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*** White House Commission on Complementary and Alternative Medicine Policy ***
*** Meeting Transcript: Washington, D.C  10/05/00  Evening      session     ***
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 E V E N I N G  S E S S I O N
DR. GORDON:   We thank everybody for bearing with
the time.  The information is very interesting.  There is a
lot of it and through a little crossed signals, we wound up
going a little bit behind time.  Because of that, Dr. Winn,
who has an appointment in a little while, is going to go
first and we will ask him a few questions and then we will
listen to the other three speakers and ask questions after
their finished.
So, Dr. James Winn.
 Session VI: Research in the Regulatory Framework
DR. WINN:  Thank you very much, Dr. Gordon.
My name is Jim Winn.  I am the executive vice
president for the Federation of State Medical Boards of the
United States.  I welcome the opportunity to meet with you
today.  My position in this whole controversy perhaps is a
little different than any of the other presenters that you
have heard before or will hear after in the fact that I
represent the regulators and perhaps not directly involved
in any kind of research agenda.


Having said that, though, I think that what I
would share with you today might have some importance to you
and the opportunity for you to ask questions to me as a
representative of all the medical licensing authorities in
the country, would be important also.
I had originally prepared a power point
presentation for you today and so at the last minute sort of
changed format.  So, you have some handouts that really
reflect the previous presentation.  I hope that won't be too
distracting.
What I would like to do is sort of skip through
the first part of that presentation, which basically lays
out the background for the Federation of State Medical
Boards.  But I would like to highlight a couple of areas and
that is to reinforce the medical boards' responsibility to
the public.
That responsibility is to protect the public's
health, safety and welfare and to do that by assuring that
they are protected from unqualified and unfit physicians.


This is accomplished primarily by assuring that
only qualified individuals are allowed to render medical
services to the public and that rules and regulations are
developed and standards are enforced for medical practice.
Then when it becomes necessary, to take an appropriate
action against a licensee in the interest of the public's
protection for grounds of unprofessional or incompetent or
unlawful practice.
The physicians have a number of responsibilities
if they choose to practice medicine.  I would just mention
that perhaps the most importantly of that is to maintain
professional standards, to practice within the ethical and
practice standards of the profession and to maintain
professional behavioral in conduct.
To do that, you have to know the Medical Practice
Act in the state in which you have chosen to practice.  Now,
that sort of leads us into CAM and the concerns of the
regulatory bodies, at least those that regulate physicians.
 There is certainly no argument about the proliferation of
complementary and alternative medical practices.  When we
have a rapid proliferation like that, there are certainly
some concerns that get raised about whether or not the
public is being exposed to unsafe practices.


Many of the practices and proposals, therapies and
so forth tend to lack scientific research or clinical
validation.  There is not an easy way to determine whether
they are safe and effective for the public.  Unfortunately,
there are some of these practices that are outright
fraudulent and deceptive in their nature.
There may be multiple reasons for the
proliferation of these therapies.  On the one hand, I think
many people say, well, there has been a demand by the public
for these therapies.  But there also perhaps underlying some
of this has been the willingness of traditional
practitioners to embrace some therapies, particularly some
of the marginal therapies because of the effect of managed
care on their financial status and practices.
Also, I think, the technology situation, where
there has been a marked increase in technological advances
in medicine, has created a greater divorce between patients
and their practitioners, is something that they really
expect.  They expect to have a relationship that is lacking.
 In many cases they feel that they have been disempowered in
their own medical care.


I think the medical boards basically are concerned
about adverse impacts on patients and, unfortunately that is
our job, to look at the adverse side of it and try to make
sure that doesn't happen.
There are three basic areas of harm that we might
identify.  One is economic harm and that is basically just
where it results in a monetary loss but there is no real
health hazard, where the therapy is just totally ineffective
or has no reasonable expectation it is going to help.  But
it doesn't harm anybody.
Indirect harm would be that which while not
providing harmful therapy, results in a delay of appropriate
treatment for a serious illness.  Of course, then direct
harm, which would be directly linked to the treatment
provided the patient.


The federation in 1997 convened a special
committee that was called "The Special Committee on
Questionable and Deceptive Health Care Practices and the
objective of that committee was to provide guidance to
medical boards in evaluating, investigating and prosecuting
cases regarding questionable and deceptive health care
practices for which they had received complaints about.
The report basically provided a guide for how to
assess both conventional and unconventional practices.
There was not a distinction between whether this was
alternative or complementary, but, in fact, any such
practice that was complained about would be evaluated in
sort of the same light.
The bottom line, as far as medical boards are
concerned, that what whatever the practice that is being
given or the therapy that is being given.  The physician
must, in fact, abide by the rules of good medical practice.
 There is not a release of that simply because the doctor is
providing a different type of treatment than what has
traditionally been provided.
In your notes, there are some lists of some of the
elements utilized in the evaluation of health care
practices.  I am not going to spend time this evening on
going through those, although you might have some specific
questions later about that area.  The federation has moved
forward after that research report that was issued a few
years ago.


This committee has continued to look at and review
on behalf of medical boards different practices and to
provide information about those practices so that the
medical board remained updated on current information
regarding practices that they were receiving complaints
about.
Now the federation will move forward to develop
guidelines to assist state medical boards in educating and
regulating physicians who use CAM in their practices.  In
other words, we want to have the medical boards be able to
tell their licensees what the expectations are if they are
practicing in an integrated environment or co-managing
patients with licensed non-physician alternative providers.

So, the objective of this would be to have CAM
utilized in a manner that is consistent with safe and
responsible medicine.  We believe that those guidelines will
be substantially complete within the next six to eight
months and will be promoted to the medical boards for their
usage.


Now, part of the questions that were posed for me
from this group was does the medical boards or the
regulatory community view things, such as office-based or
practice-based research.  I think that medical boards will
expect physicians who engage in research, either in an
institutional setting or a practice setting, to fulfill
their ethical responsibilities and they will apply
guidelines, such as those that are promoted by the American
Medical Association, that a physician may participate in
clinical investigations, only to the extent that those
activities are a part of a systematic program, competently
designed and under accepted standards of scientific
research, expected to produce data, which are scientifically
valid and significant.
There is this issue and I think it will become a
bigger issue for medical boards of the disciplinary
sanctions to be imposed against individuals who engage in
investigative fraud.  Our counterparts in Western Europe
have already had to address these situations.
Four medical boards have already adopted rather
specific policies; Illinois, Kentucky, Nevada and Texas.
These are basically based on what I said before that the
physicians are obligated for good medical practice.


My time is running short.  I won't dwell on these
other areas, except I would like to ask this group to focus
on our concerns and that is that we need, as medical
regulators, good solid information about alternative and
complementary therapies.  Things like chelation therapy,
that has been around for a number of years and as you know,
has created a great deal of controversy with medical boards.
Despite it being around for a long period of time,
there is almost no credible evidence that it effective for
what it is claimed to be.  In fact, over the past several
years, the claims of effectiveness have actually increased.
 What we need is good research that would tell us whether or
not this is effective because quite honestly if it does what
it is said to do, then medical boards should be holding
physicians responsible for not submitting patients to that
before more invasive procedures are used.


If, in fact, it doesn't do that, then doctors
should be held accountable for using a therapy that has no
benefit but has the potential for patient harm.  So, I think
that we would want you to focus first on a research agenda
that helped identify the effectiveness of those therapies,
which carry some risk to the patient, but if they, in fact,
are beneficial and the benefits outweigh the risks, then
they should be embraced.
If on the other hand they have no significant
likelihood of effectiveness and they have a likelihood for
patient harm, medical boards should hold physicians
accountable for exposing patients to that risk.
I have run out of time and I thank you for your
attention and certainly I will answer any questions.
DR. GORDON:  Thank you very much, Dr. Winn.
Are there questions for Dr. Winn?
DR. LOW DOG:  Do you have any idea of how many
complaints have actually been registered by patients towards
physicians, who are practicing integrative or CAM therapies?
DR. WINN:  No, I don't have that information with
me.  The federation keeps track of actions taken, but not
complaints received by the different medical boards.  So, I
don't have access to that information.
DR. LOW DOG:  Do you have any idea how many
actions there have been?


DR. WINN:  I don't have it with me, but we
certainly could go through that.  I mean, I could do a quick
search of the database and let you know.  But I don't know
off the top of my head how many actions have been taken.
DR. GORDON:  That would be great.
Wayne and then Conchita.
DR. JONAS:  I really appreciate your comments.  I
think there are a number of issues that you bring up in
terms of access.  We hear access, access, access and along
with that has to go accountability.  It is kind of like
safety and efficacy.  They kind of go together.  I am
surprised that some of the individuals involved in
complementary medicine haven't said wait a minute.  I don't
know if we want to be integrated or not because then
evidence, accountability, scientific rigor, as well as
health care management will then become ours, which may or
may not be very useful.


I think it would be extremely interesting and
useful to try to at least get some input as to whether there
is a way in which some of the areas that you all are
concerned about, the specific practices could get on the
research agenda in terms of what public money ought to be
investing in, such as chelation therapy.  I mean, this thing
has been floating about for years and we still don't have
information about it.  So, you know, we talked about how
does the public get input, but I think it would be extremely
useful to figure out how can some of the state regulators or
some of the people that are out there looking at these
practices from a regulatory point of view also be brought
into helping in terms of the research agenda.
That would be, I think, extremely useful, at least
for me and perhaps for the board.  The other issue that
probably someone else will bring up is also how to deal with
a practitioner that is doing something that perhaps us from
a research point of view want to investigate and, yet, it is
considered a non-standard or a fraudulent type of practice.
 You know, how do those intersect.
DR. GORDON:  Do you want to pose that as a
question?


DR. JONAS:  I could pose that as a question,
although you could do it better.  I mean, the issue is is,
you know, there is a practitioner that is using, perhaps,
some kind of unusual treatment that has claims and wants to
be involved in that and, yet, it would be perceived from the
state point of view as being fraudulent practice and that
person should be disciplined.  So, a lot of practitioners,
of course, would withdraw from participating in research
because of the perceived risk that that might then expose
them to.
DR. WINN:  Well, let me see if I can answer that.
 I think that is sort of one of the objectives that we want
to accomplish with our committee in developing guidelines
is, for instance, if a research project is going to be
undertaken in this area and the individual is not part of an
institution.  So, the institutional review board is not
involved.


How does that occur?  Well, probably the medical
board should meet with that individual, understand what the
research protocol is and how this will be accomplished so
that the patient's safety is involved.  One of the things
that all sort of gets mixed up because some practitioners
will tell you, well, I am doing research, but then you look
at it and the patients haven't signed a consent form.  They
didn't know they were part of a research project and they
were paying for therapy.  So, that sort of begs the issue of
really what are you doing here.
I think it ought to be on the table, clear and
easy to understand for everybody involved and I don't think
a practitioner, who is legitimately doing research is going
to have any kind of problem.
DR. GORDON:  I want to just follow up for a minute
and then come back to you, Conchita.
I am sorry you can't stay because I would have
loved for you to be able to hear some of the people who are
grappling with this issue.  So, we will send you some
transcripts of what happens.
We have people who are trying to do research.
They are perfectly happy to have IRBs to constitute them or
get them, but they are in private practices and they are
lacking, sometimes they need help with expertise from
others.  Sometimes they need economic health to pull
together the data or do the analysis.


I am wondering if you can think now or, you know,
in these next weeks and months of some ways to facilitate
this process so we don't get into a situation that I know
has happened, where people who are doing research that, you
know, they fully intend to study, sometimes they have IRBs,
sometimes they don't have IRBs.  They are genuinely
committed to the research.  They are not doing harm.  There
are no patient complaints and, yet, they run afoul of state
medical boards.
So, I feel we need to grapple with this really in
a very intimate way because it is a major problem.  It is a
major problem for a small number of people, but our thought
has been that we might get even more interesting research if
we can figure out strategies for working with us.
DR. WINN:  Well, we would be happy to work on that
because I don't think that medical boards are interested at
all in being a barrier or obstruction to legitimate
research.  What we are interested in is making certain that
the public and patients are protected.  So that consequently
that is the number one priority and then the second priority
would be okay if you are protecting patients, let's go ahead
and figure out how you can do the research, but you are not
putting patients at risk just because we need to know
something.  That would be, I think, inexcusable for
practitioners to do.


DR. GORDON:  I appreciate your answer.
Conchita.
DR. PAZ:  My question comes just to develop that a
little bit further, is how to get more states to develop CAM
policies.  You just mentioned four here, but that is such a
pitiful amount that how can we provide that more.
DR. WINN:  We are an organization that has no
authority to make every state endorse that, but what our
history has been, for instance, with pain management and so
forth, that once we put out a very reasoned process of
policies and so forth, the states will, in fact, develop
that.  So, what I would tell you that probably in the next
24 months, you will see a significant number of states have
policies about CAM therapies.
DR. GORDON:  Thank you.
Joe.


DR. FINS:  It is the exact follow-up.  I was going
to compliment the federation on its recent work on pain
management.  One of the upshots of that, there has been a
lot of state medical boards that have actually looked to
pain experts to be on the boards to assess not only do they
have the therapeutics, but also concerned with the research
aspects.
Is that something that you would consider as being
a beneficial recommendation, to recommend CAM participation
on medical boards, you know, people like Dr. Jonas, for
example, to sit on a medical board in his state to help you
guys sort out whether or not --
DR. WINN:  Certainly, and there would be no
objection to somebody of Dr. Jonas's statute, but the
process as you probably know is really politically
gubnatorial appointments that go to the medical board.  So,
there are people who engage in CAM therapies, who currently
sit on medical boards.  Many boards do have practitioners
who have practices primarily of a CAM nature.
But I think the suggestion is appropriate that
medical boards should, in fact, have if not people on the
board, consultants available to them to assist in their
evaluation of cases and any kind of complaint that comes
forward.


DR. GORDON:  Thank you very much.  We really
appreciate your coming and we hope we will be able to
continue -- do you have your hand up?
DR. JONAS:  I just want to follow-up on this just
a little bit.  I mean, this is not necessarily a solvable
problem but the variety of opinions and types of regulations
that are in our states really make it extremely difficult to
come up with any kind of uniform policy because there are
states that have attempted to or even perhaps will see
successfully eliminated, the whole regulatory aspect in
terms of this.  The Minnesota law, for example, is a real
issue in terms of what actually is going to happen with
that.  So, there is wide variety of attempts to address
this.
DR. WINN:  Right.  I agree and that is the reason
we need the national effort that we are trying
to --
DR. JONAS:  Right, and since this is a federal
commission, it would be extremely useful for us to think how
can we appropriately address that in a way that does not
interfere, obviously, with state rights in terms of
authority --
DR. GORDON:  Thank you for coming and being with
us and we hope we will continue the dialogue.


DR. WINN:  Absolutely, Dr. Gordon.
Again, my apologies to you and the Commission for
my requirement to leave early for another meeting.
Thank you.
DR. GORDON:  Thank you.
Next is Dr. Floyd Leaders.
DR. LEADERS:  Thank you very much for inviting me
to come.
We are going to have a little shift of paradigm
here and go just about as far to the other end of the
spectrum as we can get.  I work for a profit-making,
hopefully, organization that is interested and committed to
bringing mechanical products through the FDA as drugs.  We
are speaking to exactly what you said, why would anybody
want to do that.
The reason is very straight forward, that we
believe that botanical products, the natural products, have
much more potential than just for over-the-counter products
or products that can be sold in the DSHEA marketplace.  It
would be very hard to sell a product for the treatment of
cancer in a food store.  So, that is the reason.


I was asked to speak on three different aspects.
The first one was how do the current regulations impact on
doing research on botanicals.  Keep in mind that what I call
research, you probably would call development.  We are doing
research within a regulatory framework.  They even have a
name for it.  It is called regulatory science.  That may be
an oxymoron, but it is, indeed, the environment in which we
work.
Within that framework, there are several things
that have inhibited what we are doing from the private
sector purpose.  The first of these, I will say is money and
I think you heard that from both Dr. Woodcock and Dr.
Levitt, particularly Dr. Levitt in the dietary supplement
area.
There are not enough resources to go around to do
the things they have to do.  The other major thing, however,
is mind set.  Now, this is particular for our industry but I
have a feeling it may bleed off slightly into other areas
also, that we have a very good example here, the botanical
guidance document, that Dr. Woodcock talked about.


First, let me say that is a giant step forward.  I
am extremely pleased to see that come out.  We have been
working on it since 1994 and I am very pleased to see it
because now we have something we can look at.  It scares me
a little bit that she says it is a cookbook.  We will come
back to that later.
But mind set is extremely important in that
document.  I don't know how many here have read it.  I have
just spent the last week involved in more telephone calls
than I have any desire to be because we have responses to
get in by next Tuesday.  But this particular document is a
very good start, but let me put it in context of our group
of people, that it basically takes the new chemical entity
paradigm and overlays it with the botanical requirements,
which some of them will be very difficult to do and other
ones will not be so difficult.
We can get into that more.  I just want to hit the
high points and if you have specific things you want to talk
about, I am available, obviously.


The second one is how can research methods and
approach be expanded to address the safety and efficacy.
One thing that has not been mentioned here at all and you
will not hear it mentioned probably is to lever off a
previous human use.  I can't say that strongly enough.  That
is the one difference between the botanicals that we are
working with and other people are working with and a new
chemical compound as just been synthesized that has never
been in man before, women, too.  Never been in humans
before.
But we need to learn how to evaluate human data
and with all due respect, the FDA does not have enough
personnel of the right kind to really know how to evaluate
that.  We are still in the position of looking at animals to
predict human safety when we can't have human safety in
humans, the species of choice.
In the guidance document, I will use this as the
specific example, to get into the clinical trials, you can
get in fairly easily without a lot of the things that are
necessary.  But by the time you come out at the end of Phase
3 clinical trials to get NDA approval, you have effectively
done everything that a single chemical entity has to do.  We
have thrown away all of the knowledge we may have about how
this works in humans.


So, my plea would be, and I will come back to
this, my plea would be to consider how the resources can be
brought to bear to allow previous human experience to count.
 Maybe that can apply to other things as well.
Last is should changes of any be made to the
regulations?  If so, what should they be?
The main one is, perhaps, proprietary,
intellectual property rights.  I am going to offend some
people from other places around the table, but I don't think
even NIH has enough money to totally fund the development of
this whole group of products.  It is going to take private
sector doing it.  What motivates the private sector to take
risks is the chance to make a profit off of it at some
point.  Whether they make too much or not, I won't go there.
But there has to be some kind of return on
investment.  I told you this was going to be a paradigm
shift.
We need to establish, if we can't get patent
protection, because you are here -- I am probably the only
person here not asking for money because I think our
industry has to fund this.  If you have a way to give it to
a private company, I think we would take it, but I don't
really see how that can be done.


So, I am not asking for money.  But I am asking
potentially for the impact you could make into some of the
regulations and some of the looking at these, that if we
cannot get patent protection on these products that have
been around for a long time, is there any way to grant
regulatory exclusivity that would allow a company to justify
making an investment of $150-, $200 million to bring a
product through all of the quality control, all of the
manufacturing, all of the research hoops that we need to go
through to really show safety and efficacy, so they can't be
beaten over the head.
The third thing, the change in mind set we have
already talked about.  I want to talk about DSHEA.  Now that
I have been involved with CDER, I will talk about CIFSAN
[ph].  There is a major impediment in the Dietary Supplement
Health and Education Act to inhibit research.


When the act was passed, they were looking at
these products as foods, an orange is an orange is an
orange.  It may be green if it is from Florida.  It may be
orange if it is from somewhere else.  Botanicals are a very
weird breed.  They are the group of products that basically
test the law.  It is unfortunate because they are
manufactured like a biological in that they are manufactured
under heavy process control.  They are sold and advertised
as foods, dietary supplements, by congressional fiat.  They
are used by the public to treat disease.
We all know that everyone here drinks coffee in
the morning because they like the flavor.  You can't say it
stimulates because that would make it a drug.  So, that is
just an example.  The problem with botanicals, and this is a
four line sentence, the process defines the product.
Under DSHEA, you can take data from a product made
by one entirely different process and use it to support your
product and that can be made by a different way.  It is like
using data on grapes to justify wine; quite different ways
of looking at it.  This has been overlooked in the law.


I don't think the industry wants to go back and
revisit that because just like having a constitutional
convention, you are never sure what would come out.  But if
you want to ensure research, give people some chance of
getting paid back for doing the research.  It is that
simple.
Thank you.
DR. GORDON:  Thank you very much.
Next will be Mr. Robert McCaleb.
MR. McCALEB:  Thank you.  I would like to thank
the Commission for inviting me to address you today.
I am going to start with just a brief response to
my friend, Floyd.  He and I disagree a little on this.  When
something has been used for many, many centuries for
particular medicinal or health beneficial use, it is
difficult to give the rights of exclusivity to any one
company for that.  We don't believe that anyone should ever
have the right exclusively to make a claim for ginseng or
garlic or any one of the other 2,500 or so herbs that are
sold in this country, unless they can actually invent
something about it.
I also think that in terms of the application of a
claim to research, the research must support the claim being
made for that product; that is, if the research is on a
particular type of extract, I agree that only that type of
extract should be allowed to make a claim that is based on
that research.


Let me talk a bit about the state of nature
products research in the United States.  In the last 40
years, we have essentially shut down natural products
research in this country.  We have failed in the last half
of the last century to approve a single new drug from plants
unless it was produced as a single mono-substance, such as
Taxol, and even that had some protection under the law to
give it some exclusivity it might not otherwise have had.
Because of that, these things fell into disuse and
because of that, they fell out of the pharmacy and medical
schools and out of the organizations that grant money to do
research.  There is a cascade that has really shut down the
research and approval of botanicals in this country for use
in health care.


One of the tragedies there is that so many
botanicals are used for preventive medicine or for health
maintenance.  In the absence of the ability of our Food and
Drug Administration to approve preventive medicines, we
really literally only have a few, things like sunscreen and
motion sickness pills.  Those are really two of maybe only
four preventive medicines ever approved for over-the-counter
use by the FDA.
So, in the absence of approved preventive
medicines, we use dietary supplements for health
maintenance, for preventive medicines.  DSHEA works and I
think that is one of the first things I would like to point
out as a part of my message is that there is more research
right now ongoing and more completed in the United States or
funded by American companies since the passage of DSHEA than
has been done in decades before.
Why is that?  It works in exactly the same way
that it has worked in incentivizing European research.  The
ability to make a claim on a realistic threshold of evidence
is what drives companies to do research and it is also what
drives the public sector to invest in research as well.
So, we have seen in this country what we have seen
in Europe.  Just the ability of a company to make a claim or
to achieve a claim without a $200 million expenditure has
driven research so that companies can make the claim to
doctors and pharmacists that their product is clinically
researched.


In addition to research incentives, we now have
more informative labels on these products that give much
better information to the consumer about what the product is
intended to do, better third party information.  Although
there is a confusing level of information out there, there
is certainly some very high quality information that has
been produced since DSHEA and because of it.
We need to improve the path, I think, to stronger
claims.  It has been suggested that one of the ways to do
that might be to allow the elimination of that disclaimer on
a DSHEA regulated label if a certain threshold of evidence
is achieved for it or the ability to use certain types of
research in advertising or labeling a product.
If a company did research on its own product,
clinical research on its product, maybe it would be allowed
to make a stronger claim than a company that was sort of
piggybacking on that research or using what they called
borrowed science.


One of the ways to a stronger claim is over-the-
counter drug status.  Now, this is something that was a very
strong recommendation of the Commission that I sat on, the
Commission on Dietary Supplement Labels.  The FDA did not
take us up on that recommendation, but many people within
and outside the agency have praised the model of the German
Commission E, which was actually very similar to our own
over-the-counter drug review process.
That is, we had panels of experts, who sat and
discussed what they knew and what they seen in the evidence
on particular drugs and how they might be approved.  They
approved those based on their opinions of that evidence.
There was no gold standard and in some cases things were
approved with not a single clinical trial.  We have a real
mystification of that process in the United States.  Few
Americans probably recognize how little evidence was
required to achieve over-the-counter drug status.


But all dietary supplement products are sold over
the counter.  They are not prescription products.  So, we
think it is a legitimate model.  I am not suggesting that
they be removed from dietary supplement status, but only
that there be a natural products OTC panel empowered to look
at natural products, pull in experts in specific medical
disciplines and make some decisions about the safety and
efficacy of the substances sold now as dietary supplements
that could then make stronger claims as over-the-counter
drugs.
I think we need to increase the focus on
traditional medicine, recognizing that DSHEA leaves that
out.  Many of the forms of traditional or folk medicine used
in this country are based on historical, cultural
information or on energetic principles that don't really
fall within the scientific model that DSHEA embraces.
These are often less static than the European
phyto medicines that have become most of our dietary
supplements in this country, but they are used by more
people worldwide than any other form of botanical medicine
and they are used by most of our minority populations;
African Americans, Hispanic populations, Asian populations.


As Dr. Federman said, anecdotal information can be
good.  When you have anecdotal information, that      is,
experiential information that comes from trained observers
over generation after generation of humans, you have
something more than just someone saying I think this stuff
helped me.  You have a higher level of evidence.  I think
that is what Dr. Leaders was alluding to also, that we need
a way of looking at historical information and using it in
our evaluation of efficacy and safety.
We need more international outreach  in terms of
accessing the information from European and Asian clinical
practice.  Remember now, some of the things that are being
sold in our pharmacies and grocery stores have been used
under physician supervision for decades now in Europe.  We
need to get access to the clinical experience that those
physicians have and incorporate that into our decision-
making process, too.
There is also safety data from decades of
pharmaco-vigilance programs in Europe that so far we have
been unable to access.  I don't know of anyone else who has
been successful there either.  But I would really love to
see this group make an effort to get at that pharmaco-
vigilance data that every European country requires of its
phyto medicine manufacturers.  I think this would be very
useful information for the American public.


Information systems, we need a greater focus on
information systems.  There is confusing information,
contradictory information and there is misleading
information on both sides.  There is hype on the marketing
side and there are scare stories on the media side and on
the government side.  We really need to cut through that
maze of information and try to get information, especially
for consumers and practitioners that is quality evaluated,
so people can trust the information and utilize in their
decision-making process.
I would certainly include in that, as a specialty
library, that we need more library funding and collaboration
to utilize the resources that are currently untapped.  There
are a lot of people in this country who have specialized
collections that could provide a greater level of
information than we currently have.
I would advise extreme caution in public
statements by our regulators and scientists.  We have heard
some already, sort of overstatements about ephedrine adverse
reactions.  The birth control issue with St. John's wort has
been a subject of speculation, but the truth is there is no
direct evidence that St. John's wort affects the
effectiveness of birth control at all.


There are two anecdotal cases of breakthrough
bleeding, but that is common with birth control anyway.  So,
really, that is something that someone found in dinavir
[ph].  Cyclosporin activity was affected, speculated that it
was a cytochrome P450 effect and then went from there.
Finally, I believe true cooperation and
collaboration between government, academia and industry can
help us all through research and education toward a more
appropriate, safe and effective use of complementary and
alternative health care modalities.
Thank you.
DR. GORDON:  Thank you.
Dr. Anthony Rosner.
DR. ROSNER:  Thank you very much.  I want to thank
all the panel members for inviting me to share a little bit
about our background and sharing some real concerns and
possible solutions to alternative medicine research.


I particularly want to thank the panel members for
establishing such a congenial and inquisitive atmosphere.
This has very much the feeling of the Chantilly meeting some
eight years ago.  So, as an alumnus of the esteemed class of
1992, I am happy to outline a little bit of what the
foundation has done and talk about barriers.
Now, I did list the barriers and I guess the sort
of Audubon field guide, which is at your disposal.  There
are ten critters here that I think you need to be aware of
and I also listed 13 possible solutions.  So, please bear
with me.  Strap yourselves in and I will try to do justice.
 But forgive me if there is a little bit of the hit and run
aspect to what I will be talking about.
Our foundation has been around for 50 years and it
has essentially bootstrapped about 175 projects in the area
of chiropractic.  We are very pleased that the first federal
funding that was talked about earlier by Bill Meeker really
came at centers that had been funded by us initially.  We
have also supported some 125 research fellows, maybe 25
residents.


As you probably are aware, 25 years ago,
chiropractic research was vastly underdeveloped and appeared
very much as an oxymoron.  It was in 1975 that a conference
at the NINDS concluded that, this is a quote, "There was
little scientific data or significance to evaluate this
chiropractic clinical approach to health and the treatment
of disease."
Since that time, we now have seen 40 randomized
clinical trials supporting spinal manipulation, comparing
with other treatments, meta-analyses and systematic reviews
and multidisciplinary panels representing the governments of
the United States, Canada, Great Britain, Sweden, Denmark,
Australia and New Zealand.  These have all expressed similar
recognition of the robust evidence in support of spinal
manipulation for managing low back conditions.
Well, this brings us to the problem of barriers.
Dr. Federman had talked earlier, I guess, of savage
prejudices and, unfortunately, these exist.  Most of these
do remain in place.  Some of these have just been lifted,
but I did want to go through this list with you.


No. 1, we have to talk about collaborative
arrangements.  This goes back to 1993.  The Office of
Alternative Medicine required that researchers in
alternative medicine collaborate with people from an
orthodox medical background.  These would be individuals
familiar with conventional research methodologies.
Obviously, this was meant for educational
purposes, to improve the quality of research, but my only
cautionary note here is that if funds are not sent to
alternative medicine research centers in great amounts,
there is the risk of strangling some of the origins of where
these ideas came from.
So, we have to be aware of an equitable
distribution of funds and resources.  Obviously, NCAM's
establishment of specific research centers, chiropractic,
that would be Palmer University and recent RO1 research
programs, which individual researchers in CAM can step
forward, these are obviously major steps in the right
direction.


The second issue, domestic institutions, there
have been a number of major milestones in research that have
significantly lowered barriers to both the practice and
research of chiropractic and these have been accomplished
abroad.  We talk about the low back studies of Meade in
Great Britain, tension headache studies of Dilsen [ph] in
Denmark, the first randomized trial addressing colic.  This
is possibly a non-musculoskeletal condition, and this is in
infants.  This is in Denmark.  Numerous asthma case reports
and a pilot for randomized clinical trials from Australia to
lay the foundation for future clinical trials, these are
just a few of the outstanding examples.  So, the requirement
of many past federal programs restricting grants to domestic
institutions only would represent an impediment to the
accomplishments of potential research in alternative
medicine, which recognizes no national boundaries and which
has clearly benefited from additional resources available
beyond American borders.


No. 3, composition and proceedings of
institutional review boards, undoubtedly these are an
indispensable component for ensuring patient safety and
knowledgeability in the clinical trial.  Unfortunately, from
my own experience at a major medical institution, there have
been instances in what a proposed randomized clinical trial
that seemed to pass some preliminary scientific review, was
rejected out of hand for what was probably the harboring of
anti-chiropractic sentiments by the head of the IRB.
Obviously, while implementing panels to monitor
the behavior of IRBs may seem a bit excessive, the issue
does bear further scrutiny in the event that viable and safe
alternatives in the patient's interest fall victim to
prejudice within an IRB.  This leads directly to the fourth
problem, study sections, for many of the same reasons I just
talked about.
We need an equitable number of individuals within
each study section of a grant proposal, who are familiar
with and sensitive to the conduct of therapeutic regimes to
be tested.  Common sense dictates that as eloquent and
sympathetic a presentation of the therapies to be studied be
made to the study section as a whole.


Fifth, we have to talk about publication bias and
quotas.  There are examples of editorial bias and quotas,
which have prevented the most robust of chiropractic
research from reaching the necessary audiences.  A headache
study by Beline [ph], for instance, which was rated the
highest by two independent systematic reviews, was denied
publication in The New England Journal of Medicine, Headache
and Cephalgia, before it finally appeared in the Journal of
Manipulative and Physiological Therapeutics.
Two years later, there are examples in which
editorial comments to the principal authors of studies have
clearly indicated that obtaining negative results, results
for spinal manipulation was the criterion for acceptability.
 Thus, it is with dismay that I find two inferior and widely
publicized studies of chiropractic, which did get published
in The New England Journal of Medicine.  These have been
rebutted extensively elsewhere and to add frosting to the
cake, there have been statements from two previous editors
of this journal, offering little encouragement.
They have been quite biased with little
qualification in their negative assessments of CAM.


The sixth point, this goes on to the press and the
journals, this type of bias and editorial policy, obviously,
has ramifications in what is actually stated in papers and
subsequently published in the lay press.  One study
published in The New England Journal of Medicine, for
instance, stated a conclusion that was far beyond anything
supported by the data.  Specifically, the study discouraged
the routine referral of patients to chiropractic.
It said, "Given the limited benefits and high
costs, it seems unwise to refer patients with low back pain
for chiropractic or intensive therapy."  This is to me an
egregiously out of bounds statement for a scientific journal
and, of course, when the lay press gets its on it, which
they did, it only got worse and we saw such scare headlines
as, "Study Targets Worth of Chiropractic," "Chiropractic
Care Blasted in Two Studies."
You can imagine this only poisons the atmosphere,
inhibiting further research efforts, inducing third party
payers to deny reimbursements for chiropractic services, in
which the outcomes have yet to be definitively disproved.
So, news releases such as these need to be actively
discouraged and the public needs to be further enlightened
as to research and potential of multiple modes of
alternative therapy, not just chiropractic.


Mainstream versus alternative status of
chiropractic, this is an unusual bird because when we talk
about low back pain and headache studies, chiropractic has
more or less moved into the mainstream category.  Bill
Meeker had called this the elephant in the room.  But we
have other types of interventions.  We have other types of
conditions for this intervention seems promising.
Here we talk about scoliosis, otitis media and
infantile colic, to name a few.  This I would suggest is the
lion pacing in the wings, besides being the elephant in the
room for mainstream practices.
Origins of mainstream medicine, No. 8, this is not
infallible.  The preamble to the five year strategic plan of
NCAM says as CAM practices once considered unorthodox, are
proven safe and effective by rigorous scientific
investigation, they become part of mainstream health care.


This is certainly the way we would hope to
transform good research into practice.  Clearly, this would
be the mission of NCAM, this commission and our foundation,
but since only a minority of medical procedures have been
supported by documentation, we have to be wary that all
procedures are, in fact, going to be supportive.
No. 9, paradigms.  In The New England Journal of
Medicine, chiropractic has often been confused with high
velocity thrusting of the spine and this would reduce it to
a one dimensional specialty of cracking joints.  It
represents much more of that.  We are talking about the use
of hot and cold packs, electrical stimulation, soft tissue
procedures and nutritional counseling as other types of
therapies that have been licensed.
The last problem that I will state, I will not
talk about the solutions, these are in the handout, is the
RCT, Tieraona Low Dog had asked about, other types of
approaches.  Here we have to appreciate that in randomized
clinical trials, the placebo has inappropriately been
represented.  This is dealing with a sham procedure, which
is some times confused as not having an effect at all.
Meta-analyses outside of chiropractic have been
misinterpreted such that depending on whose scale one uses,
totally diametrically results can be obtained.  So, it is a
question of what values are put into scales such as this.


The third and final example with pharmaceutical
companies has to deal with antifungal agents in which one
agent was inappropriately administered orally instead of
intravenously and in this case there wasn't ever a chance
for a fair comparison.  Yet, you know, this was laid out as
gospel.
So, in closing, I guess I want to just caution the
Commission to understand that there are other types of
clinical evidence, as David Sackett has pointed out, and I
would wish that the Commission place far greater emphasis on
cohort studies and case series in reaching its research
goals rather than to assume categorically that they provide
inferior guidance to the clinical decision-making than RCTs.
It should be quite clear that a well-crafted
cohort of case series is really more informative than a
flawed or corrupted randomized clinical trial.
DR. GORDON:  Thank you very much for this
extremely well-written, thoroughly-documented, written
testimony.  I think it will be extremely helpful.


For others who will be testifying, I think we need
to encourage people to prepare exactly this kind of
testimony wherever possible because not only can we listen
to you and talk to you, we can go and check it out for
ourselves.
DR. ROSNER:  I hope so.
DR. GORDON:  Which is really very helpful.  For
any of you, we would appreciate any documented evidence,
anything you would like to send us you think would further
our knowledge, we would welcome.
We have some opportunity for questions.  Bill and
Tom first.
DR. FAIR:  I would like to clarify one thing with
Dr. McCaleb.  You said that in the last 40 years, there has
not been a single natural product in the United States.  Is
that correct?
MR. McCALEB:  Right, approved as a new drug.
DR. FAIR:  Then you mentioned Taxol.  What was the
different situation with regard to Taxol that got Taxol
approved?


MR. McCALEB:  Well, pharmaceutical companies have
been looking for single chemical entities in plants.  They
have achieved approval for a few, vincristine and
binblastine [ph], Taxol, captophecan [ph].  There are a few
examples there.
Taxol was approved for one substance as a sort of
orphan drug as I understand it, for one type of cancer, but
is actually being used for breast cancer, which is much more
common and would not have qualified it for that orphan drug
protection.  In any case, the point I was trying to make is
that for complex botanical extract for anything other than a
pure chemical entity, we have failed to approve any as new
drugs since 1962 when the efficacy provisions were added to
the statutes.
MR. CHAPPELL:  Dr. McCaleb, thank you for your
recommendations and I would like to explore a little bit
more about the natural products OTC idea panel and so forth.
 You are suggesting that botanicals can have a sort of
monograph equivalent that could be set up as a standard so
that everybody could make the claim, so long as it was
meeting that monograph.
Is that what you are envisioning?


MR. McCALEB:  Yes.  This was the unanimous
recommendation of the Commission on Dietary Supplement
Labels, that because botanicals and natural products are
different and more complex than the single chemical entities
that are commonly studied in health care, that a special
panel should be empowered with pharmacognicists and
anthrobotanists and the kind of people who specialize in
this area.
Then unlike the model of OTC review, where you had
a cough/cold panel and the different specialties, that this
panel could then pull in those specialties as needed,
bringing in doctors who specialize in a particular
condition, to assist them in making decisions about a
botanical or other natural product that was to be used for
that purpose.
The point was to have a panel of experts, who were
really specifically focused in this area of natural product
health care, to sit on an ongoing panel and look at the
evidence and make decisions.
MR. CHAPPELL:  So, your view is we would have an
upgrade of DSHEA that is short of an NDA or drug?
MR. McCALEB:  Right.  Certainly still the --
MR. CHAPPELL:  In terms of claims.


MR. McCALEB:  -- prescription drug process is
still open to botanicals, but, yes, this would be a panel
approach of expert opinion, making decisions rather than the
full NDA process.
DR. GORDON:  Wayne.
DR. JONAS:  There is a lot of talk about
incentivizing the private sector and this is of great
concern to us about how to go about doing this.  Obviously,
it is very clear that the NIH will never be able to fund
probably even a fraction of the potential therapies that
have even been identified in multi-center, large,
randomized, five-armed placebo-controlled trials.
So, how to incentivize the private sector to
invest in this area is part of what we are going to discuss
actually tomorrow and also, I think, a little later on
today.


But what I heard you say, Floyd, is that there is
a problem in the patenting process or at least there are
issues that are obstacles in terms of the patenting process.
 As far as I can tell, we haven't really addressed that and
don't have it as a major item on the agenda.  I am wondering
is that something that would be an important area to
specifically look at in terms of its influence on this
incentivization process and should that be something the
Commission should be looking at and if so, how.
DR. LEADERS:  Let me come back to that because I
understand where Rob is coming from on the taking these
products and giving the exclusivity to one particular person
or one particular company.  I fully appreciate that.  I am
not talking about the general kind of products, like the
ginkgo biloba, the hypericum [ph] and so forth.  I am
talking about a botanical that is used not like Taxol, where
you take out a single active ingredient, but maybe an
extract of Taxol that has several of the other ingredients
in it also.
There is a place for some of these products.  The
patent protection probably can be gotten on some of those
that have not been as widely used.  But there needs to be a
guarantee or some kind of -- there is really no reason,
nothing to motivate a company to invest the kind of money we
are talking about.
I think that it should be looked at.  There are
several proposals to Congress on this kind of thing.  I
don't think that they --
DR. JONAS:  Specifically addressing the patent?


DR. LEADERS:  Dr. de Felice's [ph] act on and I
can't remember the name of it, but it basically would set up
a whole new process.  I am not sure one is needed.  But if
there were a legislative way of saying if you have a
particular extract and you have documented this and you have
gone through all the hurdles, you should be able to have
some kind of legislative time to get your money back.
DR. JONAS:  Should we ask for the patent office
and some of those folks to be in here and talk to us about
it?
DR. LEADERS:  Yes, it would be interesting because
we have patent lawyers here in the Washington area.  We
believe we can get proprietary protection on some of them.
But I think it would stimulate research, yes.  I think that
is another way of doing it.
DR. JONAS:  I had one question for Dr. Rosner.


That is, what is the status of the chiropractic
research network?  Is there such a network?  I know there
used to be and the reason I ask that, of course, is because
this is a potential mechanism for collecting data in actual
practices and the question of what is needed to encourage
that, if we are going to be doing outcomes or observational
or cohort research as you describe it is crucial.
DR. ROSNER:  I know.  You are talking about a
database per se or --
DR. JONAS:  Well, I mean, it is more than a
database.  No.  I am talking about research practitioners
that is organized in such a way that you can actually
collect practice-based data.  I mean, this exists in a
number of conventional areas.  I don't know of any good
network like that among complementary medicine
practitioners.
I know the Naturopath Liana [ph] has put together,
and you all had some and I am just wondering what the
situation is with that and is there some way in which that
can be developed?
DR. ROSNER:  Yes.  We have had a number of ongoing
discussions about this problem and there have been localized
attempts at this.  I guess the most courageous effort has
been mounted at Palmer, as far as organizing a database for
both practitioners and researchers to get into to understand
what information sources are available, how to conduct a
case study.


One of the things we are very sensitive about is
starting at the very beginning, which is record keeping.
This is something we are constantly visiting practitioners
and lecturing about because it is really the very first
step.
DR. JONAS:  I think it would be useful to hear
what could occur to help develop this and perhaps you and
also Bill could discuss that and give us some suggestions as
to how to do that because, clearly, if there is no
infrastructure, if there is no organized way of collecting
data among practitioners and, yet, the practices are
delivered out there in diffuse groups, then there will be no
way of actually collecting this observational data.
DR. ROSNER:  Again, these are localized efforts,
but this is something that David Eisenberg, we basically
started Eisenberg with a grant from our own and other
sources before he went on to federal funding.  This is now
covering eastern Massachusetts, as you know, practitioners
in acupuncture, massage, chiropractic.


It is a database as far as methods used or
concerned outcomes within cost will follow.  So, these will
probably be models to what we will be proposing.
DR. GORDON:  Are there any other questions before
we go on to the final panel?
Yes, Tom and then Bill.
MR. CHAPPELL:  As I understand it, single herbs
are going to be researched, have been researched and the
cost is what it is.  Someone will have to pay that price and
right now, NCAM is farming that out to centers and we are
getting documentation on the mechanisms and the
effectiveness of single herbs.
Is that correct?
MR. McCALEB:  It is correct, but there is also
prior to the funding, where companies are taking their own
formulas and doing the research, yes.
MR. CHAPPELL:  We are doing that as well.  Are
formulas or single herbs --
MR. McCALEB:  Both.


MR. CHAPPELL:  I wanted to address just the
singles.  Single herbs, it seems to me, obviously, everyone
has an interest.  It should be public domain, public cost,
public domain.  The private protection I hear you asking
for, Dr. Leaders, is the blend, the proprietary, the
imagination, the unique perspective on a blend of certain
herbs that need to be protected is going to have its cost of
research.  Is that where you are looking for the
exclusivity?
MR. McCALEB:  Yes, that is one.  There was a
conference here in Washington last year on the use of
natural products in the treatment of cancer.
There was a conference here at NIH on the use of
natural products or botanicals in the treatment of cancer.
There were a couple of those that fascinated the heck out of
me.  Some of them were single chemical.  Some of them were
Chinese of the variety where you have more than one.  That
is the kind of a product, something that would be -- I will
give you an example that was at that conference, a product
that in theory lowered the viral titer in hepatitis B and C.
Also, after treatment or during treatment, the
fibrosis in the liver went away.  Those kind of things would
be extremely interesting for a very serious medical
practice.  That is the kind of thing I am talking about, to
give the incentive to really bring a tool like that.
DR. GORDON:  Bill.


DR. FAIR:  Just a quick question.
Are there any difficulties with going into a
foreign country and taking a plant and bringing it back to
the United States, legal difficulties?
DR. LEADERS:  Yes.
DR. FAIR:  Is that one of the factors also that
has stopped the development of this field?
DR. LEADERS:  Yes, it has.  My advice would be to
work with somebody in that country.  Don't necessarily bring
it back to the United States.  Why not work as a partnership
within that country?
DR. GORDON:  Thank you.  Thank you very much.
Thanks for your testimony and for being with us.
Again, we will stretch for about two minutes and
then we will sit for the final panel.
[Brief recess.]


DR. GORDON:  I want to thank the four of you very
much for your patience and your hanging in there with us and
also for traveling to be with us and to share your
experience.  This is a very important panel to us because we
have kind of indirectly been referring to you during a good
deal of the day in talking about some of the possibilities
and some of the challenges of doing research when you are in
private practice.
So, I am glad to welcome you and also glad to
welcome Dr. Jeffrey White from the National Cancer
Institute, who was here with us at the beginning of the
morning and who has been a major force in helping people to
do research in the field.
So, let's begin with Dr. Nicholas Gonzalez.
 Session VII:  Outcomes Research Part I
 Interface Between CAM
DR. GONZALEZ:  When I think about my work, I think
about it in terms of a good idea that we are trying to keep
alive.  It certainly isn't my idea.  So, I am not giving
myself credit.  At lunch I gave the five minute version.  I
will give you the 11 minute version now.  I promise I will
keep it short.


But without discussing some of the history in
terms of viewing the regulatory problems in the past, it is
not going to put it in a full context.  The roots of what I
do actually go back to the turn of last century 100 years
ago and the Scottish embryologist, John Beard, who was a
full professor at the University of Edinburgh.  He was a
Ph.D. who first suggested pancreatic proteolytic enzymes
represent the body's main defense against cancer.  He didn't
pull this out of the air.  He had spent 30 years studying
the embryological development of the pancreas.
He was well-versed in scientific method and
published a series of articles in 1902 to 1905 showing both
in animal models and some preliminary human evidence that
pancreatic enzymes not only might prevent cancer, but might
be useful as a cancer therapy.  He was universally derided
and ridiculed, I should say near universally, because there
were several physicians, eminent physicians at major
institutions that took Dr. Beard very seriously and working
with him, used injectable pancreatic enzymes, proteolytic
enzymes, to treat advanced cancer.


Their successes are documented carefully and
clearly in the orthodox medical literature in journals such
as JAMA, the Journal of the American Medical Association,
the Medical Record, the British Medical Journal.  I have
those articles.  They are very interesting.  In my
estimation, they represent the first cases of cancer
regression.  They use the word "cure" with nonsurgical
therapy.
However, at the same time, Madame Curie, very
well-known, very well-loved, an international celebrity,
announced to the world that radiation therapy was a simple,
easy, non-toxic way of curing all cancers.  Of course, she
would die from radiation-induced cancer damage.  A whole
generation of radio-oncologists were follow her to the
grave.
We learned subsequently during the 1920s and the
thirties after Beard was gone, that radiation wasn't simple,
wasn't non-toxic, didn't work for most cancers.
DR. GORDON:  Excuse me, Nick.  Could you slow down
a little in the interest of the efficiency of the
transcriber.
DR. GONZALEZ:  If I go too slow, you will fall
asleep.


Madame Curie announced to the world and
subsequently died from radiation damage, I said that, and a
whole generation of radiation oncologists would follow her
to the grave.  During the 1960s, the eccentric and
controversial dentist, William Kelly, resurrected Beard's
enzyme therapy and developed a very complex, nutritional and
enzyme therapy to treat cancer.  His attempts to revive
Beard's work were met with great hostility from regulatory
agencies.
He was repeatedly thrown in jail.  First he was a
dentist.  Dentists aren't supposed to treat cancer.
Secondly, this was the 1960s, where if you mentioned cancer
and nutrition in the same sentence, it virtually was a
federal offense.  This is one example, as I said earlier at
the press conference, where both local, state and federal
agencies worked together very well to harass Dr. Kelly.  It
was a miracle that he was able to survive.
I first heard of Dr. Kelly at the end of my second
year of medical school in 1981, when I was at Cornell.  I
had gone to Cornell because I was interested in cancer
research and Cornell was associated with Sloan Kettering.
The then president of Sloan Kettering, Robert Goode, had
sort of adopted me as kind of, as I said earlier, maybe he
thought I could be useful cleaning test tubes or something
in his lab.


After I met Kelly, I went to Dr. Goode and said I
have met this eccentric, controversial, crazy dentist, who
thinks he can cancer with pancreatic enzymes.  He has been
universally vilified in the press.  He has been arrested.
There is absolutely no reason why I should believe that what
he does works, except he does seem very sincere about
wanting to have his work tested.
This was before the Best Case Series concept.  Dr.
Goode was always willing to support controversial areas of
research and that eventually led to his demise at Sloan
Kettering and he suggested I begin this as a student
project.  What began as a simple summer's project eventually
developed into a five year research project, which I
completed while doing my immunology fellowship under Dr.
Goode, who by that time had already left Sloan Kettering.
This was a very exhaustive investigation.  It
wasn't done in a cursory fashion.  I think in many respects
represents the first academic, Best Case Series or best case
evaluation of an alternative therapist, who is doing things
outside the academic mainstream.


I went through 10,000 of Kelly's records,
evaluated over 500 of his cancer patients in detail, got
full medical records and put my findings together in a 500
page monograph.  One of those patients, whom I mentioned
earlier today, was a lady with biopsy-proven pancreatic
adenocarcinoma with metastases into the liver.  The liver
nets were biopsy-proven at the Mayo Clinic.
She was told she had six weeks to eight weeks to
live in 1982.  She is still alive.  Two weeks ago, as I said
earlier, referred a patient to me, 18 years later.  I know
of no such patient in the orthodox medical literature.  If
you can find some, please let me know because I have been
unable to do so.
I thought that having done this five year
expedition under Dr. Goode's direction, he was at the time
the most published author in the history of medicine, I
would have no trouble getting it published.  Boy, was I
foolish.  I spent two years trying to get this study
published.  I was universally attacked.  Robert Goode at the
time was up for the Nobel Prize.  He w as sent letters from
editors saying that his involvement with this kind of
garbage would jeopardize his chance of winning the Nobel
Prize, that he should dissociate himself completely.


When I finished my fellowship training, I left his
group because I could see the writing was on the wall.  I
came back to New York.  Dr. Kelly gave up, closed his
practice, figured his work would never see the light of day
and I very cautiously or perhaps insanely began to treat
patients with enzyme therapy myself in New York.
My 1993, the National Cancer Institute had begun
to investigate alternative therapies and I was one of the
first people invited down there to present a series of cases
as part of their initial attempts to evaluate non-
traditional therapies.  On July 7th, 1993, I came prepared
to present 25 cases, which I did.  It was a three to four
hour session.
Wayne Jonas was there.  It was kind of an
interesting panel.  There were at least 20 people there.
One of the cases I presented, and I can use his name because
he is going to be actually on the Discovery Channel, they
are doing a piece on him, Mort Schneider, who had metastatic
pancreatic cancer with four tumors in his liver, two tumors
in his adrenals, metastases into his lung, all biopsy-
proven, diagnosed in September 1991.


Now, at the time I presented at the NCI, his
tumors had not regressed.  They had stayed the same.  At
that time, the definition of a response was a 50 percent
reduction in tumor size that lasted four weeks.  I argued
that the NCI had to start considering quality of life as
well as survival, in addition to this arbitrary designation
of a 50 percent reduction that lasted four weeks.
Mort Schneider is still alive nine years later.
In 1997, we repeated his scans and all his tumors were gone.
 As a result of that presentation, the NCI suggested I do a
pilot study with pancreatic adenocarcinoma, the thinking
being pancreatic cancer is the worst cancer there is.  If I
could show any response at all, people would take it
seriously and the NCI would take it to another level.


Michael Freidman, who at the time was associate
director and suggested the pilot study, said if I could get
three patients out of ten to live one year, he would be
impressed.  We were fortunate at the time that the Nestle
Corporation became interested in funding some research of my
work.  Their medical appeared yesterday, the former director
of the Pasteur Institute, had done a case review in my
office.  He spent two days in my office and went through
hundreds of cases.
There is a reason I mention that specifically.  He
invited me to Switzerland.  I presented to his senior
scientific staff just about the same time the NCI suggested
I do a pilot study.  On the basis of that presentation,
Nestle agreed to come up with the money to fund the pilot
study, which we began in 1994.


Eventually we had 11 patients in the study.  Eight
out of 11 were biopsy-proven in Stage 4.  The other three
were biopsy-proven in Stage 2, but inoperable.  They were
all very sick patients.  Of the 11, 9 lived one year; 5
lived two years, 4 lived three years, 2 surpassed four
years.  One died at five years from a heart attack.  To put
this in perspective, in the clinical trial of Jim Seidebene
of 126 patients, not a single patient lived longer than 19
months and only 18 percent lived one year.   We published
that in Nutrition and Cancer in June of 1999.  As a result
of that publication and that study, the NCI suggested that
we do a large scale randomized trial.  Now, Wayne and I were
talking about randomized trials before.  I was against the
idea of a randomized trial for the simple reason I wasn't
sure it was going to work.  There was already so much
interest in my work, I figured patients who are interested
in my study would want to be in my arm.  That is exactly
what happened.
After trying to get the clinical trial to work for
years in randomized study, of course, for the non-scientists
in the audience, a randomized study simply means patients
who agree to go into the clinical trial, have no choice of
treatment.  In this case, it was a two-armed treatment.  It
was my therapy versus Jim Seidebene and the latest
chemotherapy approved for the treatment of adenocarcinoma of
the pancreas.
Since no one lived 19 years and my preliminary
pilot study had shown good results, out of 260 patients who
expressed in the study, only three agreed to be randomized,
two when they were assigned to chemotherapy dropped out of
the study and the other one who was assigned to me, decided
she didn't want to do anything and quit the study.  So, it
was really not working.


Eventually, working with the NCI and the NIH and
the National Center for Complementary and Alternative
Medicine, who actually put up the money, we agreed to make
it a case control study.  So, this is an example of some of
the difficulties you face when trying to do rigorous
scientific study.
The reason I mention the fact that I was flown to
Switzerland to present to Nestle, the very day I was in
Switzerland presenting to Pierre Gastri's [ph] group was the
very day the medical board served my office with a subpoena
announcing they were going to try and close my office down
because to sum it up in non-legalese terms, I basically
represented a subhuman pond scum that was, you know, taking
money from unsuspecting cancer patients.
All the time while I was trying to present my work
and getting funding and doing clinical trials, the medical
board relentlessly tried to basically close my office down.
 We eventually prevailed.  It is an interesting situation to
be an alternative practitioner, particularly since I come
out of an orthodox research group.


It is a very dangerous world out there.  In the
State of California, it is a felony to treat a cancer
patient with anything other than surgery, chemo and
radiation.  Interestingly enough, they left off
immunotherapy.  I have not heard of anyone getting arrested
for using Interleukin and Interferon.  Had I treated Mort
Schneider, that pancreatic cancer patients who was night
years out, in California, I would have been guilty of a
felony and we could be in jail right now.
The reason I bring all that up is Jim said what
can we do.  You have an extraordinary opportunity, an
extraordinary mandate, to help develop and protect new
ideas.
The essence of the democratic society, of course,
is the protection of new ideas.  One of the characteristics
that you commonly find in all tyrannies is they legislate
scientific truth.  The California law is an attempt to
legislate scientific truth.  I think it is extremely
dangerous.


What can you do practically?  I think you should
serve as an forum, that if an alternative practitioner or
any scientist thinks that he is being harassed unfairly
because he has a new idea, he should be able to come to you
as an independent group.  What power do you have?  There
isn't a state in this union that could survive if the
federal government shut down Medicare or Medicaid funding to
that state.  The economies of these states would collapse.
Yes, I understand the separate of state and
federal government, but you have enormous power in the
state.  Certainly you should use that power to help protect
new ideas.  I don't think there is a more noble effort than
that that any of you could do.
Thank you.
DR. GORDON:  Thank you very much.
Next will be Dr. Ann McCombs and Dr. Devi
Nambudripad.  They will share the time, as they share their
work.
DR. McCOMBS:  Thanks for staying so late to hear
what we have to say.  I know you are exhausted and we are
happy to be able to talk to you today.
You want to know some of the obstacles.  I think
Nick summarized them extraordinarily well.  The first time I
have actually gotten to meet him was in June of this year,
although we have talked on the phone several times when I
have consulted him about other patients over the years.


I was involved in the American Holistic Medical
Association meeting in Seattle in 1994 and putting that on
and he couldn't even come then because the medical board
said you either be here on this day or you won't have your
license.  So, we didn't get the benefit of hearing him at
our conference, right on the spur of the moment, two days
before, we were supposed to hear him.
That is a very real outcome of what we face as
practitioners in this day and age.  I mean, exactly what he
is talking about is the fear elements that all of us face.
Dr. Mildred Paz [ph] from California, she is exactly in the
milieu that he described in Washington.  I am not in much
better milieu myself there.


When I treat cancer patients or I use these kinds
of CAM therapies, I do them very quietly.  I do them behind
closed doors and I do them only with patients that I trust,
who, hopefully, it won't be a problem for.  I let them know
right up front there is no research information that I can
actually show them, but that I have had good clinical
outcomes and on the basis of my relationship with them as
their physician, they come.  They get treated and they get
well and I tell them to be very quiet about it and don't
tell anyone because I can't afford that.  I don't want to
lose my license.
At least in one case in our state, we were all
reminded that having a medical license was a privilege not a
right and that the medical board could take away our license
just because they want to because it is not our right just
because we have been through medical school.  It is only a
privilege.
So, money, time and fear.  Those are our obstacles
in a nutshell without going into a lot more data.  Insurance
reimbursement is a huge, huge factor right now.  It doesn't
matter what we do.  We can code using the CPT codes.  We can
do all the things that we have been trained to do.  It
doesn't  make one bit of difference.  If they want your
chart notes, they see what you are doing, they will cut the
reimbursement to the client off without anything else.  Your
name goes on a list.  My name is on a list certainly in my
state and all over the country because I treat patients all
over the country.  As soon as they see that my name is on
the list as the physician, my patients won't get
reimbursement.


So, that limits what I can do to the people who
can afford my care.  That is not why I went into medicine,
at all why I went into medicine.  You know, I didn't go to
Cornell.  I didn't do the research track that Nick did.  You
know, would have loved to.  Now I am interested in practice-
based research.  I know that we can do it.  I know that with
some help we can present a research paradigm that will work
and with Dr. Nambudripad, it is a very simple technique,
non-invasive and we have, you know, a practitioner network
of 4,000 practitioners and growing, but she trains
practitioners every other month to do this very, very simple
technique that works across many diseases, all the way from
any kind of allergy component, all the way to cancer.  I
will let her speak about that.


So, our needs really are for people to be open
minded about the approach that we use, to be able to think
outside the box and to really look at the methodology that
we have come to in a way that diagnoses and treats, that is
different from what we were all trained to in school.  I
have had to get a whole new practically degree in
complementary and alternative medicine since I got my degree
in 1988, but you know why?  Because for the 15 or 20 percent
who never get well, under the way I was trained.  I don't
want to practice medicine like that.
Medicine, I can't do it in seven minutes.  The
managed care issue is a very big real issue in practice-
based medicine and I am not interested.  I would rather not
be a doctor than to do managed care.  That is blatantly how
I feel about it.
I don't like the fact that I can't treat Medicare
patients because it doesn't come under Medicare guidelines.
 I don't like the fact that I can't work in the low cost
clinics in which I was trained, in which the medicine I did
with my hands as an osteopath and maybe that was all I could
do for them that really did help.  I a restrained in that
way and I feel constrained.
We need sort of that kind of open mindedness.  We
feel that we would be protected as practice-based physicians
if we had the blessing of the federal government, of the
state government.  I don't care where we get the blessing
from, as long as somebody comes out and says you can do
this.  It is okay.  Nobody can take your license away.  Now
have at it.


We would like to put it through our 4,000
practitioner network and we would like to ensure them that
if they participate with us and do this, that their licenses
won't be in jeopardy either.  I don't have time.  I am not
going to be able to mastermind this research, except between
2:00 and 4:00 a.m. in the morning.  I am too busy treating
patients, who fail therapies all over the country and who
come to me through my back door and that I have to treat
quietly and I would like to be more open about what we are
able to do.
So, that is what I have to say and I want to turn
the rest of the time over to Dr. Nambudripad.
DR. NAMBUDRIPAD:  Thank you for inviting me here.
 This is a surprise.  Life is full of surprises for me
lately.


For the past few years, 17 years, I have been
treating patients for allergies.  I am a chiropractor from
California and I am an acupuncturist.  My license is in
California.  I am not supposed to treat cancer and I don't
treat cancer.  Patients come to me with allergies and I
happen to treat them and this is a technique I learned 17
years ago and you can eliminate the allergies and they don't
come back.  They don't cause anymore problems.  I look at
everything with my eyes, with a narrow tunnel vision for
allergies.
So, when I treated these patients with a cancer
with allergies, their cancer went into remission and they
started getting better and then the word started spreading
and I do train a lot of doctors.  It is not only me.
Everybody else can reproduce the same kind of results.  So,
that is where the word got into.  They asked me to come and
present Best Case Series in last June.
Since I don't treat cancer, I cannot have a Best
Case Series.  If I treat cancer as everybody else mentioned,
I will get into trouble.  I don't want to step beyond my
scope of practice in California.  So, that is one of the
biggest obstacles I have there because I cannot treat anyone
for cancer.


If the side effects of allergy treatment will be
getting better on the cancer, that is the only way I can
present a case here.  So, that is one of the problems I am
having about treating cancer.  There are so many patients
who would like to come and get treated if I had a chance, if
I had another station to do that.
We work very hard, of course, and you have to come
up with a lot of money to hire someone to do all this work
for us, the writing up and publishing and et cetera.  I did
do some studies on my own, just to prove it to myself how
this will -- am I imagining this or is it really working.
So, I did a study, a milk study and an egg study and a
cholesterol study and a few other studies.  I know that they
work.  I haven't published.  So, I don't have any published
to present.
Anything else Ann wants to add, she can add.
DR. McCOMBS:  We have provided you with some
information that is very similar to exactly the kind of
information that Dr. Beard, you know, was suppressed after
1923.  I just happen to have had a mentor from Germany.  So,
the information I gave you was from Reckeweg, from Germany.
 Reckeweg's research was known there.  It wasn't known here
very much.  This book just got translated from German into
English.  So, you wouldn't have even had a opportunity to
learn about that.


I happen to have a German mentor and I took German
in college.  So, I learned a little bit about it myself.
But this kind of thing is just not readily available to
practice-based people until, you know, the Internet, for
example, the advent of the Internet.  You have patients come
in and they say, you know, Dr. McCombs, what do you know
about this?  For the most part I don't know.
You know, if I happen to have time to be on the
Internet, I might know and I certainly try to take the time
I can, but then it stimulates me to find out more.  As I
said, the people that lead you by the nose are the ones that
don't get well.  That is that 15 to 20 percent that you
always want to help because they are outside of that bell
curve.  It is the people that we are treating, you know, we
can certainly treat within the bell curve, but it is those
people on the fringes, you know, who are on either side of
the bell curve that we end up seeing day in and day out in
chronic pain and chronic illness.
DR. GORDON:  Thank you.
Dr. White, would you like to say a few words?
DR. WHITE:  Well, thank you.  I actually didn't
prepare any specific comments, but I could react to some of
the things that I have heard.


I actually did wonder why I was asked to speak in
this session about the interface between CAM research and
regulatory agencies.  I thought, well, it sounds like an FDA
type issue.  I think it is becoming much more clear to me
why you asked me to come to this panel.  It perhaps may not
be of as much value for you as it perhaps is for me to hear
some of these issues.
But I would still like to offer some ideas about
things.  I am certainly more aware of Nick's situation since
we are directly involved in research together.  But the
other issues that are raised, it is important for me to
become more aware of them.  The Best Case Series program is
what we have been partly talking about and what Nick did
allude to, one of the programs that he did get involved in.
 The program is very dependent upon practitioners feeling
comfortable presenting documentation of their practices to
us, to the federal government.


We do go through great efforts to try to keep this
information confidential.  When it is reviewed, it is
reviewed in closed forum so that we can talk about patient
identifiers and not have all that information aired to the
general public.  But many elements of the Best Case Series
are open to the public.
I have been somewhat unclear about the degree to
which these kinds of concerns that Dr. Nambudripad is
raising and other issues that Nick has expressed, the degree
to which these have affected the flow of submissions to the
Best Case Series program.
Basically, our approach has been to try to have it
become better known among CAM practitioners.  It has really
been an unadvertised program until about the past year.  So,
we are trying to get it better known.  But I think that will
certainly not affect these other issues that were discussed.
 So, I would be happy to explore with you ideas about how
issues about regulation could help the Best Case Series
program become more productive.
The second thing we didn't quite mention it here,
but it is about INDs, I wanted to at least mention that.  I
have recently become more aware of the problems with getting
INDs for certain herbal products and the degree to which
that has inhibited some cancer research.


Well, it is an issue that we are planning to have
a meeting with the FDA to explore more fully and with the
guidelines I think it is certainly the right time to be
discussing this.  But I do have concerns that I would like
to learn more about what these problems are.
Some very high quality cancer researchers have had
some difficulties getting INDs for products and I think it
is just an issue that we need to explore more.  The third
thing was about expanding safety and efficacy of CAM
products, one of the issues that you asked us to address.  I
think basically we are providing funding through certain
mechanisms to try to improve at least that side of the
equation.  We have an RFA, request for applications, out to
the comprehensive cancer centers to support developmental
research.  So, this is research that doesn't really require
a lot of previous data.
So, it would be amenable to bring along projects
that deal with products with very little in vitro or
previous human data.  These are just some general ideas.  I
will leave the rest of the time to respond to questions.
DR. GORDON:  Great.  Thank you very much for
coming.  We appreciate it.


So, questions that anyone would like to raise?
Yes, Joe.
DR. FINS:  Dr. Gonzalez, I just want to ask you
one question.  These are enzymes that are taken orally?
Yes.
DR. FINS:  As proteins, why aren't they --
DR. GONZALEZ:  Why aren't they destroyed in the
gut?
DR. FINS:  Right.
DR. GONZALEZ:  The first paper proving that orally
ingested pancreatic enzymes are not destroyed in the gut but
are absorbed intact goes back to 1976 in a Science article.
 We have a whole pile of papers.  In fact, there was a
conference in 1994 in Germany on the oral absorption of
pancreatic enzymes, an entire conference devoted to that.


There was a very basic study done in Leningrad in
1980, where they took trypsin and put it hydrochloric acid
and boiled it for an hour and there was no loss of activity
whatsoever.  It isn't destroyed by acid.  It is absorbed --
they are both active transport mechanisms and passive
diffusion mechanisms for the absorption of proteolytic
enzymes, even though they are big molecules.  That has been
documented carefully.
DR. FINS:  Okay.  The second question is your
story here is really as a personal narrative very compelling
and am just wondering if you had to do it all over again,
looking forward to, you know, future Dr. Gonzalez's, who are
going to have similar kinds of problems and are looking for
the kind of confirmation that you are hopefully going to
achieve with this collaborative effort, what would be the
role of a basic science model, animal models, more
preliminary studies?  Would you have done it differently and
not done it in a clinical trial mechanism but more to try to
prove it in a different, less threatening way, in a more
incremental way?


DR. GONZALEZ:  Oh, I would have voted 100 percent
to do it in a nicer, simpler, easy, less threatening way.
Unfortunately, as Dr. Straus said quite eloquently, a lot of
these developed out there in the fringe, away from the
academic centers on patients without any documentation of
animal studies, but in terms of pancreatic enzymes
specifically, there are animal studies that go back 100
years.  There was an animal model for cancer, the Jansen
sarcoma model, at the turn of the last century, that Dr.
Beard used very effectively and published his results.
There are studies from 1965 showing that orally
ingested pancreatic enzymes in the CH-3 mouse model do
protect against carcinogens.  There is a lot of animal
research.  It has just been ignored.  One of the reasons it
has been ignored is pancreatic enzymes cannot be patented.
No drug company ever took up the cause.  I think if it had
been a patentable substance, pancreatic enzymes would be
used in every major cancer center in the world today.
DR. FINS:  So, you are saying its market forces
not solely disbelief of the science?
DR. GONZALEZ:  Animal studies have been done.


Oh, I think along with the market force goes a
disbelief in the science.  Because it has been marginalized,
along with that goes, well, it can't be true.  If it were
any good it would be used.  The fact of the matter is when I
got interested in this and started looking through the
medical literature, I found animal studies eloquently done,
properly done studies in the major literature confirming
that pancreatic enzymes have an anti-cancer effect, proving
that they are absorbed, all of these issues that you have
raised, completely ignored.
That is why you folks have such an extraordinary
opportunity to help nurture new -- forget my idea, but there
are other new ideas out there that need nurturing that
didn't exist when I started doing this.  I worked under the
former head of Sloan Kettering.  It didn't make a darn bit
of difference.  In fact, it was even used against him.  It
was going to jeopardize his chance for getting the Nobel
Prize.
DR. McCOMBS:  I would like to add to that.  The
first time I heard about pancreatic enzymes was in 1994.  I
was at a conference in Mexico.  I spoke to the researcher,
who was from Germany, who was at that conference as well.
The conference was held outside of the United States so that
we could talk, so that we could actually talk freely.


The woman from Sweden, who had done the original
research at Karolinska Institute was there, people from NIH
were there.  There were people from all over the world who
were there.  We could not hold this conference in the United
States because of the fear of what would happen.  Pancreatic
enzymes at that time from Germany, which were the only ones
we could get a hold of then were being sold on the black
market for an exorbitant price.
I had a pancreatic cancer patient, who could not
afford that.  There wasn't anything I could do.  I knew
about the research.  Nothing I could do about it because we
couldn't get it in through the FDA.
DR. BERNIER:  I would be very curious, what other
kinds of tumors has it had activity against, other than
pancreatic?
DR. GONZALEZ:  In the Best Case Series we did of
Dr. Taylor, we looked at 26 different types of cancer.  That
includes some subdivisions of the various lymphomas, but we
looked at both epithelial and bone marrow tumors, such as
myeloma and leukemias.  It seemed to work across the board.
 In my own practice, I have treated everything from
glioblastoma to acute leukemias with effect.


We are using it in pancreatic cancer for the
clinical trials, only because pancreatic cancer is
considered to be the worst cancer; maybe acute myelocytic
leukemia is a little bit more aggressive.  But that is why
we are using pancreatic cancer, but they seem to work for
just about any cancer.
DR. BERNIER:  It has been as efficacious?
DR. GONZALEZ:  Yes.  Admittedly, with something
with like acute myelocytic leukemia, there is such a narrow
window of opportunity to get them started on the program.
You have to move real fast.  I probably have 250 patients
with breast cancer in my practice, ovarian cancer, colon
cancer, metastatic colon cancer, lung cancer.
DR. BERNIER:  Myeloma?
DR. GONZALEZ:  Myeloma, yes.  In fact, I presented
a myeloma case to Jeff just last week in my office.  He was
in New York and I presented a six year survivor of myeloma.
 They want to do a bone marrow transplant.  Never had any
chemo or radiation or anything like that.
DR. BERNIER:  That is great.
DR. GONZALEZ:  Thank you.


DR. GORDON:  Effie and then Bill and then Wayne.
DR. CHOW:  I am also touched by what you have
reported.
One simple question, is Dr. Kelly alive?
DR. GONZALEZ:  He is alive and he is on the
Internet ranting and raving that I am part of an
international scheme for the CIA to steal his work.  In
1987, after all the stresses, he really went off the deep
end.  He is clinically paranoid.  I mean, he was arrested at
gun point in front of his four adopted kids at midnight.  I
mean, the authorities when they want to harass you, they
know how to do it really well.  They would do everything
they could to humiliate him.  They would drag him in
handcuffs in front of his neighbors.
Thirty years of that finally got to him.  Those
were the days, again, where if you mentioned nutrition and
cancer in the same sentence, you were in serious trouble.
It just got to him.  I have nothing but -- it is a very sad
story.
DR. CHOW:  It is a sad story.  Is he pleased now?


DR. GONZALEZ:  Oh, no.  He is beyond being able to
be pleased or to be happy.  He is beyond that.  That is why
I said when I began this talk, this is a story of trying to
keep a good idea alive without giving myself credit because
I didn't invent the idea.  I am just trying to keep it
alive.
DR. CHOW:  I have just one more question.
I don't recall you saying whether this is being
used now, I mean, still being researched, but it seems a
shame that so many people are dying of pancreatic cancer.
Is it available to be utilized?
DR. GONZALEZ:  This is not a gratuitous offer.
You are all serious invited to come to my office and spend a
day and watch my staff deal with the hundred calls we get
sometimes a day from desperately ill cancer patients all
over the world that I could not possibly see because there
is only me and my colleague, Dr. Linda Isaacs and we don't
run an assembly line.  We will spend four hours with a new
patient.  We can see maybe two or three new patients a day.


We will get 50 calls a day.  Just this week we
turned down a 32 year old woman with three kids, who had a
bone marrow transplant for breast cancer and ended up with
cancer everywhere.  We just can't see her because we are
booked and I have to come to a conference like this.  So, we
are turning her down.  She is hysterical because it is like
her last chance.
So what we need out there, Jim, and all of you is
we need help.  There are people like myself and Ann, who are
trying to do really serious work and we need help.  It is a
tragedy.
DR. CHOW:  You need to develop a training program.
DR. GONZALEZ:  That is right.
To answer the second part of your question, it is
only available in our office and the reason we are doing it
is because I was trained in research.  I believe in
research.  I don't want this to be out there until we prove
it works by the strictest standards of orthodox medicine.
What I have wanted from the day I began researching this
under Dr. Goode at Cornell in 1981, was to do appropriate
clinical trials.  That is the way I was trained.  I expected
to spend my entire life in basic sciences.


I believe in the scientific method.  It has taken
19 years.  That is okay.  But the tragedy is when you sit in
my office and sometimes I can't sleep with the patients
calling, begging for this therapy.  The enzymes we use are
not commercially available.  If we did that, you know, you
are inviting trouble, but I also believe we have to prove it
works first, but it is a terrible dilemma.
DR. CHOW:  But there must be a balance, though,
you know, because the traditional method is accepted, but
they are having side effects and everything.  With things
like this working, there must be a balance where you can
continue research and then be able to utilize it.
DR. GONZALEZ:  Well, we are treating patients in a
private practice situation.  It is just we are just limited
by how many patients we can see.  Yet, we don't want to
start training doctors because it is like putting the cart
before the horse.  First, you want to prove a therapy works
before you start training doctors.


You know, I think that is appropriate.  We could
have training seminars.  I am not criticizing my colleagues
for doing that.  We have decided not to do that.  We want to
prove it works.  When we prove it works, we are begging for
the NCI and the NIH to help us to get it out there.  I mean,
if it works, it should be and we will need help because, you
know, we are just two doctors in my office.  We don't have
the capabilities or the resources to do that.
DR. FAIR:  Nick, I am sort of curious as to why
this was not picked up, say, in Germany or some other
countries.  We heard about all the herbal research being
done in other parts of the world.  I know pharmaceutical
firms are often farming out their clinical trials to other
countries, where it may be easier to get it done.
Why hasn't this been picked up in some of the
German clinics using chelation and --
DR. GONZALEZ:  They do use pancreatic enzymes in
German clinics.  There is a German formulation called
wobenzime [ph], which you might have heard of.  Without
getting into the criticism of their enzyme preparations,
what I think is Kelly really perfected the therapy and he
really perfected it as an oral therapy.  Beard only used
injectable enzymes, believing that they would be destroyed
in the gut.  One-hundred years ago, that is what they
believed.


Kelly perfected it as an oral therapy and really
helped develop an oral preparation of enzymes that just
isn't available anywhere else and he became an expert in
enzymes.  I have had to become an expert in the
manufacturing of enzymes.  We have actually spent the last
ten years perfecting the way to manufacture enzymes to
protect their anti-cancer effect.  Most pancreatic enzymes
available in health food stores or drug stores are there to
help digestion.
No one even things of them as an anti-cancer
element and the way they are made, the processing technique
that is used destroys a lot of the co-factors necessary for
a major anti-cancer effect.  We have had to figure that out
without any resources.
So, there are enzyme preparations available in
Germany.  They don't know how to use them right.  It is not
as sophisticated a therapy as Kelly's.  It is a very
complicated issue.  Like any good therapy, it is a
complicated issue.
DR. LOW DOG:  [Comment off microphone.]


DR. GONZALEZ:  Oh, was that the question?  I am
sorry.  I answered the wrong question.  That is okay.  Maybe
you learned something from the wrong question.
DR. FAIR:  That was my question.  Why not use your
enzymes in Germany?
DR. GONZALEZ:  Oh, I see.  No one has asked me.
DR. GORDON:  I think the other thing that is
important to point out is that yours is a comprehensive
therapy.  It is not just the enzymes.  It is individualized
diets.  It is detoxification.
DR. GONZALEZ:  Oh, yes, it is a complicated
therapy.  It is not just using enzymes.  Yes, the enzymes
have an anti-cancer effect.  The animal studies deal only
with enzymes.  Beard used only pancreatic enzymes.  Kelly
enlarged it to diet, accessory nutrients, specific diets for
each patient.  It is a very complicated therapy.  I think
that only increased its efficacy.  I don't think they are
just window dressing it.  I think it really makes a
difference in using pure enzymes.
But the simple answer is no one from Germany has
approached me to do that.
DR. GORDON:  Wayne and then Charlotte.


DR. JONAS:  We started with a book on scientific
opportunities and public need and talked about setting
research priorities and how do we do that.  We talked a lot
about the public and praised the importance of making sure
NIH is involved in the process.  What I hear, and I am very
saddened actually by the diminishing energy at the end of
the day, when we hear this in retrospect and everything is
better in retrospect.  Perhaps this should have been first
and I think we even had discussed that, because the
individuals who are setting the priorities in these areas
are not sitting here to hear this.
DR. GORDON:  That is right.
DR. JONAS:  I would suggest that one of the things
that we might, except for one individual -- I think it would
be very useful for us to hear not only the importance of
public input into the prioritization process, but
practitioner input into the prioritization process.  How can
we do that?


In an ironic twist, this is also the suggestion
that I made to Dr. Winn, who doesn't feel like they have had
much input into getting chelation tested, for example.  So,
if there were some suggestions that we could have, again, it
is going to have to come from multiple, but at least from
you all and also from others that we talk to about how to do
that and about the type of research that would be important
and the issues that go into setting priorities.
I think this would be key.  Related to this -- you
want to respond to that and then --
DR. McCOMBS:  I do want to respond to that.  I
think that is an excellent point that you are making and one
of the things, for example, that we are looking at is
looking at the United States public health departments list
of the top 35 public health problems and addressing those
particular issues and, you know, aiming our therapies to
that, you know, that group of top 35 ailments, shall we say,
that are problematic for every United States citizen, much
less any person in the world, but in our country in
particular.


That is one way that I think that we as
practitioners can look at that.  A second way, I believe, is
that we have to be able to, as I said earlier, think outside
the box.  When I couldn't get these enzymes in 1994, I just
started thinking of other possibilities.  When I can take an
ovarian cancer patient and see her one time, treat her using
the therapy that I learned from Dr. Nambudripad in 1994 and
on Monday she goes to surgery and they don't find the
cancer, it gets my attention.
I have to say what happened and why.  These are
the kind of things we need to be researching because if it
is working, we need to be doing more of it.
DR. JONAS:  Thank you very much for that.  I think
we are going to hear probably tomorrow a bit about attempts
to do this, attempts to actually bring these things
together.  But my suggestion would be that if the
practitioners can help us in terms of saying what types of
methodologies provide the information they think is
important, again, since we are focused on research
methodology.
Nick, I don't know if you talked about the fact
that NCI attempted to do this as a randomized controlled
trial.
DR. GONZALEZ:  I did, yes.  You were out when I
discussed that.


DR. JONAS:  And why they did that when that is --
it is kind of one of the premiere examples as to a situation
in which you don't do a randomized controlled trial.
Therefore, what has evolved in that and what has facilitated
the ability of you to move to a radically different research
design, hopefully in a way that will be acceptable and will
move these areas forward.
Do we need gold standards or what we mean by gold
standards?  Do we need gold standards in the sense that
there is a methodology to which everything is held up to.
Or are there appropriate methodologies that then become the
gold standards for the information they are going to provide
for the audiences who are going to be using them?  I think
these are issues that we need to hear from practitioners, as
well as the public.


DR. GONZALEZ:  Well, as you know, coming out of
the government, that gold standards can be waived whenever
we want them to be waived.  For example, Interleukin-2 got
approved by the FDA in 1990 as a treatment for metastatic
renal cell carcinoma, based on a pilot study.  When the
randomized trial was finally done and published in 1998, lo
and behold, Interleukin-2 for renal cell carcinoma worked as
well as placebo.  Six percent of patients on Interleukin
responded, 6 percent of patients with placebo responded.
Interesting study, that even with nothing, 6 percent of
patients will respond.
I think it is an interesting finding, but
certainly Interleukin-2 proved to be less than what we had
hoped initially, but there is a case where there was so much
enthusiasm about it, in fact, Dr. Rosenberg, who developed
the original trials, ended up on the cover of Time magazine
in 1986 over Interleukin-2.  Based on the enthusiasm,  it
got approved.  Based on simply a pilot study.  So, even
within the orthodox medical world, as you know,
,methodologies can often be waived.
DR. JONAS:  Oh, they are.  We have the
methodologies actually.  As Bill mentioned, surgery really
is an example of an entire field that has been developed
based on observational research, where there is a will to do
it, where there is a rational to do it.
So, the question is how can that be developed in
these areas, how can that also be -- and we will hear from
them, I am sure.  So, that would be useful for us.
DR. GORDON:  Charlotte.


MS. KERR:  I have sort of a comment and a request
for feedback now or later and maybe something for us as a
panel to think about.  It has to do with the area of ethics.
 What really prompted me to think about it -- I mean, there
are so many things that have been said that have prompted
the thought of ethics, but one certainly is the actual issue
of the lady with the three children who wants treatment and
how long -- and I know there are protocols and this and that
for ethics for how long something has to be examined before
it can then become practice.
I think we may need to look at that in another way
or a new way, but there may be a new ethics.  We have new
committees now in hospitals for people dying and all this,
but, you know, it seems to me there needs to be some kind of
new ethics in the complementary and alternative medicine.  I
only put it as a seed because I don't know quite what all I
mean by it yet.  But there is something about even the
medical doctor, who said if we are continuing -- I thought
it was incredibly wonderful what he said about if we know --
if chelation could be helping these people and we are
insisting on whatever we are insisting on, angioplasty,
bypass, then this is wrong.


It is the same here, applied to this.  So, how
responsible are we to address the 25 list of public health
problems and not look at these new therapies.  I would like
to have the brains and ethics, which we have here -- Joe, of
course, is a major brain -- but this is exciting to me.  You
know, how is this to be applied and be thought through in a
new way in this field and just future for healing.
Thank you.  I won't comment, but --
DR. GONZALEZ:  One comment to your comment.  I
think the history of science when you look at it is
basically orthodoxy is right even when it is wrong and
unorthodoxy is wrong even when it is right.  I think it
would be nice the first time in the history of Western
civilization to change that model, that something may be
write even if it is not orthodox.


DR. McCOMBS:  It is not only in cancer.  I mean,
we get these same kind of phone calls everyday.  She just
fielded them yesterday.  I field them everyday.  I have a
staff who fields them, you know, and it is ALS, it is heart
disease, it is every malady that you can think of or, you
know, mothers who can't afford the treatment but who have,
you know, asthmatic children, who can't afford to keep going
to the emergency room, for example, just for example.
To turn these patients down, I can't tell you what
this is like,, those of you who are practice-based
physicians will know what I am talking about.  This is heart
rending.  This is the stuff that keeps me up at night and I
worry.  I worry.  You know, you talk about ethics.  I think
it is a perfect example and I know what you mean about
getting phone calls in the middle of the night.
Those of us who are out there doing it want to
keep doing it, but we need help.  We need tremendous help
and we need help in a way that our licenses aren't
jeopardized.  We can get you the proof that you need and
want and that we need and want.  I think sometimes people
think practice-based physicians don't want this because we
are not academicians and we didn't decide on research as our
career.  That is not true.


We want efficacy.  We want safety just as much as
you do and when we find therapies that do work and drive us
to those places because our patients, 51 percent of the
population is paying out of pocket for these kind of
therapies and they come to you and they say help me.  You
know, as physicians, I think -- as practitioners, let's just
take it out of the physician realm here, we all have an
obligation to do something about that.
We have a 4,000-practitioner network that we can
plug this kind of stuff into, but we need help.  We can get
you the data, but we need help and we can't do it alone.
DR. GORDON:  I want to come back to that, but
first, Effie, and Joe, and Bill.
DR. CHOW:  Sorry.  This is late in the day, but
this panel, the discussion has brought up, I think, an
extremely important area that we need to deal with as part
of the Commission, as part of the practitioners, and I am a
practitioner myself, that -- and also former Congressman
Berkely Battle [ph], who was very instrumental in this whole
movement, he was also distressed.


Maybe we can explore it and you folks may be a
good input in this is that how can we continue to research?
 I want to really pose this as a question.  How can we carry
on research and where there is some indication that it is
valid, but the validity was before the research was carried
out in that there were some evidence-base, I mean,  evidence
in clinical work that it is successful.
So, if there is a research that is done and maybe
not accepted totally yet, the people are dying.  So, how can
we balance the two, continue research, good research, but
perhaps we need to recommend as part of our duty is to can
we use that for the people because they are dying.  They are
dying the next week.  They are dying the next day.  Hundreds
of people are dying.  So, can we balance that?  I just want
to throw that out as a very important issue.
I think that faces a lot of practitioners out in
the field.
DR. GORDON:  Joe.


DR. FINS:  I think this is perhaps the most
fascinating part of the day and it is compelling again to
hear this.  Charlotte's question about the new ethic -- I
just want to observe a paradox and if you don't mind, Dr.
Gonzalez, I just want to use you as sort of the poster child
for this issue, because I think it is really so compelling.
You know, you were sort of a victim, as it were,
of the pathology of science, but you stayed true to the
science and that is really a mark of professionalism.  I
think it is really is what is the professional ethic of all
practitioners?  It should be efficacy, sort of the  next --
that has been a big part of your career, but still not
deviating from the scientific norms that you have maintained
and embraced even when it didn't embrace you.
So, I think that is the paradox and I think that
the things we heard about this morning, that tried to bring
people who have novel ideas back into a mechanism where they
can access the science, which ultimately is going to
validate this is really, I think, tremendous progress and I
think we can learn from your own narrative about, you know,
what kind of ethic and methods and procedures we should try
to recommend that promote and not inhibit.


I want to just ask one quick question for Dr.
McCombs because if we are going to bring people who are
complementary practitioners in and ask them to share their
insights and their innovations and their practices, some of
which might be sanctionable in certain state situations, do
you think that there should be a safe haven or immunity
legislation for these practitioners so they can share their
best practices without fear of sanction and that should be,
you know, kind of a special relationship?  I don't know who
we would do that.  We would need a lawyer to help us with
that, but is that something that you think is necessary to
engender trust?
DR. McCOMBS:  I think it is mandatory.  I think
you won't get what you are after -- this commission will not
get what it is after from practice-based clinicians if you
don't guarantee them some kind of protection.  We will do
the research for you if we can just get -- we can't be
clinicians and researchers, but if we can get grants to do
it, help to do it, help to collect it, help to write it up,
we will do -- we have got the data.  It is not like we are
not sitting out there with the data.  We have got it.


But we don't want to come out of our closets, if
you will, and give it to you for fear of what is going to
happen to us.  This is a prime example.  I feel like Aaron
with Moses here.  I mean, I truly do.
It was truly out of -- having no access to the
kinds of things that Dr. Gonzalez was talking about, and I
just think it is funny that we are finally sitting here, six
years later, on a panel together.  You know, I couldn't get
those enzymes that he was researching.  I didn't know he was
sitting over there researching them.  I live in William
Kelly's state.  I only know about Kelly's view of things
over here.  I know what problems he had.  So, I go to an
alternative, you know, way of doing it, discover this woman,
who is a true pioneer, just like Beard was in his day, just
like Kelly was in his day.  Find something that works, but I
have to be so quiet about it.  I can't tell anybody because
I am afraid I will lose my license.
Now, I have got full practice rights in this
country.  Nobody can fault my degree.  Okay?  She doesn't.
Okay?  But she is over here writing books like this.  God
knows when she has time to do it.  She writes more books and
has more cases, 4,000 plus cases, 4,000 practitioners she
has trained.


You know, I want to help her.  I want to help her
because when I can do this kind of work with an -- it moved
me beyond tears.  I am telling you, to treat this woman on a
Friday night, have her got to surgery on a Monday and that
cancer was gone.  I can't tell anybody about it for fear of
what might happen to me, to her, to anyone else and then
tell the patient don't tell anybody.  Don't tell anybody.
DR. FINS:  Your analogy to Moses might be apt
because Moses did not make it to the Promised Land.
DR. McCOMBS:  That is right.  Moses did not make
it to the Promised Land, but we can.
DR. GORDON:  We are getting late.
Bill and then Tom.
DR. FAIR:  I would just like to revisit the issue
of the ethics and how heart rendering the stories you tell
are.  Of course, every practitioner has -- I used to hear
that when I was an active surgeon.  Why can't you operate on
me instead of going to somebody else.


But, you know, I have heard Steve Rosenberg and
Marsha Lenihan say that at the time when IL-2 looked like it
would work.  We are all familiar with suits brought against
HMOs and insurance companies for not authorizing autologous
bone marrow transplant, when we thought that worked.  So, I
don't think we can excuse or bring things into practice just
on the basis of the fact that some people feel that if they
have access to them, that they will be cured.  In other
words, nothing is 100 percent.
But I am curious, Dr. McCombs, why can't you do a
Best Case Series, and show Jeff White what you are dealing
with there?  In one of his meetings, he had a couple
homeopaths from Calcutta and I think the NIH is now helping
them to collect data.  Is that right?
DR. McCOMBS:  We will do it.  You know what?  Some
of us have to stand up and we will do it.  That isn't the
issue.  We will do it.  You know, if my license goes on the
line, I am going to writing you, calling you, saying "help."
 Okay?  But I am going to do it.  In my lifetime this will
happen because I am just tired of fielding these kind of
phone calls and dealing with these heart rending kinds of
situations.


I now use a paradigm, for example, that will
require you, for me to explain it to you, for you to think
outside the box, but I can individualize it now, treat
people.  It won't matter where they go but if you stand ten
people up against that wall with the exact same diagnosis,
their treatment course will not be the same.  It is the same
thing that was talked about earlier.  Yes, we have got a
protocol, but as a practitioner you have got to say I have
got to up those level of enzymes or I have got to take those
down or take those out of the treatment protocol because it
is not working for this patient.
So, it is a way to individualize that kind of care
and have that kind of a paradigm for both diagnosis and
treatment acceptable.  The research on that, on the paradigm
itself, has been done.  It is being ignored.  It was done in
Israel.  I have sat here and listened to other people talk
about it, but, you know, Valerie Hunt did at UCLA in unified
field theory.  Nobody is listening to her either.


I am just saying the research that you are talking
about is out there.  You have just got to allow us to use it
and build on the research that has already been done.  So,
we don't have to reinvent the wheel again.  Nick over here
had to reinvent the wheel because nobody would listen.
We don't have interest in reinventing the wheel
and I don't think you are interested in having us reinvent
the wheel.  We would like to build on what others have done
and then be able to easily stand up and say we are going
forward.
DR. FAIR:  But, again, an individual, a
standardized therapy is not -- that is not a sine quo non of
good science.  You can evaluate traditional Chinese
medicine, the little bit I know about Effie, and there is no
cookbook approach to traditional Chinese medicine.  You may
get ten patients with the same symptoms and be treated
differently.
Is that correct?  So, you evaluate the system not
the approach.  So, I am still --
DR. McCOMBS:  The approach has been criticized
significantly.  I won't go into this --


DR. GONZALEZ:  I agree with you, Bill.  I think
you have to do research.  That is why we haven't
commercialized what we are doing.  I absolutely believe in
the scientific method.  If it takes 100 years, if it takes
my grandkid -- if it takes them to finish doing it, tough on
me, but that is the way it has to be done.
Jeff is sitting here very quietly.  I really want
to say the NCI has been wonderful through all this.  I mean,
they are really helping us to do good science and that
hasn't been said yet.  He is remarkable and he has taken a
lot of gaff for what he is doing, too, as you can imagine.
But the NCI is determined in the most objective proper
scientific way to test any therapy, be it, you know, moon
dust from Pluto, pancreatic enzymes or chemotherapy and I
think they really mean that and they are helping.
So I think Bill is right.  You should be able to
do a Best Case Series.
DR. GORDON:  We are going to be informally having
dinner.  If there is something you want on the record, Tom,
that is fine.  Otherwise, there will be plenty of time to
talk with them.
MR. CHAPPELL:  I would like it on the record.
DR. GORDON:  Sure.  Then go ahead.


MR. CHAPPELL:  I think for me the understanding
the discovery process is as important an issue as the one we
identify three months ago and that was the need to talk
about a world view.  Discovery process is a very unique
beast.  As I said earlier today for the other people, it is
sponsored by the highest authority that gives that process
extraordinary permission to occur.
It is championed by belief and passion and
intimacy, the intimacy of the subject, the trust of those
very close to that understanding and the passion.  They are
the ones that create the model and the prototype.
Third and only then do you expand it into
collaborative integration with the rest of the system.  It
is kept out of the system until it is ready to be believed
and I really think we have to lift this out as
-- it is bigger than how it works at Harvard or how it works
at the University of Pennsylvania.  It is as big as this
whole question.  So, I would like to recommend that we have
evidence again that we need to raise up the fact that
discovery has to be given permission, nurtured in a close
intimacy of small working groups, not large, that come to
the larger only when they need to be refined, understood
better and institutionalized.
I just think that is important.


DR. GORDON:  I just want to conclude with one
comment.  The reason that we asked this particular group to
come is precisely because of the issue of how we can help to
midwife this kind of discovery.  I think that Ann may have
said it and one of the things that we saw at our conference
in June so clearly is that Dr. Nambudripad was forced to
talk in a way that was at best paradoxical if not
incomprehensible at times because of the difficulty that she
is being put through by the fear of retaliation.
So, I know this panel comes late in the day, but
it is really meant to set a new path for us and help us to
understand this issue among the many other issues, which is
precisely how we provide some kind of protection for people
who are sincerely committed to doing research on their work,
which at present lies outside the box.


The issue here is, what I am hearing is an energy
of people's responses, is that we need to come back both
with some of the suggestions that you made and if you have a
couple of suggestions, more suggestions for ways that would
be helpful, and then perhaps we need to proceed and we have
talked about, Jeff White and I have talked about this at NCI
as well, what can we do as a commission, what kind of
recommendations can we make to foster and nourish this kind
of research and how can we reach out to the medical boards
and provide some kind of protection so that people can move
ahead and what are the criteria and what are the conditions
and what are the needs to take that next step.
So if you have any final words, great.  If not,
please, we are going to continue the dialogue and we
understand that this is an issue we need to deal with.
Thank you very much.
[The meeting was recessed at 7:22 p.m. to
reconvene the following day, Friday, October 6, 2000, at
8:30 a.m.]
 + + +










 CERTIFICATION








This is to certify that the attached proceedings



BEFORE: White House Commission on Complementary
and Alternative Medicine


HELD: October 5-6, 2000



were held as herein appears and that this is the official

transcript thereof for the file of the Department or

Commission.



DEBORAH TALLMAN, Court Reporter

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