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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
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