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Doubletree Hotel
Plaza Ballroom I & II
Rockville Pike
Rockville, Maryland
Thursday, February 21, 2002 &
Friday, February 22, 2002
Thursday, February 21, 2002 - Afternoon Session
- Meeting Contents and Participants (10K bytes)
- Thursday, February 21, 2002 - Morning Session (180K bytes)
- Thursday, February 21, 2002 - Afternoon Session (251K bytes)
- Friday, February 22, 2002 - Morning Session (304K bytes)
- Friday, February 22, 2002 - Afternoon Session (277K bytes)
A F T E R N O O N S E S S I O N
[Reconvened at 1:45 p.m.]
DR. GORDON: We are going to begin again, and we are going to
move through Research, and then Education and Training, and Access and
Delivery. The way we are going to proceed, and I want to make sure
the public knows this, this is going to be somewhat differently from
this morning, that is, we are going to look at the recommendations
with which we can live, and we are going to put those in one column,
that Ken will put up on the board. Then, we are going to put the ones
with which some or all of us can't live, and we are going to put them
in the other column, and then we are going to discuss those, in turn,
and then we are going to go back and look through the text and look at
the supporting material and see if it works.
Is everybody on-board, that this is the way we are going to
proceed with this? The other thing is I just handed out a piece that
I did sometime ago for the Alternative Therapies Journal, which Joe
Fins has mentioned a couple of times, on the Flexner Report and the
White House Commission. We don't have to discuss this now. We might
want to talk about it a little bit tomorrow. I thought I would draw
on some of this for the vision statement in talking about the role of
the Commission. I think most of you may have seen this before, but I
just wanted to hand it out again. Tom wanted to say something just
before we begin the discussion on Research, and then we will begin
with the recommendations on Research. Tom.
MR. CHAPPELL: Thank you. I have a recommendation of how we
handled some of these questions in the report, the language in the
report that deals with whether we are trying to integrate CAM into
conventional health care system or vice versa. My advice on this is a
technical strategy as a writer. We could assume a social location as
the voice of the writer, consistent with policymakers in Congress.
That is, "social location" in writing is a term describing where, in
the context of all the constituencies, is the voice from coming from,
is the writer coming from. If we look at some of the language in the
Research Section, you will see language like CAM integrating into the
health care system. The question is, is CAM accountable to the health
care system or is it accountable to health policy, and what is
Congress to do here.
I recommend that we modify the voice and location of the
voice throughout the report to be that in the shoes of the Congress
person, because it is in that location we are able to hold, we are
able to be consistent with public policy expectations health policy,
consumers, and so on, and when we address CAM issues, we can say we
expect CAM to be accountable to public policy rather than accountable
to conventional health system, and it also allows us to say we expect
the same of conventional health system. I think the language could be
modified, "nuanced" I guess is the word, which really would take away
the concern I have been hearing here, is that this is really a report
that is written in the context of conventional medicine. It does away
with that, and it holds everybody accountable to the same standard,
i.e., the shoes of Congress.
DR. GORDON: Linnea, did you want to say something?
MS. LARSON: Perhaps we need a little bit more clarity on
this, what constitutes public policy. I think that that is maybe my
one minute, and time me on this, is that we are making recommendations
that have to do with legislative and administrative actions. That is
what constitutes public policy, and the public policy has to do with
such things as budget expenditures, which then the Congress takes
action on. That is public policy. So, when I have been referring
over and over again to let's be clear about what we are looking at
when we say we are making recommendations, we recommend that the
President do something through the administrative actions, and through
congressional and laws. I don't think that that is quite accurate,
Tom, what you are saying about the location of voice. I understand
the concept.
Open Discussion: Coordination of Research
DR. GORDON: What I would like us to do is focus on the
recommendations and see how these issues of voice and clarity are
played out in specific recommendations. I again ask you, if there are
issues, this is the time to bring them up. So, let's move through the
recommendations first. First recommendation. Actually, we can look
at the section. We can just look at all the recommendation section,
and we can work with that section. Is that easier for people, or is
it easier to work in the context of the text? Okay, fine. Let's look
at Recommendation 1 on page 9. This is the Research. "Federal
agencies should receive increased funding for clinical, basic, and
health services CAM research." Should I read the action items along
with that, as well, or do you just want to start with the
recommendation? Start with the recommendation. Linnea.
MS. LARSON: One of the points that Wayne brought up in his
memo of a few weeks ago was the statement "CAM research." It is not
CAM research, it is research on CAM, and I think that that is critical
in terms of -- no, this doesn't have different standards than research
methods, it is research on CAM. This is throughout the text and also
throughout all of the recommendation and action items. So, simply
switch from "CAM research" to "Research on CAM."
DR. GORDON: Are we okay with that? Okay. That is a
beginning. Thank you, Linnea. Joe.
DR. FINS: I find it very vague. It is like what does this
mean, increased funding for clinical, basic. I mean it is like yes,
but at the expense of what, and it is not an actionable item really,
and it is so vague, and there is not texturalization against other
competing strea
MS. I guess one of the things here about
research is that -- go ahead, do you want to interrupt?
MS. POLLEN: No, I don't want to interrupt, I want you to
finish.
DR. FINS: I think that part of the problem here is -- and it
gets to the scarcity point that I made earlier -- is that NIH's budget
has doubled in the last 10 years. It is probably not going to do the
same, you know, there are lots of constraints, what is this against.
I think we are better positioned to really talk about strategies to
allow research to occur within the peer review mechanism that exists
within the major funder.
DR. GORDON: Gerri, go ahead. I was asking a question, but
you may well be able to respond to it.
MS. POLLEN: I agree that this recommendation needs more
context. Instead of approaching it from the point of view of
competing priorities, I think the context it needs, and the suggestion
I will make, is the reason why the funding is needed. So, I have
added a suggested continuation of that. "Federal agencies should
receive increased funding for clinical, basic, and health services
research in order to accelerate findings on safety and efficacy, or
lack thereof, of CAM products and practices that are used widely by
the public." That puts it into a context of why the funding is needed
without getting into the budget aspects about where the money is going
to come from. "Federal agencies should receive increased funding for
clinical, basic, and health services research on CAM in order to
accelerate findings on safety and efficacy, or lack thereof, of CAM
products and practices that are used widely by the public."
DR. GORDON: So, that is the revised recommendation, is that
right, Gerri?
MS. POLLEN: That is my suggestion.
DR. GORDON: Joe.
DR. FINS: This has a recommendation and a justification
together. We need to make the recommendation and then we need to have
the justification. That is the justification, that is not the
recommendation. The recommendation is, you know, here is the
recommendation. There should be an RFA for, or, you know, there
should be joint initiatives for, to promote, there should be
interagency cooperation, things like that.
DR. GORDON: Joe, some of those are in the action steps. The
rationale, as Joe Kaczmarczyk just explained to me, and that is what I
was looking for Steve for, of breaking this down into recommendations
and action steps was -- and, Steve, correct me if I am wrong in this
-- that the recommendation was to be a more general piece, and the
action steps were to be more specific.
DR. GROFT: Yes, the idea being also the actions, as we state
them, could actually be implementation strategies if we wanted to go
that far, but I think we chose "actions" just as a word to describe
what needed to be done. Originally, it was "action items," and people
felt that was too bureaucratic, so we thought we would stay with
"Actions."
DR. LOW DOG: I would need some help from other people that
know more about this area, but on the Action Item 1.1, when we talk
about all federal agencies with research, and then funding
initiatives, application proposals, CAM-focused offices, centers, that
just seems very large, because there is so many agencies, and what
kind of CAM professional, so is each group going to have a
chiropractor and an acupuncturist and a herbalist and a massage
therapist, and a naturopath, I mean it just becomes this kind of
unwieldy thing when you think about it. My question, and it is more
of a question, is with NCCAM and ODS and some of these groups that are
pulling together expertise, and are doing research, and have
congressional mandates, shouldn't those groups be more of the ones
that are networking with all of these agencies, so that every agency
doesn't have to have this full complement and cadre of all of these?
It's a question, but when I read that, it just looks so big when you
stop to actually think about it. It makes one question if because the
expertise within CAM, and all the multidimensions is very large when
you think about it, but it seems like it is better to have that in a
centralized place where people can then refer than having them in
every different agency. It is just a question.
DR. GROFT: The problem is, though, every agency does their
own research, and there is all the different focus. The Department of
Energy does distinct research from NIH. So, if you remove Energy,
say, and you don't specify them, or you miss someone, then, they say,
well, it doesn't apply to us. I think that is why we tried to give
the general approach, is that if you have an activity related to
health care, then, you should think about CAM research, increasing
your research for CAM activities. I guess that is the idea behind the
broadness is we cannot spell out everyone, every agency.
DR. LOW DOG: Should it be that you should increase your
CAM-related activities, or are there other ways of making the
language, because I am not sure that that would be absolutely relevant
to what I am studying. There should not be a discrimination for
research that is outside of the conventional paradigm, et cetera. I
don't know, but I have some fundamental problem with 1.1 because it
seems so big.
DR. GROFT: It is big. I think because CAM is so big and
touches so many aspects of the entire federal government and all the
other agencies, that is part of the problem, part of the problem with
CAM.
DR. GORDON: Gerri.
MS. POLLEN: Tierona, to get to a point you just made, I have
two thoughts. One is instead of saying "All federal agencies with
research or related health care missions," it could say, "All federal
agencies should increase their research or related activities with
respect to their missions." In the next sentence, it could say,
"Activities could include," because they don't have to include all of
that.
DR. LOW DOG: I like that better.
DR. GORDON: Tom.
MR. CHAPPELL: I think that the format of the recommendation
followed by the actions is a good format, and I would like to adopt it
as the way we accept a recommendation. That is, we are going to work
on the recommendation and the action steps. I don't think it is
necessarily too broad. I don't think the audit that Gerri offered is
necessary in the recommendation itself. So, I find the recommendation
really succinct, inclusive, and to the point as it is presented along
with the action steps, and the modification that Gerri suggested
responding to Tierona's concern about broadness, I think would be
fine. I just think the first recommendation, as it is, is also okay.
MR. ROLIN: My comments, she answered once she did the
modification, it's okay.
DR. GORDON: I want to remind everybody we have a little less
than an hour and a half, about an hour and 20 minutes for each of
these three sections. So if these are things we can live with, with
the modifications, let's move ahead. I also want to remind everybody
-- and I am not trying to close off discussion -- I just want to
remind everybody that we have also, many of these, including I believe
this one, we have agreed to as a whole commission before. Go ahead,
Joe.
DR. FINS: Well, I guess the question is if somebody is
running an institute, and has a certain number of staff positions, and
they see that they have to have certain CAM-focused staff positions,
does that mean they have to eliminate some of their research
scientists? Will there be new money? I mean how does this thing get
played out, and what are the consequences for the research
infrastructure?
DR. GORDON: Wayne can probably speak to more details. It
can be played out in many ways. There is a mandate for all of these
institutes at NIH to have somebody concerned with CAM in that
institute. Sometimes that was a part-time job, sometimes it was a
full job. Usually, there were many people who volunteered, who were
interested in being CAM liaison and sort of working on the CAM
efforts, and Wayne was involved with this right from the beginning. I
think different institutes and different agencies respond differently.
Wayne, do you want to add?
DR. JONAS: They will each implement this in their own way as
is appropriate. Again, that is one reason why I think the general
recommendation is better because it is going to be implemented -- we
are not dictating to them what the priorities should be, and I like
the rewording of the action steps. So, this will be manifest anyway
through their normal processes. I do think, however, that the issue
of some kind of statement about proportionality probably should be in
here somewhere, and this was brought up both by Max and by several
other individuals. Right now the statement says more money, and as is
pointed out, there may not be more money, and if there is not more
money, then, the response was likely to be okay, well, we will do it
when we get more money. So, attached to the idea of doing more
research, there ought to be some kind of an assessment or evaluation
by each of the institutes as to what the appropriate amount of
research expenditures on CAM within their institute or within their
agency should be, so that they can do an internal study and look at,
okay, what do we need in this area compared to other areas appropriate
to their mission.
DR. GORDON: Wayne, do you have any suggestions on how to
approach that?
DR. JONAS: Well, I would suggest yes, that it is added as an
additional action statement that deals with the issue of
proportionality, you know, should research resources not be
immediately available, then, there should be a study by each of the
agencies to evaluate the proportional budget allocations appropriate
for CAM activities relevant to their mission.
DR. FINS: Do they have the option of saying zero if they
don't think it's --
DR. JONAS: Sure.
DR. GORDON: What I would like to do is, as Wayne has stated
it, is that an action item that we feel comfortable adding? Okay.
DR. FINS: I am not sure I can agree to that, the way it is.
I think I am in favor of more research, but I think it is pervasive,
it is perhaps overly global. I think that agencies should have a
mechanism to determine -- what I am saying is I don't think entities
that are doing good research, that is important, should be distracted
and diverted from their mission by doing something that diverts
resources in a time of scarcity.
DR. GORDON: Fine. I think the issue that Wayne has said is
they should determine what proportionality, and it could be zero.
That is up to them to determine.
DR. FINS: But you have already stated in the first two lines
that they should increase their research and related activities.
DR. GORDON: Right.
DR. FINS: What we should say, maybe the recommendations of
the agency should determine how they might increase their research and
related activities related to CAM through an internal mechanism, and
then allocate funds accordingly. In other words, what is here, the
premise starts with that they should increase and they should study.
The question is they should study and then determine how they should
increase.
DR. GORDON: This is an important distinction, so let's have
some discussion of this before we move ahead. Tom.
MR. CHAPPELL: I don't think there is a single person that
came into any of the hearings throughout the last two years that
didn't express a need for increased funding on CAM. I just couldn't
imagine presenting a recommendation that didn't request an increase in
spending on research for CAM products and services.
DR. BRESLER: I think maybe the way to reconcile this is to
say that these agencies should include CAM in their considerations
when prioritizing their projects. I think that is what we are asking,
isn't it, that CAM-related projects and activities be included in
their considerations?
DR. GORDON: No, I think it's different from that, David. I
think it is saying that the amount of research should be increased,
and then Wayne's addendum says the degree to which it should be
increased should be assessed.
DR. JONAS: Had we requested to the NIH that they consider
evaluating whether they should increase their funding for alternative
medicine research, there would not be an NCCAM at this time. So, I
think the strong language is a very important way of stating it.
DR. FINS: I don't mean to get bogged down in this one, but I
think once we settle this, others will follow, because this is sort of
the overall picture. I think it is one thing to say that the NCCAM
should have more funding. It's another thing to say that other
agencies have to divert resources, and that is a distinction that I
think is important.
DR. JONAS: Let me rephrase that. Had it not occurred at the
OAM, at the time of the OAM, there would not have been an OAM. I mean
this was not something that was reasoned consideration by the federal
agency who has an established mission. It was not on their radar
screen. So, I think to weaken it when the need for research, if there
was a universal statement, that certainly was one, so if we don't make
that strongly, I think we have abdicated our primary responsibility in
recommendations.
DR. LOW DOG: I think partly what I am hearing though also is
not just that we need more research, because I think we all agree to
that -- I hope we all agree to that -- but that the statement is sort
of all federal agencies, it is kind of very broad, and that was my
original question, because I just don't know how they all work, in all
honesty, to know if that is a reasonable recommendation that every
single federal agency that does anything, anywhere, with any kind of
health or research of any kind should have to implement research under
CAM. I didn't know, it does me overly broad when you step back from
it, which I think is different from saying that there should be
research. I don't think anybody is questioning that. I think what I
am hearing, is it necessary that all of these agencies do this. I can
live with this language here, especially with the qualifier of if
there is not enough money, letting people sort of internally do that.
I could live with it, but I do think that it is a little sticky. When
you read that, it does seem very grandiose.
DR. FINS: The other question is, is it through the normal
competitive process. If investigators apply and they get certain
rankings, will this mean that some people who got ranked higher in a
conventional sense, will get bumped, because the CAM investigator,
that kind of research has to get funded? I would like some sort of
additional qualifier here, you know, high quality, competitive
research, because we don't want to simply fund CAM research, we want
to fund competitive research that would meet the standards.
SISTER KERR: The first, the most simple, is just because of
the fear of the statement sounding so grandiose, just eliminate "all,"
and just put federal agencies with research or health-related
missions. But my comment that I wanted to say first was that I think
given Wayne's addendum, you cannot provide for every eventuality or
criticism we are going to receive related to the inclusion of the
request of CAM research, so we have to kind of get our grip on our
anxiety and fear of what colleagues or other people might say. I just
think that is part of the deal.
DR. GORDON: Tierona.
DR. LOW DOG: Can we just sort of see what we have got? We
have got the recommendation as it is except we changed "Research on
CAM" and "CAM research." Then, Gerri made an addendum for Action Item
1.1, and Charlotte has proposed that we just eliminate "all," which I
will tell you I think makes the sentence read a little bit better.
Then, we have left 1.2 by itself, and then 1.3 would be the item that
Wayne added about proportionality. Can we have some consensus on
that?
DR. GORDON: The only thing I would add, I would make Wayne's
item 1.2.
DR. LOW DOG: Move it up? Fine.
DR. GORDON: Tierona is asking for consensus on this
recommendation. 1.1, then, the proportionality that Wayne suggested,
and then 1.3 as it stands now.
DR. FINS: The only thing I would want to insert here is
something about the quality process. NIH funding means something
because it means something. I mean NCCAM also has adopted standards
that are commensurate with the other institutes. We heard that in
testimony. So, I think here we should say something about through the
competitive process, and if people are not competitive, they don't get
funded. I mean qualitatively.
DR. GORDON: That's the way it always is, Joe, there is no
other way that funding happens. It is kind of a redundancy.
DR. GROFT: Unless there are set-aside funds.
DR. FINS: But this could be interpreted as saying so.
DR. GROFT: That is up to the agencies and departments to
determine themselves what they want to do with their funds, and if
they do an evaluation and say, yes, we need to fund some CAM research,
or there are some good proposals, if they receive some unsolicited
proposals, they are going to be scored and then adjudged whether it is
to be funded, and if they decide they need to fund things out of
order, they go to second degree of council review. If the council
says yes, we agree that it should be funded out of order, that review
has taken place. I think there are adequate safeguards and
protections that we are getting good research that is being funded.
In fact, if you look at the level of funding and the competition
factor for NCCAM coming up, it is going to be horrendous what they are
able to support this year as far as new research grants. It is
getting down into single digits again. There is no doubt you are
getting high-quality research.
DR. GORDON: Can everyone live with this one now?
Essentially, what we are saying, recommending additional research
funding, and it is up to each agency to determine how much and how it
is going to fund, just the way they currently do.
MS. POLLEN: I need clarification on whether the addition
that I read at the beginning to the original recommendation should be
used or not. COMMISSION MEMBERS: No.
MS. POLLEN: So, just stop it as "Research on CAM," period,
and don't have the rest of that.
DR. GORDON: Stop at CAM. Let's look at No. 2. "Congress and
the Administration should enact legislative and administrative reforms
to provide greater incentives to stimulate private sector investment
in CAM research."
DR. FINS: We skipped 1.2.
DR. GORDON: I thought we had agreement on that. Okay.
"Congress should provide adequate public funding for research on
frequently used or promising CAM products that will be unlikely to
receive a patent, and therefore unlikely to attract private research
support." That is a form of general guidance. Again, I am happy to
hear statements about it. We have discussed this one several times.
Tierona.
DR. LOW DOG: If people don't like the wording, we could
discuss it, but I think the real key part here, this goes back to
prevalence. We talk about the prevalence of many of these dietary
supplements, and botanicals in particular, that are commonly being
ingested and used. The safety data is not available for them. It
just hasn't been done, and it is growing in its research, but that was
a lot of my impetus for this is because the safety data is just
lacking for these. Even if you don't have efficacy data, if you can
at least get safety data, that is I think important for the public
health.
DR. GORDON: David.
DR. BRESLER: I think it should be "products and practices,"
because particularly in the mind-body medicine field, there is a lot
of research that is also needed, and it is not around a product at
all.
DR. GORDON: I brought that up to Gerri before, and she
responded as follows.
MS. POLLEN: We are talking about patents here, and practices
aren't patented. In other words, this is specifically products.
DR. BRESLER: Where do we deal with Congress putting funding
for non-products?
MS. POLLEN: All through the rest of it.
DR. GORDON: Look at Recommendation 3, David. I think that
is covered there. Where are we now? Any other comments on this?
DR. PIZZORNO: I would like to follow up on what Tierona had
to say on 1.2. Suggest we insert between "funding for," and before
"research," "efficacy and safety." If we can't get the efficacy, at
least we can get the safety.
DR. GORDON: I'm sorry, Joe.
DR. PIZZORNO: 1.2, the first line. After "funding for,"
insert "efficacy and safety." Between "funding for" and the word
"research," insert the words "efficacy and safety."
DR. GORDON: I don't understand. Those are not modifiers.
"Efficacy" and "safety" are not adjectives. Research on the safety
and efficacy?
DR. PIZZORNO: Yes, "of frequently used."
MR. CHAPPELL: That is going to increase the price
considerably of the research, Joe. Safety should be everyone's number
one concern, and that costs one price, but if you want to understand
the mechanisms of action of some of these herbs, boy, you have got a
whole lot of additional work to do, and I am just not sure we should
be that specific in this recommendation, but rather leave it to the
institution itself to make that decision. I would rather leave it as
it is just because I know that every agency is going to put safety
first, and efficacy will have a price and a judgment.
DR. GORDON: What you are also suggesting that mechanism of
action may have nothing to do really with safety or efficacy directly.
MR. CHAPPELL: I am saying that mechanism of action is very
hard to determine, and I just think that is more costly research.
Yes, it does equate to efficacy.
DR. GORDON: Nobody is suggesting mechanism of action
research in particular here.
MR. CHAPPELL: When you mention efficacy, you certainly are.
DR. LOW DOG: Tom's suggestion was just to leave it the way
it is, which just says for research. That is what I heard, let's
leave it open to the institutes to determine that.
DR. FINS: I would like to delete the thing about the patent
and private research support. I don't that adds -- did you already
talk about this when I was out?
DR. LOW DOG: I might disagree with you here only from a
safety perspective. I feel that many of the supplements that are out
there, because of the way that the DSHEA Act is written, do not
require, in my opinion, adequate safety data before they are launched
on the market. Now, many of these are already on the market, and
nobody is going to pay for it, and unless you are going to overturn --
I'm sorry, I didn't mean to use that word -- unless you are going to
revisit, redo, relook at the Dietary Supplement and Health Education
Act, there is going to have to be some public funding, I think, for
these products, and part of the reality is the reason that they are
not going to be studied is because they are not patentable items.
DR. GORDON: Let me point out that we are on Recommendation
1, and we have a number more to go. I want to see if we can get some
kind of agreement.
DR. FINS: Let me just say that I agree with that completely,
and I think that is in the justification of why this is so compelling,
but the way it reads here, one could read this and say it is to help
the marketplace, whereas, the real goal is really to protect the
public, so it kind of has a mixed message here.
DR. GORDON: Joe, how would you reword it?
DR. FINS: "In order to protect the public health and
maximize benefits, Congress should provide adequate public funding for
research on frequently used or promising" -- and I might want to say
"supplements" here, not "CAM products" -- CAM products is better --
"CAM products." Then, the justification is, "This is necessary
because there are items in the marketplace already, and because many
of these items are not patentable, and would not lend themselves to
New Drug Applications, there is an additional need for public
support."
DR. LOW DOG: So, you would suggest putting this into the
text, the justification, buffing that up in the text, and then just
including "in order to protect the public safety and maximize the
benefits, Congress should provide." I think that is a good
recommendation.
DR. GORDON: So, where are we with that issue? Tom.
MR. CHAPPELL: I would support striking the language about
attracting private research and the patent issue, because it may
complicate just basic research that we want done.
DR. GORDON: Wayne, go ahead.
DR. JONAS: I would say strike patent if you want, but the
point about this is that we want some support for areas where private
investment is not going to occur, whatever the reason.
DR. LOW DOG: I think we addressed the issues of patentable
and stimulation of private sector research in Recommendation 2, so I
don't think, under 1.2 or 1.3, or whatever, whatever it is going to
be, you could end with "products" period, and then we will move into
discussing the next part.
DR. GORDON: I feel comfortable with that as long as we make
sure that the justification is outlined clearly in the text. Are we
all right with this? Gerri.
MS. POLLEN: "Patent" can come out, that is not necessary to
be there. But if you take out, "unlikely receive private research
support," that is the bridge to the next one. I am just saying if you
don't think you need that bridge, and you want to stop it.
DR. GORDON: I think it would be helpful to have the bridge
myself. I also think it makes us stronger.
DR. PIZZORNO: As Wayne said it, I agree.
DR. GORDON: Can we keep part of the bridge then, "unlikely
to attract private research support." Okay? Let's move on to No. 2
then.
MS. LARSON: Do we have somebody taking down these exact
words?
DR. GORDON: We are trying to, and it is also being recorded,
and we hope to get a transcript then. Thank you, Linnea. On to No.
2. Gerri is taking them down, we will have a transcript that we will
have back in a couple of days. No. 2. "Congress and the
Administration should enact legislative and administrative reforms to
provide greater incentives to stimulate private sector investment and
CAM research on products that may not be patentable." And then 2.1
through 2.4, which I am not going to read, you can read them yourself.
What do you think? David.
DR. BRESLER: Just again in the language, I don't know what
they mean by "reforms." I would just strike "reforms to provide
greater," just take those four words out, and just say, "should enact
legislative and administrative incentives," and do we want to
stipulate that those incentives could include low-interest loans, tax
deductions, things of this sort, because the point is, is that this
doesn't require an allocation?
MS. POLLEN: That language is in the text because that was an
earlier decision, we could pull it out and put it here, but
originally, the decision was to leave that in the text. It could
either way, if everybody wants it back in here, we can do that.
DR. GORDON: Go ahead, Joe.
DR. FINS: Not to nitpick, my concern about this is it looks
like a subsidy to industry. Indeed, that is what it would be. There
may be a precedent for it, but this looks like a subsidy to industry.
It may result in lower tax revenues, and actually, what we are doing
does two things. It protects the public health presumably, but it
also could engender profitability for industry.
DR. LOW DOG: Part of this was they had addressed this
actually with orphan drugs, looking at how are you going to get
pharmaceutical companies to spend the money when it is not very
profitable to put the research in it. There was a time line on it.
It wasn't forever, indefinite, and I don't know if we need to have
that or not, but it was a way, without giving money, but a way of
streamlining the process to help these pharmaceutical companies
investigate research under these drugs that nobody would have studied.
I think that unless we begin to address ways that companies will be
able to do research and development on these products and spend R&D on
them, it will not happen because the industry is not as large as the
pharmaceutical companies, and because they cannot patent their
product, there is no way to recoup or to have a market share or gain.
It is a real problem with the industry, so I wouldn't think of it as
really a subsidy, but we have done this in other areas where we have
needed research, but there has been no incentive for the manufacturer
to spend the money.
DR. GORDON: I would like us, as we look through these, to
think again. We have gone through virtually all of these in research
have been approved before. Again, I am not trying to stifle
discussion, but I want us to be really sure. We have gone over these,
and I don't know why some of these issues haven't been discussed
before, so I want to make sure the objections are crisp or the
concerns are crisply stated, and that we move through them crisply.
Okay? David.
DR. BRESLER: Just real quickly, Joe, even if it might
generate profitability in the private sector, those profits are going
to be taxed, and that money will come back into the government, and
there are government programs designed to do exactly that.
DR. GROFT: Actually, one of the biggest ones is the SBIR
program to stimulate small businesses.
DR. GORDON: George.
DR. BERNIER: Is it right to be on 2.4? Tierona, do you see
the same down side to that, that has been voiced on the earlier ones?
This is 2.4 with, "The manufacturers of CAM products and devices
should become acquainted with potential sources of research funding
and requirements they must meet to access such resources
successfully?"
DR. LOW DOG: I am not sure what you are asking, George.
DR. BERNIER: I am asking you if it is the same issues of NIH
supporting the manufacturers.
DR. LOW DOG: Well, I think there is already a lot of
collaboration that goes on with manufacturers of drugs, and there is a
large amount of money, public funding, that goes into drug research
right now, so I am not sure this is asking for something really that
different. I think that if there is research funding -- if you are
going to do a trial on Black Cohosh for menopause, you have to have a
product. You have to have a product, and it has to be a product that
is reproducible in a clinical trial, and so manufacturers should be
made available of what research is out there, and that also begins to
open up avenues for them to be able to participate in research on
their product. I think this is important. I may be very off base,
but I don't think so. I think that we are not asking for really that
much that is not already done with public funds for drug research.
DR. FINS: I have something that might make me a lot more
comfortable, and I think maybe addresses George's concern, but I
really want to hear what Tom would think about this, is that if a
company is getting some sort of tax break or an incentive to do this
kind of research, it is not necessarily to benefit the company, it is
to benefit the public, and there should be some kind of quid pro quo
about the disclosure of what is learned, which is comparable to the
requirement for disclosure with a patent, for the exchange of the
period of exclusivity with the discovery. So, I think that there has
to be some nod towards disclosure of what is learned, so that we are
not simply helping one company, but we are helping the entire
industry, so if Tom's company, for example, was to learn something
that was truly beneficial or truly dangerous with an incentive from
sort of federal entitlement, I would expect that there would be
disclosure of that discovery in the scientific literature.
DR. GORDON: I think this might be something that could be
discussed in the text. It doesn't sound like a recommendation. I am
not sure how it would fit as a recommendation. It also feels like we
are trying to hedge everything so carefully, Joe, and I just don't
know. As a principle, it's a good principle, but how do you fit it in
a recommendation?
DR. FINS: You say, you know, and what is learned should be
disclosed to benefit the public.
DR. GORDON: Tom.
MR. CHAPPELL: I just wonder what 2.4 is in there for at all.
If we are trying to establish a voice of policymakers, do we need this
at all? I think we should strike it.
DR. FINS: It still brings back the issue for 2.1.
DR. GORDON: Are we striking 2.4? Yes? Okay. Gerri, is
there a reason not to?
MS. POLLEN: No.
DR. GORDON: One of the things I want to say is we have 20
minutes to go through the next seven recommendations. This is just a
reality. I feel like we are trying to fine-tune these a little too
much when we have already agreed on these, that there are major areas
where we have questions and disagreements that we need to deal with.
Joe, with all due respect, I feel like we have got to devote our time
and energy to those, unless there is something really disturbing here.
DR. FINS: I do think that the issue of writing a report that
serves the supplement industry is something that we do not want to be
a party to, and so I would really like to assert that any kind of
federal entitlement is not a simple gift, but it is a gift in exchange
for something. So, I would really strongly urge us, I think it is a
safeguard to the intent of what we are all trying to do is to have
some nod towards disclosure of what is learned to promote the public
health, disclosure to promote the public health.
MR. CHAPPELL: I had hoped not to comment on this one, but
now I am drawn out. So, my comment, Joe, to your good suggestion is
that your suggestion will deter industry research for two reasons.
Private foundations do work on time, and nonprofit foundations don't.
Secondly, private foundations keep information private. Manufacturers
like to pay for work that is theirs. So, I am just giving you the
motive of the person in the shoes of the company, and this is not an
entitlement, it's an incentive. This is an incentive to draw them in
to doing research on a product that they want to market. It is not an
entitlement. It is not like getting a grant, an investment. If it's
a grant, I would feel you have grounds to stand on, but where it is an
incentive to say come on, do more research to make these products safe
and efficacious, they will say okay, and then we want to go with our
data as the basis of claims on our product, and that is our market
right.
DR. FINS: So, what kind of incentive are we talking about
here? I was thinking like, you know, it is a tax break or something,
which be like a grant.
MR. CHAPPELL: But it is not a grant, it is not the same
thing.
DR. GROFT: Plus a grant, what comes out of a grant goes to
the institution that receives the grant. It does not revert to the
government. The institution receives the benefits of what the
research has done.
MR. CHAPPELL: If I have a university do research for us, the
university has an obligation to publish that data. Right?
DR. FINS: If you are a not-for-profit.
DR. GROFT: And the publication of data depends on the
reviewers and the journal who you submit for publication. They may
elect not to publish.
DR. GORDON: Julia, and we have got to move ahead with this.
MS. SCOTT: I am really concerned about the process and the
amount of time that we are spending here. We cannot fine-tune every
recommendation, we cannot read into how it is going to be implemented.
I think it would really be helpful if we, Jim, have some decision
about how we are going to pass these things. Is consensus going to be
enough, or does everybody have to sign on the dotted line at this
moment? If we could just move things, and say is there general
consensus, and if one person or two people have a problem with it, put
a little tick by it, and we can come back to it. But I don't think we
are going to get anywhere. The afternoon has gone, and we have got
two more subject areas.
DR. GORDON: The problem is, Julia, from my point of view, I
don't know when we will have time to come back to those one or two
people, which is why I am try to hear -- I am trying to strike a
balance between moving as quickly as possible and hearing --
MS. SCOTT: I feel that, and I really feel for the remarks.
I can see people's side of it, but at some point we are going to have
to decide if 19 people are in consensus, and one person is against it,
whether the whole show stops or not. I mean this is a practical
consideration. I love the richness of the discussion, but we do have
a deadline.
DR. GORDON: Do we have a general consensus that we need to
move ahead? Can I see hands?
DR. JONAS: Jim, I have wording changes on the
recommendations, and I have several of them. I would like to do that,
because I generally agree with almost all the recommendations that are
here. I would just like to have those discussed if we could.
DR. GORDON: Either that or we could have a later dinner
tonight, stay longer, and come earlier. That is another option if
people want to take this time, we will eat later and wake up earlier,
or we can try to move ahead expeditiously within the time frame that
is set.
DR. JONAS: Move ahead.
DR. GORDON: Okay. We have struck 2.4. I think we need at
least some statement in the text talking about the public good, and
that our work is in the service of promoting the public good. I think
we can accommodate that easily. Joe, I hope that will be of help to
you.
DR. JONAS: Jim, I actually have a specific wording. This is
where I think David's prior suggestion about putting practices in
ought to go, under this recommendation. "Products that may not be
patentable and practices that may not be profitable," because there
are good CAM practices, health care practices that you don't get paid
for, and we should also incentivize those, not saying how, but we want
to see those incentivized in the private sector.
DR. GORDON: Is everybody okay with that? Adding that, and
practices that may not be profitable? I have got to see. Linnea,
yes, adding that or not?
MS. LARSON: Yes.
DR. GORDON: Let's move on to No. 3 then. "Federal, private,
and nonprofit sectors should support research on CAM practices that
build on lifestyle and self-care and on therapeutic approaches that
integrate CAM and conventional medicine." Veronica.
MS. GUTIERREZ: One word change. I would like to strike
"therapeutic" and insert "other approaches."
DR. GORDON: I don't understand.
MS. GUTIERREZ: Line 2 in the recommendation, "lifestyle and
self-care and on therapeutic approaches," I would like to strike
"therapeutic" and say "other approaches." In many cases, therapeutic
approaches is exclusionary.
DR. WARREN: I agree.
DR. GORDON: I am not sure I understand. What does that
mean?
MS. GUTIERREZ: Not all CAM practices are therapeutic. In
the diagnosis and treatment model, there are other approaches like
Qigong, for example, that are approached --
DR. GORDON: That is a therapeutic approach.
MS. GUTIERREZ: Do you consider yourself therapeutic?
DR. CHOW: Yes. It is also diagnostic.
DR. GORDON: I am not sure what the issue is here.
DR. FINS: She is saying it's too narrow.
MS. GUTIERREZ: I thought it was too narrow, that's right.
DR. GORDON: Strike "therapeutic"?
DR. WARREN: She mentioned "other" approaches.
DR. GORDON: Linnea.
MS. LARSON: I have no idea what "CAM practices that build on
lifestyle," what the heck does that mean? Whose lifestyle are we
talking about?
DR. GORDON: Who formulated the recommendation?
MS. POLLEN: I think it was Jim.
DR. GORDON: Me? I never use the word "lifestyle."
DR. JONAS: Lifestyle involves diet, exercise, stress
management.
DR. GORDON: What about build on self-care, and not say
lifestyle?
DR. CHOW: Lifestyle is a little bit different from
self-care. When you talk about self-care, it is more therapeutic sort
of type. Lifestyle is doing things every day that you do to keep well
and enjoy being well, instead of because of a problem.
DR. GORDON: Linnea, you raised the issue.
DR. JONAS: Religious and spiritual practices are part of a
lifestyle, but they are not necessarily self-care.
DR. GORDON: We need to go one way or the other with this
now.
MR. CHAPPELL: Leave it alone.
DR. GORDON: To me, Linnea's point is well taken. Lifestyle
is a word I don't particularly like. I mean I am not the only one,
but I am just pointing out that it is one of those funny words that
people have lots of feelings about one way or the other.
DR. FINS: If somebody read this, they wouldn't even know
what to make as an implementation. It is just vague. I think what we
are trying to say here, you know, is to promote wellness, health
promotion kinds of things that are not like disease-oriented. I think
what we are trying to get at is the kind of research that is not
geared towards the treatment of illness, but the promotion of
wellness. That may be is what build on lifestyle, self-care, those
are elements that promote wellness. Maybe we should fund research
that promotes wellness.
DR. GORDON: I think we say it very nicely in the action
statement.
DR. LOW DOG: That should be the recommendation, the action
item.
DR. GORDON: So, the recommendation and action item are the
same here. Okay.
DR. FINS: How about behaviors that promote wellness versus
wellness behaviors?
DR. GORDON: Fine. Very good, Joe, thank you. It reads,
"The federal government should stimulate private investment and
research on CAM modalities and approaches that are designed to improve
self-care and behaviors that promote wellness."
DR. FINS: Can i just say that that is narrower? It was
"Federal, private, and nonprofit." Here, it is just private
investment. So, you want to say, "The federal and private should
support research on CAM modalities and approaches."
DR. GORDON: I want to announce that I have just been given
tea and cookies.
DR. FINS: The next course is a Prilosec or something.
DR. GORDON: What do we want to do? Do we want to make the
recommendation and the action item the same, or do we want to leave,
"Federal, private, and nonprofit sectors?"
COMMISSION MEMBER: I would add all three phrases.
DR. GORDON: Okay. Let us move ahead.
Recommendation 4.
COMMISSION MEMBER: What was that?
DR. GORDON: "Federal, private, and nonprofit sectors should
support research on CAM practices that build on self-care and on
approaches that integrate CAM and conventional medicine."
DR. FINS: No, no, no. My understanding is, "Federal,
private, and nonprofit sectors should stimulate research on CAM
modalities and approaches that are designed to improve self-care and
behaviors that promote wellness."
DR. GORDON: Perfect. Okay. That is the recommendation.
The action item is just the federal government.
DR. PIZZORNO: I think the recommendation is the action item.
DR. GORDON: Is the recommendation the action item here?
DR. PIZZORNO: Yes.
DR. LOW DOG: It is just a question because we were talking
about trying to condense our recommendations. Since we added in
practices that may not be profitable under Recommendation 2, and we
have taken away the action item and just made it a recommendation,
can't we just make the recommendation an action item under
Recommendation 2?
DR. GORDON: Is that okay with everybody? Make 3.1, 2.4.
Okay.
DR. LOW DOG: And we got rid of a recommendation.
DR. GORDON: Let's move on to Recommendation 4. "Federal,
private, and nonprofit sectors should support new and innovative CAM
research on CAM practices and products, and on core questions posed by
frontier areas of scientific study associated with CAM that might
expand our understanding of health and disease." That is a long one.
Wayne, any comment about that one?
DR. JONAS: Yes. Actually, I have a lot of comments on this
one. I think this should be reorganized to split out the specific
aspects that we want to see underneath those, because it is combining
a variety of things, CAM practices and products, frontier areas,
things that might expand our understanding of health and disease.
Under the action items, I would have to think about how this could be
reworded, but under the action items, there are specific issues about
prioritizing research that should be done by a particular agency, the
IOM, about frontier sciences that should be done by a particular
agency, the NSF, about prevention and health care, which should be
done by a particular agency, the CDC, and I think that those things
ought to be specified under action items. You could keep this one
fairly general, if you wanted to, the actual recommendation, and then
underneath it, put the specific action items that specified which
activity, dealing with what section we would like to see it addressed,
because it is clearer which agencies would be the ones that need to do
that, and that would make it more concrete. I am afraid I haven't
written these all out. They are actually in here, but the study on
prioritization of research and research strategies, which is a task
that the IOM has already done in the conventional medicine area, and
this should be applied to these areas, looking at how frontier
sciences can be properly investigated, and that is something that the
NSF should do, and CAM could probably do that, but I think the NSF
should be involved in that.
The role of complementary medicine in prevention in public
health, that is a mandate for the CDC. Examining the importance of
health services research and review standards is something that AHRQ
does, so we ought to specify, I think, those are items that we would
like to see each of those agencies do, that would "concretize," if you
will, Recommendation 4. World Health Organization is under here, under
4.2, that is not a federal agency, but we might suggest that NCCAM,
working with the World Health Organization, then also specifically
study how to investigate traditional medical practices, and they have
actually started on that once before, and reinforce that, it's on the
way. That would be my suggestion is that they be made concrete.
DR. GORDON: Any comments?
DR. LOW DOG: I fully support those, because we talked
earlier about not being specific enough and sort of being vague. I
think this really clarifies, and this is what these institutions and
groups already do.
DR. GORDON: Okay. I want to ask if we can have a general
consensus that Wayne will take these and make them more specific, and
then that will be part of what gets submitted back to us. Wayne, you
are up for that? Great. Is everybody with me on this one? Okay.
Let's move on to No. 5. "It should be duly noted that human subjects
participating in CAM-related clinical trials are entitled to the same
protections as required in conventional medical research," and then
there are four action items, which I ask you to look at. I think we
went over these pretty carefully.
DR. LOW DOG: It doesn't sound like a recommendation when you
say it should be duly noted.
DR. GORDON: It doesn't sound like a recommendation, does it.
DR. FINS: Just say, "Human subjects participating in."
DR. GORDON: Okay. But that is still not --
DR. FINS: How about, "Investigators engaged in CAM-related
clinical trials should ensure that human subjects participating in
clinical research receive the same protections as required in
conventional medical research?"
DR. GORDON: How does that sound? Great. Everybody? Thank
you, Joe. Let's look at the action item.
DR. FINS: I think these are okay. There is a little bit in
Recommendation 6, which is related. It is a slight edit, but this
section is okay.
DR. GORDON: Are we okay with these action items?
DR. LOW DOG: Jim, just at this corner of the table.
"Federal agencies and investigators," not just "Investigators," in the
recommendation.
DR. GORDON: I'm sorry, how would that be said?
DR. LOW DOG: Five. In the recommendation.
DR. GORDON: Say it out loud.
DR. LOW DOG: We had, "Investigators in federal agencies
involved" -- "should assure," I can't remember verbatim.
DR. GORDON: You are just adding "Federal agencies."
DR. LOW DOG: Yes.
DR. GORDON: Okay, everybody?
MS. POLLEN: Why are we adding "Federal agencies?"
DR. JONAS: Because we are making recommendations to a
federal agency. We are trying to make it an actual recommendation.
DR. FINS: We are saying any investigator engaged in research
must adhere.
DR. JONAS: Federal agencies should be involved in assuring
that that happens.
DR. FINS: And they are. The OHPR does.
DR. JONAS: Oh, it does?
DR. FINS: Well, that is part of their mandate.
DR. LOW DOG: So, we don't need that?
DR. FINS: Can we read back what we have?
MS. POLLEN: At this point we have, "Investigators engaged in
clinical research on CAM should ensure that human subjects
participating in clinical trials are entitled to the same protections
as required in conventional medical research."
DR. FINS: We could add more specificity by saying the Office
of Human Research Protections. No? Okay.
DR. JONAS: No, but I do think we need to make sure that
federal agencies take this on as a responsibility, because they are
not doing this in all CAM research.
DR. FINS: Why don't we preface it by saying, "Federal
agencies responsible for the oversight of human subjects research
should ensure that."
MS. POLLEN: We can say it, but it is sort of a foregone
conclusion.
DR. FINS: No, it is not a foregone conclusion, and Wayne is
telling me it doesn't happen, and the question is there is no
enforcement. The problem is that they enforce research compliance at
universities, major universities, but some of these investigators are
outside the scope of the conventional paradigm, and if they are
engaged in human subjects research, they should be under the purview
of OHPR.
DR. GORDON: Does everybody agree on this then? Please,
everybody stay with us, okay? Not just because I want your attention,
but because we may need your attention. You may pick up something.
Anybody in this room may pick up something that the rest of us miss,
so please hang in there with all these recommendations.
DR. JONAS: Jim, I would also, in that same light, change
that one word "clinical trials" to "clinical studies" or "clinical
investigations."
DR. GORDON: In two words, explain why.
DR. JONAS: Because there is a lot of clinical research that
goes on that is not clinical trials. It still needs the assurance of
subject protection.
DR. FINS: Any human subjects study, not necessarily a
clinical trial, but any human subjects research, period, is covered.
DR. GORDON: Let's move on to Recommendation 6. "State
professional regulatory bodies should include language in their
guidelines stating that licensed or other authorized practitioners
will not be sanctioned solely because they are engaged in CAM research
if they are: One, engaged in research that is approved by an
appropriately constituted IRB; two, are following the requirements for
the protection of human subjects; three, are meeting the same
licensing or other authorizing standards of practice to which all
similarly licensed or authorized practitioners are held." Don.
DR. WARREN: I think we ought to start on the third line,
after "CAM research," and drop everything else in that recommendation.
DR. FINS: No.
DR. WARREN: I think if they are engaged in research that is
approved by an IRB, the rest of that recommendation, I don't like. I
think it's sanctioned solely because they are engaged in CAM research,
and then you put a bunch of stipulations in there, that they have to
be in an IRB, they have to be -- I am looking at it.
DR. GORDON: Another way to look at it is that we have
already made those stipulations in the previous recommendation, so it
may not be necessary because it's redundant, because the previous
recommendation essentially says that all these thing have to be done.
Joe, go ahead.
DR. FINS: This engendered a lot of discussion, and the
intention here was that state regulatory bodies should not sanction
these individuals simply because they are engaged in this research if
they meet certain stipulations. One is that it is approved by an
appropriately constituted IRB and are following -- I would just add
"federal requirements for the protection of human subjects." This
last part, No. 3, is something that is new to me. I don't think it
was in the previous iteration. Since they might be practicing outside
the scope of their practice and it is not practice, it's research, it
is probably not productive here.
DR. GORDON: Gerri.
MS. POLLEN: This was recommended by a lawyer who works for
the Attorney General, the State of Washington, and it is important
because one of the issues was the concern that practitioners had of
losing their license. So, it was recommended that we make it very
clear that as long as the practitioner was meeting the licensing or
authorizing standards of practice, that other similarly licensed or
authorized practitioners are held, that they would then be able to
retain -- the concern about losing a license would not be a concern
anymore.
DR. FINS: But you are saying that up top, by saying licensed
or other authorized practitioners. Presumably, they are authorized to
do the kind of practice they are engaged in, in general, but here, we
are talking specifically about research. This recommendation has been
misrepresented in some media reports after the last meeting, and I
sought to correct that in I think it was the blue sheet, and we
communicated with the editor of that journal for clarification, but
the goal here was to say that if somebody has met the objectives of an
appropriately constituted IRB and are following federal human subjects
protection, and they are engaged in research, that in and of itself is
not a reason for sanction. If they are practicing out of the scope of
practice, that is another issue, but part of the IRB process would be
to ensure that appropriately credentialed, appropriately qualified,
this is part of those regulations, that they were entitled to do this
research. So what we are trying to say is if you want to do CAM
research, this kind of participation in this process, which are very
high ethical standards, should give you some kind of protection
against arbitrary sanction simply because you are engaged in research.
DR. GORDON: Gerri is shaking her head.
MS. POLLEN: Just having IRB approval is not going to do it
by itself. You also have to be meeting the requirements of your
profession. That is what that last part is saying. The standards of
practice must be met in all cases. It is not enough just to have IRB
approval.
DR. FINS: I understand what you are saying. I don't know
how to resolve this expeditiously, and I am sensitive to Julia's
comment about time, but you say here "licensed or authorized
practitioners." That presupposes that they are doing research that is
within the reasonableness of what they are doing, but these guys are
doing research that is -- it is not within their scope of practice
necessarily.
SISTER KERR: Aren't you saying they are doing something in
their practice that is not licensed? Like if I am not an
acupuncturist, and I am doing acupuncture doing a research project,
you are just saying I can't do that. But that is just like a muddling
statement to just say you are supposed to follow licensure laws.
DR. GORDON: I am still not sure what the confusion is here,
but if you can elucidate, Joe, if you can shed some light on this.
DR. PIZZORNO: I think my understanding is that we are trying
to do two things here. One is for practitioners engaged in research
that is not the standard of practice, that they are not prosecuted to
be engaged in such research. However, we don't want to open the door
that the person can do anything they want and just say that they are
doing it as research. This has to be worded very carefully, and I
think the wording is fine except for "authorizing standards of
practice." I am concerned that that phrase there puts them right back
into the liability issue. I don't think that phrase should be in
there.
MS. POLLEN: If someone doesn't receive a license, but some
other standard of practice, how would you say it, that is authorizing
them to practice?
DR. GORDON: It's a registration rather than licensing.
MS. POLLEN: Yes, this wasn't meant to be a catch-all for all
other.
DR. PIZZORNO: Make it "authorization to practice." Just
remove that word "standards of practice." Standards of practice is a
specific phrase.
DR. GORDON: Or "other authorization to practice."
DR. PIZZORNO: Yes, "authorization to practice." That would
take care of that.
MS. POLLEN: I think that would do it.
DR. GORDON: Don, you had a concern. Do you want to re-voice
that, or are you okay with this now?
DR. WARREN: I am just concerned that anybody engaged in
anything with CAM may be construed as research at this point, and
state boards may come in and say, well, we are going to nail you
because you are doing CAM.
DR. GORDON: I couldn't hear.
DR. WARREN: State boards may come in and just say, well, you
are doing CAM, so you are going to be guilty of malpractice or
whatever.
DR. GORDON: But it says they cannot be sanctioned solely
because they are engaged in CAM research.
DR. WARREN: That's right, and that is where I said let's
drop the rest of it.
DR. FINS: I think the issue here is if someone is engaged in
CAM practice, there are issues of licensure and everything, and that
exists here. What we are saying if someone is engaged in a clinical
protocol, they have gone through the process of review, they have met
federal expectations through the agency of their local IRB, and that
in a sense should give them some sort of deference with respect to the
state medical board. We are simply saying that the mere fact that
they are engaged in research about novel issues should not lead to
sanction. This protects the researcher who complies with regulations.
DR. GORDON: I think, Don, the difference is this is
addressed purely to research.
DR. FINS: Research, not practice.
DR. GORDON: This is the issue that was brought up by the
people who were doing research on NEAT and by Nick Gonzalez, as well,
the whole issue of how do you move the research agenda ahead and
provide some sort of protection from unfair prosecution for these
people. So, this is purely a research, and not a practice issue. I
don't know that Nos. 1, 2, and 3 are necessary because I think they
are covered by what is under 5, but I am not opposed to it. We
already have said this once.
DR. FINS: Well, this relates to the state boards. I don't
think we talk about state boards elsewhere.
DR. GORDON: Can we get agreement on this with the change?
DR. FINS: Jim, maybe to make it a little less stand-alone,
and to put it in the context, why don't we make this 5.5, and not
Recommendation 6, because then it sits better with its neighboring
recommendation about research.
DR. GORDON: No, I think it needs to be alone because it is a
separate point. It is a separate kind of shield. I think it is a
very important recommendation, and it is separate from the rest.
DR. FINS: If I could, the text should capture the
justification, that this to meant to incentivize the investigator
involved in CAM research, not only to realize the obligation to follow
these rules, but that there is something protective in complying with
the regulations, because it confers an element of immunity against
idiosyncratic prosecution simply because they are engaged in research.
DR. WARREN: But another thing is that most CAM practices are
a research project in the making.
DR. FINS: Well, then, they should be in clinical trials.
DR. GORDON: This is offering an incentive for people to do
research in a sense. It is saying, look, if you want to do something
that is a little bit out of the ordinary, that you think is very
useful, you get an IRB to do it, and we will say, as a White House
Commission, we feel you should be protected. So, it is a way of
incentivizing research. I don't think it is negative about people
doing practice, whatever practice you are doing, that is a whole other
area which we may need to come back to when we talk about regulation
and practice.
DR. FINS: And that's about a licensure issue.
DR. GORDON: And licensure. Do you follow, Don? This is
really just purely a research issue here. Veronica.
MS. GUTIERREZ: What about grandfathering in? I mean we are
talking about the ideal that may be implemented sometime in the
future. What about right now, any consideration?
DR. FINS: There is zero tolerance for human subjects
protection, I think, and that is a categorical.
DR. GORDON: I will just say two words about this. I think
this potentially can help the field tremendously. We have done
research under these strictures. We set up our own IRB, we have done
research, it has been fine, and I think it can really help move things
ahead. I think the practice issue and the persecution in practice is
a whole other issue that we need to look at later, but this is saying,
okay, let's get those CAM folks out there doing research, and let's
help them do it.
DR. WARREN: It was the persecution that I was concerned
about, that I read into this, and I am okay if we are going on to
something else.
DR. GORDON: Let's move on Recommendation No. 7. "To
facilitate CAM integration into the health care system, increased
efforts should be made to strengthen the emerging dialogue among CAM
and conventional medical practitioners, researchers, and accredited
research institutions, federal and state research, health care and
regulatory agencies, the private and nonprofit sectors, and the
general public." Eight action items. Tom.
MR. CHAPPELL: This is one of those cases where the
introduction to facilitate CAM integration into the health care
system, I feel that the language is moving accountability to the
conventional health care system. What I would like to do is to strike
that introductory phrase and then the rest of the recommendation
stands alone, and the whole action steps are clean in terms of that.
DR. GORDON: Is everyone okay with that? Okay. Thank you,
Tom.
DR. FINS: I have one minor thing on 7.7. Everything else to
me looks okay. This line 9. "IRB should consider requiring that all
research subjects be asked about their use of herbals or dietary
supplements, and hospitals should consider requiring that all
inpatients and outpatients should be asked about their supplement
use." First of all, IRBs do not dictate the research agenda, so that
clearly doesn't make sense to me, and I think that should be struck,
and the issue about hospitals getting information is kind of
prescriptive and we deal with this in Access and Delivery, I think
later on and elsewhere. I just think this 7.7 is problematic on two
fronts, and maybe would suggest humbly that we just delete it.
DR. GORDON: Other comments on that, 7.7?
DR. JONAS: I agree. The hospital issue is not a research
issue, it's a practice issue. IRBs, however, can specify that this is
what you have to collect on your patients, and if that is not done, if
they are not aware of it, then, a lot of that hidden stuff will not be
found out, as evidence the NIH study, for example.
MS. POLLEN: Yes, this is based on what the NIH is doing at
the clinical center, and the IRBs, I think are appropriate for this
section. The part on the hospital could be taken out.
DR. GORDON: Are you okay with that, Joe?
DR. FINS: Wayne, you are saying that this is kind of like --
DR. JONAS: It is saying that those that approve research
should be aware or should try to be sure that investigators collect
this information on these practices basically.
DR. FINS: Could we say in appropriate trials? I mean there
are certain trials -- is this a categorical, across the board at the
NIH for everybody?
DR. JONAS: Well, let's put it this way. NIH did a random
survey of people enrolled in their intramural clinical trials, and
only asked about herbs. Sixteen percent of them were using some kind
of herb or supplement at the time, and nobody knew about it.
DR. FINS: You are saying this could alter outcomes.
DR. JONAS: Yes.
DR. FINS: Okay, I agree.
DR. GORDON: Have we got this one? Perfect. Let's move on
to No. 8.
DR. WARREN: So on 7, we struck --
DR. GORDON: We struck that first part.
DR. WARREN: The first part or the last part?
DR. GORDON: We struck the first part of the recommendation
and the last part of 7.7, the hospital part.
DR. WARREN: Okay.
DR. GORDON: Recommendation No. 8, page 22. "Public and
private resources should be increased to strengthen the CAM research
and research training infrastructure, conventional, medical, and CAM
institutions, and to expand the cadre of basic clinical and health
services researchers who are knowledgeable about CAM and have received
rigorous research training." Joe.
DR. FINS: I agree with that, but I think there was somewhere
here we have no -- as far as I could tell, nowhere where we are
setting priorities. We have never made a recommendation that NIH
should look at their aggregate cadre and determine priorities. I mean
there should be some sort of priority-setting recommendation, and it
struck me here that this might be the place to set up an intramural
mechanism to determine priorities vis-a-vis the relationship between
CAM funding and other kinds of funding, because, really, this might be
at the expense of what. I think if we made a recommendation to this
end, we would probably do more to promote more funding rather than
less funding, and in the absence of it, it is kind of vague.
DR. GORDON: Can you give an example of that kind of
recommendation?
DR. FINS: We could say that, you know, the leadership of --
you know, there is an interagency or inter-institute sort of council
look at ways to appropriately allocate, you know, the kind of language
Wayne had suggested before about proportionality, just so there is
some mechanism where the decision can be made in a way that doesn't
dictate what the numbers should be, but we say that there is some
mechanism, so that this discussion occurs.
DR. GORDON: Does somebody want to suggest wording? Wayne,
Linnea, Tom?
MR. CHAPPELL: I don't think the wording is appropriate
because again, you just have to leave this consideration to the
judgment of the leadership of the various agencies. If, on the other
hand, we wanted to make a prioritizing recommendation about what
recommendations in total we think are more important than the other,
that's fine, but the kind of tradeoff that I hear Joe talking about is
really beyond our reach, and it is the holistic view that the head of
the agency needs to consider, how much is going to go into CAM, you
know, strengthening CAM researchers versus whatever else they are
doing. But our directive here is to be sure that more dollars are
going into the training of researchers of CAM practices. That is the
directive, and I don't think it is up to us to try to suggest to the
ultimate agency how they are going to spread that money.
DR. GORDON: I wanted to check in with you, Linnea, because
you were concerned about specificity, whether you had a thought about
this.
MS. LARSON: No.
DR. GORDON: Okay. Wayne.
DR. JONAS: I think this recommendation actually is supposed
to be targeted, and it looks like most all of it is targeted to
research training. So, in the actual recommendation, that is a bit
confusing because it says, "CAM research and research training," when
we already made a general recommendation about CAM research in
general, so I think we should strike the CAM research, focus it
specifically on training.
DR. GROFT: Wayne, I think that is research infrastructure.
Maybe we should rephrase it.
DR. JONAS: Well, it says, "research training
infrastructure."
DR. GROFT: Maybe "research infrastructure and research
training infrastructure."
DR. GORDON: How would you like it to be?
DR. JONAS: I am just trying to get clarified. Is this
supposed to be research infrastructure and training instead of
research training infrastructure?
MS. POLLEN: Research training and research infrastructure,
or it could be the other way around.
DR. JONAS: They are separate issues, training and
infrastructure.
MS. POLLEN: Well, it is not as crisply written as it should
be. I will clarify that.
DR. JONAS: I think that would help because then the
Recommendation 8.4 makes sense, which is about developing research
infrastructure.
MS. POLLEN: Right.
DR. GORDON: Do we have a rewording of the recommendation?
MS. POLLEN: Yes.
DR. GORDON: Go ahead, give it to us.
MS. POLLEN: "Public and private resources should be
increased to strengthen CAM research training, and research
infrastructure at conventional, medical, and CAM institutions to
expand." So, I could either say "research infrastructure and research
training" or "research training and research infrastructure." The
infrastructure is more than research training. It includes research
training.
DR. JONAS: I agree. I mean you can just say "research
training and infrastructure" or "infrastructure and training," however
you want to do it. I don't think you have to use "research" twice.
DR. GORDON: Having said that, what about the issue that is
still on the table? Joe suggested that we might want some language
about prioritization. Wayne's response was we are already doing it
enough here?
DR. JONAS: In the original recommendation under 4, where we
said we want to have these things looked at and prioritization, we
have something under there, and in the ones that I am going to
rewrite, there actually is a specific request to do prioritization and
address the issue of prioritization. So, I am not sure if we need to
stick that in this one also. I think it is assumed under our general
one. You could add something similar to what we did under
Recommendation 1, in there, saying, you know, proportionality and
prioritization need to be addressed, there should be a study by the
institutes to look at this or whatever, the agencies to look at this.
It doesn't matter to me.
DR. FINS: I think as long as it is somewhere in this
section. It doesn't matter if it is here or somewhere else.
DR. GORDON: You are saying it could be in the text,
discussing the issue?
DR. FINS: It's in a recommendation.
DR. GORDON: It is in the first recommendation now. We added
it. Is that okay?
DR. FINS: Yes. I agree with Tom, we don't want to
micromanage it, but I think there should be some nod towards the
importance of, you know, realizing that there is not an unlimited pie.
I think Veronica said this morning about "should" and everything. I
have trouble here with telling medical schools what they should or
should not do. One is perhaps an unfunded mandate, and two, as an
abridgement of academic freedom. I think we heard that from the AAMC
when we had some discussions with them. I just think that language
like "should" here, there is probably a more productive way of
characterizing that.
DR. GORDON: George.
DR. BERNIER: There are a number of phrases you can use, but
"ought to be considered" or "should consider."
DR. GORDON: The concern I have had personally about the
"consider," is they are already considering it. The question is how
do we help them to take the next step beyond "consider," because
considering, as you know, can go on for a long, long time. The idea
is there, so how do we do that?
DR. PIZZORNO: I think different from what it has been in the
past, we are not telling the institutions to do this, we are saying
the funding should be provided for it, and then institutions will have
the incentive to do it.
DR. FINS: If you look at 8.2, the institutions should
support da-da-da-da. Some of it is true, Joe, but some of them, it is
what they themselves are doing.
DR. GORDON: Funding should be made available. That is a
federal function. That comes back to Linnea's concern, and then it
gets away from the "should," and says we are going to make funding
available to you to do this.
DR. FINS: I think the parallel structure for 8.1 would also
be good, because we are asking the leadership "should" develop. So,
if we say "funding should be promoted to develop programs."
DR. GORDON: -- accredited CAM to develop, how about that?
DR. FINS: That's better.
DR. GORDON: Got that, Gerri? All right, let's go on.
Recommendation No. 9. "Public and private resources should be
used to support, conduct, and update systematic reviews of the
peer-reviewed research literature on the safety and efficacy of CAM
practices and products." I have a problem here that I don't see
addressed. I want to make sure that that information is available in
a form that is easily understood by the general public. This is not
just research for researchers, this is research for everybody. So,
that is what I would like to add, and I felt somehow that got dropped
out. Gerri.
MS. POLLEN: [Off mike.] 9.2 does say specifically --
DR. GORDON: I know, but it says for the public, but there is
information available for the public now, that the public cannot
comprehend.
MS. POLLEN: That is why that one is written, so that
hopefully, it will be very explicit that it be in language -- okay.
DR. GORDON: "Systems and treatments that can be easily
understood by both health care practitioners and the general public."
DR. LOW DOG: I think that's fine to add that here, but no,
that we have expanded a lot on that under the Information Section. We
have really addressed this.
DR. GORDON: But I think we need to have it here under
Research, as well.
MS. POLLEN: Easily understandable.
DR. GORDON: Easily understood --
MS. POLLEN: By health care practitioners.
DR. GORDON: And the general public. Any other issues here?
Wayne.
DR. JONAS: I would just like to add "collate" after
"conduct." It's implied in the action steps, but I would like to put
it in there. What I would like to see actually is something like
clinical evidence, I mean where they actually have a summary ongoing,
updated, one source using the same standards, so you can go, aha, here
it is, and now I can go back and check and see what the current update
is, and this type of stuff.
DR. GORDON: That is what we had in the document, and this is
justified by the text. These are the recommendations. Are there
issues in the text? We have agreement on the recommendations, which
is wonderful, and we have hashed it out. We have taken perhaps a
little longer than we would like. What are the issues in the text
that need to be addressed? Tom and Joe.
MR. CHAPPELL: I just want to repeat that where we see the
phrase "integrate into health care system," I would like that language
changed. If we look at page 2-25 and 3-25 -- I'm sorry, it appears on
page 2, line 25, on page 3, line 25, and it's the language,
"integrated into the health care system." It's about CAM being
integrated.
MS. SCOTT: It's line 8 on page 2 in our binders.
DR. GORDON: Page 2, line 8.
MR. CHAPPELL: Do you see my point?
DR. GORDON: Tom, why don't you express your concern and say
how you would rather see it be.
MR. CHAPPELL: I would like simply the writer to change his
or her location by standing in the shoes of the Congress, and talking
about holding accountability of safe and effective CAM treatments
rather than talking about integrating them into the health care
system. This is the point that I made at the opening of the morning.
DR. GORDON: Any other comments on Tom's comment? Joe.
DR. FINS: I gather, Tom, that you don't want these CAM
treatments and approaches to be subsumed by.
MR. CHAPPELL: That's right.
DR. FINS: However, there is an alternative maybe, because I
think we want the safe and effective integration of CAM and
conventional treatments. In other words, if it is not into a system
of conventional medicine together to promote the public good, I
appreciate what you are trying to capture about not being subsumed or
overwhelmed or diluted, but at the same time, I also want to try to
convey a sense that these two things have to mesh without being
diluted, if that is how people can be best protected. I don't know
what the language is.
DR. GORDON: You wanted to talk about the use of safe and
effective CAM treatments both within and outside of the conventional
medical system, something like that.
MR. CHAPPELL: I agree with that, Jim. In fact, you could
say, "to contribute to the accountability of safe and effective CAM
treatments" period, so you don't have to talk about it being
integrated.
DR. FINS: I think this represents kind of a philosophical
divide here. I fully appreciate the point you are making about the
sort of independent legitimacy of these endeavors outside of
integration. My concern is that there is a need for a relationship
between these two entities, these two worlds.
DR. GORDON: Can we instruct the writer to take account of
both the independent development and of the relationship? Would that
satisfy both of you?
MR. CHAPPELL: Sure. I want both systems to be accountable
to the public.
DR. GORDON: Exactly.
MR. CHAPPELL: That is the language I am striving for.
DR. FINS: They have to be accountable when they are engaged
together.
MR. CHAPPELL: No, they do not.
DR. GORDON: They do, don't you think?
MR. CHAPPELL: No, that is not my objective. My objective is
to hold each system accountable for safety.
DR. GORDON: They are all accountable to the public.
MR. CHAPPELL: Right.
DR. GORDON: Whether it is integrated or not integrated, it
is still accountable to the public.
MR. CHAPPELL: That is correct. I have supported all of the
integrated language in the research, and I would in many systems, but
I don't think it has to be integrated. I want it to be accountable to
good public health policy, and that is what I would like our
recommendations to be, whether it is conventional medicine or CAM, but
I am not asking that it be integrated.
DR. GORDON: I am not hearing real opposition. I think you
are saying integration is one of the areas that has to be accountable,
and he is saying if it is not integrated, it still has to be
accountable.
DR. FINS: Right, we don't disagree on that, but the point is
that simply being accountable in their own distinct world is not
enough.
MR. CHAPPELL: Accountable for safety and efficacy?
DR. FINS: Right.
MR. CHAPPELL: I think it is enough.
DR. FINS: Let me just make an example. St. John's wort is
safe and effective. In combination with a protease inhibitor, it may
not be safe, and it may be less effective. A protease inhibitor is
safe and effective on its own side, but when these things are brought
together, that is really to me a central important --
DR. GORDON: I don't think, Joe, that what he is saying
violates what you are saying in any way. It is still accountable. I
mean whether it is used together or used separately, there is no
difference.
MR. CHAPPELL: There is only one world view in this statement
at the present time, the way it is stated, and that is CAM needs to
integrate into the conventional health care system, and I don't think
that that is our vision.
DR. GORDON: I don't think that that is part of our world
view.
MR. CHAPPELL: It is not, but I am just talking about this
sentence.
DR. GORDON: It is talking repeatedly about integration and
collaboration.
MR. CHAPPELL: Right, and so I would like the language
combed.
MR. CHAPPELL: If everybody understands this principle, that
we are talking about collaboration, and the point is well taken, and
not just integration, can we move on because we are already at 3:30?
Linnea.
MS. LARSON: I know we already settled this. I just wanted
to add one little tweak to the last one on 9. "Public and private
resources should be used to support, conduct, collate, and update
systematic reviews of the peer-reviewed research literature on the
safety and efficacy and cost-benefit of CAM practices and products."
DR. GORDON: Okay, everybody? Please nod your heads. We are
talking about text here. General comments on the text.
DR. JONAS: Prior to the first recommendation is what I
consider the heart of the research discussion, the text. I mean there
are other things spread throughout, but I think these are some of the
key issues. I have a number of fairly minor edits, I think wording
changes that I don't need to go over in detail, because a lot of them
are fairly minor. However, there are a few things that I think I am
obligated to at least say about because they may have some meaning
differences.
DR. GORDON: Okay.
DR. JONAS: There are a couple of things that I think need to
be added. I think the way the definition of CAM is co-opted by all
parties to decide what research is being done or not being done, and
where dollars go is extremely important. The CAM community will
co-opt things that are traditional, that are conventional medical
aspects, and say, oh, this is actually CAM all along. The
conventional community will then co-opt standard things that they have
been doing all along, and say, oh, now it is a supplement, so it's
CAM, and this type of thing. That has major consequences for the
shift of research funding dollars and prioritization. So, I think we
should describe that issue at least, so that people are aware that
this is there, and that therefore the need for prioritization process.
So, that links us back to the actual recommendation where we say the
IOM and others should -- but primarily the IOM -- should establish
prioritization and definitional criteria. So, I would like to add
that in.
DR. GORDON: Is everybody with Wayne on that, or any
questions about what he is saying?
MS. POLLEN: Yes.
DR. GORDON: Are we all right with that?
MS. POLLEN: I am not. I am not quite sure I know where
Wayne -- Wayne, where were you with that?
DR. JONAS: Well, I was going to stick it under No. 1,
somewhere under No. 1.
MS. POLLEN: No. 1, you mean Recommendation 1?
DR. JONAS: No, under text No. 1, Research Support under
Current CAM Research Activities. Probably I would do it on the third
page, maybe line 18 or something in there, but we can find a place,
because it is really a topic that is not addressed at all in here.
MS. POLLEN: And that is again the same issue which you
brought up for the recommendation, which was the proportionality
issue?
DR. JONAS: Well, it relates to the prioritization issue.
MS. POLLEN: Prioritization.
DR. JONAS: Yes.
DR. GORDON: Are you going to want to say anything about
criteria for prioritization?
DR. JONAS: Well, yes, I would like to, but I think that
those issues can be left to -- if that occurs, if the IOM says all
right, we are going to do our process for looking at the
prioritization, which, by the way, they have already said they would
do, they developed a whole plan for doing it, in fact, then, that can
be addressed at that time. I do think that to talk about the
definitional issues as a way in which, without prioritization process,
all sides begin to co-opt research dollars, and therefore, don't allow
you to do proportionality estimates on these areas, should be at least
stated in there as a challenge that justifies then this. I would like
to least say something about the definitional issues in terms of how
that influences. I do think that a statement about -- I don't think
the federal government should be expected to fund all things that are
non-patentable, that is impossible, and some statement in there to
that effect. We have said that we think that they should fund more
that is not patentable, but I think it should be clear that we are not
going to rely on the federal government to do this, we need to be
aware of that, that this is going a token in many ways.
MS. POLLEN: A bridge there could be that because the need is
now, the federal government has to do what is necessary, but at the
same time, there needs to be stimulation for the private sector.
DR. JONAS: Exactly, and we have that.
MS. POLLEN: And eventually, there will be less federal and
more private.
DR. JONAS: I agree. We should make that clear in the text.
DR. GORDON: You can't lose the thrust that the federal
government needs to step out and do it now, Wayne.
DR. JONAS: No, I agree. I am not saying not to do it. I
just think that we should be aware that it is never going to be able
to do it all, and we shouldn't be expecting that this should be the
sole source. On No. 3, in terms of the whole person, I think we also
ought to add a little bit more emphasis on whole systems, whole
persons and whole systems, and we have talked about that, it is fairly
easy, the importance of looking at whole systems, and that is actually
being done.
MS. POLLEN: Wayne, whole systems is picked up under
Expanding Areas of Scientific Inquiry.
DR. JONAS: I saw that, and I thought it was weak in that
area, but we could expand it in that area, too, if you wanted to. I
would like to have something about it under Whole Persons and Whole
Syste
MS. I think there ought to be something to emphasize
that, and maybe it's a rearrangement of what is in there.
DR. GORDON: Are we all right on this, as well? Good. Go
ahead, Wayne.
DR. JONAS: I think that we should put something in about the
need to really look at research methodology for two purposes, one of
which is to come up with standards that are applicable to
complementary and alternative medicine, and this is probably the most
problematic area, and let me explain what I mean. The way I would
phrase it is that we need to come up with creative methodologies,
"innovative," you could use, et cetera, et cetera, to address areas
that don't fit currently into a neat little bundle in terms of
standard approaches. For example, what if you never come up with an
active ingredient, or you don't know what the active ingredients are
in an herbal product, then, you will never be able to just plug it
into a drug trial. You can approximate it, but you can never just
plug it in like you would do a drug trial.
DR. GORDON: You would put that under No. 5?
DR. JONAS: Yes, I would put that under No. 5 exactly.
Another area is behavioral medicine and mind-body types of techniques
that involve learning. It doesn't mean you can't do good research on
it, but it means that there need to be creative ways of addressing
this, and this then backs up one of the recommendations that will go
under No. 4, which is that the NIH should focus on development of
creative methodologies that are specifically applicable to CAM in
those areas. There is a number of other minor things. I don't think
that they are that important. I could actually put that also under
Pluralism.
DR. GORDON: So, these are some changes, and, Wayne, you are
going to be working on these with Gerri, is that right?
DR. JONAS: Yes.
DR. GORDON: Don had an issue, and then Joe.
DR. WARREN: Page 1, line 6. Instead of saying, "Cost
effectiveness of CAM treatments," let's change that to "CAM care, and
to discover the basic mechanisms underlying this care," instead of
these treatments. Not all of CAM is treatments, but it is care,
though.
DR. GORDON: Is that okay with people? Let me see a show of
hands. Okay.
DR. FINS: I think on page 3, to strengthen the argument
here, lines 11 to 17, it would be helpful just to have percent success
rates and how that compares with the other institutes.
DR. GORDON: Percent success rates?
DR. FINS: Scores, you know, people with certain scores and
what percent rates, because if they are high scored, and as Steve
said, they are in single digits, and other institutes are in double
digits, then, that makes --
DR. GORDON: Can we get that information, Gerri, you think?
Some of it may be a little hard.
MS. POLLEN: It may be very difficult to get that at this
point.
DR. GORDON: We could probably get the NCCAM information, but
not so easy to get the information from the other institutes.
MS. POLLEN: That's right.
DR. FINS: It is not a "must do," but I think it is worthy of
an effort. I just want to echo on page 4, lines 15 and 17, I think we
have to really tread very carefully about the patent issue,
intellectual property issue. We just have a couple of lines here, and
I think it is better to just lay out why funding is necessary versus a
resolution. I think all this, the technology transfer, these are very
complicated issues, and I think it is simply enough to say that there
is a public health need, the kind of what we talked about with the
recommendation, to protect the public. This is not always amenable to
private funding for a variety of reasons including patentability,
intellectual transfer of innovation, et cetera, and not get as much
into it.
DR. GORDON: Let me make sure that everybody understands and
that Gerri in particular understands, that everybody understands and
agrees, and that Gerri understands.
DR. LOW DOG: Part of what I am hearing, though, is also that
we don't have to come up with all the answers for how these things are
going to be implemented, that we can pose the problems and the reasons
why they exist, and then we are making recommendations for people to
try to figure out how to incentivize it. We don't have to create the
answers. We may come up with the wrong ones. I think that is what I
am hearing.
DR. FINS: We haven't heard testimony and we haven't studied
it in depth to make cogent suggestions about the resolution --
DR. GORDON: Joe, can you give a sense, maybe a clearer sense
because people are a little confused of what you would like in place
of that?
DR. FINS: I would say lines 15 through 18 or so, like we are
making recommendations about tax incentives, market exclusivity, and
resolution of intellectual property issues. I think it is a little
too prescriptive based on the nature of the testimony we heard, the
expertise around this table, and the fact that there is a depth of
scholarship in this area that we haven't even begun to tap. So, I
think it is better to posit the problem than to try to fix it. I know
you are saying "might consider," but it still comes across as too --
DR. GORDON: David.
DR. BRESLER: Actually, at the New York meeting, there were
representatives of Wall Street there that some of us had a chance to
talk to for a while about what was going on, they attended our
hearings. These were some of the things that they had suggested could
stimulate interest in them getting involved in investing in this. I
don't think it is prescriptive. I think these are action-oriented
recommendations that we are going to make. I would vote to keep them
in.
DR. GORDON: Julia.
MS. SCOTT: I agree that we should keep them in. They are
not prescriptive. They are suggestions of ways in which it might be
done. I think the other thing we need to keep in mind is, you know,
you send up a policy recommendation to Congress. It takes on a life
of its own, and they are going to whittle it down and change it, you
know, to do the minimum, many of us think. So, we don't need to do
that for ourselves. I think it is great to highlight pitfalls that
might happen, but I don't think we need to cut it down or be that
prescriptive, which I don't think we are in this case.
DR. FINS: I think it is an area of great interest and
promise, and I just would editorially just tinker with it a little
bit. On page 5, I think that there is an element here about this
going back to the very first introductory section about respect for
the whole person, and I think we want to say something here about
convergence and shared, you know, concerns about the broader
bio-psychosocial model, not to say that only CAM is concerned about
health and the whole person, going back to what we agreed to this
morning.
DR. GORDON: How is everybody with that, okay?
DR. FINS: We agreed on it this morning, it is just
consistent, I think.
DR. GORDON: I just wanted to make sure.
DR. FINS: On page 7, the expanding area of scientific
inquiry. I am reminded what Marcia Angell said, "Science is science,"
and I agree that there is a need for novel approaches. You would use
language like "novel approaches that maintain rigor," that maybe
employ the social sciences, as well as the biological sciences, but
this seems like a kind of a swipe at science, you know, "moderate
reductionistic expertise," which I am not always a proponent of
reductionism myself, so I find myself sort of out of place arguing for
reductionism, but reductionism has its place at times. I think we
want to maintain the rigor of science here. We shouldn't develop a
methodology that generates an answer that we want, but methodology
that is rigorous.
DR. JONAS: Would you like a word change somewhere on this,
on page 7? Do you want to get rid of "modern reductionistic
expertise," or maybe make it approaches or something like this? I
think maybe the way it is expressed is perhaps a little unclear in the
sense that what we want is we want to look at whole systems. I think
people are doing that. In fact, even conventional research, they are
doing that, and perhaps we are talking about kind of objective
measurements or something like this.
MS. POLLEN: Aren't we talking about bringing together both
approaches?
DR. GORDON: Joe's point is that science is science, and
Wayne's point is yes, science is science, and there are many kinds of
science that need to be used. I don't think there is a contradiction,
and I think that his approach will resolve it.
DR. JONAS: I am just wondering, are there some wording
changes in this particular section that you would feel more
comfortable with?
DR. FINS: I think a lot of us feel that, for example,
acupuncture might one day be explainable through the biological
sciences, through imaging studies. There is already some preliminary
evidence that the neuroreceptors in the brain light up when
acupuncture is done. So, I don't think we want to necessarily foster
the sense that because we don't have the science to explain it now,
that science one day could not necessarily explain it. On line 16,
Wayne, the spectrum includes areas of challenge, biological scientific
concepts, and assumptions. So, you are challenging the scientific
method, the scientific paradigm with some of these issues. Some of
these things are not studyable by science. Some of these things are
not scientific questions, like spirituality, that is a different kind
of question.
DR. JONAS: Perhaps the word is materialistic, challenge
materialistic assumptions.
DR. FINS: I would say current biological and scientific
assumptions. I think current would help a lot.
DR. JONAS: Current.
DR. FINS: How about our current state of knowledge, because
I mean current state of knowledge about biological and scientific
concepts and assumptions, but we are not challenging the scientific
method. We are just challenging -- it is challenging the current
state of scientific knowledge. I can live with that if you guys can
live with it.
DR. GORDON: I would like to live with it, and I would like
to move on.
DR. FINS: I am done.
DR. GORDON: Any other issues here? We are now done with
this section. We are going to take 10-minute break and then we will
come back and look at Education and Training. Thank you, everybody.
[Break.]
Open Discussion: Education and Training
DR. GORDON: We are going to begin. The plan is as follows.
We are going to begin with Education and Training, and then we are
going to go to CAM Central, because some Commissioners are going to be
working on Access and Delivery overnight. Speaking of overnight, we
are staying here until 7:00, and we will start again -- unless we pick
up the pace, we are staying here until 7:00, and we start again at
7:00 tomorrow morning.
MS. SCOTT: Wait a minute. You need to say that again when
the rest of the people are here.
DR. GORDON: I will. Let's get started. I will make the
announcement again when they come back, but let's get started on
Education and Training. We are going to proceed the same way we did
with consent. Yes? Okay. Julia is nodding her head. I want to see
other heads, signs of consciousness. Good.
The first recommendation. "The education and training of CAM
and conventional practitioners should be improved to ensure public
safety and to increase the availability of qualified CAM practitioners
and knowledgeable conventional practitioners." That is on page 1. The
first action item is on page 7.
DR. LOW DOG: I just want to say, as a general comment, the
formatting should be consistent.
DR. GORDON: Is that okay with everybody? Consistency of
format. Is that okay with all the staff, is everybody tuned in on
this one? Okay.
DR. KACZMARCZYK: It was that way previously.
DR. GORDON: Are we agreed? The implication, Joe, is that
the commissioners then decided they wanted a different format? We
need to make sure that, as commissioners, we agree with Tierona's
suggestion that we want the same format for every section.
COMMISSION MEMBERS: Yes.
DR. GORDON: Great. There is the first recommendation and
then action item. The first action item is page 7. The second is page
9. Third is page 10, and so on. You have to look through the whole
text.
DR. GROFT: I think what we tried to do here was meet the
suggestion that we put the action item close to the language in the
text itself. I think that is why they are separated.
DR. WARREN: On Recommendation 1, line 25, page 1, it says,
"should be improved." That implies deficiency. Could we put in
there, instead of "improved," put "structured" as a recommendation?
It says, "conventional practitioners should be improved." I would
like to change "improved" to "structured."
Recommendation 1, page 1, line 25, fourth word, change from
"improved" to "structured."
DR. GORDON: Should be structured to ensure, I see.
DR. WARREN: Basically, we are talking about education and
training.
DR. GORDON: Because the way it is now implies that it is not
in good shape across the board.
DR. JONAS: What about "facilitated"?
DR. WARREN: No. Should be facilitated, education and
training should be facilitated to ensure public safety? No.
DR. GORDON: How about designed?
DR. WARREN: I will take "designed." It makes sense, but
"facilitate" doesn't really turn me on.
DR. GORDON: What is on the floor right now?
DR. LOW DOG: The Recommendation 1 on page 1. "The education
and training of CAM and conventional practitioners should be designed
to ensure public safety."
DR. GORDON: So, we are okay with "designed"?
COMMISSION MEMBERS: Yes.
DR. GORDON: Other issues and recommendations?
DR. PIZZORNO: Would you go back to why "improved" is not
accurate because "designed" implies they are not designed to do this,
or using "structured" means they are not structured to do this
currently.
DR. WARREN: To me, it seems like when you say "improved,"
implies that it is worse than could be. It is, we know that, but I
don't know, I like something a little more positive. "Improved" has
more of a negative connotation to me.
DR. PIZZORNO: How about "enhanced"?
DR. WARREN: We will take bids on this. I move we accept
this with the word "improved" changed to "designed," and accepted as
written.
DR. GORDON: Okay. Julia.
MS. SCOTT: I have a problem with the second part of that
sentence, "to increase the availability of qualified CAM practitioners
and knowledgeable conventional practitioners." So conventional don't
have to be qualified? I don't understand.
DR. LOW DOG: Could it be partly that some of these
practitioners may not be licensed, so we are using the word
"qualified," because some of them may not be licensed practitioners,
and conventional practitioners pretty much, by definition, have to
have licensure. I think that was maybe the reason "qualified" was
chosen instead of using "licensed."
DR. GORDON: I thought of another word, which might be
"scientifically-grounded CAM practitioners." I am open to other
possibilities. What we are talking about here, I think we need to
look at the action items, and the action items, there is something
about them I think that may not quite fit with the overall
recommendation, because the action items are largely for CAM
professionals to learn more about Western scientific methods, and for
Western professionals to learn more about CAM approaches, so that is
why I am trying to balance the overall recommendation. Tierona.
DR. LOW DOG: I have a more fundamental challenge on this
section here, which is because we are using the term "CAM," that it is
just then all-embracing. I am not sure how much yoga instructors, how
much Western science they really have to have. I am not sure how much
Reiki therapists or polarity. I think there is all these different
levels, and so what we have just done is scientifically-grounded CAM
practitioners, and yet there is a big spectrum of those.
DR. GORDON: How would you reconceptualize this
recommendation in this section given what you are talking about, given
that wide spectrum?
DR. LOW DOG: Well, I don't mind the recommendation as it
stands. I think the text needs work, but when you say that the
education should be designed to ensure public safety, that sort of
means that each group, you are going to look at what their necessity
is of how much they need to know of this, and then to increase the
availability of a qualified CAM practitioner, that, you are just
saying if he or she is a yoga teacher, that they are qualified to
teach yoga, but that may not be the same requirement as somebody else,
so I am fine with it.
DR. GORDON: So, you are okay with the current wording then?
DR. LOW DOG: Yes.
DR. GORDON: Linnea.
MS. LARSON: I don't have anything else really to offer than
I do think that there really is an embedded assumption here, that that
which we have now has not provided an assurance of public safety, and
that actually what we are asking for is a recognition that public
safety, in what we think of as two worlds, is the most important
thing. That is the recognition. After that recognition is that
whatever action items come will be to design to improve public safety.
But there is an implication in here, whether we substitute designed,
enhanced, or whatever, that public safety has not existed. I think it
is simply just I can't get my mind around the right words.
DR. GORDON: What is your position about the statement you
just made? Do you think we ought to be focusing more in the text on
public safety? I heard what you said, but I am not sure what the
implication is.
MS. LARSON: The implication is that we need to have a better
crafted recommendation. It is not within the text, it is a better
crafted recommendation. At this minute, I don't have it at the top of
my head.
DR. GORDON: Okay.
MS. LARSON: It is simply the systems that have existed for
education have always included some level of public safety. What we
are asking at some level is to set up that qualified or licensed
increases perhaps the public safety. That is another of the
implications.
DR. GORDON: Charlotte.
SISTER KERR: I just pretend I don't know anything, and I look
at Recommendation 1, and I see it as just a big run-on sentence, and
it is just not clear, just to start there. I would say Recommendation
1. "The education and training of CAM and conventional practitioners
should be" -- let's just say -- "designed to ensure public safety."
What I can't even help us with is what the heck we are trying to say
in the second part. Are we saying the education and training of CAM
and conventional practitioners should increase the availability of
quality CAM practitioners -- period? Are we saying that? And then
are we saying da-da-da should be to increase knowledgeable
conventional practitioners? If we are saying that, that's all crazy.
DR. GORDON: Is what? I'm sorry.
SISTER KERR: It is not even a statement to me that is clear.
Is that what we are saying? Is it basically three sentences, that
education and training should increase the availability of qualified
CAM practitioners?
DR. GORDON: I think you are right. It is a little
confusing, because it is two different thoughts. One is increasing
availability, and the other is ensuring public safety, and it may have
somewhat different mechanis
MS.
SISTER KERR: I think someone should say in just third grade
language what are we saying. We know the first one, we have got that,
we want designed to ensure public safety. Now, what do we want to
say?
DR. GORDON: Joe K., do you have a comment on this?
DR. KACZMARCZYK: As I recall, the work group wanted to
express two different views or ideas. Number one was the overriding
emphasis on public safety. Number two was increasing the availability
of both qualified CAM practitioners and knowledgeable conventional
practitioners. That was the intent of the work group as I recall it.
Joe Pizzorno.
DR. PIZZORNO: I would like to suggest a slight reword here.
I think that is what we are talking about. "The education and
training of CAM and conventional practitioners should be designed to
ensure public safety and improve health." I think that gets what we
are trying to do.
DR. GORDON: So, basically, you are eliminating the second
thought because it is confusing and confounding, I assume.
SISTER KERR: It would be a very important recommendation if
we want to say, we want to recommend that the number of qualified
complementary practitioners be increased. I mean that is very
dramatic and specific, but is that just the recommendation? No
specificity, no whatever.
DR. GORDON: I have Tierona, I have Joe, and I have George
Bernier. I'm sorry, go ahead, George, in his role as co-chair of this
committee.
DR. BERNIER: Another way of expressing those three ideas
together would be to say, "The education and training of CAM and
conventional practitioners should be strengthened to ensure public
safety and to increase the availability of both CAM qualified
practitioners and of knowledgeable conventional practitioners." I
think it was a pretty strong feeling of the committee that it was
important to include both the CAM physicians and the conventional.
DR. GORDON: Tierona.
DR. LOW DOG: I agree that we need rewording, but when I read
this, it is not to increase actually sort of let's bring on thousands
more people, but actually, of the people that are already out there,
to increase their knowledge base, so that those that are out there or
those that are in training will have increased knowledge relevant to
what they are practicing -- I mean that is part of it, too -- relevant
to what their role is going to be and their scope, but your whole
argument in this text is that conventional professionals need to know
more about complementary and alternative medicine, so that they are
more knowledgeable about what is out there. The other argument was --
and I do have some caveats there -- that depending upon what your
scope of practice is as a complementary and alternative medicine
practitioner, that you have an understanding of Western sciences, and
so that if we have this sort of cross-training, that that will somehow
enhance the public safety. When I read this, I am not getting that we
are going to increase the absolute number, but what we are doing, we
are making more knowledgeable practitioners of both CAM providers and
conventional providers.
DR. GORDON: I just want to check. Is that the intention,
Joe, of this? If we are agreed on the intention, we can work on the
wording.
DR. PIZZORNO: Let me try again. "The education and training
of CAM and conventional practitioners should be designed to ensure
public safety, improve health, and increase the availability of
qualified and knowledgeable CAM and conventional practitioners."
SISTER KERR: I thought the ending was really good. I just
had the question. You included "ensure public safety, improve
health." You just feel that you want to amplify that?
DR. PIZZORNO: That's why we are doing it. We want the
practitioner to be more effective in improving the health of the
population.
SISTER KERR: And to increase the availability of qualified
and knowledgeable CAM and conventional practitioners. If that is the
intention, then, I think that is certainly clear.
DR. GORDON: Joe.
DR. FINS: I guess what is missing is the aspect of
cross-training. It seems to me that if we could somehow capture in a
preamble to this, you know, to promote the health of the American
public as they make use of conventional and CAM modalities together
and in isolation. You know, we recognize the need to improve the
training of CAM and conventional practitioners.
DR. GORDON: What about just adding at the end, "and enhance
collaboration among them?"
DR. FINS: But that is an access and delivery kind of thing.
DR. GORDON: I am not sure what you are looking for.
DR. FINS: I am saying that, again, the metaphor that I keep
on thinking about is people going back and forth between two worlds,
and we can't protect them in each of the worlds if we don't protect
them as they move back and forth in the transitions. I think in order
to meet the needs of the American citizenry as they make use of
conventional and CAM modalities and treatments, together and in
isolation, we need to have a work force that is appropriately trained
with the interface. I need to know something about acupuncture when
my patients are visiting Effie, and she needs to perhaps know
something about hepatitis B, so if a person comes in icteric, she will
know to use universal precautions, and those kinds of issues.
DR. GORDON: My question to you is, does that need to be
expressed in the recommendation, or can that be an action item?
MS. SCOTT: No, it doesn't, it's in the action item.
DR. GORDON: Was there anyone else before -- Julia is next.
MS. SCOTT: I was just going to say that a lot of what Joe is
speaking to is in the specific actions. They are hard to find. I
went to the Recommendation Section because they are all together. In
this one, it is labeled 1.2, but there are two, 1.2's on the
recommendation page, so maybe in the text they will be separated out.
They are? Okay. So, I guess it is 1.3.
DR. LOW DOG: Have we gotten consensus on this?
DR. GORDON: No, I don't think we have consensus. First of
all, I would suggest that everybody look at the action items, and I
know it requires a little paging through, and then see whether the
recommendation, as stated and as amended, works with the action items
or whether it doesn't.
MS. SCOTT: I would like to recommend that as Joe read the
recommendation, it stand, and our other Joe's consideration of
cross-training, et cetera, it is, I believe, covered in the action
statements, as well as it is included in methodology when you teach.
We can't do every detail of curriculum planning, and I think the
spirit of that is definitely contained both in the recommendation and
in the action.
DR. GORDON: Don?
DR. WARREN: Are we on action items now or what are we on?
DR. GORDON: I want everybody to look at the action items, so
you know what they are, and you see how they go together with the
recommendation, and then I would like a restatement of the
recommendation for everyone's consideration. So, just a take a minute
and look at the action items, if you would. In this instance, all the
action items go with one recommendation, so it is important to get the
whole picture.
DR. LOW DOG: Maybe we should go through the action
ite
MS.
DR. GORDON: The first action item is on page 7.
"Conventional health professional schools, postgraduate training
programs, and continuing education programs should develop core
curricula of knowledge about CAM in conjunction with CAM experts and
CAM institutions, so that conventional health professionals can
discuss CAM with their patients and clients and guide them in the
appropriate use of CAM." Veronica.
MS. GUTIERREZ: I did e-mail a message about this. I thought
the phrase "and guide them in the appropriate use of CAM" resembled
the gatekeeper mentality, and I would like to see the sentence end
with "patients and clients." That way we keep personal biases out of
it.
DR. GORDON: Let's have any discussion about that
recommendation. Joe.
DR. FINS: I agree, it is really not about directing people,
but maybe to maximize the benefits and minimize the risks. I would
also take out this little parenthetical here, "in conjunction with CAM
experts and CAM institutions." That can be put in the text because
all we are saying here is that these schools should develop a core
curriculum about CAM, that would prepare -- prepare the conventional
health practitioner or professional to discuss the risks and benefits
of their patients' use --
DR. GORDON: We now have a suggestion, an amendment, and a
second suggestion. Tierona.
DR. LOW DOG: I also wish to take out "in conjunction with
CAM experts and CAM institutions," because we also don't do the same
when we talk about CAM education, we don't list in conjunction with
conventional, so I think keeping parity there. I just want to comment
about the "guiding" them. I am not attached to that particular
language, but there are a lot of people that are using CAM products
that are not under the guidance of anybody. They just go the health
food store, they just purchase things, and nobody is giving them any
kind of guidance, and I think it is to everybody, the chiropractors
and the pharmacists and the dietitians and the doctor, I think
everybody has to help guide folks, because a lot of what is being
consumed out there is not being done through a CAM professional, it is
just being purchased at a health food store or through multilevel
marketing.
DR. GORDON: I want to come back to the second point that Joe
raised, the "in conjunction with CAM experts and CAM institutions."
At least a couple of people have said that should be stricken because
it doesn't work both ways. George.
DR. BERNIER: I think it was very clear with this group
anyway that we felt it was critical for the CAM-accomplished
individuals to be able to pass that education on to the conventional
medical student, postgraduate, et cetera. It seems to me we are
running in two different directions here.
DR. FINS: I agree with that. I am just saying that it
should be in the text, but not necessarily in the recommendation, like
how you do it. I agree with the sentiment, but I think it goes into
the text.
DR. GORDON: Is that okay, put that in the text, and not in
the action item? I want to see heads. I want to see if that is all
right. We are going to put in the text, and take out of the action
item, the phrase, "in conjunction with CAM experts and CAM
institution."
DR. KACZMARCZYK: It is already in the text.
DR. GORDON: Then, we take it out of the action. Fine.
Let's go back to the second point that was raised regarding the last
clause here, "and guide them in the appropriate use of CAM." There
have been a couple of opinions expressed. Other opinions on this one?
My own opinion, in case you were wondering --
DR. FINS: You have been very judicious about sharing your
opinion, and I really want to congratulate you for holding back. You
have been great.
DR. GORDON: The reason that I think this could be important,
and I am not totally wedded to it, but I think the concept is
important because one of the main issues that I hear from patients,
particularly patients with serious illness, is I want my doctor to
help me figure out what to do, not just discuss CAM. That is the
first step. But they want to know, if they are going to see an
oncologist, they would like that oncologist to refer them to somebody
to give them more guidance about how to use these approaches, so that
is why I felt it was important to put in here.
DR. PAZ: Well, you know, there is actually a fair amount of
people who are not knowledgeable about CAM and their practices, so
they do ask what would be appropriate. So, I think that would be very
important to know.
DR. PIZZORNO: Veronica, was there other language you would
suggest?
MS. GUTIERREZ: Language, no. If somebody felt that that was
an issue, which is the other side of the scale, I suppose of what I am
talking about, what I deal with in my office on a regular basis.
Perhaps there could be the discussion in the guidance relating to CAM,
could be in the text of the document instead of the recommendation,
and I will tell you my problem with "appropriate" use of CAM, it is
just relating to chiropractic. People have concepts of chiropractic
that are as old as the profession itself, and we don't all twist
necks, we don't all twist low backs, and we don't all apply force, but
there are many, many medical doctors in our community that say, oh,
don't go to a chiropractor, you know, you have got osteoporosis, or
whatever. Right at the present time, I don't think it is appropriate.
Maybe it's a visionary thing that we can incorporate in the text.
DR. GORDON: Joe.
DR. FINS: The point here, it is coupled with education, and
that is why I want to use the word "prepare" them, that we should have
these things to prepare these practitioners, so that they can discuss,
but I think guidance is important. It is not in any way meant to be
like in a gatekeeper mode. It is really to have the heart-to-heart
kind of conversation that allows patients to make informed -- maybe
informed choices. Maybe that is the metaphor, "to prepare patients to
make informed choices about therapeutic options."
DR. GORDON: Linnea.
MS. LARSON: I had a solution to the recommendation.
DR. GORDON: Okay. We will come back to it. Joe.
DR. PIZZORNO: The majority of health care in this country is
provided by medical doctors, and the majority of their patients are
using CAM in one form or another, and the majority of them are doing
it without guidance. So, this is a problem that has to be addressed.
I think one of the problems we have historically is we don't trust the
guidance they would get, because either they are not knowledgeable or
they have biases, but we are about fixing that. We need to fix this
in a primary care environment, so people do get appropriate guidance,
and that is why I was asking you for some other kind of wording we can
use.
MS. GUTIERREZ: I like the phrase "informed choices," and
perhaps the professionals can discuss CAM with their patients, and
encourage all decisions be made out of informed choices, or something
of that type. That is no problem.
DR. GORDON: Joe.
DR. FINS: Conventional health professional schools,
postgraduate training programs, and continuing medical education
programs should consider -- I mean that is the other issue -- should
develop core curriculum about CAM to prepare conventional health
professionals, so they can discuss CAM with their patients to help
patients make informed choices about the use of CAM modalities,
something like that.
DR. GORDON: So, you are crossing out the "discuss," and you
are saying to help patients and clients make informed choices.
DR. FINS: Yes, because it is a collaborative model, and it
gets at Veronica's concern that we are kind of pushing them in one
direction. The patient is making the choice, we are not making the
choice.
DR. GORDON: It feels okay to me. Does it feel okay to
everybody? Okay. Let's do it. We are going to move on to Action
Item 1.2. For those who came late, after the break, we are going to
be working until 7:00 tonight, and we are going to be starting at 7:00
tomorrow morning.
DR. FINS: This is part of new wellness effort.
DR. GORDON: After two hours of yoga the first thing in the
morning.
MR. CHAPPELL: I would be available earlier than that, if you
would like, tomorrow morning.
DR. GORDON: I have to take care of the animals and the
fields first, so I can't get here until 7:00. 1.2. "All CAM education
and training programs should develop curricula that reflect the
fundamental elements of biomedical science and conventional practice
in order to ensure safe and beneficial care of patients." Tierona.
DR. LOW DOG: This comes back to my earlier comment about we
need to phrase this in a way that it is relevant to the practice, what
they are doing, because again if you are doing yoga or Tai Chi or
Reiki, I am not sure how much of this you need.
MS. LARSON: Same comment that I had.
DR. GORDON: Same comment. Okay. Good. Joe, do you have a
suggestion about how to rephrase it?
DR. FINS: Yes.
DR. GORDON: Good. Please.
DR. FINS: So it is consistent with their scope of practice.
DR. LOW DOG: Conventional practice?
DR. FINS: [Off mike.] -- that reflect the fundamental
elements of biomedical science and conventional practice consistent
with the scope of their practice, their CAM practice.
DR. LOW DOG: Just their practice.
DR. GORDON: How about "develop curricula consistent with
their practice?"
DR. FINS: Consistent with their scope of practice.
DR. GORDON: Scope of practice. That way, it is less clumsy.
Okay? Are we all right with this one?
DR. FINS: "All CAM education and training programs should
develop curricula consistent with the practitioner's scope of practice
that reflects the fundamental elements of biomedical science and
conventional practice in order to ensure safe and beneficial care of
patients." We have an extra "practice" in there we can take out.
DR. GORDON: Tierona, you look troubled.
DR. LOW DOG: I just actually think it reads better when you
put develop curricula that reflect the fundamental elements of
biomedical science and conventional medicine or whatever relevant or
consistent with their scope of practice because I think that is where
it fits. Or you can use conventional therapy, conventional medicine,
you can put whatever you want, or just the elements of biomedical
science.
DR. GORDON: Let's have someone state it, please. Do you
want to state it, Tierona, or, Joe, do you want to state it?
DR. LOW DOG: "All CAM education and training programs should
develop curricula that reflect the fundamental elements of biomedical
science and conventional medicine consistent with the practitioner's
scope of practice in order to ensure safe and beneficial care of
patients."
DR. KACZMARCZYK: Excuse me. Instead of "conventional
medicine," I think it should be broader, "conventional health care."
DR. FINS: Instead of saying "consistent," say "relevant"
now, "to the practitioner's scope of practice."
DR. LOW DOG: Can you put "in order to ensure patient safety"
or something?
DR. GORDON: The question is do we have to add that last
phrase, because that's in the recommendation.
DR. FINS: That's in the original recommendation, which we
will get back to.
DR. GORDON: I just don't think we have to keep repeating
that every time if it's in the original recommendation. Let's read it
once more without that last phrase.
DR. LOW DOG: "All CAM education and training programs should
develop curricula that reflect the fundamental elements of biomedical
medicine and conventional health care relevant to the practitioner's
scope of practice."
DR. GORDON: Don.
DR. WARREN: Did we change "biomedical science" to
"biomedical medicine," which is what you just said?
DR. LOW DOG: Oh, is that what I said?
DR. WARREN: Yes.
DR. LOW DOG: I didn't mean to say that. I meant to say
"science."
DR. WARREN: It should read, "All CAM education and training
programs should develop curricula that reflect the fundamental
elements of biomedical science and conventional health care consistent
with the practitioner's scope of practice."
DR. GORDON: Relevant.
DR. FINS: One more delete stylistically. Instead of saying
"All," just say "CAM education and training programs."
DR. GORDON: "And foster collaboration between CAM and
conventional students, practitioners, researchers, educators,
institutions, and organizations." Comments, additions, questions?
Okay. I just added one phrase, "To foster critical discussion and
collaboration."
DR. FINS: No.
DR. GORDON: No, you don't like that?
DR. FINS: It is implied in there.
DR. GORDON: Fair enough. Are we okay with this? All right.
Onward. "Increased federal, state and private sector support should
be made available to expand CAM faculty, curricula, and program
development at accredited CAM and conventional institutions." How are
we with that? I added one little addition, which I will offer up. I
would say, "Expand and critically evaluate." We don't need to put it
in, I am just think it's important that we evaluate the efforts that
we make in this direction.
DR. FINS: I think it is very important. I would endorse
that strongly.
DR. GORDON: We are not really critically evaluating faculty.
DR. KACZMARCZYK: Well, it's faculty development, Jim, it's
not faculty.
DR. GORDON: Faculty development, okay. Is that okay,
faculty development? All right.
MS. GUTIERREZ: If the institution is accredited, isn't that
the job of the accrediting agency to critically evaluate faculty
curricula?
DR. GORDON: My thought is that, for example, we have a grant
at Georgetown to develop a CAM curriculum. A significant part of that
grant is evaluating how well the curriculum works for the students. I
am just adding it. The reason I am adding it is because I think it
says we are serious about this, this in not merely giving some money
to folks. We really want to find out how it works. That is why I
want to put it in there.
DR. FINS: Maybe there is another action item here that is
consistent with your insight here. Maybe support should be made
available to accrediting bodies to critically evaluate. I am saying
like LCME, for example, we have no recommendations about LCME that go
into, say, medical schools to accredit them. We have nothing about
that, that I am aware of, in any of this, and the accrediting bodies,
if they are going to accredit, say, a medical school's program in CAM
education, so this is just on the conventional side, they are going to
need some kind of guidance. Now, maybe this is the next stage. Maybe
George could comment on that.
DR. BERNIER: Actually, the LCME knows a lot more about what
is happening in the CAM education process than I think we give them
credit for. I can see that being over the next few years, a really
key part of it, but I think at the moment, I would not add that last
phrase.
DR. GORDON: 1.5, page 17. "The eligibility of CAM students
for existing loan programs should be expanded."
MS. LARSON: I have a substitute recommendation that actually
orients it to something that is doable. It is, "The Department of
Health and Human Services should conduct a study to determine whether
and in what ways and to what extent should eligibility be expanded to
students of CAM." So, it sets it up before we just willy-nilly, say,
open everything up, and it gives direction to it. That is something
that we need to discuss.
DR. GORDON: Joe.
DR. PIZZORNO: Aren't the chiropractors already included in
the Heal Loan Program now?
DR. KACZMARCZYK: In the text, it states that chiropractic
students are included in two loan programs, Heal and SDS, which is
Scholarships for Disadvantaged Students.
DR. GORDON: Joe, expand on that a little. So, what is it
saying and what is not being said?
DR. KACZMARCZYK: I don't understand your question.
DR. GORDON: You are saying two programs allow chiropractors
in. In all states?
DR. KACZMARCZYK: These are federal progra
MS.
DR. GORDON: And other programs do not allow chiropractors,
is that right?
DR. KACZMARCZYK: Those, to the best of my knowledge, are the
only programs that include CAM students.
DR. PIZZORNO: I think for those two programs, that students
at accredited CAM institutions should be included, because that pretty
much is going to limit it to those that have licensing standards. I
think those are the ones that are accredited.
DR. GORDON: What is your position vis-a-vis Linnea's
substitute?
DR. PIZZORNO: Since the doors already have been opened to
those two programs for chiropractors, I think that any CAM student at
an accredited institution should be eligible to those programs, but to
open up other programs, I think we should go through this process that
you discussed. I am kind of separating the two pieces.
DR. GORDON: Go ahead, Linnea.
MS. LARSON: So, you are saying, you limit it to those
programs, such as Scholarships for Disadvantaged Students and those
from the Heal Program that already have scholarships and loans
available for chiropractic students, and that you limit it also to
those in accredited complementary and alternative medicine
institutions, and then the rest of the programs that you would have
feasibility studies for.
DR. PIZZORNO: Yes, I did, I agree.
DR. GORDON: Tierona.
DR. LOW DOG: These are loans, right, and you have got to pay
them back. So, you have got to pay them back. Why is it even an
issue? I just don't understand it. I mean if you are going to borrow
money to get an education, whatever that education may be, if it's
accredited, I just don't understand. I think it is different when you
are talking about loan forgiveness and primary care, and all that kind
of stuff. This, to me, just speaks about loans and being able to get
a low interest loan to go to school. I would expect that whether you
are going to be a teacher, or you are going to be a chiropractor, or
whatever, so I just support that they should be expanded, because they
are loans, you are going to pay them back.
DR. WARREN: Aren't these loans federally guaranteed loans,
so that if you decide not to pay them back, the Feds pick up the tab,
and then they go after you.
MR. CHAPPELL: I am fine with the action as it is stated
originally.
DR. FINS: I have a couple points. One is that chiropractic
was singled out because it met a need. They went through with this
process, said these folks are qualified for these loans because they
fulfill a need. I think Linnea's language that if other disciplines
meet a certain need, then, maybe it's considerable as an option, but
the one thing that I would -- and I am willing to kind of think about
that -- the thing that I want to distinguish, though, is the National
Health Services Corps scholarship, which has all kinds of associations
with what is primary and underserved populations.
DR. GORDON: That's the next one.
DR. FINS: I think that is very different than the kind of
language that Linnea had, you know, looking at the viability of this
without an endorsement of it.
DR. GORDON: I have a question, and this follows up what
Tierona said, and Joe or others, Steve might be able to answer. If I
can get a loan to go to school to study Serbo-Croat or to study
becoming a beautician, why shouldn't I be able to get a loan to go to
school to be a naturopathic physician? I don't understand. I am sort
of essentially saying the same thing Tierona is saying, reminding us
that many of us may have gotten loans to go to college to study
snowboarding or whatever it is we studied in college. Charlotte.
SISTER KERR: I want to say my clarification of it, but in
response to that, too, it may be that the committee should know more
details to this, but what I wanted to say, I hear two options. One
would be the statement that Linnea made, which is that we do a study,
and part two of that was what Joe said, that the professionals within
accredited schools would be eligible, so that is A. B was to leave 1.5
as it was based on this philosophy that, hey, if you want to go to
school, you should be eligible. If we go with B, which I am called B,
1.5 as it is, I think we should be very specific like the eligibility
of CAM students should be included in existing loan and scholarship
programs, period. Now, the only C is whether or not there is some
other information that we don't know, that is making this a big deal.
DR. GORDON: That is what I am trying to find out. Joe.
DR. KACZMARCZYK: It is not a big deal. The two loan
programs that are referenced in the text, that is, Heal and the
Scholarship for Disadvantaged Students are based on financial needs.
They are administered by the Bureau of Health Professions, Health
Resources and Services Administration. They are included in
legislation in Title 7, and it looks like in the 2003 budget, many of
those programs are going to have significantly reduced funding. Those
programs are administered in part by the institutions, specifically,
the SDS, so the money would go from the federal government to the
institution, and the institution would then actually implement and
manage that particular program, and these are based on the financial
need of the student.
DR. FINS: But also they have met certainly their
professions.
DR. KACZMARCZYK: The profession is mentioned in the
legislative language. Unless the profession is indicated specifically
in the legislative language, a student of that profession cannot
participate in either Heal or SDS, and the current legislative
language specifies that chiropractic students are eligible for
participation in Heal and SDS.
DR. GORDON: How does this relate to -- and maybe Joe
Pizzorno can answer this, too -- how does this relate to ordinary
loans that all students can get?
DR. PIZZORNO: Students at accredited CAM institutions are
eligible for the same financial aid as colleges. The reason Heal
exists and these others is because health care education is, at a
graduate level, more expensive than the regular loan programs that are
available. So, this basically adds to the loan limit that students
can get.
DR. GORDON: The first thing I would like to say that we need
some of this background in here to understand why this is important
and why this is even an issue, which is not immediately apparent to me
or to Tierona. Joe, go ahead.
DR. PIZZORNO: It is a problem because the students doing
graduate education in CAM have tuition and room and board, and such,
which is substantially in excess of the Stafford loan, which is what
they are eligible for. So, this is to put them on the same ground of
getting more in debt as conventional medical practitioners.
DR. GORDON: So, there is a clarification. Linnea.
MS. LARSON: I actually think that in the text, it is there.
It just is not as clear as we want it. That is one of my suggestions.
Actually, I have a visual aid of a grid, saying this is who is
eligible, and this is how it works. I have actually written it out if
anybody wants it.
DR. GORDON: George.
DR. BERNIER: I just want to be sure that we are all looking
at the same deck of cards. The students who are in the CAM programs
are not eligible by the way the rules are written for the disbursal of
HRSA loans or other ones that primary care physicians in the United
States during their education can be fully funded through that, so it
would require that the law be changed.
DR. FINS: And that means to designate those folks as primary
care providers, which is, in my view, problematic, but my
understanding from Joe here, is that this is a different pool of money
that doesn't require the primary care designation, which is to me a
critical distinction.
DR. GORDON: Can we have a recommendation for how to word
this action item?
DR. LOW DOG: I just had another question, though, that I am
still unclear about. Say it wasn't a health-related field, if I am
going to go to law school, and it was going to be $20,000 for the
year, and I didn't have anybody to help me, what funding would I go to
for that? I mean I just don't understand enough about the way loans
work for these kinds of things to know what is available. I guess I
am an advocate for people being able to take out loans for education,
and I just think that that is important because it is going to be paid
back, so how do you make that available to people to get education,
but I don't really know the extent of what is available out there and
what other kinds of loans people could get. If you are taking it away
from a certain pot that doesn't have a lot of money, then, that is an
issue that has to be considered. I just don't feel like I know enough
about this to know where people are going to go get their -- where do
people get their money?
DR. PAZ: One of the things to also think about is that with
the loans, there is different amounts of interest rates of them, and
some are much higher than others. Some of these federal ones have
much lower interest rates than some of the others.
DR. TIAN: If I understand, I think that for CAM students,
they do have it difficult to get a loan. First of all, the school,
for instance, either traditional Chinese medicine or acupuncture
school, this school has to be nationally accredited, otherwise, you
can't get a loan. I think the point here is very important. We want
to help those students they can get a loan, even that school may not
be accredited now, may be in the future, but again it takes about
three years, sometimes five years to get accredited, so I think that
point is very important we should mention it.
DR. GORDON: Let's come back once again. We have the action
item, we have Linnea's revision or alternate version or Joe's
alternate --
DR. FINS: No, I don't have it. You see, I think this gets
back to some fundamental issues about whether something is a
profession, whether somebody is going to an accredited institution or
not, whether there is an unlimited pool of money for loans, you know,
if you said to me, you know, this money will prevent a respiratory
therapist from going to school versus somebody to go to an
unaccredited traditional Chinese medicine school, you know, those are
tough choices.
DR. GORDON: I would like somebody to make a proposal. This
is a very good discussion, and I think we are getting ready for a
proposal here. We want to say something about loans, and I want to
know, do we want to say what is written down here, do we want to say
what Linnea said, or based on this discussion, do we want to say
something else? Tom.
MR. CHAPPELL: My recommendation is that this concern be
dealt with in the copy of the text, and that the action remain as it
is originally stated.
DR. GORDON: So that the action is the same as it is here.
MR. CHAPPELL: That's right.
DR. GORDON: And that the concerns be described in the text.
MR. CHAPPELL: Correct.
DR. GORDON: Linnea, do you want to respond or say whatever
you have to say?
MS. LARSON: It's clarified if you look at the text with
respect to loans and scholarships. It sets out there are these
progra
MS. The one that gets into the issues about primary
care is the National Health Service Corps. There is a rationale for
this in the text. This is as it stands, and it is open enough. The
one that is the trickiest is the one that relates to the definition of
primary care.
DR. GORDON: If that is the case, I would like to get final
on this action item, and then move to that, that relates to primary
care, which is the next action item.
DR. FINS: Linnea, do you still have your text somewhere,
your original proposal?
MS. LARSON: 1.5 now has two parts to it.
DR. FINS: If we took Linnea's recommendation, we have here
the way Tom has written in 1.5 now, it is "Existing Loan Programs,"
which would include all of them, all three categories. I think we
might have agreement on Heal and SDS. If we took Linnea's initial
recommendation and said that they should conduct a study to determine
whether, in what ways, to what extent eligibility should be expanded
for Heal and SDS and accredited institutions. The second question is
the National Health Service Corps, which is a separate issue, but I
mean we might be able to agree to one, and not the other.
DR. GORDON: She said something a little different, Joe. I
think what Linnea said was that chiropractors are getting the loans,
all other CAM practitioners should get the loans, and that other loan
areas should be explored and studied. You said it more nicely than
that, though. Go ahead, Linnea.
MS. LARSON: The text needs a little bit tightening up in
terms of clarity of the progra
MS. They are spelled out.
There is an SDS program. There is a Heal program. There are some
programs that only -- most of these progra
MS. We are not
talking here at all about the National Health Service Corps. If this
1.5, as it stands, what Joe Pizzorno would like would be to add the
portion of accredited, those who come from accredited schools. Then,
we break it down into two separate recommendations. But the text can
justify and has to be spelled out, because the text says this is what
is available.
DR. GORDON: Can we have the wording on this, please?
DR. PIZZORNO: Here is what I would like to suggest. "CAM
students at accredited institutions should be eligible for Heal and
SDS loans." So we just say just those programs just for accredited
students.
MR. CHAPPELL: Then, who are we excluding?
DR. FINS: Those who don't go to accredited schools.
DR. PIZZORNO: And other loan and scholarship programs are
not included. We are just doing just those two progra
MS.
MS. LARSON: I think that is really good and clear, but what
I feel unable to do in coming to closure to that is until I have that
further discussion on the primary care and the other progra
MS.
DR. GORDON: This is separate.
MS. LARSON: I know, but it may be limiting. I may want to
include that in this recommendation.
DR. GORDON: Let's bracket this one. If we are agreed on
this one, for now let's leave it at this, and then let's go on to No.
1.6. Tom, are we okay with this one?
MR. CHAPPELL: I am not familiar enough with what schools we
would be excluding that are not accredited.
DR. GORDON: Ming said schools that are not yet accredited or
schools that never will be accredited.
DR. FINS: And students shouldn't go to those schools.
MR. CHAPPELL: And does the student loan program require
accreditation anyway? Then, why are we editing the statement?
DR. PIZZORNO: Because if we don't say they have to go to
accredited schools, that means all schools are open, and I believe we
should not open loans to students in schools that aren't accredited
because accreditation is our national standard to determine that
schools have qualified faculty, good quality education, et cetera.
MR. CHAPPELL: I guess I would argue that we all have to
start somewhere before we get accredited. In your experience, were
you accredited on day 1 of year 1? Then, how do these people have a
financial strategy that includes loans?
DR. PIZZORNO: It is part of the challenge for the student.
MR. CHAPPELL: It's not a scholarship, it's just a walk up
the ladder, and these perfectly good -- and there will be new ones,
and there will be more, they have a right for students to have
eligibility for loans, as well, so, no, I don't agree with the edit at
all.
DR. FINS: It seems to me it is unfair to the student to
impose a burden of indebtedness to an entity, you know, based on an
experience that doesn't give them a quality educational product, and
schools should be able to get accredited.
MR. CHAPPELL: But they did get a quality experience at many
of these schools that started before they were accredited. That is
part of the chicken and the egg issue.
DR. GORDON: This is real difference of opinion. Let's hear
some other thoughts about this, and see if there is some way we can
reconcile it. Joe, go ahead.
DR. PIZZORNO: Tom, having gone through this process, I am
sympathetic to the challenge. As a practical matter, I cannot
envision the Department of Education accepting the responsibility to
provide loans to schools that aren't accredited. It would open up the
door to huge abuses of the system. There has to be some way to
determine which schools should have eligibility for loans and which
ones shouldn't, and without some kind of standard, it's impossible.
DR. LOW DOG: I would just support that because part of even
the accreditation process is just how you protect the students, you
know, how are their grades done, it is this huge process, and the
students really have no protection in unaccredited schools. It
doesn't mean that they are not good, but I don't think we are ever
going to get this passed, if it's not through an accredited school.
MR. CHAPPELL: I'll go along.
DR. GORDON: Thank you, everybody, on this one.
DR. WARREN: Who does the accrediting, is it a nationally
accredited school or is it a state?
DR. GORDON: What does it say, Joe, in the Heal regulations?
DR. KACZMARCZYK: Department of Education.
DR. PIZZORNO: The Department of Education publishes a book
of all the schools that are approved for accreditation.
DR. GORDON: Do you want to read that again, Joe?
DR. PIZZORNO: "CAM students at accredited institutions
should be eligible for Heal and SDS loans."
DR. GORDON: Julia.
MS. SCOTT: I'm sorry, I got lost in all of that. I just
want to make sure I got this. 1.5 now has two different sections, or
there is one? There is one. Okay. So, what we are expecting is
Joe's edit.
DR. GORDON: Just as he said it. Joe's revision of Linnea's
edit, yes.
DR. GORDON: One of the nice things about this recommendation
is it has specificity, and it makes very clear recommendation, and I
think the fact that we make it accredited schools makes it very
believable to the Department of Education, as well. Let's move on to
a more complex issue, 1.6, which I will read. "The Department of
Health and Human Services should conduct demonstration projects to
determine the feasibility of CAM students participating in the
National Health Service Corps Scholarship Program." Tierona.
DR. LOW DOG: I would like to move that we take Linnea's
recommendation from the last recommendation or action item or
whatever, but just make it relevant for this, for the feasibility
studies.
DR. GORDON: Somebody with a mike, read it.
DR. KACZMARCZYK: "The Department of Health and Human
Services should conduct a study to determine whether and in what ways
and to what extent should eligibility be expanded to students of CAM
in the National Health Service Corps Scholarship."
DR. FINS: That would be 1.6?
DR. KACZMARCZYK: That would be 1.6, that is correct.
DR. GORDON: Let's discuss it. Tierona, go ahead.
DR. LOW DOG: I just wanted to finish my thought because I
had thought, on our conference call for this section, that it may have
Maureen that had said that before you start doing a demonstration
project or whatever, you need to actually have feasibility studies,
and you need to sort of thing through the process. I think it needs
to go back a step from the demonstration project to this, and also to
determine which CAM providers, if any, would be eligible for this.
So, I would propose that.
DR. GORDON: Other comments on this?
DR. KACZMARCZYK: Much of that is addressed in the text.
DR. GORDON: I'm sorry. What, Joe?
DR. KACZMARCZYK: Much of Tierona's concerns is addressed in
the text.
DR. GORDON: Joe.
DR. PIZZORNO: I agree we need to do a study first. I think
we also said that, and if feasible, then demonstration projects should
go forward.
DR. FINS: The whole thing here, as I understand it, is to be
part of this program, you have to be providing service after you have
been trained as a primary care provider. That is the sine qua non for
this scholarship program. I will not be convinced that these folks,
even that small subset of people, are equivalent as primary care
providers. With all due respect to what a naturopath would bring to
the patient's well-being, that individual does not have the skill set
of a family practitioner, an ob-gyn, a pediatrician or an internist.
The scope of training differs. The duration of training differs, and
I think it puts the public at risk to say that these folks, who bring
other things to the table, are primary care providers, especially when
we are talking about underserved communities that would be the
recipients of these individuals. This loan program is predicated upon
people paying back with their expertise to underserved communities.
If you look at all the things that they are meant to do on page 16,
these are not necessarily services that they are trained to provide.
DR. GORDON: Charlotte.
SISTER KERR: From what we have just said, with all respect,
nobody is debating that right now, and also, as far as the state, I
guess Washington, naturopaths have been defined to be able to do
primary care. So, the point is Linnea's proposal anyway is just
saying we want to do studies, so it's an opinion. But I want to say
this just for a sense of history, if you look back in our History
Section, page 5, Recent History of CAM, it is very interesting to
note, "The vast majority of primary medical care in this country was
provided by botanical healers, midwives, chiropractors, homeopaths,
and an assortment of other lay healers." Of course, it did progress,
but, you know, it is just a point that we could discuss for a long
time what the primary care is.
DR. LOW DOG: But, Joe, I guess I just want to ask the
question, if we are talking about a feasibility study, which will
evaluate all of this and determine if a direct entry midwife, who is
licensed interstate, would be able to provide some women's health
services in a community. All we are saying, I think, is that somebody
other than us should probably go away and look at this issue, and they
may come back and say not yet, not now. But is there a problem with
the feasibility study, I guess?
DR. FINS: Should I respond or should I wait?
DR. GORDON: Why don't you respond.
DR. FINS: Congress just decided that chiropractic was not
primary care, and primary care means something special. It is not to
say that others don't provide first-person care, but it is a scope of
practice and a kind of expertise. I would much prefer some kind of
consideration of alternative loan sources that do not somehow equate
this with primary care. The fact that Washington State has done this
doesn't mean that it's right. It might mean there was good lobbying
or there was a constituency or whatever. It is not necessarily the
way that the country should go.
MS. LARSON: I would actually like to have that
recommendation read again, so it is very clear. It is about a
feasibility study, and it says what, whether or not, and to whom this
is extended. Secondly, I would like to make a comment that I really
do not know what this is. It is Senate Bill something or other that
is on the table right now that actually looks to expand -- what I was
just talking about -- to include what I think has been a significant
absence is behavioral scientists within this domain. They are not
considered primary care, but I can tell you that a physician or a
nurse practitioner without the necessary behavioral science is
crippled, and most of the community health centers do not have those
services provided. So, I am just saying this is all it is, is a
feasibility study.
DR. KACZMARCZYK: The legislation you are referring is the
NHSC reauthorization.
DR. GORDON: Veronica.
MS. GUTIERREZ: I was going to suggest amending the sentence
at the end, the 1.6 remaining the way it is, and adding, "If this is
found to be congruent with legislative intent," because at the time
Title 7 was written, and I am not even sure when that is, medicine was
the politically dominant health care model, and that has changed. I
know there are a lot of legislators that have talked to our national
organizations, and are willing to revisit the Title 7 the way it is
defined. So, rather than even proceeding with feasibility studies,
and so forth, I am willing to go on the line and offer that this be
done if it is found to be congruent with legislative intent, and if it
is not, I am more than willing to give up the battle. Secondly, I
would like to say not opening the door for this opportunity is not
congruent with even one of our guiding principles of the Commission.
DR. PIZZORNO: I have to say, Joe, I am surprised that you
are objecting to this because I thought this was what you and I had
worked out.
DR. FINS: That was something else.
DR. PIZZORNO: I'm sorry, I thought this was what we agreed
to. We actually agreed to a demonstration project. We actually
stepped back to do a feasibility study. I am actually quite confident
in doing a feasibility study that will lead to a demonstration
project, because we are already doing it in Washington State, and it
is working great. So, let's just make it a more formal process.
Let's do this.
DR. GORDON: Tierona.
DR. LOW DOG: Part of when you are talking about the
feasibility study, it may address if this should be value added, if it
should be done in conjunction, but I think that that is partly what is
left to the feasibility study, is to actually try to address all of
those issues. I think this is a good compromise for a very sticky
subject, I really do. I think the feasibility study, it is not saying
let's go do it, it is saying let's look at all the available options
and let's see what comes out of it. That may be paring, it may be not
a rural primary care. It may be saying inner city. I think that
there are so many options that we just don't want to limit ourselves
to it, but we want to just say feasibility studies because we don't
know what would show up.
DR. GORDON: Joe K.
DR. KACZMARCZYK: I think this would be vastly improved if we
took the words "demonstration projects," out and used "feasibility
study."
DR. GORDON: We are discussing the amended version.
DR. KACZMARCZYK: I brought this up because the two other
Joe's were going back to a previous issue about demonstration
projects. So for clarity, let's just stick to the feasibility study,
and not the previously discussed demonstration projects.
DR. FINS: I just want to see, Joe, because yes, that it was
in conjunction. In other words, my real concern is value-added. I
think you and I both agreed that we would both be uncomfortable having
naturopaths designated in an isolated area as the only practitioner.
DR. PIZZORNO: We don't agree, because I have graduates out
there doing that right now.
DR. GORDON: I think we are not talking about a demonstration
project. We are talking about a feasibility study. What we are
saying is, we are open to the possibility. We're not saying, let's do
it. We're saying we are open to the possibility that this may have
value. That's it.
DR. FINS: Why do we have to link the possibility of value to
a program that is exclusively for primary care providers? That's the
question. Why don't we say that there needs to be another feasibility
study to determine a new loan forgiveness scheme, or program, outside
of the National Health Service Corps, because the National Health
Service Corps is about primary care. It is not about other providers.
DR. GORDON: Joe, I practiced Chinese medicine for 25 years.
In China, there are people who practice Chinese medicine who have a
pretty good Western medical education as well, even though their
licensure is Chinese medicine. I bet they would be quite good at
doing primary care practice. I would love to see what it looks like.
They are doing it in China. So I'm just saying the possibility.
Naturopathic medicine is expanding and growing in all kinds of ways.
You deliver babies, don't you? Naturopathic physicians deliver
babies, they do minor surgery, they can give injections, they can do
many, many things. I think we just don't know, and that's why I think
it is fair to see in an open-minded way does this work or doesn't it
work. That's where I am.
DR. FINS: Why don't we study and see whether it works or
not, and not link it to the question of loan forgiveness.
SISTER KERR: I have a sense you have a feeling that something
will be lost in doing this rather than what is the opportunity in
revisiting a definition of primary care and who could possibly help
people. But, wait. There is the worry that there is a big pot of
money and that it won't be enough because, first of all, what I have
always been advised in legislation, just like in writing your home
budget, you may say, "I need prescription glasses. I want to put that
in the budget," and they come back and say, "Too bad. We can only
afford the dime store." So, if we look at the pot of this money for
loans, it will be shared or one will be deleted or whatever, but we
are not to have to worry about that. So, what is the concern for you,
which is obviously very important?
DR. FINS: It is really not about the money because I think
overall all these programs are under-funded. So, we are really
talking about the equivalence, the move towards equivalency between
scopes of practice and training that are not commensurate.
SISTER KERR: In your definition. That is --
DR. FINS: Huh?
SISTER KERR: In your definition they are not commensurate.
DR. FINS: In my definition, and I think a lot of internists
would have a hard time with that.
SISTER KERR: So then, that is the protection, but as Jim
said, like acupuncture, for example, in Chinese medicine is primary
care in China. The bottom line, millions of people, that is primary
care. Acupuncture is a system of preventive medicine. We talked
about using in sick care. I learned it as preventive.
DR. GORDON: Effie had her hand up, and Tieraona had her hand
up.
DR. CHOW: I know we have gotten into debates like this
before, and it comes down to definition. So many times we have gotten
into trouble with all this debate because we don't have definition of
primary care other than the medical primary care. So I don't know. I
haven't heard anything further about the glossary definition.
DR. FINS: In the Public Health Service Act, Section 3.30 on
the bottom of 15. It is not my definition, it is by statute.
DR. CHOW: I am not saying it is your definition. I am just
saying that that is the traditional definition.
DR. GORDON: I think the issue, though -- excuse me for
interrupting -- Joe, is if this is primary care, then, as defined, the
question arises, can these other people provide it. That is an open
question. I mean, at least that is the way I see it. I am not trying
to convince you.
DR. FINS: This, to me, is, I think I can say without any
kind of doubt, the most important issue for me. This may reflect a
world view kind of thing, and I may have a hard time with it. However
this turns out, you may want to go forward without me, and that is
perfectly fine. I think the country will be served by an articulation
of the issues, and hopefully, something will, in a Hegelian sense,
synergize out of it. I just have a hard time with it and I have had a
hard time expressing it to this group based on where people are coming
from and what their own backgrounds are. I respect everybody's point
of view. I respect barefoot doctors in China. I understand that, but
I would not equate a barefoot doctor with a fully trained family
practitioner and internist. So I think this may be a discussion that
we could continue at dinner at Ming's house but it may not be fruitful
to continue it here. I say that with all humility.
DR. GORDON: I appreciate that. I just want to clarify one
thing. I was not talking about barefoot doctors. I was talking about
people who have been through the complete training in Chinese medicine
who have also had significant Western medical training. Barefoot
doctors is a whole other category. I am talking about people with a
very deep knowledge of Western science who happen not to be M.D.s but
who happen to practice Chinese medicine. This isn't, again, part of
the discussion. I shouldn't carry on. I'm supposed to cut discussion
off, but I would suggest that if you go down this list, it is entirely
possible the naturopathic physicians might do everything on this list
of primary care. Just saying that as a possibility, I think we just
don't know. That is where I am. I will shut up now. Tieraona,
Linnea, Tom, and let's close with Joe.
DR. LOW DOG: I need better clarification because when it
said that NHSC scholarship programs are limited to U.S. citizens
enrolled or accepted for enrollment in fully accredited U.S.
allopathic or osteopathic medical schools, nurse practitioner, nurse
midwifery P.A. schools, or dental schools, dentists are not primary
care. I guess my problem here is that I have no position at this
moment. Rather, I believe that a naturopath, a midwife, a massage
therapist, I have no opinion on whether they should be in this program
or not, but I am fully willing to engage in a feasibility study where
people will look at the issues with objectivity and try to figure out
how do we maximize benefits for the public. Again, I just want to
point out, when I read this, nurse midwifery programs, they do not
teach people to do all of primary care. A nurse midwife out in a
rural area does not do all of primary care. Neither does a dentist.
So I'm not sure if maybe I am just misunderstanding the NHSC. Maybe I
just don't understand it enough.
DR. KACZMARCZYK: As the law is currently written, those are
the health professions which are eligible for participation. The text
originally said pilot program parenthetically after dentists. That is
currently a pilot program.
DR. LOW DOG: Oh, that's a pilot program?
DR. KACZMARCZYK: Yes. That pilot program was removed in the
editing because the document as a whole is too long, too verbose, and
efforts were made, wherever possible, to abbreviate it.
DR. GORDON: Linnea, Tom, and George Bernier.
MS. LARSON: The only thing I would have to say is to second
what Tieraona said and that all we are looking at is simply the
feasibility. That's it. Also, if we look at 1996 Institute of
Medicine Book on Primary Care and what they look at as a primary care
team, that is different, okay? We are not excluding and saying there
is equivalency. Having worked in a community health center in which
there were recipients of National Health Service Corps, I can tell you
how devastating these areas are. We need people. We need, quote,
behavioral science people in there. We're not asking that a
substitute physician or whatever, we're asking for a feasibility study
because we want to expand the possibilities, at least in my mind, for
collaboration, for collaboration.
DR. GORDON: Tom.
MR. CHAPPELL: I support the language as we have been
referring to the feasibility study because I think the consumer, whose
interests we represent here, needs to have more opportunity to make
the choice of primary care. It has nothing to do with how many years
of education that professional has had, it has to do with how
confident the consumer will ultimately feel in selecting a given
practitioner for primary care based on their experience in working
with that professional. We have got to open up the opportunity for
that model, or various models, to be determined by the feasibility
study.
DR. GORDON: Joe.
DR. PIZZORNO: Just real quickly, Joe, I look forward to this
conversation continuing in the evening, but I want to assure you I
don't consider a naturopathic doctor, a broadly trained chiropractor,
a Chinese-trained Chinese medicine person to be the equivalent of a
medical doctor. Clearly, they have different abilities and such.
However, I do maintain with a great degree of confidence, because I
have done it, that in a primary care setting we have a lot to offer.
We are not replacing you, but there are many places where what we have
to offer is of great value. That door needs to be opened and
understood.
DR. FINS: May I? Linnea said something that might be a way
of tweaking this. I want to just suggest it but not commit to it,
because I really need to see it in print. We might want to say
something that, recognizing to provide comprehensive primary care is a
team approach, and there are lots of different ways of contributing to
primary care, under the rubric that there may be a mechanism to
include people who add to the comprehensive quality of palliative and
the contributions of each. So primary care, but it is comprehensive.
I mean, you see this in managed care companies or managed care
situations where it is better to have the visiting nurse, and the
doctor, and people, all in the aggregate, together. I think maybe we
have to think a little bit out of the box, which is stuff that we said
at the very first meeting, we've got to think out of the box. Maybe
we need to think about the definition of primary care, not primary
care practitioners but the comprehensive quality of primary care,
which involves a lot of different kinds of practitioners.
MS. LARSON: That was my intent. We have an excellent
example that is given by the Institute of Medicine in 1996. It is
superb. It goes into detail about the collaborative team, et cetera.
DR. GORDON: George, and then Conchita, and then let's come
to a close.
DR. BERNIER: I guess we are dealing with two issues, the 1.5
and the 1.6. The 1.5, we passed?
MS. LARSON: Yes.
DR. BERNIER: The 1.6, I think there are just lots and lots
of ways of looking at it. I know we had had some very long talks
about it, and it seems to me that we could go into the demonstration
projects or their equivalent without destroying what seems to be a
really good process that has gone on so far. I think everybody is
tired, but I would like to urge that the group very strongly consider
supporting the idea of having expanded loan programs and then the No.
1.6, to look at that as the opportunity to really test how students
from various backgrounds are able to contribute to the well-being of
the patient.
DR. PAZ: Coming from a state that is mostly under-doctored,
and we do occasionally, rarely, get National Health Service Corps
primary physicians, the fear would be that they would send an
alternative therapist or a practitioner in place of a physician. I
would probably support it if we could include that team approach in
the wording.
DR. GORDON: Tieraona, go ahead.
DR. LOW DOG: I just wondered if in the text we could expand
upon the notion of team approaches, referencing back to the 1996 study
that really talked about this -- the way we are moving in medicine,
anyway, is co-management -- and really explore that within the text,
so that it sets the stage when we talk about a feasibility study. If
you want to include in the language about teams or whatever. This
would set the foundation for the recommendation.
DR. GORDON: Joe.
DR. FINS: Maybe the most time-effective way is if a few of
us over dinner take a pad out, and we just try to work this out.
DR. GORDON: Julia, did you want to say something?
MS. SCOTT: I guess I just want to say I support the
recommendation for a feasibility study to see if there is anything, or
any way, that roles could be expanded and other students can be
accepted. It doesn't say that we are training people to take the
place of, or anything.
DR. GORDON: Linnea, will you bring it to a close?
MS. LARSON: I like the the action item as it stands, and I
think that it can have a rationale in the text that makes reference to
the 1996 description of the Institute of Medicine that says, this is
what we see and this is what is needed. So that is a rationale.
DR. GORDON: So let me tell you what I am hearing. What I am
hearing is that everyone, with the exception of Joe -- and Joe may as
well, Joe Fins -- feels good about the feasibility study if the
groundwork is laid to discuss teamwork, to discuss the issues, to
discuss that this is not replacement in the text. We still have to
come back to the original recommendation. So let's proceed with that
in mind, and it would be wonderful if you all wanted to gather and
pull some of that together.
DR. LOW DOG: We can revisit this in the morning?
DR. GORDON: We can revisit it in the morning if you would
like, yes. Let's move ahead. Yes, Linnea.
MS. LARSON: Did we settle on the recommendation? I have a
solution. Are we still going through the action items?
DR. GORDON: We have one hour and 10 minutes until 7:00, in
which time we need to finish both this section and CAM Central. So
let's move forward with the recommendations. We are now on No. 1.7 on
page 19, the action item. Is everybody with me on this? "The
Department of Health and Human Services, and other federal departments
and agencies, should convene conferences of the leaders of CAM,
conventional health, public health, evolving health professions, and
the public, of educational institutions, and of appropriate
organizations to facilitate establishment of CAM education and
training. Subsequently, the guidelines should be made available to
the states and professions for their consideration." Comments about
this. Does this action item feel comfortable?
DR. FINS: Can I be out of character for a minute, and say I
like it?
DR. GORDON: All right. Are we okay with this?
PARTICIPANTS [En masse]: Yes.
DR. GORDON: Thank you. No. 1.8: "Demonstration projects of
residencies in post-graduate training for appropriately educated and
trained CAM practitioners should be conducted to determine the
feasibility of such programs and their impact on clinical competency,
quality of health care, and collaboration with conventional
providers."
DR. FINS: I thought, last time, we talked about
"post-graduate training programs," and left "residency" out because
"residency" entangled us with something, I don't remember anymore,
about GME monies. We just decided as a compromise. So we struck
"residency in post-graduate training programs for." I thought we had
compromised on it, "demonstration projects."
DR. GORDON: You said "post-graduate training," but struck
"residency"?
DR. FINS: Yes. "Demonstration projects and post-graduate
training programs for appropriately educated and trained," to avoid a
morass with GME funding.
DR. GORDON: How does that sound? Joe, speak up, please.
DR. PIZZORNO: Because we are training people to be primary
care providers in many of our professions, we really need the
residencies. So if we want to do demonstration projects, that's fine,
but this is something that is critical. I know the naturopathic
profession, the chiropractic profession, and now the acupuncture
profession, we are all adopting residency programs. This is something
that we need to enhance our clinical training. So if you want to do a
demonstration project, that's fine, but I think we should be there.
DR. GORDON: Joe, can you explain the difference between
post-graduate training and residency, why that word is particularly
important to you?
DR. PIZZORNO: I don't know.
[Laughter.]
DR. PIZZORNO: We call them "residencies" because that is
what we are doing.
DR. GORDON: "Residencies" used to mean that you were in
residence in the place, so you would sleep over in the hospital. I
mean, I believe that is where it came from.
DR. PIZZORNO: Well, we do have several programs that are
like that at hospitals right now. I know the chiropractors do, and I
know the naturopathics do.
DR. GORDON: Other comments? George, did you want to make a
comment about this?
DR. BERNIER: You were saying what residents are. Most
physicians, after four years of medical school, have three years of
training. If they are going to go into a sub-specialty of the given
area, that is an additional two, three, four years. So, it is really
a time thing. You have to have a significant base of people to be
able to fill out in a guaranteed way the residency slots, and that is,
really, a very difficult thing to do unless you have got the manpower.
I think that the big problem was that was discussed at that meeting
was that the manpower just wasn't going to be there to fill out the
slots.
DR. GORDON: Joe, go ahead.
DR. FINS: I think part of it is that a residency implies the
same issue, that accredited residencies are eligible for GME monies.
So, if you have not evolved to an accredited residency program, you
are not eligible. On page 20, lines 25 and 26, the text says that
these projects would be distinct from current GME education funding
streams, which are a major source of funding for hospitals and really
supports residency training programs, indirectly the care of the
under-served throughout the country.
DR. GORDON: I'm sorry. Where are you?
DR. FINS: On page 20, lines 25 and 26. Page 20, lines 25
and 26. So, I do not want to imperil GME funding streams because
hospitals are already strapped with the Balanced Budget Act, and to
somehow take money away from that to do this would really, I think,
hurt inner city hospitals and the under-served. So, the issue of
calling these things residencies links it up with that. Post-graduate
training programs, really, is what we are talking about because some
of these programs will not have yet evolved into residencies.
Residency is something more concretized, and post-graduate training
programs are not necessarily eligible for GME funding because they are
not accredited in the same way.
DR. GORDON: Tieraona.
DR. LOW DOG: Well, I hate to go back a step, but I had
thought we had actually discussed a feasibility study because part of
what we were looking at was which CAM practitioners. Some CAM
practitioners may be at a place where even potentially residencies may
be appropriate. Others, residencies wouldn't even be appropriate but
post-graduate training might be more appropriate. Some, it may just
be continuing education is all they need to really keep up. So, I
thought we had actually talked about stepping back to look at all of
this so that we can address the next step instead of just jumping into
a demonstration project because you haven't even defined which ones
and who and for how long or anything else. Feasibility studies would
at least look at all of those things and determine which groups of
people may be ready for that next step or not.
DR. GORDON: Joe K.
DR. KACZMARCZYK: That is the intent, and I think, as you
suggested, if it is stated as "feasibility studies of" blah blah blah,
I think it would accomplish what everyone hopes it would.
DR. GORDON: Joe Fins has asked Joe K. to fill in the
"blah-blah-blah."
DR. KACZMARCZYK: I think that is filler at this time,
B-L-A-H.
[Laughter.]
DR. KACZMARCZYK: I think, seriously, if you just restate it,
so that it reads: "Feasibility studies of residencies and
post-graduate training for appropriately educated and trained CAM
practitioners should be conducted to determine." Then you could go
into the types of practitioners in their settings and their impact on
clinical competency, quality of health care, and collaboration with
conventional providers.
DR. FINS: I think that we should really stress right there
that this is distinct from GME sources of funding. It is in the text.
DR. LOW DOG: In the text I would suggest that we clearly
state that if these feasibility studies show that certain groups may
be ready for that, that we should say in the text that additional
funding, separate additional funding, should be provided for this. It
should be clearly stated in there based on whatever happens with the
feasibility so we are not taking away funds from the GME but
additional funds would be set aside. You would have to have a new pot
to take from.
DR. FINS: If it demonstrated the value-added.
DR. LOW DOG: Exactly. Which may or may not happen.
DR. GORDON: Joe, do you want to come back to us with the
wording, the precise wording, tomorrow morning? Would you do that,
Joe K.?
DR. KACZMARCZYK: Yes.
DR. GORDON: Great. Thank you.
Let's move on. Is that okay with everybody? Good. No. 1.9,
page 22: "All practitioners who provide CAM services and products
should consider completing appropriate CAM continuing education
programs to enhance and protect the public's safety." Joe.
DR. PIZZORNO: I don't like the "consider" there.
DR. GORDON: I don't, either; "should complete."
DR. FINS: This links up the licensure stuff later on. I
mean, for ongoing certification as a condition of that sort of thing
practitioners should meet appropriate CME program guidelines. I mean,
Charlotte, and I think Effie, were talking about their CME with
acupuncture hours. We were talking about this during the break. So
the issue people have is requirements, and I think we should encourage
that as part of what it means to be a trained professional.
DR. GORDON: I would also add something else, and I am adding
this partly in consideration of a conversation I had with Dean. So
let me read it to you, because I think it is an important note. I
know it will be an important element for him. I think it is fair
enough. "All practitioners who provide CAM services and products
should complete appropriate CAM continuing education programs, dash,
which would include critical evaluations of the discipline and
approach to enhance and protect the public's health and safety." So
if I am doing my continuing ed in acupuncture, I would also get
somebody telling me, well, what do the studies look like, and what do
we know now, and what did we know three months ago, and where are we
in the practice. I think it would make him feel somewhat more
comfortable about some of these other disciplines.
DR. KACZMARCZYK: You spoke so quickly that no one got that
except for Linnea.
DR. GORDON: Sorry, what's that?
DR. KACZMARCZYK: Could you repeat the clause?
DR. GORDON: Sure. Read it again?
DR. KACZMARCZYK: Yes, please.
DR. GORDON: "All practitioners who provide CAM services and
products should complete appropriate CAM continuing education
programs, which would include critical evaluations of the discipline
or approach," -- dashes around that -- "which would include critical
evaluations of the discipline or approach," dash, "to enhance and
protect the public's health and safety."
DR. FINS: Take "all" out.
DR. GORDON: Take "all" out. Okay, fine. Is that okay?
Everybody okay with it? Great. Yes, Linnea?
MS. LARSON: Let's go back.
DR. GORDON: Are you ready to go back to the initial
recommendation? We are back on page 1.
MS. LARSON: How does this sound? "The education and
training of complementary and alternative medicine practitioners and
conventional practitioners should be designed to ensure public
safety," comma, "improve health," comma, "increase the availability of
qualified and knowledgeable CAM and conventional practitioners, and
enhance the collaboration between them."
DR. PIZZORNO: Good.
DR. GORDON: How does that sound? You want to read it once
more so everybody can get it? Because we will want it up or down now.
We will revise and so forth.
MS. LARSON: "The education and training of complementary and
alternative medicine practitioners and conventional health care
practitioners should be designed to ensure public safety," comma,
"improve health," comma, "increase the availability of qualified and
knowledgeable CAM practitioners and conventional practitioners, and
enhance collaboration between them."
DR. GORDON: Charlotte.
SISTER KERR: I think it's great. Even though we are saying
"conventional" and "CAM," should we say "among them"?
DR. GORDON: Julia, do you have a question or comment? She's
saying "among" as opposed to "between." Are we okay with this? Let
me see heads. Joe, you okay?
DR. FINS: I guess. Yes, it sounds fine.
DR. GORDON: I want to check in with everybody. Is this one
okay? This is very important. This frames all the action items that
follow.
[No response.]
DR. GORDON: Thank you. Thank you very much. Is there
anything else in the text that we need to address here that we have
not addressed in our discussions?
DR. FINS: We still have to write No. 1.6, or whatever.
DR. GORDON: Well, we have the No. 1.6, we have the textual
justification that has to be written.
MS. LARSON: I understood he didn't want it in the action
statement, though, that has to be worked on further.
DR. GORDON: I'm sorry?
MS. LARSON: I understood Joe to say that perhaps in the
context it might be good but he may want to say something in the
action statement as well.
DR. GORDON: All right.
MS. LARSON: So that has to be re-looked at.
DR. GORDON: We can bring that back tomorrow. Who is going
to be working on that? Joe and Linnea, and Joe.
DR. FINS: It may be Tieraona, too.
DR. GORDON: Tieraona, okay.
DR. FINS: And George.
DR. GORDON: You guys have got to have time to eat, though,
too.
DR. FINS: Yes.
DR. GORDON: George, you are going to be involved in it. All
right. Anything in the text that needs to be addressed. Joe.
DR. PIZZORNO: Joe K., this is for you. This is on page 20,
line 4, and says, "In outpatient clinics that are not affiliated with
any hospitals," two of the residency programs are affiliated with
hospitals.
DR. KACZMARCZYK: I have the total of three naturopathic
residencies. There are 40 slots. At National College there are 27
positions. Three are outpatient, three are hospital, one is
hospital-affiliated outpatient. Twenty-one of those are first-year
residencies, six of those are second-year. At Bastyr, there is a
total of eight. All eight are outpatient. Six are first year, two
are in the second year. At Southwest College, there are five total.
They are described as outpatient but they have hospital rotations at
Maricopa County. Four of those are first-year, two are -- excuse me,
one is second-year. So we looked at that and decided the best way to
summarize it succinctly was as it is written there.
DR. GORDON: Suggestion.
DR. PIZZORNO: Thank you for the good summary of the
residencies. I agree, they are primarily outpatient residencies, but
the point I am trying to make is there are a couple of them that are
at hospitals. I think that should be stated, that's all.
DR. GORDON: Other issues. Tom.
MR. CHAPPELL: I just would like to know if we should be
stating dentists interested in oral-body systemic health is one of the
alternative modalities. Of course, it is a very significant new piece
of information and emerging work in dentistry, and yet in the
modalities where we described the modalities, we never mentioned
dentists in CAM.
DR. GORDON: Where would you put it, Tom or Don?
MR. CHAPPELL: I'm looking first at page 2. It says, "In a
study of allopathic medical schools with no" blobbity blah. It talks
about 10 CAM modalities. Now, that is referring to a specific study,
but again, the dentist is not mentioned there. Or, the chart going
back to the Research section where we had the different modalities.
It is the dentist interested in oral-body systemic health. It is a
huge piece of research.
DR. GORDON: Joe, do you have any comments on the Education
section here with dentists?
DR. KACZMARCZYK: Dentists are mentioned along with the other
conventional health care professionals in allied health in two
sections. Or, I shouldn't say two sections. In two different areas
in the text when the language tried to be more inclusive because it is
saying, this should be not be restricted to just medical education.
This needs to be expanded to all the conventional health care,
including but not limited to, and you can go on and on and on.
DR. GORDON: Joe, a question for you. In the statistics on
CAM teaching in medical schools, is there a similar survey of dental
schools that has been done?
DR. KACZMARCZYK: I am not aware of any.
DR. GORDON: I don't know of any, either.
DR. KACZMARCZYK: I am not aware of any.
DR. GORDON: Tom.
MR. CHAPPELL: What was the question?
DR. GORDON: The question was, is there a similar survey of
CAM teaching in dental schools.
MR. CHAPPELL: I happen to know of some that are considering
changing their curricula very much in the near term. We will get Don
to accelerate that information.
DR. GORDON: Don, do you want to address that?
MR. CHAPPELL: Do I want to address it?
DR. GORDON: No, did Don want to. I thought Don might have
something to add.
DR. WARREN: At this time I am not aware of any dental school
that has a CAM program active. The biggest thing they have is the
"Scope Manual on Nutrition," which is about 28 pages, and that is it.
MR. CHAPPELL: I am aware of one school.
DR. WARREN: Is it active now?
MR. CHAPPELL: It is not active yet, but they are in the
process.
DR. WARREN: Good.
DR. GORDON: So, the question is, how do you want to address
this.
MR. CHAPPELL: When you look at the amount of money that is
going to be spent in research oral cavity/body systemic health, it is
amazing. I mean, the body of knowledge is already there.
DR. GORDON: We are talking about the Education section. Do
we have a place where we want to address it here, right now?
MR. CHAPPELL: That is why I raised the question. I don't
want to see us lose the opportunity to be inclusive of this new field.
It is major.
DR. GORDON: I am asking a specific question. Where do we
want to address this, and how.
MR. CHAPPELL: Joe, where do you think we should put it?
DR. KACZMARCZYK: At this time I do not know.
MR. CHAPPELL: Well, can we sleep on it?
DR. GORDON: Tom, I think if you could find a place or places
in the text specifically where you think it might need to be
addressed, it would be helpful to us and then we could take that up
tomorrow, okay? Joe.
DR. FINS: A couple of things. I have a bunch of things I am
just going to ramble through. I don't think any of it is major but
just little stuff. Page 1, we mentioned national guidelines are
needed for education and training. I think that we have talked about
having national guidelines are kind of problematic, imposing them on
the medical schools here. When Jerry and I were doing the Education
thing before it switched, we were very clear that just core elements
of competencies but not guidelines that will be imposed upon the
schools. So I would try to address that. I mean, we need to
establish there are curricular elements needed for CAM education and
training, or something like that. In other words, not to impose
guidelines from some central office.
DR. GORDON: I think you are right. Even if we wanted to, it
is much too early. We haven't established the groundwork, especially
in this opening portion.
DR. FINS: The next thing is on pages 4 and 5, bottom of 4
and the top of 5, I really found this kind of in the advocacy tone,
that we want to give medical students the opportunity to personally
experience CAM and self-care. I mean it is like saying, we want
medical students to experience a colon cystectomy so they can have the
experience of surgery.
DR. GORDON: Joe, let me respond to this. I feel this is an
absolutely crucial element of CAM education, that we are talking about
self-care. We are not talking about surgery. You cannot teach
self-care unless you experience it. You can teach surgery without
having had surgery. I think there is a fundamental difference. I
don't think, I know it is of fundamental importance.
DR. FINS: It has an element of proselytizing CAM.
DR. GORDON: I think it can be worded, perhaps, differently,
but I think the element is that there are certain things that you
can't be taught simply as academic subjects. They have to be learned
in order to be able to teach self-care. This is a long argument, but
I feel extraordinarily strongly about this, that you cannot teach
self-care without learning it yourself.
DR. LOW DOG: But perhaps, then, the language should be more
specific about self-care instead of CAM.
DR. GORDON: Fine. That's fine.
DR. LOW DOG: Maybe even some specificities inside
parentheses what that means.
DR. FINS: Moving on, a few more things. On page 13, line
20. Well, there is a "G" there, "bringing." I am not sure. A lot of
these entities are not necessarily funding sources. They are more
sort of professional associations, so I don't know if any of them are
actually funding sources.
DR. GORDON: Fair enough. That one okay, people?
DR. KACZMARCZYK: Excuse me. The intent was to bring
together funding sources and organizations such as. It is funding
sources plus these organizations.
DR. FINS: Say, "organizations with funding sources."
DR. GORDON: "Funding sources together with organizations,"
right, Joe?
DR. KACZMARCZYK: Yes. That is the intent.
DR. FINS: Good.
DR. GORDON: I have got one question, and I asked this before
and I am still not clear on this, Joe K. On the third line on page 15,
the point you are making about exclusive participation, it just isn't
coming across clearly. What are you trying to tell us?
DR. KACZMARCZYK: The point that I am endeavoring to make
here is that this particular program, that is NHSC, is not terribly
effective when it meets only 10 to 15 percent of the identified need.
DR. GORDON: Now, is that because students are not applying
for it or because there are not enough slots?
DR. KACZMARCZYK: There are, apparently, a host of reasons
for this, and I would not presume to speak at this time for NHSC, but
it would appear as if number one is that the demand far exceeds the
supply. Two, there are so many administrative impediments. For
example, the particular geographic area has to be designated as a
health professional shortage area, which has its own set of
requirements that it becomes rather difficult to meet all of these
requirements, and then the profession has to be named in the
legislation and those individuals have to meet certain criteria, and
there is a competitive award process, and it goes on and on and on and
on.
DR. GORDON: What I am saying is that the idea of exclusive
participation leads us off in the wrong direction. What you are
really saying is that because of a variety of impediments the NHSC
cannot fulfill its primary care function or can only fulfill 12 to 15
percent of the spots. Is that right?
DR. KACZMARCZYK: In short, yes.
DR. GORDON: Tieraona.
DR. LOW DOG: Are we still on text? Are we working through
the text?
DR. GORDON: We are still on text, yes.
DR. LOW DOG: I had some problems reading through this text.
I know it is the end of the day, but Joe, I think we could tighten it
up a bit. Basically, we say that 72.5 percent of medical schools
teach CAM. That's 91 out of 125, but more needs to be done. I mean,
so part of it doesn't seem to flow very well from what we are trying
to say and get across.
DR. GORDON: Tieraona, why don't you suggest a better way to
do it.
DR. LOW DOG: Well, I actually have moved the paragraphs
around on my computer and changed it around a little bit. Maybe we
could just print it off and see how people like it. I think it just
reads easier. I think there are ways to manipulate the paragraphs
around so they flow nicer.
DR. KACZMARCZYK: These have been manipulated so many times
that they have fingerprints on them. Most recently, they were
manipulated by copy editing.
DR. LOW DOG: Then, on page 3, I don't know why we talked
about things like, "while many CAM courses are taught," lines 16
through 18, "are taught either from an advocacy or neutral view, some
believe that all CAM courses should be taught critically." Well, of
course. I mean, I don't know why we would even say that. Of course
they should be taught critically. I mean, just like any other course.
I don't understand that statement.
DR. GORDON: So, how would you reword it?
DR. LOW DOG: I mean, I guess you have to include something,
but it just seems like of course you would teach or we would hope that
you would teach the course critically. It shouldn't be from an
advocacy view. I mean, it should just be taught critically the way
you would expect any subject to be.
DR. GORDON: So, would you like to say that, "and all CAM
courses should be taught critically" or something like that?
DR. LOW DOG: Or, "as all conventional courses should be
taught." They should all be taught critically. Otherwise, I don't
really understand what it means.
DR. KACZMARCZYK: Excuse me. That particular reference was
from Wallace Sampson.
DR. LOW DOG: Sampson, I know.
DR. KACZMARCZYK: That is why it was included.
DR. LOW DOG: Well, in all due deference, but --
DR. GORDON: But it is not "some believe."
DR. LOW DOG: What I am saying is, we should all believe
that. We should all say that they should be taught critically, and
all classes should.
DR. GORDON: Do we have agreement on that? You are sort of
quoting Sampson's assessment, right? We want our assessment, and our
assessment is that all CAM courses need to be taught critically, is
that correct?
DR. LOW DOG: Of course it should be.
DR. GORDON: "Like all conventional courses."
DR. LOW DOG: Right. Let's see. I did most of this on my
computer.
DR. GORDON: Tieraona, if there specific editorial
suggestions for tightening, maybe you can get together with Joe --
DR. LOW DOG: With Joe.
DR. GORDON: -- and work on that.
DR. LOW DOG: I would be glad to.
DR. GORDON: Any other text issues?
DR. LOW DOG: Oh, one other one. I didn't know why we, on
page 18, line 13, "For physicians practicing medical acupuncture which
confused," and I know that means "not to be confused," "which should
not be confused or equated with traditional Chinese acupuncture." I
don't know why that whole sentence is in there, why that whole little
place between the parentheses. It seems somewhat inflammatory to me
because, for physicians practicing medical acupuncture, the American
Board is the administrative board. I don't know that we need the,
"which shouldn't be confused or equated with." I would leave it out.
I think there are places in here that are like that. They are a bit
inflammatory. That was 13 through 15 on page 18.
DR. GORDON: Page 18, line 14. So, Tieraona, I agree with
you on this. Are there other inflammatory places or unnecessarily
inflammatory places?
DR. LOW DOG: There are two places like that.
DR. GORDON: Where somebody is being singled out and where a
kind of negative statement is being made, is that what you are saying?
DR. KACZMARCZYK: The intent was not negative. It was
mentioned as an illustration.
DR. LOW DOG: With all due respect, though, listening to all
those people that sat at those tables over there, people will read
that as an inflammatory statement.
DR. KACZMARCZYK: So it needs to be made less?
DR. GORDON: I would just eliminate it.
DR. LOW DOG: I would just leave that part out.
DR. GORDON: Just eliminate that one. Are we okay with that?
[No response.]
DR. GORDON: Are there any others like that? Tieraona, if
there are others?
DR. LOW DOG: [Off mike.]
DR. GORDON: So, the general principle is that we are trying
to make positive statements, and unless it is absolutely necessary, we
don't have to make all these distinctions. Is that the general
principle?
DR. LOW DOG: Yes.
DR. GORDON: With me? Buford, with me? Don? It is a good
thing you're with me because you're up next. Joe, anything else that
we should be looking at that we need to think about and you can see?
We're okay, we're fine? We're cool here? Great. Thank you, thank
you very much. Thank you, Joe K. Yes, Tom.
MR. CHAPPELL: I have those edits completed, if you would
like to hear them.
DR. GORDON: I'm sorry?
MR. CHAPPELL: I have the dental edits, if you would like to
hear them. There are three locations in the text that you asked me to
work on. I have done it. Do you want it?
DR. GORDON: I just want to make sure we get through CAM
Central, and we want to end by 7:00, which is 37 minutes from now, or
approximately. It takes two minutes. Then maybe, if we are still
conscious, we can come back and Tom can present us with that history.
Shall we break for three minutes? Five minutes. A five-minute break.
We will come back, and we will go to CAM Central. Thank you.
[Break.]
Coordinating and Centralizing Federal CAM Activities
DR. GORDON: Don is present and accounted for. We will do
the same thing that we did with the other sections. I will read the
recommendations, then we will go back and look at the recommendations
first, and then we will look at the text. Let's say that this is the
only one that has had a unanimous consensus up to this point.
Recommendation: "The President, Secretary of Health and Human
Services, or Congress, should create an office to coordinate and
facilitate integration of safe and effective complementary and
alternative health practices and products into the nation's health
care system." I will read the three action items, and then we will go
over the whole thing.
Action Item 1.1: "The office should be established at the
highest possible and most appropriate federal level with sufficient
staff and budget to meet its responsibilities." No. 1.2: "The office
should charter an advisory council with members from both the private
and public sectors to guide and advise the office about its
activities. We will go through them, and then we will go back over
them.
No. 1.3: "The office's responsibilities should include but
not be limited to coordinating federal CAM activities; serving as a
federal CAM policy liaison with conventional health care and CAM
professionals, organizations, institutions, and commercial ventures;
planning, facilitating and convening conferences, workshops, and
advisory groups; acting as a centralized federal point of contact
regarding CAM for the public, CAM practitioners, conventional health
care providers, and the media; and facilitating implementation of the
Commission's recommendations and actions." As Don has pointed out, we
had unanimous agreement on this before. So let's start with the
recommendation and see if we still have agreement. Any comments on
this? David, and Linnea.
DR. BRESLER: My first thought when I saw this report was
that it was bass ackwards and that wellness was in the front of it and
CAM Central was in the end. I think that this is one of the single
most important recommendations that comes out of all of our work
because it represents the next step of where we are going. I'm
thinking from several points of view, including introducing this to
the media, that this ought to be our number one hit. It ought to be
right after the introduction. We ought to really feature this as one
of the prime recommendations that we make because it is very easy to
justify why. When people ask us what you guys have done for the last
two years, we have really looked at how to centralize this within the
federal government. I think that could be a great accomplishment.
DR. GORDON: Linnea, and Effie.
MS. LARSON: I don't have at this time worked out a No. 1.4,
but I do have the beginnings of a second sentence of the text that
then would tie into an action item. Can I elaborate a little bit?
DR. GORDON: Do you want to give us a hint, or do you want to
just come back to it?
MS. LARSON: I think that the second sentence should have to
do with the full range of CAM perspectives are part of the
decision-making dialogue that guides this office and policy and
implementation activity. That should be the second sentence, and you
should excise the stuff about HIV and attention deficit, et cetera.
DR. GORDON: Wait. I'm sorry. I don't understand where we
are. In the text or in the recommendation?
MS. LARSON: I was making a statement that I actually think
that there should be a No. 1.4 action item that I have not come up,
but it would be related to this idea that I just articulated. The
idea would actually follow the first sentence of the text, okay?
DR. GORDON: Can you articulate this in the next 15 minutes
or so? Write it down.
MS. LARSON: Yes, I hope to.
DR. GORDON: Great. Thank you. We will come back to you,
then. Effie, you had something you wanted to say.
DR. CHOW: I wanted to underscore what David said, and this
is something that was said before, about that this is one of the
central important things and it should be up in front. It is the only
thing that everybody has come to an agreement on. Within the text
itself, then, it said that one of the most key issues or key functions
of this CAM Central is to facilitate the follow-up of the
implementation of the Commission's recommendations and actions, and it
is the last line in the whole recommendation. That should be first,
too, as well. We tend to put last the most important thing.
DR. GORDON: So, you are suggesting that the last line of No.
1.3 should be earlier in the action steps?
DR. CHOW: Yes, because it is stated in the body that one of
the most pressing --
DR. GORDON: Where would you put it?
DR. CHOW: I would put it, probably, in No. 1.3, and right at
the first, as the responsibility.
DR. GORDON: Don, do you or Joe want to address why you did
it the way you did it?
DR. WARREN: I think what we were talking more about, when we
put the implementation of the Commission's recommendation actions back
at the very end of this, is we didn't want to seem like we were really
being self-serving. We want to do these other things and in addition
to that also implement all these things. I am really glad you all
want to put this the first in the report. I think it is neat, but
that is not the charge that we have and I think we need to address our
charge first and then follow it up with other things.
DR. GORDON: Thank you. Joe, did you want to add anything to
that, or Steve?
DR. KACZMARCZYK: I agree with what Don said. Those
responsibilities are laid out in a very deliberate sequence. There is
a logic to that sequence, and Steve would agree to that because we
have talked about that at length.
DR. GORDON: It is important to reiterate so everybody is on
the same page with this, we understand the reasoning why it has been
done this way. Steve.
DR. GROFT: If there is an office -- it is almost a given
that it is going to occur -- I think the other activities there in No.
1.3 need an emphasis to say that this is what the office should do.
What we are missing is not an office to implement the recommendations,
even though it is, but we really need some group to coordinate the
federal activities and the rest of the other activities before we get
to the implementation. Again, if the group feels that we should be
moving that up?
DR. GORDON: I think it is important, Steve, that this is
articulated very clearly why we are doing it, and then we can discuss
other ways to approach it.
DR. GROFT: I think that was it, that we felt that the other
activities really needed the emphasis and that once the office is
created, it is a given that they would be responsible for overseeing
the recommendations and the other activities.
DR. GORDON: Effie, and Charlotte.
DR. CHOW: I appreciate the explanation. However, I don't
think the development of a CAM office is to serve ourselves because
this is what has come up from the other groups, too, from the
Georgetown group and previously. There should be a central
coordination office.
DR. GORDON: I am not sure what you are saying.
DR. GROFT: I don't disagree with that at all, Effie. I am
in agreement. I just think what I was referring to was really the
implementation, that statement about the implementation of the
Commission's recommendations.
DR. GORDON: Charlotte, and then Tom.
SISTER KERR: I missed the first few minutes and I had a
little lag in my thinking, so I apologize if you all did more of this
than I am aware of. This goes just to the general, basic introduction
of how we identified three areas where this office could go:
executive, DHHS, et cetera. For myself at this point without any
further information, I have felt that we should say where we think it
should go rather than leave it up. My question, then, is we don't do
that, from what I can see, in the final draft here. I really don't
think it should go in the White House because it changes with the
administration. Also, whatever the other office we had, surgeon
general. So, my request is, do we, as a group, want to consider
actually giving a recommendation so that we really hold it. As we
say, the public stressed the importance of creating a sustainable
environment, so I would like to really look at that again.
DR. GORDON: Don, do you want to address that?
DR. WARREN: I believe that with the wording and the
appropriations for next year that we can assume at this point that it
is going to be in the Secretary's office, Department of Health and
Human Services, in one part of it.
DR. GORDON: Yes, but it is not worded that way. It is
really worded as several options.
DR. GROFT: I think in wording this we were trying to be
consistent with what the administration had advised on some other
recently formed commissions in which they said to express options if
we could not come to an agreement. I think we also wanted to give the
administration the opportunity to identify where they felt it would be
most appropriate. Again, I think the text talks so much about DHHS
somewhere there, but again, I think it was just to give them the
options.
DR. WARREN: When we wrote this, we didn't know about the
wording. Now, should we, since we know about the wording, eliminate
the other options? Or, should we give the branch and the Secretary a
chance to put it where they wish, give them the option, don't hem them
into a corner?
DR. GORDON: That is a question that is on the table. This
relates both to the recommendation and to Action No. 1.1. Let's have
some discussion about it. You have raised the question. Tom, and
Joe. Tom has had his hand up for a bit. Yes, go ahead.
MR. CHAPPELL: I wanted to address the order of the
presentation of this recommendation.
DR. GORDON: Can we just focus on one issue, because we have
been all over the map. So, if we can focus on this first issue now
and then we can come back to the order, okay? So, the issue that we
are talking about is, should we make a specific recommendation about
the location of the office. Let's try to focus on this. Joe, you
wanted to say something about that?
DR. KACZMARCZYK: The way I see it is that if you provide a
list of options that is consistent with the information that Steve
described, but also, and more importantly, increases the likelihood of
the creation of this office.
DR. GORDON: Effie.
DR. CHOW: I think I agree that giving them the option that
we can always set priorities, and they will set their own priorities
anyway, but offering our preference.
DR. GORDON: You would like to offer a preference?
DR. CHOW: Yes.
DR. GORDON: What would your preference be?
DR. CHOW: One is that it should be in the President's
office, and with Congress, right away, taking action to put it through
Congress.
DR. GORDON: That it would be at the Secretary's office?
Where should it be, though?
DR. CHOW: In the President's office.
DR. GORDON: In the White House?
DR. CHOW: In the White House, yes, and then Congress right
away take action to legislate it into official being, so there is
longevity.
DR. GORDON: Other comments about this.
DR. CHOW: Well, can I just add, because it was set up at the
President's level, and we are one of the few commissions out of the
200 commissions that have been appointed by the President, by
executive order -- I'm sorry?
DR. PAZ: It was a different president.
DR. CHOW: Well, but still, it is there, and I think we
should operate at a optimistic level.
DR. GORDON: So there is a specific recommendation. You are
making the recommendation that we say where it should be and that we
say in particular that it should be part of the White House, right?
DR. CHOW: With Congress taking action to make it permanent.
I am saying, offer the other option, too.
DR. GORDON: Congress has already taken an action. Steve, do
you want to clarify what Congress has already said? It is important
to see what the lay of the land is. If we are making recommendations
into the wind, we have to know that.
DR. GROFT: In the appropriations language that came from the
House-Senate Conference Committee, there was language that the
committee urged the Secretary, or encouraged the Secretary of HHS, to
establish an office or an activity within the Department to coordinate
CAM activities. I can get the specific language for you.
DR. GORDON: That is basically the gist of it?
DR. GROFT: Right.
DR. GORDON: So already there is legislation saying put it
within the department. So, let's continue with the discussion. Yes.
I'm sorry. Joe.
DR. KACZMARCZYK: The specific language was, "The Conferees
urge the Secretary of the Department of Health and Human Services to
form a coordinating unit to review the commission's report and
implement ways of improving coordination of the department's many
CAM-related activities," end of quote.
DR. GORDON: Don.
DR. WARREN: Let me say, we are not trying to name this
entity, either. We are just calling it, as they say, a "unit." They
will probably put whatever name they want to on it.
DR. GORDON: Other comments about this issue. Do we want to
recommend -- yes, Charlotte -- where it should be?
SISTER KERR: Well, I am just making my comment further. I am
continuing to be open, but my sense is that this is even being
recommended because of Senator Harkin, who is doing this. I think if
we felt clear that we should go ahead and be congruent with that,
which is to say HHS. I do think, even though I don't know and I
assume and I think great things about the administration, that it is
more consistent to leave it in the Department of Health and Human
Services, which is what I hear you having as a value, Effie, which
perhaps either I or you are not as clear of where will it be the most
consistent. It sounds like HHS. I think what we would have, even
though we want to be permissive and inclusive and all of this, and
respectful, that it is okay for us to say, we looked at all of it and
here is where we came down as a committee. I think it is a clear
energy force, if we feel that way, if we are all conscious of HHS, the
language is in, we know what we are doing, it will happen.
DR. GORDON: Steve wanted to say something.
DR. GROFT: I don't know if you recall the preceding
sentence. It said, "The Conferees understand the White House
Commission on Complementary and Alternative Medicine Policy will
release its final report early in 2002." So, that was the preceding
sentence. Then, "The Conferees urge the Secretary." So, I think we
could construct language, as we have done in others, stating that we
are encouraged, the Commission was encouraged, by the language
included in the appropriations bill for DHHS and we agree that an
office should be established within DHHS. Or, if we want to retain
the options, any way I think is okay. I think, get one, though.
DR. GORDON: Yes, Tieraona.
DR. LOW DOG: I would agree with Charlotte. I think that if
you have already got the momentum and there has already been
recommendations going on the table that you should move with that and
be grateful.
DR. GORDON: We have had a couple of recommendations. I
don't know how you feel at this point, Effie, but there have been a
couple of recommendations to go with the direction that Congress is
moving in and recommend that it be at the level of the secretary of
HHS. Is that correct?
DR. CHOW: I just heard that today. I mean, what you are
reporting now.
DR. GORDON: No, I understand.
DR. CHOW: I just heard that today, so certainly, I believe
in going with where the action is.
DR. GORDON: So, should we make that specific recommendation?
Don.
DR. WARREN: These things are in the text here. I think we
need to give the options just in case one falls through. That is my
own personal belief.
DR. GORDON: All three options that you listed?
DR. WARREN: Yes.
DR. WARREN: If the group says one, then we will do one.
MR. CHAPPELL: I agree with that, and if we want to add a
paragraph in that section where we list the three options, we just add
a couple of sentences indicating that we are aware of the current
legislation. That would be fine, but I like the idea of leaving the
three options.
DR. GORDON: David.
DR. BRESLER: I, of course, go the other way. I think it
should be at the White House because my concern is that it is going to
end up in somebody's drawer somewhere and nothing is going to happen.
I would be okay to go with HHS if there were some language in it that
would say that we want to put it in the area where it is going to get
the most support and where this work is going to continue, wherever
that tends to be. We have had this discussion and we have spent a lot
of time talking about the advantages of all these different options,
and again, I would like to see it go where it has got the greatest
likelihood of continuing.
DR. GORDON: So we have some differences of opinions. Julia.
MS. SCOTT: I want to weigh in on the other side of not
putting it in the White House, dependent upon whatever administration
is there. I think we have seen some pretty significant offices just
about disbanded with the change of the administration: AIDS and many
of the women's progra
MS. I think it makes sense -- we are
talking about the health of the nation -- to have it attached to the
organization that is charged with the agenda for the health of the
nation. So, I think, maybe as a part of what Tom said about putting
it in the text, that it could be placed in several places, but I do
feel as a Commission we could come out and strongly recommend that it
be in HHS. The reality is, it could be changed in Congress. I mean,
if they wanted to change it, they could.
DR. GORDON: I would just like to say something as a
long-time Washington resident. The trend is very much in the
direction of it going to HHS. HHS is getting ready for it. I don't
think the White House wants it. There is no great interest in it
right now. They have a lot of other things on their mind. I don't
think it is realistic.
DR. BRESLER: So, Jim, let me ask you, then, one of the
concerns that we had is it is going on in agencies way outside of HHS:
in Agriculture, in Energy, and some of these other government
agencies. Is there some way that we can acknowledge that and say that
it needs to be coordinated beyond the department?
DR. GORDON: I think that is there in the text. I am pretty
sure that that has been made clear, that HHS is the location for it
and the place from which coordination will take place. Steve, you
have been around as long as I have, and Joe has been around for a
while, and others, too. Isn't that your sense of where it is headed
and what is happening?
DR. GROFT: That appears to be the case.
DR. GORDON: So, I think that we can't ensure anything. I am
just going to put out my synthesis of what I am hearing. I think it
is fair enough to put the three possible locations, talk about the
advantages and disadvantages of each, and then, perhaps, come down on
the side of the location of the highest level of HHS. The problem is,
the White House is incredibly vulnerable to change. The surgeon
general has variable power, depending on who is the surgeon general
and who is the president. HHS is always going to be there. If there
had been tremendous enthusiasm in the administration, I would say,
great, let's try to get it at the White House, but that is not what we
have at this point.
DR. BRESLER: How about at the Supreme Court?
[Laughter.]
DR. GORDON: So, let me make that as a suggestion, that we
put down, maybe, a little bit more on the advantages and
disadvantages, we talk about the legislation, and we say that we feel
that it appears to us that HHS would be an appropriate home for this.
Does this feel okay, Wayne? You know the scene, too.
DR. JONAS: Yes, I agree. I mean, there are pros and cons to
all this, but the pros of putting it at HHS versus the White House are
much greater than the cons. To me, it is a non-issue. I think,
certainly, when you describe the roles, the down side in HHS is that
it has less jurisdiction over some of the other federal agencies that
we are targeting. However, if you put in some of the roles that this
specifically is to look at the other federal agencies, it is going to
do that anyway. It is much more likely, given the current climate,
that there would be appropriations to actually allow it to do
something in there.
DR. GORDON: Joe, yes.
DR. FINS: I kind of agree. I think it will be less prone to
ideological influences in Health and Human Services, and I think that
would be for the long-term probably better.
DR. GORDON: So, do we have agreement on this? Great. There
are a couple of other issues that have been raised. Tom, do you have
another issue?
MR. CHAPPELL: On the order.
DR. GORDON: Right. Thank you.
MR. CHAPPELL: I heard the explanation of why you don't feel
placing it in the front of the report is appropriate, but I would
argue that I do think we have the license to put this where we want.
I like the boldness of this right up front. It is very provocative.
Not provocative, it is bold and it is crisp, and it suggests something
very important that they are about to read. It lends importance to
the whole rest of the report.
DR. GORDON: So this is a discussion about the placement of
this whole section on CAM Central. Other comments on this. Sorry.
Julia, and Joe.
MS. SCOTT: I'm sorry. This kind of throws me. I thought we
were going to go through the action steps first.
DR. GORDON: Thank you.
MS. SCOTT: Then we can talk about the placement.
DR. GORDON: Fair enough. Joe, do you want to say something?
MR. CHAPPELL: I think on the placement issue, I mean I think
--
DR. GORDON: Wait. Let's not talk about the placement issue
now. Let's go through the action steps -- I think this is a better
order -- and then come back to the placement issue.
DR. GROFT: Tom, when I spoke about the placement, I was
really referring to Action No. 1.3 and the discussion of the
facilitating implementation of the Commission's recommendations. I
wasn't talking about the positioning of the recommendation itself and
this section, so just to clarify that. We are still open. We will
talk about that in a little bit.
DR. GORDON: So, let's go through the action ite
MS.
Thank you, Julia, for bringing us back. Then we can talk about the
placement of this section, okay? So Action No. 1.1, I am assuming
that we are putting in there "HHS," right? We are being specific in
Action Item No. 1.1. We have that agreement?
[No response.]
DR. GORDON: No. 1.2. Any issues on No. 1.2? Yes, Joe.
DR. PIZZORNO: To the advisory body, I think we should
specify that it includes CAM and conventional medicine practitioners.
DR. GORDON: How would you have it read, Joe?
DR. PIZZORNO: No. 1.2, it says, "with members from both the
private and public sectors, comma, including CAM and conventional
practitioners to guide and advise."
DR. FINS: On page 4. You say this on page 4, line 6 to 13.
DR. GORDON: But he is questioning whether it should be in
the action item and the recommendation. Your suggestion is, it should
be. Yes, Don.
DR. WARREN: Another thing, the word "stakeholders" in here,
I think we need to change that to "interested parties in CAM," which
would include practitioners.
DR. GORDON: That is not in the action item?
DR. WARREN: No.
DR. GORDON: So, can we deal with Joe's addition to the
Action Item No. 1.2? Are we in agreement on that? Tieraona.
DR. LOW DOG: I guess my only thing there is if you are going
to start listing who you are going to have, then that is an incomplete
list. I mean, that is the only thing, is that including CAM and
conventional practitioners, I mean it would also be researchers and
scientists.
DR. GORDON: Right.
DR. LOW DOG: I mean, so I guess I am not clear if we have
explained this in the text, why it does need to be in the action item,
because it is also an incomplete list, then. That is just a question.
DR. GORDON: Joe, can you explain why you feel it is
important to have it in the action item?
DR. PIZZORNO: Because I believe that they are the two most
critical on the list, and I want to make sure that they are
specifically included.
DR. GORDON: Effie, and Tom.
DR. CHOW: I think what is critical should go into the action
line because a lot of people don't go and look at the text. I think
it should be in there, too.
DR. GORDON: You agree with Joe?
DR. CHOW: Yes.
DR. GORDON: Tom.
MR. CHAPPELL: I guess I would leave this makeup of the
advisory council to the office, the newly formed office. This
particular group was not made up of CAM practitioners and conventional
doctors, and we did pretty well.
DR. GORDON: In part. I think that the way the
recommendation reads would be "including conventional and CAM
practitioners as well as members of the public and private sector."
MR. CHAPPELL: I see.
DR. GORDON: It is not exclusive.
MR. CHAPPELL: I see.
DR. GORDON: That is what you had in mind.
DR. LOW DOG: I'm sorry, but I guess if you are going to say
what is critical, I think in an advisory council like this it is very
important that you would have rigorous scientists on here as well
advising. So I am not sure that I think this is the most critical
aspect of this advisory council, so my only question is, can this be
really discussed well in the text about how there needs to be a well
thought of group and what we would envision this to be. I don't think
it would just be the practitioners that are your critical aspect on
this advisory council.
DR. GORDON: Joe.
DR. PIZZORNO: Tieraona, I agree with you. The challenge is
the experience we already have with the NIH. It started out with some
CAM people being on it. They virtually all got eliminated. We had to
put legislation into Congress to require that they be on the advisory
board. So, unless we are really specific that CAM professionals must
be included, they will just get left out for one reason or another.
Just practical experience.
DR. GORDON: Are we okay, then, with including that? We are
not saying it is restricted to them, we are just indicating the
importance of including those two groups. Okay? Great. No. 1.3.
How are we with the content and the order? Don, do you want to say
something?
DR. WARREN: Well, all these five parts of this No. 1.3 were
designed to give us the broadest maximum efficiency or effectiveness
in this office, and I think they ought to stay the way they are.
DR. GORDON: Are we okay with this? Or, are there comments
or corrections or critiques of this? Joe, please.
DR. FINS: We are not talking about the text? I am not sure.
What are we doing? PARTICIPANT: We are talking about the actions.
DR. FINS: Okay, then.
DR. GORDON: I would like to get agreement, if we can, on
this and then look at the text and then look at No. 1.4.
DR. CHOW: I still think that "facilitating implementation of
the Commission's recommendation and action" should be up front there.
DR. GORDON: Can we have a discussion about that? Does
anybody want to make any comments on that? Effie is suggesting that
the last part be the first in No. 1.3. Yes, David.
DR. BRESLER: Again, there may be some issues in which we
don't reach consensus or have quite different opinions in our
recommendations. Again, putting this up front, we can say that it
could also continue to explore areas that the Commission was not able
to complete or was not able to resolve.
DR. FINS: I think having No. 3 last, I mean it is there.
Putting it first looks like we are trying to perpetuate ourselves. I
think it is more modest to say there should be an office, there should
be an advisory body, and they should do all these things and also
consider the implementation of these recommendations. I mean, it is a
little more prudential and a little more like we did our thing, we
sunsetted, this is the next process.
DR. GORDON: George.
DR. BERNIER: Yes, I would agree with that. I don't think it
is our responsibility or our privilege to name the committee.
DR. GROFT: I actually tend to agree that it is better to
have it last. It is pretty clear what we want to have happen.
DR. GORDON: For me, this is one of the issues that is clear
in making statements to the press. It is an important issue, and it
is already happening. So I don't think we need to belabor it. If it
weren't happening, I might want to push it more, but since there is
already a congressional mandate for it to happen, I feel much more
comfortable being kind of relaxed about it. Steve, you are a
long-time observer of the scene.
DR. GROFT: To me, the significant point is to create an
office and then things get done. Without creating an office, you
don't have that focus of activity. What the placement is, it's not
really that important to me. I mean, as a person in the government, I
just look for language that enables me to go and work in a particular
area that needs to be worked on. You do what you can do in the time,
and there is a time and place that you are able to facilitate the
implementation of these activities.
DR. GORDON: Thank you, Steve. Effie, and then Joe.
DR. CHOW: I think it has been misunderstood. I didn't mean
put 1.3 up to 1.1. I'm just talking about the reorder of the
activities in 1.3
DR. GORDON: Oh, I see.
DR. CHOW: Within 1.3, the implementation.
DR. GROFT: I think you want to move up the "and facilitating
implementation of the Commission's recommendations and actions" to
within No. 1.3, up to the beginning.
DR. CHOW: No.
DR. GORDON: No, no, no. She is saying moving all of 1.3.
DR. GROFT: Oh, okay. Then I misunderstood it, too.
DR. CHOW: I don't mean that. That is what you people are
thinking I said.
MS. SCOTT: What she means is, she wanted to take that last
sentence and put it as part of the first sentence of No. 1.3.
DR. CHOW: No. 1.3.
MS. SCOTT: "The office's responsibilities should include
facilitating the implementation of the Commission's recommendations
and actions," and then continuing on with, "serving as a federal CAM
policy liaison."
DR. GORDON: So that is a suggestion. What is the response?
Do we want it the way it is? Do we want to put "facilitating
implementation of the Commission's recommendations" first in this
order? Let's get a show of hands. This should be a simple
up-and-down. Do we want "facilitating implementation of the
Commission's recommendations and actions" to be the first item in No.
1.3? How many would like that?
[Show of hands.]
DR. GORDON: How many would like it to be the last item?
[Show of hands.]
DR. GORDON: The majority says it is the last item. I mean,
we all want it there, it's just a question of placement. Is there a
No. 1.4 that you have for us?
MS. LARSON: I can't do it.
DR. GORDON: Linnea was looking for a No. 1.4.
MS. LARSON: I can't do it.
DR. GORDON: Yes, Joe, go ahead.
DR. FINS: Just a couple things. I don't remember, on page
1, that parents of children with ADHD, these various folks
specifically talked about the need to coordinate an effort. If that
is there, that's fine.
DR. GORDON: No, what they primarily talked about, they
wanted more information, they weren't able to get information, they
weren't able to get the government to pay, they couldn't figure out
who in the government to deal with.
DR. FINS: It has been deleted? Let me just say one more
thing. On page 4, when we are talking about who is going to be on the
committee or this advisory thing, I agree with it being in HHS. I
think that is a good idea. I just raise this as an issue, really, for
the government aficionados here, whether or not we want to say
something about this body having some representation from the Office
of the Domestic Policy advisor.
DR. GORDON: I think that is a great idea.
DR. FINS: As a way of reaching out to other federal agencies
that are domestic but not in HHS.
DR. GORDON: I think that is a really important addition, and
there may be several agencies that we want to list in here. Do we
have a sense of agreement on that? Because all we have here is HHS
agencies, and we may want to give a couple of examples. So, we are in
accord with that? I would say Department of Defense, VA. I mean,
those are the clear ones. PARTICIPANT: Education.
DR. GORDON: Good. So we will put that in. Joe K., are we
okay with that? Okay. I'm sorry. Tom, and Tieraona.
MR. CHAPPELL: I am sensitive to the fact that we are guests
for dinner tonight at a private home, and I feel a real strong
obligation to adjourn right now.
DR. GORDON: So if there are any other textual issues, we
will take them up first thing tomorrow morning, and then we will take
up Tom's dental concerns.
[Laughter.]
DR. GORDON: Will we have Access and Delivery first? Or, do
you want to put Access off? Access first? Put it off. So we will do
Information first, at 7:00. I apologize, but I am concerned. I do
not want to leave us hanging at 3:00 or any other time. I want us to
complete our work, so we begin at 7:00 tomorrow morning promptly.
Thank you all very much.
[Applause.]
[Whereupon, at 7:16 p.m., the meeting was recessed to reconvene
the following day, Friday, February 22, 2002 at 7:00 a.m.]
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Top | Contents
CERTIFICATION
This is to certify that the attached proceedings
BEFORE: White House Commission on Complementary
and Alternative Medicine Policy
HELD: February 21-22, 2002
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
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