply focus on the
same box that has existed for 75 years, I don't think you
are going to get anywhere.
 DR. ORNISH:  Last quick question.  I don't know if
you are going to be at the next session or not, but just in
a nutshell from the services standpoint, you are also
recommending there should be no regulation, no licensure,
that people should be able to practice anything they want,
and again, that people will somehow find out what works
amongst themselves.
 MR. LANDRY:  As long as it doesn't involve things
that are invasive, where the potential for harm is of a
serious nature, then the public domain works very well with
respect to complementary and alternative therapies or
holistic therapies, because we are simply talking about
giving people, empowering people with their own individual
health and giving them that, and let them make their own
decisions.
 After all, there are many states in this country
that if you walk out of your doctor's office, your
physician's office, and you choose not to do what they tell
you to do, the only legal thing you can do is go home and
sit in your rocker.
 DR. ORNISH:  The final thing is that the
presumption in what you are saying is that unless there is
something invasive, that complementary and alternative
medicines are all safe.
 MR. LANDRY:  I didn't say that.
 DR. ORNISH:  Then, what are you saying?
 MR. LANDRY:  What I said was, if there is a
propensity for harm, or if the practice itself is inherently
harmful, then regulation probably should be involved, but if
there isn't any, then there ought not be any regulation of a
licensing nature.
 DR. GORDON:  Tieraona.
 DR. LOW DOG:  I am actually sympathetic to many of
the things that you are saying.  I know that in England,
because of Henry the Eighth's charter, herbalists can
practice legally and freely in England without any training,
but even though, they have restrictions and Part I and Part
II poisons and who has access to certain herbs.
 I want to see if you agree.  Part of the gift
that, perhaps, science can bring is establishing safety.
Efficacy, I think a lot of that will sift itself out in the
public.  A good example for me has always been, coming from
a Native American community, that for hundreds and hundreds,
and possibly longer, hundreds of years, women consumed
alcohol during pregnancy.  That is not a Native American
thing, but that is when it really was realized to the extent
that it was because of alcoholism on the reservations.
 There was evidence of fetal alcohol syndrome 500
years ago, but we didn't associate alcohol and birth defects
and fetal alcohol syndrome until 1972.  It took a long time
to understand the harm that came from a practice, even
though it was prevalent in society.
 So sometimes harm, and chronic harm, can be
difficult things to assess.  I think science has a real gift
that it can play without impeding people's rights to
practice and rights to access.
 Would you agree that, in perhaps that case,
science can be appropriate?
 MR. LANDRY:  Right.  I think a lot of the things
that are commonly sold.  If there was a tremendous amount of
problems associated with them, we would have already found
out.
 Now, new things --
 DR. GORDON:  Excuse me.  There is somebody who is
coming in to testify by phone and are scheduled to call, and
that is what is happening.  So forgive us for us for the --
 [Interruption.]
 MR. LANDRY:  I think one of the things, especially
in nature, and you will probably understand this more than
anybody else, that within the confines, and I believe it is
about a 10-yard circumference around a poisonous plant, is
the anecdote.  Just little things like that.
 DR. GORDON:  What I would like is, at least if you
would come for public comment during the licensure
discussion.
 MR. LANDRY:  I would like to make a presentation,
if that is available.  I was going to contact Dr. Groft.
 DR. GORDON:  Contact Dr. Groft.  That is certainly
a possibility.
 MR. LANDRY:  I would be glad to.
 OPERATOR:  I have a Dr. Cramer on the line.
 Dr. Cramer, are you there?
 DR. CRAMER:  Yes.
 DR. GROFT:  Elaine?  Hello?
 DR. CRAMER:  I was trying to call you guys for the
last 45 minutes.
 DR. GROFT:  Our apologies.  We missed you.
 DR. CRAMER:  It's okay.  I am here now.
 DR. GROFT:  Do you mind holding on?  We are in the
midst of an open public session with speakers, and we have,
what, two more to go.
 DR. GORDON:  Two more speakers.
 DR. GROFT:  So maybe a total of 10 more minutes.
So just hold on, please.
 DR. CRAMER:  Sure.
 DR. GORDON:  Are there any other questions for
Boyd Landry at this point?
 DR. LOW DOG:  No.
 DR. GORDON:  All right.  Thank you.
 Next is Richard Pavek.
 MR. PAVEK:  I am Richard Pavek again.  I want to
give you two intersecting thoughts.  There is a growing
segment of the population that believes the fewer
medications, the better, and are turning wherever possible
to drugless therapies.  Several of these fall into the
category of hands-on biofeel therapeutics.  All of these,
therapeutic touch, healing touch, and my own physiomuscular
release therapy, have demonstrated the ability to reduce or
eliminate medications for anxiety, pain, and mild sleep
disorders, to name a few.
 Taken together, there is a considerable body of
research to support efficacy, but the concept of promoting
research to reduce medications does not appear to be a focus
of the NIH.
 There is a belief among a number of physician that
have personally spoken to me, and others as well, that once
we have a good drug for the condition, we don't need to look
any further.  I think we do.  I think researching drugless
treatments should be expedited.
 Surely, this fits into the idea of bettering the
health of the people.  Also, I submit that subjecting
therapies of this type to the same research review process
that was designed for dangerous toxins and potentially
damaging chemical products is totally inappropriate.  These
therapies have demonstrated no downside risk that I know of.
 There may be some, but it certainly hasn't been very
apparent.
 There are estimates now of perhaps half a million
people trained in these various therapies, utilizing them
professionally and non-professionally for treatments for
friends, clients, and otherwise.  I came out of the fields
of aeronautics and electronics.  It is inconceivable to me,
from my experience, that there would be one measuring tool
that would measure everything that I wanted to work with.
It just doesn't make sense.
 The idea of a randomized double-blind study which
was designed to commonize the study population by filtering
out individual characteristics, how can that be applied to
therapies that deal with individual characteristics?  It is
upside-down.  Now, I have no quarrel with the double-blind
randomized trials being used for the places where they are
appropriate, but it simply isn't appropriate for work of
this type.
 I know that we are going to hear some
presentations on other approaches which fit this much
better, but as to the first thing that I had to say, I
really think this idea of getting rid of drugs wherever
possible is appropriate.  I know that in my own life,
through these means, and other means as well, I take far
fewer pharmaceuticals than I had at any previous portion in
my life, and I am a lot more healthy.
 DR. GORDON:  Thank you, Richard.
 Are there questions for Richard?
 [No response.]
 DR. GORDON:  Thank you for coming again.
 Thomas Deboroski.
 MR. DEBOROSKI:  Good afternoon.  My name is Thomas
Deboroski, and I am a struggling entrepreneur.  There I have
said it.  I appreciate the opportunity to be with you today,
and I thank you for your efforts.
 My company has developed some targeted nutritional
products, utilizing some rather unique product design
strategies that have been shown to be pretty effective, in a
pilot study, at migraine prevention.
 Prior to my present effort, I spent six years
helping to market a rather unique predigested fish powder to
the alternative doctor community.  So I had the opportunity
to see the naturopaths and the chiropractors, and the whole
gamut, and it was all very interesting.  That followed a
career in commercial lending in the banking industry.  There
is a little divine inspiration somewhere in there that
changed my career.
 I come to you today to share a few thoughts and to
ask a couple questions, for whatever you decide they are
worth.  One of the things I was going mention, I will just
brush on quickly, is my concern that the gold standard of
scientific research, that being the blinded study, may have
a little fool's gold attached to it, in that, we also can't
ignore the second gold standard of scientific research.
 I don't come from a scientific or medical
background, which you will probably be able to tell.  The
other gold standard in scientific research has always been
the individual practitioner or scientist's ability to
observe.  I think this was brought up yesterday a little
bit.  Certainly, outcomes-based instruments are an option in
allowing that to be recognized.
 As a layman and a business man, I struggle with
the definition of the word "disease."  One of the reasons I
am here is I am concerned as we accomplish what we intend to
accomplish relative to targeting nutritional products for
specific disease states, then I am not going to be allowed
to say it.
 Now, if you go the American Medical Association
web site and you look up colitis, migraine, arthritis, any
number of chronic disease states, somewhere in the midst of
that literature, they will admit that this is a disease that
is incurable of unknown cause.
 Now, if it is incurable of unknown cause, how do
you define it?  And more importantly, how do you heal it?
In our targeted nutritional approach, we have had success in
people no longer getting migraine headaches.  I don't know
where to go with the definition.  Then the FDA, of course,
establishes their regulations based on definitions that seem
to be incomprehensible to me as a business man and a layman.
 I don't think we can underestimate the value of
empowering the patient.  One of the things that I say to my
friends when they ask me how I am doing, I say, look, what I
have learned is that it is not important whether you go to
the doctor and get a drug, go to the naturopath and get an
herb, go to this guy and get that.  What is important is
that as an individual you pursue all the options that are
out there for you.
 In the path of learning, somewhere along the way,
you come to the place where you say, gee, that makes sense.
 It is my belief that at that point you have aligned mind,
body, and spirit to accept that treatment, and you have
increased your chances of responding, probably, by several
hundred percent.
 The last thing I wanted to mention was an
organization that may be of value, not only to the
committee, but to others who have spoken before me, and that
is an organization that I am aware of.  I don't know if your
organization has talked to them or not.  It is Medical
Outcomes Trust.  They are an M.D. organization out of
Boston, and they have designed outcome-based instruments.
Fortunately, for us, one of them being the migraine-specific
Quality-of-Life Survey.
 They have also designed other instruments, which
may be valuable in a clinical setting for looking at health
related, quality of life issues.
 I want to mention the Medical Outcomes Trust
because I think it had value to people that are looking for
measurements.  I don't know that their work has been widely
publicized.  We use their migraine-specific Quality-of-Life
Survey in our migraine study.  It was actually designed by
Glacxo when they got Imatrex approved.  It is a pretty
simple instrument, and I know they at least have an
additional instrument called the Health Related Quality of
Life Survey.
 The interesting thing about these instruments is
they have gone through scientific review.  There are
research articles on assessing and establishing the validity
of the instruments.
 DR. GORDON:  Great.  Thank you very much.
 Are there questions?  Wayne.
 DR. JONAS:  I just want to emphasize the
importance of outcomes measurement, because in all this
discussion we have had all day yesterday, I don't think
anybody really specifically talked about it.  I think
outcomes issues are extremely important in terms of doing
research that addresses or provides a kind of information
that are important to certain types of audiences.  Different
types of audiences want different types of information.
 If you are interested, and I am not saying this is
the only thing, but if you are interested in getting
patient-relevant outcomes, then obviously you have to have
validated outcome measures that also have face validity and
have been validated on the population that you are going to
study.  So having instruments like this, I think, is
extremely important so that we don't do surrogate measures
that might not be relevant, in fact, to the public, if that
is what our target audiences are.
 So I am glad you mentioned that.  There are a
number of other groups.  At least, I am very familiar with
Medical Outcomes Trust and the work of John Wehr [ph] and
many others that have done those types of things.  It has
been mostly in the context, however, of health services
research, and very rarely is it brought into efficacy and
effectiveness trials.  So I think doing that and bringing
those together is extremely important.
 DR. GORDON:  I also wanted to say I appreciate all
four presentations.  The last three of you, in particular,
are bringing to our attention an issue we do need to pay
attention to, which are those people, call them traditional
healers, folk healers, unlicensed, or uninterested in being
licensed, healers.  I think that part of our mission is to
understand who these people are and how they function and
how they do and how they might fit into this whole health
care scheme around the country.
 So I really appreciate it.  All three of you shed
light on it from different perspectives, and I want to thank
you for that.  And thank you, too, of course, Ned.  We will
see you.
 We are coming to a panel, and hopefully we will be
in touch with Spain very soon.  This panel is on outcomes
research.  There are three people who are embodied in the
room.  If you three could come and sit at the table, Leanna
Standish, Lydia Segal, and Douglas Lloyd.
 So what we are going to do is wait for Elaine
Cramer to call in.  We will begin the session, and then when
she calls, we will grab her.  Steve says we will grab her.
So forgive us if technology is a little imperfect here.
 The first speaker is Dr. Leanna Standish from
Bastyr University.
 DR. STANDISH:  I want to take my first opportunity
to take just a moment to celebrate the amazing successes
that we have seen in the development of CAM research since
the establishment of the Office of Alternative Medicine in
1992.
 When I first got involved, and many of you in the
room have been involved since then, I think there were two
main obstacles before us, and those were a lack of federal
funding for CAM research, and the other one was lack of fair
peer review of CAM proposals at the NIH.  It appears as
though those two obstacles have diminished significantly in
the last eight years, and I just want to take a moment to
thank Steve Groft and Wayne Jonas for their wonderful in
accomplishing both of those goals.
 In my estimation, we now face four main obstacles
in front of us around CAM research, and they are a need for
infrastructure and research training at CAM institutions,
CAM academic centers, that have true CAM expertise.
 Much has already been said about this.  I am not
going to dwell upon it.  When you come to Seattle at the end
of October -- some of you will be visiting us in Seattle --
I am sure there will be more opportunity to talk about that.
 I would rather focus my comments on the other three
obstacles, the first one being FDA policies and procedures.
 Despite the fact that we have made great progress
in the relationship between CAM researchers and CAM
practitioners in the FDA, I think we have a long way to go.
 I thought I would make this alive for you by just telling a
story of an actual thing that happened in my research
domain.  In 1994, the Office of Alternative Medicine,
through a cooperative agreement with the National Institute
of Allergy and Infectious Disease, gave a grant to Bastyr
University to form an AIDS research center focused on CAM.
 One of our early actions was to fund a few small
pilot projects of innovative CAM research in HIV AIDS.  We
put out an RFA, we assembled a peer review committee.  There
was one proposal that got a very high priority score and we
wished to fund it, and it was a double-blind, placebo-
controlled trial of homeopathically-prepared insulin live
growth factor in AIDS-related wasting.
 Now, the reason why I want to tell this story is
because what happens when you are funded by the NIH, and
this happens to all of us who are PIs, principal
investigators, is you get a letter from the NIH that says
congratulations.  You have been funded to do this clinical
trial, and now you need to get an IND, an investigational
new drug approval and license number from the FDA to conduct
this trial.
 The principal investigator of this study, and I as
her project officer, decided the best course was to request
a waiver of an IND.  So she went ahead and submitted a
letter with a half-inch pile of documentation around this
issue.  The reason we wanted a waiver and we thought that it
was appropriate, is that, as most of you know, in many
homeopathic dilutions there are no original molecules of the
substance that was going to be delivered orally.
 This was five years ago.  The FDA has not yet made
a judgement on this.  It has been five years.  Now, I don't
want to suggest in any way that there is malintent at the
FDA.  I think the problem is that in this particular area,
ultra-high dilutional or homeopathic preparations, there
just isn't a box.  There isn't an office.  There just wasn't
a place, a desk, for this to sit on.  Even though there were
many conversations, there has really been no action.
 So the answer to this question has not yet been
answered.  This is not an isolated problem.  In November of
1999, in anticipation myself of doing a study in this area
of ultra-high dilutional biology, I wrote a letter to the
FDA, asking about an IND waiver for ultra-high dilutional
interluken-2, which I think might be something to look at in
HIV disease.  I still haven't gotten an answer.  Almost 11
months have gone by and there is just no response, despite
repeated attempts at contact.
 I feel like this will improve significantly.  It
was just so wonderful yesterday to see FDA, fairly high-
level, staffers here talking to us.  It is a great moment.
 My other issue that I wanted to bring up, another
obstacle, is the need for CAM understanding at institutional
review boards.  Mostly at conventional universities and
medical schools that make go/no-go decisions about CAM
clinical trials.
 I just want to give you a real-life example.
Hepatitis-C study.  Bastyr University scientists thought it
was really appropriate to do a study on an eight-medicine
combination therapy that is used in clinical practice all
the time.  We thought it was time for us to actually do an
evaluation of this program of treatment.
 The Bastyr University IRB did a very vigorous and
thoughtful review, and ultimately approved the study.
Because we are collaborating with the University of
Washington, which is about 15 minutes away, the Hepatology
Department, we needed to go through the IRB as well because
we are doing biopsies that are totally appropriate.  Well,
the IRB there, they are balking.
 The reason they are balking is around this
combination thing, and we have gotten a letter saying, well,
we don't understand how you are going to know about the
independent effect of any one of these eight items.  Of
course, our response is, that is not the research question
being asked.  It is like a conceptual block, and I can
remember that block when I was on the other side of the
aisle.
 The fourth obstacle is the one that I really want
to spend the remainder of my time on.  It is the one that
this panel is about, which about practice-based outcomes
research.  So I want to pose the question, why have we made
so little progress in the last eight years in this area?  I
want to suggest some solutions to this problem.
 We have an excellent program at the National
Cancer Institute called the Best Case Series program.  It
was started, as most of you know, in 1992, I believe.  In
the last eight years -- I was just talking with Dr. White,
and he tells me -- there have been 30 contacts made.  Yet,
out of those 30, only four Best Case Series have been
submitted in the last eight years.
 Now, it is not for lack of trying.  The Best Case
Series program needs not only advertising, which is now
being quite aggressive, and I really want to applaud Dr.
White and his office staff for initiating that, but I think
this program needs funding, and I think it needs trust-
building.
 I would like to give you a little story.  Bastyr
University was contacted about a year ago by a rather well
known, maybe notorious even, CAM clinician in California who
has been claiming to cure cancer.  This clinic called us up
and said, would you help us do a Best Case Series.  I said I
would love to, and I meant it.  I would love to do this.  So
they said, well, okay, what is it going to cost.
 So I sat at my desk and I really thought about
what would it take to choose the inclusion criteria, do the
chart reviews, find the pathology reports, get the slides
from the pathology departments, contact the patients who are
no longer in the state, search death records, putting
together a cogent document at the end to submit to the NCI.
 My estimated cost of that was between $35- and
$75,000.  It takes time.  Yesterday, we heard from Dr.
McCombs, who is sitting right here in your spot, and she was
telling us, I think, a very powerful story about the
difficulties of doing this kind of practice-based research.
 I don't really think it is feasible for someone
like Dr. McCombs to do a Best Case Series.  It takes a lot
of time.  So what I would like to see is partnerships
between CAM academic centers and CAM practitioners,
especially in the cancer area, to come together and to have
that collaborative work be funded by the NCI.  I think that
kind of an approach would bring into the arena, not only the
funding necessary to do this important work, but also the
trust-building.
 Then finally, I want to talk just briefly about
prospective outcome studies.  They are hard.  They are very
hard to do.  I just want to give you an example.  One of the
most pressing questions in my mind is, does it really make a
difference when a woman with breast cancer goes to a
naturopathic physician, receives comprehensive care, and
gets a treatment program?  Does this make a difference in
terms of quality of life, survival, progression, the kinds
of things that we are interested in?
 We don't know the answer to that question.  I have
done some thinking and some very deep consultation about
this, the same size.  In order to know whether it really
does make a difference in, say, Stage 1, Stage 2 breast
cancer, we would need a sample size of 2,500 patients.  Now,
to do that we need a network of naturopathic clinics all
over North America to collaborate.  We need a data central.
 This is going to take money, it is going to take
networking, and it is going to take research clinical trials
consortium development.
 I think we need to do that, not only in
naturopathic medicine, but in Chinese medicine, the massage
community.  The chiropractic community has already shown
great leadership in this area.  All the CAM professions need
to do this.
 I just want to summarize -- not summarize, but I
want to say one last sentence, which is that we are at a
time now, all the issues are on the table.  This has been an
incredible two days.  I think every single issue that we
know is important as an obstacle to CAM research has been
discussed or mentioned in the last two days.
 For the first time this year, I feel a wonderful
optimism about our ability to solve them.  Thank you.
 DR. GORDON:  Thank you very much, Leanna.
 Dr. Lydia Segal, please, from Kaiser Permanente.
 DR. SEGAL:  As Jim says, I am a physician
representing Kaiser Permanente.  I would like to start by
having you all imagine that you have back pain.  You have
been sitting here for two days now, and some of you actually
probably do have back pain.  Imagine that this back pain
started a year ago.
 After trying some over-the-counter ibuprofin, some
rest, doing all the logical stuff, you went to see your
primary care doc.  Your primary care doc gave you slightly
stronger medication, maybe recommended some back exercises,
and you went home.  Yes, you did some of them, you didn't do
some of them, but you didn't get a whole lot better.
 So you did what an otherwise intelligent person
would do, you went and asked your neighbors, your
colleagues, you checked the Internet, and, lo and behold,
there were all these other kinds of modalities.  There was
chiropractic care, acupuncture care, massage.  My god, there
were these supplements you didn't know anything about.
 You thought to yourself, does any of this stuff
work?  My doc didn't recommend them.  I don't know.  So with
trepidation, you go back.  Your doctor doesn't even go there
with you on that second visit, actually sends you to the
specialist who wants more tests and more medication that you
are actually not interested in doing.
 You don't raise the issue, and maybe they don't
raise the issue either because maybe they are not so sure
about this stuff.  They don't know what their colleague is
going think.  They don't know whether their income stream is
going somewhere else.  In the end, none of us knows, the
patient, the providers, we just don't know what works.
 Unless we do clinical outcomes research, we will
not know what is efficacious, what is effective, what is
safe, to respond to the conversations that were just
happening.  We need to know that because the ultimate value
to the patient is being able to have a wider choice of
treatment modalities to help your back pain, and yours, and
so forth, and to know which one is effective.
 [Interruption.]
 DR. GORDON:  We will hold the thought.  Thank you.
 On the phone is Dr. Elaine Cramer, a medical
epidemiologist at the CDC from Spain.
 Dr. Cramer, hi.  This is Jim Gordon here.
Welcome.  I think we are actually ready, willing, and eager
to hear you.  We are waiting.  What we have here is the
Commission sitting here.  There are three other panelists on
the panel on Outcomes Research.  We have a number of people
who are in the audience as well.
 DR. CRAMER:  Okay.  You asked me to speak to the
issue of alternative research.  In 1997, the CDC was asked
by a representative of the Office of Alternative Medicine at
the NIH to conduct some pilot studies to assess the
feasibility of a field investigation-style approach to the
evaluation of complementary and alternative medicine.
 Do you have that study in front of you?
 MS. CHANG:  Yes, we do.
 DR. CRAMER:  The study that is in front of you is
one of two of the studies that we conducted.  The first is a
-- investigation that drew a number of conclusions about the
role of observational research in the evaluation of the
effectiveness of CAM therapies in the clinical setting.
 MS. CHANG:  Yes.  Go ahead.
 DR. CRAMER:  Conducting analytic observational
studies called, chart abstractional, by surveying incoming
patients in a clinical setting is relatively easy, either
retrospectively or prospectively, and I think it is also
relatively inexpensive.  Using these observational methods,
we can characterize the scope and practice of CAM, as well
as describe patient socio-demographics.
 These data are useful for understanding the
spectrum of therapies and modalities that are used by
patients, and also for profiling the treatments prescribed
by practitioners.  I think these data will lay the
foundation for priority-setting with respect to identifying
the most commonly used modalities and systems of care, and
also the populations who are using them for directing
funding and research efforts.
 I think most of the limitations are inherent in
data collection and in interpretation using observational
studies designs involved, such as cohortive case-controlled
studies.  With observational methods, we generally analyze
data collected from patients in a study where we don't
control the exposures, but from patients who naturally
select their own exposures.  We simply describe and document
the outcomes.
 I conclude that the experimental study design,
such as randomization of patients to various treatment arms
are the most useful and the most preferred methods for
evaluating CAM therapies for several reasons.  First,
because of the limitations of abstraction based on
retrospective chart review, we are able to access all the
information that is adequately documented in the patient
chart.  As you know, providers don't always write detailed
notes about all their symptoms, and it depends on the
priorities of the group.
 So chart documentation varies greatly among
various providers, and it makes interpretation of findings
in charts, a mathematical analysis, limited.  So unless we
actually collect specific data elements which are planned
for in advance using a -- collection tool, the data
collection will be -- and actually will probably be limited
by the lowest common denominators that are available on all
the charts.  So it may not be as detailed as we would like.
 The second reason for experimental study designs
being preferable is that we know that there are inherent
differences which exist between patient populations who seek
CAM therapies.
 We can address the differences we know about,
which are called confounders, such as the differences in
mean monthly income, average age at the time of treatment,
or the use of blood pressure medication among patient
groups, and we can factor those that we know about into a
statistical comparison, but it is the unknown differences
that challenge the validity to the studies.  The only way to
sufficiently direct the unidentified differences is to
randomize the patients to treatment arms.
 Thirdly, I think that when we are evaluating any
therapy, including CAM therapies, we are equally interested
in qualitative as well as quantitative outcome measures.
For example, if two patients are receiving treatment for
breast cancer, they may actually survive, possibly, the same
amount of time, but let's say in mind-body therapy, for
example, we could have a therapy, use it on these patients,
and it might result in an improved quality of life during
the course of treatment for one of them.
 So we need to design a study to evaluate the
measures which involve using qualitative survey instruments
and those have to be incorporated into studies designed at
the outset.  We might also be interested in cost benefit and
cost effectiveness measures.  Those really need to be built
into a study, so that there aren't inherent inaccuracies in
collecting those data.
 I think the final argument for experimental study
design is that it is an important feature of evaluating
effective therapies is the choice of a comparison group.
That is really the essence of a valid study, and we want
that comparison group to, as closely as possible, resemble
those who receive the CAM therapies.
 There really aren't very many -- in the United
States where patients receive CAM therapies or integrated
therapies side by side with patients who receive only
conventional treatments.  So in order to identify --really
requires expanding the study arena beyond just the office of
one CAM practitioner.
 So for all those reasons, we elected to move to
the experimental study design.  As some of you may know,
that is where the experimenter, as one example, may
randomize patients to different treatment arms.  One of
those, of course, could be a CAM system of care or a
modality.
 Whether it is designing a study, designing a CAM,
as long as the experimenter keeps in mind the essence of
integrated herbalistic medicine, and then even imposed
system of care, such as naturopathy or entire modalities,
say, such as acupuncture which is the unit of measure being
evaluated, then we don't really use alternative scientific
methods.  There are good epidemiological statistical methods
that exist, and in my view we don't need to redesign those
methods.
 Let me give you an example of an aggregate system
of care and tell you what I mean by taking into account the
unit of measure.  If you look at something like classical
homeopathy -- I am going to refer to it as an aggregate
system of care -- patients are treated on the basis of their
own constitutional profiles, which are determined by a
homeopath on the basis of characteristics that are unique to
each patient.
 So the patient is assessed, for example, as to
whether he or she tends to be thirsty or whether they prefer
sweet or salty foods, what fears they might have in the
experience, plus the symptoms that they present to the
office with.  The homeopath, based on a classical approach,
would actually give different remedies to a patient who
presents with the same complaints.
 So let's say with shoulder pain, if we rush to
evaluate only one homeopathic remedy for shoulder pain, we
are going to miss evaluating the essence of the homeopathic
system of care by only focusing on one unit of measure.  In
the example I am giving you, the exposure in this case is
the constitutional homeopathic remedy, and the effect on the
shoulder pain is really the outcome.
 So in the aggregate system of naturopathy, if you
only evaluate just the mechanical -- and we don't take a
step back, we are going to find, sure, that the substance
may not be inert if we have bioactivity, but we are also
going to be evaluating the effects of the aggregate system
of naturopathy.
 So basically, it is the entire system, like
lifestyle, exercise, plus the addition of dietary
modification that really comprises -- and we really need to
analyze a therapeutic approach that is not too refined,
otherwise we will really miss the forest for the trees.
 Now, I am almost wrapping up, and then I presume
that you will want me to stay on the phone and be on the
panel.
 DR. GORDON:  We will have a few questions, I am
sure.
 DR. CRAMER:  So let me just say that the other
advantage of using an outcome-based approach is that we can
really evaluate systems or modalities that have no
scientific explanation.  If findings from the evaluation of
an entire system or modality shows promise, then I think we
need to go in -- and use existing scientific methods to
dissect all the components, and then go to a laboratory-
based analysis of botanicals or substances.
 We probably would expect those to display some
biochemical activity, but start with a clinical study, and
then move backwards to a basic science approach.
 So finally, for a clinical study, the findings
should be as valid and as reproducible as possible and,
really, that is best accomplished by assembling an
integrated team of clinicians with both clinical and subject
matter expertise.  It requires involvement of a set of
statisticians and programmers, et cetera.
 So to offer a margin of sample size in patients
with multiple treatments arms and a comparison group, you
really need to put together an integrated team of
researchers from both the CAM and conventional communities
who are open-minded practitioners, who are really willing to
collaborate and randomize patients to CAM treatment arms as
well.
 So in conclusion, descriptive epidemiology is
good.  It is good for characterizing patients and therapies,
for diseases which are most commonly treated by CAM, it
helps to identifies those suitable for further evaluation,
but it is really the experimental study design that is the
gold standard to address both the identified and the
unidentified sources of consignment, which would really move
the validity of the study if it is only conducted by
observational methods.
 By keeping in mind the objectives, in the absence
of integrated and holistic medicine, we should be -- that
the unit of measure and the evaluation is the aggregate
system, and not simply a -- therapy or we will really miss
the essence of what the CAM practitioners are doing and
providing in the community.
 Finally, integrative medicine requires integrative
research, and the way to properly evaluate any exposures
through a team-based approach using existing methods.
 I have come up with, I think, three possible ways
that I think will help to implement these strategies in a
community setting.  One is to solicit proposals from
integrated research teams which are comprised of both CAM
and conventional practitioners who demonstrate the ability
to collaborate on, not just the study design, but case
definitions, the selection of exposures, and the designation
of CAM and conventional treatment sites.
 The second possible approach is to assign a
research mentor to CAM practitioners who are interested in
evaluating CAM therapies, but whoever needs research and who
really needs some assistance with both protocol and study
design development.  I think there are many of those in the
community.
 The third approach may seem impractical, but it is
possible to establish experienced research teams that are
comprised of scientists, subject matter experts.  Instead of
-- them, actually send them out en masse to selected
research sites to really expedite development and
implementation of the protocols for CAM evaluation.
 I think I will stop at this point.
 DR. GORDON:  Thank you very much for sharing your
experience and your thoughts with us, and thanks so much for
overcoming the technological obstacles.
 QThe first questioner is Dean Ornish.
 DR. ORNISH:  Thanks for your time.  We really
appreciate it.
 DR. CRAMER:  Sure.
 DR. ORNISH:  My name is Dean Ornish.  We struggle
with the same kind of issues, methodologically, that you
have talked about here.  You have identified that when you
don't do randomized trial, you have the unknown variance
from factors that you don't identify.
 When you are doing this study, that we have a copy
of the pilot study, you adjust for a number of different
factors, but there is a presumption that one knows how much
to adjust for, particularly on the kind of outcomes that you
are looking at.  I am not sure that we really do have that
data, plus you don't know how to adjust for the fact that
there is positive expectations and placebo factors and other
things that go into something like this.
 I am just wondering, do you just say, well, there
are limitations and that is all we can do, or is there some
methodology to compensate for these things that I am not
aware of?
 DR. CRAMER:  Do you methodology to compensate
apart from randomizing patients?
 DR. ORNISH:  Apart from randomizing.  Part of what
we have talked about the last couple of days is that, as you
said, integrative medicine requires research.  One of the
questions is, are there methodologies that maybe we haven't
considered that might be somewhere between a randomized-
controlled trial and a case-matched or adjusted study that
you are talking about.
 You have obviously given a lot of thought to these
areas, and I am just curious to know what you might have
come up with.
 DR. CRAMER:  Well, first, let me just talk about
doing some observational research to try and adjust for some
of the factors that we are talking about, then I will
actually address the issue of a case-matched study.
 One of the things I found in the study that you
have in front of you was that a lot of the data were present
that were objective data, such as mean monthly incomes,
blood pressure, medication use.  Actually, in the second
study, which was the community health centers of King
County, we actually had a formulary so we could find out all
the medications that the patients were on.
 All of the things that turned out to be different
among three patient groups, in other words, when we compared
the conventional patients to care users, there were many
things that we could identify, and we were able to, as you
say, adjust for those things with the three-dimensional
logistic regression model.
 It took a lot of fancy work to do that,
mathematically, which is not uncommon and it is doable, but
the problem is in over-interpreting data.  When you look
through a chart and you see that a conventional doctor
writes "patient is feeling better," and then you look
through another chart and the naturopath writes down three
paragraphs, there is already an inherent bias in the data
collection.  So it is very limited.
 I think I am able to over-interpret those data,
and they become basically dichotomous.  It is going to be
either yes, they do, or no, they don't have any symptoms,
because we will actually build into our interpretation all
kinds of biases.
 So I think no matter what we do, we are going to
have trouble adjusting for all of the differences, even in
the setting which I evaluated, where, actually, the context
was the same.  It was the same administration, the same roof
over the two clinics, the same secretarial staff.
 DR. ORNISH:  So recognizing the limitations, which
I think we all do --
 DR. CRAMER:  Right.  You could, theoretically, try
and compensate for that.  You could actually collect data
from patients who come through the door, and try and capture
the data in a more standardized fashion.  So have both CAM
providers and conventional physicians filling out a
standardized survey form.
 If they are randomizing patients where they are
still selecting their own treatment group, the physicians
and all the CAM providers could be more standardized in the
way they collect data, and then what could happen is, the
patients themselves could fill out an evaluation after they
are seen.  Those data would be subject to, certainly,
interviewer bias.
 DR. ORNISH:  Are you familiar with Zelin's work,
using the NF-1 studies, those kinds of things?
 DR. CRAMER:  No, I am not.
 DR. ORNISH:  Just curious.
 DR. CRAMER:  There are also studies where you
could actually use the patient as his or her own control
group.
 The truth is that no matter how you slice it, what
happens is that in my discussions with reviewers, peer
reviewers from all of the major journals, they always come
back with the same thing, and that is that these patients
are home schooled, they are drinking more water from wells
that they have on their own property, and there are so many
problems that we can't identify, that, I think, make, not
only the validity challenge, but certainly when it comes to
CAM therapy, it has to be twice as valid to be considered
equal.  That is just the truth of the matter.
 DR. ORNISH:  Exactly.  Thank you.  That was very
helpful.  I appreciate it.
 DR. GORDON:  Another question coming up from Wayne
Jonas.
 DR. JONAS:  Hello, Elaine.  Can you hear me?
 DR. CRAMER:  Hi, Wayne.
 DR. JONAS:  Welcome back from the bowels of
Harvard.
 DR. CRAMER:  Well, thank you.
 DR. JONAS:  I see you have learned a few things
there.  You even said some words I didn't understand.
 I had a focused question, hopefully, here, because
I want to make sure that we are not misinterpreting you
here.  That is that my feel from what you said is that you
would not recommend observational research in these complex
areas, and I want to see if that is correct.  I understand
that you think, and we have discussed, really, a lot in the
last couple of days, the importance of randomization and
balanced group designs, and this type of thing, and also its
problems.
 Is your sense now, after having been one of the
few people, other than at some of the centers, to truly
attempt to do observational practice-based CAM research,
that this is not a very viable approach and that you would
abandon it?  Let me be very clear.
 DR. CRAMER:  Well, I would say that it is limited,
Wayne.
 DR. JONAS:  I understand the limitations, but is
this -- go ahead.  I'm sorry.  I don't want to interrupt
you.
 DR. CRAMER:  That's okay.  I think it is very good
descriptive studies.  It is even possible to do the studies
prospectively, but the original intent was to go into these
practices and try and do, what we say in CDC, is a quick and
dirty study, which is basically use the data that are there
in the clinic, whether we use their computer system for
billing to identify cases, or whether we use the charts and
abstract them, or do random chart-polling, or review every
case that has ever walked through the door, I still think it
is limited.
 If we set something up prospectively, it is
possible to do that in such a way where with a lot of
manpower, we can actually do what Dr. Ornish suggests, which
is to do a case-matched approach, but I am not sure the
juice is worth the squeeze on doing case-matched approaches
where we are looking for matching comparison group outside
of the practice, because even so, there will be limitations
to the validity.
 DR. JONAS:  That is a rock.  You might not get a
lot of juice out of it.
 DR. CRAMER:  I am not sure that juice is really
discriptive in terms of being able to use the data.  What
will happen is, we will come up with an answer, but it will
only be a suggestion looking for a future study.
 I will just give you a quick example.  One of the
other places that I evaluated was an oncology clinic, which
was an integrative setting where one of the practitioners
was treating a variety of cancers.  I looked at all the
charts in the practice, and there was a whole list of
patients who had a variety of diagnoses: breast cancer;
prostrate cancer.
 The data were all there, not only that, but all of
the laboratory studies.  There was no paucity of
information, but the problem was even in trying to do a
survivor analysis, even in trying to say, do these patients
live longer, what we wanted to do was go to national
database and look at survival of comparable patients.
 It is very difficult to identify a comparison
group, even using a national database, because a lot of the
patients in these practices, they have tried everything
else, and they either end up there by virtue of finding that
this is their last hope, or it is unclear, actually.  This
is something I found even more often, it was unclear what
their previous series of treatments were.
 So even looking at a national database, we were
not able to see whether they are comparable.
 DR. JONAS:  So I understand, what you are saying
is it is a very complex phenomena.  It is not a simple
phenomena to do, even prospective or retrospective
observational research from practices, and you have made
some recommendations here as to actually how to possibly do
that.  So I assume that you don't think it should be
abandoned.
 DR. CRAMER:  No.  I don't think it should be
abandoned.
 DR. JONAS:  Okay, because that was my question.
Let me ask a little bit on resources, then, because you said
the juice is not worth the squeeze, or may not be worth the
squeeze.
 In your specific study at the King County Clinic,
what was the total number that you had?  What estimate of
time and cost went into that?
 DR. CRAMER:  At the King County Clinic, what I did
was I talked to all the patients who met the case definition
from the start of the clinic right up until the time when
the study was conducted, and I was able to identify 80
patients who met the case definition, after reviewing,
probably, more than 600 charts.
 So we cast a broad net and found 80 who met the
case definition.  Then what I did identified 160 in the
comparison group.  So there were 240 total charts that we
ended up abstracting and including in the study.
 DR. JONAS:  So you had 600 you screened, 240 that
you actually went through the problem of abstracting, and
then 80 that actually entered into study.  This took you how
many years?
 DR. CRAMER:  Well, it didn't take years.  The
analysis took years.  The actual study was quick.  I
probably was in Seattle for three weeks.  We were able to
abstract the data in a little over three months.
 DR. JONAS:  I understand, but the process that you
had to go through, including all the approvals and the IRBs,
and all this type of stuff at the CDC to do this, from the
time we told you we would like you to do this and supplied
some of the money for it, was about what period of time?
 DR. CRAMER:  January through September of '98 for
actual data collection, and September of '98 until September
of '99 for analysis, not including the fact that I wasn't
working on it full time.
 DR. JONAS:  And that was obtaining a subgroup of
80, which is, as we have already discussed, was real
problematic in terms of analyzing any of the subgroups or
other types of confounders.
 DR. CRAMER:  I don't think the sample size in
itself was large enough.
 DR. JONAS:  I will stop now.  I won't ask you to
elaborate all the other complications that you had in terms
of making the arrangements and the practitioner issues, and
this type of thing.  Thank you very much.  It is very good.
 DR. CRAMER:  I will just mention one thing.  I
think it cost probably about $60,000 total.
 DR. JONAS:  The point is -- and Elaine, I think
you have made some suggestions to set up teams, for example,
that involve statisticians and methodologists, and this type
of thing -- is that it is a very substantial effort, even if
you are collecting what would be considered pilot data for
analysis for making decisions about where we would do a
controlled trial.
 In your trial, you found improved outcomes in the
naturopathic for certain symptoms, but not improved in other
areas.  So perhaps, one would consider, then, a controlled
trial for looking at the value of naturopathic treatment and
those particular symptoms.
 Is that correct?
 DR. CRAMER:  That is correct.
 DR. GORDON:  Thank you very much.  When will you
be back?
 DR. CRAMER:  From Spain?
 DR. GORDON:  Yes.
 DR. CRAMER:  I am coming back on Tuesday.
 DR. GORDON:  Tuesday.  Well, then, certainly by
the next time we have research discussion, we will be able
to talk with you.
 Maybe if some of our members want to give you a
call to discuss some of these issues further, would that be
okay?
 DR. CRAMER:  It would be absolutely fine.  I am
sure Michele and the rest of the team knows where to reach
me.
 The last thing I just wanted to mention in
response to Wayne's inquiry was that, the three
recommendations I made, while it is true that I think they
would lay the foundation for a real trial, I think that
these recommendations probably go directly into Step B,
where you are going with a team and actually set up a very
sound study to start with.
 DR. JONAS:  I like that one the best.
 DR. GORDON:  Okay, thank you.
 DR. CRAMER:  Sure.
 DR. GORDON:  Dr. Segal.
 DR. SEGAL:  I can go now because Elaine Cramer
said everything I needed to say.
 It is a collaboration with someone who has that
kind of expertise that I, as a clinician, I, as the founder
of the Kaiser Permanente's alternative medicine in this area
of Virginia, Maryland, and the District, I don't have that,
and it is that kind of quality research that allows us to
establish a level of credibility, and that credibility
allows you, as that person with back pain, to come to me,
the clinician, and say I don't want all that other stuff.
Which one of us passes Elaine Cramer's strict credibility,
which one of it has validity and reliability that meets
strict standards?
 Once you have the credibility and the acceptance
both by the patient, by the provider, then, the medical
community and even the insurers are going to start rolling
in, where it is appropriate, different modalities for
different disorders, and once they do, and they roll things
into the base product, something I am sure you are all
familiar with in an insurance industry, then, the big time
payers, employers, government will make sure that you have
access to that alternative modality, assuming you have
insurance -- not having insurance is not an issue in today's
conversation -- and that access won't be an issue anymore
because you all who have insurance, if you do, will have
access to it.
 So, credibility based on really quality research,
that people like Elaine Cramer can help us design, leads to
a level of acceptance both by the medical community and the
patient, leads to an integration of service into the medical
community, and then issues of access almost go away because
it becomes established as routine care, but it is another
modality that can be used.
 So, you may all say so why is this not happening
although you have sat here for the last two days and you
probably know why it is not happening, from my perspective
there is four general reasons why it is not happening.
 You may say, Lydia, you are sitting on 8 1/2
million covered lives in the largest nonprofit HMO in the
country, we have no vested interest in going after one
modality or not going after another.  It is a total wide-
open ballpark here.
 I am sitting on half a million lives locally that
I can do big, large population studies.  I have multicenter
I can go after.  I have got an electronic medical record.  I
can go after demographics, I can randomize, I can look at
utilization, so why the heck aren't I doing it?
 Well, I am doing a little of it, but I and my
colleagues, my equivalents across the country, have had this
conversation more than once, and I can tell you that
although it looks real easy, it is not, and it comes down to
three things in our lives.
 Jim is writing this down, but he really doesn't
have to, because it's just so simple.  It is time, it is
energy, sort of finding the energy to do it, and it is
expertise.  It is I, as a clinician, and my partners, you
know, we are pretty smart.  I am not bragging, but we do
what we do.  I am a physician, I am an acupuncturist, we do
what we do pretty well.
 But you come to me and you have this idea, and I
say great, design that research project.  I need an Elaine
Cramer to help me design that research project.  But let's
say all on my own I do, then, I have got to sit down and
fill out that 30-page grant application.  I have just
listened to one of my partners yell about a 30-page grant
application.
 Then, after I get to that point and they give me
the money, then, I have got to set up the research -- Dean
is going yeah, yeah, he has been there -- have got to set up
the research, collect the data, analyze it, then, I have got
to write it, and I have got to write it so well, and it has
got to be done with such rigor that it gets accepted at a
credible journal, because without it being accepted at a
credible journal, it doesn't go back and establish the
credibility that needs to be there to expand the modality,
so that your back pain or your back pain has more options
now to go after.
 So, one of those limitations is strictly
practical, it is the time, the energy, the expertise.
 The next is a theoretical one, and Dr. Strauss
mentioned this yesterday.  When we look at cause and effect,
and we look at this whole body, you are not going to get
cause and effect when you look at an outcomes trial.  When
you are at the bench in the lab and you are looking a
molecule or a mouse, you might get cause and effect, but if
I send you to the acupuncturist for your back and you come
back and you are better, and you get back to work sooner,
your employer will be happy.
 And your family sees you and your functional
status is improved, you are happier, you can do more around
the house, your quality of life is increased, that's great,
and, you know, I, as a clinician, may actually not care
whether it's electromagnetic waves, whether it's this cheese
stuff -- what is this cheese stuff -- I may not actually
care, because you have gotten better, and I have an extra
modality to go after your back pain with.
 So, I think we have a real reason to use outcomes
measures.  We have got them, we can randomize.  We have
challenges, but we have got smart people like Elaine Cramer
to go after and help us with those challenges.
 So, that is a theoretical question.  On a more
technical level, these studies need to be huge.  No matter
how much they cost, they need to be huge.  It is nice to
have anecdotal reports, it is nice to have case reports, it
is nice to have pilot reports with 12 and 20 and 50
patients, like I have in some of my research.
 Those are building blocks, but we need really big
studies, big populations in my view, to be able to establish
again that credibility that leads to that acceptance.
 So, now we come to the last of my obstacles, and
that is a paradigm shift that others in this room have
spoken of, and that is having respect for that particular
modality that you are looking at, and taking respect for
that modality and weaving it into the actual research.
 Jim, I am going to use you as an example.  You
have come to me with that back pain, and I have done a
history and physical on you, and I have even done x-rays,
and I have made a diagnosis that you have age-related, age-
appropriate arthritis of your back.
 I am going to send you out to one of my favorite
acupuncturists who happens to be in the audience.  When I
send you, I don't just send you, but I happen to send your
twin brother out, as well.  Maybe you don't have one, I
don't know, I am making one up.
 When I look at you and your twin, to me, you both
have the same demographics, your age, sex, your x-rays look
almost identical, but the acupuncturist, that is not what
she sees.  She sees two individuals.  She does a very
different history from I, as a westerner, that may be doing
a history.
 She sees in one of you an excess of maybe dampness
and another one of you, maybe a deficiency in your wind.  I
don't know what she sees, because she is seeing it with a
totally different set of eyes, and as she sees it with
different eyes, she is putting needles in different spots.
 Now, if she is my colleague in a research project
and I am sending her back pain, I really want her to put
those needles in exactly the same spot, so we can have an
absolutely perfect study, and we can say, well, you have to
put them in this spot, this, and this, and that is not going
to happen if we come to respect the modality that we are
working with.
 I think that we can respect those other modalities
and still design very rigorous trials.
 So, my suggestions here are that we have some kind
of a research training program for clinicians that allow the
clinicians to stay in their practice, be it a mentoring
program like Elaine mentioned, or we have a partnership with
academic institutions, with government institutions, that
hopefully brings those researchers into the clinical
environment, and with clinical research outcomes that we can
establish a more effective, broader array of treatment
modalities that get integrated into the medical care
delivery system, and that might even potentially be cost
effective, so that your back pain, and yours, and yours, all
have other and additional modalities to be treated with.
 Thank you.
 DR. GORDON:  Thank you very much, and thank you
for your forbearance.
 DR. SEGAL:  Not a problem.  I learned a lot from
Elaine.
 DR. GORDON:  The final person on this panel, the
final speaker will be Douglas Lloyd, who is speaking on
behalf of the Association of Schools of Public Health.
 DR. LLOYD:  Thank you, Mr. Chairman.
 My name is Doug Lloyd.  I am a preventive medicine
and public health physician and I am appearing here today
representing the Association of the Schools of Public
Health.  We are a membership organization of the Nation's 28
accredited schools of public health, and our interests span
contemporary health problems facing the country today.
 If you quickly scan the volumes of Healthy People
2010, you will find the topics listed are the research
activities of our academic public health institutions.
 It was a little over a decade ago that the
Institute of Medicine took us to task for having faculty
isolated from public health practice and unresponsive to
public health professional education and training.
 Since the publication of The Future of Public
Health, much progress has been made in reaching out to those
practitioners in public health and including them in the
curriculum reform and the development of our professional
competencies.
 New training centers funded by the Health
Resources and Services Administration and the Centers for
Disease Control and Prevention have recently been designated
to devise new approaches to training today's public health
practitioners who may have had a career that spans many
different fields and responsibilities.
 Preliminary work at the training centers indicate
that new efforts will tailor courses in skill building to a
work force in need of rapid access to solving developing
community health challenges.
 A distance education, once an experimental
approach to conveying information, is now part of many
schools teaching methods and even degree-conveying programs,
flexibility in our scheduling sites to help the students who
may have full-time practitioner, balancing job and family
demands with the needs to keep up.
 Over the past 10 years, all the schools are now
involved in the community with students and faculty
routinely taking part in programs of local health
departments and other organizations, working with
disadvantaged communities and analyzing tough health
problems from AIDS through substance abuse to child neglect
and abuse.
 Public health is truly a multidisciplinary field
and the scope of community issues requires a variety of
talents, so schools of public health maintain experts in
many different fields.
 Departments of biostatistics, epidemiology, and
behavioral sciences are found in all of our schools.  These
areas are key to the most recent research done in the
community, and it is likely, as I found out again last
night, that many of our faculty are involved in
complementary and alternative medicine projects.
 Certainly, the disciplines and the faculty from
them can be very helpful in future research and education in
CAM, and that brings us to today's conference.  The deans in
the schools, of the schools of public health, have
established a research agenda.  It is a process not
unfamiliar to many health professional schools.
 We meet frequently with our main funding agencies,
the NIH, CDC, HRSA, ATSDR, and EPA.  Each federal agency has
its own set of priorities, and we attempt to match them with
those of our researchers, and I was thinking of that today
when I heard Dr. Cramer talk as one of our biggest funders
across our 28 schools is the CDC, and we work closely with
them.
 Overall, these priorities tend to reflect the
contemporary health problems that faced our country, schools
like the federal government underscore the need to conduct
research which is found to be safe and effective.
 But as our laboratories, the community, and our
discipline population-based research, we are always
interested in new questions to be answered, and it is in
this spirit I want to tell you about a new project that we
have started with HRSA, the Health Resources and Services
Administration, under our cooperative agreement with them
involves public health and chiropractic.
 Chiropractic is one of the largest direct access
health care disciplines in the U.S. with about 50- or 60,000
licensed practitioners in 50 states.  There are all things
that you have heard repeatedly over the last couple days.
 There are 16 accredited colleges, 14,000 students.
 Most of the schools of chiropractory have had at least some
coursework in public health although the coursework is not
standardized and the content varies widely depending on the
instructor interest and the expertise.
 Observers have remarked that these courses often
do not cover prevention topics and the role of the
chiropractor in public health.
 Chiropractors have been involved with the APHA,
the American Public Health Association, for some 25 years,
and have been recognized as a special interest section since
1984, but more significantly, since 1998, chiropractic
health care section has been developing a plan for a modern
syllabus in public health education for chiropractic
colleges.
 The Association of Chiropractic Colleges suggests
in a policy statement that the purpose of chiropractic, of
course, is to optimize health.  With this background, a
project has begun this summer that will develop a model for
teaching chiropractic students public health.
 The Yale School of Public Health and the
Bridgeport, Connecticut College of Chiropractic are
developing a working group composed of chiropractors and
public health experts.  This panel will assess the baseline
attitudes, knowledge, and behavior of students, faculty, and
practitioners in chiropractic towards public health.
 Based on these findings, a workshop will be
convened to analyze and begin the task of developing a
curriculum and a workbook for future students.  The working
group has committed to dissemination of findings and the
workbook for all chiropractic colleges.  Yale and Bridgeport
have indicated that they will evaluate this process and the
outcome of the project.
 While it is too early to say, it would appear that
the spirit of cooperation between two academic institutions
and two very different disciplines would benefit both and
lead to a beneficial dialogue in both disciplines.  The
result we feel will be a healthier community.
 This brings us back to ASPH and my concluding
remarks.  Our member schools recognize that complementary
and alternative medicine is in a growth phase.  The public
interest has been well established.  Conferences, such as
this one, underscore the awareness and the involvement of
the NIH, the FDA, many other federal agencies, universities,
foundations, and the private sector.
 As the research agenda grows, and it will, we wish
to once again remember to ask our colleagues to remember
that the Nation's schools of public health are, in fact, an
ideal environment for complementary and alternative medicine
research.
 Thank you.
 DR. GORDON:  Thank you very much.  Thank you all
for your different, and again, complementary perspectives.
 Are there questions?  Yes, Bill.
 DR. FAIR:  I guess not so much a question as a
comment.  Dr. Segal, I really enjoyed your presentation.  I
think you covered in that presentation about all of the
problems that one deals with in trying to do this type of
research, but it seems to me that you also provided a
solution, and Dr. Cramer alluded to it, and Dr. Lloyd
mentioned it right now.
 It would seem that the natural solution to this
problem is to integrate or to collaborate with the school of
public health or a Bastyr University, although I recognize
it is the wrong area of the country, but it would seem to me
there it wouldn't give you any more time perhaps, but you
could get the energy and the expertise that may not be
inherent in an individual practitioner's backyard.
 What are your thoughts on that?
 DR. SEGAL:  And, in fact, in the Northwest
regions, we have -- I don't know if we have a relationship
right now with Bastyr, I think we have, or my sister
organization of Puget Sound has -- there are in some areas
of the organization, relationships.  For me, those are just
scratching the surface.
 We have the opportunity to do much more research
given the population that I have got.
 DR. FAIR:  So, would one of the things this
commission might consider recommending is ways to improve
the access to investigators like yourself with institutions
or organizations that have the expertise, would that be a
recommendation we should make?
 DR. SEGAL:  One of my fantasies would be give me a
researcher who knows their epi, who knows their biostats,
more than a level of just an MPH, who has a Ph.D. and is
really skilled, and I will facilitate getting the patients,
I will facilitate the alternative practitioners, and we can
put that together.

 I can do it independently within my system, but on
a much smaller scale, but now when we need the huge numbers
that I think that we all feel that we need.
 DR. FAIR:  Would you share your other fantasies
with us as relates to this subject?
 DR. SEGAL:  No.
 [Laughter.]
 DR. SEGAL:  But I will tell you that if you take
the shuttle to New York and if you tell the gal who is
checking you in that your fantasy is you want a certain
seat, she will usually give it to you.
 DR. GORDON:  Wayne and then Joe.
 DR. JONAS:  Also, Dr. Segal, what is the umbrella
organization for the health insurance, what is the name of
that health insurance?
 DR. SEGAL:  It's called the Health Plan.
 DR. JONAS:  Not for Kaiser, but for the umbrella
organization for all of the health insurance plans, there is
an organization -- HIA, which stands for the Health
Insurance Association, yes.  Thank you very much.  I
couldn't remember that.
 I am wondering, first of all, if it would be
possible or why it isn't, that the health insurance plans
aren't already collecting and funding observational data
collection on complementary and alternative medicine to find
out if it is something that might be useful or not useful
for them.
 In Germany, this is occurring, for example, a
number of health plans support and pay for these types of
practices provided that there is an evaluation component to
it, in other words, a good epidemiological or research group
-- you need more than a statistician to do this -- comes in
and does that, and they actually pay for that.
 It seems to me that this goes on in conventional
medicine all the time where they are monitoring and
collecting data on their own outcomes and that this would be
perhaps something that should be explored.
 I would be very curious to know how this can be
stimulated, again, through what policy mechanisms that could
be stimulated, probably not by providing money, but
whatever, and who should we go to, to find that out.
 DR. SEGAL:  Is that the bottom line question is
who do we go to?
 DR. JONAS:  Yes, that is the question.
 DR. GORDON:  The earlier question you asked,
Wayne, is why aren't they doing it.
 DR. JONAS:  Yes.
 DR. GORDON:  So, any ideas you have about that.
 DR. SEGAL:  I can't answer the question about why
the health plans aren't funding it.  I mean if that is the
first question, why health plans aren't funding this kind of
research, I don't have any answer for you.
 My second answer would be the National Trade
Organization exists right here in D.C., and it would take a
phone call or two for me to actually get the answer to your
question about why they are not doing it on a national
level.
 I can say that within my organization, there is a
small amount of dollars going for research.  I think if I
was sitting in their shoes, they would say we have got
dollars going for all sorts of research, this is just one
piece of it.
 DR. JONAS:  Sure, and to how to facilitate that, I
think is a big question.
 Dr. Lloyd, I think the public health schools is
the ideal place to begin to do this, and I am just
wondering, certainly there could be some simple ways that
some of your main funding agencies could stimulate this, and
I bet a lot of the schools would respond.
 Do you have any thoughts about how that could best
be approached for the schools?
 DR. LLOYD:  Well, I think we have already heard
some reasons in the last couple of days what we can do.  For
instance, we need to clone Elaine Cramer and take her around
more to talk to more of the schools of public health.
 I think there is often a question of the
possibility of studies that is not broached, that needs to
be broached.  I think the step by Yale and by Bridgeport
towards bringing people together, where they will not only
obviously talk about education, they will talk about ways of
answering questions, does it work, is it safe, et cetera,
which is part of the research protocol.  I think all those
things are beginning to evolve, but I think it probably
could take a little nudge.
 DR. JONAS:  Are the schools at a point now where
an RFA, for example, soliciting projects of a collaborative
nature like this would be appropriate and could be responded
to?
 DR. LLOYD:  Yes, absolutely.  I think, as a matter
of fact, it happens to be that one of the senior public
health people at Georgetown told me that their
biostatistician is in the midst of just writing something up
right now.  I am not sure what aspect that this is, but it
is happening.  We don't have any way of knowing exactly
where it is happening and how large.
 DR. JONAS:  In terms of a federal agency that
might perhaps come out with such an RFA, where, from the
school's perspective, would be the best place for that to
come from?
 DR. LLOYD:  Well, again, the money for the project
with Bridgeport and Yale is coming from HRSA.  A lot of
these research questions about what works in the community
comes from CDC, and a lot of the funding comes from NIH
also.
 DR. JONAS:  Yes, so those three places it would
be.
 DR. GORDON:  Thank you.
 Joe and then Effie.
 DR. FINS:  Wayne anticipated my question to Dr.
Segal, and I was going to ask you more specifically about
CQI, which is continuous quality improvement, a way of
marrying data collection and recordkeeping, so that you
actually have a record that is usable perhaps for assessment
of quality, but also collection of standardized data, and
how it might fit in with NCQA, which is the accrediting body
that assesses whether or not managed care is up to snuff,
and whether or not it will be productive to engage in
dialogue with them, so that plans would collect the
requisite data to assess the dollars that they are spending
in the care that their patients are receiving.
 DR. SEGAL:  I am not exactly sure if there is a
question there, and so if my response is not what you are
going after, please ask me again.
 I will give one small example.  NCQA likes
functional status data, so you can look at an FS-36, but
they actually like an FS-12 even though it is not as strong
an instrument.  So, we will in a pain program that I run,
that is a mindful meditation, cognitive behavioral, a little
yoga movement stuff program -- we don't use all those words
when we publicize it -- but we do pre- and post-treatment
FS-12's to look at just that, because we are expecting NCQA,
I am just waiting for NCQA to come and say, so, does your
program make a difference in functional status, and I can
say yes, it does, and I have got the numbers.
 So, we are just starting to roll out those kinds
of instruments where it is appropriate.
 Does that address your question or not?
 DR. FINS:  Well, I guess one thing that we could
recommend is that for accreditation and Medicare eligibility
and federal entitlements, that there is adequate assessment
of functional status.
 DR. SEGAL:  Actually, NCQA is in the process of
doing that, as I understand.
 DR. FINS:  And maybe it shouldn't be an FS-36, it
should be 50, so we get into mindfulness, you know, as an
extra indicator.
 DR. SEGAL:  I think it is a wonderful idea,
absolutely a wonderful idea.  I support it entirely.
 DR. GORDON:  Effie.
 DR. CHOW:  Wayne and Joe have taken care of some
of the questions, so I am left with one question, but I
really appreciate this panel and giving such clarity and the
obstacles, and you have given a variety or the variation in
your case you gave about acupuncture, about how the
diagnosis is different when they go to the practitioner and
then each person with the same diagnosis could be treated
differently.
 That, I think pinpoints some of our concern, much
expressed concern elsewhere, too, about the individuality of
treatment and that we can't treat everybody the same.
 Do you have further comments about that or
recommendations about that?
 DR. SEGAL:  I actually do because if you come to
me and you need a hernia surgery --
 DR. CHOW:  There are over 100 different diagnoses
for hernia in China --
 DR. SEGAL:  No, I was actually coming back to
Western medicine.  You come to me and you need hernia
surgery, there is multiple ways to go after repair of that
hernia surgery, and within one surgeon may choose a
different way with you or your twin sister.  So, I don't
know that we actually have to say the acupuncturist must put
the needle in, in exactly the same spot on the next thousand
patients for your back pain.  I don't know that it has to be
done.
 We would have to sit down with the Elaine Cramers
of the world and work that out, but I think it is workable
out.  I don't think it's actually rocket science, I think we
can do it.  Maybe that didn't answer your question.
 DR. CHOW:  And then what about addition of
counseling and things like that, the emotional, the mind,
and spiritual along with the actual needle implantation?
 DR. SEGAL:  For me, that is very easy.  The field
of psychoneuroimmunology is 20, 30 years old.  The work of
Adler and Engel, I guess, from Rochester is well
established.  There are ways to go about that research, and
I think you can take that as an arm or take that as part of
a piece as you say doing acupuncture, and you can look at
it.  It's a piece I strongly support.
 I don't know if that answers your question.  That
doesn't answer your question?  I think there is research out
there, and there can be more research.  You can look at the
work at Ohio State of Kendicott Glazer [ph] that says what
are the hormones and neurotransmitters that change when you
do mind-body studies, and it is there.
 DR. STANDISH:  Jim, could I just respond to that?
 Is that okay?
 DR. GORDON:  Sure, please.
 DR. STANDISH:  This issue about individualized
treatment is so important, and one of the potential
solutions is taking a whole system and looking at it as an
algorithm.
 I think each one of us who does complicated
therapies, as most CAM therapies are, if you really sit down
-- it is not rocket science -- you can just say that it is
an "if then," and you have flow charts of how you end up
giving a particular set of therapies for a patient.
 I think if we were to ask practitioners in a study
to develop those algorithms and sort of formalize them, that
we can do individualized therapy inside of a clinical study,
I think that is possible.
 DR. LOW DOG:  I would like to just continue on
that theme a bit.  One of the things that has always been
interesting and also challenging for me with this type of
therapy, well, with any therapy -- I am going to include
Western medicine -- is that most of our studies have worked
very hard to remove the role of the healer.
 I mean that is why we do double-blind and
randomized trials is so that nobody knows who is getting
what patient or practitioner, where, in reality, my own
belief is that the role of the healer is extremely important
in the relationship and that in complementary medicine, what
I hear from many of my patients who go where they have more
time than a seven- or 10-minute HMO visit, when they have
more time, is that they have a deeper sense of partnership
or relationship with the practitioner that they are going
to, that they spend 45 minutes or an hour, that they really
listen to them, they are exploring emotion, they are
exploring why do you think you are sick, all these kinds of
things.
 I think that when we are studying, you know, does
ginkgo affect dementia, well, that is kind of an easy thing,
but when we are talking about modalities, when we are
talking about acupuncture or naturopathy, I guess what I am
trying to ask is shouldn't we, if we really want to
understand the impact of many of these systems, shouldn't we
also be looking at what makes certain practitioners perhaps
very effective at what they do, so that we could take that,
that they do well, and try to teach that.
 I mean it is like if acupuncture works for
migraine, great, then, we could use that information to
perhaps even perfect better techniques with acupuncture in
migraines, but if we found that it was no better than
placebo, but placebo was 28 percent, perhaps we could still
study what was the psychological impact of why 28 percent of
both groups got that, what happened.
 So, I guess my question is, in all this
randomized, double-blind trial -- I am primarily into botany
and plants, so my model works pretty well for the double-
blinded RCTs -- but what I am hearing a lot or what I hear a
lot from complementary practitioners is that it is an
artificial trial, it is more than individuation is what I
have heard.  It is more than just individualizing therapy.
 There is a relationship.  Physicians used to have
this very much, like the home visits that you went on.  I
don't know how you measure that, but it seems that we need
to come up with instruments.  Leanna, I think that you
should be doing this up at Bastyr, studying the relationship
of the patients and the practitioner as a part of the
modality.
 DR. STANDISH:  You know, that is such an important
issue, the practitioner effects, and I guess my response is
this.  Let's go back to this question does comprehensive
naturopathic medicine really help women with breast cancer
as an example of the question.
 See, for me, I just want to know whether what I do
makes a difference first.  Now, it could really be, as many
detractors have said, it is just because you are spending
more time, it is the relationship, it has nothing to do with
the therapies or the actual modalities that are being
applied.
 That is a secondary question.  First, I want to
find out if what we do as a practice makes a difference or
not.  If it does, then, the next place to go is, well, what
is making a difference inside of the practice.  There is now
a whole field of research in this area, and it is a
tremendous amount of work, but once again it is solvable.
 DR. LOW DOG:  I don't think it has to be a
detractor.  I am confused by that whole thing, that if it
was the amount of time or the handling, if that was what
actually did affect that, that is good information to know.
 DR. GORDON:  I am going to interrupt just for a
minute.  I want to let everybody know we can go on, and it
is now almost 4:30.  We are going to take a five-minute
break, and then we are going to come back and we have one
more panel.  It is not that anything anyone is saying is not
valuable, it is just a question of time.
 With that in mind, that is fine.
 Tom.
 MR. CHAPPELL:  Tieraona, I think Dr. Templeton
would be very interested in that question because that
really is a spiritual, the partnership or the relationship.
 DR. GORDON:  I have one very brief question, which
is NCAM currently funds a number of centers.  Leanna, you
were director of an OAM-funded center.  I am wondering how
you think the centers that are funded might provide some of
the assistance that Dr. Segal was talking about and that
seems to be so necessary to so many people.
 DR. STANDISH:  Oh, I think the centers could play
a very important role in Best Case Series in providing
methodological support, such as Dr. Cramer could do, yes.
But, you know, it is funny, it really hasn't happened to the
extent that we had hoped, and I think we need to put our
heads together to really answer why has that connection
between the CAM practitioner community and the centers not
really jelled together, and I don't have an easy answer.
 DR. GORDON:  Thank you.
 Joe.
 DR. FINS:  I just want to make the observation
that this problem is not unique to CAM research and that
there is a universal problem even in major academic medical
centers that have departments of public health, the need to
set up a kind of biostatistical infrastructure through a
CRC.
 So, I think that we are focusing on the nuances of
CAM research, but the epidemiologic challenges are out
there, and all of the challenges that you mention are time
and energy and motivation is more of a generic than a
specific problem.
 DR. GORDON:  Effie.
 DR. CHOW:  I think that is true.  The only thing
that makes a difference in this case, paradigm number 6
perhaps, medicine, is the energetics that is new now -- not
new -- bringing ancient into the new and the adaptation of
the old ancient theory of chi or ki, or prano or mano, that
makes the difference.  We have to look at it with different
eyes.
 DR. SEGAL:  I agree.
 DR. GORDON:  Thank you.  Thank you very much, I
appreciate it.  We may come back for further suggestions
about moving this field ahead.
 We will take a five-minute break and then we will
come back for the final panel.
 [Recess.]
 DR. GORDON:  This is going to be another panel on
Federal Agency Support for CAM Research.  One of the things
that we feel is very important is to look at although the
bulk of funding, as you have heard, federal funding comes
through NIH, it is important for us to look at the
opportunities that are arising and that are being made by
other federal agencies, as well.
 So, we have asked three people to speak about the
issues, two in person and one hopefully by phone.
 We will begin with Dr. John Demakis from Veterans
Affairs.
 Thank you both for your patience with us.
 Session XII: Federal Agency Support for CAM Research
 DR. DEMAKIS:  Thank you, Mr. Chairman.  It is an
honor for me to be here representing the VA.  I am sorry Dr.
Burris, who should have been here, had a last-minute
emergency and asked me to fill in.
 First, I will tell you a little bit about the VA.
 The VA, as many people may not know, is not simply a large
health care delivery system, which it is, of course, it also
is a research granting agency.  It has a line item from
Congress to perform research in the Veteran Affairs
hospitals.
 This gives us a very unique opportunity, not only
to deliver care, but also to do research with the patients
we give care to.
 As far as health care delivery, the VA has over
170 hospitals, over 200 nursing homes nationally, and many
hundreds of clinics, both hospital based and community
based.  We have almost every type of long-term care service
available including hospice, respite care, and many others.
 We care for approximately 4 million unique
veterans every year.  We also, as I said, are a research
granting agency.  We have a line item in the federal budget.
 This last year it was $320 million was granted to the VA by
Congress to do research as an intramural program.
 In addition, our investigators and our clinicians
in the VA successfully competed for another $370 million in
other federal grants from NIH and about another 200 million
in non-federal grants.
 The VA also has a very large cooperative trial
program.  You heard from the lady who was sitting in this
seat a few minutes ago how difficult it is to do cooperative
trials.  The VA, in fact, has several centers dedicated to
doing cooperative trials.  Traditionally, we will have a
minimum of 10 or 15 hospitals, and our largest cooperative
trials to date, we have 120 hospitals enrolled.
 These centers have their own IRBs, have their own
data monitoring boards, have their own specialists in
knowing how to do randomization, methodologic studies,
statisticians, et cetera.  We have done quite a few
cooperative trials, and interestingly enough, we have quite
a few ongoing in CAM right now.
 Let me tell you a little bit about what the VA is
doing as far as CAM goes.  For a little over 10 years, the
VA, out of that federally-appropriated budget, has funded
$60 million worth of research into CAM, 9 million alone in
1999, 6 million in 1998, et cetera, but a total of 60
million in the last 10 years.
 Likewise, VA investigators -- by the way, that was
475 individual projects -- in addition, the VA investigators
have competed successfully for another 970 projects over
these last 10 years from other agencies, for a total of $92
million.  The two of those figures together comes out to
$152 million spent on CAM research in the VA.  About a third
of that the VA funded, and two thirds funded by other
agencies.  That was 1,300 or 1,400 projects.
 In addition, the VA researchers did another 2,000
projects which are listed as CAM projects without funding.
This was done locally, on their own, through different
mechanisms that only they know and we don't bother to find
out.
 The types of studies we are either doing or have
done in the last 10 years including studies on acupuncture,
antioxidants, aversive therapy, behavior therapy,
biofeedback therapy, counseling, various types of
interventions, electromagnetic fields, and I think as you
can see, it sort of covers the spectrum of CAM.
 I have more details, by the way, if anybody would
like them.
 In addition to the research that the VA is doing
in CAM, the VA recently awarded a contract to survey
alternative practices as they might apply to our system of
health care, elements of the report which would include the
current state of use and familiarity with CAM practice
within our system, a review of the VA's patient database,
and a literature-based assessment of the applicability of
CAM practice to VA patients, an evaluation of the state of
alternative practice in the private sector, and an appraisal
of the cost effectiveness of CAM practices.
 Unfortunately, the report has not yet been
completed.  We do, however, have some survey data regarding
the state of alternative practice in the VA facilities.
While knowledge and even awareness of CAM practices varies
widely among providers and facilities, most facilities in
our system provide some such treatments.
 These have generally included modalities, such as
acupuncture, diet therapy, yoga, biofeedback, relaxation,
music therapy, and Native American therapy, such as sweat
lodges.
 These practices usually reflect the presence of
practitioner advocates and managerial willingness to accept
the implementation of these programs.  Most facility
management teams were reported as pragmatically oriented and
described as having no biases for or against CAM treatments.
 The main concerns expressed related to the highly
variable training and credentialing of practitioners, the
lack of sound scientific evidence supporting the use of many
of the CAM therapies, and uneasiness about budgetary impact
of alternative practice in an environment of constrained
resources, such as the VA presently finds itself in.
 I will stop there.  Those are the few remarks I
had planned and will be happy to take any questions at the
end of the session.
 DR. GORDON:  Thank you very much.  We appreciate
it.  I am sure we will be coming back to you with some
questions.  It seems to be an impressive amount of activity
at the VA.
 Our phone caller perhaps will come later.  For
now, Dr. Craig Vanderwagen representing the Indian Health
Service.
 DR. VANDERWAGEN:  Thank you, sir.  My name is
Craig Vanderwagen and I am the director of Clinical and
Preventive Services for Indian Health Service.  I am happy
to be here.  I am from Zuni, New Mexico.
 The other thing to be said is that again in the
world that I live in, the complementary and alternative
practices are very well funded, 16 billion to NIH to
research, allopathic interventions, which in the world that
I come from are the alternative or complementary practices.
 I sort of joke about that, but I think that that is true
for many societies.
 Let me say that Indian Health Service is the
federal partner for an Indian health delivery system.  The
other partners in this, of course, clearly are the tribal
governments and the tribal programs, and a very small amount
of funding, unfortunately, is provided to urban Indian
programs to try and address the health needs of Indian
people.
 As my colleague in the VA indicated, certainly we
are never happy with our funding which right now amounts to
about $1,400 per capita compared to Medicaid at about 3,000
per capita, and the VA at about 5,000 per capita.
Obviously, we don't have much squeeze room for activities
other than the provision of basic patient services.  We are
not authorized or funded to provide research.  We are
authorized and funded to provide health services to Indian
people, and our mission is to elevate the health status as
best we can to the highest possible level.
 Now, we have had some success in that the life
span for Indian people since I was a child has increased
about 40 years.  Infant mortality now is essentially at the
U.S. average in most places.  The exception to that is the
Dakotas where, in fact, infant mortality is about twice what
the national average is.
 But we have had some success, and that success has
come because we have empowered the Indian people to control
and operate their own programs.  That is, those of us that
are public health providers know that changes in health
status emanate from the community itself, not from somebody
externally applying some process to how health practices
occur and the behaviors that people choose.
 I personally have been the agent for the federal
government in transferring about $500 million to tribal
control to operate their own programs and design them in the
ways they want to as the law provides for them.
 The role of traditional healing practices in those
communities is variable.  There are 558 federally recognized
tribes.  They are each a sovereign and independent entity,
and we deal with them on that basis.
 Their cultural practices are not homogenous, they
are very heterogeneous, and consequently, any attempt on our
part to direct and legislate through standardization,
certification, credentialing, et cetera, for traditional
healers is ludicrous on the face of it.
 More importantly, the moral basis on which we
operate would prohibit us from expropriating what is the
patrimony of these people in some large measure.  Because
their traditional healing practices emanate commonly from
religious and spiritual values, it is not appropriate for
us, as a federal entity, to attempt to bureaucratize those
processes and expropriate them into a federal system.
 Now, that presents us with some dilemmas at times.
 On the other hand, it is very positive, and we have found
great support for this notion in the World Health
Organization and particularly the regional entity OPS/PAHO
in its initiative for indigenous people in that a major
element of that is the respect, the support for the use of,
and appreciation and respect for, those traditional healing
practices.
 We work very closely with Los Pueblos Indigenas,
the American Centrel, the America del Sur, with indigenous
people in Central and South America.  We have a
collaborating center for Indian health or indigenous health,
not traditional practices per se, but indigenous health on a
more broad basis in the works with PAHO at the moment.
 So, where are we with research on traditional
practices?  We do not fund or support traditional practices
research at this time.  We believe that there may be
interest on the part of some Indian communities in this.
 Some Indian communities are very well organized in
the way they practice and work with traditional practices.
Navajo, for instance, has a Medicine Man Society that is
pretty big.  They may have interest, but our recommendation
to you would be that if you are interested in exploring
research in traditional practices as utilized by American
Indians and Alaska Natives, you need to work with tribal
governments to establish those research priorities.
 They are not unfamiliar with research.  In fact,
they will tell you they have been researched to death in
some way.  They understand the technical jargon that we
practice in that they understand what IRBs are.  They have
IRBs, and they have a mechanism for controlling research in
their environments.
 NIH has helped greatly in the last year by
announcing funding for Native American Centers for Health
Research.  This can be a platform for focused research
whether it is in the area of traditional healing practices
or other research practices, and an absolute requirement for
funding of those centers is that they are governed by tribal
entities.  It may be the University of Arizona, it may be
Hopkins, it may be these places, but priorities and policy
will be set by Indian people, not by researchers.
 Those platforms, however, provide a great
opportunity for exploring with tribal people how they might
want to explore the impact, the efficacy, the outcomes of
traditional healing.
 We have actively supported this practice.  We have
constructed our facilities in such a way that we may have
specialized healing rooms.  If you go to Navajo, our
facilities are constructed with a healing room that is
centered and placed in a proper and appropriate manner.
 Many of the tribes have a whole program of
traditional healing services that they provide in
conjunction with the allopathic programs.  So, it is an
important part of healing in Indian communities, and I
resonate very much to the notion that the healer has a ton
to do with this, and I think Indian people would see it in
some large measure in that way, as well, and there are
opportunities in exploring priorities and how they would
like to proceed.
 I apologize for our director, he is not here
today.  He is actually out in Indian Country, which is where
he is probably 50 percent of the time, which drives some of
our colleagues in this building crazy, but that is where our
people are.  That is who we serve.  That is what we exist
for.  So, you are stuck with me today and I apologize.
 DR. GORDON:  Thank you.  Thank you for coming.
 Thank you both.  I think we are not going to wait
for the phone call.
 You both represent very interesting and very
special groups of people.  I would like to ask Dr. Demakis,
how do you choose what kind of research you are going to do
on CAM therapies, and are the priorities set specifically by
the specific needs that veterans have?
 DR. DEMAKIS:  We do in certainly different ways.
We can indeed put out a solicitation as we have done on many
of these when we perceive there is a need and there is a gap
in the knowledge we have or on the research we are doing.
 We have oversight committees that look at our
research portfolio and where there are gaps, they recommend
that we put out solicitations to that effect to fill a gap.
 So, that is one way we can do it.
 Another way, most of our research is done from our
investigators in the field, our practicing clinicians.  I
should tell you also the VA research is intramural, only VA
clinicians can apply for VA research funds, so the doctors,
nurses, social workers that take care of our patients are
the only ones that can apply for our research grants.
 I have rattled off to you the numbers of how much
CAM research we are doing.  For the most part, this came
from our practitioners themselves.  They perceive the need,
they perceive the idea, and they came to us.  Much of our
resource starts with a concept paper, a letter of intent
that, once approved, they then go on to a full proposal that
has to meet a rigorous merit review.
 DR. GORDON:  Thank you.
 Joe.
 DR. FINS:  Dr. Demakis, I just want to thank you
for your service to those who serve the Nation.  It is
vitally important and, having lots of friends who are
academics in the VA system, I know the good research that is
being done and how collaborative it is.
 I just wanted to ask you about the structure of
the organization of the CAM research, is there any kind of
infrastructure, because unlike the national center at NIH,
you are dispersed throughout the entire country, which
raises the possibility of having expertise of the sort that
you describe available, so is there any kind of organization
of the people who are doing this that could be tapped into
from outside sources and foster the kinds of synergies that
we have been talking about for the last two days?
 DR. DEMAKIS:  Did you say you were a veteran?
 DR. FINS:  No, I am not, my father is.
 DR. DEMAKIS:  Because, you know, we don't like to
take thanks from a veteran, we say thank you to them,
because they are the ones that have made the sacrifices.  We
never forget that, we try to instill in our younger
colleagues.
 No, the answer to your question is we do not have
an organized approach to doing CAM therapy.  It has come to
us from the field for the most part.  So, I can tell you how
many projects we have in any of these areas.  We have got
them all categorized out.  We have not sat down and said we
need more of this and more of that.  These are what has come
and is passed through merit review.
 DR. FINS:  So, just to make this a question, would
the VA be interested in funding our resources to sort of
organize that in an organized way?
 DR. DEMAKIS:  How do you mean fund the resources?
 DR. FINS:  Well, in other words, one of the things
that we have the ability to recommend is funding for an
office for complementary, alternative medicine research
activities within the VA health care system.  It seems to me
that for very little cost, you know, you have a budget here
which rivals what is going on at the NIH, but it is
extramural in a sense, it is outside, it is around the
country.
 So, for a small incremental investment, we could
organize that conceivably and leverage that expertise, so I
am wondering if that would be something that you and your
colleagues would be responsive to.
 DR. DEMAKIS:  I don't know if our director would
be responsive there, that is an interesting point you bring
up.  The research in the VA is organized among four major
types - basic medical research, which is usually your wet
lay-up, your bench research, and that sort of stuff,
rehabilitation research, health services research, that
happens to be what I do in outcomes research, and finally,
cooperative trials.
 So, we have not listed them by that sort of
special category, and I would be a little bit concerned
about that, because there could be many other special
interests that would want their special interests carved
out, as well.
 So, within the four areas, we think we do pretty
well.  Now, I understand where you are coming from.  There
is not an organized way of looking at CAM research, and that
is something I think we could take a look at and explore
better, and I think we would certainly welcome ideas and
thoughts to do that.
 We could put out new solicitations, you know, very
focused ones.
 DR. GORDON:  I just want to say that Bill Fair,
Charlotte Kerr, and Tom Chappell have to leave in a few
minutes.  I am wondering if any of you who has to leave for
a plane has a question that you want to ask before you go,
and then we will come to the other people.
 Bill.
 DR. FAIR:  Dr. Vanderwagen, I had a question.  You
mentioned, and Tieraona mentioned that earlier, about the
impact of the healer, and, of course, this is true of any
medicine, it is true of science.  Durkie [ph] said,
"Scientific observation is the interaction between the
observed and the observer."
 So, I think that this is a factor that is true in
any healing tradition.  You mentioned the Society of
Medicine Men, was it?
 DR. VANDERWAGEN:  Yes.
 DR. FAIR:  I didn't get from your presentation
where we would go if we really wanted to find out what are
the CAM areas that might be worthy of investigation.  Would
it be the Society of Medicine Men?
 DR. VANDERWAGEN:  Again, we are missing my good
friend and colleague, Buford Rolin, here, and I think Buford
will be an ongoing source for you of counsel and guidance in
that direction.  I was happy to hear that his coronaries are
slick as can be, and I will see him in Nashville next week.
 There are a couple or three ways to go.  I mean
there is the National Indian Health Board, which Buford was
the former chairman of.  The National Indian Health Board
reflects the health interests of the tribal governments
nationwide.  It is representative, they are elected
representation, and that group is a policy entity that has
some merit as a policy entity to look to for counsel and
advice on these matters.
 That becomes then an entree point for specific
medicine groups, whether we are talking about the Navajo
Medicine Men Society in Alaska.  There are collections of
healers.  A sidebar comment here.  I mean the power of an
individual healer, as an individual, is memorialized in many
ways in many Indian societies.
 In Zuni, where I grew up, there is the Nawayquay
[ph] and the Nawayquay is the Medicine Society whose healing
power is conferred on them by the fact that they survived
whatever that illness was, and therefore, their healing
power in that environment is totally through that individual
because of the power.
 That is a sidebar note about the impact of an
individual healer and how that could be even
institutionalized in some societies, but, yes, I think the
National Indian Health Board is a nice policy tribal-
directed entity that offers an entree into a variety of
tribal environments that reflects those tribal governments.
 That is who we think the entree point would be.
 Now, there is also a National Council of Urban
Indian Health here in this country, and they represent or
speak to a set of different interests, and that is Indian
people who either by the government's intent or by economics
moved into urban environments and do not have the kind of
tribal ties perhaps that folks in the reservation
environments would have.
 That is significant.  That is 45 percent of the
Indian people in this country.  So, that is a significant
entity, as well, and I think they have a point of view and
operating realities that are somewhat different than if you
were just focused on reservation-based Indian people.
 DR. GORDON:  Thank you.
 Wayne and George and then Effie.
 DR. JONAS:  I have two questions, two and a half
questions.  Dr. Demakis first.
 I didn't see in the materials, and perhaps I just
missed it, what is the research budget of the VA?  What is
the annual research budget of the VA?
 DR. DEMAKIS:  The VA is appropriated $321 million
last fiscal year, however, that is sort of misleading
because since the entire program is intramural, we do not
pay salaries nor indirect costs out of that.  Every hospital
is expected to be both medical care, research, and
education.
 So, if you were to take the costs of the salaries
and indirect costs, that would more than double that amount.
 So, a much more honest figure than 321, it would be more
like 700 million.
 In addition, our investigators and clinicians get
about that much more from other federal and non-federal
agencies.  So, there is about a $1.2 or 1.3 billion of
research going on in the VA, of which 321 million is funded
directly by Congress.
 DR. JONAS:  Amazing.  Actually, I didn't realize
the scope of that.
 It has always seemed to me that the VA would be an
ideal place to do demonstration projects, and I am wondering
if there would be some way in which, in the area of
complementary medicine, a demonstration project or two or
three, or now that I hear the budget, four or five, could
perhaps be facilitated.
 DR. DEMAKIS:  I think so.  I think that is quite
appropriate.  As I rattled off the figures, again, it is not
as if we are doing a small amount, we are doing quite a bit
already, but we do expect the investigators to come forward
with the ideas.
 They are all looked at carefully and they all take
their place among many other research that is going on.
 DR. JONAS:  So, all of this is within VA
investigator-initiated stuff.
 DR. DEMAKIS:  Yes.
 DR. JONAS:  So, there are no specific RFAs or
types of things within the --
 DR. DEMAKIS:  We put out a lot of RFAs, as well.
We certainly could put out an RFA specifically for CAM.  If
I were to look at all of our RFAs, I would probably tell you
CAM is covered in it, maybe not as -- maybe we could be more
specific, but certainly we welcome research and proposals in
innovative new therapies.  With the amount of funding we
have, I think you can see we do not discriminate against
CAM.
 DR. JONAS:  Right.  I think it would be very
useful to look at what is already going on.
 DR. DEMAKIS:  I think what you see is the interest
of our clinicians, and we probably don't have a lot of
clinicians who have special interest in certain types of
CAM.  Most of our researchers are physicians, and that
probably limits again the type of research that is being
done, CAM especially, but any type of research.
 DR. JONAS:  It is also an advantage in many cases
now.
 DR. DEMAKIS:  Oh, yes.  We have a terrible gap in
rehabilitation research.  Although we have a large
rehabilitation research group, when you look at the VA and
the type of people we care for, we should be doing much more
in rehabilitation research, but unfortunately, the
clinicians doing rehabilitation are often not well trained
in research methods, have a hard time getting projects
funded.
 That gets back to a question that was asked of the
previous panel, that I think a lady was alluding to.  Most
clinicians are not trained to do research, and those that
are trained, they are usually not the ones that would be
interested in this type of research, but that is a problem.
 DR. GORDON:  Do you want to yield for a moment to
Dean, because he has to go.
 DR. ORNISH:  I am really sorry I have to go.  I
thought we were going to end earlier, and I have got to fly
to the West Coast, so I apologize.
 I wanted just to say in many of the kind of CAM
interventions I can think of would really fall into three,
if not all four, of your areas of expertise, I mean your
rehabilitation, your health services research, cooperative
trials, even basic looking at mechanisms.
 So, what percentage of your studies are RFA
directed and how many are investigator directed, just
ballpark, half, two-thirds, one-third, something?
 DR. DEMAKIS:  I am not trying to evade the
question, I really don't know.  For each of the four
sections it probably is different.  For cooperative trials,
I think it is almost all investigator initiated.  That is
maybe less than a quarter of our total budget.
 I would say half the research budget is biomedical
research, and that is almost all investigator initiated.
For health services research, I would say probably our
stuff, probably at least half of it is RFA initiated, the
other half is IIR.
 We put a huge push on quality improvement.  I
could tell you all of our research is quality improvement,
but we have a new endeavor called "QuERI," Quality
Enhancement Research Initiative, in which we have made a
concerted effort to get the clinicians, the managers, the
policymakers together to look at what are the key areas they
need to do to improve quality, taking available research
findings and applying it to the patient.
 What we find is there are a lot of good research
findings out there that are not being used and have not been
translated into either policies, practices, attitudes to
improve patient outcomes.
 So, we have made a concerted effort in eight
fields.  They are clinical areas - diabetes, heart disease,
spinal cord injury, HIV/AIDS, mental illness, stroke, and I
probably forgot one or two -- substance abuse.  These are
the highest number of cases we care for in the VA.
 We have taken those, and we have made a concerted
effort to improve quality outcomes in those areas, and
translating our known findings.  That is a very difficult
thing to do, to take a research finding and to get it into
the practice.
 DR. GORDON:  Thank you.
 DR. JONAS:  Dr. Vanderwagen, I have really two
questions for you.  It sounds like you have really
decentralized your health care delivery, and I am extremely
curious about whether you have looked at the effect.  You
have said it has been highly successful.
 Now, I assume that by decentralizing it, you were
not in the process of regulating, licensing the
practitioners in their particular practice to practice
medicine or this type of thing, so I assume that many of
these deregulated practices have practitioners in them that
would not necessarily fit into a category outside of the
Indian Services as a medical doctor or something like that.
 So, I am just wondering how that aspect of it has
gone.  It sounds like you said it has gone very well, but
the thing I am mostly curious about is have there been any
increase in adverse effects due to that, have there been
problems with quality in terms of health care delivery, have
people gotten inappropriate practices, for example, and not
gotten appropriate practices because of perhaps less well
trained practitioners from a conventional point of view, or
vice versa.
 I mean you could say have not gotten appropriate
Native American practices because of inappropriate training
on the medical side.
 DR. VANDERWAGEN:  Well, the second arm is harder
to know anything about than the first arm, but has the
transfer of the programs to tribes led to any change in the
quality of services provided, and the answer to that is no.
 What is the evidence to support that assertion?
The quality of care is measured by the usual industry
standards, and that is JCAHO, AAAHC.  Every one of our
facilities is accredited.  In fact, the tribes have
demonstrated higher scores on accreditation site visitation
than the federal hospitals is the reality.
 Now, there are a couple of reasons for that.  One
is the tribes have a lot more latitude to bring in other
revenue streams.  Certainly, we capture about a half a
billion a year in revenue from Medicare and Medicaid, and we
have the authority to do that, but the tribes are able to
tap other revenue streams, whether it is gaming money or
whether it is other funds, tribes are investing in the
program beyond what the federal government gives them.
 As I have suggested, the federal government is
failing to meet its obligations is the reality.
 Now, as to providers per se, we have hired
providers and called them mental health technicians when, in
fact, they were traditional healers.  You have to put them
into some kind of GS place to cover them.  So, we would hire
them as "mental health technicians," in quotes, but, in
fact, there really was traditional healing practices.
 Now, that varies from location to location in how
the tribe use -- how actively they want to be involved in
that clinical environment.
 The other piece of evidence that I would offer you
is that tribes are covered under the Federal Tort Claims Act
when they take over, just like federal facilities are.  We
have seen an increase in tort claims in Indian Country over
the last 10 years, but that rise reflects the same kind of
rise in the balance of the society vis-a-vis litigation
activity, and it is not focused in any way on traditional
practices as opposed to allopathic practices at all.  In
fact, it is all exclusively allopathic practices.
 DR. JONAS:  So, it is actually less
proportionately in traditional practices.
 DR. VANDERWAGEN:  True, because I mean the fact of
the matter is, and, of course, I was raised in a pueblo
environment, so I have a slightly different view than some,
but traditional practices have to do, the worth of those
practices is measured, not by how much money the federal
government would pay them as addenda under a contract
arrangement, it has to do with how much the family and the
patient themselves put into that process.
 So, it is difficult to monitor the utilization in
some ways, because we aren't running a cash register when
those transactions occur, and that is how we generally
monitor utilization, rates of failure, and so on, in the
society is when the cash register rings.
 DR. JONAS:  So, there is some data that you can't
capture really in terms of that.
 DR. VANDERWAGEN:  Right.  It is more anecdotal.
Now, how those centers that I described to you, and how CAM
might reach out to tribal communities and offer them tools
and techniques for examining internally the effectiveness of
their providers, that is a good question, and it is one that
I think some people have an interest in.
 DR. JONAS:  I think it is very interesting, and
you have been able to put them in mental health categories
and somehow gotten away from federal perhaps issues about
their qualifications because they are not required to have
state qualifications if they are on the reservations, is
that correct?
 DR. VANDERWAGEN:  Sure.
 DR. JONAS:  Can I ask just one other question, and
this really has to do with research methodology, the other
one was practice.
 The folks that are working in it, have been
involved in these Native American research centers that you
have talked about, you have mentioned and I believe you
completely, understand data, they understand research.
 My sense is or my perspective is there is perhaps
some value differences here in terms of what kind of data is
useful and should be collected, and I am wondering if you
could mention how that is managed in an NIH-funded set of
centers, how has that occurred.
 DR. VANDERWAGEN:  Well, they just started the
funding process, so we don't have an experience base to
really rely on, but I will give you reflections from the
Association of American Indian Physicians, many of whom have
been researchers.
 Walt Haller runs a program to train Indian
research fellows up at the University of Washington, and I
think that the experience has been that they are willing to
sort of push the limit, and not be constrained by what has
been traditional qualitative or quantitative measures, even
though I think for some people, that has led to some
personal difficulty because their professional colleagues
have a tendency to sort of say, well, now, isn't that just
like what you would expect.  I mean it is sort of a banana
republic attitude, which is the way we have been treated as
a federal agency, too.
 I mean I am speaking now from the perspective of
living inside an Indian world, and so that problem is there
for people, how much are they willing to risk scientific
credential, going with their heart and their society telling
them is appropriate versus what the dominant mainstream,
whatever you want to call it, society says is appropriate.
So, it is a challenge for those researchers.
 DR. JONAS:  I guess it is something we should look
at in great detail.
 Thank you very much.
 DR. GORDON:  George, Effie, and Joe.
 DR. BERNIER:  Dr. Demakis, I want to thank you for
testifying today.
 Over the last three or four decades, the VA really
achieved a place of enormous prominence in terms of its
research.  The classic studies on coronary artery disease,
bypass versus angioplasty, really became the world standard.
 With all that success behind the program, you, as
an institution, have made the decision to pursue in a much
greater way CAM.  We have been hearing the last couple of
days how hard it is to do something like that.
 Do you have feelings about, one, how easy was it
to accomplish, and two, what is it about the VA system that
lends itself to such rapid change?
 DR. DEMAKIS:  Rapid change, I don't know.
 DR. BERNIER:  Quasi-rapid change.
 DR. DEMAKIS:  Most of the studies that we have
here, that we have funded, as I said, have come from the
investigators themselves, and I think all that showed you we
have not been prejudiced against CAM, rather, we have taken
every proposal and every grant on its worth, and it has to
be rigorous.
 Our cooperative trials are done in a very
interesting way in the VA.  You have to first bring up about
a five- or seven-page concept paper, which has some of the
background, why is this a compelling question you want
answered, and if it is decided this is worthwhile looking at
-- and many of the CAMs have been that way -- the VA, in
their Cooperative Studies program, will then allow you to
set up a committee of 10 to 15 experts from around the
country, and they will pay for them to come together twice,
face-to-face meetings, to put together a proposal that could
pass merit review.
 It is not surprising when you bring in 10 to 15 of
the experts, there is about an 80 percent funding rate of
those that get to that point, so that many of our
cooperative trials that we have ongoing or have completed,
have had the benefit of having this type of, shall I say,
executive committee that put together the proposal, and they
are very successful in getting done.
 I think more basically, they have taken pretty
much every proposal and every concept paper at its worth,
and I think have been very good in not showing bias against
any form of treatment.
 I don't know if that answers your question.
 DR. BERNIER:  So, was it easy to do?
 DR. DEMAKIS:  Well, I have been here two years.
The previous 27 years in the VA, I have been running after
VA monies, okay?  I have been on the other end of it in
Chicago.  No, it is not easy to do, but, you know, from some
of the horror stories I hear other places, the VA is
probably as good as can be and gives it a good-faith effort.
 It is rigorous, and it should be rigorous, it should be
rigorous.
 DR. BERNIER:  And I am a veteran.
 DR. DEMAKIS:  I salute you, sir.  I won't ask you
which war.
 DR. BERNIER:  It was Vietnam.
 DR. GORDON:  One of the things I think I heard you
say is in some ways it is easier to do research in the VA
than most anywhere else.
 DR. DEMAKIS:  Oh, I think so.  As I told you,
first of all, we have a health care delivery system.  We
have one database, national database for all our hospitals,
all our nursing homes, all our outpatient clinics, so it is
very easy -- and these are all rolled up in one place,
Austin, Texas -- so it is fairly easy for us to do large
studies, and not having to develop new databases each time.
 DR. GORDON:  And you are willing to bring together
a committee of experts to help people develop their
projects.
 DR. DEMAKIS:  These are for cooperative trials.
These are traditional, you know, randomized, controlled
trials that you heard so much about just before from the
young lady from -- Cramer, right.  We are experts in doing
that.  We have several centers doing nothing but that, and
it is hard to do, but because of the way the VA is
structured, we are in an ideal situation to do that, and we
do quite a few of them.
 We have five centers nationally, one in New
Mexico, by the way, that do nothing but that, and they have
data monitoring boards, they know how to do the
randomization, they know how to do all that sort of stuff.
It is a lot of work.  You don't just dismember those things
and start again when you want to do new studies.  These are
standing committees that do this.
 DR. GORDON:  Effie.
 George, are you finished?  I am sorry, I didn't
mean to cut you off.
 DR. BERNIER:  I will wait.
 DR. CHOW:  Please go ahead and finish.
 DR. BERNIER:  I also worked in some of the VA
studies, and I must say there was a time that the VA was
extremely concerned that it was going to be dismembered,
that it would be shut down.
 It seemed to me that that was right at the time
that the VA was approaching the crest of its outstanding
clinical research programs, and I think it was the presence
of those programs that deterred that action from happening,
that is, to consign the VA medical system into ashes.
 Is that from your perspective?
 DR. DEMAKIS:  I would like to think so.  The VA
has been a marvelous institution.  I think where the
troubles began with the VA, it was always a sacred cow, I am
sure you have heard that before, but there were always a
large number of veterans serving in Congress, both in the
House and the Senate.
 I think there came a time probably in the early to
mid-eighties where a lot of the veterans, congressmen
retired, and so a whole new set of congressmen came in who
didn't have the same allegiance to the VA.
 Also, at that time, the eighties were more
difficult, I think, the health care costs were rising and
people asked why support a VA medical care program, why not
just, you know, for a while the private hospitals were
having trouble, why not just let them go to private
hospitals and let Medicare take care of them.
 But I think the research and the educational
mission of the VA is what really saved it at the end,
because there was no longer that hard-core veteran serving
in the Congress, where we do have a very deep and very well
respected research program.
 Many of the breakthroughs that you mentioned, you
mentioned coronary bypass, the treatment of hypertension,
treatment of depression, I can go on and on.
 DR. BERNIER:  Nobel prizes.
 DR. DEMAKIS:  Nobel prizes.  Unfortunately, a lot
of people don't realize how deep and how impressive and how
meaningful, what impact the VA budget, the VA research has
had on the care of not just veterans, but on setting the
standard of care for the country.
 DR. BERNIER:  Yes.
 DR. DEMAKIS:  So, I think more and more people
came to realize that and, of course, the medical schools
were adamant, they wanted the VA because close to half of
all medical students and residents are trained in VA
hospitals, that the VA pays for, as a matter of fact.
 So, I think a lot of our friends finally came out
of the woodwork, and I think we have turned the corner.  The
bigger problem, of course, is there is fewer and fewer
veterans, thankfully I guess, that means there are fewer and
fewer wars, but we now have 26 million veterans.
 That is a big drop from where it was about 10 or
15 years ago, and by 2025, if there is no new war, and
hopefully, there will not be, the question is will there be
enough veterans to sustain having a VA, and that is real
question.  Hopefully, I won't be around to worry about that
problem.
 DR. GORDON:  Thank you.
 DR. DEMAKIS:  Thank you for those nice words.
 DR. GORDON:  Effie.
 DR. CHOW:  Some of the comments that I have had or
questions have been sort of answered, but I really
appreciate the two major sort of, I call it monolithic
systems, that is outside of the main system, and the power
that you have.
 I had the pleasure in mid-seventies to explore the
VA, guiding, you know, the potential national health systems
that was coming out with the seven laws, John Kennedy's law,
and all that, so I had the chance to kind of explore into
the system.  Also, I had the chance to deliver Chinese
medicine to the Indians, teaching them through the system.
So, I had great contact with them.
 I am impressed, perhaps you can reconfirm, that if
we had a study with the VA or the Indian system that proved
to be valuable, that you can still move it to your different
centers for multiple research.
 That is what I was impressed with, that once you
have one research carried out and it was proven well, good
potential, that you have the power to move it and do
multiple studies, and this is where I think the Commission
here would benefit from having the alliance with the system.
 Now, is that so?  You are nodding your head, but
is this so?  My question is would that be so with the Indian
health care system, too?
 DR. VANDERWAGEN:  To the degree that Indian people
themselves felt like they owned what went into the process
up-front, then, dissemination or diffusion or replication is
clearly -- I mean Indian people, as you recognize, are
fairly pragmatic.  If something seems to work, they are
going to pick up on it and use it where it fits their needs.
 So, I think the fact that we have decentralized in
the way that Wayne talked about, and we are not a federal
monolith, I mean the initial swing is, you know, give us the
money and get the hell out of the way, I mean that is sort
of one response that went on five or six years ago, but now
the pendulum has swung back because people recognize the
power of shared energy, shared resource, and shared
emphasis, so that even though we don't have the top-down
hierarchy, we now have the sort of lateral or horizontal
diffusional mechanisms strengthened in ways they never were
before.
 DR. DEMAKIS:  I would just say, too, in our case,
we are able to diffuse research findings out to the field
fairly quickly, either to make changes in our practices or,
if we do a developmental trial or a demonstration project,
and it looks very promising, we can then move it along to a
large cooperative trial.
 We had one of the first trials, in fact, in my
hospital, one of my colleagues was the PI, that showed that
hospital-based home care was indeed cost effective.  From
that, we made that into a large cooperative trial involving
15 large hospitals to take a look at that.
 Unfortunately, we found out that that was not the
case once you enlarged it and got a larger power, and that
is the other reason why you do these randomized controlled
trials.
 At our hospital, one doctor was able to probably
make the difference.  It was a well-published study to show
that hospital-based home care was quite cost effective, had
good outcomes, et cetera.
 Once you spread that into 15, 20 hospitals,
however, we were unable to replicate that, and it probably
was the fact that this one person was so powerful --
probably the wrong word -- but so charismatic, was able to
do it, and one person was able to show that, in her hands,
hospital-based home care was cost effective, was better
outcomes, the patients loved it better, but when you put it
throughout the system, in large numbers, we found that
wasn't true, and that is the importance of having
randomized, controlled trials, and not simply taking, you
know, one guy did a few cases and found this, and that's
good.
 The other thing I feel what we can do is we had a
large study comparing two drugs for treatment of benign
prostatic hypertrophy, obviously very common in the VA since
90-plus percent of our patients are men, a very expensive
drug finasteride and a very cheap drug terazosin.
 We put them head to head, and we did a large
cooperative trial nationally and found that the cheaper drug
terazosin was about 10 times cheaper than finasteride and
much better.
 What we did, we took finasteride out of the
formularies of all the VA hospitals.  The VA can do
something like that.  As a result, finasteride use went
down.  Of course, Merck, which had finasteride, was not a
very happy camper, and they helped fund the study, and they
were quite angry, as a matter of fact, but that obviously
was something the VA, we were research agency, found the
finding, and were able to put it into our practice
immediately.
 DR. CHOW:  Thank you.
 DR. GORDON:  Joe.
 DR. FINS:  Dr. Vanderwagen had a lovely phrase, I
believe I got it right.  He was talking about the moral
imperative of not expatriating patrimony.  It raises a
question that I don't think we have ever thought of before,
and I would like your comment on this, but it is sort of the
protection of religious freedom, and whether, you know,
regulating some practitioners in the context of the practice
of a religious belief raises constitutional questions, you
know, much bigger than whether a state medical board could
regulate, and sort of like the Jehovah's Witnesses refusing
blood.
 I just wondered if you would like to comment on
that speculation.
 DR. VANDERWAGEN:  Well, there is a law that
protects Indian people and their religious practices, Indian
Religious Freedom Act.  So, I mean there is a statement out
there.  As an agency, we fully comply.  But there is a moral
leadership principle that is involved there, as well, and
when I alluded to the relationships with OPS and folks in
Central and South America, I mean the globalization effect
for Indian people oftentimes means expropriation of
traditional practices, so a pharmaceutical company can
create a profit engine.
 That expropriation of patrimony becomes a killing
blow.  I mean genocide is still being practiced directly in
many parts of the world on indigenous people.  We stopped
killing Indian people in this country 100 years ago or so,
and there were 100,000 Indians left.  Now there is 2 1/2
million.  The new census may show us more.
 We have achieved a large measure of self-
determination as the principle that we operate within on a
federal perspective with those people, but that is not true
elsewhere in the world, so that that whole principle, the
moral leadership is an important issue, whether it is a
legal prohibition as there is in this country or not.
 DR. FINS:  Can I just ask a follow-up question
that your comment sparks?  We heard earlier during the day -
- at this point I can't tell you if it was in the morning or
in the afternoon because we have been here all day -- but we
were hearing that pharmaceutical firms looking for products
that come out of indigenous communities, and I am just
wondering if you have any thoughts about the appropriate
recompense that comes from the hundreds or thousands of
years of activity that have demonstrated that bark of willow
could have some promise, and, of course, it became aspirin.
 So, how can we think about the proper
compensation, in what kind of ways, and who should we talk
to, to make sure that these communities are rewarded for the
inheritance, as it were, of all that hard work that had been
going on?
 DR. VANDERWAGEN:  One of the problems is that you
are talking apples and oranges because recompense to
indigenous people often has nothing to do with material
wealth.  It has to do with freedom.  It has to do with self-
determination.  It has to do with the ability to control
their own life and world.
 I don't think we always attend to that, and that,
to me, I mean it is a wellness of that society that becomes
the challenge there.  I mean we talk about complementary
medicine vis-a-vis individual patient care, and that is
important and appropriate, particularly in a society that
values individuals as the core and the center, but we are a
traveled society is the more important issue than individual
care.
 Wellness involves the notion of that population as
a whole.  Now, we call that public health in this country in
some ways, and that is not a real popular way of viewing
health in this country in general.  I mean we are struggling
to build back public health infrastructure that has been
decimated over the last 20 years.
 I mean it is a way of viewing what is wellness and
what is our concern about the wellness of people, and while
we may want to research the efficacy and utility of
individual patient therapies, be they looking at the
provider and their impact, be it looking at a particular
modality and its impact, and so on, and my colleague from
CDC articulated those questions very nicely, but what is the
wellness of people and what is our obligation to think about
that.  I mean that is an alternative way of looking at
health, too.
 Sorry for the sermon.
 DR. FINS:  No, I think that they are incredibly
thoughtful comments that we have to really take into
consideration and realize that the recommendations can have
kind of downstream effects that could be unintended, and I
think that we would probably need to dialogue with Buford
and yourself to make sure that it is culturally appropriate
and it is sensitive to all the important points that you
raise.  So, thank you very much.
 DR. VANDERWAGEN:  I think you have attended well
in the distribution of people that you have in this group in
some measure at least to reflecting that the tradition that
gave us allopathic medicine is not the tradition that
affects the majority of the world, so reflecting that in the
makeup of this body is an important piece.
 DR. GORDON:  Wayne has a question and I have a
brief question.  Are there any others around the table?
 My question that I will ask briefly is, has there
been any research done on Native American church and the use
of peyote?
 DR. VANDERWAGEN:  I am not aware of any specific
studies done other than maybe Don Jinero [ph].
 DR. GORDON:  This is an issue that we may take up
in a future panel, but since these plant medicines are used
as sacraments and as healing, they have a tremendous
potential it would seem for healing particularly in
conditions we might call psychological or spiritual, and I
am wondering if you have thought about it and what obstacles
you have run into if you have thought about it or if the
leaders of the Native American church have thought about it.
 DR. VANDERWAGEN:  Let me feed back a thought.
Again, there are people that Buford and I could recommend to
you to talk to in the Native American church directly, and I
think you need to talk to them directly because I can't
speak for them.
 But it would be like asking Catholics to assess
the efficacy of participating in communion.
 DR. GORDON:  That is happening.
 DR. VANDERWAGEN:  Well, I mean that is fine, but I
think you have to market it in a very different way than
talking about it as scientific research per se.
 DR. GORDON:  Actually, there is very interesting
research going on in South America of indigenous communities
using Iowaska, and using Iowaska for healing a variety of
different conditions.  So, that is why I am asking in that
context.
 I would like to know the names of people whom we
should get in touch with.
 DR. VANDERWAGEN:  That is part of the popular
initiative I think, too, and there is a partnership for you
with those folks because part of that indigenous initiative
has to do with --
 DR. GORDON:  I am sorry?
 DR. VANDERWAGEN:  -- part of that support that
they provide for the indigenous initiative is to try and
support those very kinds of issues, convincing the
allopathic practitioners in Central and South America that
their Indian neighbors may have useful practices.
 DR. GORDON:  Thank you.
 Wayne.
 DR. JONAS:  I think that getting at the cultural
perspective in terms of research is extremely important
because we clearly have a very dominant paradigm and an
important one, that there are particular substances that
produce effects, and we want to know what those are, and
that type of thing.
 I will never forget, however, the comment of
someone, and I do not remember his name right now, but he
was a traditional practitioner, a Native American
practitioner who was sitting on one of the first ad-hoc OAM
advisory groups.  This was before they had officially
established an advisory group, and we had this large
discussion about placebo and placebo-controlled trials,
specific agents, et cetera -- and he sat there for a long
time listening to this elaborate set of comments, and then
somebody said, well, how is this dealt with in the Native
American community, and he said, well, let me tell you about
how we deliver medicine.
 So, then he described that he had a patient in
which they had very serious acute, a blast crisis, with
acute myelogenous leukemia.  They went through a ceremony
and put together a concoction, et cetera, et cetera, et
cetera, and delivered it to the patient, and they got well.
 People around the table then -- he kind of paused
-- people around the table looked and said what was in it,
and he said it was Kool Aid.  He said all of our pills have
eyes and ears, and I will never forget that phrase.
 DR. VANDERWAGEN:  It was either Paul Ortega or
Edmund Attachi [ph], and that sounds like Paul more than Ed.
 DR. JONAS:  Thank you.  I couldn't remember who it
was.
 DR. VANDERWAGEN:  Again, that goes to the great
belief in the power of the healer and the attention beyond
physiology.  I mean when we look at allopathic remedies, we
are inevitably dealing with molecular biology and
physiology.
 That is a biological phenomenon.  But in an Indian
environment, [Indian language], the way it is in Zuni, there
is the holistic concept that I have heard people talk here,
and the question that Effie asked Dr. Segal, I think, from
Kaiser, what about mental health interventions, counseling,
and that sort of thing, well, I mean there is the mind, the
body, the spirit, and you have to get all that really, and
that is what Paul is speaking to.
 DR. GORDON:  Yes.
 DR. DEMAKIS:  Unless somebody has any direct
questions to ask me, I would like to enter into the spirit
of this a little bit.  At the beginning of the Christian
era, there was a large body of people who felt that
Christians should not go to doctors, the belief that Jesus
Christ not only saved souls, but saved the body, as well.
 In the West especially, in the Catholic West, this
was very, very common.  In the Christian East, however, they
sought to look to how to bring the science of medicine and
the belief in God, the spirituality together.
 In a very beautiful book by Timothy Miller called
"The Birth of the Hospital, the Byzantine Empire" sort of
chronicles the development of this attitude of how science
and medicine and spirituality can go together.  I would
suggest you might want to take a look at that.  Many of
these things we are arguing over, or maybe not, arguing is
the wrong word, but discoursing together really is not new.
 It is a very old, old thing, and you might want to
take a look at how the Eastern Christians of that time
solved the problem of trying to wed science, at that time,
which was the cutting edge what they had, whatever they had,
with spirituality and belief in a higher being.
 I think it is done in a very beautiful way.  Of
course, that empire was destroyed in 1453, but up until that
time, all their hospitals had chapels, many of their first
doctors were monks who indeed practiced spirituality, as
well as giving medical care.
 DR. GORDON:  By Timothy Miller, "The Birth of the
Hospital"?
 DR. DEMAKIS:  It is called "The Birth of the
Hospital; Byzantine Empire" by Timothy Miller.  The second
printing has just been out about three or four years, they
reprinted it.
 DR. GORDON:  Thank you.
 DR. DEMAKIS:  I think it you might find it sort of
covers medical care from ancient Greece to the incubation,
that sort of stuff, up to modern times.  It gives you a
different insight.
 DR. GORDON:  Those are our questions.  Thank you
very much for sharing your experience.  I would very much
like it, Dr. Demakis, if there is a list of research, could
you give that to us, that is being done in the CAM area at
the VA?  I think that would be very helpful.
 Also, Dr. Vanderwagen, if you have any other
suggestions about ways that we might -- I mean I think this
was a very interesting discussion -- any other suggestions
about ways that we might think about approaching Native
communities and talking about research issues.
 DR. DEMAKIS:  All of our research, by the way, is
up on our web site, VA.gov/restev.  All of it is in there, I
don't think it is categorized the way you want it.
 DR. GORDON:  Thank you very much, and I want to
thank the Commission members, all of you who are here and
all of you who have stayed through to the very fruitful end.
 We will see you in the beginning of December, if
not before.
 [The meeting was concluded at 5:45 p.m.]
 + + +






















 CERTIFICATION








This is to certify that the attached proceedings



BEFORE: White House Commission on Complementary
   and Alternative Medicine


HELD: October 5-6, 2000



were held as herein appears and that this is the official

transcript thereof for the file of the Department or

Commission.



SONIA GONZALEZ, Court Reporter