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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?
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