|
|
Doubletree Hotel
Plaza Ballroom I & II
Rockville Pike
Rockville, Maryland
Thursday, February 21, 2002 &
Friday, February 22, 2002
Friday, February 22, 2002 - Morning 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)
P R O C E E D I N G S
[7:17 a.m.]
Opening Remarks
DR. GORDON: Thank you all for being here, so bright-eyed at
this early hour. And Ming, thank you for the wonderful party last
night.
[Applause.]
DR. GORDON: So let's just sit for a moment, gather ourselves
together, and then we will begin.
[Moment of silence observed.]
DR. GORDON: I wanted to give Dean a chance, and ask Dean if
he would take a few minutes to express some of his hopes and concerns
for the meeting, just as we all did at the beginning of yesterday's
meeting. I also wanted to thank you, Dean, for the detailed Email
that you sent, and for the thoughts you expressed to us there. After
Dean is finished, we will move back into the final part of the CAM
Central discussion.
DR. ORNISH: Well, thank you, Jim. I want to again say I was
sorry that I couldn't be here because of a prior conflict. I won't
repeat most of what is in my Email, since I think most of you have a
copy of it, and there is so much to cover, I don't want to spend too
much time doing that, except to say, I guess the summary of my
concerns is that I want our report to be effective and I want it to
make a difference, and I think we have a real opportunity to make a
difference here in advancing the field.
My concern is that if we get too far ahead of the evidence, we
may lose our opportunity, that we may become ineffectual if we become
easy targets for people, if we go beyond what the evidence suggests,
and, in that sense, compromise our credibility. To the extent that we
are viewed as zealots or advocates or crusaders, as opposed to a more
reasoned, dispassionate, White House commission that systematically
reviewed the evidence, and heard testimony from a variety of different
people, and synthesized that, and made recommendations that don't get
ahead of what the evidence is, I think we can be very effective.
I was pleased to hear that yesterday a lot of progress was
made in that direction. I think having to write dissenting opinions,
or having to people take their names off the paper is really going to
make it even more ineffective and just gives people that much more
ammunition for trying to dismiss for what we have done.
And so, to whatever degree we can find a middle ground, as I
mentioned in my memo, it's a very unusual position for me to be in, to
be on the more conservative end of the spectrum of any group of
people. Yet, I think that because I feel so strongly about this
commission and have such respect for you all and really want this to
be something that is more than just a document that gets read and
tossed aside, I think that it is important that we address these
issues. So, thank you.
DR. GORDON: Thank you very much, Dean. We were mindful,
both of your concerns yesterday and also of the concerns of others. I
agree, I think we have moved in a wonderful direction of coming
together and really finding that middle ground among us.
Steve, do you want to say anything before we move into the
rest of the day?
DR. GROFT: It will be an extremely busy day. I think we set
a nice tone yesterday when we got into a pattern of review and
revising. I do just want to caution the group, when we get into
Access and Delivery, Michele is not going to be here.
In fact, what you received during the mail was a revision of
what she had written by several of the staff members. We took time to
go through it and tried to make revisions. So there could be some
weaknesses, as we go along today, trying to make an explanation of why
certain things are included or why they were omitted.
I think what we are asking you to do is to identify the areas
that need work, need to be added, and among the staff members, we will
try to correct it and get it going the way you would like it to be.
DR. GORDON: Great. Thank you, Steve.
We are going to begin, as I said, with finishing up the
discussion of CAM Central, and then we will move into Information,
then we will go to Access and Delivery, Reimbursement, then this
afternoon we will focus on Wellness, and then either before or after
the public testimony ?? hopefully, we will be able to start before ??
we will go over once again the steps that we will be taking in the
next two weeks to bring everything to fruition.
So let's conclude with CAM Central. Then, Tom, you have a
couple of points you want to make, too, about insertion of fillings,
right? Thank you.
Coordination of Federal CAM Activities (Continued)
DR. GORDON: Don, do you want to pick up where we left off?
DR. WARREN: Yesterday, we went over the recommendation. I
believe the Commission accepted that. Then we had three action
points. Linnea, did you have a fourth that you came up with last
night? Can you read it for us?
MS. LARSON: This has to do with the insertion of a sentence
in the second paragraph. I will read the sentence that we inserted,
and then I will read the action item that relates to it. So the
sentence is on the first page. This is after the sentence "The
Commission agrees" at line 21. Following that: "This office should
include the full range of complementary and alternative medicine
perspectives as part of the decisionmaking dialogue that guides this
office's policy and implementation process."
DR. GORDON: Which page is this on, Linnea?
MS. LARSON: The first page. On page 1 after the first line.
DR. WARREN: Could you read that one more time?
MS. LARSON: Okay.
DR. GORDON: Page 1, line 24.
MS. LARSON: This is inserted on page 1, beginning line 24.
After the sentence, it goes: "This office should include the full
range of complementary and alternative medicine perspectives as part
of the decisionmaking dialogue that guides this office policy and
implementation process." Then the action item that follows is: "The
selection process for advisory committee members should guarantee that
the full range of complementary and alternative medicine perspectives
are part of the decisionmaking dialogue that guides this office's
policy and implementation activities."
DR. GORDON: Great. Thank you. So that that is part of 1.2.
Is that right? Or, is it a separate one?
MS. LARSON: Well, I thought of it as a separate one that
then leads to 1.2.
DR. GORDON: Okay. Discussion about this? Sorry, Tieraona.
Go ahead.
DR. LOW DOG: I just want to reiterate that I think that to
make this not seem as strictly an advocacy position that is just going
to bring a bunch of people who believe in CAM to make decisions about
it, if you are going to start specifying who all you are going to have
on there, you are going to need to take the balanced approach in
there, as well, to include language that there needs to be people with
rigorous scientific backgrounds and those that are not strictly
advocates. I do think Steven Strauss has been able to make some good
headway, because many people believe that he is not an advocate.
DR. GORDON: Would you like to amend Linnea's language in
some way to include that?
DR. LOW DOG: Well, I just heard about it, and it's 7:00. So
I'm going to have to warm up to it, but I'm not saying I am opposed to
having that because I think the language is important. I'm just
saying it seems lopsided now.
DR. GORDON: Other comments? Julia?
MS. SCOTT: First, I would like clarification. You're
talking about the advisory committee, or the staffing of the office?
MS. LARSON: The advisory council.
MS. SCOTT: Oh, okay. Then I will think about that some
more, the advisory council.
DR. ORNISH: Are we talking about Recommendations 1.1 through
1.3? Because this is an example of what I was trying to say before.
I think that rather than saying we should create an office to
coordinate and facilitate integration, again, there is a presumption
that these things work, and I think that, really, we should be
creating an office to assess and evaluate. For those that are then
found to be effective and safe, I am not sure that there are enough ??
I mean, again, there is a presumption that there is a body of CAM
modalities that have proven to be safe and effective sufficient that
it is worthy of establishing an office to figure out how to implement
these, and I don't think we are there yet.
I think that we need to be a little more modest in what we are
recommending and say there isn't enough ?? I don't personally think
there is enough out there to talk about the President, the Secretary
of Health and Human Services, and Congress to start to finger how we
can implement these in the Nation's health system. I think we should
be more in the evaluation and assessment end of the spectrum for now.
DR. GORDON: David, and then Tom.
DR. BRESLER: I understand your concerns about this, Dean,
but on the other hand, I am dealing with patients who are asking very
reasonable questions about why acupuncture is not covered by Medicare
when there is plenty of sufficient evidence in the arena of pain
control and arthritides and things of this sort that it is an
effective modality. I think this is part of the potential of the
Commission, is to open the doors for things for where there is
sufficient evidence of efficacy and safety to begin the integration
process. I think it needs to be done critically, but I think there is
sufficient evidence for some of the CAM modalities to begin this
process in integration.
DR. GORDON: Tom.
MR. CHAPPELL: I would use language to accomplish what I
heard both Linnea and Tieraona talking about that sounds like this:
Following "advisory council," "The office should charter an advisory
council inclusive of members" ?? or, "inclusive of practitioners from
both conventional and CAM health systems."
DR. GORDON: We are working on two pieces. There is Linnea's
recommendation and then Dean has gone back, so I would like to focus
first on Linnea's, and then we can take up Dean. Linnea has either
amended 1.2, or made a separate 1.4. So I would like to get some
sense of where we stand, and both Tom and Tieraona have suggested that
we include conventional. I would say conventional researchers as well
as practitioners on the advisory council. Linnea, do you want to
speak to it?
MS. LARSON: I am simply agreeing. I really do agree with
what Tieraona was saying about it should not be an us and them, and it
should be a little bit wider range, and it should include people with
rigorous scientific training, researchers.
DR. GORDON: So, Tieraona or Linnea, either one, can we have
a rewording of what you would like to see here and then we can get an
up or down on it, and then we can go back and address the issue that
Dean and David were discussing?
DR. LOW DOG: Well, yesterday, we had also said that we did
not want to really tell them what their advisory council should be
comprised of. I mean, I thought that was where we were, and then we
sort of slipped in CAM and conventional practitioners. So yesterday,
there was discussion that we shouldn't be telling them what they
should comprise their advisory council on, and I guess if we are going
to add that we are going to have this full range, I would just say
that if you are going to have a full range, it should include those
with expertise in CAM and conventional medical practice, scientists
with rigorous backgrounds. But, see, my problem is I don't know that
we can sit here right now and say what the best constitution of that
advisory council should be, and I am not sure we should be listing in
the recommendation who they should choose.
DR. GORDON: Since Joe Pizzorno is not here, let me raise the
concern that he raised that Wayne also spoke to yesterday, which was
that in the past, what has happened is that when ?? and this happened
at NIH ?? is that when committees were set up to deal with CAM, that
sometimes people who knew anything about CAM were excluded from those
committees, and that was Joe's concern. That was certainly what
happened with the first review committees of CAM projects even after
OAM was set up, when it was left to the NIH as a whole, and I think
that is the concern that he was speaking to, and I don't know, Wayne,
if you want to speak to it again. I thought we came down on the side
of understanding that even though we might not want to dictate all
details, we wanted to give a certain broad picture. Wayne.
DR. JONAS: Julia asked to speak.
MS. SCOTT: I think, Tieraona, my experience has been with
the setting up of advisory committees that while we might not want to
have a very prescriptive charge, I think you do have to state when you
want to make sure that certain representation happens. It happened
when we decided we needed to have women on some of these NIH research
committees, that we needed to have minorities, and it has to be said.
Now, I agree. I don't think we need to make a long list. I thought
yesterday, after this discussion, we had agreed to simply including.
So that, it didn't mean that we were going to list everybody that
needed to be there, but it said including those with CAM expertise and
CAM and conventional, that that was enough to say that we wanted to
make sure we had an advisory committee that knew what they were doing.
So I still feel like we need to at least make that statement.
DR. GORDON: Wayne.
DR. JONAS: Yes, I agree. I think if we just specify that it
should be a balanced committee that includes CAM and conventional,
those with CAM and conventional expertise, that should be the end of
it.
DR. GORDON: Joe.
DR. FINS: Maybe in the action item, the original action item
as written in the book, 1.2, and it might have been revised yesterday,
but let's just go with that. Suppose we simply said, "The office
should charter an advisory council with members with expertise and
diverse backgrounds and training necessary to guide and advise the
office about its activities." It is simply to say that they have to
have the expertise and diverse backgrounds necessary to perform this
function, and then in the text be more specific about it.
DR. GORDON: Tieraona.
DR. LOW DOG: Yes. I am fine with that. I could go with
that, I could go with including those with CAM and conventional
expertise, not just practitioners. I don't have an issue. I just
think that when you start getting into full cadre or full ranges of
that, you know, that could be 20 people, I mean just in that one area.
So I just have some concerns.
DR. GORDON: Effie, and then I would like to come to a close
on this. We really need to move ahead.
DR. CHOW: Yes. My experience is also that many people are
put into positions of decision that have not had CAM experience nor
have any knowledge of it. So I want to just reiterate support for
that.
DR. GORDON: There are basically two proposals on the floor.
One is that it be more general, which is Joe's, and the other is that
it be more specific and name people and say "expertise in CAM and
conventional health care."
DR. CHOW: I support the CAM and conventional expertise. Be
specific.
DR. GORDON: CAM and conventional expertise.
DR. CHOW: Yes.
DR. GORDON: Okay. Can we get a sense of which of the ?? I
mean, we are all in the same ball park here. Linnea, would you agree
that ??
MS. LARSON: Yes. I think that Joe Fins actually had a
resolution to that in his expression.
MS. SCOTT: Jim, I think if we put this in the text, this
more descriptive sentence in the text, then in the action 1.2, we then
include the language that Joe ??
DR. GORDON: Okay. So, Joe, do you want to repeat the
language and let's see if we can agree on Julia's proposal, which
seems to be what Linnea is supporting and Tieraona is shaking her head
as well. Go ahead, Joe.
DR. FINS: Again, this would be with the additional
information in the text. "The office should charter an advisory
council with members with expertise and diverse background and
training necessary to advise and guide the office about its
activities."
DR. GORDON: Are we okay with that one, Tieraona? Yes?
DR. LOW DOG: Yes.
DR. GORDON: Everybody, can I see nodding of heads? Okay.
Great. Let's go back just for a moment, Dean. Yes, David, I'm sorry.
DR. BRESLER: I think there is a way to reconcile the
concern. The recommendation itself does take an advocacy position in
the sense that it is asking for integration before the fact. I think
what we want the recommendation itself to say is that CAM Central is
to coordinate federal efforts and federal activities rather than to
say it is going to implement CAM into conventional health care. I
think the recommendation itself needs to be less of an advocacy
position. The real focus is to coordinate the activities of the
federal government.
DR. GORDON: Is that satisfactory to you, Dean?
DR. ORNISH: Yes. I was going to say something similar to
that, that it would be more along "efforts to coordinate and
facilitate evaluation," as opposed to "integration." One has a very
different connotation. Or, the efforts for something, but
"integration" implies that you already know these things work and you
are ready to rocket. I also think there should be something in the
discussion that says that we recognize that most CAM modalities are
yet unproven, but some are. Certainly, acupuncture is one of the few
that really is proven, and even then, for certain modalities. If we
could say something in that, that we recognize that most of them are
not yet proven but that because more research efforts are going on
within CAM and others, it would be useful to have an office to
integrate things as they become more proven.
DR. GORDON: See, I think that you are narrowing the scope of
the office too much. The office is not just about research, the
office is about many things that are already going on, public
information activities. The office is about services that are already
underway.
DR. ORNISH: I wasn't limiting it to research. When talking
about evaluation, it is not just research.
DR. GORDON: No, but what I am saying is, as opposed to the
research section, that the office has many functions, and when you
read the section on the office, part of it is providing information,
part of it is working with different agencies so they can talk to each
other about what they think about CAM activities. So I am not against
striking the "integration" and working that in a different way. All
I'm saying is that the office does not stand or fall on the research
evidence. The office is not created because the state of the research
evidence is great or poor. The office is created to help provide
information about the research, whatever it is. It is there to help
people in different agencies who are considering CAM activities to
talk with each other. It is a different kind of function, is all I am
saying, and I just want to make sure we don't lose sight of what the
function is.
DR. ORNISH: I understand, but if you are talking about
facilitating integration, I think that is ahead of where we are,
that's all.
DR. GORDON: No, I heard that. Yes, Joe.
DR. FINS: When you use a word like "integration," well, it's
too soon. We are not ready for integration. Then the other
implication vis?a?vis Tom's comments yesterday, is, it means that we
are going to subsume. So I think when you start getting specific, you
lose potential roles for this office. You say, simply, "to coordinate
federal policy with respect to complementary and alternative
medicine," and the specific actions are in No. 1.3 and elsewhere.
DR. GORDON: Tom.
MR. CHAPPELL: Thank you, Joe. So I think the language could
be "to coordinate and facilitate the accountability of safe and
effective complementary and alternative health care practices and
products into public health."
DR. GORDON: I think that is certainly possible. All I am
saying is, when you say "accountability," there again, it is hard to
know exactly what that means. I like Joe's wording better because we
get lost in "accountability." That word kind of takes it a little bit
off track because the office doesn't have that authority.
MR. CHAPPELL: Okay. What I'm trying to do is avoid this
presumption that we have to squeeze it all through the existing
system. So, Joe, if you have language that accomplishes the intent.
DR. FINS: The question that Tom is raising about
accountability is one that I think we have to address. I mean, who
will be accountable for the actions of this office and CAM policy in
the country? Let's say there is an assistant secretary. He or she
would answer up the chain of command, and would ultimately would be
accountable to the Secretary. So there are lines of authority in that
regard, simply by its position in the government. So I think it is
implicit, and I think if we said, just, "coordinate federal policy
with respect to complementary and alternative medicine," we don't have
the overstating and we don't have the subsuming concerns on both sides
of the table.
DR. GORDON: How does that sound? Don, how does that sound
to you? You've been working on this. Dean, how does it sound to you?
DR. WARREN: It sounds an awful lot like what we first came
up with.
[Laughter.]
DR. WARREN: The Commission wanted "safe and efficacious" in
there, and "integration" out of it, so we put that in. Now the
Commission says, well, we don't want "integration," we don't want
"safe and effective." So what are we going to do?
DR. ORNISH: Well, I certainly didn't say we don't want "safe
and effective." I mean, that is something that I think should go in
everything.
DR. WARREN: So we put "safe and effective" in the initial
recommendation, and it was "integration of safe and effective." That
didn't imply research or shoving anything through the system.
DR. ORNISH: I like Joe's recommendation of, "coordinating
federal policy."
DR. FINS: "With respect to complementary and alternative
medicine."
DR. ORNISH: Yes. I can live with that.
DR. GORDON: Are we okay with that? My memory is being
jogged. I recognize that is where we started, and maybe that is where
we belong.
DR. WARREN: Could you repeat it again?
DR. ORNISH: "Coordinating federal policy." I would keep,
certainly, the "safe and effective" in there, but instead of saying
"facilitate integration," it would be "coordinating federal policy."
MS. SCOTT: "Regarding safe and effective"?
DR. GORDON: Let me just say that these are two different
functions. The "safe and effective" was there when we were talking
about integration. There is nothing wrong with "safe and effective"
except that part of the office's function is to say what is not safe,
what is not effective, what is going on, what we know, and to present
information about all the approaches. So for me, "safe and effective"
comes in if we are saying that something needs to go ahead, but part
of the office's function is to say, what do we know. If we don't know
anything, then we need to say that as well.
DR. ORNISH: That's what I was saying about "evaluate," and
you said that was a bad idea.
DR. GORDON: I'm sorry?
DR. ORNISH: When I first started talking this morning, I
said that the office should be about evaluating and coordinating, and
you were saying that it shouldn't be about evaluating.
DR. GORDON: I think what I am saying is that I think Joe's
description makes it very simple and doesn't get us bogged down in
specific functions beyond the specific functions that we list in the
action item.
DR. FINS: Can I just say ??
DR. GORDON: Yes, go ahead.
DR. FINS: I agree that we need to evaluate these things,
obviously, but it may be further downstream, and it may not be at this
level. Just as we can't, as a panel, evaluate modalities, this
advisory body might have a composition that would not lend itself to
the scientific evaluation of an herbal or something, but it should
coordinate and delegate that responsibility to make sure that it is
happening somewhere in the federal government. That is why
"coordination" is the verb that I like, or the gerund.
DR. GORDON: Julia and Tieraona, please.
MS. SCOTT: I just want to make sure we are, again, not
putting a lot of pressure on this body of people as different from
other federal offices that coordinate activities around a specific
area. We are recommending that this office be under the auspices of
DHHS. There is a whole chain of command, there is an evaluation
process that has to happen. This happens with the Women's Department,
this happens with the Office of Minority Health. I mean, it happens.
So I don't think we have to add on all of this stuff. My memory is,
the original recommendation had, just, "coordinate," and then people
got concerned about any kind of CAM coming through. So the language
that we agreed on was "integration of safe and effective," so that it
was clear that this office wasn't just going to try to get all kinds
of CAM, unproven CAM method therapies, shoved through the system.
So that is just a rationale for why we put those words in, and
we are now agreeing that it muddies the water and we should take it
out, but we did have a thoughtful process on why we included those
words.
DR. LOW DOG: I just love Julia's memory. She always
remembers everything. I would just like to support the language of
"coordinating the federal policy," and not include "safe and
efficacious," though that is obviously a part. Federal policy may
actually be about taking care of products, getting rid of products
that are not safe. So this office may be in charge of a broad
spectrum. I move that we put Joe's language up for a vote.
DR. GORDON: Dean.
DR. ORNISH: I think it would be a real mistake to take out
"safe and effective." I think there are ways of making it clear that
if we are coordinating and evaluating, or even just coordinating
activities, that the goal is somehow to end up with ones that are safe
and effective. I think taking that out would be really unwise, and a
step backward.
DR. GORDON: So, Dean, how would you amend Joe's statement?
DR. ORNISH: Joe, read the wording that you have.
DR. FINS: "The President should create ?? I'm sorry, where
am I?
DR. ORNISH: "Should create an office to."
DR. FINS: "To coordinate federal policy with respect to
complementary and alternative medicine." I just was beginning to
revise it to incorporate this, "so that the American public has access
to safe and effective."
DR. GORDON: Tom.
MR. CHAPPELL: I think the language should be, "create an
office to coordinate and facilitate the safe and effective
implementation of complementary and alternative health care practices
and products."
DR. BRESLER: Again, we're okay with integrating into our
health system those practices that are determined to be safe and
effective, are we not? Okay. Then how about the language to say that
it should create an office to coordinate federal CAM activities and to
facilitate integration of those alternative health care practices and
products into the nation's health care system that are determined to
be safe and effective?
DR. FINS: Maybe that goes into No. 1.3 as an element.
DR. BRESLER: Yes, it could.
DR. FINS: Not No. 1.1.
DR. GORDON: I would like to get closure. I think we are all
in agreement. I would like to just get some wording that we can agree
to, and move ahead with this.
DR. BRESLER: What I am suggesting is that for the
recommendation itself, that we clarify that it is to coordinate
federal activities, and then, as those CAM practices are determined to
be safe and effective, to facilitate the integration.
DR. GORDON: Okay.
DR. ORNISH: I can live with that. I can live with that.
DR. GORDON: You agree with that, Dean? Okay. David, would
you read that again, and let's see if we can go with that.
DR. BRESLER: "The President, Secretary of Health and Human
Services, or Congress, should create an office to coordinate federal
CAM activities and to facilitate integration of those alternative
health care practices and products into the nation's health care
system that are determined to be safe and effective."
DR. GORDON: Are we okay with this? Wayne?
DR. JONAS: Well, I mean, you can say that if you want. I'm
not going to object, but I think it really is redundant. I think it's
not necessary, it's not what is actually going to happen. The office
is going to coordinate federal activities, and that is all it's going
to do. I think it narrows it down. There are a lot of things about
integration that occur in medicine that have nothing to do with
science or proven safe and effective, and will occur in this area just
like they occur in regular science. I think it should be kept simple,
it is coordinating federal activities.
DR. GORDON: We have two proposals on the floor. One is the
simple "facilitate coordination," and the other is to "facilitate
coordination and integration of safe and effective." Dean?
DR. ORNISH: Without trying to belabor it, Wayne, that is the
very thing that I was trying to say in my memo, that just because a
lot of allopathic things are used that aren't proven to be safe and
effective doesn't mean that we should necessarily say that that is
what we want to do with CAM.
DR. JONAS: I agree, and I don't think we should make another
standard. I think we should just keep it simple and say this is
coordinating federal efforts. Whatever those efforts may be is going
to be determined by the office.
DR. GORDON: Now, we have two proposals. One is to
facilitate coordination of federal efforts, and the other one adds the
piece about integration of safe and effective. Can I get a sense?
How many would prefer just the "facilitate coordination"?
[Show of hands.]
DR. GORDON: That's, what, seven? Eight. Let's see that
again.
[Show of hands.]
DR. GORDON: I think the simple wording has it. I think we
can put in the text some of the issues related. Will that be
acceptable, to put those in the text, issues related to safe and
effective, integration of safe and effective? Dean?
DR. ORNISH: The vote has been taken.
DR. GORDON: I'm sorry?
DR. ORNISH: Everybody has made a decision.
DR. GORDON: I can't hear you.
DR. ORNISH: I said the vote has been made. It doesn't
matter what I think.
DR. GORDON: No, I am asking how about putting it into the
text.
DR. ORNISH: I think that would be useful.
DR. GORDON: Okay.
DR. WARREN: I'm glad we had a consensus on this before we
started.
DR. GORDON: Okay. First of all, are there any issues about
the text, any other issues about the text, that need to be addressed
in this section? Then we need to take up the last issue that was
raised, about where this should be positioned in the report.
Tieraona.
DR. LOW DOG: I just think you need to get rid of that whole
"parents of children with attention deficit," blah-blah-blah, just
narrow it down. You could say something like, "consumers,
manufacturers, both CAM and conventional practitioners," or that, "We
heard from a broad spectrum who testified about the need for," and
then finish it. Then you could say, "This is consistent with findings
of other groups as well, several national meetings," just make a nice
segue. But I don't think it reads very well.
DR. GORDON: Okay. Any comment on that? Joe.
DR. FINS: I agree with that. On page 4 --
DR. GORDON: Let's deal with that one first, okay? Are there
other comments about this particular change?
[No response.]
DR. GORDON: Okay to change it that way? Okay. Thank you,
Tieraona. Joe, you have another?
DR. FINS: Yes. On page 4, we are talking about who might be
on this council. In addition to the recommendation that somebody from
the Office of Domestic Policy Advisor, from yesterday, that I
suggested, I also think we should make some explicit mention of CMS.
DR. GORDON: Okay. Explain to everybody what CMS is, Joe.
DR. FINS: It is the HCFA, the new HCFA, which will have
important implications for bringing safe and effective things to the
reimbursement within the federal government, and that, I think, is a
very important player to be in that loop.
DR. GORDON: Okay. Is that all right? Fine. Anything else
in the text that needs to be addressed? We did some of this
yesterday, but if there is anything more. No? Okay.
The final issue with regard to this section was the placement
of the section. Right now, we have it at the end of the report.
Yesterday, a couple people suggested it might be placed at the
beginning, or elsewhere in the report. I would like to get some
discussion and some resolution, if possible, about that. David.
DR. BRESLER: Yes. Again, I brought this up yesterday where
I thought it was backwards, but it started with Wellness and ended
with CAM Central, and I think it should go exactly the opposite way.
I think we should put our most important recommendations first.
Again, as Dean pointed out, I think that there are, maybe, two or
three really key recommendations of all the ones that we are going to
recommend, and I think that they should be strongly emphasized right
up at the front of the report, and this is maybe the most important
one of all.
DR. GORDON: I just wanted to make a point of information,
that Wellness is not going to be at the beginning of the report. That
is not the current plan, and I will just give the rationale for it
briefly, and then we can go on. The current plan is to address the
mandate areas first, and then to follow with Wellness and CAM Central
at the end. So I just wanted that as a point of information.
DR. BRESLER: I understand. We even talked about the
possibility of putting Wellness in as an appendix, too, since this
goes a little beyond our mandate, but even though that was our
mandate, I think the report shouldn't just necessarily follow what we
have been asked to do, but it should emphasize what we think are the
most important things to do first, and this is one of them.
DR. GORDON: Other discussion about this? Tom, and then Joe.
MR. CHAPPELL: Yes. I will just repeat what I said
yesterday. I think putting CAM Central first is certainly license we
can take, and I think it presents a very bold and powerful opening to
the whole document.
DR. GORDON: Joe.
DR. FINS: I think what we might want to do is to finish
going through all the sections, and then figure out how they sort out.
I mean, arguments could be made to put Research early on because
everything, in many ways, follows downstream from that. I think it is
premature to have the meta discussion before we go through the details
of each section.
DR. GORDON: Does that feel fair enough to everyone? Okay.
Let's make sure we get back to that at the end. Then let's close this
discussion. Tom, you had a point you wanted to make. Then I want to
welcome George DeVries and give George a chance to say a few words, if
you would like to. Charlotte, you had something you wanted to say?
SISTER KERR: Yes. I'm not so sure about putting it first. I
honor everything everyone said. My sense is that we need an organic
process for the reader, or the evolutionary process, so that we bring
them into the thinking and consciousness where it's really going to
take a federal-level coordination to do this rather than, here we are;
we want a big?time thing. So that is my thinking, and I just share
that with the group.
DR. GORDON: Thank you, Charlotte. What I would like to do
is defer, per the discussion, defer the discussion of the order until
the end, and then move ahead. Thank you. Tom.
MR. CHAPPELL: I have completed the edits to the Education
section. If everyone could go to the Education section. The task I
was working on, with Steve's help, was to include the dentist and
dental education as part of everything we are doing here. So if you
open the Education and Training document, there are four very simple
edits and they begin on page 3 with the heading "CAM in Medical School
Curricula." I would simply like to amend that line, that header, to
say "CAM in Medical and Dental School Curricula."
DR. GORDON: Okay. Why don't you go through all of them and
then we can see where it all falls.
MR. CHAPPELL: They are all consistent. Two lines after
that: "integrated into allopathic medical and dental school
curricula." The next paragraph: "CAM taught in the context of
conventional medical and dental education." There is one more edit of
that type, which I will find here in a minute.
DR. GORDON: All right. So the proposal is simply to add
"and dental" to "medical." Joe, and then Charlotte.
DR. PIZZORNO: Actually, we were going to say the same thing.
SISTER KERR: Yes. Go ahead, Joe.
DR. PIZZORNO: I think Tom has actually brought up a very
good point, but why just medical and dental? Shouldn't it be
conventional health care education, as what we are talking about?
Because I think nurses should know about CAM, because they have
interaction with the patients. I think we should broaden the language
to everybody, just broaden the language.
SISTER KERR: I was kind of shocked that I just missed that.
It absolutely should be all the health care schools and allied health
care, and this is even part of the NCCAM money. I know nursing, in
particular, got languaged in for the funding, and, in fact, it is
being done. So right now, even our school is hooking up with the
University of Pennsylvania. All the professional health care schools
will be doing complementary medicine.
DR. GORDON: Any other comments on this? Do you want to
amend Tom's proposal? Julia, go ahead.
MS. SCOTT: I just want to make sure. If we are adding this
in the text, then we need to have at least a line, or something about
each of those, or not.
MR. CHAPPELL: If we could just make a decision on the
language. There is one more line. I found it. It's in the
paragraph, page 3, beginning with "Georgetown University" four lines
down: "CAM and existing medical and dental schools." Now, I am very
happy to be more inclusive with the description, so I defer to the
broader language. I just was concerned that "medical" had excluded
dental.
DR. GORDON: Joe.
DR. PIZZORNO: Actually, if you look at Action Item 1.1 on
page 7, we start out with "conventional health profession schools."
So I think we just make sure the rest of the language is consistent
with that.
DR. GORDON: Okay. Would that be all right with everyone,
make sure it is conventional health professional schools, and not just
restricted to medical school? Yes? Good. Let's move on, then.
Before we go into Information, George, yesterday, everyone said a few
words about their hopes and concerns and wishes. Dean spoke a little
bit this morning. Welcome to you from the red?eye. Would you like to
say a few words to the Commission?
MR. DeVRIES: Well, good morning. It's great to be here.
This is obviously our last session together as a Commission, and I
know there are still a lot of dynamics that we are working through,
but out of the many, many recommendations -- there are so many of them
-- there are actually a few of them that are so critical to the future
of complementary health care.
So, as we delve through this, I think there is a real
opportunity, even with the few critical ones, as well as the majority
of the many, there are real opportunities to create a lasting
impression and lasting impact on our field as we look to the future.
So I am excited about that. Thank you.
DR. GORDON: Great. Thank you, George. So let's begin.
Turn now to the Information section.
DR. KACZMARCZYK: I would like to, as we make a transition to
the next subject, thank Don Warren, Effie Chow, Veronica Gutierrez,
and Wayne Jonas for the contributions to CAM Central, and I have a
little something to show our appreciation.
[Presentation of certificates.]
DR. WARREN: Thank you, Joe.
CAM Information Development and Dissemination
DR. GORDON: We are going to begin now with the Information
section. For George and for Dean, the procedure that we have devised
is to go through, recommendation by recommendation, to get a general
sense that the recommendation works for us. If it works for us, to
let it go at that point and say it's a recommendation. If it doesn't,
to work on it until it makes sense in some way, or else to say we are
not going to make the recommendation. Once we have gone through the
recommendations, then to go back and look at the text and look at all
the issues in the text that may present problems that need to be
amplified or clarified.
So what I will do is, I will read the first recommendation,
then ask you all to read to yourselves the action items, and then we
will go through them one by one, starting with the recommendation and
the action items, and we will have discussion on each.
So the first recommendation is on page 7 of the Information
section, and it reads as follows: "The availability of reliable,
useful, and easily accessible information for the public on CAM
practices and products should be enhanced."
Then I ask you to take a minute to read through the action
items under that, 1.1 through 1.4, and then we will begin to discuss
the recommendation.
[Pause.]
DR. GORDON: Let's begin with a discussion of the
recommendation. Tieraona, you have your hand up, and Don as well.
DR. LOW DOG: Well, I guess my question is just, is
"reliable" the best word, or is "accurate" more powerful? "The
availability of accurate, useful and easily accessible information"?
DR. GORDON: Let's continue. Don.
DR. WARREN: I like "accurate." Are we doing the actions
yet?
DR. GORDON: Let's look at the recommendation. If we can
work with the recommendation first, that would be great. If we can't,
we will go to the action items and work back. Any other others on the
recommendation itself? Yes, Charlotte.
SISTER KERR: All along, in the recommendations, I had trouble
with the fact that they weren't behavioral, and because we do
'shoulds' and get better and work harder, but when we have "enhanced,"
I'm like, what the heck is "enhanced"? It sounds like perfume or
something. So in this case, we want people to have more accurate,
whatever, information. What do we want to say? The country should
improve by 50 percent? We should have six more articles a year? How
will we know if we achieved the objective? It actually is a question
I still have about our recommendations, of how they should be more
behavioral, some kind of measurement.
DR. GORDON: So, do you have a wording that you think would
be better and more action?oriented, so to speak?
SISTER KERR: No. I just said the dilemma. I mean, do we
want something measurable: 50 percent; six articles; a new authority
figure; a 911?
DR. BRESLER: How about something like, "The federal
government should increase the availability of accurate, useful, and
easily accessible information for the public on CAM practices and
products"?
DR. GORDON: I would also add to that, after "products," "and
their safety and efficacy."
DR. LOW DOG: Or, you could do: "The federal government
should increase" ?? however we come up with it ?? "the availability
of accurate, useful, and easily accessible information on the safety
and efficacy of CAM practices and products," period.
DR. GORDON: Okay. How does that sound? Yes? Don, what?
I'm sorry?
DR. WARREN: Let's hear another reading of it, please.
DR. GORDON: Another reading, Tieraona.
DR. WARREN: Say it again, Tieraona.
DR. LOW DOG: "The federal government should provide
accurate, useful, and easily accessible information on the safety and
efficacy of CAM practices and products," period.
DR. GORDON: Does that sound good to you? Comments on this?
MS. AXELROD: Jim, one of the reasons we did not put "safety
and efficacy" or "safety and effectiveness" in the recommendation is
that we don't want information to be limited only to those practices
and products that are safe and effective.
DR. LOW DOG: That's not what it means. That's not what it
means, though, Corrine. I would just beg to differ. When you're
talking about the safety and efficacy, you're talking about, perhaps,
the lack of safety, or you're talking about the lack of efficacy.
Talking about safety and efficacy does not in any way imply that it is
only safe. You're just talking about safety as a category, and it may
have a little safety or a great deal of safety, but I think people
need to know the difference. So I'm talking about information on the
safety and efficacy.
DR. JONAS: Why don't you just say "information, including
the safety and efficacy." Then it doesn't limit it.
DR. LOW DOG: Corrine, do you think that sounds okay?
DR. GORDON: Okay. Can we read that again and see if we are
okay with this? Tieraona, do you want to read that?
DR. LOW DOG: Is this like a test? Let's see: "The federal
government should provide accurate, useful, and easily accessible
information, including the safety and efficacy of CAM practices and
products."
DR. GORDON: I think Wayne had it the other way around: "for
the public on CAM practices and products, including their safety and
efficacy," "including about their safety and efficacy."
DR. LOW DOG: Well, Wayne, you read it.
[Laughter.]
DR. GORDON: Go ahead.
DR. LOW DOG: "The federal government should provide
accurate, useful, and easily accessible information to the public on
CAM practices and products, including their safety and efficacy." Did
we do it?
DR. JONAS: Yes.
DR. LOW DOG: Okay.
DR. GORDON: "Including information about," to make it clear,
because otherwise it is not quite grammatical. "Including information
about their safety and efficacy."
DR. LOW DOG: There you go.
DR. GORDON: Okay. Are we okay with this? Okay. Great.
Let's go to the action items, then. Comments? Don.
DR. WARREN: Yes. No. 1.1 is CAM Central, isn't it? No. 1.1
appears to be CAM Central and the advisory council on CAM Central. I
think we probably strike it here.
DR. GORDON: Strike it here. We actually had a lot of
discussion about this in our group and the reason that it is included
here was, if CAM Central didn't go forward, or if it were limited in
other ways, we wanted this issue addressed. It may get subsumed under
CAM Central, but we think it needs to be handled one way or another,
even if CAM Central doesn't become real. That was our thinking about
it at the time.
MS. AXELROD: If I could also add that the task force is
different than the advisory council, that CAM Central, if it exists,
may convene this and make sure it happens, but the task force members
are not the same people as the advisory council.
DR. GORDON: Are you clear on that, Don?
DR. WARREN: You are saying the task force is different, is
an additional group.
DR. GORDON: I think, also, that the way things work in
practice, is, if CAM Central happens, that function will be subsumed,
almost certainly, under CAM Central, and the task force will be
appointed by CAM Central. I mean, I think that's what will play out,
practically. David's concern is if CAM Central is not created, that
the function still needs to go ahead. Other discussion about 1.1?
Yes, Charlotte.
SISTER KERR: Again, the words "to enhance," do we want it to
say "facilitate the development and dissemination of CAM information"
on the first line, in 1.1?
DR. GORDON: So that, the change would be from "enhance" to
"facilitate." Is that okay? Okay. Anything else on 1.1? All right.
We are okay with 1.1, then, with that understanding that David gave
us. Let's go to No. 1.2. David.
DR. BRESLER: Real quickly, let's take out the "all," just to
keep it consistent with our other action plans.
DR. GORDON: In 1.2, okay. So let's look at 1.2. Comments
about 1.2? Tieraona.
DR. LOW DOG: I just wanted to add, Corrine, what do you
think about, at the bottom, "safety and effectiveness of CAM products
and services"?
MS. AXELROD: Okay.
DR. GORDON: Is that okay with everyone?
DR. LOW DOG: Or "practices."
DR. GORDON: "Practices."
DR. LOW DOG: I just didn't want to limit it to products.
DR. GORDON: "Practices." Good. Anything else on 1.2? Any
hands up? Okay. We are okay with 1.2, then, with those two small
changes: "all" stricken, and adding "practices" at the end. No. 1.3.
Charlotte.
SISTER KERR: Just a clarification. The American Library
Association, the National Library Association, is that the working
group? So that, we are actually affecting the working system of our
library system?
MS. AXELROD: Yes.
DR. GORDON: Anything else on 1.3? Okay. We are okay with
1.3. Yes? No. 1.4, any discussion on this one? Okay. We are all
right with 1.4. Yes? Okay, good. Thank you. Let's move on to
Recommendation No. 2 at the bottom of page 9. David.
DR. BRESLER: Again, to keep it consistent, along with
Charlotte's concerns, I think we should say: "The federal government
should improve the quality and accuracy of CAM information on the
Internet."
DR. GORDON: This is Recommendation No. 2, at the bottom:
"The federal government." What are you suggesting, David?
DR. BRESLER: "The federal government should improve the
quality and accuracy of CAM information on the Internet."
DR. GORDON: Well, let me read it the way it is, because that
may or may not be the intent. What it is here is: "The quality and
accuracy of CAM information on the Internet should be improved."
You're making a suggestion that it is the federal government.
DR. BRESLER: It's tricky because we don't want Big Brother
in this particular medium, for sure, but we want to make it an
action?oriented behavioral recommendation.
DR. GORDON: Let me suggest, before we discuss the
recommendation, that everybody look at the action items, and then
figure out how the recommendation should be worded.
DR. ORNISH: I like the recommendation myself.
DR. GORDON: Dean? I'm sorry, go ahead.
DR. ORNISH: I like the recommendation.
DR. GORDON: You like the recommendation as it is?
DR. ORNISH: Yes.
DR. GORDON: Okay. Other discussion about the
recommendation? Joe, and then George.
DR. PIZZORNO: I don't think we should put in "federal
government," because there are already several independent agencies
out there testifying to the quality of health?related content on the
Internet. So let's have everybody responsible, not just the federal
government.
DR. GORDON: Okay. George.
MR. DeVRIES: Yes. I wouldn't lead with the "federal
government," because if the federal government doesn't do it,
basically this still needs to be done, and as Joe said, there are a
variety of organizations that are stepping up to provide that kind of
oversight and accreditation.
DR. GORDON: David, where are you on this?
DR. BRESLER: I'm fine with it.
DR. GORDON: Okay. So the recommendation is all right as it
stands?
SISTER KERR: A question.
DR. GORDON: Yes.
SISTER KERR: Again, it's not a big deal, but people with
better words than I might do this: "The quality and accuracy of CAM
information on the Internet should be improved," and I wonder if we
want to be more specific, like, "It should be accurate and up to
date," words that may be a little more specific. What would be
something to indicate we are not going to do something?
DR. GORDON: Let me suggest, Charlotte, that we look at the
action items and see if we want to take any of the wording in the
action items and put them back in the recommendation or not. Let's
look at the action items with the opportunity to go back and look at
the recommendation again, in the light of the action items. Is that
okay with you if we do that?
SISTER KERR: Yes.
DR. GORDON: So let's look at the action items, and then see
if we want to revise the recommendation based on that, because I think
a lot of the wording that you are looking for is in the action items.
So let's look at 2.1 first. Discussion about this? Any problems or
concerns about 2.1?
[No response.]
DR. GORDON: Okay. No. 2.1, we are all right with. I need
to get little signals, head signals or hand signals. All right,
great. No. 2.2 all right? Yes?
No. 2.3, the Privacy section. We are in agreement on this?
Great. Joe.
DR. PIZZORNO: I think, right now, the FTC is responsible for
evaluating the accuracy and appropriateness of information on the
Internet, and we don't seem to have supported them in that process.
MS. AXELROD: The FTC oversees advertising, and that would
include on the Internet, but this is really about the content of
Internet sites that provide information on CAM services and products,
and other health information.
DR. GORDON: Okay. So are we all right, then, with 2.3?
Yes? Okay. I'm sorry, David. Go ahead.
DR. BRESLER: The question is, do we want to include little
pieces of 2.1, 2, and 3 in the recommendation itself by saying how it
should be improved: "should be improved by establishing a voluntary
standards board, public education campaigns, and actions to protect
the privacy of," et cetera, just somehow include two or three words
about each of these action steps in the recommendation itself, so it
is not so vague, like "should be improved."
DR. GORDON: It would be easier if you could give us the
precise wording. Then we could have a discussion about that.
DR. BRESLER: I can give it to you now, if you want.
DR. GORDON: Yes. Go ahead.
DR. BRESLER: Okay. "The quality and accuracy of CAM
information on the Internet should be improved by establishing a
voluntary standards board, public education campaigns, and actions to
protect consumers' privacy."
DR. GORDON: Okay. Responses to David's follow?up on
Charlotte's suggestion that we might want to be more specific?
Charlotte, do you have any response?
SISTER KERR: Taking it in, it sounds pretty good.
DR. WARREN: What was the last part of that again, David?
DR. BRESLER: "Actions to protect consumers' privacy."
DR. GORDON: Dean, what is your sense of that?
DR. ORNISH: I'm not sure, if it is in the actions or the
recommendations, that it really matters that much, but if it makes
David comfortable, I'm all for it.
DR. BRESLER: Again, it was just our concern that a lot of
our recommendations are sort of vague, and sort of like, "let's get
world peace." Let's put something a little bit more specific with the
recommendation.
MS. SCOTT: Quite frankly, many people are going to be
pulling from this report, and many people won't pull the
recommendation and the action. So I think, in that sense, it is just
the addition of a couple more words that it makes sense.
SISTER KERR: My bias is just what Julia said. I think there
will be the executive summary readers, there will be just the
recommendation readers, and I think our recommendations need to have a
little more juice to them, like David is suggesting.
DR. GROFT: We are not planning to separate the
recommendations from the action items in the appendix. They will all
be included together. The second part of that will be, the
recommendations and action items will be highlighted, as far as the
organization that is responsible for implementation, such as the
department, such as the private sector. If there are specific ones
towards FDA or NIH, they will be so identified.
DR. GORDON: Steve, okay, so you are saying that the
recommendations cannot be pulled out.
DR. GROFT: Someone would have to remove the action items
from the recommendation itself.
DR. GORDON: So, do you have any feeling about being more
specific in the recommendation?
DR. GROFT: If you wanted to add those three statements there
that follow, or the three phrases, it's okay to just continue on.
DR. GORDON: Okay. Tieraona.
DR. LOW DOG: Yes. Corrine, do you think that is okay?
Because it is very brief and it just makes it more specific, I would
support the additions.
DR. GORDON: Okay. David, read them once again so everybody
can hear them.
DR. BRESLER: Recommendation No. 2: "The quality and
accuracy of CAM information on the Internet should be improved by
establishing a voluntary standards board, public education campaigns,
and actions to protect consumers' privacy."
DR. GORDON: Okay. Are we in agreement with this? Do we
feel this is something we can live with, want to live with? Yes?
Okay. Any problems? Great. Thank you.
Recommendation No. 3. Let me read this, and Corrine, you have
that wording down. Great.
Recommendation No. 3 on page 11: "Information on the training
and education of providers of CAM services should be made easily
available to the public." Then if everyone would read through the two
action items there.
[Pause.]
DR. GORDON: Okay. Discussion of the recommendation. Are
people happy with the recommendation? Satisfied with it? Any
concerns about it?
[No response.]
DR. GORDON: Okay. So the recommendation is all right.
Let's look at the action items. Let's go to 3.1, "states require all
persons providing CAM services to make information available." Yes,
Charlotte.
SISTER KERR: Again, it's almost like Action Item 3.1 should
be the recommendation. It just says the recommendation more clearly.
DR. LOW DOG: Would you suggest something like "states should
improve," something like that? Is that what you want in the
recommendation? Because it's more than just the CAM services
providers, it's also that they should maintain information on
guidelines in that, et cetera.
DR. GORDON: It is more active, is what you are saying. It
is more active, more specific than the recommendation. The
recommendation is more general and somewhat more in the passive mode.
Linnea, were you about to say something? Or, George?
MS. LARSON: This is something I still have not resolved
myself, but I still have great difficulty when we tell states what to
do, and there may be some way of rewording that or something, but to
have that as the recommendation, states should do this, again, it
comes back to my point of, we are trying to guide federal policy and
then maybe give some support to states as they are carrying out some
activities that we would recommend.
DR. GORDON: Okay. George?
MR. DeVRIES: I certainly understand the concern, but it is
certainly reasonable and within the scope of this commission to make
recommendations to states, and I believe that these are good
recommendations to states and I actually think they are pretty well
worded. So I think, in the context of our role, making
recommendations like this is a good thing.
DR. GORDON: Can you help Linnea with her concern? You're
saying it is within the role of this commission. Do you want to
explain to her why you think that?
MR. DeVRIES: Well, you have 50 individual states who are
making decisions on how to appropriately regulate health care and
licensed health care providers, and ultimately those 50 individual
states don't always see it on a national level, and that is the
opportunity for this commission to give the states a reference point
and recommendations, and that is going to be very helpful to them. I
do know, in talking with a couple representatives of state
governments, that there is interest in having this commission make
recommendations, and that is the way it is seen.
DR. GORDON: Okay. Other discussions about this whole
recommendations to states issue? Yes, Veronica, and then Joe.
DR. GUTIERREZ: I'm not sure how you accomplish this, other
than posting your diploma on your state license. How in the world do
you make information more available, or easily available, to
consumers? I don't know what this means.
DR. GORDON: Charlotte, do you want to respond to that?
SISTER KERR: It's a little bit more muddying things, to me.
There is a de?emphasis in this recommendation of the personal
responsibility of the practitioner to say who they are, what they do,
and there are some people who will not yet even be in registrations
and licensure. It's back to the consumers being educated themselves
to know what to look for, and the responsibility of a practitioner to
say what the story is. So mine is almost saying we want to say states
and practitioners are responsible for making known their level of
practice or experience.
DR. GORDON: Tieraona?
DR. LOW DOG: I would support states and practitioners making
that. I just know that we don't live in an ideal world where
everybody is up front about that. Your point is well taken about the
license and diploma here. I think this is really trying to get at
more of an ambiguous category of people who are not licensed but who
provide services, and the informed disclosure-type of model where this
commission has not taken the position to restrict their ability to
practice, but that we feel, for public awareness and safety, that they
should know who this person is and what their training is.
The problem will still be that if it says some school of
healing or something up there, the consumer has no concept if that is
a valid diploma or not. So it is still problematic, I recognize that.
DR. GORDON: So there are two issues on the floor right now.
One has to do with whether or not there needs to be instruction to the
states or whether the recommendation should be to all practitioners --
I'm hearing that nuance from you, Charlotte -- and Linnea's concern
about instructing these states, and George's feeling that it is
appropriate and asked for. David? I'm sorry, Joe is first, and then
David. I'm sorry.
DR. PIZZORNO: These are all great points, and I think Linnea
and George raised very valid points. I think we have to be careful
about that, where we draw that line. So I think that one area that is
clearly over the line is to say that the federal government should
require states to do X. That is going over the line, but for us to
recommend an action to the state, I think, is really appropriate. So
I think we should be careful about our language. I think "recommend"
is very appropriate language. "Should" is language we must be very
careful about. I wonder if there is some way we can modify it rather
than just using "should," "should consider."
DR. GORDON: What about saying "The Commission recommends
that states require."
DR. PIZZORNO: Yes. That kind of language would work.
DR. GORDON: Does that work? Does that work for you, Linnea?
MS. LARSON: Yes.
DR. GORDON: Do we want that as an action item, or do we want
that as the recommendation?
DR. LOW DOG: Would you read your recommendation?
DR. GORDON: Just, "The Commission recommends that states
require all persons providing CAM services to make information
regarding their level and scope of training easily available to
consumers."
MS. AXELROD: Just for consistency, we have stricken "The
Commission recommends" from all of the recommendations to avoid
repetitiveness, so this would kind of stick out a bit, to word it that
way.
DR. GORDON: Yes. We may want it, I don't know.
DR. GROFT: I think, in this case we are looking at states'
rights, as opposed to federal involvement. Maybe this is one time
when we can just go with recommending it, since every recommendation
would not have that language in it.
DR. GORDON: David?
DR. BRESLER: I think our responsibility in our charge is to
look at this from the point of view of the American public, and there
are some things that the federal government regulates, there are
certain things that the states regulate, but our mandate is to protect
the American public, and I think in those situations where it is
really the states' responsibility, I don't have any reservation about
strongly recommending what the states need to do to protect the
American public. That is part of our charge, as far as I am
concerned.
DR. GORDON: What we are talking about is making 3.1 the
recommendation. No? Leaving the recommendation as it is?
DR. BRESLER: Leaving the recommendation as it is.
DR. GORDON: The action item being the way I just stated?
DR. BRESLER: The way it is.
DR. GORDON: Okay.
DR. BRESLER: I wouldn't be concerned about telling the
states what to do.
DR. GORDON: Are we all right with that, then? Okay. Let's
look at 3.2, then. We are in agreement the recommendation stays as it
is? No?
DR. WARREN: You have confused me.
DR. GORDON: I'm sorry?
DR. WARREN: You have confused me on 3.1. Read 3.1.
DR. GORDON: No. 3.1 would be, Action Item: "The Commission
recommends that states should require," et cetera, et cetera.
DR. WARREN: Okay.
DR. GUTIERREZ: I would like "disclose information" rather
than "make information." Disclosure, to me, denotes a little more
honesty, maybe.
DR. GORDON: So it would read, "To disclose information
regarding their level and scope of training to consumers."
DR. GUTIERREZ: Yes.
DR. GORDON: I'm sorry, "disclose information regarding their
level and scope of training to consumers." Okay. Great. Let's move
on to 3.2. Do we want to reword it in the same way, or do we want to
keep it this way?
DR. BRESLER: Again, I think we may all be more comfortable
just recommending things to the state to say specifically that "the
Commission recommends," and then take it out of everywhere else.
DR. GORDON: So that it would read something like, "The
Commission recommends that states make information," et cetera, et
cetera. George?
MR. DeVRIES: Yes.
DR. GORDON: Yes. Dean?
DR. ORNISH: This is not important enough to me to spend a
lot of energy on, but, as Corrine said, in every recommendation is
implicit the statement "the Commission recommends." I'm not sure why
this is different. It doesn't change anything. It's just redundant,
but I don't really care.
MR. DeVRIES: I would just add, I think Stephen made a good
point, which is, we can err on the side, on this one, which says, "the
Commission recommends" because we really truly are, just on this,
recommending to the states a course of action, and erring on that side
is probably prudent on our part.
DR. GORDON: So, in a sense, what you are saying is, we are
taking our function as a recommender, we are not violating states'
rights, and that is why we are putting in the "recommend" here and not
elsewhere. Is that correct?
MR. DeVRIES: Yes.
DR. GORDON: Okay. Joe.
DR. PIZZORNO: One is, I don't know if we should change
"information" to "disclose" on this one because the state, we are
assuming, is open. However, I have a concern. Do states have the
legal authority to make public disciplinary action against health
providers?
DR. LOW DOG: They do.
DR. PIZZORNO: They do?
DR. LOW DOG: They do for conventional practitioners. It is
the wall of shame.
DR. GORDON: Okay. No. 3.2, anything else on that?
[No response.]
DR. GORDON: All right. We are fine with 3.2, with that
amendment of "The Commission recommends that." Let's go on to
Recommendation No. 4 on page 14.
MR. CHAPPELL: Jim?
DR. GORDON: Yes, sorry.
MR. CHAPPELL: I would like to speak to the recommendation.
DR. GORDON: Which recommendation?
MR. CHAPPELL: No. 4.
DR. GORDON: Let me read it, and then let's give people a
chance to read the action items first.
MR. CHAPPELL: Okay.
DR. GORDON: Recommendation No. 4 on page 14: "CAM products
that are available to U.S. consumers should meet or exceed minimum
standards of quality and consistency." Then if everyone could read
the action items, and then, Tom, you will be first to speak on this
one.
[Pause.]
DR. GORDON: Okay. Tom, you wanted to speak to the
recommendation.
MR. CHAPPELL: Yes. Thank you. I would like to add the idea
of safety to this recommendation for two reasons. Safety is expressed
in Action Item 4.4, and safety is the number one concern that
surrounds this whole subject. We have not been able to embrace the
notion of safety in any of the other recommendations throughout the
document, and it seems to me this is the place to do it. To talk
about quality and consistency falls short of the concern that has been
expressed throughout the hearing process for safety. So my language
change here would be very simple: "CAM products available to U.S.
consumers should be safe and should meet standards of quality and
consistency."
DR. GORDON: Okay. Thank you. Let's have discussion. Dean,
and Tieraona, and Ming.
DR. ORNISH: Yes, I agree with Tom. When you think about it,
"should meet the minimum standards," I mean, that is a pretty low bar.
I think we can do better than that.
DR. GORDON: Tieraona.
DR. LOW DOG: I would agree about the safety, products that
are safe. I think consistency is problematic at this point for crude
botanicals. Because of the variability of constituents within them,
having consistency can be tough depending upon how you are defining
that. So I would say "should meet quality standards." I need to work
on the language, but I think "consistency" is going to need to go,
only from a technical point of view because of how you are going to
define "consistency" from one product to another.
DR. GORDON: How are you with the safety issue?
DR. LOW DOG: I am absolutely in support of safety and
products that are safe. Again, that needs to be determined, because
safety for many of these products hasn't been determined. That is
what we are trying to get to in the items.
DR. GORDON: Ming.
DR. TIAN: I think safety and quality will be enough. We
don't need consistency because that is part of the quality. In No. 2,
I don't like the "minimum." What is a minimum standard? I think
there is only one standard for both. It doesn't matter if it is
pharmacy or food or dietary supplement.
DR. GORDON: So, how would you say it, then?
DR. TIAN: Well, just "safety and quality, to meet the
standard."
DR. GORDON: "Should meet standards of."
DR. TIAN: Right. Right. There is one standard. We don't
want to have two standards.
DR. GORDON: Okay. George DeVries.
MR. DeVRIES: I would support the recommendations related to
inclusion of "quality" in the recommendation, as well as eliminating
"consistency" for the reasons stated, and basically say: "CAM
products available to U.S. consumers should meet or exceed standards
of quality and be safe," or, as Tom said, either way.
DR. GORDON: Okay. Yes, Joe?
DR. FINS: I mean, I think you could have quality products
that, in isolation, would be quality products but they may not be
consistent from batch to batch, and as you think about adverse events,
consistency is very, very important. We are going to get to that. So
I think consistency is an element that we might want to maintain.
DR. GORDON: Tieraona.
DR. LOW DOG: Yes. I would like to just respond to that. It
is like saying that every apple has to have exactly the same
constituents from apple to apple. You are just never going to get it,
because depending upon when the apple was harvested and what the
environmental conditions were, it is going to influence how many of
the constituents ?? and there are hundreds of them in an apple. It's
the same thing with botanicals. Now, when you are talking about a
dietary supplement, it is much easier to get consistency, but even a
product that is standardized, for instance, if you standardized it to
a marker compound, other constituents will vary greatly within the
plant. There is just no way to completely control complex mixtures in
that way.
DR. FINS: If I could respond here, and maybe you guys
changed this when I was out for a moment, but you are using the phrase
"CAM products." Maybe that is too vague a term, because the argument
for consistency is good for supplements, but it is not good for other
things.
DR. LOW DOG: That's correct.
DR. GORDON: Joe.
DR. PIZZORNO: I think we can handle this by putting in the
term "appropriate" instead of "minimum standards." That way, with
dietary supplements, clearly we want much more consistency, where,
with botanicals, we realize there is going to be some variation, and
that is appropriate.
DR. GORDON: So, can you give us a wording?
DR. PIZZORNO: Okay. "CAM products that are available to
U.S. consumers should be safe and meet appropriate standards of
quality," period.
DR. LOW DOG: Say it one more time, Joe.
DR. PIZZORNO: Okay. "CAM products that are available to
U.S. consumers should be safe and meet appropriate standards of
quality."
DR. LOW DOG: That's good, because consistency would be a
part of quality for many products.
MS. AXELROD: Well, I'm just wondering, if we have the word
"appropriate," if it would be okay to leave "consistency" in. I'm
looking back at the text where we have really gone to great lengths to
describe the problems with consistency. If you look on page 12, line
335 and down, for instance, it is a big problem, and I think it is
something, if we have the word "appropriate," that would give a little
bit leeway. What is appropriate for one may be different than
another.
DR. LOW DOG: Corrine, I think you are absolutely right on
leaving that in. I just want to point out again that if you are using
a marker compound and you've stated that you have a certain amount of
that substance, your quality standards will guarantee that you have
that. But I could live with it either way. If you are using
"appropriate," I could leave "consistency" in.
DR. GORDON: Where are you?
DR. PIZZORNO: I don't think we have to put it in there, but
if people prefer it, I'm okay with it.
DR. GORDON: Okay. Would people like to have "consistency"
in, modified by "appropriate"? It sounds like they would. So let's
read the amended recommendation.
DR. PIZZORNO: Okay. "CAM products that are available to
U.S. consumers should be safe and meet appropriate standards of
quality and consistency."
DR. GORDON: Are we all right with this? Great. Let's move
on to Action Item 4.1. Any discussion on this?
[No response.]
DR. GORDON: Are we okay with this? Good. Please, I am just
going to move through these, so everybody pay close attention. If
there are issues, this is the time to discuss them. No. 4.2.
Charlotte.
SISTER KERR: Sorry. Back on 4.1, I would recommend on the
third line, "Reference materials for dietary supplements should be
improved and accelerated." "Enhanced" is just not a word that I think
says a lot.
DR. GORDON: Are we okay? Instead of "enhanced"? Is that
all right with everyone? Yes? Okay. Let's move on to 4.2, then.
MR. CHAPPELL: Jim, Tom here.
DR. GORDON: Tom, sorry.
MR. CHAPPELL: I think the last sentence, the word "complex"
is really unnecessary to use in the text. Delete it.
DR. GORDON: Is everybody okay with that? Anything else in
4.2? Thank you, Tom. That is one of those places where we
unnecessarily make things more complex, right? Anything else with
4.2?
DR. FINS: Jim?
DR. GORDON: Yes.
DR. FINS: The proposal concerning GMP, is it a specific
proposal here? I mean, I know what it refers to, but it looks like it
is "the proposal," and I'm not sure if it makes sense to the reader,
in isolation. Could we specify a little more?
DR. GORDON: Corrine, do you want to say what the proposal
is? Or, Ken is here.
MS. AXELROD: Well, it's a proposal and it's pending, so I'm
not sure what your confusion is.
DR. GROFT: Or, would you want to add "the proposal to
establish good manufacturing practices"?
MR. DeVRIES: I think Tieraona suggested "the proposed good
manufacturing practices," which made it clearer.
DR. GORDON: Okay. Are we okay with that emendation? We are
okay with 4.2 as it is? Fine. We are eliminating "complex," and
saying "the proposed good manufacturing practices." No. 4.3. Any
issues regarding 4.3?
[No response.]
DR. GORDON: Okay, No. 4.4. Yes, Tieraona.
DR. LOW DOG: Corrine, to whom, and how, should manufacturers
make available scientific information? "Manufacturers should make
available," but we don't really say to whom.
MS. AXELROD: I think this was intended to the FDA.
DR. LOW DOG: Should we be more specific here?
MS. AXELROD: Yes.
MR. CHAPPELL: Jim?
DR. GORDON: Yes, Tom.
MR. CHAPPELL: I think this is a burden of responsibility of
manufacturers to have in their files when they are creating new
products. I'm not sure I am comfortable making those manufacturers
accountable to the FDA to present that. I think it should be
available on request by any regulatory agency.
DR. GORDON: Can you explain why you are saying that, Tom?
It might help people understand better.
MR. CHAPPELL: Well, if you make the manufacturers
accountable to produce this safety data to the FDA, you will wait and
wait and wait and wait before you can produce a product, and a lot of
the safety data is very readily available as secondary research
information, number one. So it fulfills the responsibility, in my
opinion, to require manufacturers to have this data on hand and on
request, but it poses a whole different burden to make them
accountable, or for the FDA to approve.
DR. GORDON: Okay. Tieraona.
DR. LOW DOG: I'm not sure that we were looking for approval
here. I am sensitive to the problem here, and I am open to more
exploration, but I think that the problem here is that because safety
data is not required, we end up, then, back?pedaling when there is a
problem, and that the reality is that safety data information is not
available for many of the botanicals. You have in vitro data, but
that is it. There is no safety data, other than we have used it for a
long time. So I don't know if there needs to be a review of this,
maybe, before we make the recommendation that manufacturers do this.
Maybe there needs to be a recommendation for a review of how safety
data is made available. I think that, right now, we keep talking
about safety throughout this document, that people have the right to
have safe products, but I'm not sure that I trust every manufacturer
to have the safety data available in a file someplace.
DR. GORDON: Any other thoughts? Joe.
DR. FINS: There are two issues. I understand Tom's point
and I think that it works fine when everything is fine, but when there
is a problem and there is an adverse event, and a manufacturer is no
longer in business, or there is a weekend and there is a tryptophan
sort of story, and we are trying to figure out what the problem is, it
would be nice if some of that information was on file and readily
available. So I think there are really two issues. I mean, I think
the manufacturers should be required to keep a file, but there has to
be a way of accessing it in a situation that is emergent.
DR. GORDON: Joe, do you want to provide some wording that
might cover that?
DR. FINS: Well, I think that maybe it is complicated, and I
think there are competing interests here. Maybe we should leave it as
is at this point and say, we recommend that the FDA consider
mechanisms, feasibilities, working with industry to coordinate this
process," or something. In other words, not to say that it has to
happen right now, but to figure out a way to achieve this end. I
don't have language for you.
DR. GORDON: Joe, and then George DeVries.
DR. PIZZORNO: I think this is an incredibly important issue
because we want to facilitate the public safety, but we also don't
want to put barriers in the place of good quality products being
available to the public. I'm thinking about, we want to help the
public and the manufacturers of high quality differentiate themselves
in the eyes of the public and practitioners from those that are low
quality, and that is a real problem right now, as I think we are all
conscious of.
I wonder if we could have in this ?? I'm kind of thinking out
loud here ?? some kind of a voluntary submission of safety data to the
FDA that could then show up in some way on the person's label or
package documents, so that they are showing to the public that they
really are taking a next step to being more safe and have higher GMPs
in the development of their products. I'm not sure how to word that,
but it is a concept.
DR. GORDON: George, and then Dean.
MR. DeVRIES: I think the issue of safety is the primary
issue here, and yet we are trying to come up with a mechanism. The
mechanism that is being recommended, I hesitate on it also, and for
some of the reasons that Tom has mentioned. I think it also places a
great burden on the FDA. I am not sure they would see it has having
the same value as maybe some of us would. I am going to suggest,
maybe, that we encourage a process such that the outcome is assurance
of safety.
DR. GORDON: What would that process be? Because I think we
have to come to some kind of conclusion.
MR. DeVRIES: Perhaps FDA and/or HHS task force to evaluate
and to come up with a solution to ensure safety.
DR. GORDON: Okay. We can come back to specific wording.
DR. ORNISH: Well, we are not talking about efficacy, we are
just talking about safety, and I think that it seems to me almost a
given that if you ?? it is like we are for world peace in a way, as
David was saying. I mean, who could argue against having safe things
that say what is on the label? I mean, I am not sure why this is even
controversial. If we are asking, and we may not necessarily want to
specify it is the FDA or whomever, we should say an appropriate
government agency should be responsible for making sure that these
things contain what they say they contain, and that they are safe,
period.
DR. GORDON: The recommendation here, though, is directed
toward the manufacturers. So that has a different spin on it.
DR. ORNISH: Well, it is both. I mean, it is both the
manufacturers, but it is also the regulation of the manufacturers.
You can't have one without the other. We are not asking this to be
done voluntarily, and I think it is entirely appropriate that both the
manufacturers be held accountable and that they be regulated to make
sure that what is in the product is what is on the label, and vice
versa, and that it is safe. I can't imagine anyone would be against
that.
DR. LOW DOG: I agree with you. There are a couple issues
here. One is the GMP will take care of making sure that what is on
the label is what is in the bottle, so that is covered under GMP.
Safety is a different issue, though. Trying to have adequate
toxicology studies for acute and subacute and these kinds of things,
most of them have not been done for these products, and so when you
are requiring safety data, how much is going to be the standard and
what kind of studies need to be done, what would have to be supplied
by a manufacturer, because the Dietary Supplement Health Education Act
of 1994 has put these into a different sort of category.
So I need to tell you that I don't argue against safety. I am
absolutely for safety, but right now, we just seem hog?tied. I mean,
we can't even come up with ephedrine guarana answers. Maybe the best
thing, at this point, is to require manufacturers to maintain records
of this, and that we have a recommendation that states that HHS or
FDA, or collaborations of these agencies, create a task force to
address the potentially serious problem here that we have with
inadequate safety data and the fact that it is not submitted to the
government.
DR. GORDON: I would like this, if we could, in the form of
wording that would address these issues. Tom.
MR. CHAPPELL: It seems to me, again, the burden needs to be
on the manufacturer to establish safety. Now, I want to maintain
flexibility for the manufacturer in so doing because there are many
manufacturers that are responsible, and I want to maintain their
flexibility. The idea for me would be to simply publish that safety
data to the FDA, to simply put it on file with the FDA. It is not
getting permission, it is just filing its safety data with the FDA.
So it would say: "Manufacturers should make available to the FDA
their scientific information to substantiate their determinations of
safety."
DR. GORDON: Tieraona.
DR. LOW DOG: My problem with that would be, what if it is
basically a cell culture and that's it, and that's all we have
determined as safety? It is a brand new designer drug that has never
been seen on the planet before, and we have put it in as a dietary
supplement, and there is no safety data available. What is the
responsibility, then, of the FDA?
MR. CHAPPELL: There are other mechanisms to provide for that
kind of scenario. First of all, the FDA regulates claims, so
everything is claim?based. If you are making a claim that is hinged
on an ingredient, then there is DSHEA, or there is a monograph, or
there is the NDA route. Those are the avenues that you can go. Now,
you're shaking your head. I beg to differ with you.
DR. LOW DOG: No. All I am saying is, that claim doesn't
have to do with safety, Tom.
DR. GORDON: Tieraona, let me just interrupt for a second.
We can't solve the whole problem here. I think what we need to do is
have an action step that is a step in the direction that we want to
go.
MR. CHAPPELL: As this is written, I personally would accept
it as it is written, but I also think that we could push a little
harder on this. It is simply to put on file with the FDA the
manufacturer's safety data, and that is just an inventory of data.
DR. FINS: I mean, in a sense, we are asking for something
here that is a kind of modification of existing statute, and we don't
know what it should be. So we are asking you to file, but we don't
know what the filing should be comprised of. So I think what we need
to do is say that, you know, we might say in the text or something
that we recognize that this ultimately is what should happen and that
the FDA should engage in a feasibility study to determine what should
be filed in the safety documents, what the periodicity should be, and
what the elements are, because this action item, in and of itself,
will not lead to any action, but a recommendation for a feasibility
study would be the first step towards the goal that we all share.
DR. GORDON: Okay. I want Julia, and then Tom. Julia, you
had your hand up?
MS. SCOTT: No.
DR. GORDON: No, you're okay? Tom, go ahead.
MR. CHAPPELL: I think that is an intelligent idea, Joe.
There are times when I prefer wisdom over intelligence.
[Laughter.]
DR. GORDON: And wit over brevity.
MR. CHAPPELL: So I do not want you, in this language, to tie
the hands of the manufacturers. I just want you to hold them
responsible for safety.
DR. GORDON: Tom, we need wording here.
MR. CHAPPELL: I gave it to you.
DR. GORDON: We need to come to a conclusion.
MR. CHAPPELL: I gave it to you. I gave it to you.
DR. GORDON: Let's say it again.
MR. CHAPPELL: "Manufacturers should make available to the
FDA scientific information to substantiate ??
DR. GORDON: Okay, and so on.
MR. CHAPPELL: Yes.
DR. GORDON: Okay. Let's talk about this wording, let's see
if it works. If not, Tieraona is also coming up with wording.
Comments? Joe first, and then George, Joe.
DR. PIZZORNO: So, Tom, a manufacturing question to you.
Would it be of value to a manufacturer, or would it be too great a
burden that those manufacturers submit information to the FDA, and the
FDA approved their GMPs and safety data to be able to put on their
label, "The FDA has approved the safety of this product"?
MR. CHAPPELL: I think it is up to the FDA to assess whether
or not it has any concerns about the data that is submitted, and I
think that is their domain to deal with. I don't think it is our
domain. So I am not able to go beyond simply publishing the available
safety data. They know whether we are dealing with something that is
at risk here.
DR. PIZZORNO: Tom, you didn't quite answer the question I
asked.
MR. CHAPPELL: Let me hear it again, then, Joe.
DR. PIZZORNO: It seems to me it would be a huge advantage
for a manufacturer to be able to put on the label that the FDA has
approved the safety of this product.
MR. DeVRIES: You know, guys, we are really going outside of
the laws that are in place. I think we are going way far afield, and
I want to go back to suggesting what has been mentioned, whether it be
a task force or a feasibility study. I know Tieraona is working on
some language related to a task force which I think can really help to
narrow down a process, which I don't think, frankly, we are equipped
to suggest the process that should be put into place today, but I
think we can say there needs to be a task force that goes through
these steps.
DR. GORDON: Okay. Joe.
DR. FINS: I agree with George, but I do want to close the
loop very tightly here because I don't want this to look like we are
just creating another task force. I would like that to be tagged to a
report back to Congress to see whether or not there are any statutory
changes that may need to be made based on that feasibility study. In
other words, this reporting mechanism fundamentally raises the
question of whether or not there is a modification of DSHEA, and I
think that to just have a task force without a recommendation that it
goes back to Congress is too open?ended.
DR. GORDON: Can we have George, Tieraona, somebody want to
write some wording for this?
DR. LOW DOG: Well, we are trying. Let me just respond. I
think, Tom, I think at this point, we would not want to recommend
anything other if we were going to make this recommendation about
manufacturers simply making available safety data. In addition, I
would like to make an additional recommendation that would say
something like, "The appropriate federal agency" ?? and I don't know
who that would be; I would need your help, Corrine, in that ??
"should establish a task force to evaluate the current reporting of
safety information by manufacturer to FDA of CAM products to maximize
and ensure public safety," something like that. I am on the spot.
Right now, the law is what it is. So I think that if we are
saying manufacturers simply reported, the problem is a slippery slope
on both sides. You could have the FDA using that information to say
that it is inadequate safety information in trying to remove products,
which isn't our intent; and on the other hand, you may have
manufacturers who are not taking that responsibility.
So I would either say that we could leave 4.4 the way it is
where it is just simply a reporting, or we could remove it and you
could substitute it. So you could add a Recommendation 4.5 about an
establishment of a task force that is reportable to the Congress, or
you could substitute it for 4.4.
DR. GORDON: Tom and George. We need to come to a closure on
this. We have two more major recommendations in this section and we
are already behind time.
MR. CHAPPELL: Okay. I think 4.4 is a very important action
step and I would be highly opposed to removing it. I am not opposed
to an additional 4.5 that tries to bring some standard to process or a
process that establishes a standard for safety.
DR. GORDON: Okay. What about the 4.5 that Tieraona read the
??
MR. CHAPPELL: Well, I need clarification from Tieraona. Are
you opposed in 4.4 to making reference that this be filed with the
FDA?
DR. LOW DOG: Absolutely not.
MR. CHAPPELL: Okay. So manufacturers should make ??
DR. LOW DOG: I feel very strongly about 4.4.
MR. CHAPPELL: Yes. So 4.4 would say, as it has been
amended, as I was proposing the amendment, "Manufacturers should make
available to the FDA scientific," blah, blah, blah. So that is where
we are in our current process.
DR. LOW DOG: Can we accept 4.4, then?
DR. GORDON: Can we accept 4.4 as amended or not? Joe?
DR. PIZZORNO: I have a question about it. So we are having
manufacturers submit the data to the FDA. What does the FDA do with
it? Is it just archiving it?
DR. LOW DOG: They have it on file.
DR. PIZZORNO: Okay. A concern I have is what if a consumer
has a reaction to a product that shows a lack of safety? Can they
then come back to the federal government and sue the federal
government because the FDA had the safety data and didn't do anything
about it that showed it was not safe? I am just wondering.
MR. CHAPPELL: For me, the recommendation to include the FDA
here in 4.4, just filing, is a responsible step that this commission
is recommending in view of the great concerns for safety in this area.
DR. GORDON: Okay. Can we agree to this? Joe, having heard
your concern, I don't think we have the answer to whether ?? anybody
can sue anybody any time. Whether they can win or not is another
matter and really not our ultimate concern. Our concern is, are we
willing to accept 4.4 here as amended? I don't mean to be short; I am
just trying to move it along. Yes?
MR. DeVRIES: Can we agree to 4.4 the way it is?
DR. GORDON: Just as Tom read it now.
DR. LOW DOG: It is exactly the same, but "make available to
the FDA scientific information." That was the only amendment I heard.
Is that correct, Tom?
MS. AXELROD: And are we leaving in the second clause in
that? The second part is in there, "Current statutory provisions
should be periodically reexamined." That is still in? Okay. Good.
DR. GORDON: Okay. George, are you okay with that? George
DeVries.
MR. DeVRIES: It is a bit unclear. I mean, "should make
available," does that mean upon request from FDA or automatically on
an annual basis?
DR. WARREN: Shouldn't it be "filed with the FDA" so that
they have a file on hand?
MR. CHAPPELL: Sure.
DR. WARREN: Instead of "making available upon request," have
it a requirement that they file it.
MR. CHAPPELL: Sure. I will amend that. "Should file with
the FDA."
DR. WARREN: "Should file."
DR. GORDON: "File with the FDA." Where are you with this?
MR. DeVRIES: Well, I just think we are creating burdens for
agencies and not giving them a role to say these are the ways to
ensure safety. We are saying we think this is the way safety be
ensured, so go do it, and they might respond, you have just spent a
huge amount of resources on our behalf, thank you, we would rather be
spending it this way because we think we could do a better job
ensuring safety this way. So I am just concerned we are ??
DR. GORDON: I think if we cannot come to some kind of
agreement ??
MR. CHAPPELL: I am suggesting, George, that we fix 4.4 and
then take up 4.5 to deal with the process question, George, okay?
DR. GORDON: But 4.4 will still stand, Tom. We are still
saying, even if we going with the process, that the recommendation
still says, give this to the FDA. We haven't asked the FDA if they
want it and we have consulted with them about virtually all the other
recommendations. So I think that George's point is well taken that we
?? you know, we are introducing something that we have no idea whether
it is wanted or not at this point, or needed.
DR. LOW DOG: Well, I think that the other alternative, then,
is to propose the task force to evaluate what is needed and what is
required as a way of addressing these questions, because they may have
minimum standards that they require.
DR. GORDON: That is fine. I am just saying ?? I am just
really sort of rephrasing what George said, is that we really have to
think through the recommendations in terms of whether they fit and
whether they are going to do any good. Charlotte and then Joe.
SISTER KERR: I want to agree with George, though this is not
my area. I think we have a clear intention of goodness and safety.
What we are unclear on is that we are birthing a new baby in this
country in particular, how to do it, and I think we need to be careful
and not put burdens on people in case we won't get the outcome we
seek. So I would support this 4.5 concept, and really, from
everything you as experts are saying to me, it sounds like that is
only where we are, at the beginning of assessing what is wanted and
needed to achieve the objective.
DR. GORDON: Okay. Joe?
DR. FINS: What I would suggest, and I think that ultimately
it should go to the FDA, but I agree with George's concern, but
suppose we did something like that? We made 4.4 "should file with the
appropriate government agency," and then 4.5 is that we would
respectfully ask the FDA to conduct a feasibility study to assess how
this scientific information could be best provided to the government
in order to ensure safety.
DR. GORDON: Is that okay, George?
DR. FINS: So 4.4 simply becomes "Manufacturers should file
to the appropriate government agency scientific information to
substantiate," blah, blah, blah.
MR. DeVRIES: How about, instead of "should file," because
you have automatically created a tremendous amount of paper, huge
amount of paper, you could say, "Manufacturers should make available
upon request to the appropriate government agency." And if the
government agency says, you know, that's a good idea, we want it from
every manufacturer on every product, they can request it.
DR. GORDON: Okay.
MR. DeVRIES: If they are saying, it is not appropriate for
us to collect all this, they don't need to ask for it.
DR. FINS: Okay. But then 4.5 should say that the FDA should
conduct a feasibility study to determine how best to collect ?? to
determine how the federal government, because it may not be them,
should ??
DR. GORDON: Can help ensure the safety ??
DR. FINS: Can help ensure the safety of these products, and
specifically address issues of filing, registration, et cetera, so
that these questions get played out in a sort of scientific way.
DR. GORDON: And let me say we need to move ahead, okay? So
if we have a consensus on 4.4, which I think I was hearing that we
had, I would like to get that clear, okay? So there was a wording I
think, Joe, that you used that people ??
DR. FINS: Yes.
DR. GORDON: Corrine?
MS. AXELROD: I just wanted to let everybody know that the
FDA has reviewed this document and has not objected at all to this
recommendation, so just, you know, to put you at ease on that. There
is also an element of prevention in this that currently the
manufacturers only need to submit a statement saying that the product
is safe. So just even knowing that they must provide a little bit
more information may act as some deterrent to the unscrupulous
manufacturers who really don't have that safety data. My other little
comment is I don't think it is a feasibility study; I think we should
just say study.
DR. GORDON: Joe, go ahead and read your amended 4.4.
DR. FINS: Okay. Four?point?four is that "Manufacturers
should make available" ?? we were going to say "upon ??
DR. GORDON: "Upon request."
DR. FINS: "Upon request to the appropriate government
agency" ?? "to the FDA." Okay. We are back to the FDA. "Scientific
information."
DR. GORDON: Okay. Are we okay with that? Good. Now, 4.5.
MR. CHAPPELL: Would you be all right, Joe, with
"Manufacturers should have on hand and make available upon request"?
In other words, I want to establish the fact that their burden is to
have it on file.
DR. GORDON: Okay? So let's read that once again to make
sure ??
MR. CHAPPELL: "Manufacturers should have on file and make
available to the FDA upon request."
DR. GORDON: Fine.
DR. LOW DOG: That's good.
DR. GORDON: There is a recommendation for 4.5? Let's hear
that, please.
DR. FINS: It is not drafted, but it is, "The FDA should
conduct a study to determine how best to manage and oversee ?? I
mean, I don't have a wording here, but the filings or whatever.
Tieraona, do you have ??
DR. LOW DOG: Right, but can we agree? I would just like to
have consensus on it and we can send it out. Corrine can certainly
make a recommendation and get the words right.
DR. GORDON: Basically a recommendation to the FDA to look at
how best to ensure safety of products.
DR. LOW DOG: Yes. Yes.
DR. GORDON: Okay.
MS. AXELROD: It may not be the FDA that ??
DR. LOW DOG: It may be an appropriate agency.
DR. GORDON: Appropriate agency.
DR. LOW DOG: Yes.
DR. GORDON: Fine. Could you try to get that together and,
if possible, even read it to us at the end of the day so everybody can
be clear? If not, we are all in agreement about the general sense.
Joe.
DR. FINS: And then attach to that a report back to ??
DR. LOW DOG: Congress.
DR. FINS: Right.
DR. LOW DOG: Right.
DR. GORDON: Okay. We need to move on. Page 20,
Recommendation 5. I am going to read the recommendation and then ask
you all to read the action steps and ask everyone ?? it was well
spent, but we don't have the time to spend that kind of time on any
more of these recommendations, okay? "The public should have accurate
information on the quality and safety of CAM products." And there are
five action items. If everyone would read through them and if we
could expedite the discussion of this.
[Pause.]
DR. GORDON: Okay. Let's begin now. Recommendation 5.
Comments. "The public should have accurate information on the quality
and safety of CAM products." Joe had a comment.
DR. FINS: Did we move on to the action or not?
DR. GORDON: Let's talk about the ?? are we okay with the
recommendation, at least provisionally, or do we need to address that
first? Charlotte?
SISTER KERR: If I were being asked a question about
Recommendation 4 and 5 in a public hearing, I don't see what ?? first
of all, the subject in both is products, and 4 is asking that they
have good quality and consistency and 5 is asking that they have
quality and safety. What is the difference here? Why didn't we put
all of these in one recommendation, like safety, quality and
consistency?
DR. GORDON: Well, Corrine may want to explain this.
Corrine?
MS. AXELROD: Maybe Tieraona or George wants to explain it.
[Laughter.]
MR. DeVRIES: I think Recommendation 4 is more about the
quality and safety of the products themselves and 5 is dealing more
with the information and the advertising and how those things are
presented. So it is content versus presentation of the products. Is
that good?
DR. GORDON: Are we okay at least provisionally with the
recommendation and then we can move into the action items? Yes?
Okay. So let's move into the action items. Joe?
DR. FINS: I have one thing about this section. It seems to
be, except for a little caveat in 5.2, exclusively about supplements,
and I am wondering whether we want to be more specific in the
recommendation or not, because it really is about supplements. But
that is an aside.
DR. GORDON: That is what it is about.
DR. FINS: Yes. So I wonder if we should say safety of
supplements versus safety of products.
DR. GORDON: Products is supplements. How do you ??
DR. FINS: Supplements is a subcategory of CAM products.
SISTER KERR: We need to define products here because I don't
know if we are talking about gadgets and ??
DR. FINS: Right.
DR. LOW DOG: We could say dietary supplements.
DR. FINS: Well, I would say, you know, safety of
supplements.
MS. AXELROD: No, 5.2 is more than just supplements.
DR. FINS: Well, I appreciate that and that is why it ??
DR. LOW DOG: So you are probably going to have to leave
"products," "CAM products."
MS. AXELROD: We could say "dietary supplements and other
products."
DR. FINS: Yes. That is good.
DR. GORDON: All right. "CAM supplements and other
products."
DR. FINS: Okay. Good.
DR. GORDON: You want to say "dietary supplements and other
CAM products"? How about that?
DR. FINS: Yes, that is perfect.
DR. GORDON: All right. "Dietary supplements and other CAM
products." Let's move into the action items. Thank you, Joe, for
pointing that out.
DR. FINS: I have an action item.
DR. GORDON: Go ahead.
DR. FINS: On 588, ?89, one thing I think that we need to add
in that last line, "so that consumers have truthful, complete and
scientifically valid information on the benefits, appropriate uses of
dietary supplements, and important drug supplement interactions on the
product label at the point of sale."
DR. GORDON: Okay. Everybody got that, adding "and important
drug supplement interactions." I would also add "hazards of the
product" as well as "important drug product interactions."
DR. FINS: And "hazards." Okay.
DR. GORDON: "And hazards of the product and important drug
product," and so if you are giving somebody ephedra, they need to know
the potential liabilities.
DR. FINS: Maybe "risks," because "hazard" is maybe ??
DR. GORDON: "Risks" is fine. Tom?
MR. CHAPPELL: Well, I just want to say that the task of
establishing scientific evidence of the synergies of dietary
supplements with drugs is beyond what any manufacturer can do and it
is a task that will take a decade for the government to do.
MR. DeVRIES: How about "significant and established"?
MS. AXELROD: Can I just make a point for clarification?
This issue is actually dealt with in 5.3 and we separated out the
appropriate use and benefits from the interactions, hazards, risks,
because the mechanisms to do that are so different; and that in terms
of the interactions and risks, that falls under the caveat of material
facts and that when those facts are known, the manufacturer must
disclose it. There is no requirement that they do the research on it,
but when they know it, it must be disclosed. So those are dealt with
separately.
DR. GORDON: Corrine, I think if we are indeed going to deal
with them separately, "material facts" has to be explained, because
that is a technical term and not one that is accessible to people.
MS. AXELROD: It is explained in the text. Do you feel it
needs to be explained in the action item?
DR. GORDON: It needs to be explained in the action item.
MS. AXELROD: That is not an easy thing to do.
DR. FINS: I understand what you are saying, but I also think
that this is ?? you know, 5.1 was kind of ?? it is really a very
consumer?directed action item, and they are going to see the label.
You know, the disclosure is an upstream thing but the label is how it
gets disclosed. So I really think the consumer needs to have ?? it
should be in 5.1 and ??
MR. DeVRIES: Say, Joe, if that is needed, if you look at the
last part of 5.3, it says, "Public will know about known risks and
well?documented and significant interactions." Can we take the phrase
"known risk" and "well?documented and significant interactions"? I
mean, if you want that in 5.1, that would be the phrase.
DR. FINS: I really want to say something. I want to
specifically say, "significant interactions between drugs and
supplements" or "supplements and drugs."
MR. DeVRIES: Well, it is not just interactions between
dietary supplements and pharmaceutical drugs; it is also
non?pharmaceutical drugs, OTC, tobacco, food, alcohol.
DR. FINS: Right.
MR. DeVRIES: I don't think you want to limit yourself.
DR. FINS: Okay.
DR. GORDON: Can we take that phrase that George has
suggested and put that in 5.1? Yes? Joe, yes?
DR. FINS: Yes.
DR. GORDON: Okay. Let's move on, please. So you have that
down, Corrine? So it would be, "on the benefits, appropriate uses and
known risks and well?documented significant interactions" will be
inserted on line 589. Yes, Joe.
DR. PIZZORNO: So is that being removed, then, from 5.3 and
just put into 5.1?
DR. GORDON: I think we can leave them in both places as
well.
DR. PIZZORNO: Okay.
DR. GORDON: At this point. But let's put them in 5.1.
DR. LOW DOG: With 5.1, I need to get at what we are trying
to really get. "So that consumers have truthful" ?? well, that's
already required by law. You can't make untruthful statements. The
law requires they be truthful, and so the law would need to be
enforced if you are looking for truthful. "Complete." "Complete" is
defined by what? Including "significant interactions"? I mean, is
that what we are looking for "complete"? And "scientifically valid."
Well, there are already laws in place for scientific validity and what
you have to do to move through it. So are we asking for ?? I think
if we are asking for more than what we are asking here, we need to be
more specific, because right now, you have ??
DR. GORDON: I am not sure what you mean.
DR. LOW DOG: We are saying right now that we should have
further input followed by rulemaking, oversight, and legislative
reform, so that consumers have truthful, complete and scientifically
valid information on the benefits and appropriate uses.
DR. GORDON: Right.
DR. LOW DOG: Are you asking that we are revisiting the
structure function in that?
DR. GORDON: Yes. That is the way I read it. I mean, the
group that formulated this is the Information Group, but essentially
yes.
DR. LOW DOG: Well, I know, I am on that group.
DR. GORDON: So that is what you are asking for.
DR. LOW DOG: But it has changed so many times. This
actually was ?? we had at?length discussions about this and this has
continued to change.
DR. GORDON: This is your group. Corrine, do you want to
clarify this?
MS. AXELROD: Well, it hasn't changed since right after the
last meeting when we did the revisions based on some comments from
George, and then we had several conference calls and we worked it out.
So, as far as I know, it hasn't changed.
DR. GORDON: This is what I have seen since the first
revisions after the last meeting.
DR. LOW DOG: We had at?length discussions about DSHEA and we
had ?? because we had focused primarily on these other issues, and
then it was brought to our attention that other commissioners really
wanted to visit the scientifically valid information and structure
function, and that is okay. I am just wondering if it could be more
specific in the recommendation if that is what we are asking for.
DR. GORDON: If you want to make it more specific, could you
do that? I want to move through these, Tieraona, because if we don't
??
DR. LOW DOG: Yes. I am just saying right now, it makes it
sound, Jim, like right now the laws say that you can be untruthful,
incomplete, and put scientifically invalid information on there, which
is not true.
MR. CHAPPELL: Jim, this actually is not what the committee's
subcommittee came up with. We didn't support this idea, just so you
know. This is not a committee?based, this is something other than the
committee. Am I right on that?
DR. LOW DOG: I was on all those calls and we discussed this
at length. This is not what exactly we came up with in our group.
MR. CHAPPELL: If George, Tieraona and I agree to that point,
you can rest assured we ?? this did not come out of the committee.
DR. GORDON: So tell us, what are we going to do with 5.1?
MR. CHAPPELL: George, the process that we have in
Recommendation 4, is that sufficient, or do we need a process ?? that
is really my only question of you, because you are the one that has
been promoting the process here.
DR. GORDON: Let me just say, to take it one step back, that
there was considerable concern and discussion from the Commission as a
whole that we wanted better information to be provided to consumers,
and you were one of the leaders in that, as I remember.
MR. CHAPPELL: Yes, and we came up with language at the last
Commission gathering that was not this language.
DR. GORDON: What I would like to do is, if you all are still
having a difficulty with this language, I don't think we can take ??
what we need you to do is maybe at lunchtime sit and come up with
better language and work with Corrine, and with Steve, if you want,
certainly with Corrine to do that. We need to move through these,
because what I am looking for is the deliberations of the
subcommittees based on last?time's meeting, and if you are saying this
isn't what you did, then let's move on and go to what you did, and we
have to come back to this very quickly, though, okay? So let's look
at the rest of 5, 5.1, 5.2, 5.3, 5.4 and 5.5. I think the intent of
5.1 that I heard and I just want to make sure you address is that the
Commission as a whole wanted more information easily available to
consumers about the benefits and risks. However you want to state it,
that is the general intent and that is really ??
DR. FINS: And also point of sale.
DR. GORDON: At point of sale, as Joe is saying. Yes.
MR. CHAPPELL: I remember that was the Commission's intent.
DR. GORDON: Great. So as long as you have our intent in
mind, go back and work out the wording. Meanwhile, let's look at the
rest of No. 5.
MR. DeVRIES: One question, though. I heard you say earlier
how much ?? because as we worked through it on a committee, it was
saying, yes, there needs to be better information but in the context
of saying really the current laws really need to be reinforced, to be
enforced. We are not talking about rewriting the laws.
DR. GORDON: Again, the Commission's concern, George, again,
the Commission's concern is that better information be available at
the point of sale whether the laws have to be rewritten or not. That
is your judgment as to how to best implement that, okay?
DR. LOW DOG: We are going to meet at lunch for a few
minutes, our group, and we will get back to you right after lunch,
okay?
DR. GORDON: Great. Thank you. Let's move ahead with 5.2,
5.3, .4 and .5. Yes, Joe.
DR. FINS: George, on this issue, I mean, I might have missed
it, but where do we say that DSHEA should be fully enforced as an
action item? That is kind of important. And that it should be
revisited if it is found to be inadequate. That seems to be a major
??
MR. DeVRIES: That was the core of the committee's
discussion. All current laws need to be fully enforced because some
aren't being.
DR. FINS: Right. And then, because that is a tease point,
it should be, but we know it is not, so that is why we the
reintroducing it again. So we need to have that language back, "fully
enforced," and then go back and revisit it after a period of time and
report to Congress.
DR. LOW DOG: To see if it is adequate or not.
DR. FINS: To see if it is adequate or needs to be revisited.
Thank you.
DR. GORDON: Thank you, Joe. Let's move ahead, please.
MS. AXELROD: Can I just point out that is in 5.5?
DR. FINS: We don't explicitly say that DSHEA should be fully
enforced. I think we should explicitly mention DSHEA somewhere ??
DR. GORDON: So mention DSHEA in 5.5.
DR. FINS: And then come back and say "fully implemented,
enforced and funded," which is implied, and then say we are going to
come back and then Congress should revisit the issue based on all of
those resources ??
DR. GORDON: Joe, are you suggesting that instead of it being
5.5, that there should be a separate recommendation, or are you
content with the 5.5?
DR. FINS: It almost seems to me that this is ?? the full
implementation of DSHEA, its enforcement and its revisiting, is almost
at the level of a recommendation, not an action item, because
everything else kind of follows in that context.
DR. GORDON: Okay. Is everybody agreed on that? Then we
would like 5.5, which essentially is what you are saying, but it needs
to be made explicit, right?
DR. FINS: As a recommendation.
DR. GORDON: As a recommendation.
DR. FINS: Not as an action item.
DR. GORDON: I got you. As a recommendation. Everybody
agree with that, that 5.5 would then become a recommendation?
DR. LOW DOG: Not 5.5. Please let us just take it at lunch.
We will take the implementation and enforcement of DSHEA and look at
that as making a recommendation, but there are other things in 5.5
that we are not going to include in the recommendation.
DR. GORDON: Okay.
DR. LOW DOG: Such as English language, et cetera.
DR. GORDON: All right.
MS. AXELROD: Jim, for clarification, will that replace the
current Recommendation No. 5 or is that an in addition to?
DR. GORDON: No. That would be in addition, is what I am
hearing, or it may replace. I don't know. We have to see.
DR. FINS: And I would just argue that it should precede the
current 5, I mean the first statement about DSHEA and about these
issues.
DR. GORDON: All right. So what we would like from you all
is for you all to reformulate this and come back to us, okay? Now,
does it make sense, then, to go through 5.2 through 5.4, or are we
fine with those recommendations or those action items? Yes, Veronica.
DR. GUTIERREZ: One comment. It might be obvious under 5.2,
Subsection 2. I would like to have it read "use appropriate CAM
experts in the process."
DR. GORDON: Is that okay with everyone? Okay. Good.
Anything else? All right. So we are asking, Tieraona, you and George
to go back ?? excuse me, Tieraona? We are asking you and George to go
back. There needs to be a recommendation that specifically addresses
implementation of DSHEA and there needs to be whatever rewording of
5.1 there needs to be to address the concern of the Commission that
there be adequate information at point of sale.
DR. LOW DOG: We understand.
DR. GORDON: Okay. Joe?
DR. PIZZORNO: Isn't 5.4 a restatement of what we are trying
to create with 4.5, a new 4.5? I think that should be moved over
there.
MS. AXELROD: One is before the fact and one is after.
DR. GORDON: Did everybody hear what Joe just said, that 5.4
is perhaps a restatement of 4.5?
DR. PIZZORNO: The new 4.5 we are writing.
DR. GORDON: The new 4.5. Yes? Okay.
MR. DeVRIES: We were just chatting that we would like over
lunch the opportunity to look at 5.1 to 5.5, because that problem ??
we were discussing 5.4 ?? seems out of place now and 5.5 needs rework,
5.1 needs rework.
DR. GORDON: All right. Please do that. We will probably
come back to it at the end of the day, though, okay, because we need
to move through the other sections.
MR. DeVRIES: Got it.
DR. GORDON: All right. Let's move on to Recommendation 6.
On page 22, Recommendation 6: "The collection and dissemination of
information about adverse events stemming from the use of dietary
supplements should be improved." Please read the action items under
this.
[Pause.]
DR. GORDON: Okay. Steve was pointing out to me that already
in the appropriation language additional funds have been provided to
update and modernize the adverse events reporting system. Are we okay
with these, Recommendation 6 and the action steps? Joe.
DR. FINS: On page 23, 649, we have this elsewhere. We made
this request that they file safety information, and that was not
voluntary, and now we are saying but they should voluntarily register
in the event that there is an adverse event. So I am confused about
that.
DR. GORDON: Do you want to clarify that?
DR. LOW DOG: Yes. Actually, unless I misunderstood, I
thought we had said that manufacturers will have on file and make
available upon request. So they weren't just making the filing. And
because you are going to have to mandate this ?? I mean, we were just
asking for voluntary until it could become ??
DR. GORDON: Wait. But now you are confusing us again. You
are adding something and now you are taking it away.
DR. LOW DOG: No, I didn't do anything. All I said was that
on four?point?whatever?it?was, we had said that manufacturers will
have on file and make available upon request, so that is something
separate. That wasn't voluntary or mandated; we are just saying that
they should have it on file.
DR. GORDON: Okay. What do you want to do here?
DR. LOW DOG: This one, I like it the way it is. I like it
just the way it is. It says that you are going to register ??
DR. GORDON: Okay. But Joe doesn't like it the way it is.
MR. CHAPPELL: Okay. Well, Joe, this is adverse events and
that is different from the larger picture of safety data.
DR. FINS: Maybe really in 6.2, I think we would want to
mandate reporting of adverse events, whereas, you know ?? because 6.1
is that you are voluntarily registering as a manufacturer. In the
event that something were to happen, they could find you.
Six?point?two is that we are asking them to report adverse events to
the agency, and that it is a requirement. So I think we are covered.
I think that works.
DR. GORDON: You think it is okay.
DR. FINS: I think we are okay.
DR. GORDON: Julia? Okay. So we are okay. There is not a
problem. Effie.
DR. CHOW: In 6.1 or 6.2, should consumers come in there or
does that assume that, reporting to the manufacturers, that the
consumers are going to be notified right away of adverse events? So
in 6.1, on page 23, "so that manufacturers and suppliers and consumers
can be promptly notified if a serious adverse event is identified."
DR. LOW DOG: Yes, I understand what you are saying there.
The way this is written is that the reason we are asking manufacturers
and suppliers to register is so that they can be promptly notified if
there is a contaminant, adulterant, or concern. Obviously, if there
is a concern, the FDA would need to make that known to the public, if
there is an adverse event.
DR. GORDON: Effie, are you asking if that needs to be in
here?
DR. FINS: It is in 6.3. It is in 6.3, Effie, line 661.
They mention consumers.
DR. GORDON: Okay.
DR. FINS: Jim?
DR. GORDON: Yes, Joe.
DR. FINS: On 6.3, I would like to include ?? I have said
this a thousand times ?? CDC because it is not here, I don't think.
DR. LOW DOG: We had had that before.
DR. FINS: Okay. "Provided to FDA and CDC." The reason I
say that is an adverse event, once it is known to be attributable to a
drug or a supplement, is under the purview of FDA, but if children are
having rashes in the schools, it is the EIS that is going after and
trying to figure that out, and it may be a supplement or it may be ??
DR. GORDON: Okay. Are we okay with that, adding CDC?
DR. LOW DOG: Yes.
DR. GORDON: Okay. Good.
DR. FINS: And the other thing is, I would add on No. 3, "an
increase in outreach activities and education to consumers" and all
that, et cetera, but I also want to make explicit resources available,
and we mentioned poison control centers and to emergency medical
services. They need more than outreach and education; they may need
some real resources. So I don't think outreach will meet the need for
the training and the information that they require.
DR. GORDON: What are you suggesting adding?
MS. AXELROD: Ken just reminded me that this section is on
information, it is not on education and training. So we just need to
keep that in mind in terms of going out to train other people.
DR. LOW DOG: Right. And that first line is "additional
resources and support."
DR. GORDON: Okay. I would like to get agreement on this. I
think we are really in an incredible time bind and I need to let
everybody know. We should have been through two sections by now. We
are only through one. I want to get a reading from people. How many
people will be here until the end of the day?
[Show of hands.]
DR. CHOW: What is the end of the day?
DR. GORDON: End of the day is midnight. No. End of the day
is when we finish, because we need to finish this today. There are no
ifs, ands or buts about it. If everybody wants to be here to finish
it together, everybody has to move faster, okay? I can't do it
myself. We have to be completely mindful and only focus on what is
most essential. Don.
DR. WARREN: It seems like in this 6.1, whatever it is, we
are setting a higher standard for the adverse reporting system for
nutritional supplements than we have for vaccinations. It does not
make sense. Are the manufacturers of supplements liable for suit and
the manufacturer of immunizations aren't? What are we doing here?
DR. GROFT: No, there is a vaccine injury compensation
program already available. It is federal dollars.
DR. GORDON: And vaccines have to register.
DR. GROFT: And licensed.
DR. GORDON: They are registered and licensed.
DR. GROFT: They need to be licensed and adverse events must
be reported as part of the licensing process.
DR. GORDON: Tom.
MR. CHAPPELL: The issue that you are ?? I don't see the
equation here, so I think our language is fine as it is.
DR. GORDON: Are we okay, then, with 6 as it is, and action?
Any major issues with the text? Minor issues, please contact Corrine
outside of this meeting. Joe, go ahead.
DR. PIZZORNO: Page 10, line 287. I don't like quite the way
that is written and I would like to suggest that after "for example,"
in front of "naturopathic," maybe if you put the word "lay" there,
that would help make that work better; and on line 288, after
"naturopathic physicians," cross out "may."
DR. GORDON: Is that all right with people?
DR. PIZZORNO: Line 287, after "for example," insert before
"naturopathic" "lay," the word "lay," l?a?y; and on line 288, after
"naturophatic physicians," cross out the word "may."
DR. GORDON: Is that okay with everyone? Okay. Anything
else on the text? Okay. We are going to take a ten?minute break and
then we are going to come back with Access and Delivery and we are
going to finish it by 11:45. We will be beginning with Wellness and
then we will Access and Delivery right after lunch. So thank you for
your indulgence for this necessary change.
[Break.]
DR. GORDON: A couple of points. One is Public Comment will
be at the time that it was scheduled. There are seven people signed
up, seven or eight people signed up for Public Comment. Each person
will have three minutes. They will be in panels and we will have an
opportunity to talk with them after each panel. The Commission will
adjourn here at about 10 of 12:00, and then commissioners are going to
be getting together over lunch and having discussions, sort of
figuring out various things. Then we will come back here at 1:00
promptly. We will begin again, we will go up to the time of Public
Comment, and then we will continue after the Public Comment.
It is entirely possible that the meetings will continue until
6:00 or 6:30 this evening. It's just necessary for us to get through
the business we have at hand. I would suggest, and I know a number of
you have begun to do this, if you could reschedule flights so that you
can be here until the end. We really want everyone here, even Don.
We want to make sure Don is here, too. This is our last meeting and
we want to make sure that everybody has input into all the sections.
So let's begin now. Thank you, and thank you especially,
Corrine, for your indulgence in doing one session right after the
other.
CAM IN WELLNESS AND HEALTH PROMOTION
DR. GORDON: Let's begin with the Wellness session, and I
want to remind everyone that the current order would have the Wellness
session just before the CAM Central section, which is at the end of
the report, okay? What I am going to do once again is to read the
recommendations. Yes, Joe?
DR. PIZZORNO: I think it may be more appropriate to discuss
now where it is going to be located and then get the recommendations,
because it may change the character of how we go through this process.
If that is okay, I would like to put on the table that this be an
appendix, not be one of our sections.
DR. GORDON: That is a recommendation put on the table. Tom?
MR. CHAPPELL: I think wellness is so much a part of the
world view that that would be disvalueing the work. So I would argue
that we keep it where it is presently intended.
DR. GORDON: Other comments? Julia?
MS. SCOTT: I really would like us to press forward on the
recommendation. The placement of any of this, I think we can do
later, but it is very important while everyone is here that we get
consensus on the recommendations or the need to make changes. The
placement in the report is important, but not as important as getting
us while we are here to agree on the recommendations.
DR. GORDON: So can we move forward with the recommendations,
then, and defer any discussion? Okay. Let's look at Recommendation
No. 1 on page 7. It reads, "Safe and effective CAM practices should be
utilized to help achieve the Nation's health promotion and disease
prevention goals and to promote wellness throughout the life span."
And then there are several action items and six action items, so if
everyone could take a little time to read through the action items,
please.
[Pause.]
DR. GORDON: Dean, do you want to begin?
DR. ORNISH: Yes. First, let me thank you again for the
scheduling. I am not going to repeat everything that was in my memo
yesterday, but I want to just highlight one part of it which I think
is, to me, among the most important, and that is that many if not most
of our recommendations are not about specific modalities, they are
about CAM, and CAM ?? we made a joke about it a moment ago, but almost
anything passes for CAM. So it concerns me when we talk about here
again CAM practices, CAM practices. What are we referring to? So at
a minimum in Action Item 1.1, I would like to see "CAM practices that
have been proven to improve nutrition, promote exercise"; in other
words, add the four words "have been proven to" in that one, at least
to help to narrow it down a little bit.
DR. GORDON: Dean, do you want to also, while you have the
microphone, say if there is ?? that is a quite clear recommendation
there. There are a number of recommendations that talk about CAM
practices throughout the different action items here. Do you have a
general kind of way of looking at it that you want to outline?
DR. ORNISH: Well, short of revising the whole document, no.
I mean, that is part of the problem. It is not just in this section,
it is in all sections. When we talk about CAM, it is one thing if you
are saying ?? I mean, you may be talking about CAM or David Bresler
might talk about CAM and say, well, that is acupuncture because that
is proven, but if you look at Table 1 in the very first section of the
document, not this chapter but the document itself, it can include,
you know, coffee enemas, it could include all kinds of stuff that ??
sitting under a crystal pyramid to some person is a CAM practice. So
I know that there is an ethos that goes through this document that
when we talk about CAM, we tend to think of those modalities that we
have the most experience with, that we have seen clinical efficacy of
even if they may not be proven in randomized trials. But I think we
need to also wear the filter of someone saying, well, that could also
include almost anything, and that is why I keep coming back to safe
and effective as just one shorthand way of trying to limit the scope
of it, but even that really doesn't address the issue fully.
DR. GORDON: Okay. Well, let's try to go through the
specific action items keeping that in mind and addressing it in a way
that feels like it is appropriate. Yes, Tieraona.
DR. LOW DOG: Can I make a comment on the recommendation?
DR. GORDON: Yes.
DR. LOW DOG: I would opt to change that "CAM practices and
products should be evaluated to determine what role they may have in
improving the Nation's health and disease prevention goals."
DR. ORNISH: I like that a lot, actually, because it
completely addresses the issue that I have, which is this ethos of
presuming that these things are beneficial and just finding out how we
can implement them.
DR. GORDON: Let's read it again, please.
DR. LOW DOG: "CAM practices and products should be evaluated
to determine what role they may have in improving the Nation's health
and disease prevention goals."
DR. GORDON: And you are leaving out "and promoting
wellness"?
DR. LOW DOG: I just sort of figure that's part of the health
promotion. And you can add that, I am not attached to anything; I am
just trying to find ??
DR. GORDON: I think that is a distinct thought.
DR. LOW DOG: Fine.
DR. ORNISH: I would add that since it is part of the
chapter.
DR. LOW DOG: That is fine.
DR. ORNISH: But I completely like what you are doing.
DR. GORDON: Okay. So we have a recommendation for the
recommendation on the floor.
DR. ORNISH: I recommend that you accept the recommendation
about the recommendation.
[Laughter.]
DR. GORDON: Okay. Are there any other recommendations about
this or discussions about this? I think this is very important that
we discuss it, that if people have concerns about it, that we
enunciate it here at the beginning, because this is going to help
shape all the other recommendations. Yes, Joe.
DR. FINS: I really resonate with what Dean said and
Tieraona's suggestion, but if you think about it logically, it is
really a research question, it is not a health promotion question. I
mean, the question is that we need to study whether or not this stuff
causes decreased morbidity and mortality and promotes wellness. So it
really is logically a research question, and I think that the tone of
this section has a proselytizing quality to it which is
anti?scientific. I think it undermines the entire rest of the report.
This is the implicit question in so much of what we are doing, and I
think you are basically undermining the seriousness with which this
report would be accepted.
DR. ORNISH: I don't quite follow you. Are you saying that
the act of saying that we need to do research as well as promotion
undermines the credibility of the report?
DR. FINS: I am saying what you said before in a slightly
less clear way.
[Laughter.]
DR. GORDON: I appreciate less clarity, Joe.
DR. FINS: I am agreeing with what you said before about
making claims for the imposition of vague modalities yet to be proven
and established, and just agreeing that whether or not these
interventions will impact the public health in decreasing morbidity,
mortality, is a question to be determined.
DR. ORNISH: I agree with you, but I think that the nature of
this chapter is it overlaps a lot of other chapters.
DR. FINS: Right.
DR. ORNISH: I mean, I was arguing against having this
chapter in from the very beginning. Now that we have it, though, I
think that we need to make the best of it, and so given what we have,
I think adding Tieraona's qualifying language to me makes perfect
sense. I also would like to say that some of the narrative could come
out as being a little more balanced and a little less as an advocate.
I think there would be some value in that, too. We don't have time to
go into that line by line now, but as a general ??
DR. GORDON: We will have time. I want to get some other
thoughts about this discussion that we have here on the floor.
Charlotte.
SISTER KERR: I need to say this recommendation again from
Tieraona. Complementary practice ?? "CAM practices and products
should be evaluated to determine their role in achieving the Nation's
health promotion and disease," da, da, da. Now, I think this
conversation is really good, though. It is a challenge, because I
think Joe's point is important in terms of is it a research question,
and this feels like it is going to be one of those ones of not making
the enemy ?? perfect the enemy of the good.
By saying as it is, "safe and effective CAM practices," we are
resting upon almost all our other chapters that we are requesting; for
example, the last work we just did with guidelines on adverse
reactions. We are resting upon the fact that we are recommending many
things in research, so that this recommendation comes to say, yes,
indeed, only those things that we know at this point that are safe and
effective we want to include in schools, and I think to do it as
Tieraona is saying is to totally drop out of the whole recommendation,
really. It is kind of like, let's do a study on so?and?so, and then
after we do that, we will decide whether or not we want to do
anything. And if I have not understood this, then I am open to ??
DR. ORNISH: Tieraona, if I understood you correctly, you
were saying that, "CAM practices and products should be evaluated to
determine their role in achieving the Nation's health promotion and
disease prevention goals and to promote wellness," blah, blah, blah,
and that those that are safe and effective should be implemented. You
are not saying we don't make any recommendations about implementation,
but that we qualify by saying that we also need to evaluate them.
DR. LOW DOG: I am saying that right now, right now,
practices without products, first of all, because I think products
need to be in here, that if you are just relying on those that have
actually been shown to prevent disease, you are going to have a very
short list of implementation because ?? I mean, you are. And I think
that you want to set the stage here that we want to evaluate and we
want to determine what role and for what populations and to whom.
This is a big area. It is not just an adult group found this if you
are suggesting it is going to go to kindergartners. I mean, I think
that you have to have some serious thought. If you really want to
make an impact on the Nation's health, you have to evaluate the data
that is there, and that will help drive research questions.
I am not asking for research here; I am asking for an
evaluation of the data that is out there to determine what role and
for whom this may play a role.
SISTER KERR: But we did delete "safe and effective," correct?
Okay. But then if that statement would become the recommendation, I
think we would have no actions because you are stopped at we are going
to evaluate.
DR. ORNISH: In other words ??
DR. GORDON: Please, let Charlotte continue, okay? This is
not argumentation; this is learning from one another about what our
positions are. So please, let's allow Charlotte to speak and then if
others want to speak, please feel free to speak. Dean, you can
respond.
DR. ORNISH: No, I am not arguing with you at all; I am just
trying to clarify that we are not taking that out, we are only adding
the other. In other words, it wouldn't take out the part about that
we want to utilize those that have been found to be safe and
effective. That stays. It is only adding that we also want to
evaluate the data that is there.
SISTER KERR: I didn't hear that. When Tieraona read hers,
she didn't leave that line in, or did I misunderstand?
DR. LOW DOG: We can just include at the end "those that have
been proven safe and effective should be integrated" or "should be
put," whatever words you want to put in there.
SISTER KERR: So then let's read it as we are saying it
because that is not how I understood it, and if that is the case, it
may be very fine.
DR. ORNISH: This is what I was reading. I was trying to
clarify. Again, I am not in any way trying to be argumentative, at
least not at this particular point. "CAM practices and products
should be evaluated to determine their role in achieving the Nation's
health promotion and disease prevention goals and to promote wellness
throughout the life span. Those that are found to be safe and
effective should be utilized to help achieve these goals."
DR. GORDON: So that is the recommendation.
DR. ORNISH: That is the recommendation.
DR. GORDON: Okay. I agree with Charlotte. I didn't hear
that in the beginning.
DR. ORNISH: Okay.
DR. GORDON: Okay. So that is the recommendation as amended.
Are we okay with that?
MS. AXELROD: Can I make a comment, Jim? The way that it
just read makes it sound like you are evaluating it for safe and
effectiveness, when, in fact, you are evaluating these things to see
their applicability to the goals and objectives that are laid out in
H.P. 2010 and 2020. So I think we need to clarify that we are not
looking to evaluate safe and effectiveness here; we are looking to see
which ones ?? we are evaluating which ones that have been shown to be
safe and effective apply to the goals and objectives.
DR. GORDON: That is a different question.
DR. ORNISH: I mean, you are saying they are ?? I mean, in
some ways the data would be evaluated to see if they are safe and
effective and then to further evaluate them in the ways you are
describing.
DR. GORDON: Tieraona.
DR. LOW DOG: That was actually a good distinction. I guess
you could say that ?? I don't know how to get around that, because at
this point, you are needing to determine the effectiveness. Safe and
effective CAM practices and products should be evaluated, but if you
had done that, then they are effective, you already know, though you
still may not know for the specificity for what groups that we are
talking about.
DR. GORDON: Joe.
DR. FINS: They have to be safe. Whether or not they are
effective for this purpose is the question, right?
DR. ORNISH: Can you explain, again, Corrine, what you are
saying? I don't quite follow you.
MS. AXELROD: I think that what we want to look at are safe
and ?? CAM products and practices that have been found to be safe and
effective should be evaluated to determine their applicability to the
Nation's goals and objectives for health promotion/disease prevention.
DR. LOW DOG: Say it again.
DR. GORDON: That is a different recommendation because that
doesn't ?? the recommendations that follow may or may not fall under
that one, right? Everybody see there is a bit of a ?? I mean the
action steps may not fall under that particular recommendation.
MS. AXELROD: I am just building on what Tieraona had
suggested about doing an evaluation, but that we need to be clear this
is not research, we are not researching whether CAM products and
practices are safe and effective. We want to look at the CAM products
and practices that are safe and effective, how they can be utilized to
help achieve the Nation's health promotion/disease prevention goals.
DR. ORNISH: I was only really talking about changing the
Action Step 1.1; in other words, to ?? I am okay with the
Recommendation 1. I was referring to, when you get into things ??
particularly when you are talking about kids where it is a real
red?hot button for a lot of people, what you teach my ?? what are you
going to teach my kids in the school? You are going to teach them
about coffee enemas? You know, it is easy to distort this, very easy.
I am just saying I am only arguing something that seems to be pretty
reasonable, which is that CAM practices that have been proven to be
safe and effective ?? excuse me ?? that have been proven to improve
nutrition, promote exercise, et cetera.
DR. GORDON: I think we are okay with that. I think, Dean,
we are still on the recommendation, though. I think 1.1 is a separate
issue, and we haven't really had discussion on that, although I
suspect that your addition is fine. The question is, what about the
recommendation as a whole?
SISTER KERR: I would like to respond again. I think, again,
I think leaving the recommendation as it is and adding Dean's thing in
1.1 is a reasonable compromise in the attempt to be more specific to
protect people and to just restate we want safe and effective. You
cannot get this, I think, perfect.
DR. GORDON: Joe.
DR. PIZZORNO: Another potential wording would be to leave
the current wording in Recommendation 1 as written with this following
addition. That is, "Safe and effective CAM practices," insert "when
appropriate should be utilized," or "appropriate safe and effective
CAM practices."
DR. GORDON: Is that okay as an addition?
DR. ORNISH: I think that is great. So it would say, "Safe
and effective CAM practices, when appropriate"? Is that your
recommendation?
DR. GORDON: Julia first.
DR. PIZZORNO: "When appropriate."
MS. SCOTT: It looks like there is going to be consensus on
new language. I just wanted to say, I think what has been suggested
really addresses our concerns. "Safe and effective CAM practices and
products should be evaluated to determine" ?? not for safety and
whatever because we are assuming they are going to be safe and
effective ?? "determine their role in achieving the Nation's health
promotion and disease prevention goals and to promote wellness
throughout." I mean, I think that says it pretty specifically. I
also feel, after reading the actions, that those actions are still
appropriate to that recommendation and I would second Dean's addition
to 1.1.
DR. GORDON: Where are we? Charlotte, where are you with
this?
SISTER KERR: I heard two things. One, for myself even, and
again, this is just thinking, leave the recommendation as it is, not
with Tieraona's addition or anything; and the second thing I am
hearing is make Recommendation 1 with this additional concept of
evaluating, determining their role, so forth, and just stop there
before we go into action steps. But I thought we were kind of going
back to leaving Recommendation 1 as it was because safe and effective
took care of it.
DR. GORDON: Joe? Joe is next, and then Tieraona.
DR. FINS: I think the confusion might be that a CAM product
or service can be safe and effective on an individual basis for a
person, but the question is whether or not it has an impact on a
population, and Healthy People 2010, 2020 is health services, broader
public health issues. So I think clearly, you know, it is like
aspirin is safe and effective; does it decrease the morbidity from
heart disease in a population? So that is sort of the analogy, and I
think that needs to be clearer because I think we are confusing safe
and effective for an individual versus its impact on a population
vis?a?vis the articulated goals of the U.S. Public Health Service.
DR. GORDON: Charlotte, I want to get a sense of where you
are with this, because Joe is addressing it to you, and then Tieraona,
if you want to add something.
SISTER KERR: Was I clear in the distinctions I made, that
there are two suggestions for recommendations?
DR. GORDON: Yes, there are two suggestions. One has to do
with evaluation and the other has to do with leaving it the way it is.
SISTER KERR: Right.
DR. PIZZORNO: And mine, which is the third, would be "when
appropriate."
DR. GORDON: And the third would be "appropriate." Thank
you, Joe.
SISTER KERR: See, I think we are unclear. Appropriate, to
me, was under Action 1.1. So Wayne's suggestion under Action 1.1 is
appropriate CAM practices.
DR. GORDON: One?point?one, we already ?? let me just suggest
that under the action step in 1.1, on the floor is Dean's addition,
which was "CAM practices that have proven to improve nutrition," et
cetera, et cetera, et cetera, should be included.
DR. ORNISH: Can I make a suggestion that would combine
everything?
DR. GORDON: Let's go back to the recommendation, though, if
we could, okay, and get that cleared up.
DR. ORNISH: There are actually four things on the floor and
I just want to suggest something as a compromise that might meet
everybody's needs just in the spirit of moving forward and just tell
me how you all feel about this. It would be something like, "CAM
practices and products should be evaluated to determine their role in
achieving the Nation's health promotion and disease prevention goals.
Those that are safe and effective should be utilized," you know, just
the way that it reads right now. It would just be a sentence before
that, and then the second part of it would be just as it is.
DR. GORDON: Does everybody understand? Wait. Before we go
any further, does everybody understand what Dean just said? Okay.
Tom, you have not had a chance to speak. Please go ahead.
MR. CHAPPELL: I think we accomplish what I am hearing we are
striving to do with the existing recommendation edited only by
changing the concept of "utilization" to "evaluation." I do think
that that is not asking for research, just discernment, and so "Safe
and effective CAM practices and products should be evaluated to help
determine their role in achieving the Nation's health promotion and
disease prevention," et cetera.
DR. GORDON: What about the second sentence? Dean says bring
back ??
MR. CHAPPELL: No, I don't think you need the second
sentence. Then you go into 1.1 to be edited ??
DR. GORDON: Okay.
DR. ORNISH: I mean, I think that is fine; it is just that
some people thought there should be inclusion about utilization, but
that may be implicit in the actions that we are recommending. So I
can live with that, too.
DR. GORDON: Wayne, you have your hand up.
DR. JONAS: I think that is fine; however, then I think there
should be, under the action statements, there should be an item that
specifically says who is going to evaluate it or at least emphasizes
the evaluation component. There should be a federal panel or there
should be members of a task force that specifically looks at Healthy
People 2000, et cetera, to accomplish these goals. A lot of the other
action steps under here really are about utilization, and so if you
drop the utilization out of the overall recommendation, then they
don't kind of make sense under ??
DR. GORDON: There is a 1.5. That action step is there.
DR. JONAS: Oh. Sorry. Okay.
DR. GORDON: I understand your point. Tieraona, go ahead.
DR. LOW DOG: I think part of my problem with the utilization
was that they have not been appropriately evaluated, and I think you
need to evaluate before you utilize. So I feel strongly that the
recommendations should include an evaluation so that we can determine
what and to whom it is going to be, and maybe we could move the ?? if
you think that is sufficient, the Healthy People Consortium, or if you
think that should be something else, that that maybe should be moved
up to 1.1 so it is the first thing that you read, is who is going to
do this.
DR. ORNISH: So, Tieraona, are you comfortable with Tom's
recommendation, then?
DR. LOW DOG: Yes. Absolutely.
DR. ORNISH: Okay. Can we all agree on that and move
forward?
DR. GORDON: All agree on what, Dean?
DR. ORNISH: On what Tom recommended, which was simply to say
that "Safe and effective CAM practices should be evaluated to help
determine their role in achieving the Nation's health promotion,"
blah, blah, blah.
DR. LOW DOG: Since it is a little confusing, let's read
things specifically out, because we are going to perhaps have a
question on "utilization" inclusion. So please read it exactly as it
was stated, please.
MR. CHAPPELL: "Safe and effective CAM practices and products
should be evaluated to help determine their role in achieving the
Nation's health promotion and disease prevention goals and to promote
wellness throughout the life span."
DR. ORNISH: And implicit in that, because you have a lot of
these action steps, is that there is ?? you know, it doesn't just
include evaluation, it includes utilization is what we are
recommending.
DR. JONAS: Then you have to eliminate about half the action
steps underneath there.
DR. ORNISH: No, no, no, I wouldn't eliminate them; I would
just say you don't have to necessarily spell it out in the
recommendation, because implicit is that we are talking utilization as
well as evaluation.
DR. JONAS: I think they are going to have to be reworded,
then.
DR. GORDON: I would like to add that second sentence,
because I think it is important, that you left in, Dean. "Those have
been proven safe and effective should the utilized." I think it is
necessary and that it helps ??
DR. ORNISH: I am okay with that.
DR. GORDON: ?? to move things forward.
DR. ORNISH: That is fine with me.
DR. GORDON: So if you could read that fully as you had it
before, and I think that will satisfy us, and then we can move ahead.
DR. ORNISH: Julia wants to say something pretty badly.
MS. SCOTT: No. I had a recommendation how to incorporate
both of them. "Safe and effective CAM practices and products should
be evaluated to determine their role in achieving the Nation's health
promotion and disease prevention goals. Those found to be safe and
effective should be utilized to promote wellness throughout the life
span."
[Applause.]
DR. GORDON: All right. Excellent. We are all agreed? All
right. Thank you.
DR. JONAS: Just a minute. Wait a minute.
DR. GORDON: Wayne?
DR. JONAS: I like that very much, except now you need to cut
out the first "safe and effective" because you are talking about
evaluate. So the very first one, you just have "CAM products and
practices" and use it in the second half.
MS. SCOTT: Okay. I am all right with that.
DR. LOW DOG: I move that Julia read the corrected amended
version and that then we move to accept it.
DR. GORDON: Right. Julia.
MS. SCOTT: That is what happens when you open your mouth.
"CAM practices and products should be evaluated to determine their
role in achieving the Nation's health promotion and disease prevention
goals." Second sentence: "Those found to be safe and effective
should be utilized to promote wellness throughout the life span."
DR. GORDON: Okay. Are we okay with that? Charlotte?
SISTER KERR: Yes.
DR. GORDON: All right. We are fine with this? Great.
Let's move on. One?point?one. Dean has an amendment on the floor for
1.1.
DR. ORNISH: Right.
DR. GORDON: Do you want to read that, Dean?
DR. ORNISH: Yes. Selected, inspected, rejected and
dejected. I just added four words. "CAM practices that have been
proven to improve nutrition, promote exercise," blah, blah, blah.
DR. GORDON: Okay. Are we all right with that? Yes?
MS. AXELROD: Can we say "have been shown"?
DR. GORDON: "Have been shown"? Okay. Do you accept that
amendment to the amendment?
DR. ORNISH: I didn't hear that part. I'm sorry.
DR. GORDON: "Have been shown" as opposed to "proven"?
DR. ORNISH: Sure. What is the difference? Fine.
DR. GORDON: "Have been shown." Okay. Let's move on to 1.2,
please.
DR. ORNISH: One?point?two I have a problem with just
because, again, it just said all these things should be incorporated
in CAM practices. Which CAM practices? For whom? You know, again,
it is way too broad for me.
DR. GORDON: How would you like to amend it to make it ??
DR. ORNISH: You know, the same way that we had before. "CAM
practices that at a minimum have been safe and effective." I don't
know. Anybody ?? "or should evaluate and ?? you know, I like the
same pattern that Tieraona is talking about.
DR. GORDON: One at a time.
DR. ORNISH: Okay. So I think "Federal agencies such as,"
blah, blah, blah, "should evaluate CAM practices and those that have
been found to be safe and effective should be utilized" or "should be
incorporated into national guidelines on wellness." Tieraona, does
that work for you?
DR. GORDON: All right. That is an amendment on the floor.
George, did you have something to say? Tieraona?
DR. LOW DOG: I think we are close, but again, I would say
that these agencies should evaluate CAM practices to determine their
role in wellness and prevention for children or whatever. My concern
with this whole thing, and I just need to state it right now, is that,
to me, it sounds like, when you read that, we are just going to
incorporate all these CAM practices into wellness and prevention
practices, and we just haven't a clue, especially in pediatrics, what
is going to affect wellness and prevention.
DR. GORDON: Okay. I think we have all accepted that. What
we are looking for is the specific wording, and what you are saying
has to do with evaluation, so I would like you to repeat it.
DR. LOW DOG: "Should evaluate."
DR. ORNISH: Tieraona, I completely agree with what you are
saying, so why don't you say how you would like it to read.
DR. LOW DOG: "Federal agencies such as Health Resources and
Services Administration, the Centers for Disease Control and
Prevention, and the Department of Agriculture, should evaluate CAM
practices and products," I guess, "to determine their role in
enhancing wellness and" ?? is that "disease prevention in children"?
DR. GORDON: The issue here, I think, and Corrine can correct
me, has to do with national guidelines. So I think that is what needs
to be addressed.
DR. LOW DOG: Well, yes. I mean, you need to ??
DR. GORDON: "And should evaluate their relevance to national
guidelines."
DR. ORNISH: "To evaluate their effectiveness in order to
determine their role in national guidelines."
DR. GORDON: Is that okay?
DR. LOW DOG: I don't like the recommendation. I think it is
premature. I think that you need to go through the very first
recommendation, which is the evaluation of these and how they fit into
promotion and disease prevention, and then you start thinking about
national guidelines.
DR. GORDON: I think the issue here, and I want to try to
make it clear ?? maybe Corrine can clarify it even more ?? is that
there are things that are underway, and the evaluation is a perfectly
legitimate step, but we are trying to indicate ?? I think the thrust
of these recommendations is to say, okay, there are efforts that are
underway, how do we get these approaches, those that are safe and
effective, considered for inclusion in these activities that are
underway?
DR. ORNISH: What activities are underway?
MS. AXELROD: That is correct, Jim, and I think this
recommendation reflects the very strong sentiment that has been
expressed by the Commission to address the children, the obesity, the
eating habits, the influence of everything that is going on with
children, and that there are existing guidelines ?? this was described
in detail in the text ?? that the Health Resources and Services
Administration has developed. They are actually working with the
American Academy of Pediatrics right now. The Centers for Disease
Control and Prevention has guidelines that are used in every single
school in this country. So the idea here was to not do something
completely out of, you know, what is existing, but to build on that to
incorporate where things have been, you know, shown to be safe and
effective, may be applicable, and should be looked at to see if they
can be built into the existing guidelines.
DR. GORDON: Conchita is next, please.
DR. PAZ: Then what we might say is to evaluate and then
incorporate those to be determined to be beneficial into the national
guidelines.
DR. GORDON: Other comments on this? Yes, Wayne and then
Tieraona, okay?
DR. JONAS: I have a suggestion that might help manage this a
little bit. If the overall recommendation involves this two?part
aspect, "evaluate and those proven to be safe and effective," or
whatever the terminology that would be used, "should be then utilized
or incorporated," then the first action step really should be how do
we want to evaluate that? We talked about 1.5 doing that, although I
think it needs to be reworded to do that. But the Healthy People
Consortium now incorporates all of these agencies that we just talked
about. They are involved in developing this plan.
So if we move 1.5 up to the top and said, "The Healthy People
Consortium should evaluate the role of CAM" or "the potential role of
CAM for the 10 leading health indicators and develop strategies for
the use of proven CAM practices in this areas," and then in the
subsequent action steps in which we are saying incorporate,
incorporate, incorporate, put "proven" in front of "CAM" every single
time so that it is contingent upon what comes out of the evaluation
component that is number one. Then that follows from the original
recommendation which has the two parts. It says where we want the
evaluation to occur ?? within Healthy People Consortium ?? and then
the rest of that is all contingent upon whether what they had
discovered may be useful in that.
Anyway, end of suggestion.
DR. GORDON: Thank you.
DR. ORNISH: Wayne, I like your suggestion a lot. At the
same time, I do think it is worth being a little redundant by putting
under each action step that we evaluate and then those that have been
found to be effective are implemented because these may be taken out
of context and I think it is just useful to be a little redundant
here.
DR. JONAS: Okay. I have no problem with that if we can
figure out how to do that in an expeditious manner.
DR. GORDON: The question is, can that be formulated right
now, or do you want to take some time at lunch to formulate the
correct ??
DR. ORNISH: I think it is pretty simple, really, I mean if I
understand Wayne correctly, and, Tieraona, if you are comfortable with
it. Basically Action Step 1.1 would be to take 1.5, move it up to the
beginning, and then how would you strengthen 1.5, Wayne?
DR. JONAS: This again is saying strategies to encourage the
use of CAM practices, and what we want to say is Healthy People
Consortium should evaluate the role of CAM's potential for the 10
leading health indicators and develop strategies for the use of proven
CAMs or ??
DR. ORNISH: I think that sounds great. Tieraona, what do
you think?
DR. JONAS: Or you could even eliminate the strategy issue if
you just want to be clear about ?? take the Healthy People Consortium
and ask them to do an evaluation component. Then that becomes your
standard for determining what has been demonstrated to be useful, and
then that is inserted into each of these subsequent recommendations.
DR. ORNISH: I think that is great. Tieraona, how do you
feel about it?
DR. GORDON: Let me tell you, the only concern that I have,
immediate concern relates to 1.1, which I don't want to wait for the
?? 1.1 as amended is "CAM practices that have been proven to improve
nutrition." I think this is one that is important to me, it was
extremely important to Bill Fair, and I feel it is very important to
the Commission that we begin to move ahead with this right now and not
wait for the Healthy People Consortium.
DR. ORNISH: I am okay with that.
DR. JONAS: The Healthy People Consortium, I mean, we are not
asking them to prove it; we are asking them to evaluate it. So this
actually wouldn't take that long in the scope of things. One could
say ??
DR. GORDON: Let me just say that I think ??
DR. JONAS: One second. One could say "Appropriate practices
found by the Healthy People Consortium to be useful for the 10 leading
indicators should be incorporated."
DR. GORDON: What I would say, though, on the school issue is
that I think that this is an issue in which Secretary Paige is quite
interested, the Department of Education. I think it is one of the few
issues in which we can really make a difference.
DR. ORNISH: We are saying the same thing. All that Wayne is
saying, which I think is really smart, is that if I say "CAM practices
that have been proven to improve nutrition," blah, blah, blah, you
have to say, well, according to whom? That's all. And he is saying,
according to them. I mean, you may assume or I may assume that
something has been proven, but there has to be some standard of what
do we look to to say that this has been proven or not, and you are
just giving a mechanism.
DR. GORDON: Tieraona.
DR. ORNISH: I think we are all in agreement about that.
DR. LOW DOG: I am willing to compromise on CAM practices in
1.1 because I didn't like it. I wanted, "Strategies should be
developed that improve nutrition, promote exercise and teach stress
management," because I am not convinced that a lot of our best
evidence and our best techniques to do this are going to be found just
under CAM. So if I am really interested in promoting the health of my
kids in school, I am going to look for the best strategies out there,
not just those that fall under CAM. So I am willing to go with "CAM
practices that have been proven," but you have to have somebody to do
the evaluation, and I think before you start to implement things in
kindergarten, you better be very sure that what you are putting in
place is valid, scientifically valid, appropriate, period.
DR. GORDON: The question I have here is if something has
already been proven ??
DR. ORNISH: According to whom? That is the question.
DR. GORDON: Well, for example, it has been proven that
calorie?dense snacks are not particularly healthy for kids.
DR. LOW DOG: Right. That is not a CAM practice, either.
DR. GORDON: I understand. I understand. But what I am
suggesting is this is one of the areas where ?? and we make this very
clear and I think that a lot of Joe Fins' points have addressed this
very clearly, that there are many areas where CAM and conventional
medicine or public health overlap. This is one of those, clearly one
of those areas, and the issue here is do we want to begin to use
proven strategies for improving nutrition, promoting exercise and
teaching stress management with kids or not?
DR. ORNISH: Jim, the whole issue is proven according to
whom? And what Wayne is outlining, which I think makes perfect sense
to me, is a mechanism by saying that these are proven. You could talk
to somebody who might say, you know, sitting under a pyramid is proven
because I have three patients who did and they got better. You know,
we need some kind of way of saying what does that mean, that they are
proven?
DR. GORDON: Let me come back to something that Charlotte
said earlier, is that in various portions, we have used safe and
effective and we have not said who determines safety and efficacy. We
have assumed that that has to do with published research in peer
review journals. That is what I am talking about. There is a
difference between setting up a whole other mechanism here ?? let me
just finish my sentence, and I have David first and then Tieraona ??
setting up a whole separate mechanism here from what we have done in
every other section in the report. So I am not saying that we can't
do that; I am saying I don't see the reason. If we are saying safe
and ?? I see the reason for the Healthy People in regard to those
specific task forces that are addressing issues related to Healthy
People. That makes sense to me. It may not make sense if we are
talking about preventing ?? you know, we are talking about promoting
wellness, promoting better patterns of exercise in children. So I
think there are two separate issues here and we are invoking a
different standard here. David and then Tieraona.
DR. BRESLER: Again, I see an opportunity here, and I think
what Wayne is saying is right on target, but I think it could be
expanded even more. In those areas that would not be appropriate to
go through that review agency, maybe we can recommend funding for
consensus conferences or other fairly well established ways that we do
look at the status of things and make determinations as to where we
stand.
DR. ORNISH: But he is saying why is this held to a different
standard if we don't do that ??
DR. BRESLER: I think we need to address that issue in all
the safe and effective. I think we need to ?? why not take that on
and say very often the questions come up. There are some things that
appear to be safe and effective, there are others that we need to do
more research to determine it. That affects all of our
recommendations and maybe we need to address that issue directly and
request funding to make those determinations either through Healthy
People or through consensus conferences or in some other way. Maybe
that is something we need to do.
DR. GORDON: That takes us back to the whole rest of the
report, too, though. So I want to just point that out. Tieraona.
DR. LOW DOG: It is not enough to have one study in one
journal saying something works in one group of people when you are
going to be making national guidelines or broad statements about that
this should be implemented at the federal level for public policy. It
requires more than a study, and somebody has got to do the evaluation
before you say, in our national guidelines, we are suggesting this.
It is a little bit different. If you want to use glycocyamine for
your arthritis, that has a different ?? that has something different
to me as a consumer, what you are willing to choose to take care of
your arthritis. It is a very different issue when we start saying
that we are going to make federal policies. And we are going to make
claims about disease prevention? That is a very hard thing to prove,
disease prevention. Health promotion. Improving nutrition.
Promoting exercise. I think that you have to have more thought and
there needs to be a respected body that is going to take this on to
evaluate what is out there.
DR. GORDON: Any other comments on this? Yes, Julia.
MS. SCOTT: I think first I would like to remind us that the
Chair's admonition that we are spending too much time is clearly on
Recommendation No. 1. I think we really have to pay more careful
attention to the clock. Having said that, I also agree with Wayne in
terms of the recommendation. If our recommendation is that it needs
to be evaluated, it seems to me that 1.1 needs to then describe the
mechanism through which it would be evaluated and then everything else
should be addressed. I agree it is important to get the aspect of
offering these kinds of things in a responsible way to children and
whatever, but I do think a logical progression, if we recommend an
evaluative body, that we then say who that body should be and then
continue with the rest of the recommendation.
DR. GORDON: Okay. Other comments on this? Yes, Charlotte.
SISTER KERR: Just a question. Corrine, where is it that we
validate stress management so that we ended up listing it in our
action? Is it in the text?
MS. AXELROD: When you say "validate," you just want to know
if it is ??
SISTER KERR: We obviously pulled that one out and I am just
wondering where did we discuss it that we decided on that one. It is
sort of, in my mind, a continuation of this evaluation conversation.
I am just wondering what we did already responsibly so that we
included that particular behavior.
DR. ORNISH: There are some studies looking at stress
management in kids, and I think that, whether they are in this section
or not, that we discussed them. But maybe we could just add that to
there if they are not there already. I want to just bring up the
point that Jim mentioned, though, which I think is a really important
one, and that is that I think the real issue is not how come we need
to specify here how they are going to be evaluated to be safe and
effective, but to say we really need to be mindful of that throughout
the report to come up with at least some general guidelines that can
help people determine a mechanism for deciding what is the state of
the evidence.
DR. GORDON: Wayne.
DR. JONAS: I do think that if you are going to make policy
statements and say this should be implemented, that is different than
many other areas of the report which are about professionalism,
access, licensing, education, you know, which they are different. So
I think especially in the areas we are going to determine, you know,
what is proven and what should be established in a policy, you do need
to have a process that involves a national body. Maybe this is not
the right one, maybe we should put the Healthy People Consortium and
other national groups to broaden it a little bit. I think that even
things that are already proven, they still need to be evaluated this
way because they have to be looked at for their potential impact on
the top 10 leading indicators and in Healthy People 2002, so even the
proven literature. It isn't necessarily always safe and effective. I
mean, some things are implemented because they are felt to be just
logical and they make sense and we want to see them happen. So
"appropriate" is probably a better term. Often it is based on whether
they have been proven safe and effective, but that is part of what the
national body would do.
DR. GORDON: Wayne, I am going to ask you if you could reword
and reorder the action items for us, because I think we are at a stage
where we have had a lot of discussion about this and then we still
have a couple of specific action items we haven't discussed. So maybe
we can discuss the specific action items and then get a rewording and
reordering for this. Is that okay? Yes. I'm sorry. Tom, Effie.
MR. CHAPPELL: I wanted to just ask the Chair if he could
share with us your concerns about the Healthy People Consortium. I am
feeling you don't have an adequate opportunity to participate in this
discussion and I would like to give that to you for our benefit.
DR. ORNISH: Jim is so laid back and we need to give him
assertiveness training.
MR. CHAPPELL: I didn't call on you, Dean.
[Laughter.]
DR. ORNISH: We don't need to give you assertiveness
training.
DR. GORDON: Let me say, I appreciate the wisdom ?? and I
appreciate having the chance to talk ?? I appreciate the wisdom of
having this evaluated. My idea is, I don't want to be restricted in
the way we are going to implement this. This, for example, is an area
where I would like to go directly to Secretary Paige and the
Department of Education and talk with them about a mechanism to
determine how to begin to improve the health and health education of
school children. Obviously evaluation would be a component to decide
what went into that, and that is not a decision that would be made
just by one person.
What I am concerned about is that this is one of the
strongest, I feel, one of the strongest recommendations, one of the
ones that the public has the most interest in, certainly one of the
ones I am most interested in and what clearly Bill Fair was most
interested in, and I don't want to be tied to the operation of a
committee that may meet occasionally and may not come up with
recommendations to which we may not have much input.
I feel just as we are making recommendations for more research
in certain areas that are not necessarily tied to the meeting ?? that
are just trying to open up the domain of research, so similarly what I
am suggesting is that this may be an area where we can go and talk
with people in Congress, where we can go and talk with the Department
of Education, where we can begin to facilitate the process, which may
not fit so neatly or may take a long time to fit under the Healthy
People process.
That is my major concern, and I am not saying it is the
exclusive domain of CAM. I have never thought that and don't think
that now. I think that this is part of good health education, and I
think we as a Commission as well as individuals have something to
contribute.
DR. ORNISH: But, Jim, how do you address the concern that
Tieraona and others have expressed that there is a presumption in what
you are saying that these things are already proven, you know what
works, you know how to implement it, and then it is just a question of
getting the Secretary to do it?
DR. GORDON: No, I think that some things are proven and some
things are not proven. I think there are a whole range of things. I
think what we need to do is to encourage ?? the idea is to encourage
the Secretary of Education to look at these issues, not to just leave
it for Healthy People 2010 or 2020.
DR. JONAS: Who would you like to target that to, then? Who
would you like to target that to, then, if ??
DR. GORDON: I would like to target it to the Department of
Education.
DR. JONAS: To the Department of Education.
DR. GORDON: Yes, in this instance.
DR. JONAS: All right. So then Department of Education in
collaboration with Health and Human Services should then evaluate, et
cetera, et cetera?
DR. GORDON: Yes, something like that.
DR. JONAS: Okay.
DR. GORDON: But I am not sure if it has to be ?? I mean, if
it needs to be in collaboration with Health and Human Services. They
are perfectly capable of setting up their own ??
DR. ORNISH: I don't think you are really saying that, Jim.
You are really saying you don't want anybody to evaluate it, that you
already know what is proven.
DR. GORDON: No, I am not saying that. What I am saying is I
want to encourage them to consider including these approaches.
Basically, as you know, health education now is a series of don'ts.
Don't do this, don't do that, don't do the other thing. There is very
little emphasis and even less time devoted to helping kids find what
are healthy behaviors.
MR. CHAPPELL: Jim, could you help Wayne with the language,
then, that you would like during lunch?
DR. GORDON: During a healthy lunch?
MR. CHAPPELL: Yes. Because I think we are appreciating your
point of view, having heard you. So could you help craft that
language for this piece during lunch?
DR. GORDON: I could do it during lunch, but it is basically
just encouraging the appropriate departments, including the Department
of Education, to develop strategies for improving the health of our
children, which may include CAM practices that have been proven to
improve nutrition, promote exercise and teach stress management,
something like that. Yes, Dean.
DR. ORNISH: Again, please don't misunderstand me because
there is nobody more committed to teaching people how to change their
behaviors than I am, and certainly that includes kids. But I do think
it is a perfect example of what I was trying to talk about in my memo,
which is that there is this ethos of presuming that certain things
work and then wanting to find the most direct way to implement them,
and I think this is what, Tieraona, you are very eloquently having
some concerns about, which is that just because I might think
something works doesn't mean that it does, or just because some people
think it works doesn't mean it does. Tieraona, can you elaborate on
that just a little more, and then maybe we can just get closure on
this and move on?
DR. LOW DOG: Well, I am just frightened by the notion that
you can just sort of go lobby people to go implement things. I just
think that is not a thoughtful way to do things. You know, I believe
in martial arts, I believe in Tai Chi, we eat a vegetarian diet. I
mean, my own personal life is based around this, but I would not
presume to say that the way I have chosen to live or raise my children
is the way that is going to work for everybody. I strongly support
the recommendation that was made that an evaluation be undertaken. I
fully endorse that that could include the Department of Education in
collaboration with X, Y and Z, and that based upon that evaluation and
determination, that those that have been shown to be effective, even
demonstration projects I would say would be the next place to move,
not just implementation, but demonstration projects to determine how
to best implement it, and I think taking a step?wise approach is the
way that 20 years from now our children will be healthier. But to try
to just bulldoze through it in a year to make it happen is not, I
think, the most effective way to ultimately make the change that will
protect us.
DR. GORDON: I think we are in complete agreement. I don't
think there is any disagreement between us about how it is going to be
implemented and how it is going to move ahead. I think what I was
saying is all the recommendations in this area should not be tied to
Healthy People 2010, 2020, because that mechanism may not be the most
appropriate.
What I am suggesting is that we may want to work with other
and make recommendations to other departments that they can begin this
process, which, of course, would begin with evaluating what is most
appropriate, with demonstration projects and, if the demonstration
programs are effective, with implementation.
DR. LOW DOG: I think we need to just say that.
DR. GORDON: That is fine. Joe?
DR. FINS: You know, I really want to urge caution here,
because I think where we started yesterday morning and where we were
before we got to this section was a lot healthier for the well?being
of our report. I think we are really at a juncture here where we are
at risk of CAM creep, we are at the risk of end?running the processes
that exist, and it really does sound like proselytizing. I think you
may win a rhetorical battle, but you are going to not promote the
public health. I think that there are mechanisms in the federal
government, there are ways of conclusively proving things work or
don't work. There are health indicators, there are responsibilities
of certain agencies versus others that look at health indicators, and
I think we have to be very careful to deal with this incrementally and
prudentially.
DR. GORDON: Joe, that is fine. What I want to do is get the
wording for the recommendation, okay?
DR. LOW DOG: Wayne had a recommendation earlier. Joe, would
it be all right if we ?? Wayne do you have something?
DR. JONAS: The only difference I can currently see from what
we had done before is instead of targeting it toward Healthy People
Consortium, the evaluation component, and implementation aspects and
recommendations will come out of that, I think. So I don't think that
evaluation means this is delayed, I think it is actually the most
efficient way to do it, but it would be targeting something a little
broader so that others could be involved in that. I mean, you could
say the federal government should, or you could say the federal
government including the Department of Education, Health and Human
Services, and the Healthy People Consortium, if you wanted to try to
highlight those, should evaluate the role of CAM or CAM and CAM
related, okay, CAM or lifestyle if you wanted to, for the 10 leading
indicators and develop strategies for the use of appropriate practices
in these areas.
So that is basically a rewording of 1.5 as I described before,
but just broadening it so it is focused on federal agencies, highlight
the ones that you think ought to be the leads in that, put it up at
the top so it is Action Item 1.1 or in a separate recommendation, if
you want, and then just make sure through the rest of the
recommendations you say that the CAM practices that have been found to
be useful for this, and that means found by this particular evaluation
process.
DR. GORDON: This is fine. I want to move ahead. We need to
really move down the list of action items.
DR. ORNISH: Let's move ahead.
DR. GORDON: Effie, do you have a comment before we do that?
DR. CHOW: Yes. I think the problem we are running into is
that when I look at that recommendation, it suddenly is all about
children, and then the last few are about the general population. I
agree with Wayne that we should take 1.5, but along with 1.5, we
should take 1.6 as well as a grouping to move it up, and if there is a
problem, as Jim was saying, that you want some action, perhaps we need
a separate recommendation to deal with the children, because I think
that is very important, too, and then that doesn't tie it in with what
is part of this recommendation.
DR. GORDON: Okay.
DR. FINS: The most vulnerable members of the constituency of
people are the elderly and the children, and I think the standards ??
I mean, from my point of view, since an adult could be willing to
voluntarily participate in a study, that person, you know, he might or
she might be willing to accept risks and benefits and make decisions.
Children, because they are underage, are not able to provide consent
to participate in things. So to start with children seems to me
inverted, and I think it is, for all reasons that Tieraona said
earlier, is really problematic. It strikes me that there may be more
receptivity in the Department of Education, so we are going there,
versus HHS, where there may be the little more scientific rigor, and I
think that we have to be very careful about that.
DR. GORDON: What I would like to do is to go with Wayne's
recommendation, which is talking about a number of agencies that will
become involved in different ways depending ?? just the way the
Department of Defense might become involved in other issues. There
are a number of agencies. My comment was really addressed to the fact
that one specific process may not fit all these recommendations,
including recommendations about children. We need to move ahead,
okay?
DR. ORNISH: Let's move on. Okay. Let's move on. If I can
move now to the second ??
MS. AXELROD: Jim, just for clarification, the Healthy People
Consortium already includes all of the federal agencies you have
mentioned, plus more, plus state, plus other organizations, so it is a
little bit redundant to say it that way. The Consortium is actually
one of the best examples of partnerships between federal agencies, the
feds, the states, private organizations, and consumers.
DR. ORNISH: Okay, I agree with everything, and just to move
on, I agree with everything, the last things said. Again, to address
your point about the vulnerable populations, that is all the more
reason to have a rigorous evaluation, because of that. I also want to
say that I spoke with Secretary Tommy Thompson yesterday, or the day
before yesterday, and also Mark McClellun, in the White House, who is
President Bush's main health policy advisor in these areas, and they
are totally committed to prevention. They want this to be the
prevention administration.
Ken Cooper is probably going to be the new surgeon general. I
don't think we have to worry about these things being implemented by
simply making them evaluated properly. So I think we are okay there.
Can I move into the next section now?
DR. GORDON: Please.
DR. ORNISH: Which is Recommendation 2.
DR. GORDON: No, no, no. We need to finish with ?? we have
not gone through all the action steps in 1. I want to make sure that
we are agreed on the action steps here.
DR. ORNISH: We have done 1.1. One?point?two is ?? again, I
think that ??
DR. GORDON: We have not looked at 1.3.
DR. ORNISH: Have we done 1.2, then?
DR. GORDON: And we haven't done 1.4 or 1.6, and 1.2 we have
not come to a conclusion about.
DR. ORNISH: All right. So we talked about 1.2 is about ??
instead of saying they should incorporate these practices, that they
should be evaluating ?? to evaluate them to determine their role is
kind of a corollary to what we have been talking about. Tieraona,
that was your idea. How do you all feel about that? Can we agree
with that? The idea of the step?wise progression, that we do the
evaluation, and then those that have been found to be useful, then we
talk about how they should be incorporated.
DR. GORDON: Tieraona, do you agree with yourself?
DR. LOW DOG: I just want to know how that relates to our
recommendation now that we have about these agencies and Healthy
People Consortium and stuff like this. I want to know how that
relates to this, Wayne, when we look at 1.2.
DR. ORNISH: As I understand it, Wayne, all of these
recommendations would fall under that evaluation.
DR. JONAS: Yes.
DR. LOW DOG: Right. So it just seems redundant.
DR. JONAS: That I think would be the most parsimonious way
to do that, is that most of these are actually implement type
recommendations, and instead of trying to rephrase them all to ??
DR. LOW DOG: Right.
DR. JONAS: ?? include evaluate, evaluate, evaluate, you make
them contingent upon the evaluation aspect.
DR. GORDON: I just want to check with you and make sure that
is the case.
MS. AXELROD: Well, just because of the way the bureaucracy
is, that is just not going to happen. There is a group that works on
the Healthy People initiative, the 10 health leading indicators and
all that stuff. There is an entirely separate group that works on the
guidelines in the schools. So, you know, whereas it makes sense the
way you are saying it, in reality these paths do not cross.
DR. ORNISH: So what is your recommendation if the goal is to
try to have some group that is considered an authority to evaluate
what is considered ?? where the level of evidence is sufficient to
talk about implementation?
MS. AXELROD: The evaluation could be done by a group ??
well, actually, again, we are looking at how these would apply to the
goals and objectives, how they would apply to the existing curriculum,
so you really need the people that are working on those to look at
these things. I don't know, I think we have to work out ??
DR. GORDON: I feel like Tieraona's original amendment to 1.2
works perfectly well: "should evaluate CAM practices and determine
which safe and effective ones can be incorporated or can be included
in national guidelines." I think that covers it. It relates to the
specificity that Corrine is talking about about this being a group.
It covers your concern for evaluation first before recommendation.
Tieraona, are you with me on this?
DR. LOW DOG: Well, if you are going to have this one, why is
there not the American Academy of Pediatrics in here if we are talking
about national guidelines on wellness and prevention in children?
DR. GORDON: This is federal agencies, No. 1.2.
DR. LOW DOG: Well, okay. I would ask for their input at
some point.
DR. ORNISH: Another approach is just to say "a body of
authorities," without talking about which ones.
DR. LOW DOG: So "should evaluate CAM practices to determine
their potential inclusion." I don't know.
DR. GORDON: That's fine. Dean, let me respond to you. This
is, as Corrine is explaining, about a specific project which has to do
with these agencies. That is why they are included by name.
MR. CHAPPELL: Jim, I need to ask that our process return to
order, where you are calling on people and people are waiting to talk.
The conversation that is going on on one side of the room is leaving
the rest of us just out of the picture all together. I need more
order. We will do better if we have order.
DR. GORDON: Thank you. So let me try to keep the order
here. The order is we are on No. 1.2.
DR. ORNISH: I need a point of clarification, because in the
past when we had sections that we were in charge of, the person in
charge of that section ??
DR. GORDON: No.
DR. ORNISH: Is that not the case?
DR. GORDON: I am in charge of the whole meeting. That's
what Tom is referring to, that you are obviously the major resources,
but that this is a discussion that the chair moderates. The issue
with 1.2, as raised by Tieraona, is, I think, quite appropriate here,
and Wayne may have another suggestion, that this is a particular
initiative as Corrine has described it. The same principles of
evaluation and possible incorporation are being articulated here.
Wayne, do you want to comment on that?
DR. JONAS: Well, I agree with Corrine that if it was just
contingent on the first evaluation and everything followed, that these
would not cross paths. I want to just suggest a wording thing that I
think you are trying to get at, Tieraona, which is essentially the
same thing that is there, but then say, "should evaluate and
incorporate appropriate CAM practices into national guidelines on
wellness."
DR. GORDON: Okay. Are we okay with that, Tieraona? Because
we really need to move along.
DR. JONAS: That links the two for that particular action
item.
DR. GORDON: Are we okay with this? Let's move to 1.3,
please.
DR. FINS: We have excluded children.
DR. GORDON: What, Joe?
DR. FINS: It is a generic statement, it does not
specifically focus on children as it is written now; is that correct?
DR. GORDON: No, 1.2 does focus on children as it is written.
DR. FINS: So could we read the whole thing with the whole ??
I would leave out the children.
DR. GORDON: No, this is a specific initiative that has, as I
understand it, Joe, that has to do with children that Corrine is
talking about. Corrine, do you want to explain again?
MS. AXELROD: This is specifically about guidelines that are
either under development or in existence. CDC has had guidelines for
several years and they are developing more guidelines that are
utilized in all the schools. HRSA has been working with the American
Academy of Pediatrics to develop separate guidelines to address
different aspects of children's health. So by taking children out,
you might as well take the whole thing out because this is specific to
guidelines for children in schools.
DR. JONAS: Okay. If you are going to do that, then you need
to specify the particular program. Right here, all you have
identified is the agency, and they are doing other things besides the
ones you have just mentioned that aren't about children but are on
these topics.
DR. GORDON: So, Corrine, is there a special program that you
can put ??
MS. AXELROD: I will add that language to make it specific to
those programs.
DR. JONAS: I mean, if you made it generic, then it would
allow them to focus on those particular programs around children, or
if you put "including children" in it, then it would emphasize that we
want to have children focused on and use these programs, but then it
wouldn't limit it to only those.
DR. GORDON: Okay. Let's go to 1.3, please. Do we have
agreement on 1.3? Yes? Yes? Okay. One?point?four, please.
DR. JONAS: I want to also suggest we say "including
children" instead of "among children," which limits it to children.
DR. GORDON: I'm sorry. That would read, "Healthy behaviors
among all Americans" or "among Americans including"? How do you want
to say it, Wayne?
DR. JONAS: "Including children."
DR. GORDON: But child is not a healthy behavior. I mean, I
am just looking for wording.
DR. JONAS: "Including among children"?
DR. GORDON: "And encourage healthy behaviors."
DR. JONAS: "For All Americans including children Americans,
little Americans."
[Laughter.]
DR. GORDON: "For all Americans including children," all
right? As if they were not Americans.
[Laughter.]
DR. GORDON: Okay. Let's go on to 1.4.
MS. AXELROD: Do you want to say "particularly children"?
DR. GORDON: Do you want to say "particularly children"?
DR. JONAS: I think that is fine.
DR. GORDON: Joe, you are shaking your head.
DR. FINS: I mean, I have said what I have had to say about
the tone of this section. I have nothing else to say about it.
DR. ORNISH: Well, I have a question. I mean, we are going
to talk about again this whole issue about who determines what
behaviors we are going to be encouraging? Should we refer it back to
1.1 again?
DR. GORDON: Well, I think 1.1 is the framing statement for
all the ones underneath here, as I understand it.
DR. ORNISH: I mean, do we want to just simply add "as
indicated in 1.1" or something so it is clear that we have some
mechanism that is maybe redundant, but it is clear?
DR. GORDON: That is an open question. Listen, we need to
get organized on this, so we need everybody to be focused on each of
these recommendations as they come up and to move through them as
quickly as we can, okay? We are getting bogged down. So the question
on the floor that Dean has raised is ?? say it again, Dean, please.
DR. ORNISH: I am not trying to bog things down; this is
basically a yes or no. Do we want to make each action recommendation
referred back to what will be 1.1, which is ?? in other words, do we
say ?? we are talking about a public service campaign to encourage
healthy behaviors. Implicit in that is we know what healthy behaviors
are, and we have already said that we really need some authority or
some body to try to sort through the data to say what it is.
DR. GORDON: I think that that has been framed by the new
1.1. Wayne, would you agree?
DR. JONAS: I think 1.3 and 1.4, which, in fact, do not have
the word "CAM" anywhere in them and are simply statements of, gee, we
want to see more healthy behavior activities, I think that is
adequate.
DR. GORDON: And I think the reports have been deciding what
?? you know, framing healthy behaviors quite well. Yes, Joe.
DR. FINS: I think we really should be, again, cautious about
this, and I think this crosses political lines and ideological bends.
What constitutes the right kind of behavior? And this could become
very prescriptive and this administration or any administration could
use this to promulgate certain kinds of moral stands about what is
right and what is wrong that Americans would not necessarily agree
about. Can I ask my colleagues to just tune into this for a second?
I really think this is a land mine. It could be usurped in ways that
we can't anticipate, and I think that whether you are a Democratic or
Republican, Conservative or Libertarian or Liberal, this is potential
problematic. So, I mean, to get prescriptive in this way is a kind of
proselytizing that I find objectionable and it is not only CAM creep,
it gets into other areas where people could dictate abstinence as a
way of dealing with sexually transmitted diseases, for example.
DR. GORDON: Joe, let me ask you a question which I hope will
clarify it. We are framing this according to the objectives of
Healthy People 2010, 2020. Healthy behavior derives from that. Do
you still object to it?
DR. FINS: Well, I mean, if we took it ?? no, I endorse those
reports as I understand them, but when I start looking at public
service announcements and how the sound bites get constructed and what
the message is that gets distributed and how it is interpreted and
which public figures are chosen and what the implicit message about
their representation means, I start getting concerned.
DR. GORDON: So even if this is all framed by Healthy People
?? essentially what we are saying here, as I read it, is that there
are objectives in Healthy People, some of which have to do with CAM,
some of which don't, and that we are saying we want those objectives,
those behaviors that are discussed in there to receive a higher
profile and to have more public notice. I feel that is the intent of
these recommendations.
DR. FINS: I think it is the line between ?? and this is why
I was concerned about moving to the Education Department away from HHS
-- but it is the line between ideology and what is scientifically,
from a public health perspective ??
DR. GORDON: Obviously, we need some more discussion about
this. Dean, and then we have a number of other recommendations in
this section. It's not going to be 6:00. We're going to be here
until much later than 6:00 if we don't move ahead. Okay. Please.
DR. ORNISH: This is one of the areas Joe and I don't agree
on. I think it is actually a very good recommendation, but I just
want to make sure that it refers back to 1.1 or whatever we have that
somebody can help determine what is considered a healthy behavior and
that we just don't assume it, that we all know what that means.
That's all.
DR. GORDON: I think the intent is very clear as we have now
reconstituted it that this comes under the Healthy People advice.
DR. ORNISH: I am happy with it.
DR. GORDON: Julia?
MS. SCOTT: I was just going to say, you know, again, this is
another place where I don't think we can prescribe what is going to
happen with it. I think we can only set out what we think should be
the goal and how it should be incorporated, and I don't think ?? they
might come out with an abstinence program for all we know, but I don't
think we can do anything about that right now. But I think we have
made clear our intent here.
DR. GORDON: Okay. Let's move ahead. One?point?four. We
have agreement on 1.3, then, with the understanding that this is
framed by Healthy People? One?point?four.
DR. ORNISH: It sounds great.
DR. GORDON: Okay. One?point?four? Joe, 1.4?
DR. FINS: Yes.
DR. GORDON: Okay. Five. We already made that 1.1.
One?point?six. Are we all right on that? Yes? Basically again
referring back to national health surveys. Good. Thank you.
Let's look at Recommendation No. 2 on page 9. Let me read it
and then you can read to yourself the action items. "Research on the
role of CAM and wellness and health promotion, the application of CAM
principles and practices, and the role of CAM practitioners in the
management of chronic disease should be expanded."
Please, before you make comments, give everybody a moment to
read the action items, then we will come back to the recommendation.
[Pause.]
DR. GORDON: Read the action items? Dean?
DR. ORNISH: This is something very close to my heart, no pun
intended, and I happen to like this recommendation a lot, and you
might even want to make reference to the work that we have done
because it is a perfect example of that. We did randomized trials
showing it was medically effective. We are in the middle of a
Medicare demonstration project to see if it is cost effective. It is,
to me, the very kind of thing that we are talking about and I like it.
DR. GORDON: Other comments on Recommendation 2? Veronica?
DR. GUTIERREZ: I would just like to know why it is not in
the Research chapter. Why isn't this in the Research chapter?
DR. GORDON: Corrine, do you want to address that?
MS. AXELROD: Wayne?
DR. JONAS: Yes. Because we thought this was an important
enough item that it should be highlighted in this section also. We do
discuss the importance of research on wellness in the Research
chapter, but we felt like that this was an important enough topic that
we also should have it in here.
DR. GORDON: Okay. Anything else about the ?? do we accept
the recommendation? Yes. Let's go to Action Item 2.1, please. Joe.
DR. FINS: We have here special mention of underserved and
special populations. I think we don't want to single them out for
special treatment because they are otherwise vulnerable and don't have
health care services. I would not want this to be misconstrued as,
you know, they would be more willing to agree because they don't have
health insurance and they don't have access to services, and I
wouldn't want this to be perceived as being a substitute for those
services.
DR. GORDON: Do you have a recommendation for dealing with
that?
DR. FINS: I think if you ?? I mean, I think we might want
it to evaluate the clinical and economic impact of comprehensive
health promotion programs that include CAM and leave out the
populations.
DR. GORDON: Okay. Other comments on Action Item 1? Yes,
Effie and then Julia.
DR. CHOW: I recall conversations on this, and I thought that
it was very important that we do include the underserved and special
population because they are so often neglected, and it isn't just,
say, only to them, but it includes.
DR. GORDON: Julia.
MS. SCOTT: Yes. I think that you are misreading that, Joe,
because it is saying that we should have demonstration projects to
evaluate the clinical. Maybe it needs to be moved around, but to make
sure that it includes, because so often, so many of these studies and
projects just don't include us, so we don't know if it is applicable
to us.
DR. FINS: So can we put the emphasis on studying the
clinical and economic impact of comprehensive health programs that
include CAM and then the second sentence is, "These studies should
also include underserved and special populations" separately as a
second statement?
DR. GORDON: Does that suit everyone? Okay. And then
listing the special populations?
DR. FINS: I think people know what that phrase ?? demography
is being referred to.
DR. GORDON: The only question I have about this is whether
or not it should be stronger, because so many of these programs have
gone to people who have money because there have been people with
discretionary money. So there is a kind of imbalance.
DR. FINS: Well, by singling them out and saying that it
should include ?? you are acknowledging them without burdening them
with being in research when they ?? you know, similarly, people who
have discretionary income have the choice to participate. People who
don't have health insurance may have no choice but to say, well, at
least this is something.
DR. GORDON: Okay. Is everyone comfortable with this? I am
fine if everyone else is comfortable. Yes, Effie, are you comfortable
or not? I can't tell. Okay. You are sure? You don't want to add
anything or say anything? I just want to ?? you need to use the
microphone, though.
DR. CHOW: It is not my preference to make the change, but I
will go along with it if it is with the group.
DR. GORDON: Let's move on to 2.2. How does this seem to
everyone? Dean?
DR. ORNISH: Again, I think it is great, but I would just
expand it to explicitly say that the CMS, which is what used to be
called HCFA, be encouraged to fund demonstration projects in this
area.
DR. GORDON: Then you would add, for those that are safe and
effective, you would want CMS ?? that would be a second sentence?
Again, it is following the principle of evaluation first and
demonstration second.
DR. ORNISH: Yes. Well said.
DR. GORDON: Okay. Does that make sense to everyone?
MS. AXELROD: Do you want to limit it to just CMS?
DR. ORNISH: No, but I think that I would mention CMS. You
might say "federal organizations including CMS" or something like
that. I think that is a good point.
DR. GORDON: And do want to say the second sentence that
would include the evaluation, once evaluated safe?
DR. ORNISH: Yes. Just the way you said it.
DR. GORDON: Do you want to put it into words?
DR. ORNISH: Why don't you do it?
DR. GORDON: "Those programs that prove to be safe, effective
and applicable should receive funding for demonstration projects."
DR. FINS: "By CMS and other federal organizations."
DR. GORDON: Does that make sense? Joe, are you okay with
it? Okay. Good. Everybody okay with this? I just want to make sure
fatigue is not setting in. Recommendation 3 on page 12: "Safe and
effective CAM practices used in the workplace to promote wellness and
health should be expanded." Page 12, let's just leave a moment so
people can read the action items, and then we will come back to the
recommendations.
SISTER KERR: Jim, excuse me. I think you made a mistake on
the last one.
DR. GORDON: A mistake on 2.2?
SISTER KERR: Just a little inclusion.
DR. GORDON: Okay.
DR. JONAS: Well, I just think if you are going to highlight
particular agencies that are kind of ripe and ready, and where this
applies, CMS is certainly one. Social Security is clearly another,
the VA is clearly another.
DR. GORDON: So, how would you like to word that?
DR. JONAS: I would simply add those on to the end. I would
simply add them on to the end instead of just Cms.
DR. GORDON: Okay. Corrine, do you have that?
MS. AXELROD: Yes.
DR. GORDON: Great. Can we move ahead now? Discussion about
the recommendation. Tieraona, is that a beginning point for
discussion?
DR. LOW DOG: Well, it's just my same old thing, that it's
safe and effective, but how do you know which ones promote wellness
and health, and how do you implement? I guess it goes more to your
action items. CAM wellness and prevention activities should be
included. I guess I would have had some of the same languages that
somebody should evaluate what these are, and those that truly do work
really need to be implemented.
DR. GORDON: Okay. George?
MR. DeVRIES: Some of the work we did on the reimbursement
side and, in fact, a conference call we had with the IRS and their tax
attorneys related to the ability for an employer to even offer
wellness programs and the tax deductibility of those programs. I
mean, we are making recommendations that the tax code doesn't even
allow. So I am concerned that we are making recommendations that you
need to ?? we need to change the tax code first.
DR. GORDON: This doesn't have to do with reimbursement here.
MR. DeVRIES: Well, but it is wellness programs that are
being provided for employees, and therefore that is a covered benefit
as would be interpreted.
DR. GORDON: I see. The intent of this recommendation may
be, first of all, backed up to the previous recommendations where we
are talking about evaluation for appropriateness and then
demonstration projects. You are also bringing up another issue. The
question I have is how do we want to reframe, if we do, Recommendation
3? So I am looking for some wording and some guidance.
DR. ORNISH: What about just the parallel of what we did
before? I mean, it is really the same issue, just in a different
arena.
DR. GORDON: Do you want to read how that would sound, Dean?
DR. ORNISH: I don't have the language from what we had
before, but the principle is that there would be some group that is
evaluating ?? why don't you do it, Tieraona?
DR. LOW DOG: Can't we do something like, "CAM practices
should be evaluated to determine what role they may have in promoting
wellness and health in the workplace." CAM in Wellness and Prevention
DR. GORDON: One thing I do want to mention is that there is
a sizeable body of research literature on the use of many of these
approaches in the workplace, and that material, some of it was
presented to us, it was submitted in testimony. I am a little
concerned with always evaluating when we already have done a
tremendous amount of work in looking at the data.
MR. CHAPPELL: Jim?
DR. LOW DOG: Can I respond to that? I'm sorry, Tom. You
had your hand up.
MR. CHAPPELL: Jim, I feel that this recommendation needs to
be left alone. We are not talking about dictating to anybody here.
This is really just sort of encouraging our workplaces to adopt these
measures, and many of them already are, and, as you say, the
information is well along in terms of the cost?benefit relationship.
So I don't feel that we should be in the evaluation mode here.
DR. GORDON: Tieraona, yes.
DR. LOW DOG: When I look at evaluate, I guess because I
don't know how a lot of these things work, I would imagine somebody
like the Department of Labor or somebody evaluating the information in
a thorough and concise fashion, which then begins to allow, once you
have had an ?? this is not going out and doing more research; this is
evaluating the data that is already out there to determine what does
it show. My own feeling is that is the only way tax codes and other
things are ever going to be impacted is if you have the relevant
federal agencies do a formal evaluation, and that is the process to
begin to move it in, because small companies, if they don't have tax
incentives, they may not have the infrastructure or the money to be
able to implement these. So it just seems like it is a step?wise
progression, not doing more research, just evaluating what is out
there.
DR. GORDON: Dean.
DR. ORNISH: Yes, just briefly, I think this is another
example of the bigger issue, which is that there are certain of us
that want to just get in there and say, it is time to do it, let's get
it done and let's quit screwing around, and we know enough already. I
think that what Tieraona and I ?? I am speaking for you, so correct
me if I am wrong ?? are saying is that, yes, listen, I understand
those feelings. I have been dealing with Medicare for seven and a
half years, it is incredibly slow and tedious and frustrating, but in
terms of what is going to provide the most lasting change, it may be
that if we take it a little slower, that we ultimately be more
effective. That's all.
DR. GORDON: Let me offer another perspective, that there
already have been hundreds of worksite wellness programs. What we are
suggesting here is that perhaps some of these demonstration projects
might take ?? this might be a way to mediate ?? take place at the
federal level. It just seems retrograde. If we know the information
and there have been reviews of the literature again and again, aren't
we ready to at least recommend demonstration programs? That is my
perspective. Yes, Joe.
DR. FINS: We are not writing this for the true believers,
and you are going to get a lot further along by setting up a step?wise
process than by trying to push this forward. You believe it, this is
your issue, okay? It is not my issue and it is not the issue of a lot
of people who are going to be skeptical about this. There is utility,
there is value, and it should be studied, and the difference between
doing workplace studies and implementing it in the context of a
federal program, it is another level of complexity, and that I think
is what Dean and Tieraona are trying to say.
DR. GORDON: Let me just respond very briefly and then call
on George and Tieraona. This is, actually, not particularly my issue,
number one. What my issue here is, and this has concerned me at times
and other recommendations, too, is that we have heard a tremendous
amount of testimony, we have had a great deal of reviews of the
literature on certain subjects presented, including this particular
subject, and what I am wondering ?? I am just raising it as a
possibility ?? is whether or not we want to talk just about evaluation
and then demonstration programs or are, at some point, we ready to
have demonstration programs? That is my question, and I leave it in
the air and leave it up to other people, to George and then Tieraona,
to continue.
Also, I want to add that we need to come to a conclusion about
this pretty soon.
DR. LOW DOG: Okay. What we are saying here is safe and
effective CAM practices, and what I would like to point out is that
much of the research that has been done on wellness programs have not
been even primarily CAM practices. They have been weight reduction by
Weight Watchers programs in large manufacturing companies ?? just
reviewed that ?? safety belt use, tobacco cessation, and that has also
been by policies that have been made about smoking on jobsites. A
number of these proven or that have been involved in these wellness
promotions have not been what we are calling CAM practices. What we
are saying here, though, in this recommendation is that we want CAM
wellness and prevention activities to be included in these programs,
and what I am saying is that we need to evaluate which aspects have
been shown to be effective and to reduce morbidity, mortality, promote
health, promote wellness, and then demonstration projects should be
done on those to see how they impact.
DR. GORDON: Tieraona, how would you like to reword this? I
think it is time for us to come to some kind of conclusion. We have
had plenty of discussion.
DR. ORNISH: Can we hear from George, though?
DR. GORDON: George?
DR. ORNISH: George knows more about this than anybody.
DR. GORDON: George, go ahead.
MR. DeVRIES: You know, my own experience, working with
employers, Fortune 1000, is that most of them are convinced that there
is value. Really, I think you need a 3.3 here. I mean, the tax code
issues are so pervasive here that we minimize their impact, and the
reality is, is if those were fixed, the market would drive this.
There is such interest in wellness programs, it would not ?? I think
the market would drive and would move so much more quickly ahead of
really some of the solutions we are talking about, and I think a 3.3
is about fixing the tax code.
DR. GORDON: Okay, George, but what would you do with 3.1 and
3.2? I am looking right now for a way, taking into account the
discussion, a way that we can come together around a recommendation
and action steps.
MR. DeVRIES: I support Dean and Tieraona with more of a
stepped approach which says evaluation, demonstration projects, and
implementation.
DR. GORDON: Can you give us the wording for that, one of the
three of you, or anyone else, for that matter?
DR. LOW DOG: Some federal body somewhere, somehow, should,
and then we go ?? well, it is "CAM practices should be evaluated to
determine what role they may have in promoting wellness and health in
the workplace." Then I would suggest that those CAM practices found
to do this, to promote wellness and health in the workplace, that a
demonstration project should be done to show the cost effectiveness,
et cetera, and then I think there does need to be an issue in here
about the tax code, that once these steps have been done, that the tax
incentives, tax codes ?? and you would know the language better than
me, but it seems to have an organized approach.
DR. GORDON: Okay. Joe first, Joe Fins, and then Effie, and
my question is whether 3.2 could not be expanded to included your
point about the tax code. So Joe first.
DR. PIZZORNO: I was totally with you all the way, Tieraona,
until the last part about the proven part. As you have noted,
wellness and health promotion programs have already been documented to
be efficacious. You covered wellness programs. We need to deal with
that tax issue. So I think we should have a 3.3 which says that for
proven wellness programs, wellness and health promotion programs, we
need to modify the tax code to deal with as George has said. We
shouldn't say "CAM" in front of it; we should say any of them that
have been proven to be effective should be included.
DR. LOW DOG: Yes, that sounds good. George would have to
have the language for that.
DR. PIZZORNO: We need the language from you, George, what it
should say.
DR. GORDON: Okay. I'm sorry, Effie.
MR. DeVRIES: I don't think the issue on the tax code is
actually incentives as much as it is disincentives, removing the
disincentives.
DR. PIZZORNO: Removing the disincentives.
MR. DeVRIES: Just to allow an even playing field.
DR. GORDON: While you are working on that, Effie and then
Joe, please.
DR. CHOW: I think the qualification of "safe and effective
CAM practices" as we have done in all the others, and it is not only
implicated but stated in all the others that there has to be an
assessment for its utilization in the workplace, and for the past 25,
30, 40 years, the whole aspect about wellness in the workplace has
been developing and there is lots of data ?? Ken Pelletier, you know,
his book and all that. I think we are really talking a turtle
position and really going back when we then talk about these steps,
because they will need to develop these steps of evaluation. If they
are not sure, they have to research into what is safe and effective.
So I recommend that this remains the same as it is.
DR. GORDON: Joe.
DR. FINS: You know, we have heard no testimony on the tax
issue at all. It was an issue that arose last time, I guess in
December when you sent that e?mail, and I think we are basically two
steps ahead of ourselves: (1) we have to have the demonstration
project; (2) we have to approve impact; and then (3) we have to decide
whether or not there should be a tax break, and we have to recognize
there is a deficit, there is scarcity. A tax break means that less
dollars will be coming into the federal government. The question is,
do you want to spend dollars on this, something yet to be proven by
demonstration projects, or do you want to spend it on bioterrorism or
on the military or benefits for soldiers? I mean, these are questions
that we heard no testimony on, and I think it is incredibly premature.
DR. GORDON: Dean.
DR. ORNISH: I am a little bit different than that. I think
that, as Jim indicated, there is a tremendous body of evidence that
worksite wellness programs do have cost benefit, that they affect
everything from absenteeism to health claims to whatever, to even
sabotage on the job. So I think that when I am talking about doing an
evaluation, it is more along the lines of what Tieraona said. It is
not that we have to start doing a whole lot of new demonstration
projects, but somebody simply needs to sift through the evidence and
to make an analysis and say, okay, these things seem to work, let's
move forward with them. I do think that giving tax breaks makes
perfect sense. If somebody evaluates this and they found that it is
going to save more money than it is costing, then it doesn't take
money away from other resources if there is enough data now to make
those kinds of decisions, and I would defer to George on that, who
probably knows more about this than anybody.
DR. GORDON: Corrine had a point of information, I think,
here.
MS. AXELROD: Yes. Two things. One is on the evaluation
part, in the previous recommendations, it has been federal funding of
these evaluations. So my question to you is, do you want this to also
be federal funding when, just to point out, businesses are already
doing quite a bit of this? So I just need clarification as to whether
this is also federal funding of evaluations for worksite wellness
programs. Then also, if we do decide to put in language about tax
stuff, I would ask your indulgence that I can work out the language
with Maureen so it is consistent with what is in Coverage and
Reimbursement.
DR. ORNISH: If you are asking me, I am saying federal
funding of ?? she was looking at me. I thought you asked that to me.
DR. GORDON: George is next and then Dean.
MR. DeVRIES: Just in terms of the tax issues, you know, and,
Joe, I apologize, it did come up towards the end and we didn't have
someone in here to testify, and it is really not an issue of saying ??
we are not looking for tax credits or tax incentives; we are looking
for an even playing field, so that when an employer includes wellness
programs in their employee benefit plan, they can deduct the cost of
those programs just like they would deduct costs related to their
hospital or physician benefit plan. So it is just an equal playing
field. I will just read very quickly in the Reimbursement section,
and it may make sense to add this as a 3.3, but the recommendation
under Reimbursement is, "Congress and the Executive Branch should
amend the federal tax code to include CAM and wellness in the
favorable tax treatment of health benefits granted to employers."
Even playing field. That is all the recommendation is. Right now, it
is excluded. It is excluded. An employer cannot deduct those
expenses, it is not a deductible expense to them, and the employees,
basically those additional benefits are treated as compensation, and
so they would have to show on their 1099.
DR. GORDON: Do you have a question on that, Joe?
DR. FINS: I think we will come back to it in the Coverage
and Reimbursement section.
DR. GORDON: Okay. Tieraona. And we need to come to a
conclusion here with No. 3 and with the action items.
DR. LOW DOG: Fine. I believe there should be an evaluation
done. I think that if you don't do an evaluation, you have no body to
take ?? there is no body of the data. It is just scattered all over
the place. It needs to be in a particular logical format so that the
appropriate agencies then ?? because you are asking here for federal.
If all you want to say here is that ??
DR. GORDON: Tieraona, can we have wording, please? Because
I think we are ready for wording.
DR. LOW DOG: I already have given you the wording about
three times that I have suggested.
DR. GORDON: Could you do it once more, please?
DR. LOW DOG: Oh, Jim. All right. Let me see.
DR. GORDON: I defy anyone here to repeat from memory what
you said before. So please read it. Humor us.
DR. LOW DOG: "CAM practices" ??
DR. ORNISH: "CAM wellness and ??
DR. GORDON: Go ahead. Say it.
DR. LOW DOG: You just go right ahead, Dean.
DR. GORDON: Dean, do you want to do it?
DR. ORNISH: I am just repeating what she said. "CAM
practices used in the workplace should be evaluated to determine their
applicability and cost effectiveness. Those that are found to be
beneficial should be included in federal worksite wellness and health
promotion programs and should receive" the tax language that you
talked about. Corrine, to answer your question, which I thought was
directed to me, that the federal government should pay for that
evaluation, again, not in the form of doing new demonstration
projects, but just sifting through the data that is there. Finally, I
was just curious. Tom, you have a lot of experience working with
corporations. I was curious about your perspective on all this.
MR. CHAPPELL: Corporations are just going ahead and doing
it, because the benefit, it helps improve health, increase motivation
and just performance overall by the individuals. So any business is
interested in improved performance and these things do it. We are not
talking, however, about the private businesses here, as I understand
it.
DR. GORDON: Right.
MR. CHAPPELL: We are talking about incorporating these into
federal workplace settings. I just think that both concerns, whether
we are taking a turtle?like position or whether we need to come to
with a light and simple way of assessing beneficial methods, I am all
in favor of the assessment process, but we just have to be simple
about it and not put it into some bureaucratic process. That is what
I want to try to do, is keep it out of a bureaucratic process.
DR. GORDON: Don.
DR. WARREN: Tieraona, did Dean's ad lib say exactly what you
were going to read from your statement?
DR. ORNISH: I might take offense to that.
DR. WARREN: That is what you were asked to do and I would
like to find out what the actual statement is.
DR. LOW DOG: "CAM practices should be evaluated to determine
what role they may have in promoting wellness and health in the
workplace." That was the first recommendation ?? and when I mean
evaluate, just take the data that is there, don't do more research ??
because I don't think that you can have 3.1 without that. CAM
wellness and prevention activities, how would you know which ones to
include?
DR. GORDON: Then read 3.1, please, after that, as you would
amend it, then.
DR. ORNISH: Those that have been found to --
DR. LOW DOG: That's right, Dean. Take it away.
DR. GORDON: Please, Dean, go ahead.
DR. ORNISH: Okay. So she says, "CAM practices should be
evaluated to determine what role they may have in promoting wellness
and health in the workplace. Those that have been found to be
beneficial" ?? you don't even have to say safe and effective, just
beneficial ?? "should be included in," the rest of the sentence.
DR. GORDON: "In federal worksite wellness and health
promotion."
DR. ORNISH: Yes.
DR. GORDON: Okay. So, are we clear? That is the
recommendation, revised recommendation, and that is Recommendation No.
3.1. Are we okay with those? Yes? Good. Let's move on to 3.2. We
have 3.2 as it is here. Are we okay with what we have here and do we
want to add something about tax code and incentives? Yes, Dean.
DR. ORNISH: Well, I like what it says. I would just again
refer back to those that have been found to be beneficial.
DR. GORDON: Okay. Include "CAM wellness and prevention
activities that have found to be beneficial." Are we okay with that?
I want to take this step?wise. Yes? Okay. Charlotte, George and
Joe.
SISTER KERR: George, I was just wondering if, in 3.2, when
you put "should develop incentives," could you just include in there,
right there or in parentheses, "to include reform of tax codes" and
then not have to do a 3.3.
DR. GORDON: Okay. George?
MR. DeVRIES: The 3.2, you certainly could reference tax code
changes to create that equal playing field. Looking at the wording in
2.98, "to decrease insurance premiums," the relationship between the
insurance carrier health plan and the employer is that of two
corporations, and we really can't mandate a reduction in insurance
premiums. So I don't see how we quite do that.
DR. GORDON: What are you suggesting, George?
MR. DeVRIES: You could put a period at the end of
"coverage." If you really are seeking something around decreasing
insurance premiums for employers as an incentive, then you are looking
at not just leveling the playing field from a tax standpoint, you are
looking at creating some kind of tax credit or rebate to the employer
for covering it, and that is a whole different thing.
DR. GORDON: So would you recommend putting a period at the
end of "coverage" and adding the "develop incentives including" ??
what would you say about tax?
MR. DeVRIES: Yes. I mean, I would put a period after
"coverage" and say ??
DR. GORDON: You would include Dean's wording.
MR. DeVRIES: Right. Absolutely.
DR. GORDON: Dean, what was your wording again?
"Beneficial"?
DR. ORNISH: "Those that have been found to be beneficial
should be included," blah, blah, blah.
DR. GORDON: Okay. To include beneficial, CAM wellness and
those that have been demonstrated to be beneficial. Okay. George,
what would you add there?
MR. DeVRIES: Well, I think the sentence we came up with in
the Reimbursement section would fit in nicely here and I don't think
it hurts to repeat it because I think it is such an important issue.
Maybe we could drop, I think it is 2.3.
DR. GORDON: All right. Corrine and then Joe.
MS. AXELROD: Reforming the tax code would have to be done by
Congress, so you really kind of need to be separate. There could be
other incentives, non?Congressional incentives, but when you are
dealing with the tax code, that has to be Congress.
DR. GORDON: Joe, do you have a comment?
DR. FINS: No.
DR. GORDON: Tom?
MR. CHAPPELL: I agree with George that a period after
"coverage" is appropriate because I don't think we want to try to get
into the complexity of decreasing insurance premiums. So I would drop
that right out of the picture and leave the subject there. Now, with
regard to the tax code, George, do you think we even have to approach
that subject here?
MR. DeVRIES: Well, it is such an important thing and we have
one very simple sentence under Reimbursement we could drop in here.
The sentence simply is, "Congress and the Executive Branch should
amend the federal tax code to include CAM and wellness in the
favorable tax treatment of health benefits granted to employers." You
drop that sentence in.
DR. GORDON: Joe is next and then Dean and Charlotte, and
let's keep moving on this one.
DR. FINS: I just want to say for the record that the fact
that people include CAM in benefit packages doesn't necessarily mean
that they are effective and that there are economic rationales for
doing that. We heard from James Dillard from Oxford talking that for
every CAM benefit that was included in the Oxford package in New York,
there was an economic benefit to Oxford because they were able to
recruit healthy people who didn't use other health care resources.
One could also make the argument that corporations will
provide these kinds of benefits in lieu of improved salaries or other
kinds of conventional health benefits.
So I don't think the fact that corporations want to do this ??
corporations may be doing it for their own less?than?altruistic
reasons.
DR. GORDON: Corrine. Maureen?
MS. MILLER: I just want to bring up this. You know, I think
it is a good idea, but the complexity is the way the tax law works
with employer benefit programs affects all employees of an employer,
and it just dawned on me that these wellness programs are probably
only going to target subsets. So it is not going to be an easy thing
to incorporate into the current tax laws that exist. Maybe people
have already begun working on this and have a way to amend the law,
but it is a very different kind of benefit program than what employers
currently have for their HMOs and PPO plans.
DR. GORDON: Dean?
DR. ORNISH: Real quick. I think number one is the fact that
it may require an act of Congress to change the tax laws shouldn't
keep us from recommending something. I mean, there are a lot of
things we recommend that require people to do things differently, so I
wouldn't worry about that so much. The second is, how about changing
the last part of that sentence. Instead of putting a period after ??
well, let me just read it. It says, "Federal agencies in conjunction
with the business community should develop incentives for employers to
include CAM wellness and prevention activities that have been found to
be beneficial in their workplace wellness programs and health coverage
and to incentivize those that participate in them. For example," and
you could talk about the tax issue.
DR. GORDON: I would like final wording and I would like a
coming together on it. Dean, you sort of left that last part a little
vague.
DR. ORNISH: No, no. Instead of putting a period after
"health coverage," say "activities that have been found to be
beneficial in their workplace wellness programs and health programs,
and to incentivize those that participate in them. For example," and
then we can talk about the tax code language that George mentioned.
DR. PIZZORNO: "Incentivize" is already earlier in the
sentence.
DR. ORNISH: Oh. You are right. I stand corrected.
DR. GORDON: It sounds like we have agreement up to
"coverage" at this point. The issue that is still pending here is
whether there should be a sentence about the tax code, and I would
like to come to closure on that quickly because we have a major
recommendation still to do before lunch. David.
DR. BRESLER: Just quickly, I think George's point is really
well taken that basically the way the tax code is now, it
disincentives, and that is something that we have to be aware of.
There is an abuse that the federal government has inadvertently put on
employers that they cannot offer wellness programs to employees
without it being taxable, and I think we need to fix that.
DR. GORDON: So I would like some wording here that we can
make a decision. We have had a lot of discussion. George, let's hear
it again. Everybody, please, if you get impatient with me asking for
the wording again, wording that has been discussed 10 or 15 minutes
ago is not at the front of everyone's mind, so we need to hear it
again. We all need to be clear what we are agreeing on or what are
not agreeing to. So be cool. George.
MR. DeVRIES: "Congress and the Executive Branch should amend
the federal tax code to include CAM and wellness in the favorable tax
treatment of health benefits granted to employers."
MR. CHAPPELL: I buy that.
DR. GORDON: Okay. Julia and Joe have comments on that.
MS. SCOTT: I think it should be a separate recommendation,
and not tacked on.
DR. GORDON: I'm sorry, what, Julia?
MS. SCOTT: That this should be a separate action under
Recommend No. 3.3.
DR. GORDON: So it should be a 3.3.
MS. SCOTT: Right.
DR. GORDON: Okay. Let's look at it as a 3.3. Joe, you want
to say something?
DR. FINS: Yes. I can't sign on to it the way that it is,
and it might be worth looking at it and looking for the fiscal
implications. I mean, we are recommending a change in the code. Even
to neutrality means a change in revenue. Whether or not it does
improve revenue, tax receipts, because corporations would be more
profitable, would be paying more taxes on the other end, those are all
open questions. We don't know the scope of how much money this would
mean for the federal government.
I think it is premature to say we should alter it at this
stage when only some members of the subcommittee had any kind of
conversation with Treasury. The whole Commission had no testimony on
this issue, and there has been no data that has been presented to us
in the aggregate. I think it is premature.
DR. GORDON: Other discussion on this?
MR. DeVRIES: You know, the issue is and I would just suggest
I think Congress and the Executive Branch will go through this process
and GAO will go through a calculation of the cost, and it is
ultimately going to be Congress' decision of whether they do it or
they don't do it. I think we need to be highlighting the issue in
this report and saying it is an issue, it is a barrier to the
promotion of these types of programs.
DR. GORDON: Joe, is there a way you might reword it so it
would be more acceptable?
DR. FINS: I don't have it written down here, but, I mean, if
it is laid out as an issue in the text and then you say something to
the effect that an economic impact ?? that should be analyzed. The
question should be analyzed for its economic implications, because
right now we are making a recommendation that we really don't have the
kind of sound base to make that recommendation upon as we do for other
things. We were talking before about whether or not supplements
should be registered, an issue that we know far more about. We
suggested the FDA have a feasibility study.
MR. DeVRIES: Could I suggest a different language? Could I
suggest different language? Just because I think there is value in
maybe saying, "Congress and the Executive Branch should evaluate
amending the federal tax code to include CAM and wellness that has
been demonstrated to be beneficial in the favorable tax treatment of
health benefits granted to employers."
DR. GORDON: Ken has some point of information.
DR. FISHER: This is a question. You have been using the
term "recommendation." This is an action item. Does it stay an
action item? Somebody said it should be converted into a
recommendation.
DR. GORDON: No, it was another action item.
DR. FISHER: It stays as an action item.
DR. GORDON: Yes.
MR. CHAPPELL: I support this revised language very strongly
because it accomplishes everything that we are all interested in.
DR. GORDON: Let's hear the revised language once more so
everyone can get it down.
MR. DeVRIES: Okay. "Congress and the Executive Branch
should evaluate amending the federal tax code to include CAM and
wellness that have been proven beneficial in the favorable tax
treatment of health benefits granted to employers."
DR. GORDON: So it is essentially an evaluation rather than
?? it is the same format we have been following.
MR. DeVRIES: Right.
DR. FINS: If the text could also say that, "We appreciate in
times of scarcity that resources are limited, that this would ??
DR. LOW DOG: Joe, I ??
MR. DeVRIES: You know, we do have text on the tax code on
page 17 in the Reimbursement, we have a paragraph. It just kind of
talks about the issue more.
DR. GORDON: Joe is asking if we could have something in the
text to address this.
DR. ORNISH: But, Joe, the Congressional Budget Office, any
time that any change in the tax code is done, will always look at the
implication and whether it costs money or not.
DR. FINS: I think I have achieved my goal with the
evaluation.
DR. GORDON: Thank you. Are we all comfortable with this
now? Good. Let's move on to No. 4. This is the last recommendation
and action item in this section.
Recommendation 4: "Public, private and federal health care
delivery systems and health?related programs should incorporate safe
and effective CAM practices into their services to help promote
wellness and health." Please read the action items before commenting
so we can have a clear sense of this territory.
[Pause.]
DR. GORDON: Let's take a look at the recommendation and then
look at the action items. Who would like to speak? Dean?
DR. ORNISH: It is just the same issue all over again.
DR. GORDON: Since it is the same issue all over again, do
you have a wording that might fulfill some of the same goals that you
and Tieraona articulated previously?
DR. ORNISH: I would just use parallel language to what we
did before.
DR. GORDON: Parallel language about evaluation first and
then programs that are beneficial then be incorporated.
DR. ORNISH: Right.
DR. GORDON: Proven to be beneficial.
DR. ORNISH: And again to make clear that the evaluation
could include new demonstration projects, but is primarily to look at
the existing data and then decide where we need to get more
information, whether it is demonstration projects or more primary
research, and then talk about how to implement it.
DR. GORDON: Okay. Is this a reasonable ?? let me point out
that 4.5 is somewhat different than 4.1 through 4.4. What I would
like to do is, if we look at the recommendation, are we changing the
recommendation or are we simply changing the action items? So if we
can look at the recommendation first and then look at the action
items, that would be helpful. Joe.
DR. FINS: I think with that sort of preamble that we have
incorporated along the way, 4.1 to 4.4 are fine. Four?five has
actually already been addressed in the Education section.
DR. LOW DOG: Uh?uh.
DR. FINS: Well, I believe we had a discussion about that
yesterday.
DR. GORDON: I don't think it was addressed in ?? it is not
addressed in this. We had a discussion, but that was more in the text
and it was addressed in passing in the Education section but not with
this explicitness, and I think the feeling was that it needed to be
addressed in the Wellness section just the way other recommendations
needed to be addressed in the Wellness section and in the Education
section. But let's deal with 4.1 through 4.4 first and then come to
the last one. Joe, repeat what you were saying about the
recommendation in 4.1 through 4.4.
DR. FINS: I think it is the same thing we have just been
through with their predecessors with the same kind of preamble.
DR. GORDON: Is everyone comfortable with that? Charlotte?
SISTER KERR: With that. I want to speak to 4.3. Is it
appropriate now?
DR. GORDON: I want to get this general principle established
and then we can look at some of the specifics in the action items.
Tieraona, are you comfortable with this?
DR. LOW DOG: Yes. Like in 4.1, you could just take out
"incorporating" and you could put "for evaluating the potential role
for CAM wellness and health promotion activities" into these things.
So you just can take out "incorporating," which is an advocacy
position, just say, "for evaluating the potential role for CAM
wellness and health promotion activities."
DR. GORDON: As I remember, in the previous recommendations,
the first part was evaluation and then the second part had to do with
incorporation of those that were appropriate or of those that were
beneficial. So there were the two steps in each of these. Are you
okay with that? Is everyone okay with that? Okay. So we have the
general principle, and, Corrine, you can work out the wording on that.
Let's go to any specifics in 4 from the recommendation through 4.4,
and then we can move on to 4.5. Charlotte began with 4.3. Please.
SISTER KERR: No, 4.3 already included the evaluation concept,
and I wrote this one and I had wanted to be sure that this was about
wellness, health promotion, chronic illness. I want to call your
attention to the word "end?of?life programs," and this is just a word
choice. I have been advised by a couple of people for consideration
that sometimes this end of life, even though I think those are really
the more common words used now, sometimes some people feel it is a
code for kind of Kevorkian?type, you know, assisted dying, so
"hospice" might be a better word, but I would like the group to just
contemplate that.
DR. GORDON: Joe, do you have a thought about that?
DR. FINS: No. I mean, I don't think that is accurate. I
mean, people talk about end?of?life care and the program which takes a
stand against assisted suicide uses this phraseology all the time.
But, I mean, I think we might say "end?of?life program such as
hospice" to clarify.
SISTER KERR: That is good. I like that. Thank you.
DR. GORDON: End of life, not ending life. All right.
"End?of?life program such as hospice." Okay. Good. Anything else on
4.1? Dean, you had something, 4.1 through 4.4?
DR. ORNISH: No, 4.5.
DR. GORDON: Okay. Are the okay with 4.1 through 4? Joe, go
ahead.
DR. FINS: We talk about health promotion and wellness in the
context of the dying. I mean, I think there is a lot of living to be
had while one is in the process of dying, and that is really the
hospice philosophy, but I think somebody could just pick up this
recommendation and say it doesn't make sense. So I am wondering if we
could incorporate some other kind of language.
DR. GORDON: Would you want to say "end?of?life care" here?
DR. WARREN: How about add "quality of life"? After "health
promotion," "quality of life."
MS. SCOTT: Excuse me. Are we back on 4.3?
DR. GORDON: No, 4.4. Joe's concern is with the word
"wellness" going together with "the dying."
DR. FINS: Wellness and health ?? I mean, if you are dying,
you are not, by definition, well. So "incorporating CAM quality of
life promotion activities" instead of "wellness and health," because
it just doesn't quite follow editorially in this context.
DR. GORDON: I think maybe we can distinguish, though,
between the dying and the other groups, because it may be appropriate
for the other groups.
DR. FINS: Right.
DR. GORDON: Why not just "serving the aging and those with
chronic illness"? I mean "aging," that covers most of those.
DR. FINS: Well, I think we want to also cover those who are
in the process of dying.
DR. GORDON: So let's separate that out as a separate group.
DR. FINS: It is also somewhat true for 4.3, but, I mean, I
think you want to say, "The impact of CAM practices ?? in fact, if you
just took out "wellness, health promotion" in 4.3, so "The impact of
CAM practices on those with chronic illness and in end?of?life care
programs," et cetera, et cetera, and then in 4.4, you say
"incorporating CAM activities in the Nation's hospitals" without
getting into the wellness and health, because it kind of confuses it
in this context.
DR. GORDON: So how would 4.4 read?
DR. FINS: "For incorporating CAM activities in the Nation's
hospitals and long?term care facilities and in programs serving the
aging, the dying, and those with chronic illnesses."
DR. LOW DOG: Can I try?
DR. FINS: Yes.
DR. LOW DOG: "The Secretary of Health and Human Services
should establish a task force to evaluate the impact of CAM practices
on health promotion and quality?of?life issues in the Nation's
hospitals and long?term care facilities and in programs." You have
sort of taken care of health and then also quality of life.
DR. GORDON: Okay. Is that all right? So that way, you can
apply quality of life to the dying and health promotion to the ??
everybody okay with this? Let's look at 4.5.
MS. AXELROD: Jim, before we go on to 4.5, I need some
clarification on 4.3. Four?point?three currently calls for a
demonstration project, and we have been talking this whole session
about doing evaluations ??
DR. GORDON: Right.
MS. AXELROD: ?? and then, if appropriate, do a demonstration
project. So I just want to be clear. Are we adding evaluation to
this one?
DR. GORDON: I believe that is what people were saying. Is
that correct?
DR. FINS: Yes.
DR. GORDON: Okay. Let's go on to 4.5. Veronica?
DR. GUTIERREZ: One item. I think to be consistent we should
add the term "quality of life" to 4.3. "Funding should be provided
for demonstration projects to evaluate the impact of CAM practices on
wellness, quality?of?life issues, health promotion," et cetera.
DR. GORDON: Is that okay with everyone? Okay. Let's go to
4.5. Dean.
DR. ORNISH: I like 4.5. I think that it is important for
people to experience these techniques themselves, both for their own
development and also because it is ?? you know, certainly medical
training is such a burn?out experience anyway. I think the best way
to really understand these is to experience them. So I think that is
a good recommendation.
DR. GORDON: Okay. Other comments? Don?
DR. WARREN: I have got a 4.6.
DR. GORDON: Let's deal with 4.5 first. Four?point?five.
Joe?
DR. FINS: I think one of the things that we were careful not
to do in the Education section was have educational mandates. So we
should have this "should consider," which I think we agreed to about
education yesterday. And students should have the option, it
shouldn't be required, but they should have the option of
participating. So "should offer" not "include the teaching of
self?care." "Should offer."
DR. GORDON: "Should offer" rather than ?? Dean, I want you
to hear it. Joe wants to substitute "offer" rather than "include."
DR. ORNISH: "Offer" is fine.
DR. GORDON: I think we are way beyond ?? Joe, I think this
is one of those points where it is already being considered
everywhere.
DR. FINS: I know that. Then the second point here is I
think students should have the option of opting in or out.
DR. ORNISH: Yes, I agree with that, actually.
DR. GORDON: Well, why not "should offer the teaching."
DR. FINS: Right.
DR. GORDON: Okay. If we just have "offer" instead of
"include"?
DR. FINS: Yes.
DR. GORDON: Okay. Four?point?six. Don?
DR. WARREN: "Practitioners in federal health programs should
have the latitude to incorporate CAM modalities, services and products
??
DR. GORDON: Would everybody be quiet, please? We have a new
action item and I want everybody to make sure we hear it the first
time around.
DR. WARREN: I just thought I would throw it out.
"Practitioners in federal health programs should have the latitude to
incorporate CAM modalities, service and products into their individual
protocols as they deem clinically appropriate."
DR. LOW DOG: I am sorry, Don. What was the very beginning
of the sentence?
DR. WARREN: Four?point?six.
DR. LOW DOG: The next beginning.
[Laughter.]
DR. WARREN: Oh, okay. "Practitioners in federal health
programs should have the latitude to incorporate CAM modalities,
services and products into their individual protocols as they deem
clinically appropriate."
DR. FINS: That is the scope of practice. I mean, this is
not this section. I mean, I think what we should do is, when we get
to Access and Delivery, that kind of issue will definitely come up.
DR. GORDON: Because this is really, the focus here is
wellness and I think we need to reserve that to Access and Delivery,
okay?
DR. WARREN: Okay.
DR. GORDON: Everyone with me on this? Okay. Any major
textual issues aside from the ones that we have dealt with? Tieraona?
DR. LOW DOG: There are lots of them, so I don't think we
need to go through them, but ??
DR. GORDON: Do you want to make a general statement, then?
DR. LOW DOG: I think that throughout this document, we are
preaching CAM doctrine, and it needs to be far more balanced.
Teaching safe and effective CAM practices from kindergarten through
grade 12? What is that? St. John's Wort, you should take it for
your depression? I mean, I don't like it. I think there are a lot of
problems with it.
MS. AXELROD: Tieraona, I will change the text in accordance
with the changes and the recommendations, so I don't think we need to
go through each one of those because they all correspond.
DR. GORDON: Okay. Are you satisfied with that?
DR. LOW DOG: I will be satisfied when I see it.
DR. GORDON: When you see it, but you are satisfied with
that, Tieraona, as a procedure?
DR. LOW DOG: Yes.
DR. GORDON: Okay. Anything else on the text, any specific
issues? All right. We have made it through. Wayne?
DR. JONAS: Again, this is just word consistency. Through
most of the document or a lot of places in the document use terms like
"CAM activities and approaches may have an important role," but then
there are other places where you flip it over and say "do have" or
"could have" or "do contribute." For example, page 6, line 148 where
above it, it is "may," below it ?? in the upper paragraph, it is "may"
and below it, it is "could contribute," which assumes that we know it
could contribute. I think those should be made consistent and
probably changed to "may" because, again, I would emphasize the
evaluation nature of this particular area.
DR. GORDON: Okay. Is everyone on board? Tieraona, are you
on board with this? Okay. Everyone okay with this, changing the "do"
or "should" to "may"? Thank you, Wayne. We are in agreement.
We will adjourn for lunch and we will come back at 1:15
promptly. Thank you very much. We will begin with Access and
Delivery at 1:15.
[Lunch recess taken at 1:15 p.m.] + + +
Top | Contents
CERTIFICATION This is to certify that the attached proceedings
BEFORE: White House Commission on Complementary
and Alternative Medicine Policy HELD: February 21-22, 2002
were held as herein appears and that this is the official transcript
thereof for the file of the Department or Commission.
DEBORAH TALLMAN, Court Reporter
|
|
|
|
|
