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*** White House Commission on Complementary and Alternative Medicine Policy ***
*** Meeting Transcript: Washington, D.C  10/06/00  Morning      session     ***
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 WHITE HOUSE COMMISSION
 on
 COMPLEMENTARY and ALTERNATIVE MEDICINE POLICY


 + + +

 Volume II

 + + +


 Friday, October 6, 2000

 8:40 a.m.




 Hubert H. Humphrey Building, Room 800
 200 Independence Avenue, SW
 Washington, D.C.


PARTICIPANTS:


Chairperson:

James S. Gordon, M.D., Director
The Center for Mind-Body Medicine


Commission Members:

George M. Bernier, Jr., M.D.
Vice President for Education
University of Texas Medical Branch

Thomas Chappell
Co-Founder and President
Tom's of Maine, Inc.

Effie Poy Yew Chow, Ph.D., R.N., DiplAc (NCCA)
Qigong Grandmaster
President, East-West Academy of Healing Arts

William R. Fair, M.D.
Attending Surgeon, Urology (Emeritus)
Memorial Sloan-Kettering Cancer Center
Chairman, Clinical Advisory Board for Health, LLC

Joseph J. Fins, M.D., F.A.C.P.
Associate Professor of Medicine
Weill Medical College of Cornell University
Director of Medical Ethics
New York Presbyterian Hospital-Cornell Campus

Wayne B. Jonas, M.D.
Department of Family Medicine
Uniformed Services University of the Health Sciences

Tieraona Low Dog, M.D., A.H.G.
(Private Practice)

Charlotte Kerr, R.S.M.
Traditional Acupuncture Institute, Inc.


PARTICIPANTS (continued):


Dean Ornish, M.D.
President/Director
Preventative Medicine Research Institute
Clinical Professor of Medicine
University of California, San Francisco

Conchita M. Paz, M.D.
(Private Practice)

Julia R. Scott
President
National Black Women's Health Project


Commission Members Not Present:

George T. DeVries, III
CEO/President
American Specialty Health Plans

Buford L. Rolin
Poarch Band of Creek Indians


Executive Staff:

Stephen C. Groft, Pharm.D.
Executive Director

Michele M. Chang, C.M.F., M.P.H.
Executive Secretary

Joseph M. Kaczmarczyk, D.O., M.P.H.
Senior Medical Advisor

Doris A. Kingsbury
Program Assistant

Geraldine B. Pollen, M.A.
Senior Program Analyst


 C O N T E N T S

 Page No.

Session VIII: Guiding Principles of CAM Perspectives
      and Practice
Commission Discussion ................................ 4

Session IX: Not-for-Profit Sector Support for CAM Research
  Dr. John Templeton, Jr., Templeton Foundation ..... 48
  Ms. Dyanne M. Hayes, Conrad N. Hilton Foundation .. 56
  Dr. Daniel Callahan, Hastings Center .............. 66
  Ms. Teri Ades, American Cancer Society ............ 74

Panel Discussion .................................... 81

Session X: Private Sector Support for CAM Research
  Mr. Randy Burkholder, Advanced Medical Technology
    Association .................................... 106
  Dr. Raymond Ruddon, Johnson and Johnson .......... 116
  Dr. Frank C. Sciavolino .......................... 125
  Mr. Mark Blumenthal, American Botanical Council .. 131
  Dr. Annette Dickenson, Council for Responsible
     Nutrition ..................................... 142

Panel Discussion ................................... 149

Public Comment
  Dr. Richard Levy ................................. 191
  Ms. Ingrid Lucis ................................. 196
  Ms. Diana Chambers ............................... 201
  Ms. Monica Lenz .................................. 209
  Mr. Ned Hartfield ................................ 214
  Mr. Boyd Landry .................................. 218
  Mr. Richard Pavek ................................ 230

Session XI: Outcomes Research Part II - CAM Research
             and Experimental Study Design
  Dr. Leanna Standish, Bastyr University ........... 239
  Dr. Lydia Segal, Kaiser Permanente .......... 248, 273
  Dr. Elaine Cramer, Medical Epidemiology, CDC ..... 250
  Dr. Douglas Lloyd, Association of Schools of
     Public Health ................................. 281

Panel Discussion ................................... 287



CONTENTS (continued):


Session XII: Federal Agency Support for CAM Research
  Mr. John Demakis, Veterans Affairs ............... 306
  Dr. Craig Vanderwagen, Indian Health Service ..... 311

Panel Discussion ................................... 317



 P R O C E E D I N G S
 [Opening remarks by Dr. Gordon.]
 [Moment of silence observed.]
 Session VIII: Guiding Principles of CAM
 Perspectives and Practice
 DR. JONAS:  I think there are a number of core
issues for CAM research, and instead of me giving a world
view, which I think is preposterous, I decided I would just
lay out what are some of the themes that affect research
especially in these areas.
 We talked many if not all of these already, but I
would just like to list them for you and talk a little about
some of the wording that might be important in terms of
that.
 I think some of the core issues include, first,
public impact, not only the impact of the public's interest
in these areas, but what research does in terms of actually
providing public impact.  Paul Starr wrote a book, a
magnificent book, on the social transformation of medicine,
and I think this involves, really, the social transformation
of science.
 We are in the process of the democratization of
science.  Figuring out how the public and the practitioners,
as we saw yesterday, can have a place at the table of
scientific agenda, scientific methodology, and the type of
information we want to see science produce is a key issue.
 I think the second core issue for CAM is
multiculturalism, seeing different world views.  I think we
have to be able to travel around the circle.  We need to
have a circle in which individuals can say, this is what I
see from this part of the circle.  Like the blind man and
the elephant, we all have a little bit of a part, but if we
don't communicate, if we don't have the skills to go around
and communicate the aspect that we see, then in fact we will
never have, really, the whole truth.
 I think the third issue is the issue of chronic
illness.  I think there is no question that modern medicine,
and it is acknowledged all of the world, has found an
extremely powerful method of managing acute illness,
infectious disease, trauma, drug therapy, surgery, et
cetera.  There is no question that all over the world, the
modern Western medical system is the envy of this.
 The result of that is it has been very successful
in the Western world, and we are no longer dying at young
ages anymore because it is so successful.  That has created
another problem, and that is the problem of us aging, if
that is a problem, and therefore an increase in the
prevalence of chronic illness.  Chronic illness is different
than acute illness.  It is complex.  It requires a
multifactorial and a holistic approach.  Very few magic
bullets are likely to be found in the area of chronic
illness.
 The fourth area, I think which is at the heart of
how we should prioritize, certainly, our research in these
areas, is health promotion.  The term that I use for this,
the scientific term, is salutogenesis.  That is the opposite
of pathogenesis, which is the process by which disease
occurs.  Salutogenesis is studying the process by which
health occurs.  So how, in fact, on a fundamental,
biological mechanism, but in terms of biological research,
can we understand this process and therefore facilitate it.
 I think the fourth critical issue is that we are
no longer in the modern materialistic age.  We are now in
the post-modern information age.  So managing information is
crucial.  We shouldn't call it information management, we
should call it knowledge management because there is data,
there is information, there is knowledge, and there is
wisdom.
 What we hope, eventually, all to get to is to be
able to exchange wisdom, but before we do that, we have to
be able to create the data into information, and then create
it into knowledge.  Knowledge means we all at least
understand what the other person is talking about.
 So it is not sufficient to say, here is the data,
show me the facts.  We have to know in fact, what is the
knowledge that that imparts, what is the meaning and what is
the importance of it.
 What does all this mean for research?  I think
what it means is that we need to make sure that our research
agenda is balancing rigor and relevance.  There is a playoff
between rigor and relevance.  We have heard a lot talking
about the importance of science and the importance of rigor,
and there is no question about this, the type of research
you do has to be rigorous.  You have to use good methods in
these areas.
 However, the more focused you become in terms of
what is currently acknowledged as the gold standard or the
rigorous science, often the less relevant it becomes.  There
are many examples of this.  P-6 acupuncture is the only
proven acupuncture treatment that, I think everyone agrees,
works for a single condition, and yet P-6 acupuncture is
rarely used and is relatively irrelevant for your average
acupuncture practice, and there are numerous kinds of
examples of that.
 So I think as we are doing and going forward in
research in these areas, we need to change the research
hierarchy so that rigor and relevance become balanced rather
one dominating the other.
 MS. KERR:  I was hoping to have a little more time
to wake up, but I will go.
 When I reflect on the values and principles that
inform, or could inform, our reflections on CAM, I have two
paths I thought I might begin.  One is that I wanted to
reflect on the founding documents of our country that
essentially are saying that we are all of equal value,
endowed by our creator and with certain inalienable rights.
 I think it would do us well to reflect on these.  It
certainly would inform our works here.
 The other is values that I found to be reflected
in some work from the United Kingdom.  During the Sir James
Watts presidency in the United Kingdom of the Royal Society
of Medicine, he initiated a series of colloquia on medicine
and complementary therapies.  One of the presenters was a
Dr. Patrick Patroni at St. Mary's Hospital in London.
 He, like many of us here, felt that the current
biomedical model of today was, and we have all been talking
about this for years, based on the Cartesian/Newtonian view
of the universe.  It was essentially dualistic, mechanistic,
and reductionistic.  You thought that, of course, which I
agree with, that it served us in many wonderful ways, but in
about the last 50 or 70 years, there has been a growing
change in scientific thinking, and it really hasn't been
integrated into the biomedical model of health and disease.
 In fact, and I still think this is true, we really
need to inform ourselves better on the discoveries that are
challenging the philosophical underpinnings of our medical
model.
 He goes on to quote some of the innovators of this
new thinking, and some of those people who you are well
familiar with, are people like Einstein.  Einstein, of
course, said that, "We may therefore regard matter as being
constituted by the regions of space in which the field is
extremely intense.  There is no place in this new physics --
for field and matter, for field is the only reality."
 He quotes Heisenberg, David Bowen.  Then for those
who not only like to hear from the Nobel Prize winners, but
visionaries such as Lao-tsu and Plato, and others, he is
calling us to apply some of the new scientific thinking to
the revitalization of our medical system.
 What I agree with and what he concludes with is
some of the concepts that he feels comes out of the new
scientific thinking.  I wanted to submit this today, and I
want to read just a few of these.  These are only eight.
 The first is that the human organism is a multi-
dimensional being, and at one level we are bioenergetic
organisms.
 Second, is matter and energy are interchangeable
in the primary ordering factors are not biochemical,
molecular, or genetic, but field forces.
 Third, is that there is an interconnectiveness
between all living beings, non-living, microscopic,
macroscopic.  The whole is greater than the sum of the
parts, and the part contains the whole.
 Fourth, is the linear model of cause, and effect
is only partly applicable to disease and health.
 Fifth, is consciousness plays a role in the
physical universe.  We each possess a powerful innate
capacity for altering both our internal and external
environments.
 Sixth, is health and disease lie along the
continuum and represent the organism's intrinsic state of
health with the universe.
 Seventh, is one of the primary tasks of someone
entrusted to heal, be it a doctor, priest, or acupuncturist,
is to the encourage the innate capacity of the individual in
distress and help restore state of balance and harmony.
 I think these are some good places to start as we
reflect on the new science affecting medicine and disease.
Thank you.
 DR. GORDON:  Thank you, Charlotte.
 We are actually giving everybody 3 minutes, it
seems like.
 MS. KERR:  I thought we had a minute after the
first buzz.
 DR. GORDON:  We have expanded time.
 [Laughter.]
 DR. LOW DOG:  I started out, really, in the other
direction with herbal medicine.  Certainly, beginning in my
childhood believed that spirit permeated all of our life,
and that illness was very much a reflection of an imbalance
within ourselves or within the world around us.
 When I grew up and went on in my life, and later
on, went to medical school, that never changed.  Medical
school, when we got down into anatomy and cellular
physiology, I remember coming home and feeling, after I had
learned about the nucleus and the cytoplasm and the
mitochondria, the cell membrane, G-proteins, I thought, my
god, there is a god.  This is phenomenal.  I am awed and
humbled by all that we know of life and science.
 At the same time, I felt very much that science
and spirit were not mutually exclusive, that we could
embrace both willingly.  In my time as a practitioner, I
won't separate Western medicine.  It is medicine.  It is
just all medicine.  It is an artificial label that we have
given, also to keep our battles and to keep us separate.  It
is the language of separatism, not bringing us together.
 What patients really want from us, or want from me
-- I can only speak for myself -- is really my time, my
hands, my heart, my compassion.  They want me to be good at
what I know.  They don't, at the end of the day, really care
if I give them an ace inhibitor or if I give them Hawthorne.
 They really don't.  What they want from me is just to know
that for the time we spent together I was completely there
for them and I made a safe place.
 As George and I were talking earlier, I think what
is going to come out of all of this is that hopefully we are
all going to be better practitioners, we are all going to
take a little more time with our patients, do a little bit
more exploration of ourselves, think a little bit more about
what healing means versus curing, and that that is the
medicine, not so much if we are using acupuncture or
chiropractic or surgery.
 They all have value.  They all have a place.
Science can help get us there, but I just hope that we don't
forget that there are some things about healing that can't
be reduced to the double-blind RCT.
 DR. GORDON:  Great.  Thank you, Tieraona.
 DR. ORNISH:  It is a very simple idea, but it is a
very radical one in the sense that even the word "radical"
means to get to the root of something, as opposed to
literally or figuratively bypassing the problem.
 As part of that context, is the presumption that
the body has a remarkable capacity to begin healing itself
if we give it a chance to by addressing whatever the causes
are that are causing the illness in the first place.
 Now, in some places that is going to be diet or
exercise or genetic factors, which are often invoked but
less often really a causal factor, but it also includes the
psychosocial, the emotional, and the spiritual dimensions of
health and healing.  That is not only on an individual
level, but also on a social level.
 So, for me, there is an opportunity, when we look
at suffering or illness, to not just treat those symptoms,
not only just the physical symptoms but also the other kinds
of symptoms that are often medicated -- certainly, Jim, in
your field in psychiatry, we see that a lot.
Antidepressants is one very common example -- but to say,
what is really going on here, and what can we do to address
those issues.  Those issues are far-reaching.
 If we can integrate the best of these traditional
and non-traditional approaches, but not simply in the
context of what some of the people yesterday were talking
about in terms of ginkgo instead of another Alzheimer's
drug, or St. John's wort instead of imipramine.
 In a way, it keeps us in that same mechanistic,
mechanical model, and this is the larger picture of how it
all fits together.
 DR. GORDON:  Thank you.
 DR. PAZ:  Our psyche has a very big play as far as
our physical status.  If I just treat what I feel is a
medical problem, frequently I lose out on quite a bit
because one's emotional state plays such a big role in
whether one will improve or not.
 Some of the therapies that modern medicine
addresses doesn't always address that part.  I think some of
the alternative, actually most of the alternative, therapies
treat that as a complete model, and I think we need to
really look at that more, facilitate that more with our
cultural differences.
 I think we need to encourage the research and how
that works, and support the practitioners that are already
doing those kinds of therapies.  Some of the examples that
we saw yesterday were pretty touching.  I think we need to
try and be more supportive in folks who are not always doing
traditional therapy.  I think we need to facilitate the
research in that.  That is pretty much where I am coming
from.
 DR. GORDON:  Great.
 MS. SCOTT:  I agree.  I don't know if I can
improve upon it.  To me, values and principles are very
important as a foundation for how you look at the world, and
how you act in the world, and how you are in the world.
 For me, CAM, I think, offers an opportunity for a
perspective of wellness as opposed to illness.  Holistic in
its approach is the integration of physical, mental,
emotional, spiritual, and economic, because all of those
things are at play when you are dealing with one's wellness.
 I think we are all in agreement that we want
rigorous science.  We are all in agreement that we want to
have devices and drugs and botanicals, whatever, that is
safe and effective.  I do get concerned that sometimes
suggesting that there needs to be a different way to do
something is seen as not wanting to have good science.
 I think we have to keep making the point that this
research paradigm does not always work and that there has to
be an openness to change and to doing things differently.
We do have to change the paradigm.  That doesn't mean we
have to throw out everything that has worked, but we have to
be willing to look at some different ways of measuring for
the safety and the effectiveness.
 I think it is very important that what CAM brings
to the whole field of wellness and health care is validating
the person's experience and the practitioner's experience.
I think this is what has been missing from medicine.  We
have been trained to walk into the practitioner's office and
give up all of our reality, or be swayed from our reality,
to the practitioner's way of looking at it.  I think that
that is a very core and key part to the partnership in the
quest for wellness.
 The one caution I have is that I think we need to
celebrate the things we have in common in being human, but
also, and something I think that CAM does, is acknowledge
and pay attention to the differences among us, without
seeing that as a division.  I think that is key.
 So, safety, effectiveness, availability, equity.
 DR. GORDON:  Great.  Thanks, Julia.
 DR. BERNIER:  It is really important to be able to
identify agents that are really, really helpful, and
distinguish those from agents that aren't helpful.
 To me, the single most important message that the
whole CAM movement has made, and this is really reinforced
by reading your elegant book -- no plug -- was that that has
really shifted the focus to the patient and away from
systems, and away from the health care provider to a
substantial degree.
 I have worked as an oncologist for a substantial
part of my life, and I always tried anytime I got a new
cancer patient to work with that I made a house call.  I did
this for two reasons, one of which was probably self-
promoting, and that was that I felt that if I could interact
with the patient in his or her home, that they would know
that I would come if they needed me.  They rarely ever
called upon me to come.  So it was a way of ensuring some
privacy, but it also, to me, was a really important bonding
that one could witness.
 To get back to the President's charge, I think
that how much of modern-day CAM becomes part of the
mainstream of American medicine, American health care, is
going to depend, to a significant degree, on how careful the
research that is carried out is going to be, and how
critical that research is.
 The better that is, I think the greater the
likelihood that we will have sharing of the entire field by
a whole host of health care workers.  I think this is too
good an opportunity to establish the efficacy of a lot of
the agents that research is going to be critical for what
happens.  Thank you.
 DR. GORDON:  Thank you, George.
 MR. CHAPPELL:  I apologize for missing the
opening.
 I see CAM as an opportunity to be part of that
world view in which everything is related to each other.
Interrelationships versus distinct and separate and isolated
realities, which the hierarchical model promotes.  In
interrelatedness it is webs, it is networks, it is
cooperative, collaborative, and it celebrates the gifts of
each person, the different gifts of each person.
 So I see this movement as an opportunity to be
part of that way of looking at the world.  I think some of
the principles are openness, collaboration, particularly
openness, open to the new idea, the imagination of the new
attempt so that discovery can happen without being stifled
by the halls of, just, day-to-day management of different
functions.
 That is how this movement has gotten as far as it
has.  That is why the term "alternative," I believe, but I
also like the term "complementary" because I think it needs
to be a complement to the good work that has been gained to
date by Western medicine.
 Other than that, I think safety and efficacy
should still be the guiding principles that we need to
discover new protocols of understanding effectiveness.
Trying to fit this other world view into the protocols and
models of the old world view will only frustrate us.  So I
think we have to be prepared to research and find new ways
of establishing effectiveness.
 DR. GORDON:  Great.  Thank you, Tom.
 Effie?
 DR. CHOW:  This is really an opportunity of a
lifetime I see.  We must make the most of this opportunity,
as many of you have spoken about.  We must take a look at a
new paradigm, perhaps, not discarding the old paradigm.
Improving the old paradigm of medicine and health as we have
it here.
 I think we should be creative and be brave,
courageous about recommending new things.  Even that which
seems ridiculous, I think we should look at with open eyes.
 I am just really thrilled with my fellow commissioners
because I sense that is what we have here, people with
really openness.
 Chardin says we are born perfect.  In Buddhism, it
says we are created perfect, but in harmony with nature.
Khayyam says, "We cannot study life and look at cadavers."
It is true.  The energy is all gone, the Chi is all gone, so
how do you study life.  Einstein says, "We have our own
physician inside each of us," and this is every patient.
 This is sort of a few of the philosophies, my
vision, my world vision, I would like to see followed.
 We have to look at our past to talk about the
future.  In 1969 we had the first acupuncture training for
physicians at Stanford.  Since then, there has been arrests
for people using acupuncture.  They were arrested for
practicing medicine without a license.  The lawyer was
smart.  He said, no one was claiming they were practicing
medicine, they were practicing acupuncture.  It got thrown
out of court.
 So just a few of my own examples:  Hope, she is 20
years cancer-free now, and she is in my book.  She was
supposed to die in three months.  Jane, 10 years in a
wheelchair.  She is a Grade 1 school teacher.  Last
September, after three treatments, she taught standing, and
she has had her first summer standing.
 Dorianne, twelve and a half years my senior.  The
Mayo Clinic, Harvard, Johns Hopkins, said tape your eyes
shut.  She couldn't close her eyes.  She had a stomach-tube
feeding.  In five days, I got her drinking, and also her
eyes closing for the first time, and she is eating.  Andre,
in Germany, was scheduled for his fifth operation, brain
operation, and they called me and said, can you come over.
Thursday they called me.  Tuesday he was supposed to have an
operation.  So I said no, I will send energy for you, and
they canceled his brain operation.  Three MRIs showed that
his brain tumor had gone to nothing.
 There are others, MS, quadriplegics that in two
sessions we have got walking.  Now, this will blow a lot of
people's minds out, but this is happening every day.
Miracles like this are happening.  Do we call it miracles?
I think we need to look at these things, CAM, as miracles.
 So I end with saying that I believe in the rigors
of research, and as Julia said, we need to look at other
paradigms and, I think many of you have said, at other
paradigms of establishing rigor.  My recommendation to the
patient -- I don't call them patients, I call them clients
because they have the right to choose to live or die.  We
help them to die, and they die so well that they want to
live.  This is really a phenomena.
 They come for their eight hugs a day.  My theory
is at least eight hugs a day and three bellyaching laughs a
day.  Most of my clients say, I really come in here just for
my eight hugs because I can't get hugs at home.  Now, that
is a shame.
 So, anyway, thank you very much.  I hope that we
will be courageous and really look at a really new world
model integrating, as Wayne says, the multicultural, the
ethnicity, because systems has helped cultures survive for
thousands of years.  I think we should use some of those
things and not only wait until it undergoes rigorous
scientific review.
 Thank you very much.
 DR. FAIR:  Well, my view of CAM has been shaped,
both professionally and personally, professionally since my
introduction to this field.  I almost have the feeling that
I have had blinders on for most of my professional career.
 While there is no denying the advances of modern
medicine, it caused me to reflect on some of the things that
I thought were truths.  I look back with concern about some
of the things we have done.  When I was a resident, it was
standard operating procedure to give 100 percent oxygen to
premature babies.  It has been estimated there are 10- or
15,000 children that were blinded by that approach, and yet
that was standard therapy at that time.
 We mentioned yesterday, the autologous bone marrow
in women with breast cancer.  It is still being done, by the
way, and recognizing that despite the cost and toxicity,
there is no effect whatsoever.  This was also standard
therapy.
 Then on the other side of it, these mind-body
therapies that I, like many people, thought was really far
out and more or less to be ignored, I am just astonished by
some of the observations.  We were talking yesterday, some
of us, about the recent study in London taxicab drivers
showing at the posterior hippocampus, the part of the brain
that controls spacial orientation, is larger in taxicab
drivers than control -- this is in London, not New York,
now.
 [Laughter.]
 DR. FAIR:  Where it is a real profession.  The
longer the person drove the taxi, the bigger the posterior
hippocampus got.  It is the first observation that cognitive
functions can actually influence anatomy, which just is
phenomenal.
 So I think that this has been disturbing to my
professional balance, if you will, or what I thought about
the truths that were taught to me and what I thought I had
learned over the years.  Now I begin to wonder if we really
know what questions to ask to evaluate this.
 Personally, my introduction to CAM was uninvited.
 Five years ago, I was diagnosed with colon cancer, and
despite four surgeries and a year of chemotherapy, I had a
recurrence and at that time began seeking out other options.
 Thanks to Dean Ornish, and subsequently and Michael Lerner,
going out of the common wheel, I really learned a different
approach.
 I always prided myself on being an empathetic
physician and truly liked taking care of patients, but I
came to learn, through my friends, the distinction between
healing and curing, and particularly, almost the mantra of
common wheel, the idea of expanding life, even if you can't
extend life.  As Tieraona mentioned, I think I found there a
safe place, which was something I could carry with me in my
daily activities.
 These approaches have added so much to my life
that my personal goal now, and I think also the goal of this
commission, is to try to bring these approaches, again, as a
complement to standard therapy.  I don't view this as a
replacement.
 Unlike some of my colleagues, as a patient, I
don't think we need a new specialty of CAM physicians.  I
think what we need to do is to enlighten physicians to the
benefits and to bring it into the practice of every
physician, you might say getting back to old-fashioned
medicine.  We can't expect everyone that graduates from
medical school to be accomplished in all these areas, so it
involves the coordination and cooperation between physicians
and CAM practitioners in a way that I think has not been
done yet.
 So that is my personal goal.  I have changed my
career pattern.  I hope, and I really believe, that through
the workings of this commission, that we can go a long way
toward establishing that new medicine, to quote Jim.
 DR. FINS:  I, too, came from a traditional
background in medicine as an internist.  In participating
with all of us here, I am seeing, increasingly, that there
really are two parallel universes, and that both of these
universes are motivated by a very strong healing ethos
across the continuum.
 With this in mind, I think what we need to do is
to try to promote and develop a new synergism and
reciprocity between these two universes and have a sort of
reunified field theory, as it were, between these two parts
of the continuum to serve the health needs of the American
public, because I don't think our patients really are
distinguishing where they are receiving care.  They know
they are receiving care, it is just that we have
distinguished where they are receiving care.
 So I think what we should try to do in our world
view as a commission, should be to try to create enduring
structures that allow for the promotion and the sustaining
of the kind of the dialogue that we are engaging in here, I
think, so collaboratively, as Effie suggests, even though we
do all have very different backgrounds.
 Also, I think, secondly, appreciate that these
enduring structures really allow and foster the application
of the scientific method to evaluate and to assess new and
novel therapies.
 I think that, given the massive biomedical
establishment, the scientific method is going to be the coin
of the realm, and I think it really needs to be addressed
and worked with, but I also would say that we need to look
to the social sciences to assist in the assessment of border
issues or outcomes and health promotion.  Not just science
alone but the social sciences together will help promote
discovery and knowledge.
 Fourthly, I think we need to look and understand
better those parts of the health universe where there have
been successful integration of these two universes and
overcome the false dichotomy between these two cultures.  I
think we heard a little bit about that in the Best Practices
that we heard about yesterday.  Also, I think, in the world
of palliative care and hospice medicine, where people have
overcome that dichotomy and there has been successful
integration.
 I think if we do all this, it is obvious that CAM
will change, and traditional medicine will change, but the
healing arts together will be fostered.  I think  that
should be our legacy, and that should be what we are trying
to do.  I think that will create not only the articulation
of a new world view, but also a tremendous amount of health
promotion.
 So thank you for the opportunity to share that.
 DR. GORDON:  Thank you, Joe.
 It is wonderful to listen to everybody, and to
hear, see, feel everybody's commitment to this mission we
have in common.
 There were a few things I said at the end of our
talk with Dr. Straus that are some of the principles, it
seems to me, important.  They have been pretty well
articulated around the table.  One has to do with focusing
on the uniqueness of each individual and his or her journey
through life.
 The work that we do is not just about healing,
treating diseases, promoting health, dealing with illness.
Our work is the work of helping people become themselves, be
themselves.  To me, that is the deepest part of the work we
do, the highest form of being a healer.
 The second point has to do with integration and
integrating whatever works.  Buddha said, "Truth is what
works."  In my own life and in my own practice I integrate
many healing traditions.  I have learned from Chinese
medicine, I have learned from Ihrveda [ph], I have learned
from Western medicine, I have learned from shamanic healing,
I have learned from indigenous practices in the United
States.  They are all part of what happens when I am in the
room with somebody.  Whether I am in my office, or in their
home, or in an intensive care unit, that is all part of what
I am doing.
 The third perspective is a focus on wellness,
health, and especially on education.  I think it is really
so important to help people help themselves.  This seems to
me fundamental to what I do.  Whether someone has a life-
threatening illness, or whether I am working with children
in a primary school, I am helping to show them the
possibilities for healing themselves, for helping
themselves, for being happy, for celebrating life, as well
as treating whatever problems they may have.
 The fourth principle is one of outreach, of
connection to other people, whether it is in a practical way
of helping young investigators, or people from CAM
professions that have been outside the mainstream, or
physicians who are trying to enlarge what they are doing and
trying to study what they are doing.
 I think we need not only to reach out ourselves,
as we are with this commission, but to encourage all of the
government agencies, all of the medical schools, all of the
establishment, to really reach out and embrace those who
have been left outside and to bring them in, and to share
with them our privilege, the benefits that we have accrued
and what we know.
 The other thing that is fundamental to me that is
really where I started when I sat down here, is I realize
that at our Center for Mind-Body Medicine we have a mission,
and our mission is both to create a healing community and a
community of healers.  I see us here on the Commission as a
healing community helping to heal what ails medicine and
health care in this country, and also, and it was just
brought home to me by listening to everyone as we went
around the table, a community of healers working together.
 So my hope is that, as we work with all the people
who come before us, as we ask for their testimony, and as we
ask them questions, and as we formulate recommendations for
the President and for Congress, and I felt this very
strongly yesterday, we are also welcoming them into this
circle of healers, and that we understand that we are all
engaged, coming from very different points on this circle,
which is wonderful to see and hear.  We are all engaged in
the same work.
 So it is great to be here.  It is great to hear
you, great to feel you, see you.  Thank you, everybody.  We
will continue this discussion.
 Yes, Effie.
 DR. CHOW:  Can we hear from Steve, our executive
director?
 DR. GORDON:  I asked Steve, and Steve demurred,
but we can certainly hear from him.
 DR. GROFT:  I am really here to provide you with
what your needs are.  I think the audience and the public
needs to hear from you more than it does from me.
 Okay, just a few thoughts, I guess.  I know I
haven't given it a lot of thought because of the intricacies
of what we have been involved with in just getting the
meeting together.
 I guess my philosophy of life, in dealing with the
issues, are, we come into the world and we don't have any
control when we come into the world.  We are all given
different tasks to do.  In the last nine years since I have
been involved in CAM directly, I think I have tried to
create a safe environment, an environment that people could
come and present their views in a totally non-
confrontational manner, that they could be absorbed into the
system and just to be able to talk and to listen and to move
ahead, and we are moving ahead.
 I think we all strive for an inner peace, that we
work with our family, our friends, different people at work.
 We are getting there.  It is a struggle when you go against
so many organizations or individuals who are threatened by
what you would like to see, and what we know is right, and
what we know brings us peace.  That is very important.
 I think wellness is so much a part of our own
being.  Sometimes it is not because of external factors,
family and friends and the world around us, but I think we
all have to strive for that.  I think that is what we are
trying to do.  That has been, again, the religion, the
spirituality part, has been a big part of my life, and I try
to stay with it.
 DR. GORDON:  Thank you, Steve.
 I am also going to ask Michele and Geri and Joe
and Doris, if they are here, just to say a couple words as
well, because they are part of our team.  So thank you,
Effie, for asking again after he refused once.
 Michele?
 MS. CHANG:  Let me time myself here.
 DR. GORDON:  Michele is setting her own timer.
 MS. CHANG:  I think my philosophy and the guiding
principles for working with this commission are the same
that I have for living life, which is, I believe that we are
here to learn, and by learn, to teach, and hopefully, that
we will have a lot of fun in doing both.  That is what I am
here to do.
 DR. GORDON:  That is beautiful.  Does somebody
want to ask Joe and Doris to come up here, too.
 MS. POLLEN:  I would like to share with everyone
the fact that I had a very special father.  He was a
physician and a biomedical scientist, but he was also a very
beloved physician, beloved by his patients.  I learned early
from him the art of medicine as well as the science.  He
practiced the art of medicine.
 I think, as I have been listening to everyone
speak, that we lost the art of medicine.  That is the really
special part of healing, is to be cared for and feel that
you are being cared for by your caretakers, by your
physician.  That was something that my father gave to his
patients and always expressed.  He also, in the '50s,
coauthored a book, probably one of the first, on prevention
in medicine.
 DR. GORDON:  Great.  Joe, I see you in the back.
Would you say a couple of words?
 MR. KACZMARCZYK:  [Off mike.]
 DR. GORDON:  No?  Okay.  He is our silent partner.
 Doris, come up, not to put you on the spot at 9:30
in the morning.  We have just been going around the room,
and everybody has been talking about their vision of CAM and
of our work.  After Steve first didn't want to say anything,
Effie asked him again, and he said okay.  So he and Michele
and Geri have each said a few words.
 So to complete this team, I thought that maybe you
-- and Joe is here -- that Joe and you could each say a
couple of words as well.
 MS. KINGSBURY:  Well, first of all, it is a great
pleasure to be on the team working with the commissioners.
It is really great.  I am learning a lot, good experience.
That is it.
 DR. GORDON:  Okay, great.  Thank you.
 MR. KACZMARCZYK:  First of all, I don't speak
without slides.
 [Laughter.]
 MR. KACZMARCZYK:  That is an internal joke.
 I have never really had to articulate my own views
about complementary and alternative medicine because I have
been, for the last several years, the voice for the
nameless, faceless, voiceless people who do not have access.
 I come from the Bureau of Primary Health Care, the Health
Resources and Services Administration, where access is not a
buzzword or a mantra.
 I can tell you that I related to everything that
everybody said around the table, but most especially when
Julia equity because I think we are at the unique and
wonderful intersection of many opportunities.  Chief amongst
those is to have the opportunity to create an environment
that allows access to complementary and alternative
therapies for everybody and to have access to a new and
better kind of health care delivery system.
 In addition to that, we are also at the
intersection of the opportunity to not only reform health
care, but also education.  By education, I mean not only
medical education, all education.  When we talk about
education, it should include health care professionals, but
also students starting at the youngest possible age.
 Did I make it, Michele, within the time
constraints?
 DR. GROFT:  Next slide, please.
 [Laughter.]
 DR. GORDON:  One thing I want to just say is that
these five people are representatives into the world.  They
communicate not only the substance of what we want people to
come to talk to us about, but the spirit of what this
commission is about.  So they are us, and we are them.  It
is great to work with them.
 DR. JONAS:  We couldn't have gotten a better group
if we had handpicked them from the world.
 [Applause.]
 DR. GORDON:  Let's take about a 2-minute break
while the first panel comes forward.
 MS. KERR:  Jim?
 DR. GORDON:  Sure, go ahead, Charlotte.
 MS. KERR:  First of all, thank you all for serving
us so well.  I did want to say this, even in the spirit of
our joy as we have shared in this last few minutes.  I heard
some challenges and some opportunities in the speaking as we
spoke, and I wanted to say this.  I mentioned a couple of
conclusions of possible principles that would be
underpinnings, philosophical underpinnings for our work.
 For example, and this is very important to me, one
was that the linear model of cause and effect is only partly
applicable to disease and health.  When several people spoke
around the table, they talked about the need to find the
cause for certain problems.  To me, I saw a little flashing
light.  I thought, is it necessary for us to be congruent,
perhaps, in our philosophical thinking in order to have a
cohesive outcome in CAM?
 So that was one thing, because that is not exactly
how I am thinking, that there is just cause and effect when
we do research.  The other was, just to mention, as the
physicists say, we are probability patterns of
interconnectedness.  I understand and believe that.  If you
are hungry in Bosnia, I believe we cannot be full and
nourished in Baltimore or in the inner city in Washington.
We are connected.
 When one thinks this way, you immediately, at
least in my opinion, are then driven to look at public
health issues.  If this is a principle we believe in, then
this is informing us in the work we must do in CAM.
 Do you understand what I am saying?  I am speaking
to my partners here.
 So I think it is important that we really spend
some time in seeing, what are the principles we agree with,
because I, frankly, don't know if I do feel we were
congruent in our foundation here today, and I think it is
pretty important.  I understand maybe we are beginning, but
I don't have the knowledge to know we are beginning.
 DR. GORDON:  Let me say that I am not looking for
congruence.  I am just looking for each person right now to
express themselves.
 MS. KERR:  Okay.
 DR. GORDON:  We will work.  We are going to work
and see how we come and where we come.
 MS. KERR:  So this is just the beginning.
 DR. GORDON:  This is just the beginning.  We are
going to continue this process.
 DR. JONAS:  I think what Charlotte is expressing,
and also I have this sense, too, is I do not see, in the
process that has been laid out for us, time for us to really
fundamentally deal with some of these issues.  I would just
like to express that.
 DR. GORDON:  You would like to have some more
time.
 DR. JONAS:  Yes, absolutely.
 DR. GORDON:  Fine.  Actually, that was what Tom
proposed.  This is the beginning.  This is just the
introduction.  We wanted, in the first time, not to set
aside too much time but just to have each person have an
opportunity to express him- or herself.  We can talk about
how much time everyone would like to set aside.  That is
very much an open question.
 MS. KERR:  Thank you for that.  I think that is
one need.  Then the other is, how do we get on board with
one another?  One is time, but how are we educating
ourselves, perhaps, as a group to see.  I mean, we are all
doing the best we can, but we also come with different
backgrounds.
 So, Mr. Chairman, I request that we think about
that, how we will do it.
 DR. GORDON:  Yes.  I think we should think about
it.
 MS. KERR:  Thank you.
 DR. GORDON:  Steve?
 DR. GROFT:  I think as we are preparing the future
agendas for the meetings, we will factor in some additional
time just for thinking and discussing, and open mikes to us,
or to you as the Commission members, to be able to talk
about things.
 These initial meetings, I think we felt an urgency
to get things moving, that there were so many things to
cover.  I guess the agenda for these two days was
tremendously, probably overly ambitious, to really give you
an opportunity to even question the individuals
appropriately, but I think that opportunity will come in the
future.  I think we will have the opportunity for you to
talk among each other and just hash things out, where are
we.
 This is all part of the process as we begin to
think about the report, and think about the issues.  You
come together as a group, and I think as you come together
and bring all of your differences and similarities, you
become one voice, and it does happen in the process of a
commission or a committee.  You do arrive at that.  You
don't see that right now, and we don't want you at that
point right now.  We do want the variability in the
statements.  Things will start to happen as the second
meeting occurs, the third meeting, the fourth meeting, and
you spend more time together.
 It does evolve.  I think by the end of the time,
we are going to feel that we really don't want to break
apart, that you are going to miss the interactions, you are
going to miss the individuals.  That is when I think we have
accomplished the purpose.  I think that harmony will come
within the group.  We may not agree with each other, but I
think there will be an acceptance and a harmony that will
follow.
 DR. GORDON:  I think it is very important that
part of our work is to come together among ourselves, but we
are coming together among ourselves with all the people who
are coming before us.  We don't want to have what is a
premature closure of our accounts with reality.  So, as a
kind of sense of welcoming in the people who are coming, and
us evolving our process as well at the time.
 So we can set aside more time.  What we need from
you, and maybe we can talk about this a bit later, but that
is also going to require more time for participation from
everybody here.  If there is a willingness to do that, then
we can set aside more time.
 Yes, Effie?
 DR. CHOW:  Just to affirm, I really feel strongly
on that, too.  I think we should know where we agree, and
then respect where we disagree or have different ideas.  I
think that is what we are chosen for, not everybody thinking
the same way, but the diversity that we can come to respect.
 DR. GORDON:  Exactly.  Exactly.
 DR. CHOW:  This is how we are going to deal with
the bigger vision, too.  Thank you.
 DR. GORDON:  Great.  Joe, did you want to say
something?
 DR. FINS:  I think the agreements and
disagreements can be about ends and means.  So I think that
we probably have a comparable sense of where we want to go
and what the end point is, but how we get there and the
balance we put on the various opportunities, is, I think,
what we will probably have to negotiate and talk about.  I
think you are absolutely right in bringing this up now.
 I wrote Steve a note that you need a little bit of
dissonance to have a good sense of harmony, otherwise it
becomes a Gregorian chant, and we are all singing the same
tune, but it is a good tune.
 DR. JONAS:  I think, also, one thing in terms of
the means is that we may find as we go around, that we don't
have all the skills necessary, sitting around this table, to
properly understand or move forward with the means, so we
might want to bring individuals, especially in policy-
setting, since that is our purpose here, to help with that
process.
 DR. GORDON:  Anyone else before we close for now?
 [No response.]
 DR. GORDON:  Okay, thank you all for this.  We
will take a couple minutes and then we will come back for
the next panel.
 [Recess.]
 DR. GORDON:  This is Session IX.  It is the
representatives of the Not-for-Profit Sector.  They are
going to be talking about support for CAM research.
 So I want to welcome the four of you here, and
thank you very much for responding.
 One of the things I wanted to say to the
commissioners is that the people who have come here, who are
coming here, are coming, of necessity, on rather short
notice.  For this first panel, we only had six or so weeks
from the time we planned to the time to ask people.  So a
lot of people who are here have really made time in their
schedules for us.
 So we appreciate that extra effort you have made
as well.
 So let's begin with Dr. John Templeton from the
Templeton Foundation.
 Session IX: Not-for-Profit Sector Support
 for CAM Research
 DR. TEMPLETON:  Good morning.  I am very grateful
for the opportunity to share with the Commission some of the
work of the John Templeton Foundation.  In particular, I am
very pleased to share with you our interest in science-based
complementary medicine research, and the application of that
research in clinical practice.
 The foundation is very supportive of the use of
the scientific method in the evaluation of spiritual topics.
 In the case of health and healing in medicine, we are
especially supportive of spiritually related approaches to
assuring and maintaining good health, as well as
contributing to more effective healing when illness occurs.
 As part of this, we are very interested in the
ability of spiritually related complementary medicine to
contribute to better health outcomes with significantly
greater cost effectiveness.
 In the last 10 years, there has been a sea change
in the growing acceptance of working with the patient's
inherent spirituality in the delivery of traditional medical
care.  When I was in medical school in the 1960s, the two
hot issues were honesty and sexuality.  The honesty issue
concerned the growing recognition of the need to include the
patient as an equal member of the patient care team.
 For example, when dealing with a patient with
cancer, the new thesis was that the patient should know his
or her diagnosis and as much as possible about that
diagnosis, and thereby participate better in choices
regarding therapy.
 In the case of sexuality, it was felt that
physicians should be more forthright in discussing sexuality
with their patients, especially when these discussions had a
bearing on the patient's health and well being.  However, at
that time, if one ever broached the topic of spirituality,
such discussions would have been considered by one's peers
as being intrusive and even unprofessional.
 Since that time, especially in the last 10 years,
surveys by Gallup and other groups have given us a new
perspective.  We have learned from these studies that 70
percent or more patients want their doctors to know about
their spirituality perspectives regarding their health.
Amazingly, 40 percent or more patients would like their
doctors to pray with them.
 Also, at the same time that we learned of this new
level of permission on the part of our own patients, we
began to recognize hundreds of scientific studies which
showed the positive benefits of spirituality in a patient's
life, both in regard to health preservation and recovery
from illness.
 Presently, most of the science-based studies in
spirituality and healing are in their infancy, in that most
of these studies are correlational, namely that there is a
correlation between religious practice and belief and health
outcomes.
 Currently, there are only a few studies that
address the issue of the mechanism of action whereby
religious practices and belief can affect health outcomes.
This is similar to the example of many advances in the
history of medicine in which valid correlations were made
prior to understanding the underlying mechanisms.
 For example, the scientific studies that
demonstrated that the use of citrus juices could prevent
scurvy in sailors were a valid correlational study that
preceded the later understanding that the mechanism of
action of ascorbic acid.
 When there is a solid scientific basis for some
component that has beneficial impacts, we feel that these
components pass into the realm of complementary medicine in
which the approach in question can serve as a complement to
traditional medicine and surgical therapies.
 For example, working with a patient's intrinsic
religiosity and belief would not replace the beneficial use
of medications and/or surgery.  Instead, spirituality and/or
religion can serve as a positive complement to traditional
medicine.
 Consider these examples of scientific studies in
this area.  In the 16-year follow-up study in Israel,
members of orthodox kibbutzim had 50 percent lower mortality
rates than did members of secular kibbutzim for a variety of
disease categories, including cardiovascular disease,
neoplasm, and external causes.
 In another study, patients undergoing orthopedic
surgery were randomized to receive chaplain intervention
visits of 15 minutes per day per patient in the test group.
 When they were compared with the control group of patients,
they had reduced length of stay by 29 percent, and one-third
the number of patient-initiated nursing calls, and one-third
the use of PRM pain medications.
 In another study of 248 men addicted to opiate
drugs, long-term religiously based therapy produced a 45
percent long-term success rate in abstinence, compared to a
5 percent success rate in the secular-based program.
 In the area of research-based mechanism of action,
there are some early studies which examine psychoneural
immunology as a possible explanation for how religion might
contribute to good health outcomes.
 In the study at Duke, frequent religious
attendance predicted lower plasma interluken-6 levels in a
variety of serious medical conditions.  These findings
suggest that persons who attend a church frequently have
stronger immune systems than less frequent attenders.
 In order to stimulate high-quality scientific
research studies on the impact of spirituality and healing
in medicine, the John Templeton Foundation has funded two
carefully designed research studies on the efficacy of
prayer.
 The first study assessed the effect of personal,
one-on-one, face-to-face prayer therapy in patients with
moderate to severe rheumatoid arthritis.  Those who were
prayed for had a statistically significant decrease in the
number of tender and inflamed joints, and a significant
increase in joint range of motion and physical mobility.
 Another study currently underway involves a
controlled and randomized multi-institutional evaluation of
the efficacy of remote intercessory prayer in 1,800 patients
undergoing standard coronary bypass surgery.  This study,
centered at Harvard Medical School, is due to be completed
within the next year.
 The first question we were asked to consider is,
how can the not-for-profit sector stimulate CAM research.
There are several possibilities: No. 1, providing seed money
to obtain pilot data for larger research grants; No. 2, to
support the publishing of research results through book
prizes or awards for the best research papers in CAM
therapies; No. 3, financial rewards for exemplary courses or
research programs in medical schools, or maybe more
importantly, during residency, in regard to how to integrate
complementary medical practices into traditional medical
approaches.
 Finally, support the convening of consensus
conferences to bring together both insiders and outsiders,
or skeptics, to discuss existing CAM research and to propose
new productive lines of research.
 Second, we were asked to address some barriers to
accomplishing this goal.  Number one, we need to address the
lack of awareness of the research which already exists or
the perception that CAM research is on the fringe.  The
solution to this problem is the publishing of research
results in peer review journals which might normally be
skeptical of such studies.
 A recent example was the publishing of a study in
the New England Journal of Medicine showing the efficacy of
acupuncture.  A second obstacle is a general lack of
traditional funding for CAM research.  The solution to this
problem is improving the methodological rigor of proposed
studies.  This will help in finding partners in the public
and the private sphere.
 The third obstacle is the need to encourage new
researchers in CAM therapies.  A solution to this problem is
to provide mentors who are well trained in scientific
research to guide junior investigators in the designing and
conducting of their research.
 The final question is, how can not-for-profit CAM
research be better coordinated with federally supported CAM
research.  My suggestion in this area is to develop new
types of collaborative relationships.  This can be done very
effectively by convening a jointly funded consensus
conference to review in depth the strengths and weaknesses
of existing research, and to propose new, well-designed
studies to advance the science behind specific CAM
therapies.
 New studies, for example, might seek to elucidate
both correlation results and mechanism of action.  In
addition, they might focus on cost-effectiveness as a means
of lowering the overall cost of therapy for the patient.  If
such research proposals are well designed, they would then
lend themselves to increased government grant support.
 Thank you very much.
 DR. GORDON:  Thank you very much.  Next is Dyanne
Hayes of the Conrad N. Hilton Foundation.
 MS. HAYES:  Good morning.  We at the Hilton
Foundation are very honored to be invited to appear before
the Commission today, and commend each of you for taking
time out of your busy professional lives to serve on this
commission.
 Dr. Chow, before I leave today, I want a hug from
you.
 [Laughter.]
 MS. HAYES:  We come together, hopefully, to create
a climate in which CAM research is more appealing in both
the public and private sectors.  Hopefully, you have had an
opportunity to read the brief profile of our recent cocaine
alternative treatment study.  I know it came in late, but I
am going to be referring to it several times in my remarks.
 I am a foundation executive with more than two
decades of experience.  I work closely with organizations
throughout the world, each seeking to alleviate human
suffering.  Thus, I understand very clearly the challenges
in competition for grant dollars, and the tension that often
occurs when grant awards are determined.
 If our diligence proves that all things are equal,
who is to say a substance abuse program deserves funding
rather than a project to eliminate preventable blindness.
 I believe the federal government faces similar
challenges, and that is what brings us together today.  How
do we step up to the plate and increase our attention on CAM
research which hopefully translates to increased support?
 As a non-scientific person, I will share with you
some perceptions that help guide me in my response to the
three questions the Commission has posed to us.  First, CAM
research seems to be the stepchild of the National
Institutes of Health.  Perhaps, I am being very impolite to
my host when I wonder whether the NIH is attempting to pass
on the bulk of this very important responsibility to the
private sector.
 Second, as complementary and alternative products
and practices continue to increasingly become more
acceptable throughout mainstream America, coupled together
with our improvement in attitudes among individuals, health
care professionals, and reimbursement entities regarding
wellness and prevention, many of us incorporate one or more
of what are called complementary and alternative into our
lives, whether it is acupuncture, nutritional and vitamin
supplements, herbalists, natural products that range from
soap, dietary products and beverages to pet food, and even
landscaping materials.
 Speaking for myself, frankly, I have been more
influenced in my choices by family and friends than
scientific data.  Perhaps, I thereby increase a risk to my
wellness.  Who knows?  I suppose that is why we must have
more data disseminated.
 I am certain most of you have read this week's
article in Time Magazine regarding the supposed dangers of
mixing herbal supplements and anesthesiology.  Just how are
we going to make these informed choices?  Which begs the
question, is the amount of research currently devoted to
CAM, at a minimum, in reasonable proportion to its
widespread use?
 My last perception, correct or not, deal with what
it must be like working with the federal government and/or a
private foundation.  Some quarters believe that government
and philanthropy have very distinct, separate roles and
should always maintain a distance.  There are those that are
quick to label foundations as standoffish and arrogant, and
probably in some instances, these labels are correct.
 Yet, I believe that if we generalize, continue to
unfairly generalize, that this will inhibit many possible
good partnerships.  Among my foundation colleagues I have
heard that working with the government can be messy,
unpredictable, and responsiveness is hardly a priority.
 The first question, and I will incorporate what I
think a role for the government might be.  First, for the
government, it is about communication.  Believe me, Dr.
Templeton and I have never met before this panel this
morning, but I am going to echo many of his remarks.
 First, begin with hosting introductory face-to-
face meetings and site visits among foundation people with
representatives of existing centers currently funded by the
NIH doing CAM research.  This provides an informative
glimpse of what is on the cutting edge of CAM research.  We
who are interested in and open to the idea of CAM research
then have an opportunity to learn, discover what the needs
are, and get ideas in which they and we might work together.
 At these meetings, use the opportunity to inform
foundation people how one actually navigates the federal
grant process.  Second, be more aggressive in seeking
opportunities for foundation representatives to participate
on panels such as this to discuss their experiences and
perceptions regarding CAM and CAM research.
 Third, at a minimum, get these foundation people
on your mailing lists, publicize the heck out of those
grants that do or have had public/private funding support.
Let us not be shy about celebrating our accomplishments or
reluctant to discuss our challenges, because both are going
to frame how we are going to go forward.
 Ways in which the foundation world might stimulate
CAM research.  First, I would like to see foundations be
more willing to fund small pilot projects.  I have been told
that government dollars for CAM research are becoming
increasingly hard to get without pilot data.  Yet, the
adequate funds -- and I am told this about $100,000 -- to do
this are very scarce.  $100,000 grant over two years seems
very reasonable for a credible pilot study.  For the type of
foundation that has an interest in this, it should be
doable.
 Second, foundations interested in CAM research
might themselves create a pooled fund of monies and announce
the competition for projects up to so many dollars.  The
collaborative would set up a scientific advisory board of
reputable scientists knowledgeable in the area in which the
proposals are being submitted.  This is done regularly among
foundations.  We do this often when we are doing urban
renewal projects.
 This willingness to co-fund helps diminish the
risk factor of being the sole donor.  Many foundation
trustees, including ours, and particularly those non-
corporate foundations, are more favorably impressed when we
can point to the fact that our resources can be leveraged.
 Additionally, when you have a mixed set of funding
partners involved, if a project falters as some do, there is
a safety net in place of smart, invested persons poised to
intervene and determined to succeed.
 The second question deals with the obstacles and
barriers.  I believe the fundamental obstacle we face is the
difference or sense of separation between two cultures,
Eastern and Western medicine.  For example, the idea of a
blinded, randomized, placebo-controlled trial, the gold
standard in Western medicine, is often not acceptable with
practitioners of Eastern medicine.  Our colleague at the
Lincoln Clinic at the Bronx, New York, Dr. Michael Smith,
and to whom I refer in the paper you have describing our
grant, refused Lincoln as a site for our study because he
and his staff feel, very passionately, that it is
irresponsible to allow a sham or a placebo acupuncture
condition for their client.
 Three other obstacles are, and they address the
lack of information or knowledge-sharing that helps to breed
misinformation and mistrust between government and
foundation staff.  First, is the dissemination of data.  It
seems to take forever for NIH to digest data and have it
available for public consumption.  Some responsibility may
lie with the researchers and report writers themselves.
 So I believe they need to apply some pressure to
mop up and finish their reports.  This is a critical part of
the necessity to build bridges between those two sectors,
disseminating data.  To expand further on the information-
sharing point, during the time when our study was being
designed, we and the site investigators learned after the
fact that there had been several very good acupuncture
symposia going on.  These would have been very helpful to
us.  Also, letting the foundation world know what has
already been funded.
 Last but not least, foundations themselves need to
do a better job communicating its funding interests to each
other and to the government.  Of course, sharing whatever
existing data we have regarding any CAM-related research
that we funded.
 We, the foundations, should be a convener and
broker of information as well.  This applies not only to our
external constituencies, but internally as well among our
own staff and trustees.  We need to send the signal that we
are willing to deal with the largest funder of health
services there is, the federal government.
 The last question, how can the two sectors better
coordinate CAM research.  My answer to this in some ways
reflects my earlier response to the previous questions.
First, the subject of timing.  If we really are going to
attempt an increased number of jointly funded research
projects, then both sectors have to assess how to be more
flexible regarding timing of proposal submittals.
 My experience with our study was that we gave Dr.
Klieber [ph] one year to match our grant or risk losing it.
 He and I both scoured the foundation world diligently to
get this match.  He gets the prize for the most rejections,
15.  By then, months had passed as well as two of the three
deadlines that year for submitting grant proposals to the
government.
 Even if Dr. Klieber had met one of the deadlines,
I understand that an application review takes four to five
months, and then the investigator doesn't learn what his
priority score or comments are for another two months.  That
is more than half a year.  Plus, if most applications aren't
funded the first time around, it takes nearly two years from
the date of submission and resubmission to get funded.
 Perhaps for CAM research the review committees
will rethink the scoring system and make the process less
tedious and time-consuming.  Thus, it really was very
unrealistic for the Hilton Foundation to expect a match for
our grant, especially for CAM research, that it could happen
in one year.  No wonder scientists are less than
enthusiastic when offered private sector support with this
type of contingency.
 In closing, I believe sincerely that both the
public and private sectors seek solutions that are practical
but effective, inexpensive, transferrable, and reliable.  We
both want to demonstrate that we care about protecting
consumers against dubiously effective, substandard or
counterfeit practices, and thereby minimizing health risks
for populations worldwide.
 Thank you.
 DR. GORDON:  Thank you very much.
 Dr. Daniel Callahan from Hastings Center.
 DR. CALLAHAN: I should say first, unlike my
distinguished colleagues, we are on the receiving end of
grants rather than providing grants.  So I come with a
somewhat different perspective, but I would like to talk
about what I think the nonprofit sector can bring to this
general discussion.
 I really got interested in the subject a few years
ago when I began noticing an uncommon degree of hostility
among a number of distinguished physicians toward CAM, and I
began asking myself, why is this hostility there.  It is
obvious from surveys that a large number of people use it,
actually a large number of educated people.  Why is it?
 I have come to think that probably the greatest
obstacle to getting more research and better research is
that remaining hostility.  Not only has that discouraged
people from looking at the subject -- it has discouraged
many good researchers -- but there is a tendency, even once
the research in underway, not to take it very seriously.
 So I think one major problem is somehow finding a
way to work better with, I will call it, the medical
establishment, whether you call it the reductionistic
medical establishment, the dualistic medical establishment,
but yes, Virginia, there is a medical establishment and it
has its lay supporters.
 Leon Jaroff [ph], a long-time writer for Time
Magazine, predicted recently in an issue of Time Magazine --
it was an issue devoted to the future of medicine -- and one
of his predictions was that within the next 30 or 40 years,
alternative and complementary medicine will have been
thoroughly debunked and removed from the scene.  If you read
the magazine reason, and there are few others, you will find
quite a great deal of hostility.
 I think that, to me, is one of the major
obstacles, how to give it a higher status, give it a
stronger reputation, and bring in people from the middle
range of medicine, if you will, who could make a
contribution.  Having said that, I would also add, I think
one of the difficulties created by this situation is it has
forced many researchers in CAM to play on somebody else's
turf, if you will.
 I certainly believe it is important to look at
safety and efficacy issues, but I don't think that would
have become the most important issues if it were not the
main medical establishment saying, by god, if you want us to
accept you, here are our rules and you show you can play by
those rules.  It seems to me, that is a kind of a trap.  The
question is, while taking that view seriously, not let that
dominate it as the model of what counts as good research.
 Well, in any case, let me suggest four areas of
research I think are important.  First, obviously, is safety
and efficacy.  Enough has been said about that and the need
for good scientific research, so I will say it no more.
 I think it is important also to ask the question,
what does the public interest in CAM say about the general
attitude of Americans toward health care in this country?
What does it say about what they are not getting, or what
they feel they are not getting?  What they feel they need in
addition to what they are getting, and how can we better
make sense of that?
 Most of the people I know interested in CAM, it is
for them an alternative.  They do both.  They usually turn
to CAM when other things don't work, and typically with
chronic illness.  But I don't think we really understand the
social dynamic, much less the medical dynamic of chronic
illness well enough.
 It seems to me, research on why people are drawn
to it, what people who are drawn to it, what do they mean by
what we say works, or what do they find satisfying about it
that they don't find satisfying in the rest of medicine.
Here a good deal of social science research would be very
helpful, cultural research as to what makes people think
about it the way they do think about it.
 It is pretty clear for many people that the fact
that personal interaction is a key element.  This is
constantly talked about in mainline medicines, the need for
better communication.  We have a project at Hastings on
communication in cancer, but it is fairly clear that it is a
problem and perhaps exacerbated by managed care.  But even
without managed care, it has always been a problem.
 We have to understand why that is the case.  Why
is it that it is so difficult to get people simply talking
with each other in health care?  CAM, it seems to me, has
some insights to offer in that respect.
 Thirdly, I think the issue of medicine as art and
medicine as science, an ancient issue, remains an important
and fascinating one.  It seems to me, when we think about
it, it is really interesting paradox or puzzle that over the
past 10, 15 years, not only has evidenced-based medicine
come to the fore, namely that we need more and better
scientific medicine, but at the same time CAM has come to
the fore.  We have got these two parallel things going on.
 I have been increasingly impressed by the limits
of evidence-based medicine.  First of all, very expensive to
do.  An awful lot of conventional medicine will never be
properly tested.  On occasion, of course, when it is tested,
it is tested, often, by pharmaceutical companies who have
got something to benefit.  So there is a certain suspicion,
anyway.  Surely, the federal government is never going to
put up the billions of dollars necessary to really review
everything.  So it can't be done in any very total fashion.
 Secondly, the results you will get are
probabilistic results.  It doesn't tell you what to do with
any individual patient.  It tells what on the whole might
work some of the time with some of patients under certain
circumstances, which means that the relevance of medicine as
an art is still as much alive as ever.
 If you get the evidence, you get the
probabilities, you have the ethical questions of, well,
should you spend the money doing something that may have a
low probability, might work with some people but not for
others; how should you think about individual patients in
the light of population statistics.
 As far as I am concerned, the interaction between
science and the art of medicine is going to be a persistent
part of medicine in the future, regardless of how much
evidence-based medicine there will be, and there will never
be enough of it.
 Finally, I think CAM is helpful in trying to
envision what we think of as the future of medicine.  My
main work is in the area of health policy.  I am interested
in the future of our health care system.  This is an
excessively grandiose generalization, but I think we face
two large problems.  One, the obvious aging of societies,
the larger and larger number of elderly people, many of whom
are going to have chronic illness.
 On the other hand, we also have a great problem of
how to educate a younger generation to stay well so that
when they become elderly they will not become chronically
ill people, but they will get through a long life in pretty
good health.
 Here, the idea of compression of morbidity, I
think, is alive and well, and worth pursuing.  For this
reason, I think CAM not only offers the possibility of
dealing better with the aging population, but also of
enabling younger people to better take care of themselves,
better understand their own health, and thus, reduce our, at
present, I think, excessive dependence on high technology
medicine to bail us out and rescue us after we have lived
unhealthy lives, or one thing or another has gone wrong.  I
don't think we can continue on that route with an aging
population.
 So in my mind, a sustainable medicine is going to
require a CAM as a fundamental part of its future because
the present biomedical model, I don't think, is a
sustainable model for the future of medicine, either
economically, or for that matter in terms of improving
health.
 So with that, I will stop.  Thank you.
 DR. GORDON:  Thank you very much.
 Next is Ms. Teri Ades from the American Cancer
Society.
 MS. ADES:  Thank you.  I would like to thank the
Commission and Dr. Gordon for the invitation for the
American Cancer Society to speak to you today.
 The American Cancer Society is the nationwide,
community-based, voluntary help organization dedicated to
eliminating cancer as a major health problem.  Because we
are community-based organization, we touch millions of
people's lives everyday.  My comments today, just to share
with you, will be related to cancer and complementary and
alternative medicine.
 We realize that there are many definitions of
complementary and alternative medicine, and I would like to
share with you what our definitions are so that we can
realize that we may all have differences in how we define
these words.
 "Alternative," to us, means a treatment that is
used in the place of a mainstream treatment.  It may be a
disproved treatment or one that hasn't been proved to be
effective.  Complementary methods are those that are defined
as used in addition to a mainstream treatment.  These do not
replace mainstream treatment, and they are not promoted to
cure or treat cancer.  Rather, they control symptoms and
improve the quality of life of the person.  This distinction
separates the methods based on how they are used.  Any one
therapy could fall into either category, depending on how it
is used.
 I share this with you because the lack of
consistent definitions has created much confusion to the
public, and for professionals, studies published in medical
journals cannot be adequately analyzed, nor can they be
compared with other studies because of the differences in
our terminology.  We do not believe that alternative and
complementary therapies are the same, and should not be
grouped as one.
 I raise this because if the body of knowledge is
to grow, we must speak with one language.  We are sensitive
to the growing public interest, in particular those living
with cancer with regard to alternative and complementary
medicine.  We also acknowledge that more research is needed
regarding the safety and efficacy as has been mentioned
previously, and we advocate for peer-reviewed scientific
evidence.
 We believe that all cancer interventions must
withstand the scrutiny of peer-reviewed scientific
evaluation before they can be recommended for the prevention
or treatment of cancer.  We also realize the need to balance
access to alternative and complementary medicine while
protecting patients against those therapies that might be
harmful to them.  We support patient access, but strongly
encourage more oversight and accountability by governmental,
public, and private entities to protect the public.
 We believe cancer is a little bit different from
some of the other chronic illnesses.  The reason we do is
that many cancers today can be cured if the disease is
diagnosed early, and if the treatment is started, and if the
treatment is the treatment that is effective for that
cancer.  If there is a delay in diagnosis or treatment for
whatever reason, then the chances of that cure may be lost.
 The potential drug interactions in people with cancer can
occur, and they must be recognized.
 Now, to address the questions that I was asked to
address, the first one: How can the public/private sector
stimulate complementary and alternative medicine research?
 I think you have a handout from us that does
describe our current research in the area of complementary
and alternative medicine.  I wasn't asked to address that,
but I do want to call your attention to that.
 I would like to revise the question that we were
asked and address: How can the public/private sector
facilitate professional participation in current funding
opportunities?
 The American Cancer Society does support the
National Center for Complementary and Alternative Medicine.
 The initial statements of Dr. Straus, we have found, are
very encouraging regarding the importance of the systematic
and scientific approach to studying various medicines.
 The Center has good funding, and we hope that the
Commission will support the Center's efforts.  A second
important component of existing opportunities for research
is the NCI's Best Case Studies.  I believe you heard about
that yesterday.
 This gives clinicians who may not have the
research background an opportunity to learn how to conduct
their study using a scientific method.  We encourage this
group and others to support this program, to provide the
necessary mentoring and coaching that clinicians need to
successfully complete their research and to publish their
findings.
 We currently have in place the opportunities for
research funding for people with cancer through our
government agencies.  More money may be needed to be able to
mentor and coach more of those who have therapies that want
further study, and if that is the case, that we ask the
Commission to recommend additional funding.  We believe that
successful mentoring will be the impetus for others to
follow.
 The second question: What are the obstacles,
barriers and possible solutions to accomplishing this goal?
 For example, the use of incentives.
 What we see as the primary barriers to more
research in this area are attitudes and perceptions.  Money
may be an additional factor, as mentioned previously.
Obviously, good research costs money, and money will attract
those who are considering further study.
 We believe the major barriers lie in people's
attitudes, and perceptions had been mentioned previously.
For example, some believe that the randomized clinical trial
cannot be done with some of the complementary and
alternative therapies.  My question is, is that fact?  If it
is, then we do need to identify those types of research that
can be used.
 We are beginning to see more research published in
some of the major medical journals, such as the New England
Journal of Medicine, the British Medical Journal, and JAMA.
 We need to see more published research.
 For others, the lack of scientific proof for years
in the past, and still today, causes trust issues, which
divide people into the "we" and "them."  We must move beyond
this to a comfort level that allows everyone to agree that
safety and efficacy are essential.
 Rather than considering incentives, we ask the
Commission to consider setting the expectation that all
therapies must be proved to be safe and effective so the
public does not have to question their therapy.
 We also encourage an educational strategy, one
that will identify and teach the research methods that are
necessary to study this area, to offer mentoring, to support
the researchers through the process ending with a
publication, and to help in breaking down the barriers that
I have addressed previously.
 No. 3: How can the public/private sector be better
coordinated with federally supported CAM research?
 We have no really good model for this, but we
believe a model could be established with the National
Center for Complementary and Alternative Medicine as the
coordinator of the group.  We would like to see the public,
private, and governmental agencies together discussing how
this might work.
 We have also seen how quickly such cancer centers
as Fox-Chase, Memorial Sloan-Kettering, Dana-Farber, and
others, have developed their integrated medicine programs to
offer complementary therapies along with their mainstream
treatments.
 These programs offer the patient the study
population needed, and the investigators clinicians to
conduct the studies in a coordinated approach to CAM
research.
 So the summarize my comments, we do support
evidence-based scientific research to prove the safety and
efficacy of new promising therapies.  We do support the
right of patients to expect that what they receive is safe
and effective.  We do support the National Center for
Complementary and Alternative Medicine, and the NCI's
research agenda as well.
 We support the Center's coordination of CAM
research involving all agencies, federal, private, public.
We ask that the cancer centers' integrated medicine programs
be considered a valuable resource.  We support existing
federal funding opportunities, and support an educational
strategy, as I have mentioned previously.  Thank you.
 DR. GORDON:  Thank you very much.
 Thank you all four for your complementary
perspectives.
 Dean?
 DR. ORNISH:  First of all, I am sure that I am
speaking for everyone here to say how much we appreciate
your being here, and how fascinated I personally am by what
each of you had to say.  As Jim was saying, it really does
complement.  I have just one question for each of you, if I
can be brief.
 For Dr. Templeton, in the pioneering work that
your foundation is funding, are you distinguishing between
what some would categorize as religion versus spirituality,
the idea that religion sometimes divides and spirituality
looks for commonality?
 In many systems of healing, the very fact of
dividing itself, may predispose to suffering an illness, and
the very fact of finding common ground leads to healing.  I
am just wondering if you make those distinctions.
 DR. TEMPLETON:  The problem of designing good
studies is difficult when you have a harder time defining an
item that you are studying and be able to measure it in
particular.  If you deal with religion or religious
practice, you could certainly assess people's attendance or
practices, whether those are prayers or devotions or any
kind of overt activity which you could quantify.
 I think that has been the big weakness in studying
the broader issue of spirituality from a scientific
perspective because people seem to have different
perceptions of what their spirituality is, compared to
someone else.
 DR. ORNISH:  Right.
 DR. TEMPLETON:  So that why I say this kind of
research is very much in its infancy.
 DR. ORNISH:  Although, when you have relatively
crude measures, and yet find dramatic differences, then you
have to figure there is something going on there.
 DR. TEMPLETON:  Yes, I agree.  That is, again, why
I say that I think much of the early assessments will be
correlational, and then you may, hopefully, in time, be able
to understand better why they have that effect.
 But yes, I think it is important to try and pick
some aspect of spirituality that a group that practices a
certain type of spirituality approaches maybe will say, this
is what we are about when we say that, and then study their
intervention.
 DR. ORNISH:  Some orthodox groups, they may
distinguish themselves from other groups, but at least
within that group there is a greater sense of cohesiveness.
 So it is even harder to tease those things out.
 DR. TEMPLETON:  Right.
 DR. ORNISH:  Thank you.
 And then, for the Hilton Foundation, I understand
you have no investigator-initiated grants.  It is all
foundation-initiated.  Are you doing anything in CAM?  I
mean, you have talked about the cocaine study, but in a
broader sense, are you planning any initiatives in CAM?
 MS. HAYES:  Nothing is in the works at this time.
 This particular study, it really has been six years.  We
expected a three-year time frame.  Now, the Hilton
Foundation does like to commit its resources long-term, but
this took much longer than we had hoped.
 However, our board is very eager to get the
results, and Dr. Klieber tells me they will be here next
month.  Regardless of what the results are, I think for a
board as traditional and conservative as ours, it was a
giant step forward for them and we have been very pleased
with the organization that we funded, the Center for
Addiction and Substance Abuse, CASA, and Dr. Klieber, in
particular.
 And so, I would hope that the board would continue
to be open if we bring something to it, because we are a
foundation where unsolicited proposals are not funded.  We
look for niches that aren't being funded or aren't
particularly popular.
 DR. ORNISH:  Thank you.
 Dr. Callahan, I was particularly fascinated about
what you were you saying about the limitations of evidence-
based medicine.  I used to get the Hastings Report when I
was in medical school, and it was one of the only things of
its kind at the time.  So I really appreciate what you did
then, too.
 One of the things that we found in doing
randomized, controlled trials, is that there has to be a
certain narrow window in time.  There has to be enough
evidence to justify doing it, but not so much that a control
group would be unethical.
 If you have a new drug or a new device, that is
less of an issue, but in CAM, by nature of the fact that so
many therapies have been around for thousands of years, they
wouldn't be around for thousands of years if there wasn't
some evidence that they did some good.
 How can you do randomized, controlled trials?  We
find this all the time in our work.  When someone gets
randomly assigned to the control group, they feel bad, and
we feel bad.  We justify it by saying, well, it is the
higher purpose of, you really need to do this to get that
sense of rigor, and yet.
 As an ethicist, what is your opinion?  Is it
ethical to do randomized, controlled trials of CAM therapies
if there is enough evidence that there is some benefit, that
they have been around as long as they have been?
 DR. CALLAHAN:  Whether it is ethical or not.  I
guess the question is, there will be circumstances where you
really can't do randomized clinical trials.  You are going
to have find some alternative method.  It simply won't even
be practically possible.
 Then I guess the question is, do you have enough
confidence in those other methods that you feel reasonably
certain that there will be no harm to the patients, that you
will really get good evidence, that the results will allow
you to say yes or no or maybe about something.
 So it seems to me, the question is really the
adequacy of the other methods of evaluation if you can't use
the randomized clinical trials.  It seems to me, an enormous
need in this field is to find some better ways of
formalizing alternative means of investigation.
 Interestingly, this issue came up in arguments
about doing AIDS research in Africa were many object to
doing placebo studies, which is a standard part of the
technique.  It is just in certain circumstances, that does
not seem ethically appropriate.  So the thing is, what then
is, if not equally good method, what is a very good second-
best method.
 I gather CAM has really got a problem articulating
some, if you will, competitive research models that seem to
have the power of the randomized clinical trials.
 DR. ORNISH:  Just as a follow-up, it even goes
beyond just adequate other methods, because we found, for
example, in our earlier studies with looking at CAM
approaches and reversing heart disease -- ideally, in a
randomized trial, you have to complete testing of someone,
and then you randomize, but in the process of testing them,
people develop such a positive expectation, despite our best
efforts, that if they were randomly assigned to the control
group, they would get angina.
 One guy called me at 4:00 in the morning from the
coronary care unit saying, I got so disappointed when I got
the control group, I got unstable angina, and I am up, and I
want you to be up, too.
 [Laughter.]
 DR. ORNISH:  Then, of course, it introduces all
kinds of confounding problems because then they are more
likely to change because you told them exactly what you are
doing.  They are more likely to drop out because they are
angry they ended up in the control group, even though you
disclosed at the beginning exactly what the odds are.
 So there are certain issues that are inherent,
almost, in many of the CAM studies that you don't find in
drug trials.  I am wondering, as an ethicist, putting aside,
can you get good enough data, is it really ethical to do
these kind of designs?
 What we ended up doing was modifying our design to
an invitational design where we would randomize people
before we conducted them.  So we had less contamination,
cross-over, drop-out, people getting upset, and so on, just
to make myself more ethically comfortable, but I think also
it gives better science.
 Do you address these issues at all in the Hastings
Center?
 DR. CALLAHAN:  We have not.  We have actually done
a lot of work with human subject research generally, but we
haven't particularly looked at CAM research as a special
subcategory.
 I guess my sense is that if you can't do what is
considered the gold standard, as they say, and nonetheless
it is important to test in some fashion, then it is
perfectly all right, I think, to pick some, perhaps, less
satisfactory method if it is the only one available to use.
 It seems to me, this is sheer necessity.  Better something
that you consider not quite ideal than doing nothing at all
and letting things just continue wandering about, as they
probably will, if you don't do the test.
 DR. ORNISH:  Thanks.
 My last question, which is brief, is, is the
American Cancer Society doing any CAM initiatives, any CAM
funding?  I wasn't able to find it.  In particular, are you
doing any kind of partnerships with the National Center for
CAM?
 MS. ADES:  In terms of our research, we have three
different areas of research, and we have activities related
to complementary and alternative medicine in all three
areas.
 Our Behavioral Research Center, which, we conduct
our own research.  Two previous studies that they have done
was the frequency of use of CAM among cancer survivors.
 Then the second one that was done was professional
perceptions of the use of CAM.  The one that is currently
going on right now is the frequency and impact of the
quality of life of breast cancer survivors who are using
complementary and alternative medicine.
 Our Epidemiology and Surveillance Department, of
course, has their ongoing cancer prevention studies 1 and 2,
started in '59.  They are following 100,000 people.  A
component of that is certainly nutrition, their nutritional
habits.  That will include vitamins, minerals, nutritional
supplements, and so on.
 In terms of our extramural grants program, I
looked quickly through to find some of the grants that we
currently are funding, and those include the use of
presurgery hypnosis, effect on post-surgery recovery of
breast cancer patients, the use of hypericin from St. John's
wort to treat tumors of the pancreas, the use of Vitamins A
and D for biologic modulation chemotherapy of advanced
breast and prostate cancers, and the applications of
acupuncture for pain management.
 Those were, just quickly, four that I pulled out.
 DR. ORNISH:  Thank you.
 DR. GORDON:  Wayne, Charlotte, Joe, and Tom.
 Let me just say to everybody that we need a little
concision, too, because we are going to be running way over
time.
 DR. JONAS:  Thank you very much for the list
because that was my question, also, as to what was actually
being funded by the ACS in these areas.  It sounds like most
of them are in complementary areas, and so an important
perspective.
 I just wanted to follow a little bit up on the
methodological discussion that was had, and just point a
different dilemma, and we don't need to go into the details,
but I appreciate any kind of thoughts on that perhaps you
could deliver to us.
 To me, I see almost an insolvable dilemma of being
able to address the need of new methodologies from the
perspective of complementary and alternative medicine.  It
is almost like saying, well, I want to test this untested
area, and I am also going to use an uncertain measurement
technique.  You don't combine both of those.
 It is very clear that the randomized, controlled
trial, as you have mentioned, is not adequate for
everything, but it is unclear as to what else can provide
you with equally valid information.  So we don't really have
a substitute at this point.  I am not sure that
complementary medicine can do that.  It is the
responsibility, really, of the mainstream scientific
community to try to figure that out.
 I am wondering if there are some ways in which we
can facilitate that, even though it is not directly on
complementary medicine.  If there are ways in which some of
the work that you are doing, Daniel, could assist, or if you
perceive ways that the Commission itself could facilitate
them.
 DR. CALLAHAN:  Well, you may remember from our
project, I found one of the things in a project at the
Hastings Center was to bring in some people who were experts
in the philosophy of science.  They weren't experts in CAM.
 DR. JONAS:  Exactly.
 DR. CALLAHAN:  It seems to me, it would be a
valuable little project to find some people who were
interested in scientific methodologies who look at different
fields, because one thing is pretty clear, there is no such
thing as one single scientific method.  Biomedical fields
use different methods of research to bring together a group
of scientists to talk about the development of some
alternatives which might be appropriate.
 If you can't use randomized clinical trials, are
there perhaps some models that research in other fields that
you could borrow from, or adapt, or modify that might work
here?
 DR. JONAS:  Should that be more of a foundation or

a think tank effort?
 DR. CALLAHAN:  No.  I think it has to be a think
tank.  It seems to me, a grant to bring together some
research methodologists to talk about this issue, and to
bring in not just people interested in CAM, but to bring in
someone who will find this a fascinating methodological
problem would be a valuable exercise and very helpful, and
probably not expensive.  People like that come rather
inexpensive.  No machines, no nothing, just real cheap
stuff.
 DR. JONAS:  Just brains, billions of years of
investment.
 I had a couple questions, well, one question,
really, for the Foundation.  I would love to get your
comments in writing, the succinct recommendations that you
had.  I didn't see all of those in here.  I think they were
excellent, both of you, in terms of some ways to facilitate
the private investment and the kinds of things that you are
looking for in these areas.
 I had one question for Dr. Templeton.  There
considerable interest in spirituality now, really, in all
sectors, both the government and the private.  The NIH
currently has a working group that I help facilitate, and it
is ongoing now.  It is cross-institutional, to look at
spirituality in health areas.
 Rockefeller has funded now a project to pull
together the science in spirituality as well as energy
healing and distant things.  Some of what you are doing kind
of overlaps that, the distant-healing study that you
mentioned looks at non-local issues in some regard.  The
spirituality observational epidemiological studies are
looking more at the traditional religious and spirituality
practices.
 I guess, from your perspective, I would be
interested to know, are there ways to kind of bring these
things together?  Do we just allow them to spontaneously
come together?  Is there a way that there can be a bridging
the Commission might help facilitate or suggest in that
area?  What would be needed in that, from your foundation's
perspective?
 DR. TEMPLETON:  We are young foundation, and we
are very early in the area of supporting individual
research.  We were impressed with the quality of the two
studies that I mentioned, which is why we supported them.
 I think that we are great believers in the
importance, as has been suggested, of consensus effort to
bring together, whether it is on the ethical or scientific
design aspect, or on the feasibility of addressing a
structured study on any kind of intervention.  For us, it
would be in the area of spirituality.
 We agree, going back to the earlier question, that
spirituality as a more general concept, is something that
needs to be addressed because most of the science has been
things that were more behavior-related in the area of
religion.
 So I think a consensus conference could be very
helpful in suggesting the ways to study this.
 DR. JONAS:  Have you done things, for example,
with one of the NIH institutes in the past in some kind of
collaborative meeting or a conference?  Has that been
something that has occurred?
 DR. TEMPLETON:  No, we haven't.  So I think we
would be interested in some sort of collaborative effort in
our area of interest.
 I thought these presentations were being
transcribed.  Am I mistaken?
 DR. GORDON:  They are.  They are being
transcribed.
 DR. JONAS:  Oh, okay.  So we will get that, then.
 Thank you.
 DR. GORDON:  Thank you very much.
 Charlotte?
 MS. KERR:  Dr. Callahan, in your report here, you
speak of the conclusions of the research group.  We have
already talked about it a bit, but the third one, "There is
no single, all-purpose, scientific methodology suitable for
CAM; and "The need to determine the methodologies are most
appropriate for evaluating CAM.
 Wayne has already highlighted this.  Also,
yesterday the founder of Bastyr suggested that we have a
consensus conference on research protocols.  I wondered what
you thought about that.  I think I have some understanding
from what you just said to Wayne.
 I often feel when we are listening to people and
scientists speak to us, and even amongst ourselves on the
Commission, that we say, well, we need rigorous scientific
study, and it seems to be an ipso facto kind of, we have got
it all down and we know what we should be doing.
 To me, it is almost a fundamental starting point.
 I have a question about that, which of course, is what your
research group is reporting.  I am wondering, in addition to
anything further to say about the way to pursue doing this,
a consensus conference, a think tank, what did you find in
your research group?  Did you find that the world view, the
new scientific thinking, is what is creating the question in
terms of research methodologies to be used for CAM?
 DR. CALLAHAN:  Well, if I understand your
question, what seemed clearly evident is that there is a
view out there that there is a single type of scientific
methodology which is the scientific methodology.  It seemed
pretty clear to us, first of all, that there isn't.  There
are many scientific methodologies.
 Secondly, that CAM, given the whole range of
things that are covered by that territory, I think to
evaluate spirituality is very different from evaluating
herbs.  You can do a pretty clean study of efficacy, but
spirituality, even if you know that there is a correlation,
it is not clear what you would do with it exactly.  There
are different implications and consequences of even the
findings in the practice of medicine than there are in the
use of herbal supplements.
 So it seems to me, what we really need is,
probably, look at the whole field and decide what are the
main types of issues and what are the appropriate
methodologies, and to move away from the idea that there is
one, and only one, scientific methodology which is all-
purpose, valid for any and all purposes.
 DR. TEMPLETON:  Just on the question of
spirituality or religion, that sort of thing, I think there
are new openings, such as in the training of medical
students, and perhaps residents, to understand that it is
appropriate to take a spiritual or religious history.  You
can do that fairly quickly, in two or 3 minutes, which may
or may not open doors that will be very meaningful to that
patient as they face their illness or their health problem.
 So I think that there are some new approaches that
can bring these spiritual or religious-based sensitivities
into the mainstream.
 DR. GORDON:  Thank you.
 Joe.
 DR. FINS:  I just want to endorse the notion of
really looking at methodology as an important issue.  I
think Wayne is absolutely right, we can have new therapies
and new methodologies coexisting.  We have to foster the
development of new methodologies, but this is an old
question about -- viability.  This was a question for
psychoanalysis.  Freud had the same problem.  So this is an
old, ancient question that we will have to address as well.
 I want to also add to the issues, and I think Dan
mentioned this, the issue that this is really a public
phenomenon, and resonate with what Dean said about the
difficulty of saying no.  I would also expand to the
psychodynamic aspects of being an investigator in CAM, being
marginalized, perhaps, by your traditional peers and finding
a tremendous resonance with your patients, and whether that
phenomenon is different than a conventional investigator who
is handling chemotherapy and can't enroll another patient
because the funding has run out or they have accrued the
number of patients necessary.  So the sociology of the
investigator as well as the phenomenon.
 I have a really concrete question, just to add to
this session, for Ms. Hayes and Dr. Templeton.
 We heard yesterday that some of the investigators,
because of the marginalization, are not affiliated with
institutions or with not-for-profits.  There are for-profit
practitioners who may not qualify for the 501(c)(3) issue.
 I am just wondering how a not-for-profit
foundation could support people who don't have their own
infrastructure, and what kind of suggestions both of you
might make to foster that as an outreach.
 MS. HAYES:  It is not illegal for a foundation to
make a grant to an individual.  It just requires that the
foundation bear the responsibility.  We call it expenditure
responsibility.  It demands more staff time and a
willingness on the foundation to do that, because many times
we fund organization that aren't U.S.-based.  We have to be
willing to take that grant.  It just requires some
additional due diligence up front and so forth.
 Unfortunately, the Hilton Foundation rarely will
fund an individual.  I can't think of an instance that we
have in our history, but we do fund organizations that are
not 501(c)(3).
 DR. TEMPLETON:  I agree exactly with What Dyanne
said.  As a new foundation and in pushing some frontiers
that are not generally picked up by a lot of other
foundations, we are more flexible in resorting to
expenditure responsibilities when we think someone's
undertaking is really worth supporting.  We don't do it
commonly, but we are much more open to it.
 DR. FINS:  But if we want to generalize it, and
have foundations that are, perhaps, less enamored with this
new evolving area of funding.
 Are there recommendations that you might perhaps
mention now or send to us, changes in the law, in the not-
for-profit law, that might help to encourage greater
outreach on the part of foundations that, maybe, do not want
to take this additional set of responsibilities on?
 Maybe you can supply that to the Commission,
because we could make those recommendations downstream.
 DR. GORDON:  Anyone else want to respond?  Tom.
 MR. CHAPPELL:  Dr. Templeton, thank you for your
presentation.  I was curious, as you were speaking about
spirituality as a complement to traditional medicine,
whether you have explored 12-step therapy, recovery therapy,
in any one of the addictions as an efficacious complement
for health.
 DR. TEMPLETON:  We haven't done it.  We try,
because our funding is to some extent limited, to find
cutting-edge research that has not been done before.  There
are a fair number of studies that have addressed the 12-step
approach, and they do seem to support the efficaciousness of
it.
 The study that I mentioned about the 200-some men
who were addicted to opiates was not our study, but that is
an example of the impact of a spirituality-based therapeutic
approach for those people who were addicted.
 MR. CHAPPELL:  Thank you.
 DR. GORDON:  Any other questions from any of the
commissioners?
 [No response.]
 DR. GORDON:  I have one.  If you could push us in
the direction of doing something, recommending something as
a commission to move the whole field ahead, I am just
curious, what would each of you suggest to us?  One
recommendation that we might make that would push or bring
with us the whole field of CAM, that would make sense from
your perspective.
 DR. CALLAHAN:  I guess I would simply stress the
point I made.  I would like to have a better understanding
of what there is about CAM that attracts so many people when
there is this alternative system that purports to be dealing
well with people.
 To me, there is a mystery here and it is worth
really trying to explore; what gap is it filling, and how is
it filling it.
 DR. GORDON:  Thank you.
 MS. ADES:  I would like to see the working group
to study the research methodology.
 DR. GORDON:  The study the research methodology,
okay.
 MS. HAYES:  I think it is about communication and
openness.
 DR. GORDON:  Any specific kind of proposal for
that?
 MS. HAYES:  Well, I am coming from a funding
perspective.  I think foundations have to be inspired to
look at this, but they need help.  The two of us here, we
are among only a handful of foundations that are willing to
look at this.  It is a very small fraction of our budgets.
 We have to be willing to share our experiences,
but at the same time, I think the government bears some
responsibility in this, too, and as I mentioned, to
facilitate those conversations.
 DR. GORDON:  So to facilitate a conversation among
foundations as well.
 MS. HAYES:  Yes, and communicate that it can be
done.  As I said earlier, it is not going to be messy and it
is not going to hurt, and we can all benefit from it.
 DR. GORDON:  Thank you.
 DR. TEMPLETON:  I would like to urge that, because
all of us are in this learning process, that if one looks to
a consensus conference or something, that it not be a CAM
consensus conference but pick two or three components of CAM
that has more coherence to it, herbal therapy or something
like that, and then work with a meeting that would involve
the foundations as well as the research experts to be able
to come up with better models for studies.  It becomes too
diffuse if you try to just do it all at once.
 DR. GORDON:  Thank you all very much.  We really
appreciate it.
 Let's take a 10-minute break now, okay, and then
we will come back.
 [Recess.]
 DR. GORDON:  We are going to begin Session X.
This is Private Sector Support for CAM Research.
 Again, thank you all for coming, and thank you for
coming and clearing your schedules on short notice.
 We are going to have five speakers, and we will
listen to all five, and then we will have a chance for
questions and dialogue.

********************************************************

 First, is Mr. Randy Burkholder from Advanced
Medical Technology Association.
 Session X: Private Sector Support for CAM Research
 MR. BURKHOLDER:  Good morning, Dr. Gordon and
Commission Members.  Thank you for having me speak here this
morning.  Forgive me if I don't directly answer all your
questions, I have been listening to the debates this week.
 [Laughter.]
 MR. BURKHOLDER:  I am here on behalf of Advanced
Medical Technology Association.  We represent the producers
and innovators in the field of medicine thank you, and our
members produce over 90 percent of the medicine equipment
and supplies that are consumed in the United States.
 Today, I hope to offer to you some insight into
private-sector research, and complementary and alternative
medicine from the vantage point of the medical technology
field.
 First of all, a little context on the health
trends shaping CAM research that I am sure you are familiar
with.  Consumers, as we all know from personal experience,
are spending more and more on health care.  In fact, that
figure has quadrupled over the past 20 years.  It now tops
$500 billion a year.
 One thing we still have money for, certainly, is
complementary and alternative medicines.  I am sure most of
you are familiar with the figure reported by Dr. Eisenberg,
that Americans spend an impressive $12.2 billion of their
own money on complementary and alternative medicines in
1997.
 Five Mountain Medicine Center in Hawaii is one
place that some of that is being spent.  This center seeks a
new model for health in the 21st century by bringing
together leading-edge technology and complementary and
alternative techniques.  Dr. Earl Bakken [ph] is president
of the board of that facility.  He also invented the first
wearable external pacemaker in 1957, and cofounded Metronic,
Incorporated.
 Dr. Bakken foresees 10 important health trends in
the coming decades.  Some of them are particularly relevant
for our discussion today.  One of those is rising demand for
quality versus cost-cutting; the rise of the individual as
his or her own health manager; the rise of the Internet, of
course; and the integration of complementary care.
 Several of these trends can be described together
as the shift toward a patient- or consumer-centered health
care delivery system.  The dramatic growth in CAM over the
past 10 years, of course, has been an important and early
indicator of this trend.
 But who exactly are these empowered health care
consumers that we keep hearing so much about?  Well, for
one, they are spending almost three times as much on diet
products, $33 billion a year, as they are on CAM.  The
outcome, or at least one way of looking at it, was reported
this week in the Journal of the American Medicine
Association, a 60 percent rise in obesity since 1991, and
obesity, of course, is second only to smoking as a cause of
premature deaths in the United States.
 It might make you wonder what exactly the health
care consumer is going to do in the coming years with all
his or her new-found power.  I think that is what brings us
to this table today, is to answer that question, what will
health care consumers do with their new clout.  With
reliable information, I believe they will do good things.
In fact, the longevity of a patient-centered health care
system depends on reliable information.  CAM, as a vibrant,
integrated component of that system, depends on reliable
information as well.
 From the private sector perspective, then, how do
you foster development of good information on CAM?  As we
consider that issue, I think it is instructive to look back
at Dr. Bakken's pacemaker.  It was, as I mentioned, a rather
bulky, wearable, external device.  Today, if you can see it,
the little one I put on the table in front of me would be on
the larger side.  Today, they are often implanted on an
outpatient basis in the pectoris with non-thoracotomy leads
inserted transvenously.  They are packed with therapeutic
capabilities that even Dr. Bakken probably wouldn't have
dreamed of 30 years ago.
 So medical technology certainly has come a long
way since the early days of the pacemaker.  There are three
fundamental characteristics of medical technology innovation
that I think are important to consider.  One, it is very
diverse.  It encompasses, of course, everything from
laparoscopes to molecular diagnostics and image-guided
surgery systems.
 Second, it is dynamic.  It draws on many different
areas of science.  It is a non-linear process and it
involves close dialogue between the innovator and the
clinicians, and it is very rapid.  The average life cycle of
a new medical technology is a mere 18 to 24 months, and in
some segments such as cardiology, it is even less than that.
 It is important to note that the incredible
technological advances of the past three decades have
occurred in concert with the development of a rigorous pre-
and post-market regulatory system in the field of medical
technology.
 In the Medical Device Amendments of 1976, Congress
set some basic scientific principles to guide the marketing
of medical devices and diagnostics.  To the extent to which
Joe Levitt or David Feigal went over those in detail
yesterday, I will keep my comments brief, but some of the
important things that Congress said in that law were, they
said if you want to sell a new medical device or diagnostic
test, you need to prove that it is safe and effective.  They
said if you want to make a new labeling claim, you need to
back that up with reliable data.
 They said if there is an adverse event with your
product that causes patient harm, or could have caused
patient harm, that you need to report that to the Food and
Drug Administration, and they said that FDA will inspect
manufacturer's facilities to ensure the quality of the
products being produced.
 This regulation, as I said, has been an important
component of the dramatic boom in innovation over the past
30 years.  It has helped inspire and maintain consumer
confidence in medical technology.  It has helped the
industry weather the rare safety problems that inevitably
arise, and it has formed an important part of the foundation
for innovation over the past three decades.
 In spite of the breakthroughs that have been made
and are still being made, there are some barriers to
continued research that we face in the medical technology
field.  One of those is a lack of research funding.  There
is less venture capital funding today as a percentage of
overall financing than there was seven s ago.  It has been
in decline over that time, in part, due to the great
interest in the Internet dot-coms.
 Sources of private research funding also are
diminishing.  The Whittaker Foundation, as you may know, is
the largest private sponsor of bioengineering education and
research at universities and medical schools in the United
States and Canada.  That foundation has decided to spend
down its principle and to cease operation in 2006.
 Finally, there is comparatively little funding at
the National Institutes of Health for bioengineering.
Currently, only 5 percent of NIH research spending, about
$500 million goes for bioengineering research.  Despite the
importance of the NIH to funding bioengineering research, it
is not explicitly recognized at the NIH.
 Regulation can, of course, be another important
barrier to research.  For complementary and alternative
medicine, I think this could take the form either inadequate
or excessive regulation.  In the field of medical
technology, we haven't faced the problem of inadequate
regulation over the past 25 years, but what I am meaning by
that is that regulations must be sufficient to govern or
direct research and foster development of reliable data.
 Further, the lack of adequate regulations in a
field like medical technology or CAM, can leave the field
more vulnerable to erosion of consumer confidence when
serious health problems or safety problems arise.  This in
turn can weaken the field overall and discourage further
research.
 That being said, excessive regulation can, of
course, also have an equally detrimental effect.  It is
interesting to hear the debate over randomized, controlled
trials over the past few days.  There has certainly parallel
debate in the field of medical technology over the past 10
years, or at least comparable in some ways.
 When regulators start asking for excessive data up
front on comparative clinical or cost effectiveness outcomes
in defined patient populations, they likely will drive away
good products and freeze further research.
 CAM, like medical technology, is a diverse field,
and it is important for the regulations to recognize this
diversity and to be commensurate with the type of technology
that is under consideration.
 Despite these potential barriers, I think there
are some encouraging trends in private CAM research.  One is
the ongoing debate over regulation.  I think this is
healthy.  It brings the key stakeholders together, and
hopefully enters into a process of defining an appropriate
regulatory system that encourages further research.
 The increasing number of medical students
interested in CAM and the increasing attention being given
to CAM at medical schools in providing instruction also is
encouraging.  Those students, of course, are tomorrow's
champions and researchers in the field.
 Third, I would point to the increasing integration
of CAM and traditional medical technologies and technology
companies.  I think that will be an important factor in the
growth of research in this field.  You can see this in the
growing number of pharmaceutical companies taking an
interest in CAM as well as the activities of companies like
Metronic, which through their foundation, are funding
research into areas that link cutting edge cardiovascular
technologies with alternative treatment techniques.
 To the extent that CAM becomes linked to these
endeavors and to these companies driven by scientific
research, research on CAM itself will increase.
 I think that leaves us with three basic points, or
it leaves me with three basic points, anyway.  One is
reliable information, a patient-centered health care system,
and I think the role of CAM in that system depends on
reliable information and the provision of that information
to the consumer.
 Second, is adequate regulation.  Companies need to
be up front, involved in a system of appropriate regulation.
 Third, is continued integration.  As I mentioned, as CAM
increasingly is linked with medical technology and
technology companies, research in CAM will increase.
 I think that would move us toward the goal that we
are seeking, which is a field based on sound science that
enjoys strong consumer confidence and continued growth in
the 21st century.  Thank you.
 DR. GORDON:  Thank you very much.
 Next is Dr. Raymond Ruddon from Johnson and
Johnson.
 DR. RUDDON:  Thank you.  Someone mentioned this
morning, I am not used to talking without slides, or as an
old professor, at least a piece of chalk in my hand.  So I
hope this will be clear.
 I also want to thank the White House Commission on
Complementary and Alternative Medicine for this opportunity
to present, from Johnson and Johnson's point of view, our
thoughts about this very important area of public health
concern.
 Meetings such as this will help focus public
policy initiates to assure that this important approach to
the prevention and treatment of human disease reaches its
full potential.  We want to address the Commission
concerning the issues involved in facilitating research in
this area, and particularly how private industry may help
facilitate that.
 Johnson and Johnson has addressed this expanding
need for research and product development in complementary
and alternative medicine in a number of ways, and I will
list a few of these.  We believe that complementary and
alternative medical products do provide a new approach to
disease prevention that is different from the traditional
medicines that are aimed primarily at treatment rather than
prevention.  As more and more people become better informed
about their own health and wellness, we believe that the so-
called complementary and alternative medical products will
come to represent an important range of new choices for
consumers.
 At J&J, we have undertaken a number of initiatives
to address this focus.  In 1997, we established a Disease
Prevention/Health Promotion Task Force, which I chaired,
consisting of members from a number of our operating
companies that have interest in this area that do provide
products for a wide range of health care products.
 This task force had the following specific aims:
first, in order to broaden our understanding of the disease
prevention and health promotion strategies, the task force
undertook an extensive review of current literature in the
field.  We also sought to identify some of the key
individuals, research groups, and organizations who are
leaders in these fields and to make arrangements to consult
with them about the status of research and potential
opportunities.
 The task force then acted to identify and
prioritize the best leads that provide an opportunity for
Johnson and Johnson, based on the quality of supporting
data, consumer self-selection, proprietary protection,
market size, and fit within the Johnson and Johnson
operating companies' existing business competencies and
platforms.
 The need for further research and the best way to
accomplish that research was carefully assessed at J&J.  We
have established a number of ways to help support projects
and bring potential products into development in this area.
 I will mention, for example, two granting
mechanisms that the Corporate Office of Science and
Technology has, of which I am the director.  One is a
focused giving grant, which is a basic grant, no strings
attached, primarily to fund academic investigators in a wide
variety of biomedical research, but this could include CAM
research.  We also have a seed grant program, which is more
focused.  There are some strings attached, in the sense of
right of first refusal for data that comes out of that.
 Finally, our task force was charged with the
responsibility of developing ways to monitor the progress of
research in the field of disease prevention and health
promotion, and to anticipate future product opportunities.
The task force interviewed, either on-site or at J&J, a
number of key investigators in alternative medicine, and
these included groups from Harvard Medical School.  We met,
in fact, with David Eisenberg twice from Harvard.  We also
met with investigators from Johns Hopkins University, the
University Illinois-Chicago, Rutgers, the National Cancer
Institute, and a number of others.
 J&J has used its seed grant program to sponsor
academic industry research collaborations.  We have one
ongoing right now at the University of California-Berkeley,
for example, on developing methods to screen bioactive
materials in complex mixtures and to do development
mechanism of action studies.
 J&J companies have also been active in the
development of products for disease prevention such as
Benecol to reduce cholesterol levels, and Splenda, an
artificial sweetener that diabetics can use.
 Our company has also pioneered in the field of
health and wellness programs, and we have a wealth of
knowledge and proprietary intervention programs which have
been introduced to American workers through job site
programs.  Indeed, we have a whole company in our family of
companies called Health Care System that is focused on this
important issue.
 Against this backdrop of activity experience, I
would like to approach the questions that were posed by the
Commission.  First: What can be done to expand the current
research environment, and can the private sector stimulate
CAM research?
 It is clear, I think, from the number of speakers
both today and yesterday, that we do need solid, basic
research to be carried out to provide the fundamental
knowledge of the mechanism of action of complementary and
alternative medicine agents and practices, on ways to
identify active components in complex mixtures, to carry out
bioviability studies, basic pharmacology and toxicology
studies.  We also need robust clinical protocols to verify
that complementary and alternative medicine agents and
procedures truly produce the claimed clinical benefits.
 Now, private industry can help these efforts
through research collaborations with academic and other
research groups, and NIH, and foundations, as mentioned this
morning.  A number of such collaborations could be cited as
precedent, including the Human Genome Project, the SNP
Consortium, and a recently funded Alliance for Cellular
Signaling.
 I think, also, we should keep in mind that there
are a couple of mechanisms available using, for example, the
Small Business Innovation Research, or SBIR, grants.  In the
Technology Transfer, such as the Cooperative Research and
Development Agreements, or CRDA agreements.
 The second question posed is: What types of
incentives are needed to stimulate research on complementary
and alternative medicine practices, and what are the
obstacles and solutions?
 In order to provide the incentives to private
industry, intellectual property issues must be resolved.
Even assuming significant consumer demand for a product or
device a reasonable business plan cannot be constructed to
enter that market unless some marketing protection is
available in return for substantiating the public health
benefits of a product.
 Additional approaches, such as legislative
exclusivity remedies, for example, something akin to the
Ortho-Drug program, may be necessary in order to provide
incentives to establish that these products are safe,
effective, and have desirable public health benefits.
 Finally, without established and transparent
regulatory pathways, well established and well-meaning
corporations, like J&J and others, cannot fulfill the public
health need for these medicines, complementary and
alternative medicines.
 The third question: How can complementary and
alternative medicine and conventional research communities
be more effectively integrated to stimulate and coordinate
research?
 A number of speakers have addressed that, so I
will just be brief in added some of these.  First of all, I
think we do need to expand communication between traditional
and conventional medical experts, and many speakers have
addressed that.  I think we do need to stimulate review and
acceptance of high-quality complementary and alternative
medical research in publication for top journals, scientific
and medical journals.
 Third, cooperative effort between private and
federal funding needs to be stimulated in this area.
Fourth, a rigorous review process involving both academic
and industry scientists should be put in place to evaluate
scientific-merited proposals.  I think that would stimulate
and foster some of these collaborations that we are looking
for if that is carried out.
 Then finally, as I mentioned, protected marketing
rights that will allow for substantial, meaningful, and
costly programs must be put in place.
 In conclusion, acknowledging that intellectual
property rights must be respected, we wholeheartedly endorse
of coordinated research programs between private and
federally funded, and between traditional and conventional
medical investigators in order to transform medical science
into the health care products and services that American
consumers want and need.
 We also see a need for discovery research in this
field, using, for example, the modern things that we know
about, using gene expression arrays, or proteolytics to
identify new bioactive substances in natural products.
 Also, to use the emerging field of
pharmacogenomics to individualize therapies.  I think I
disagree with a previous speaker who mentioned that these
data are always going to be probablistic.  We are learning
more and more ways now, using pharmacogenomic analyses to
individualize a therapy.
 Finally, we would welcome the opportunity to share
our learning and experience in order to advance both medical
science and the public policies surrounding this
opportunity.  Thank you.
 DR. GORDON:  Thank you very much, Dr. Ruddon.
 The next speaker will be Dr. Frank Sciavolino from
Pfizer.
 DR. SCIAVOLINO:  Thank you, Chairman Gordon,
Commissioners, Dr. Groft.  Thank you for the invitation to
present comments from the private sector to the White House
Commission on complementary and alternative medicine policy.
 The focus of my comments this morning will be on
one aspect of CAM, drugs from botanical or herbal sources.
I will also comment on what we think is needed to stimulate
CAM research as well.
 Several years ago, we established a research and
development initiative at Pfizer to assess whether botanical
remedies represent a viable source of new prescription
medications.  We instituted this program because nature has
traditionally been a fruitful harbinger of new medicines.
 By some accounts, nearly 60 percent of all
pharmaceuticals have their origins in natural products.
Morphine, cortisone, penicillin, paclitaxil, luvistatin
[ph], are but a few examples of prototypical molecules
occurring in nature that have led to medicines which are
safe, effective, and quality-assured.
 The largely empirical screening methods of so many
of these useful natural product-derived drug discoveries
during the middle of the last century have now fallen into
disfavor, largely because they are highly labor intensive
initiatives and they are becoming increasingly unproductive.
 More recently, R&D in the pharmaceutical industry
has toward molecular design and the use of automated
chemical technology to synthesize huge libraries of
compounds that can be screened by Ultra-I throughput methods
against novel biological targets.
 The revolutionary advances in molecular biology,
genetics, robotics, in information technology, have
propelled drug research in this new direction.  However, the
link between pharmacological activity against newly
discovered molecular targets and clinical effectiveness in
specific disease indications is not always clearly
understood, nor fully charted, despite the best efforts of
our brightest minds.
 Consequently, clinically validated mechanisms and
clinically effective new chemical entities remain highly
prized milestones in drug research and development.  The
road from a new idea to a new medicine is long, it is
treacherous, and it is expensive.  This journey from a newly
observed biological concept in the laboratory to a medically
available registered drug typically takes 10 to 15 years at
a cost which has been estimated by the Tufts University
Center for the Study of Drug Development to be in the range
of $400- to $500 million.
 A key factor contributing to the time and expense
metrics associated with drug development is attrition.  Most
drug candidates nominated by sponsors for clinical
development fail to become registered pharmaceuticals.  For
every five to six drug candidates which reach the
investigational new drug stage, the INDIVIDUAL status,
industry experience indicates that only one becomes a
product.
 The majority fail for a variety of technical
reasons, most of which involve safety, efficacy, and the
benefit-to-risk judgement, but other less prominent
parameters such bioavailability and stability may contribute
to the decision to halt development.  This is the reality of
pharmaceutical R&D today.
 With the passage of the Dietary Supplement Health
and Education Act, DSHEA, in 1994, a resurgence of interest
in herbal medicines is beginning to take hold, and natural
products are again attracting attention as a potential
source of new drugs.  The seminal change that is kindling
fresh interest in nature as a reservoir of useful medicines
is the increasing recognition of herbal medicine by
regulatory agencies.
 Enabling policy changes dealing with botanical
drug regulation are beginning to be addressed.  The draft
guidance for industry on botanical drug products, which the
FDA published for comment in August of this year, appears to
be a meaningful first step toward opening the door for
sponsors to conduct randomized, controlled clinical trials
to confirm the efficacy of botanical mixtures in patients.
 This impending change could shift the focus of
natural products research from what was largely a laboratory
effort seeking lead structures for chemical modification to
a clinically driven initiative with product orientation.
Final guidance from the FDA on the registration of botanical
drugs would be a landmark event that could stimulate
investment in this area by interested sponsors.
 In our Natural Medicines Initiative at Pfizer, we
coined the term "naturceuticals" to designate prescription
drugs of plant or natural origin that have been rigorously
characterized for safety, efficacy, and quality.
 The development paradigm for a naturceutical
differs from established pharmaceutical strategy, in that,
it seeks to rapidly address clinical efficacy up front with
candidates having anecdotal or folklore histories of use in
man.  Opportunities with proven clinical efficacy then
become the subjects of more costly investments for full-
scale registration of a safe and effective product.
 If botanical medicines are to be developed as true
pharmaceuticals, that is, naturceuticals, their development
must be conducted to the highest standards of safety,
efficacy, and quality.  There can be no compromise on the
science or medicine of naturceuticals.  We see the level of
investment that would be required for the NDA registration
of a naturceutical to be comparable to that of a
pharmaceutical.
 Therefore, a key issue in developing botanical
medicines is the need for an incentive mechanism to provide
for a return on investment.  One possibility is a Waxman-
Hatch type data or marketing exclusivity period that would
allow the sponsoring investor to fully develop the medical
and commercial potential of natural medicines.
 Nature has been an unparalleled source of unique
chemical structures with extraordinarily potent
pharmacological activity.  We urge the Commission to
recommend enabling policy that will provide incentive for
the private sector to invest more substantially in research
and development of natural medicines.  Thank you.
 DR. GORDON:  Thank you very much.
 The next speaker will be Mark Blumenthal from the
American Botanical Council.
 MR. BLUMENTHAL:  Good morning, everybody.  Howdy,
and thank you for inviting me to be with you all this
morning.  I want to also congratulate for being appointed to
this important group.
 To optimize time, I have provided some written
overview of the mission, publications, and projects of my
non-profit organization, the American Botanical Council, but
just to let you know that since 1988, we have been dedicated
to educating on scientific research on herbs and phyto
medicines, and stimulating such research in the United
States.  Since 1983, our publication, "Herbalgram," has
reported on results of foreign research on herbs when
information on herbs is almost non-existent in the medical
and scientific literature in this country.
 The federal government obviously has made
excellent progress in funding clinical research and the
other botanicals.  I will speak only on the issue of trying
to provide some private sector initiatives, of course, and
incentives.  That is my primary issue today, and not
coordination but the incentives.
 Basically, the White House Commission on Dietary
Supplements in 1997, in its report, dealt with this issue by
saying, "A manufacturer lacks incentive to expend resources
for research that might benefit competitors as well as
itself.  In other words, there is no proprietary interest
here.
 We dealt with this issue back in 1986 in an
article by Jim Duke in Herbalgram when he talked about the
high cost of pharmaceutical drug registrations and approvals
basically requires federally funded natural product research
because at that time it was not going to come from the
private sector.
 The CDSL, the Commission on Dietary Supplements,
also wrote that, "The FDA might consider a mechanism for
review of research conducted to validate a statement of
nutritional support so the label disclaimer mandated by
DSHEA could be modified or removed."
 In other words, there was guidance for the
possibility that the FDA has not evaluated the claim, and
the product is not intended to treat or mitigate a disease
might be considered for removal if a product met certain
requirements for research, although that has never been
followed up on, to my knowledge.
 Now, in the area of research, there is a clear
correlation between what is research, especially in Germany
and the rest of western Europe, and what products are the
top-selling products in the United States.  If you look at
all the top-selling products in the United States in the
mass market, except for the inclusion of Golden Seal in the
top 10 or 20, which has no research in it for the last 60
years, almost every one of these herbs are the most well
researched ones from western Europe, ginkgo, garlic,
ginseng, palmetto, et cetera.
 So there is a clear correlation between funding of
research, even though it is coming from out of the country
mostly right now, and the success of these products in the
market, success, at least, generically speaking, and I will
provide documentation of that in my written comments.
 Centers for manufacturers ought to be able to
publish clinical studies that deal with their specific
product and get that information into current medical
journals and in the news, especially when that publicity is
tied to the brand that is studied.  One of the primary
obstacles that we are dealing with right now is regulatory,
the lack of government recognition of the benefits of herbs.

 Because most of published clinical research comes
from Germany, it is instructive to look at their regulatory
system there, where they have a so-called Commission E,
which is a federally empaneled group of experts, of
physicians and pharmacists, that evaluate all the published
literature out of the 300 herbs that are sold in pharmacies
as non-prescription drugs to determine whether these herbs
are safe and effective for their non-prescription drug uses.
 Then they publish their results in these monographs which
are intended as package inserts for therapeutic guidance for
clinicians as well as for patients.
 There in Germany, you have a recognition that
these herbal products have benefits, and the government
recognizes that in the product itself.  Therefore, the
research that is being generated in Germany today is not
being done for regulatory approval because they are already
approved.  It is done for market considerations.
 The companies' research is published in the
journals, and then the detail going to the doctors and
saying, here is our study on R-ginkgo or R-garlic, whatever,
and doctors recommend them.  Half of the herbs sold non-
prescription in Germany are basically semi-ethical, doctor-
recommended or doctor-prescribed.  So there is a very strong
impulse in the German marketplace where physicians are
recommending certain brands of phyto medicines.
 Sadly, in the United States, excepting for a few
herbs approved as OTC and drug ingredients and silvium for
an NLEA health claim, our government does not recognize
health benefits for herbal preparations.  This results in
exaggerated public health concerns when adverse event
reports appear in the media against a backdrop of no
recognized benefit, having a negative effect on the public's
view of herbs, as well as professional view, contributing to
a loss of public and professional confidence in this
category, often unwarranted.
 So if promoting information on herb research
presents a unique set of challenges dealing with
phytoequivalence, science, and generitization.  Let me
explain.  Much of the European research is done on the
proprietary commercial phyto medicines, often chemically
defined and standardized.  The question arises then, when
can results of the trial on a specific commercial product be
transferred to a purportedly similar and/or different
product?  When is the science transferrable?  It is a big
issue, not often discussed in the open market, but it is
there.
 In some cases, clinical research might be
transferred to products that can prove phytoequivalence or
bioequivalence through bio assay and/or chemistry, but his
depends on formulations involved, designs of studies, et
cetera, and these questions play the open market agenda in
the United States right now.
 Further, the expropriate of European research in
the United States has caused some European phyto medicine
companies to become concerned over the borrowing and
generitization of their research efforts over here.  Similar
concerns face many U.S. companies that are doing clinical
trials on products, unless they can assure that the results
of their research is not unfairly used by their competitors.
 It is important to note that DSHEA has been an
agent for promoting herbal research in the United States.  A
DSHEA has supported the research.  New private research has
been funded in herbs here in the United States with the
passage of DSHEA since most of this has been tied to INDs
and most of it has yet to be published it is often difficult
to determine how privately funded studies are in process or
are pending publication, if at all.
 The estimates are rumored to be within 50 to 100,
or possibly more.  In the area of private sector funding by
members of the herb industry, there are numerous examples
that I could tell you about specific products, but time does
not allow this elaboration.  They are in my written
comments.
 And there are numerous incentives we can discuss.
 One obvious incentive is exclusive claims, usually for a
drug, usually requiring an MDA, very expensive, as we have
just heard.  Many of these herb products are OTC-type
products, often sold as OTCs overseas, but there is no
market protection for OTC product claims unless the company
files for an FDA.  OTC-monographed claims are not protected
by market exclusivity.
 The recently published FDA guidance document on
botanical drug products allows a five-year market exclusive
if a company has fulfilled NDA requirements.  Right now, in
Congress, the Nutriceutical Research and Education Act,
NREA, bill proposes exclusivity for nutriceutical for 10
years.  At least one acceptable clinical study is required,
according to the bill, and borrowing of research is not
allowed, unless the research supports the present study, the
new study.
 Small manufacture exemptions would be allowed to
pool resources and share claims with small companies from
their combined research efforts.  Claims under NREA would
deal with disease prevention, reduction and disease
management, but yet, public support for this bill is not
clear.
 Is there a reason to conduct clinical research on
herbs sold as dietary supplements, not as drugs?  Yes.
People want benefit-related research, not just an
explanation of mechanism of action or identification of
active compounds.
 Do we want all companies to have to conduct
studies on every product, like every garlic and every
ginseng product?  Are there sufficient financial resources
among the industry to do this?  Are there enough contract
research organizations and other centers to conduct these
studies?
 I would like to suggest some government-sanctioned
incentives that could help promote research.  First is,
structure/function claims might be approvable by FDA.  FDA
approval of structure/function claims might promote
research.  This is under DSHEA.  However, this may lead to
other problems, like long delays and additional cost, and
whether this conforms with Congress' original intent for
DSHEA.
 Further, the CDSL suggestion that modification of
the Dietary Supplement disclaimer, when its removal from a
product that has undergone some clinical study review, I
believe is worth your consideration.
 There is the issue of patents.  Herbs cannot
qualify for composition of matter patents, like
pharmaceutical drugs.  However, since DSHEA, the U.S. Patent
and Trademark Office has been very active in granting
process patents and use patents for botanicals.  These
represent potential incentives.  However, some use patents
may not be able to withstand possible future challenges
based on their claims, possibly coming from the public
domain and traditional use.
 The case of the recent reversal of the tumeric
patent is a glaring example when India protested against the
U.S. Patent Office's allowance of that patent, because
tumeric has been used in Vedic medicine for so long.
 There are also potential tax incentives, maybe
some tax credits to companies for funding research might be
considered.  Also, important, I think, is the creation of an
expert review panel.  Consistent with recommendations of the
CDSL, the government should establish an expert review panel
similar to Commission E to evaluate the safety and
appropriateness for claims for herbal products, both the
structure/function claims under DSHEA and as OTC drugs.
 Trademark value is a very important commercial
commodity, and developing consumer recognition and
confidence in a trademark is a strong motivator for research
investments.  With the herb market filled with such a wide
variety of products, many of them looking very generic,
companies are trying to establish a clear identity and
differentiation.  The recent example of Smith-Kline Beecham
introduction of Laluna, I believe, is a very useful example.
 Finally, we must find a viable balance among free
market and competitive issues, science, regulation, and the
need to respect cultural heritage, and traditional use.  It
is likely that some of the highest quality herbal products
produced in the United States are made by some of the
smallest companies.  Allowing larger companies who are able
to invest in research to satisfy exclusivity requirements
may discriminate against small businesses, posing serious
economic and social problems.
 The problems we are dealing with here require
legislative solutions, administrative attention, industry
time and attention, and commitment and cooperation.
Responsible elements in the herbal community are looking for
solutions and assistance on these issues from both within
and outside the industry.
 I thank you for your time and attention in
allowing us to be here today.
 DR. GORDON:  Thank you very much.
 Dr. Annette Dickenson from the Council for
Responsible Nutrition.
 DR. DICKENSON:  Thank you for the opportunity to
be with you here today and to share some ideas on private
sector involvement in stimulating research on CAM.
 The Council for Responsible Nutrition, which I
represent, is a trade association representing more than 110
companies in the dietary supplement industry.  Our
membership includes companies that supply the bulk
ingredients used in dietary supplements, as well as the
national brands and store brands of finished products that
are available to consumers through all types of retail
outlets, including supermarkets, drug stores, discount
chains, health food stores, direct sales, mail order, and
the Internet.
 Our member companies provide all types of dietary
supplements that are covered by the Dietary Supplement
Health and Education Act, including vitamins, minerals,
amino acids, botanical products, and specialty supplements.
 CRN was established in 1973, and prides itself on
developing policies and programs for dietary supplements
based on sound science.  CRN science staff currently
includes four individuals with expertise in nutrition,
toxicology, natural products chemistry, and genetics.
 We are in the process of creating a new executive
position charged with the specific responsibility to
identify opportunities for research partnerships with
government and with academia, and to help industry members
take advantage of such opportunities to maximize their own
contributions to current scientific evidence.
 As part of this effort, we will also seek to be
actively involved in the development of agency research
agendas and the establishment of priorities based on
optimizing impacts on public health.  Dr. Cathy Frohmus [ph]
of our staff will be taking on these responsibilities, and I
believe she is known to many of you.
 We are pleased to be able to offer some
suggestions on the role of the private sector in stimulating
research into CAM from the perspective of the dietary
supplement industry.  Regarding ways in which the private
sector can stimulate CAM research, we believe industry
should be encouraged to submit its studies to peer review
journals for publication.  Industry should also provide data
from its unpublished studies to assist in selection of
therapies for further study and to contribute to study
design.
 For example, these data may help narrow dosage
ranges for Phase I studies and alert investigators to
potential side effects.  Industry could provide the
vitamins, minerals, botanicals, and other dietary supplement
ingredients for clinical studies, and also assist in the
preparation of appropriate placebos, not an insignificant
task.
 Industry could cosponsor symposia or conferences
to provide networking opportunities between researchers and
clinicians.  For example, CRN is currently planning one such
conference in November of 2001 in cooperation with the
American Society for Pharmacognosy.  Regarding some of the
obstacles and solutions that exist in industry cooperation
in this effort, we would suggest that it would be useful to
convene meetings with journal editorial boards to solicit
recommendations which would increase the acceptance of
papers submitted by industry, which face some barriers to
that acceptance.
 We believe it would be useful for industry,
especially for smaller companies in the industry, to
generate a clinical trials guidance document outlining the
standard components and proper design of study protocols.
CRN's Dr. John Cartelina [ph] is currently working on this
type of document and will be seeking partners to contribute
to its content and enhance its value.  Resources that will
be used in preparing the guidance document include existing
NIH guidelines and information being compiled by the
International Conference on Harmonization.
 A mechanism is also needed for industry to share
study results that may involve proprietary information.  The
soon-to-be-launched ODS CARDS database, which I think was
discussed to some extent yesterday, might serve as a
repository for a listing of unpublished studies identifying
the lead investigator or contact person in order to
facilitate communication.
 We believe that standardized products that are
commercially available should ideally be used in clinical
trials when possible.  If special formulations are used that
the consumer cannot buy off the shelf, the study results
don't have the immediate translation to the direct
population.
 Industry needs to form partnerships with
clinicians or academia, depending on the type of study.
Various mechanisms are needed to bring together these
disparate communities, as has been emphasized earlier today.
 CRN is in the process of establishing a dietary supplement
information center in cooperation with a major academic
institution.  We believe this center, once established,
could also play a role in this regard.  Also, a special web
site could be established to facilitate communications
regarding ongoing research needs and opportunities.
 In response to the question regarding how CAM
research can be better coordinated with federally supported
CAM research, we believe industry representatives need to
participate on advisory panels, particularly at NIH.  A
visible representative can address the concerns of
clinicians and of government officials, and serve as a
bridge between the public and private sectors.
 A primer on funding mechanisms for research and
conferences within government agencies that apply to
industry should also be compiled to explain, for example,
cooperative research and development agreements, small
business grants, investor-initiated grants, and contracts.
 We believe ongoing research and potential funding
opportunities need to be more visible, and private studies
need to be added to government databases.  For example,
CRISP is an excellent tool to seek information on federally
funded studies, however it needs to be updated more
expeditiously and expanded to include clinical trials that
are not federally funded.
 The ODS CARDS database will target dietary
supplement research.  The project should receive sufficient
funding to include non-governmental funded research, also,
and be updated expeditiously.  NCAM serves as an excellent
model for its open and visible process in determining
priorities and future research projects.
 Concept ideas are discussed at its advisory
council meetings.  Approved concepts are posted on the web
site, and within a few months, a request for applications is
issued and also posted on the web site.  A document
explaining, for industry use, how each research agency
determines its research agenda would also be extremely
helpful.
 We believe consensus conferences would also be a
useful tool to highlight CAM therapies and remaining
research gaps.  For example, a conference on the safety and
value of ephedra for weight loss could make a valuable
contribution in this highly controversial area.  A
conference on St. John's wort should be held, we believe,
soon after completion of the NCAM NIMH-funded study which is
now centered at Duke University.
 We appreciate the opportunity to share some of
these ideas and to continue to work with you in the future.
 Thank you.
 DR. GORDON:  Thank you very much, and thank you
for the very specific suggestions.  It is extremely helpful.
 Thank you, all of you.  You are opening up whole other
perspectives for us, which are really very important.
 Are there questions from Commission members?  Yes.
 Tom, and then George.
 MR. CHAPPELL:  Thank you all very much.  It was
really very helpful, very clear.
 I guess I would like to pursue the question, Dr.
Ruddon, if I may, of the proprietary interests that need to
be part of the total picture.  If we imagine the marketplace
that consumer is driving currently, consisting of, let's
say, single herbs, some OTCs that can be formulated, a
decongestant, for instance, and then pharmaceuticals.
 Do I understand that your suggestion is that we
have private industry find a way to protect the marketing
long-term exclusivity on all three categories?  Just the
last?  Could you help me understand these gradations and
where you see private industry expecting to be protected for
the high, up-front investments.
 DR. RUDDON:  I think, to some extent, it is all
three categories.  It is certainly in the area of
pharmaceuticals.  OTCs probably somewhat less so, but
certainly still included.
 I think even in the area of nutriceuticals and
natural products, there needs to be some kind of competitive
advantage or proprietary protection that would allow the
investment and the research that has to go into these agents
to prove clinical efficacy.
 So that, even in the case of those agents, I think
the view is that there would need to be some kind of
proprietary protection, most likely, or frequently, not
around the chemical entity itself but around process,
extraction, production, and use of unique mixtures or
combinations of agents.  I think there would need to be some
exclusivity around all three of these categories.
 MR. CHAPPELL:  Especially if an NDA is required.
 DR. RUDDON:  Especially if an NDA is required.
 MR. CHAPPELL:  Thank you.
 DR. GORDON:  Mark, is your light on because you
wanted to respond to that?
 MR. BLUMENTHAL:  Well, obviously, the NDA process
if very extensive, and it is going to be a barrier to
anybody except the larger companies.
 The issue of exclusivity for dietary supplements
is something that is being discussed as part of this bill
that is NREA, allowing 10 years of exclusivity if you came
up with one clinical study that was acceptable.
 I am not sure that is going to get a lot of
industry support because, obviously, everybody is going to
be like a land rush to grab one claim for one particular
product, and then try to tie it up.  Then you run into the
issue of, how does that deal with the fact that herbs have
been part of our heritage.  We all own the right to use
herbs for various things.  Does that translate to the
commercial sector?  And to what extent does allowing people
exclusivity in the area of dietary supplements for herbs
tread on our public heritage and our traditional culture.
 Those are issues that have been dealt with, from
the patent point of view, by the example of tumeric, and
then also iawasca [ph], where native shamans from South
America have petitioned the Trademark Office for allowing a
healing patent for iawasca, a traditional vine of South
America.  The Indian Government protested the Patent Office
for allowing, I think, an inflammatory patent for tumeric,
which is part of medicine.
 So we run into a lot of issues of intellectual
property and otherwise when we talk about allowing for
exclusivity for herbs as drugs and as dietary supplements
both.
 DR. RUDDON:  I would like to just respond to that.
 I think we ought to be clear that we are talking primarily
about development of new products, not about trying to gain
exclusivity around things that people have been taking for
1,000 years.  I think we are talking about new product
development here, where there needs to be exclusivity.  A
lot of investment goes into the research, both basic and
clinical to do that.
 I don't think we are trying to gain exclusivity
around things that have clearly been in the public domain
for a long time.
 DR. GORDON:  Could you give an example of -- I
think this is a very helpful discussion between the two of
you -- an example of what you would consider a new product
as opposed to a traditionally used product.
 DR. RUDDON:  Well, I think, for example, many of
the agents that have been talked about already, St. John's
wort, ginseng, ginkgo, and so on.  I don't think one could
foresee trying to have exclusivity around those.
 If, however, there were, let's say, some new
components of green tea that were identified and had
previously been known that might, either by itself or in
combination with other agents, provide a new approach, a new
therapeutic approach, yes, then I think one might expect
some kind of exclusivity around that.
 DR. GORDON:  You mean components extracted from
green tea.
 DR. RUDDON:  Yes, right.
 MR. BLUMENTHAL:  Pure compounds, however, are
usually excluded from the definition of herb or
phytomedicinal.  So when you start getting into pure
compounds that have been extracted from a plant, that no
longer is the domain of herbal medicine.  That becomes
pharmaceutical drug, and that is a distinction.
 To give you an example of a common ingredient that
exclusivity might become a controversial in, let's take
something as common as peppermint.  Peppermint, right now,
is not included in the over-the-counter drug monograph for
digestive aids.  So it is basically just a dietary
supplement, and now FDA has allowed supplements to be able
to make heretofore unallowed claims in the area of over-the-
counter drugs if it is not a disease claim.
 So digestive aids, not being a disease has now
allowed for peppermint.  Somebody, theoretically, under some
schemes that might be proposed, could make a land rush for
peppermint for a digestive aid and try to tie that up.  Of
course, that would make it a real problem for after-dinner
mints.  It is part of our culture.
 I am just trying to raise these issues.
Hopefully, that is not an extreme example.
 DR. GORDON:  It is helpful.
 Dr. Scaviavolino.
 DR. SCAVIAVOLINO:  Maybe I can contribute in an
example from Pfizer that may put some perspective on this
for you.  We are pursuing at this time an opportunity that
we found through a botanical company in England called
Phytopharm, who in turn found an opportunity from South
Africa.  This was a material which has been publicly
designated as P-57, which was used by Hottentots and bushmen
in South Africa who were going into the bush, going into the
jungles and realized that they may not have access to food
for some periods of time.]
 In the folklore associated with this, if they
ingested this particular extract, or sucked on the juice
from this particular plant, that their hunger pains, their
appetite requests, were suppressed.  We have studied this
fairly carefully.  There are very interesting materials.  We
are pursuing it as a mixture of materials, but not as single
chemical entities.
 DR. GORDON:  You said you are pursuing it as a
mixture?
 DR. SCIAVOLINO:  We are pursuing it as a mixture
just as it has been used by the natives in South Africa.
 To make the point that what we are attempting to
do is very different from the ginsengs and the garlic
extracts, and that sort of thing.  We are really pursuing
this from the point of view of looking for medicines that
could be potentially useful, that are not commonly in the
common use right now.
 MR. BLUMENTHAL:  Something like that could be
possibly subject to a use patent and process patents, but
probably not a composition-of-matter patent.  So you have
several lines of protection there.  Then you have the
problem that the Hottentots might come back, and that you
are giving them some intellectual property, and say, hey,
wait a minute; you are patenting our intellectual property
here.
 DR. SCIAVOLINO:  If you are going to deal with
this sort of thing, you really have to incentivize all
parties involved.  So Phytopharm is involved, South Africa
is involved.
 DR. GORDON:  That is very helpful.
 Tom, is your question finished yet?
 MR. CHAPPELL:  Thank you.
 DR. GORDON:  George is next, then Tieraona, Wayne,
Bill, and Effie.
 DR. BERNIER:  I have a question for Dr. Ruddon.
 You have talked about expanding research
collaborations.  Could you let us know with whom you have
developed these collaborations?  Particularly in the areas
of SNPs or genomics.
 DR. RUDDON:  Actually, the study that I mentioned
at UC-Berkeley, part of that study is to use the gene
expression arrays to identify signatures that indicate a
particular pharmacologic activity.
 So that is one example.  There are a couple of
others that I could mention, but that is one idea of using
the emerging new molecular biologic techniques to identify
bioactive agents.  So that is one example.
 DR. BERNIER:  Do you collaborate with people who
are interested in CAM?
 DR. RUDDON:  Well, this particular laboratory,
that is what they do.
 DR. BERNIER:  That is all.
 DR. RUDDON:  That is what they do.  They are
focused on natural products, as antioxidants.  So the answer
is yes, and there are other examples where we have
collaborated with an investigator.  Rutgers looking at green
tea as a chemopreventive agent, and other tea components.
So yes, we do collaborate with investigators working on CAM.
 DR. BERNIER:  Thank you.
 DR. GORDON:  Tieraona.
 DR. LOW DOG:  Thank you.  Those were wonderful
presentations from all of you.
 We have been focusing a lot, yesterday and today,
on larger concepts, conceptual ideas around complementary
and alternative medicine.  This is an area that is fairly
specific.  Dietary supplements and botanicals, for the most
part, can be subjected to double-blinded, randomized,
controlled trials, except for individuation of therapy the
way a lot of traditional herbalists practice, but in the
large sense that the public uses.
 My question, and since we are here to develop
policy and come up with ideas on how that helps the public,
I think many physicians' concerns about botanicals and
dietary supplements is, whose responsibility is it
ultimately to determine, less so the efficacy at this point
but safety, safety in children, safety in a five-month old,
safety in a 90-year old, somebody with hepatic or renal
insufficiency.  Is it safe during pregnancy?  Can a
lactating woman use it?
 Sam-E, MSM, glucosamine, huperizia [ph].  It just
keeps coming out more and more all the time.  While we
haven't had significant adverse effects, you can just sort
of see the writing on the wall.  At some point, we are going
to have to be addressing this.
 If we don't make incentives for companies to pay
for this sort of research, do we need to put the government
more involved in this?  What are some of your suggestions as
far as this?
 Because this is an area that I think is going to
hold back many conventional medical practitioners, because
they see this as an area that has been under-investigated.
We are still debating, whose responsibility is that?
 DR. DICKENSON:  I think from the point of view of
the dietary supplement industry, we would view that the
company has the ultimate responsibility for the safety of
its product, regardless of what the target population is,
even in the case where there may be questions about exactly
what the regulatory responsibility is on the company.
Certainly, from a liability point of view, the company has
complete responsibility for the safety of that product.
  However, there are many questions such as
you mentioned, especially regarding use in pregnancy, which
came up in January through March when FDA had tentatively
proposed to allow the industry to use statements about use
of various products for morning sickness, and quickly
reversed that position when questions were raised about what
would be necessary to confirm the safety of the product for
those uses, not simply in terms of lack of any knowledge of
un-safety, but in terms of proactive, positive demonstration
of lack of teratogenicity and for safety during pregnancy.
 This clearly raises very broad questions in which
I think it is clear that the industry is going to need
partnerships with government in order to do those kinds of
studies if indeed it has concluded that the positive
demonstration needs to be made for each and every one of
these ingredients.
 MR. BLUMENTHAL:  One area of safety but one that
is not well known, the herbal industry, through its trade
association, the American Herbal Products Association, put
together a book in 1997 called "Botanical Safety Handbook"
in which they reviewed the availability literature on over
550 herbs commonly sold in the U.S. market, literature from
monographs, clinical studies, case reports, et cetera, and
triaged the herbs based on four levels of safety to try to
establish a uniform pattern of labeling under DSHEA for some
of the risks, contraindications, or drug interactions that
was now allowed by DSHEA for the first time for these
products.
 So you have at least an industry-based baseline of
some 550 herbs that is, frankly, unfortunately, not well
known but could be helpful for people to look at.
 DR. GORDON:  Thank you.
 Did any of others of you want to respond?
 DR. SCIAVOLINO:  I might just input a little bit
to that.  At various meetings that we have sponsored, and
some focus panels, we agree that it has become very clear
that general practitioners, in particular and other
physicians as well, are reluctant, concerned, about putting
patients onto supplements for particular indications without
knowing particularly what drug interactions are going to
look like.  There is very little data that is available to
them, and that is certainly an area that needs to be looked
into carefully.
 From the guidance that the FDA put out last month,
or two months ago now, it is very clear that companies
seeking to go either the OTC or NDA route will be able to
get to early Phase II trials quickly, but to obtain the full
NDA package where physicians, then, could be fully educated
on the kinetics of the material, the stability of the
material, its interaction with other medications,
particularly seniors who will be on multiple medications.
 To have that full technical package available,
they are suggesting in the guidelines that a full, typical
NDA package for a pharmaceutical is what will likely be
required, with perhaps some concessions in the CMC package,
the chemical manufacturing, the controls package.
 So that is leaning toward generating this kind of
information for those who would do it through the NDA route.
 So it would be a mechanism for generating that kind of
information.
 DR. GORDON:  Thank you.
 Wayne.
 DR. JONAS:  This is a very informative discussion,
and thank you very much for your organized and succinct
remarks.
 I had a question.  Well, a number of questions.
The attrition rate.  I was kind of puzzled by your estimate
that the costs for developing a naturceutical.  I love that
term, another one we can add to our potpourri.
 If development of a naturceutical would be in the
same range of costs as developing a pharmaceutical, and if
the bulk is due to attrition, have you done some estimates
that in fact you think this would occur, at least under
current regulatory processes?
 If those were changed, it seems to me, that it
would be possible to significantly reduce the likelihood of
the attrition rate, and therefore the cost, of developing
these products.
 DR. SCIAVOLINO:  One of the benefits that is being
suggested here is that being able to get early Phase II data
and establish efficacy and reasonable safety in limited
populations would certainly contribute to the outcome, would
potentially.  I mean, this hasn't been tested yet.
 Data would have to be generated, but one would
assume that by generating that early data and showing that
you do have efficacy and you do have safety, then the
attrition might be reduced, which then would leave you with
developing just one material instead of having to take five
or six shots on goal to get to the final product.
 DR. JONAS:  A lot of that would depend on whether
the guidance that is provided really helped to shift this
toward that kind of --
 DR. SCIAVOLINO:  Yes.  Allowing early access to
Phase II trials could help.
 DR. JONAS:  Right.  Process patents, how valuable
are those in terms of actually producing incentivization?
Mark, you mentioned there is the question of challenging
those types of things.  The idea of incentivization, to me,
seems to be a very complex task that involves both patenting
as well as FDA regulations, as well as a variety of other
things, such as copyright and getting one's name on it, and
this type of thing.
 I am just wondering, is there a mainstream in
which incentivization could occur?  Use in patent, would
that be the main focus, use in process patent?  Or, does
that not exist?
 MR. BLUMENTHAL:  One thing about the process
patent, it is sometimes easy to get around that if you
develop a similar but different process, and the difference
in your process is significant enough to allow the Patent
Office to let you around or not, depending on if you get
into a contest with the person you are competing with.
 So process patent just deals with extraction or
development of the actual material.  It is more of an
industrial issue, and the uses, of course, are obvious. With
herbs, of course, you can't get a composition-of-matter
patent, usually, because the herb is already there.  It is
public domain.
 Patents are obviously are a good way to go.  It
has been very high on people's agenda in the last five years
since DSHEA came out, so obviously it is a great incentive
for a lot of people.  I think, trademark is ultimately your
best asset because Coca-Cola and Band-Aid says it all.
 PARTICIPANT:  Tylenol.
 [Laughter.]
 DR. RUDDON:  I think I would agree with Mark.  I
think that, depending on the size of the market, the process
or use patent would certainly be an incentive.  As we just
mentioned a couple of products, certainly branding, but yet,
in order to gain that, you really need solid evidence behind
it.
 DR. JONAS:  I get the sense that that would have a
relatively small impact if that was all that happened, that
there would need to be some other exclusivity protection,
like you have mentioned, that would require a lot more than
that, and primarily around the definition of, what is a new
product that would allow you to get this kind of
information.
 For example, the gene arrays of ginkgo, for
example, a well established product, we are now finding
under gene array screening that it was useful for certain
cancers.  This potentially could be thought of as a new use
or a new product, perhaps.
 DR. RUDDON:  Yes.
 DR. JONAS:  I had one question for Dr. Burkholder.
 It appears to me, and I have been to a number of
biotech meetings where there has been a fair amount of
interest in CAM, but it appears to me that it has been more
curiosity than anything else.  I get the sense that the tech
industry itself still is not quite sure.  There is not a lot
going on in these areas, other than that there is curiosity.
 DR. BURKHOLDER:  I can speak more directly to the
medical device and diagnostics makers and biotech, but if it
is any indication, Metronic certainly is probably on the
leading edge of that interest in CAM.  A lot of other
companies, it is more curiosity, or they are not, maybe,
even at the curiosity stage yet.
 DR. JONAS:  My sense is there is practically
nothing.  Even though what Metronic is doing on the leading
edge, it is still extremely small, from what I can tell
compared to the industry, certainly.
 DR. BURKHOLDER:  That is true.
 DR. JONAS:  Just one other thing.  It would be
very useful, and this is in the whole area, to try to think
about some ways, and perhaps later on we can get focused
specifically about tech areas as well as the devices
industries as to, are there ways in which that area can be
incentivized, because I think that area is dealing with a
lot of the cutting edge technology in these areas.  So an
interface with that, I think, would be extremely useful.
 DR. BURKHOLDER:  Yes.  I think for some products
it might be easier to apply existing regulatory incentives
in some ways.  Acupuncture needles, I guess, would be one
example where they now do go through a limited premarket
process, just to at least establish safety.
 Another intriguing concept might be a use of
private or public reimbursement mechanisms as a means to
incentivize products.  I guess the reason I find it
intriguing is that it already is essentially a non-exclusive
endeavor.  At least in Medicare, if Johnson and Johnson
comes in and asks for Medicare of an intracoronary stint,
they can get the coverage, but everybody else who makes
stints gets the coverage as well.
 As much as that might spur development of data to
justify coverage, it might be an incentive.
 DR. GORDON:  Bill, and then Effie.
 DR. FAIR:  I have two questions, the first to Dr.
Dickenson.
 Would you tell the panel, what is the purpose of
this Dietary Supplement Information Center?  What gap does
it fill, and who will be served by it?
 DR. DICKENSON:  It would fill the gap that both
health professionals and consumers would actually prefer to
get information about health and safety of dietary
supplements from another third party group rather from an
industry group.  We do provide some information, both to
health professionals and consumers.
 Of course, I remember companies do directly, but
there is a demand for access to a third party academic
institution, other health professionals that are
knowledgeable about these products, that would not have the
commercial motivation.
 So the purpose of the Institute would be to make
available to health professionals, perhaps through an 800
number or perhaps through other avenues, production of
background materials and information.  For example,
authoritative information on what is the current state of
the science on either safety or efficacy of some of these
ingredients.
 DR. FAIR:  Would that be a web site, also?
 DR. DICKENSON:  Ideally, there would be a web
site, an 800 number, a generation of printed and other kinds
of materials, the availability of these people to present at
professional meetings, for example, and other areas where
health professionals will be discussing these issues.
 DR. FAIR:  And that doesn't exist now.
 DR. DICKENSON:  It doesn't exist in terms of a
group that is specifically focused on dietary supplement
type products.  Obviously, there are numerous research
institutions that have special interest in specific kinds of
products.
 For example, earlier it was mentioned that
numerous researchers at Berkeley have a particular interest
in antioxidant products.  Numerous researchers, at Creighton
[ph] and elsewhere, have interest in calcium type products,
but there is not a center that covers that whole range of
dietary supplement ingredients.
 DR. FAIR:  Thank you.
 The second question is addressed, I guess, to the
panel in general.  I think probably some of you know one of
the leading ethnobotanist at the New York Botanical Garden,
Mike Ballick [ph], has spoken and written that fewer than
half of 1 percent of all the plants on the planet have been
identified for medicinal uses.  I assume that is a valid
source.
 Now, if that is the case, which seems surprising
to me, but if that is the case, it clearly must be something
more than disincentive to look at plants.  Other countries
don't have the same regulatory problems that we have.  I
hear a lot of talk about the regulations and the lack of
incentive, and so forth.
 Is it the molecular design that has taken over?
What is the reason for that low percentage?
 MR. BLUMENTHAL:  First of all, I want to say that
Michael Ballick, Dr. Ballick, is on the Board of Trustees of
the American Botanical Council.  So I know him quite well,
which might disqualify him as an authority here now.
 I believe the figures that Frederick Farnsworth
throws out is that 5- to 10,000 plants around the world, out
of a quarter to half a million vascular plants, depending on
if you are a lumper or a splitter, botanically, how many
plants there are.  Five- to 10,000 plants have been fairly
extensively studied for their chemistry and/or pharmacology,
toxicology, for compounds in them, or whatever, and/or have
been used in traditional systems of medicine, basically.
 Regarding incentives, from the pharmaceutical
perspective, I will let some of these gentlemen here answer
that, but a lot more than that have been screened probably,
especially with some of the high-throughput screening
processes like Phytopharm does in England for compounds.
But from a total medicinal point of view, maybe 5- or
10,000, and many of them reflect those that have been used
in traditional medical systems.
 DR. FAIR:  But even that out of, what, a quarter
million plants, that is a small percentage.  What is the big
problem?  Are they deemed not worthy of looking at?
 MR. BLUMENTHAL:  Well, first of all, those are the
plants that reflect what in ethnobotany comes down to us
historically as the plants that people have been using.  So
there is a self-selection, or there is a historical
selection process over the last 60,000 years that that 5- or
10,000 represents.  It doesn't mean that people have caught
everything, but we do have give some credence to the
selection process of trial and error and empiricism.
 From a pharmaceutical perspective, I am sure these
gentlemen can give better answers, from a drug discovery
point of view.
 DR. SCIAVOLINO:  I think what has happened in
practical terms in the industry is, yes, there are
multitudes of plants that are out there and available for
people to look at.
 As I pointed out in my comments, this was an
approach to discovering drugs some decades back.  What this
has lead to, basically, is people making extracts of
materials and testing these extracts of materials through
standard screening methods.  What that leads to is, by and
large, some activity against a number of enzymes or a number
of receptors.  Then people go and they scale up those
materials, and go fish out individual components, and then
find that they followed some line of activity.  They may
come up with a structure, but that has only got 10 percent
of the activity that they were looking for, and 90 percent
is still remaining in the plant.
 So it becomes a very labor-intensive and a very
unproductive way to proceed.  So those things can be done,
but with the economics of drug research where it is now, it
really isn't a way to proceed.
 What we are advocating, and what the FDA
guidelines are suggesting, is to be able to move some of
these materials with a minimal preclinical package directly
into Phase II studies.  There you have, particularly, for
example, in chronic disease areas where you may have
multiple events going on, pharmacologically, that could have
an impact, instead of taking an individual component out of
those plants, determining the structure, scaling it up,
bringing a pilot plant into play, having to do regulatory
toxicology.  You build up an enormous bill just to get that
single component looked at.
 On the other side of the coin, you can get the
whole extract of the plant, or some preparation of the
plant, into Phase II trials to see if the whole thing is
working, where you have got multiple components at play.
 DR. FAIR:  So what you are saying is, if I
interpret it correctly, that the regulatory problems in the
United States, or obstructions in the United States
notwithstanding, the reason that pharma companies in other
areas, Germany, Europe, China, whatever, are not pursuing
this more intently is that the molecular techniques are
easier and less expensive.
 DR. SCIAVOLINO:  They can move more expediently in
those areas now.
 DR. GORDON:  Effie.
 DR. CHOW:  I want to thank the panel for the
enlightening material.
 I was especially glad you mentioned, Dr.
Sciavolino, concern about the reactive factor about herbs to
drugs, and herbs to herbs.  Also, your last comment brings
me to what some of the concerns are.  You talk about the
isolating factor of an herb, and then 90 percent is gone.
This is what I think, in the cultures that are practicing
herbs, like, let's use China, as some of the herbs are
found, that if they isolate factors, it just doesn't work.
 Now, the thing is, also, there is a cultural,
social behavior, a psychosocial behavior, that goes along
with that.  I am coming to a question.  Medicine is known
for a lot of a side effects.  I will give an example.
Chicone [ph] has reduced the side effects of medication and,
for example, chemotherapy has reduced most all of the side
effects, if used properly.  It is really amazing.  There is
a sense that herbs may fall into that factor.
 In research, is there thought about considering
researching the herbs, not as an isolated entity, even if it
is in the whole, but along with lifestyles, along with
behavior and attitudes, and all that?  There are concerns
that it may fall into an isolated, let's use this herb and
it may work.  I think it effects research, too, if herbs are
researched in isolation.
 DR. SCIAVOLINO:  I will input from a
pharmaceutical company point of view.  My colleagues can
contribute as well.
 We have not looked at this from a psychological
point of view, a quality of life perspective, at least in
the work that we are doing.  We think that that component
might well reside in the physician's corner a little bit
more as the materials come about.  Things certainly aren't
here yet.  We would tend to look more at looking at these
arrays of extracts, not from an isolation point of view, but
now that gene research has advanced so exquisitely well,
such that, in a period of time not too far down the road we
will be able to see various sequences, perhaps the entire
sequence of the genome on some type of an electronic
computer chip, and that looking at these extracts in this
fashion might be able to then get some mechanistic input,
what is going on, not from one receptor, or not from one
enzyme system, but a various cascade of things that are
taking place in the chronic disease states.
 So you really could begin to generate some
insights along these lines.  From a basic science point of
view, we are more interested in applying some of that to the
genetic side of things.
 DR. CHOW:  I guess your company, Dr. Ruddon, is
noted for its wellness component.  So I hope that there is
some thought in that area.
 I just want to make a comment.  In supplements
Vitamin A, C, and E are known to become free radicals in
this isolated usage, and there is a push now for whole
vitamins, whole food vitamins.
 If you have some comments on that, please.
 DR. RUDDON:  Yes, you are right.  In fact, our
health care systems company isn't looking at, again, the
whole concept of health and wellness as a unified field, not
just as one component, or taking one sort of remedy.  So,
yes, that is a focus that we have.
 I think, though, that the cultural aspects of
that, I agree with Frank on that.  That is something that
probably the health care provider needs to take into
consideration.  I don't think certainly in the area of
product development, it is hard to do that when you are
thinking about the things that go on in product development,
per se.  We need to identify if something is active and
safe, and so on.
 I guess I would just comment that the whole idea
of an herbal product or an herbal remedy is important.
Frequently, as you mentioned, when you start isolating
individual components, you find out they don't work, or the
activity is lost.  So there clearly are interactions that we
need to keep in mind.
 Having said that, I think we still need to try and
identify what are the bioactive materials within a mixture.
 There may be more than one.  Then perhaps we can even
optimize what is in those mixtures to put together, not
necessarily a single pure component, but the most
efficacious mixtures of those components.
 So we are aware of the fact.  I tried to find a
single bioactive --
 [Interruption.]
 DR. GORDON:  I think you said something important.
 [Laughter.]
 DR. GORDON:  Mark, go ahead.
 MR. BLUMENTHAL:  One of the things that
characterizes herbal medicines and herbal products, even
individual herbs, is often the combination of synergy of
multibly-acting, diluted active ingredients.  Volarian has
never been able to be isolated for its one active compound.
 When they are fractionated out, the central nervous system
depressant activity is less than when the whole extract is
given.  So there is definitely synergy there.
 In the case of the Chinese medicine and other
forms of traditional medicine system like Ihrveda [ph] from
India where multiple herbs are used more often than not,
compared to European model where there is often just single
herbs being done, monopreparations, you have the compounding
the issue of how many active compounds are actually in that
chemical soup or that chemical cocktail that you are taking
of the herb, or the soup, or the tea, or whatever is going
on, the extract.
 An interesting study design that is worth looking
at in trying to assess some Chinese herbs for irritable
bowel syndrome was published in November in JAMA in '98 by
an Australian herbalist named Alan Ben Soussan [ph].  I
think he is an acupuncturist.
 The thing about Chinese traditional medicine is
that they do individualized treatment, so different people
will present with the same symptoms but they will get
different treatment based on their pulse and
characteristics.  It is called differential diagnosis, as
most of you know.
 In this study, it was a three-armed study, they
did a placebo, they had a standard formula of Chinese herbs
for the irritable bowel syndrome, and then each patient in
the third arm got individualized treatment ala the
traditional Chinese method.  After a certain amount of time,
the standard formula of herbs was rated better, in the mid
term, than the placebo or the individualized treatment, but
at the end of term the individualized treatment group had
the best result.
 So it was interesting that both the herb groups
had good results, but they were randomized differently, and
that is a very interesting way to test the individualized
treatment and a standard in a very different model, or a
paradigm for a clinical study.
 DR. GORDON:  Joe, I want to say to everybody that
we are running over time, and there are people wanting to
question again.  If we are going to run over time, we are
going to go later this afternoon, and I want to make sure
that everybody is going be here to be with the preventers.
 DR. FINS:  With that in mind, I will just ask very
quick questions.  First, Dr. Ruddon, in any future editions
or current editions, which I may not be familiar with, of
Goodman and Gelman, will there be anything about CAM?
 I will just ask them all, and everybody can
respond.
 Is the NDA a good, bright-line distinction about
when you want exclusivity, or do we need a middle category
as far as timeline to satisfy the competing interests that
we heard at the table?
 Then finally, moving straight to a Phase II
clinical trial, presumed safety.  Of course, Phase I trials
are for LD-50s and toxicity.  At what point would you say we
would need to still have a Phase I trial, and what kind of
dosage escalations and things like that beyond the
conventional use?
 DR. RUDDON:  Yes.  Your point about Goodman and
Gelman's Textbook of Pharmacology is a good one.
Unfortunately, there is a bias there.  I got kicked off the
editorial board because I am now a part of industry.  So I
really don't have any input to that anymore, but I will
suggest it to the editors.  I think it is a very good point.
 Whether it is scheduled for future editions, I don't know,
but I think it should be.  I agree.
 I think it would be acceptable to have a sliding
scale in the sense that an NDA route is certainly going to
have to have more proprietary exclusivity to it, and I think
it would be acceptable to have something less than that for
a nutriceutical.  That is my opinion, not necessarily my
company's opinion, but I think that would be true.
 DR. SCIAVOLINO:  On the safety question, we
actually have examples going on right now on those
categories.  Where a substance has reasonably documented
evidence of administration to humans, for example they may
be open-label trials that were done somewhere in the world
where there is documentation available, the agency is
willing to accept that documentation for safety and allow
immediate progression to Phase II.
 In other cases, where the documentation is more in
terms of folklore and really not much is written down, we
have actually done the regulatory toxicology to move to
Phase I.  So we are probing it both ways.
 DR. FINS:  Was that at your discretion?
 DR. SCIAVOLINO:  Yes.
 DR. FINS:  Do you think we need regulations to
flesh that out a little more clearly, so that for safety
reasons we can defer to industry.
 DR. SCIAVOLINO:  From our own reasoning as an
organization, as a company, we would not be willing to
progress directly into Phase II trial without having assured
ourselves that we have got adequate safety.
 DR. GORDON:  I have just one question, which may
or not be quick.  I hope, in a way, it is, but I think it
will lead us, perhaps, to further discussions.
 The most critical point that I hear from patients
as I go around the country talking with groups of physicians
as well as patients, is very simple, how do we know that
what they say is in the bottle is really there.  I am
wondering, particularly from your, Dr. Dickenson, but others
as well, what is the industry doing to make sure that we
know the answer to that question?
 DR. DICKENSON:  Let me say first that the legal
requirement under DSHEA is that the product deliver 100
percent of what it claims to deliver.  So any product that
isn't delivering that is an illegally formulated product and
we would fully support and have told FDA in many settings
that we would fully support enforcement against products
that don't deliver that, because obviously they give
everybody a bad name.
 In addition, though, since there doesn't appear to
be resources for that amount of enforcement at this time,
the industry is about to undertake a third-party testing
program in which we would contract with an organization
called the Institute for Nutriceutical Advancement, which
has been working for the last two and a half years with
industry support on developing methods of analysis for many
of the botanical ingredients.
 We will be moving forward with them to extend that
to an actual individual product testing system in which the
companies would, up front, pay a licensing fee for third-
party testing, and then periodic retesting over a period of
time, potentially, in return for having some kind of seal,
although the seal aspect of that has not been resolved, but
certainly we do recognize that consumers and health
professionals are very concerned by the number of products
that fail these quantitative tests.
 We are trying to take expeditious action on a
self-regulatory system at the same time that we would
support strict enforcement on this as well.
 DR. GORDON:  That is the follow-up question I
wanted to ask.  Are both necessary?  Do you want a different
role for the FDA?
 As you know, our charge is to make recommendations
for legislation.  I am wondering what you think we should
recommend.
 DR. DICKENSON:  I think both parts of it are
necessary.  I think, first of all, industry has to take full
responsibility and do whatever it can to assure that
products are what they are supposed to be, but I think,
unfortunately, there are always going to be those who don't
fully meet their responsibilities in this area.  For those
companies, I think FDA does need to have and exercise that
enforcement authority.
 Our perception is that one of the things that is
needed now is more enforcement resources for FDA on the food
side.  Apparently, most of the funding that they currently
have for enforcement is in other centers on the drug side,
and they are under funded on the food side for enforcement
activity.
 DR. GORDON:  Thank you very much.
 Yes, Mark.
 MR. BLUMENTHAL:  I fully agree with Dr. Dickenson
on this matter.  Our organization has an open seat on the
INA Methods Validation Program Board.  We have been involved
with this since the very beginning to develop analytical
methods for the raw materials and the herbal products.
 I was also one of the founding consultants for the
group called Consumer Lab.com, which I am no longer
associated with, but which has been doing a private for-
profit evaluation of herbal and other dietary supplement
products, and posting the passing products on their web
site, generating a lot of publicity and some degree of
controversy.
 My own organization, ABC, has been involved for
six years in a $1.2 million study of over 500 commercial
ginseng products that we have tested in two university
laboratories by analysis methods that we developed, which
are now becoming accepted by the AOAC, the Association of
Official Analytical Chemists, which will be a worldwide
acceptance as a regulatory method for determining
ginsengicides in Asian ginseng.
 So we really have a lot of investment in this.
One of the things that is really interesting in our study on
ginseng is, we did a baseline study from 1994 to '95
-- some products were purchased before -- and after DSHEA
was passed, tested those products.  After blind-testing in
two laboratories to determine if they passed or failed, we
then contacted the manufacturers and informed them about our
results before publication.
 We went out and bought new products in '97, '98
from the companies, not directly, but from the marketplace
of the companies who failed our initial ginseng studies, and
then compared the products from '95 and the products from
'97, '98, and we found a significant increase in the quality
of these products.
 So one of the news reports that will come out of
our Ginseng Evaluation Program when we publish it in
"Herbalgram-51" in the early spring will be that there has
been significant improvement in the quality control in the
dietary supplement industry as seen through our tests on the
ginseng products.
 That is the good news.  The bad news is, you still
don't always know which products when you buy them because
there is not a universally accepted seal that is trusted.
 DR. DICKENSON:  If I could add just one point.
Mark did mention the AOAC, which is the official method, the
body of official methods that is available for food
ingredients, including dietary supplements.  USP has also
been undertaking an initiative for the last five years to
develop standards in the botanical area.
 This INA program that we are going to be working
with will be coordinating both with AOAC and USP to increase
cooperation among all of these groups.  Ultimately, on the
food side, FDA considers AOAC to be the preferred method.
So we will be feeding these methods through their peer
verified process.
 DR. GORDON:  Thank you.  Thank you all very much.
 I hope that we will be able to consult with you as we
develop other panels on public information and other issues.
 So thank you very much for your help now.
 We are going to adjourn for lunch.  We will come
back here.  We have to give people time to digest their
food, very important, so we will come back at 1:50, 1,5,0,
to begin with public comment.  That will give us close to an
hour.  Public comment people can sign up outside at the
table.
 [Lunch recess taken at 1:05 p.m.]
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